D4.2.1 ‘Standardisation and interoperability analysis’ · (AAIF), Ligia Prisaca Manesi (AAIF), Stefan Strömberg (NFT), Marlou Bijlsma (NEN), Rob ... Revision history Rev. Date

Competitiveness and innovation Framework

Programme

CIP-ICT-PSP-2012-6 325137

European Network fOr FALL Prevention, Intervention

& Security E-NO FALLS

Project Number: 325137

Acronym: E-NO FALLS

Title: European Network fOr FALL Prevention,

Intervention & Security E-NO FALLS

Call (part) identifier: CIP-ICT-PSP-2012-6

Start date: 28/01/2013

Duration: 37 months

D4.2.1

‘Standardisation and interoperability analysis’

Nature

1: R

Dissemination level2: PU

Due date: Month 19

Date of delivery: Month 20

Partners involved:

FHP Associação Fraunhofer Portugal Research

AAIF Fundatia Ana Aslan International, Romenia

NFT Nordforce Tecnology, Sweden (Task Leader T4.2)

NEN Stichting Nederlands Normalisatie Instituut (Deliverable Leader D4.2.1)

McR McRoberts, the Netherlands

SIV Siveco Romania (Work Package Leader WP4)

Authors: Liliana Ferreira (FhP), Ana Doscan (AAIF), Luiza Spiru (AAIF), Ileana Turcu

(AAIF), Ligia Prisaca Manesi (AAIF), Stefan Strömberg (NFT), Marlou Bijlsma (NEN), Rob

van Lummel (McR), Ghenadie Gandrabura (SIV)

1 R = Report, P = Prototype, D = Demonstrator, O = Other

2 PU = Public, PP = Restricted to other programme participants (including the Commission Services),

RE= Restricted to a group specified by the consortium (including the Commission Services), CO =

Confidential, only for members of the consortium (including the Commission Services)

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Revision history

Rev. Date Partner Description Name

0 2014-01-23 NEN 4.2.1 template Marlou Bijlsma

1 2014-01-31 NEN Preparation for meeting 5 feb in Delft

Marlou Bijlsma

2 2014-02-05 NEN Agreed new structure, chapter headings and responsibilities

All

3 2014-03-06 NEN Contribution chapter headings and index

NFT, AAIF, NEN

4 2014-03-31 NEN Chapters and comments from Vilanova meeting

5 2014-04-17 NEN Subchapter headings for comments to E-No falls partners

NEN

6 2014-06-11 NEN Chapters included for discussion at the telco on June 12.

SIV, AAIF, McR, FhP, NFT,

7 2014-06-16 NEN First draft for internal review

NFT, AAIF, FHP, NEN

8 2014-07-28 NEN For comments UPC Revised chapters NTF, AAIF,McRoberts, FhP, NEN and SIVECO

9 2014-08-04 NEN Draft for review E NO FALLS consortium

SIVECO, NEN

10 2014-08-21 NEN Update based on consortium/ partner review

NFT, AAIF, McRoberts, FHP, SIVECO and NEN

11 2014-09-01 NEN References updated AAIF, SIVECO, NFT, McRoberts

12 2014-09-04 NEN Final version Marlou Bijlsma

13 2014-09-08 UPC Final revision Jaume Romagosa

14 2014-09-08 UPC Final approval Andreu Català

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DISCLAIMER

The work associated with this report has been carried out in accordance with the

highest technical standards and the E-NO FALLS partners have endeavoured to

achieve the degree of accuracy and reliability appropriate to the work in question.

However since the partners have no control over the use to which the information

contained within the report is to be put by any other party, any other such party shall

be deemed to have satisfied itself as to the suitability and reliability of the

information in relation to any particular use, purpose or application.

Under no circumstances will any of the partners, their servants, employees or agents

accept any liability whatsoever arising out of any error or inaccuracy contained in

this report (or any further consolidation, summary, publication or dissemination of

the information contained within this report) and/or the connected work and disclaim

all liability for any loss, damage, expenses, claims or infringement of third party

rights.

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List of Figures

Figure 1. Proportion of state contribution to pensions ................................................................ 15 Figure 2. European pension expenditure ..................................................................................... 16 Figure 3. Retirees expenditure structure ..................................................................................... 16 Figure 4. The ADEQUACY challenge – Population (65+) living at risk of poverty or social

exclusion, 2011 ................................................................................................................... 18 Figure 5. At-Risk-of-Poverty Rate (65 years or more), 2011...................................................... 19 Figure 6. Severe material deprivation (65 years or more) by Gender, 2011 ............................... 19 Figure 7. Old-Age Population Dependency Rates vs. Pension System Dependency Rates in

Eastern European and Former Soviet Countries, Most Recent Year Available .................. 20 Figure 8. Attachment of the activity monitor .............................................................................. 37 Figure 9. Explanation of the report by the lung consultant ......................................................... 37 Figure 10. Cost of care per day ................................................................................................... 39 Figure 11. Clinical pathway COPD ............................................................................................. 41 Figure 12. HIC health Informatics .............................................................................................. 42 Figure 13. Fallers landscape ........................................................................................................ 43 Figure 14. Activity recognition process pipeline (Anguita, Ghio, Oneto, Parra, & Reyes-Ortiz,

2012) ................................................................................................................................... 46 Figure 15. ISO 9241-210 (2010) Human-centered design process for iterative systems ............ 52 Figure 16. PDS diagram .............................................................................................................. 55 Figure 17. Concurrent use landscape .......................................................................................... 73 Figure 18. Adoption of international standards in eHealth in WHO survey ............................... 77

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Table of contents

1. Abstract/executive summary ..................................................................................... 7

2. Introduction ..................................................................................................................... 8 2.1 Standardisation and Interoperability ......................................................................... 8 2.2 Standardisation and Interoperability Analysis in the Work Package ............. 9 2.3 Methodology ......................................................................................................................... 9

3. User perspectives ........................................................................................................ 11 3.1 Introduction ........................................................................................................................11 3.2 Elders perception about falling ...................................................................................11 3.3 Usability ...............................................................................................................................12 3.4 Accessibility ........................................................................................................................15

3.4.1 Affordability ............................................................................................................................. 15 3.4.2 Availability ................................................................................................................................ 21

3.5 Other stakeholders perspective ..................................................................................23 3.6 Conclusions .........................................................................................................................25

4. Clinical Perspectives .................................................................................................. 26 4.1 Introduction ........................................................................................................................26 4.2 ICT in Falls Prevention - Perspectives on Europe .................................................26

4.2.1 Telecare ...................................................................................................................................... 28 4.2.2 telehealth ................................................................................................................................... 28 4.2.3 eHealth ....................................................................................................................................... 28 4.2.4 Assistive Technology ............................................................................................................ 29 4.2.5 Smart Homes ........................................................................................................................... 29

4.3 Protocols and Clinical Guides in Falls Prevention ................................................29 4.3.1 Clinical Test for Falls Prevention .................................................................................... 30 4.3.2 Impact of Falls Prevention in Primary Care ................................................................ 31

4.4 Devices for Falls Prevention and Detection ............................................................33 4.4.1 Existing Devices ...................................................................................................................... 33

4.5 Romania Facts ....................................................................................................................33 4.6 Conclusions .........................................................................................................................34

5. Industrial Perspectives ............................................................................................. 36 5.1 Introduction ........................................................................................................................36 5.2 Market Analysis .................................................................................................................36 5.3 Technical Devices (Medical Device Directive) .......................................................39 5.4 Services .................................................................................................................................40 5.5 Standardisation and interoperability .......................................................................41 5.6 Conclusion ...........................................................................................................................43

6. ICT Research and Development Perspective ..................................................... 45 6.1 Research and development on falls and activity monitoring ...........................45

6.1.1 Current Technologies ........................................................................................................... 45 6.1.2 Smartphone Based Solutions on Falls and Activity Monitoring ......................... 46 6.1.3 Architecture and Common Standards for Mobile Solutions ................................ 47 6.1.4 Usability Challenges and Recommendations for Mobile Solutions ................... 48 6.1.5 OS Specific Guidelines .......................................................................................................... 51 6.1.6 Design Standards ................................................................................................................... 52

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6.2 Framework of the Portuguese National Health System ......................................52 6.2.1 Organization of Resources, Provision of healthcare and Funding ..................... 52 6.2.2 Portuguese Healthcare Data Platform – Plataforma de Dados de Saúde ........ 53 6.2.3 Architecture, Protocols and Data Protection .............................................................. 54

6.3 Conclusions .........................................................................................................................56

7. Regulatory Perspective ............................................................................................. 57 7.1 Introduction ........................................................................................................................57 7.2 Applicable EU Directives ................................................................................................57 7.3 Overview of EU Regulatory Framework for Medical Devices ...........................61

7.3.1 Current Regulatory Framework ...................................................................................... 61 7.3.2 Proposed Changes ................................................................................................................. 63

7.4 Two Alternative Regulatory Pathways to the Market for ICT Based Fall Prevention & Intervention Devices .........................................................................................63 7.5 Is the MDD an appropriate regulatory framework for ICT based fall prevention & intervention devices? ........................................................................................64 7.6 National Barriers for Deployment of Services/Products Resulting from falls ICT-based Solutions.......................................................................................................................65

7.6.1 Requirements for National Registration of Medical Devices ............................... 65 7.6.2 Requirements for Standards Compliance .................................................................... 66

7.7 Summary ..............................................................................................................................67

8. Standardization perspective ................................................................................... 68 8.1 Existing Standards in eHealth and mHealth............................................................68

8.1.1 Medical Record Standards ................................................................................................. 68 8.1.2 Messaging Standards ............................................................................................................ 71 8.1.3 Vocabulary Standards .......................................................................................................... 75

8.2 Use of Standards in ICT Solutions for Fall Prevention and Management .....76 8.2.1 Use of Standards in eHealth and mHealth ................................................................... 76 8.2.2 Which standards are used in the ICT based fall prevention solutions? .......... 81 8.2.3 Case Study Sona ...................................................................................................................... 81 8.2.4 Case Study Standardization Initiative Service Chain Social Care Alarms ....... 84

8.3 Conclusions discrepancy between existing standards and use of these standards in ICT solutions for fall prevention and management .................................85

9. Conclusions .................................................................................................................... 88

10. References .................................................................................................................. 89

11. Annex ........................................................................................................................... 96


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1. Abstract/Executive Summary

Effective use of technology for health can streamline processes as well as offering new ways

providing healthcare. eHealth and mHealth provide tools and solutions to improve health

systems and services, such as respecting the rights of the patient (giving them more information

about, and increased control over their health choices) and efficiently utilizing human, financial

and other resources.

The standardization of crucial aspects of eHealth and mHealth: interoperability, integration in

existing technical systems and organizational procedures, patient safety and privacy are

prerequisites for the development and deployment of ICT-based fall prevention and effective

intervention solutions for elderly people in Europe.

Standards define consistent interfaces enabling the interoperability and exchangeability of

different components; they define safety requirements or permit service offerings to be

compared.

International and European standards are developed by ‘all parties concerned’ expert

committees an published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC or ETSI.

Standard documents are stakeholder consensus agreements of voluntary requirements and

recommendations. Standards only become mandatory if a law explicitly requires compliance

with a certain standard or set of standards.

In addition to these official standards there are also “industry standards” or “de-facto

standards”, “publicly available specifications”, “pre-standards” or “application guides”. These

documents are developed and published by a large variety of committees, including the

European Commission, WHO, IEEE, IETF, OASIS, HL7 and Continua. Compared to official

standards, industry standards can often be developed and published faster since the rules for

public comment and voting may be simplified. Correspondingly, industry standards often play a

major role in fields where technology changes very quickly, such as Information and

Communication Technology (ICT) (AALIANCE2, 2013).

This report summarizes the findings of the E-NO FALLS project with regard to the analysis of

the use of standards and interoperability in the field of ICT solutions for fall prevention and

management. The issues and requirements relevant for ICT solutions for fall prevention and

management are presented from the perspectives of the different stakeholders:

- User perspective

- Clinical perspective

- Industrial perspective

- Researcher perspective

- Regulatory perspective

- Standardization perspective

Each of the chapters addresses one of the perspectives.

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2. Introduction

2.1 Standardisation and Interoperability

The standardization of crucial aspects of eHealth: interoperability, integration in existing

technical systems and organizational procedures, patient safety and privacy are prerequisites for

the deployment of ICT-based fall prevention and effective intervention solutions for elderly

people in Europe.

Standards define consistent interfaces enabling the interoperability and exchangeability of

different components; they define safety requirements or permit services to be compared.

International and European standards are developed by ‘all parties concerned’ expert

committees and published by standards bodies such as ISO, IEC, ITU, CEN, CENELEC or

ETSI. Standard documents are consensus agreements with voluntary requirements and

recommendations. Standards become mandatory when a law explicitly requires compliance with

a certain standard or set of standards. An example is the medical device market, where the EU

maintains an official list of “harmonized standards” (European Commission, 2013) which

requires compliance for every product placed on the EU market that falls within the scope of the

Medical Device Directive 93/42/EEC (chapter 7 of this report).

In addition to these official standards there are also “industry standards” or “de-facto

standards”, “publicly available specifications”, “pre-standards” or “application guides”. These

documents are developed and published by a large variety of committees, including the

European Commission, WHO, IEEE, IETF, OASIS, HL7 and Continua (chapters 6 and 8 of this

report). Compared to official standards, industry standards can often be developed and

published faster since the rules for public comment and voting may be simplified.

Correspondingly, industry standards often play a major role in fields where technology changes

very quickly, such as Information and Communication Technology (ICT) (AALIANCE2,

2013).

Standards and interoperability for ICT based fall prevention and management solutions might

contribute to:

Fostering international standards: This creates a level playing field which strengthens

competition to the benefit of consumers and the competitiveness of European industry

in the global market.

Fostering user/market-driven standards: Too often, the standard development process is

too slow and market-agnostic. Many published standards do not fulfil the requirements

of the market players and users, as technology and users' wishes have moved along.

Promoting interoperability at EU and international level: In the last years, many

programs and initiatives addressing ICT-based fall prevention and effective intervention

solutions for elderly people have been implemented in various regions in Europe

without coordination, hence resulting in a myriad of small-scale systems based on local

standards which cannot communicate with each other. The lack of interoperability is a

major barrier to the development of ICT-based solutions in Europe.

Reducing regulatory burdens: A balanced and efficient regulatory approach is needed to

allow for innovation but also for creating confidence among customers. Industry

recommends a prudent use of regulatory initiatives in the areas of certification and

interoperability conformity testing in order to minimize additional regulatory burdens.

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2.2 Standardisation and Interoperability Analysis in the Work

Package

E-NO FALLS Work Package 4: towards Market uptake

The main goal of WP4 Towards Market Uptake, is to elaborate guidelines, interoperability

standards and toolkits for accelerating the deployment of innovative and ICT-based fall

prevention and effective intervention solutions for elderly people, taking into account wider

safety and independent living support as part of integrated solutions to prolong independent

living of people at risk of falling.

WP4 concentrates efforts in three major priority areas. Each of the three tasks in Work Package

4 addresses one of these priority areas:

- 4.1. Defining the framework for a sustainable business model;

- 4.2. Foster standards and interoperability; and

- 4.3. Enable market development

Task 4.2 has two deliverables. Deliverable 4.2.1 Standardization and interoperability analysis

(this deliverable) and 4.2.2 Recommendations for standards and interoperability.

2.3 Methodology

The standardization and interoperability analysis is based on the expertise of the E-NO FALLS

project partners and network members, published literature and consultation of key stakeholders

that have developed ICT based fall prevention and management solutions.

The initial criteria for the analysis are the different stakeholder perspectives involved in the

development and deployment of ICT based solutions for fall prevention and management. The

different stakeholder perspectives are; user perspective, clinical perspective, industrial

perspective, researcher perspective, legal perspective and standardization perspective. The

partners in this report selected these perspectives in consensus during the kick-off meeting,

organized at the start of the work on the deliverable.

For each of the perspectives the criteria of analysis do not only focus on an inventory of

requirements but also on the available standards within the perspective’s scope.

Additionally each of the perspectives analyze the use of the identified standards by the ICT

based solutions for fall prevention and management. The focus is on which standards are used

and on the arguments for using or not using the existing standards.

Desk research is the primary data collection method. All partners performed a desk research on

the analysis criteria of their perspective. The information used is from different sources;

• research publications in scientific journals,

• clinical protocols in the different countries,

• reports and guidelines from renounced European and international organizations, such

as for instance the European Commission and the World Health Organization,

• standards from standards organizations (official national, European (CEN) and

international standards (ISO)) as well as by industry (de facto standards, for instance

Continua)), In addition publicly available specifications, pre-standards and application

guides are developed and published by a large variety of committees, including IEEE,

IETF, OASIS and HL7,

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• consumer requirements published in reports by consumer organizations,

• country specific information is presented as illustrations to the topic.

Each of the partners to this deliverable has selected the perspective of their expertise; for

instance: the research organization (Fraunhofer Portugal) has developed a chapter on the

research perspective, the industrialist (McRoberts) has developed the industrial perspective and

the standardization institute (NEN, Netherlands Standardization Institute) has developed the

standardization perspective. By doing so the authors of the chapters are stakeholders themselves

in ICT based solutions for fall prevention and management and write about their own

experience and way of working. This guides and adds to the desk research on the topic.

To strengthen the aspect of the use of standards in ICT based solutions for fall preventions and

management a survey was developed. The questions in the survey (provided in the annex) were

guided by the different perspectives and focus on the requirements needed to address the

perspective, the use of standards and the reasons why or why not using them. All partners used

the responses to guide the writing of the respective chapters.

The number of successful ICT based fall prevention and management solution is limited. For

this reason the standardization and interoperability analysis is much more qualitative and hardly

quantitative. ‘Case studies’ are included to allow the presentation of good examples. The ‘case

studies’ are not necessarily representative.

The approach of this deliverable 4.2.1 ‘Standardization and interoperability analysis’ is iterative

and reflective, i.e. findings of this deliverable will be fed into the further refinement and

development of deliverable 4.2.2 ‘Recommendations for standards and interoperability’.


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3. User perspectives

3.1 Introduction

In this chapter the user perspective is described regarding fall detection and prevention systems

- how these system are perceived in terms of usability and accessibility, what would make these

systems acceptable/tolerable by the users.

In other words

1) What are the perspectives of older people regarding their own fall risk?

2) What do older people view as barriers and facilitators to adopt and participate in fall

prevention programs? What these “clients” expect from these systems to be, to do, how

it should behave (on use) and how much it should cost and who should pay for the use,

maintenance and replacement or upgrade.

NOTE: In this chapter, the term “client” means “the intended user”.

3.2 Elders perception about falling

In order to understand their perspective on fall prevention and detection systems, first the

perception of elders about falling must be understood. Elder’s perspectives on their fall risk may

influence decisions about participating in prevention activities. For example, underestimation of

health risks or fatalistic beliefs, can lead to assumptions that prevention efforts are not

applicable or not beneficial.

A literature review revealed that elders tend to reject the status of “faller” as demeaning – they

see themselves as functional members of society (Simpson et al, 2003).

Perceptions of fall risk are linked to other risks, values, beliefs, and emotions. More than often

these three themes occur among elders:

• fearing vulnerability - physical losses, loss of independent living, embarrassed, and

fearing personal failure (label of “faller” create negative views of older people, which in

turn, create social stigma and contribute to ageism).

• maintaining autonomy and independence - minimizing insecurity, and staying

physically and socially active in communities. Elders that did not experience falling feel

that responding to, or dedicating too much time and attention to their own fall risk

might interfere with their freedom to engage in desired activities or worse, lead to

restricted mobility. Elders who did experience falling tend to reflect on their fall, its

cause, and future risks - that helped them to integrate precautionary actions into their

lives, which in turn helped them to overcome or minimize their fears.

• interpreting risk - while many people believe that information provided by

organizations about falls are logical, they often feel it is not personally relevant, for

wide-ranging reasons such as beliefs that:

o falls are not a serious health problem

o falls are an unavoidable aspect of aging

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o other older people are at more risk

o the occurrence of falls, like illnesses, is in the hands of God

o using common sense to assess and respond to fall risk is more acceptable than

careful calculation of risk

It is important to note that one study (Older Adults' Perceptions of Clinical Fall Prevention

Programs: A Qualitative Study (Calhoun R., 2011) ) revealed the existence of two major groups

of elders when it comes to fall prevention programs: joiners and non-joiners.

Attitude wise, a systematic review of literature revealed that statistically, six types of attitudes

towards falling can be distinguished:

• beyond personal control - falls are unpredictable and unpreventable (just an accident; I

am old, comes with the territory; bad luck);

• rationalizing away – I’m not a faller! I just tripped! I’m too old to learn new tricks.;

• salience - knowledge of risk does not necessarily translate to personal applicability or

importance;

• life-change and identity – being deemed at risk of falls is ‘the beginning of the end’.

Accepting the need for falls prevention is seen as being associated with giving up

aspects of an independent life-style, and identity as a competent and independent

person;

• taking control - Ability to decide if and when the choice is made to accept risk status

and suggestions for falls prevention is important: “The older you get, the less you want

to be told what to do.” (Yardley et al., 2006). Implementing their own ideas for

minimizing risk was highly valued;

• self-management - Self-management could give a sense of control, alleviate fear of

uncertainty and decrease feelings of powerlessness.

It appears to be clear that elders do not necessarily accept that they are at risk of falling or

accept the need for intervention, even when deemed at high risk.

The meanings associated with risk of falling centre on frailty, loss of independence and need to

control life and preserve identity as able and independent. Consequently, the need to be in

control and employ self-management strategies is highly valued and may be preferred to

adopting prescribed interventions.

Therefore, options for falls prevention should be negotiated, taking into account the

multifaceted beliefs and emotions associated with being labelled as ‘at-risk’ and individual

preferences for self-management.

3.3 Usability

In this chapter the user perception on usability of the falling prevention and detection systems

will be discussed.

Webster definition for usability:

1: capable of being used

2: convenient and practicable for use

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Although this definition is correct per se it will not suffice in the context of this document.

Hence, a more detailed and adequate definition (and understanding) is needed.

As most of the fall prevention and detection systems rely or use ITC, the below definition is

proposed:

“Usability is a quality attribute that assesses how easy user interfaces are to use. The word

"usability" also refers to methods for improving ease-of-use during the design process.

Usability is defined by 5 quality components:

• Learnability: How easy is it for users to accomplish basic tasks the first time they

encounter the design?

• Efficiency: Once users have learned the design, how quickly can they perform tasks?

• Memorability: When users return to the design after a period of not using it, how easily

can they re-establish proficiency?

• Errors: How many errors do users make, how severe are these errors, and how easily

can they recover from the errors?

• Satisfaction: How pleasant is it to use the design?

There are many other important quality attributes. A key one is utility, which refers to the

design's functionality: Does it do what users need?

Usability and utility are equally important and together determine whether something is useful:

It matters little that something is easy if it's not what you want. It's also no good if the system

can hypothetically do what you want, but you can't make it happen because the user interface is

too difficult. To study a design's utility, you can use the same user research methods that

improve usability.

• Definition: Utility = whether it provides the features you need.

• Definition: Usability = how easy & pleasant these features are to use.

• Definition: Useful = usability + utility.”

The omnipresence of ICT in our era and its influence on people everyday life is undisputable. A

study conducted by Briggs and Little shows that:

“Living in an information society social inclusion is essential to be able to participate in many

everyday activities [3]. Elderly people often have to overcome additional problems before they

can use and benefit from a range of technologies and services. Generally technology is

considered accessible if the system can be used in an identical or reasonable manner by all.

Often elderly people need additional assistive technologies to be able to use systems e.g. screen

readers, voice synthesizers. The embedded design of Ubicomp creates a problem if a person

requires some form of assistive technology to be able to interact and use the system effectively.”

(Linda Little, 2010)

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Furthermore, the study revealed a number of concerns related to the use of fall prevention and

detection systems in the context of information society:

Trust – comprising:

• Stakeholder credibility - Credibility is underpinned by concepts such as loyalty and

reputation.

• Stakeholder motivation - A key component of trust in the system, given that

stakeholders were capable of monitoring goods and people.

• Monitoring by stakeholders - Monitoring was considered very problematic. For

example, if someone was diabetic and shopping for the family would a company

decline or stop insurance because certain food was bought that he or she was not

supposed to eat?

• Flexibility - the extent to which systems could be trusted to faithfully reflect

unpredictable day-to-day changes in human behavior.

• Personalization - a personalized system would be useful and more reflective of elders

needs

• Transparency - linked to data storage, mining, exchange and access by third parties

• Risk and responsibility – both system and/or user can be wrong or do wrong when

using the system, thus generating unwanted effects.

Privacy - comprising

• Informational (Relates to a person’s right to reveal personal information to others,

which is not always under a person’s control).

• Social (The ability to control social interactions by controlling distance between people.

This dimension is associated with physical privacy and often a natural consequence of

it).

• Physical(How physically accessible a person is to others and can be linked to such

aspects as environmental design).

Can be concluded that a system or device should be benchmarked against a set of attributes -

prior it’s release – for usability.

Proposed set of attributes:

• Ergonomics – fit for human use in terms of dimensions, effort required to handle,

knowledge required to use (comprise intellectual effort to understand the interface),

• Learnable – elders either tend to refuse to learn new things either can’t learn. There for

the devices or systems must rely on what elders already know, remember and can use as

concepts, rational processes or logic.

• Poka Yoke principle – people will make mistakes. The system or device must be

mistake proven or statistically robust – so even if an error (of use, of function etc.)

occurs, the likely effect to be bearable and easy to recover.

• Satisfaction – also can be seen as effectiveness – the extent to which the device or

system provides the expected results from this use of it. Psychological comfort (privacy,

self-image, public image) can also be included here.

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3.4 Accessibility

For the purpose of this document, accessibility will be understood in terms of availability and

affordability.

3.4.1 Affordability

From elder’s perspective, the cost of purchasing and using fall prevention and detection systems

and devices is the main concern. Regardless the region, country, culture or sex, elders tend to

have scarce resources available to be spent on such items or services. The fear comes from the

fact that due to government’s preoccupation in reducing expenditure on health (or at least take

the growth of it under control – see figure 3.1 and 3.2 for pension expenditure projection for

2050), it is most likely that the cost of these services and items will come out of their own

pockets. Pockets that are already overwhelm – figure 3.1 shows that Retirees are paying more

for health care than food (US).

Figure 1. Proportion of state contribution to pensions

Source: http://www.ft.com/cms/s/0/e9601116-68f4-11df-910b-00144feab49a.html#axzz2ylVZYVhw (Financial Times, 2013)

http://www.ft.com/cms/s/0/e9601116-68f4-11df-910b-00144feab49a.html#axzz2ylVZYVhw

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Figure 2. European pension expenditure

Source:

http://www.reuters.com/article/2010/06/16/france-pensions-idUSLDE65F0A920100616

(Reuters, 2010)

Figure 3. Retirees expenditure structure

Source:

https://www.fidelity.com/viewpoints/retirement/health-care-costs-when-you-retire

(Fidelity, 2014)

http://www.reuters.com/article/2010/06/16/france-pensions-idUSLDE65F0A920100616

https://www.fidelity.com/viewpoints/retirement/health-care-costs-when-you-retire

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A WHO report from 2011 shows:

“Health system characteristics

Service provision. The use of primary care gatekeepers seemed to result in lower health

expenditure. Public sector provision of health services was associated with lower health

expenditure (Gerdtham et al. 1998).

Health financing. In terms of financing structure very few empirical studies found that the

extent to which health care expenditure was financed by the government has a relationship with

levels of health expenditure (Leu 1986; Culyer 1988; Hitiris & Posnett 1992; van der Gaag &

Stimac 2008). Differences in health expenditure between tax-based vs. social-insurance based

systems were examined in OECD countries and eastern European and central Asian (ECA)

countries (A. Wagstaff & Bank 2009; A. Wagstaff & R. Moreno-Serra 2009). The OECD study

found that health expenditure per capita was higher in countries where a social health insurance

mechanism exists. The ECA study suggested per capita government health expenditure was

higher in countries with social health insurance as compared to countries that relied solely on

general taxation.

External funds. Recently, there has been much interest in relationship between external funds

and national health expenditure in developing countries. Gaag and Stimac found that whereas

there was no significant impact of health-specific official development aid (ODA) on total

health expenditure, health specific ODA has an elasticity of 0.138 against public spending on

health (van der Gaag & Stimac 2008). Lu et al 2010 found that health ODA channeled through

the non-government sector had a positive relationship with general government health

expenditure, while a negative correlation was found when it was channeled through government

sector (Lu et al. 2010). Farag et al found that for a 1% increase in health ODA government

health expenditure decreased by 0.027% in upper-middle income countries; 0.04% to 0.09% in

lower-middle income countries; and 0.14% to 0.19% in low income countries (Farag et al.

2009).

Provider payment mechanisms. Fee-for-service systems tended to lead to higher expenditure on

average than capitation systems (Gerdtham et al. 1998; Gerdtham & Jönsson 2000). A shift

from financing hospitals through budgets to fee-for-services or patient-based payment

mechanisms was associated with increases in both public and private components of health

expenditure in a study from ECA countries (Rodrigo Moreno-Serra & Adam Wagstaff 2010).

Furthermore, the ratio of in-patient expenditure to total health expenditure is positively related

to health expenditures (Gerdtham & Jönsson 2000; Gerdtham et al. 1998). The total supply of

doctors may have a positive effect on health expenditure (Gerdtham & Jönsson 2000; Gerdtham

et al. 1998). However, the Murthy and Okunade study of African countries found no

relationship between the density of doctors and health expenditure (Murthy & A. Okunade

2009).” (WHO, 2011)

Analyzing statistical data available on Eurostat and other sources, Allianz Knowledge (an

Allianz Insurance and Financial Services website) draws some interesting conclusions:

“…the most pronounced differences in consumption expenditure on housing and healthcare

occur in the eastern countries of the European Union. Slovakians over 60 years of age spend

roughly 40% of their expenditure on housing, 9.4 percentage points more than the national

household average.

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Elderly Romanians’ spending on healthcare is disproportionately high. With a share of 10.3%,

they have the highest exposure to medical expenditure, which is 6.5 pp above the mean national

consumption. But major differences are also apparent within the Euro zone. Finland’s older

population, for example, spends 8.4 pp more on housing than the average Finnish household.

Linking pension payments to national CPI may be an inadequate way to assess the real cost of

living that retirees face. This could be providing a false impression of the adequacy of pension

benefits and, ultimately, may even undermine the adequacy of those benefits.” (Eurostat, 2012)

A short glimpse on elder’s poverty statistics is relevant in relation to this chapter subject:

accessibility (affordability) of fall prevention and detection devices and systems – see figures

3.4, 3.5 and 3.6 below.

Figure 4. The ADEQUACY challenge – Population (65+) living at risk of poverty or social

exclusion, 2011

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Figure 5. At-Risk-of-Poverty Rate (65 years or more), 2011

Figure 6. Severe material deprivation (65 years or more) by Gender, 2011

Source:

http://ec.europa.eu/europe2020/pdf/themes/04_pensions.pdf (European commission, 2011)

http://ec.europa.eu/europe2020/pdf/themes/04_pensions.pdf

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Figure 7. Old-Age Population Dependency Rates vs. Pension System Dependency Rates in

Eastern European and Former Soviet Countries, Most Recent Year Available

Source:

http://siteresources.worldbank.org/ECAEXT/Resources/publications/454763-

1181939083693/chaw_151-176_ch04.pdf (World Bank, 2007)

Some data from Romania:

In 1990, percentage of elders (>60yo) within population was 10.35% and raised to 20.31% in

2010. In July 2012 (National Council for Elders Romania, 2012):

• a percent of 27.29 out of 5.3 million retired (1.448.967 people) had a social security

allowance of 417 lei (considered to be the average monthly expenditure basket at the

time);

• 42.85% (2.275.510 people) had a pension of 562 lei (minimum survival income);

• 54.99% (2.920.054 people) had under 696 lei (poverty threshold);

• So only 45% of them had an income above poverty limit.

In United States of America:

In 1959 35% of elders lived under poverty line. In 1974, the elderly poverty rate fell to 15%. In

2006 the percentage was only 9.4%. This was largely attributable to a set of increases in Social

Security benefits. Social Security and Supplemental Security Income benefits continue to play a

key role in reducing elderly poverty, especially among women and people of colour.

However, a study conducted by Henry J. Kaiser Family Foundation reported that in 2011, 58

percent of people didn't seek treatment they needed because it was too expensive. And they

concluded: “with people living longer -- men can expect to live 81.6 years, up from 66.1 and

women are living to 86, up from 73.5 -- and 70 percent of people over 65 needing long-term

health care, the need for a "financially viable scheme" is dire”. (Henry J., 2012)

A study conducted by AXA Wealth (a major player on Investment and retirement consulting in

UK) found that:

http://siteresources.worldbank.org/ECAEXT/Resources/publications/454763-1181939083693/chaw_151-176_ch04.pdf

http://siteresources.worldbank.org/ECAEXT/Resources/publications/454763-1181939083693/chaw_151-176_ch04.pdf

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• Most pensioners in the survey (69%) retired earlier than they thought they would,

driven by ill health – either their own or their partner’s – redundancy or offers of early

retirement, and for a small number, the need to care for elderly parents.

• 58% of pensioners said that they did not seek professional advice. Of those that did seek

professional help, 14% waited until just before they retired.

• Almost 40% of pensioners do not feel “comfortably off” in retirement and would need

extra money – among them, more than half would need about an extra £4,000 a year or

more.

• Just under 40% of recent pensioners reported they have had to scale back their lifestyle

in retirement, cutting back not only on ‘life’s little luxuries’ such as holidays but more

worryingly, of those that said they have scaled back their lifestyle, 27% have cut back

on essentials such as food and heating.

• A third said that they had trouble making ends meet and felt anxious about money.

• Almost one in five report having some difficulty paying bills in the last year.

• Ultimately, three in five think that they will need to cut back further on their spending

as prices continue to go up and four out of five pensioners expect the real value of their

pension to decline as inflation takes its toll.

• On the one hand, just 10% of pensioners see the current economic climate as an

opportunity to invest - but on the other hand they need savings to generate income to

top up pensions. (AXA Wealth, 2012)

As a conclusion to this sub-chapter, it can be said that joiners will adopt and will be willing to

pay the price for fall prevention and detection systems and devices if it proves to be

“reasonable”, while non-joiners will have a positive attitude towards these systems and devices

only if they perceive them as a sweet bargain.

3.4.2 Availability

Availability can be described in a three dimension space:

- service availability – includes public services and programs, private initiatives

(volunteers, private clinics, etc.)

- knowledge and awareness availability – includes public policies, dissemination

schemes, etc.

- equipment and devices availability – includes R&D, production and commercialization

of goods, distribution network and supply chains

Each of these dimension should cover the three components of fall management of elders:

- prevention

- detection

- intervention

The spread of elders fall related injuries is endemic around the world – a large part of the

population is involved in one way or another with the management or/and consequences of such

accidents.

It is easy to observe that in this field – prevention service – efforts have been made with good

results around the world.

A study oriented on effectiveness of population-based programs revealed that they are effective

and can reduce fall occurrence among elders with up to 75%!

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The study shows:

„A number of countries have prepared guidelines to prevent falls in the elderly. Effective

interventions are available to prevent falls and include increased physical activity and hip

protectors. Strategies targeted at fall prevention include regulation, education, environmental

change and population or community-based coordinated programs. A population-based

intervention program shares ownership of the injury problem with the whole community,

experts and community members. Joint responsibility is taken for determining priorities and

appropriate interventions are widely promoted.”

And they conclude:

„…population-based approach to the prevention of fall-related injury is effective and can form

the basis of public health practice”. (McClure RJ, 2005)

In UK, the National Institute for Health and Care Excellence (NICE) provides evidence based

guidelines for “healthcare and other professionals and staff who care for older people who are at

risk of falling.” And addresses “All people aged 65 or older” and “People aged 50 to 64 who are

admitted to hospital and are judged by a clinician to be at higher risk of falling because of an

underlying condition are also covered by the guideline recommendations about assessing and

preventing falls in older people during a hospital stay.” – Guideline CG161 Falls: assessment

and prevention of falls in older people. (NICE, 2013)

Many other programs and initiatives can be listed here as evidence of a widely available

services – both public and private – aimed to prevent falls among elders. Here are some

examples:

FallSafe (UK)

The FallSafe Project: a quality improvement programme that uses specially trained nurses to

introduce an evidence based care bundle to reduce inpatient falls.

It is run by the Royal College of Physicians Clinical Effectiveness and Evaluation Unit in

partnership with the Royal College of Nursing, the National Patient Safety Association, the

Association for Victims of Medical Accidents and South Central Regional Health Authority.

It is funded by The Health Foundation, an independent charity funded by the insurance industry,

which specialises in Quality Improvement projects.

CDC – USA

Develops and maintains programs and issues guides on how community based programs can be

designed and managed in order to prevent elderly falling.

“How to Develop Community-based Fall Prevention Programs for Older Adults”

Source:

http://www.cdc.gov/homeandrecreationalsafety/images/cdc_guide-a.pdf (National Center for

Injury Prevention and Control, 2008)

Note: a more complete list of such programs can be subject of a separate research – the resulting

data can be useful to draw some conclusions regarding the best practice to be implemented

nations wide with regard to prevention of falling among elders. A unified and coherent approach

of such programs could lead to a set of effective yet sustainable measures across Europe to

prevent, detect and treat falling among elders.

http://www.cdc.gov/homeandrecreationalsafety/images/cdc_guide-a.pdf

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Such endeavours have been made to some extent and their results can be used.

The above examples also cover the knowledge and awareness area as each program or initiative

have a strong component addressing dissemination of information, rising awareness and

involving elders in adopting preventive behaviour or practices.

In terms of availability of ICT systems and devices, elders, divided in the two major groups

shown above (joiners and non-joiners) have divergent perceptions. A vast majority (over 80% in

Europe) will trust the doctor’s recommendations – both in terms of what they need and from

where to purchase the item. The non-joiners consider that they don’t have a ‘falling problem.

Admitting they become fallers is unacceptable in their view.

Both groups tend to expect that the necessary equipment should be available in specialized

shops or clinics and hospitals, perceiving these devices as prosthetics. Along with the

equipment, assistance and guidance for use and storage - and servicing - is expected to be

provided by the seller.

3.5 Other stakeholders perspective

Family and dependents

Their power is the lowest among stakeholders – they can only decide within their group what

policy, strategy or solution to adopt – if any. Their perception of their power in the matter is that

there is nothing they can do to improve how falling risk is tackled or how their quality of life

can be improved. Answers like: “I am too small and insignificant – there is nothing I can do to

change something” are common.

However, their influence on the matter is one of the highest – in their position of close

proximity with the elder at risk, emotionally and culturally connected to the elder, their tend to

take control on elder decision regarding his attitude (joiner/nonjoiner) if and what solution to

adopt in order to prevent falling risk. It is also important to note that in Romania, in most cases,

the proxies are the one that bear the responsibility of paying for the cost of the service or device

chosen. In relation with this, currently, there are no reimbursement mechanisms in place

that can ease the burden of the cost –the health insurance have not listed such devices or

services in the list of supported costs related to health. Most responders consider this as a

major injustice towards elders who ”worked hard all their life just to be neglected at old age!

They expect us to drop dead and stop waiting for charity!”

On Interest criteria this group also scores the highest (five), perceiving themselves as victims –

see statement above.

They tend to have high score in Salience - which indicates that this group should be considered

as primary target for any program or legal initiative related to fall prevention among elders. The

perspective of the group from this point of view is that since “they worked hard all their lives”

and “paid taxes and health insurance they should be reimbursed for the cost of such services and

devices – they deserve a better life”.

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Production oriented business

Device producers and service providers have discretionary power with regard to resources to be

used. It is up to them to decide whether a device or service should be produced or offered based

on their respective business interest. Since the main drive for such decision is profit generation,

becomes obvious that in the absence of a trustful mechanism for payment reimbursement

positive and strong decision in mass producing such devices (or services) is not to be expected.

The business owners tend to consider these devices and services as niche products for rich

people – those who rely on state support (public funding, health care insurance systems etc.) are

not a target for their business. In this group are also included the professional care givers that

are business oriented – based on profit.

Care givers

In this group have been considered those entities (professional or not) that provide services to

elders at risk to fall on non profit basis – humanitarians, charity, volunteers and proxies.

Although their power is low, they tend to be very influential both towards elders and decision

makers.

In this groups’ perspective, the very existence of their group is the proof that “something needed

to be done” since “no one else does”. They see their service and activity as a mean to

compensate the lack of proper funding (reimbursement mechanisms) and proper regulations

(elders at risk of falling are not medically diagnosed as in need).

In most situation this group works in close collaboration with NGO for fund raising and

awareness and involvement programs.

Another notable perception of this group is that they can be the best solution for the problem:

with little funding from state (getting the status of entity of public interest) and regulation

support from politicians (laws and regulations), they can solve the problem of falling prevention

and intervention for elders. In their perspective, the best way to improve an elder life and keep

him safe from falling is not a device but another person – caring person.

Medicine

In this group have been considered entities such as specialized clinics and hospitals and their

medical staff.

They score the highest among stakeholders since they have the power to block any program or

initiative towards the matter of elder falling (based on their unique expertise and knowledge),

their opinion is the most respected and their interest is undisputable since they have to tackle

with the effects of falling elders.

In their perspective, age induced fragility and vulnerability is a medical condition and should be

treated as a medically diagnosed condition. It is particularly interesting to note here a statement

of an orthopaedist: “since I am paid to diagnose and treat you if you have a flew, and you can

get your money back from health insurance for the aspirin, I guess it’s only normal for me to get

paid if I diagnose you with old age induced condition and prescribe some special device for

prophylactic/preventive purpose, and is only fair that you get reimbursed by health insurance

company for it – the expense is a health expenditure.”

https://www.google.com/search?num=100&safe=off&rls=com.microsoft:ro-RO:IE-Address&q=medically+diagnosticated&spell=1&sa=X&ei=zPanU5flKcn48QW7yIA4&ved=0CBsQvwUoAA

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3.6 Conclusions

It can be concluded that fall prevention among elders have three main perspectives: business,

social and moral.

Moral wise, the matter can simply not be dismissed. Old people are still humans, part of the

society, and have equal right to happiness and support from society as any other member of the

society.

Socially, they are an important segment of population – both by their numbers and their role in

society.

But as long as economically and financially (business wise) this matter is not properly

regulated, no sustainable source of funding is provided, with mechanism that are susceptible to

sustain such funding long periods of time in various political and economic environments, the

“problem” of “fallers” cannot be solved.

It seems that there is a general agreement among stakeholders that state involvement (through

proper regulation of social security policies, health care policies and health insurance

regulations) is a must.

The missing link in the matter of preventing elders of falling is a proper mechanism for

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4. Clinical Perspectives

4.1 Introduction According to the Digital Agenda for Europe, “each year, one in three people over 65 has a

serious fall, mostly in home. Often their quality of life is severely diminished: loss of mobility,

severe dependency and physical disability. The cost of falls is high and will continue to rise as

long as no good fall and fall prevention strategies are in place. And yet: falls are the most

preventable cause of people going to nursing homes, and ICT definitely can provide solutions.”

(European Commission)3

Therefore, the reduction of falls in people at risk became a critical demand and a great

challenge. Among the current innovative approaches in this field, advanced technology-based

solutions (sensors and software technologies) began to evolve and to prove their efficiency in

fall reduction and indirectly, their ability to significantly improve the individual quality of life,

the caregiver efforts and the costs of medical care. (Center of eHealth and Healthcare

technology - University of Agder)4

4.2 ICT in Falls Prevention - Perspectives on Europe

The FARSEEING project (European Project-FP7) develops a comprehensive approach to better

predict, prevent and manage falls based on a long-term analysis of behavioural and

physiological data collected using Smartphones, wearable and environmental sensors, within the

specific field of geron-technology. “Farseeing” means having or showing awareness of and

preparation for the future. Following the FARSEEING approach (data collecting, analysing and

processing) provides us with opportunity to make a real difference in the area of falls prevention

(FARSEEING)5. The project also aims to build the world’s largest fall repository. In January

2012 a consensus process involving experts from different countries in the field of fall

prevention have initiated a proposal of a standard data format on fall (Klenk, 2013)6.

Another European project, I-DONT-FALL, aims to pilot integrated and configurable fall

management solutions, for providing suitable ICT- based fall management means, centred on

the specific needs, root causes, risk factors and cultural factors associated with fall incidents.

The I-DONT-FALL approach is expected to increase the efficiency of ICT based detection and

prevention of falls, as well as to open new horizons for marketing, exploiting and sustaining

fall-related ICT solutions.

3 European Commission; PSP- proposal: Fall prevention through intelligent sensors and control systems;

http://ec.europa.eu/digital-agenda/en/ict-and-fall-prevention-elderly 4 Center of eHealth and Healthcare technology - University of Agder; ICT-PSP- proposal: Fall prevention through

intelligent sensors and control systems;

http://www.cip.gov.pl/container/ICT/Baza_Partnerow2011/Norway_fall_prevention.pdf - ICT- 5 FARSEEING; Innovation to serve the older generation towards an active and healthy ageing and to prevent falls

http://farseeingresearch.eu/less-falls-better-lives/ 6 Klenk, J et al; Development of a standard fall data format for signals from body-worn sensors: The FARSEEING

consensus; Zeitschrift für Gerontologie und Geriatrie; Dec2013, Vol. 46 Issue 8, p720

http://ec.europa.eu/digital-agenda/en/ict-and-fall-prevention-elderly

http://www.cip.gov.pl/container/ICT/Baza_Partnerow2011/Norway_fall_prevention.pdf

http://farseeingresearch.eu/less-falls-better-lives/

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Significant key facts in fall prevention, retrieved from the above initiatives may thus be

concluded:

- a good management in ICT implementation for fall prevention is necessary for prevention

and detection;

- it is important to understand that living settings (home or nursing homes) make the

difference in the approach of an ICT solution for fall prevention;

- electronic devices are important in fall prevention, clinical evaluation (tests, biological

parameters) and the readjustment of the living space for preventing falls (more light, no

carpets, furniture adaptation, etc.).

The FARAO project (Fall Risk Assessment in Older adults) - develops and tests a miniaturized

body-fixed sensor that allows ambulatory measurements of body acceleration and angular

velocity data. Algorithms and analyses are developed to detect impending falls (instability) and

actual falls in older adults in daily life, during daily physical activities, as well as to predict

overall fall risk.

The capacity of these ICT solutions to intercommunicate is a must and can be realized by using

the same taxonomy.

TAXONOMY OF SERVICES

PROFOUND, a European project started in 2007 and dealing with falls prevention has

developed the “Manual for the fall prevention classification system” initiating the falls

prevention taxonomy based on market research. The taxonomy was developed with three main

purposes: to classify and characterize the existing battery of interventions regarding falls

prevention; to promote and encourage new developments in these domain and publish their

results, as well as to create models for future applications.

A taxonomy database is already available on the ProFaNE website and on the Warwick Clinical

Trials Unit website.

There are many products that can help people with disabilities to enhance their quality of life.

Hearing aids, wheelchairs, Braille equipment, communication devices, software, urine

collection systems, oxygen apparatus, and mobile hoists may help people with disability to

better function in their daily life and to remain socially inserted. Subdivisions of assistive

products can be found in several classifications and nomenclatures: ISO 9999 (assistive

products for persons with disability – classification and terminology), (The International

Organization for Standardization)7 GMDN (The Global Medical Device Nomenclature )

8 and

SNOMED CT-systematized nomenclature of medicine – clinical terms (International Health

Terminology Standards Development Organization)9.

Another solutions proposed by IDF (I-DONT-FALL) are the IDF prevention service (exercises

for gait and balance training) and cognitive improvement (attention and executive function

inputs), as well as the IDF detection system able to modify various risk factors, e.g. to reduce

the fear of falling through safety system devices (alarm, positive feedback, better stability and

7 The International Organization for Standardization; http://www.iso.org 8 The Global Medical Device Nomenclature (GMDN) http://www.gmdnagency.org 9 International Health Terminology Standards Development Organization http://www.ihtsdo.org

http://www.iso.org/

http://www.ihtsdo.org/

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self-sufficiency). (ICT-PSP)10 ,

(Sachiyo, 2005)11 ,

(United Nations (UN), 2004)12 ,

(European

Commission)13

The largest majority of studies related to falls management using ICT targeted fall detection,

copes with fall accidents and injuries that have already occurred. Fall prevention means to avoid

falls before they occur. Only few studies have investigated fall prevention by using ICT.

Currently, there are no relevant studies to fall prevention by ubiquitous computing. The WHO-

Europe Report “What are the main risk factors for falls amongst older people and what are the

most effective interventions to prevent these falls?” elaborated in 2004, investigated the

effective measures to prevent fall in the elderly, as well as the effective support that may be

delivered by mobile and ubiquitous computing. (Wang, 2013)14

4.2.1 Telecare

Telecare can be defined as the continuous, automatic and remote monitoring of emergencies and

lifestyle changes over time, in order to manage the risks associated with independent living.

The funds for Telecare are expected to be provided by the social ensuring system.

4.2.2 telehealth

Telehealth aims to provide "good health care" remotely, by using electronic communication

means between users and clinicians. For example, a service that measure vital parameters of a

subject at home, sends the recorded values via the telehealth service to be monitored by the

clinician.

It is assumed that telehealth funds to be provided by the public healthcare system. (Tehnologia

Informatiilor si Comunicatiile in sprijinul traiului independent si al ingrijirii persoanelor in

varsta si/sau cu dizabilitati)15

4.2.3 eHealth

eHealth can be defined as health related services, information and education, provided or

improved via internet and other computer-related technologies. In terms of financing there have

been made a distinction between the activities provided for the user and the formal user-

clinician interactions. The first can be funded by the public health system, and the last in a

reimbursement system, which applies in relation to health consultations.

10 ICT-PSP; I-DON'T-FALL; Integrated prevention and Detection sOlutioNs Tailored to the population and Risk

Factors associated with FALLs; http://www.idontfall.eu/?q=content/deliverables 11 Sachiyo Yoshida. World Health Organization. A Global Report on Falls. Prevention Epidemiology of Falls.

http://www.who.int/ageing/projects/1.Epidemiology%20of%20falls%20in%20older%20age.pdf 12 United Nations (UN); World Population Prospects: The 2004 Revision. New York, USA; 2004 13 European Commission, Eurostat, Population;

http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Population 14 Wang, Weilin; Supporting Fall Prevention for the Elderly by Using Mobile and Ubiquitous Computing; Norwegian

University of Science and Technology, Faculty of Natural Sciences and Technology, Department of Biology; June

2013 15 Tehnologia Informatiilor si Comunicatiile in sprijinul traiului independent si al ingrijirii persoanelor in varsta si/sau

cu dizabilitati;

http://andrei.clubcisco.ro/cursuri/5master/savlsi/misc/TIC%20in%20sprijinul%20persoanelor%20varstnice.pdf

http://www.idontfall.eu/?q=content/deliverables

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4.2.4 Assistive Technology

Assistive technology includes independent systems of technological devices able to support the

accomplishment of daily living tasks. Funding may be provided by healthcare system or social

services.

4.2.5 Smart Homes

Smart homes specifically customized and adapted for fall prevention are included into the

category of networking systems and ICT-based control that operates at home, often being

connected to external services. The funding is expected to be made in the fields of housing

services, assistance services or social services assisting people with disabilities.

4.3 Protocols and Clinical Guides in Falls Prevention

Falls are coded as E880-E888 in International Classification of Disease-9 (ICD-9), and as W00-

W19 in ICD-10, which include a wide range of falls including those on the same level, upper

level, and other unspecified falls. (WHO)16

Another important clinical guide used in USA is the Clinical Practice Guideline: Prevention of

Falls in Older Persons (2010 AGS/BGS).

A recent clinical guideline regarding falls was published in June 2013 by The National Institute

for Health and Care Excellence (NICE) who provides national guidance and advice to improve

health and social care. Their recomandations are for preventing falls in older peoples in their

homes and for the olders during a hospital stay. (http://www.nice.org.uk/guidance/CG161) This

is in fact an update of the one from 2004. We consider their recomandations regarding falls

preventions assement very well structured and very useful in clinical practice.

In Romania:

- Guide for Good Medical Practice in Geriatrics and Gerontology including two annexes:

The Geriatric Assessment and the Medical Observation Form

http://www.ms.ro/documente/FOAIE%20DE%20CONSULT%20GERIATRIC%20-

%20Anexa%20la%20evaluarea%20geriatrica_8819_6817.pdf

- With a Comprehensive Assessment in Geriatrics and Old Age Psychiatry, approved by

the Romanian Ministry of Health Ordinance No 1454/30.11.2010

http://www.ms.ro/documente/Evaluarea%20geriatrica%20-%20Anexa_8819_6816.pdf

- Curriculum and Syllabus in Geriatric Medicine, according to the Romanian Ministry of

Health Ordinance 1041/2010 http://www.emedic.ro/Rezidentiat/CURRICULUM-DE-

PREGATIRE-IN-SPECIALITATEA-GERIATRIE-SI-GERONTOLOGIE.htm

- The Order of Nurses, Midwives and Medical Assistants in Romania; A nursing protocol

for fall prevention and management (Prevenirea si coordonarea caderilor)

www.oammr-sv.ro/files/doc/PROTOCOALE_NURSING.doc

- Association for Osteoporosis Prevention Romania (ASPOR); The role of physical

exercise for fall prevention in osteoporosis;

http://www.aspor.ro/content/view/130/53/lang,ro/

16 WHO Global report on falls Prevention in older Age;

http://www.who.int/ageing/publications/Falls_prevention7March.pdf

http://www.nice.org.uk/guidance/CG161

http://www.ms.ro/documente/FOAIE%20DE%20CONSULT%20GERIATRIC%20-%20Anexa%20la%20evaluarea%20geriatrica_8819_6817.pdf

http://www.ms.ro/documente/FOAIE%20DE%20CONSULT%20GERIATRIC%20-%20Anexa%20la%20evaluarea%20geriatrica_8819_6817.pdf

http://www.ms.ro/documente/Evaluarea%20geriatrica%20-%20Anexa_8819_6816.pdf

http://www.emedic.ro/Rezidentiat/CURRICULUM-DE-PREGATIRE-IN-SPECIALITATEA-GERIATRIE-SI-GERONTOLOGIE.htm

http://www.emedic.ro/Rezidentiat/CURRICULUM-DE-PREGATIRE-IN-SPECIALITATEA-GERIATRIE-SI-GERONTOLOGIE.htm

http://www.oammr-sv.ro/files/doc/PROTOCOALE_NURSING.doc

http://www.aspor.ro/content/view/130/53/lang,ro/

http://www.who.int/ageing/publications/Falls_prevention7March.pdf

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- The management of the Postprandial hypotension (PPH) or vitamin D deficiency.

4.3.1 Clinical Test for Falls Prevention

No screening tool has been used or validated Europe-wide to assess risk of falling among older

people, but there are tools that have been clinically used, (WHO, 2004)17

such as: The

STRATIFY risk assessment tool, (Oliver & et al, 1997)18

a screening tool based on the

PROFET study, (Close, 2003)19

Nandy, (Nandy)20

The Mobility Interaction Fall Chart, (Lundin-

Olsson , Nyberg, & Gustafson, 2000)21

etc.

Assessment of fall risk typically involves either the use of multifactorial assessment tools

(MAT) that cover a wide range of fall-risk factors, or functional mobility assessments (FMA)

that typically focus on the physiological and functional domains of postural stability including

strength, balance, gait and reaction times. The MAT typically consist of a checklist comprising

questions used to screen the level and nature of risk based on a combined score of multiple

factors known to be associated with fall-related risk. These include factors such as

psychological status, mobility dysfunction, elimination patterns, acute/chronic illnesses, sensory

deficits, medication use and a history of falling. FMA focus on functional limitations in gait,

strength and balance and are often completed by physical therapists or physicians in outpatient

or acute care settings. In most cases, the subject is required to perform a physical demonstration

of ability while the assessor monitors limitations in function compared to a pre-established

standard.

Another fall risk predictive test are used in clinical practice, and also clinical research such as:

• Downton, the fall risk index - the test is easily to perform and useful in clinical

environment / residential care, by nurses and physiotherapist;

• Mobility Interaction Fall (MIF) - the aim of this screening tool is to identify older

people living in residential care facilities who are prone to falling and Tandem Gait

Test.

Regarding other European projects (see questionnaire in Annex) we consider that all falls risk

assessment, clinical scales and clinical tests (see D2.2-5) should be easy to use and predictive

for an earlier stage of risk falling. The clinical implementation of all ICT solutions will be a

successful fall prevention strategy if the process will be active and helpful in the daily life of

older people in their own home.

A multitude of methods for assessing the risk of fall are used and accepted in the clinical

practice. Other projects, such as iStoppFalls have used different fall risk assessment tools,

among which we can mention:

17 WHO Report, What are the main risk factors for falls amongst older people and what are the most effective

interventions to prevent these falls? http://www.euro.who.int/__data/assets/pdf_file/0018/74700/E82552.pdf, March

2004 18 Oliver D et al. Development and evaluation of evidence based risk assessment tool (STRATIFY) to predict which

elderly inpatients will fall: case-control and cohort studies. BMJ, 1997, 315:1049-1053. 19 Close, JCT et al. Predictors of falls in a high risk population - Results from the prevention of falls in the elderly

trial (PROFET). Emergency medicine journal, 2003, 20,5:421-425. 20 Nandy S et al. Development and preliminary examination of the predictive validity of the Falls Risk Assessment

Tool (FRAT) for use in primary care. Journal of public health and medicine, forthcoming 21 Lundin-Olsson L, Nyberg L, Gustafson Y.;The mobility interaction fall chart.; Physiotherapy research

international, 2000, 5:190-201

http://www.euro.who.int/__data/assets/pdf_file/0018/74700/E82552.pdf

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1. Reduction of fall risk by Short-form Physiological Profile Assessment (PPA; Lord,

Menz, & Tiedemann, 2003), which includes five validated measures of physiological

falls risk, such as the visual contrast sensitivity, postural sway, quadriceps strength,

reaction time and lower limb proprioception;

2. Improvement of quality of life by 12-item World Health Organization Disability

Assessment Schedule (WHODAS 2.0;

http://www.who.int/classifications/icf/whodasii/en/) and by European Quality of Life-5

Dimensions (EQ-5D; http://www.euroqol.org/);

3. Provide an improved fall prediction and prevention assessment with balance, sit-to-

stand from the Short Physical Performance Battery (SPPB; Guralnik et al. 1994) and

reaction tests adapting for the iStoppFalls system;

4. History of falls by questionnaire and monthly falls calendar;

5. Gait velocity by 4 m walking from the SPPB (Guralnik et al. 1994), and 10 m walking

in participants' habitual speed with 2 m for acceleration and deceleration;

6. Muscle strength and power of the lower extremities by sit-to-stand test from the SPPB

(Guralnik et al. 1994) and the adaptation for the iStoppFalls system;

7. Functional mobility by Timed up and go test (TUG; Podsiadlo & Richardson, 1991);

8. Reaction time: hand and stepping choice reaction time adapted for the iStoppFalls

system;

9. Balance by Maximal Balance Range (MBR; Lord et al., 1996), coordinated stability

(CoStab; Lord et al., 1996), adapted balance tests (bipedal, semi-tandem, near tandem,

tandem stance) from the SPPB (Guralnik et al. 1994) for the iStoppFalls system;

10. Cognitive functions which include general fluid function by Digit-Symbol-Coding

(WAIS-III; Wechsler, 1997), divided and switched attention by Trail Making Test parts

A and B Test (TMT A+B; Reitan, 1958) and by Attention Network Test (ANT) on

PEBL, inhibition by the Victoria Stroop Test on PEBL, memory and working memory

by digits forward and backward (WAIS-III; Wechsler, 1997);

11. Dual task costs by 10 walk + counting backwards by 3, sway + counting backwards by

3, sway + digit forward span;

12. Self-efficacy and fear of falling by Shortened Iconographical-Falls Efficacy Scale

(Icon-FES; Delbaere, Smith, & Lord;

http://www.neura.edu.au/sites/neura.edu.au/files/page-downloads/Icon-

FES_10item.pdf).

Concerning the feasibility and functionality of the above mentioned available tools,

demonstrations will be made by comparing them with other existent systems, as well as by data

correlation from various studies and projects in which they were used as methods for fall risk

assessment.

4.3.2 Impact of Falls Prevention in Primary Care

Family doctors and GPs are the first medical contact for patients within the healthcare system.

For this reason, their training and education on falls prevention in elderly must be particularly

envisaged. Such an endeavour was realized in Romania between 2010-2013, by the SOP-HRD

46975 Brain-Aging Project [Training in Brain-Aging Medicine and Related New Medical

Technologies for Doctors and Nurses Working in Specialized Ambulatories and Hospital

Departments], http://www.brainaging.ro/ro/proiect-european, under the coordination of Ana

Aslan Intl. Foundation in Bucharest.

http://www.euroqol.org/

http://www.brainaging.ro/ro/proiect-european

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In general, in terms of fall prevention, the Family physicians (Primary care) are assumed to be

the first that people should address to. ICT solutions are however sought to be implemented and

used in hospitals (Secondary care) and care centres for seniors. Studies evidenced the positive

attitude in clinicians when developing and implementing ICT solutions in both the primary and

the secondary care sectors. One such study (Gund, Lindecrantz, Schaufelberger, Patel, &

Sjoqvist, 2012)22

conducted by the Department of Signals and Systems in Chalmers University

of Technology in Gothenburg shows that most of the clinicians are interested in using ICT

solutions in their daily practice, both in the primary or secondary care sector and as patients’

home as well. A positive feedback from elderly in Romania has been received when new ICT

platforms have been tested (Spiru, și alții, 2014)23

, (Spiru, Solheim, Turcu, Rovira Simon, &

Sanchez Martin, 2014)24

, (Schneider, și alții, 2013)25

, (Schneider , și alții, 2013)26

between 2011

and 2014 at Ana Aslan International Foundation, one of the pilot sites involved in

CONFIDENCE, MOBILE.OLD and Mobile.Sage AAL projects:

• The main objective of the CONFIDENCE project is to develop a community-based

mobility safeguarding assistance service for people suffering from mild to moderate

dementia. (Salzburg Research)27

• The MOBILE.OLD project provides a combined smartphone and TV-based service

infrastructure with residential and outdoor services that will be delivered in a highly

personalized and intuitive way and will advance the mobility of older persons. (AAL)28

• MobileSage provides to elderly people with context-sensitive, personalized and

location-sensitive tools, which allow them to carry out and solve everyday tasks and

problems in the self-serve society when and where they occur, “just-in-time”. (AAL

MobileSage Project)29

22 Gund, Lindecrantz, Schaufelberger, Patel, & Sjoqvistt; Attitudes among healthcare professionals towards ICT and

home follow-up in chronic heart failure care; BMC Medical Informatics and Decision

Making 2012, 12:138 doi:10.1186/1472-6947-12-138 23 L Spiru, I Karlhuber, I Turcu, N van der Vaart, S Schurz, JM Laperal; Advanced technology services for

supporting active seniors: The Mobile.Old project. Med-e-Tel 2014 Proceedings (CD-ROM); Global Telemedicine

and eHealth Updates: Knowledge Resources, Vol. 7, 2014. (in press) 24 L Spiru, I Solheim, I Turcu, J Rovira Simon, V Sanchez Martin; Smart technologies for seniors’ mobility: The

MobileSage project. Med-e-Tel 2014 Proceedings (CD-ROM); Global Telemedicine and eHealth Updates:

Knowledge Resources, Vol. 7, 2014. (in press) 25 Schneider C, Willner V, Feichtenschlager M, Andrushevich A, Turcu I, Spiru L; A user Centred approach to

analyse user requirements for a system supporting people with Dementia. Proceedings of the eHealth2013. May 23-

24; Vienna, Austria. OCG; 2013 26 Schneider C, Willner V, Feichtenschlager M, Andrushevich A, Turcu I, Spiru L; Collecting User Requirements for

Electronic Assistance for People with Dementia; A Case Study in Three Countries. Proceedings of the eHealth2013.

May 23-24; Vienna, Austria. OCG; 2013 27 Salzburg Research, AAL CONFIDENCE project – Mobility Safeguarding Assistance Service for People with

Dementia http://www.salzburgresearch.at/en/projekt/confidence_en/ 28 AAL Mobile.Old Project http://www.aal-europe.eu/projects/mobile-old/#sthash.6IKuMg4I.dpuf 29 AAL MobileSage Project– Situated Adaptive Guidance for the Mobile Elderly; http://www.mobilesage.eu/

http://www.salzburgresearch.at/en/projekt/confidence_en/

http://www.aal-europe.eu/projects/mobile-old/#sthash.6IKuMg4I.dpuf

http://www.mobilesage.eu/

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4.4 Devices for Falls Prevention and Detection

4.4.1 Existing Devices

Personal devices

Physical and biochemical sensors:

- Invasive: implanted brain stimulators for old people with Parkinson's disease, epilepsy,

depression;

- Non-Invasive: glucose and cardiac activity monitoring, respiration monitoring (optical,

acoustic, electric), piezoelectric sensors implanted in clothing that rely on radio

frequency for detecting movements bust, impedance measurements by level of glucose,

multi-parameter fusion data monitors, complex data analysis.

- miniaturize: MEMS (Micro-Electro-Mechanical-Systems), WIMS (Wireless Integrated

Microsystems).

Devices for assistance.

- Speech technology: we recognize synthesis, text to speech, speech to text, control

devices by voice, voice warning;

- Recovering items lost / misplaced.

Social alarm services.

- Activate "panic button" by the subject;

- Automatic activation "panic button" Passive

Elderly monitoring systems at home.

Several countries in Europe were launched pilot projects in this respect:

- UK (Liverpool City Council Telecare Pilot)

- Italy (Veneto Region Tesan system)

- Sweden (Old @ Home project initiatives complex)

- Denmark (CareMobil68) etc

- Barilife: Romania, Israel

4.5 Romania Facts

Medical parameters should be correlated with clinical status to identify individual risks (e.g.

predisposition to falls) and to estimate potential impacts of diseases / morbidity / poly-

pathology, which may lead to fall.

There is no standard protocol for preventing falls in Romania (according to the Ministry of

Health website), so standardization in this area would be welcome.

There is legislation in Romania in terms of interoperability standards for ICT. In the medical

field the gold standard system seems to be the HL7 one, already implemented by HL7

Foundation in Romania and TeamNet. (Romania H. L.)30

30 Honeywell Life Safety Romania www.hls-romania.com

http://www.hls-romania.com/

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An ITC-based system was implemented in Romania by the Honeyewell Live Safety Romania.

The display and information system Clino Dashboard is used to display information, calls and

alarms as part of the medical as nursing procedures of healthcare facilities. Clino Dashboard

thus provides information where needed and makes sense. The networking of Clino Guard

involving a nurse call system is a key feature: a wide range of functions makes it easier and

safer to organize care processes – from the protection of people suffering from dementia to

device tracking. In this way, an integrated solution has been created in order to combine all the

required functions. It provides practical support for caring process, including audit-proof

recording of all calls and alarms. (Patel, Park, Bonato, Chan, & Rodgers, 2012)31

Also, there is

an application of this sort launched by Barilife Foundation and the City Hall (bracelet sensors).

(Romania B. )32

The standardization activity, covering the whole national economy, began in 1928 when

Romania became a member of the IEC. The Standardization Commission of the Council of

Ministers of Romania was created in 1948 and marked the activity deployed in an organized

manner. Starting on 31 October 1998, the Romanian Standards Association (ASRO) has taken

over this position as a specialized private body of public interest in the standardization area, a

not-for-profit association authorized by the Government, replacing, in this respect, the former

Romanian Standards Institute. In accordance with Law 355/2002, the Romanian Government

granted ASRO recognition as a National Standardization Body that develops standardization

activities in all the fields of European and international standardization as member of ISO, the

IEC, CEN, CENELEC and ETSI. ASRO represents Romania in the international

standardization process by co-ordinating the national input, by organising the update of

information on standards and by providing a wide range of services, both for the distribution of

standards and accredited certification activities. (Romania A. d.)33

4.6 Conclusions

Currently, the communication technologies known as analogue telephony and television are

about to be replaced by digital solutions. Many major changes planned for the health care

system are opportunities for refurbishment nurse call systems, in order to transform them into

modern centres capable of efficient medical care. Equipment and infrastructure must be adapted

intelligently in order to achieve the easiest transition to future systems.

In the context of rapid global aging, societies or economies can no longer afford the “usual

care”, but require the design of new ways of care. Advanced technologies significantly meet this

need.

Technology can support and enable large-scale studies able to answer the outstanding questions

about falls. As the amount of clinical resources per older person is permanently increasing,

technological developments can help to streamline the spending of those resources, at the same

keeping the quality of care, or even enhancing it.

31 Patel, Park, Bonato, Chan, & Rodgers,; A review of wearable sensors and systems with application in

rehabilitation; Journal of NeuroEngineering and Rehabilitation 2012, 9:21 32 Barilife Romania,www.barilife.ro 33 Asociatia de Standardizare din Romania http://www.asro.ro

http://www.barilife.ro/

http://www.asro.ro/

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To achieve significant prevention/detection and reduction of falls incidence, a holistic life-long

approach combining cognitive, psychosocial and physical activities will be required. The

challenges are significant, but with close collaboration between fallers, falls experts and

technical experts they may be also achievable.

The actually ageing generations will have the needed technical skills and desire to educate

themselves and to self-manage their falls risks, but technology must be in place for them to do

so.

Primary care staff will require screening technology to identify people requiring a referral to

specialized assessment centres, and will need specific training for recognizing and advising frail

elders who are at risk to fall. (Kenny, Scanaill, & McGrath, 2011)34

34 Kenny, Scanaill, & McGrath, Falls Prevention in the Home: Challenges for New Technologies; Intelligent

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5. Industrial Perspectives

5.1 Introduction

Healthcare companies face changes in customer behaviour, market dynamics and regulatory

demands. The use of medical devices by patients in their home is developing considerably

because of a policy to cut down on the length of stay in hospital. This use has already been

experiencing a significant growth over the past few years (source: French National Health

Insurance Agency). Whilst medical devices today are used in stand-alone fashion, developments

in technology will enable them to move towards greater communication, thereby providing

them with fresh possibilities helping to ensure:

1) greater patient safety,

2) continued and regular monitoring of changes in the patient’s condition,

3) prolonged independent living.

First we will analyse the potential market for industrial application of ICT based fall prevention

products (market driven). The next approach is based on the potential available technology

(technology driven). The third market for ICT solutions is electronic health records. At the end

we will focus on the interoperability of medical devices and telehealth solutions.

5.2 Market Analysis

An industrial approach always starts by identifying markets, and then develop products for the

different market segments, called Product Market Combinations (PMC).

a. Primary care

Primary care refers to the work of health care professionals who act as a first point of

consultation for all patients within the health care system. Such a professional would

usually be a primary care physician, such as a general practitioner or family physician, a

licensed independent practitioner such as a physiotherapist, or a non-physician primary

care provider (mid-level provider) such as a physician assistant or nurse practitioner.

The primary care physician (family doctor) plays an important role in the prevention of

falls for older adults living independently in the community. They can interfere in the

several aspects of fall prevention: medication review, refer to an intervention (e.g. ergo

or physical therapist) or to a personal alarming system (with or without automatic fall

detection) as part of the home care. In case of more complex problems they will refer to

secondary care.

b. Secondary care

Secondary care is the health care services provided by medical specialists and other

health professionals who generally do not have first contact with patients, for example,

cardiologists, urologists and dermatologists. It includes acute care: necessary treatment

for a short period of time for a brief but serious illness, injury or other health condition,

such as in a hospital emergency department.

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Outpatient service.

Outpatient services are medical procedures or tests that can be done in a medical centre

without an overnight stay. Many procedures and tests can be done in a few hours.

Hospitals can provide an outpatient service for fall prevention. The goal is diagnose the

risk of falling and to refer to therapeutic interventions. The aim of medical management

is to identify factors that can contribute to falls and fracture risk such as osteoporosis,

multiple medications, balance and gait problems, loss of vision and a history of falls.

Also refer to a fall prevention intervention in the community is an option. An example

of use of body worn sensors in an outpatient service is the use of an activity monitor to

measure the burden of COPD during free living conditions35

. Figure 8 shows the

attachment of the activity monitor in the lung lab, Figure 9 shows the explanation of one

of the reports by the lung consultant.

Figure 8. Attachment of the activity monitor

(Source: McRoberts)

Figure 9. Explanation of the report by the lung consultant

(Source: McRoberts)

35

See http://www.youtube.com/watch?v=ASEOjR6KhKg for the video.

http://www.youtube.com/watch?v=ASEOjR6KhKg

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c. Tertiary care

Tertiary care is specialized consultative health care, usually for inpatients and on

referral from a primary or secondary health professional, in a facility that has personnel

and facilities for advanced medical investigation and treatment, such as a tertiary

referral hospital.

Rehabilitation

Specialized rehabilitation for fall prevention is mainly indicated for diseases which have

a clear fall risk. Examples are stroke, Parkinson’s disease, Huntington’s disease, lower

extremity amputation, COPD and others.

d. Home and community care

Many types of health care interventions are delivered outside of health facilities. These

services are seen as public health. The indication for a personal alarming systems is

often the concern of unnoticed or unreported falls of older adults living independent.

Most devices available in the market (Deliverable 4.1 chapter 5.2.2 Automatic wearable

fall detector) are developed for this emerging market. It is questionable if this service is

part of fall prevention as the alarm does not prevent falls but identifies falls.

The home environment can present many hazards. Common places for injurious falls

are the bathtub and steps. Changes to the home environment are aimed at reducing

hazards and help support a person in daily activities. Changes could include minimizing

clutter, installing grab bars in the shower or tub or near the toilet, and installing non-slip

decals to slippery surfaces. Stairs can be improved by providing handrails on both sides,

improving lighting, and adding colour contrast between steps. Improvement in lighting

and luminance levels can aid elderly people in assessing and negotiating hazards, as

discussed above. Currently, there is insufficient scientific evidence to ensure the

effectiveness of modification of the home environment to reduce injuries.

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e. Cost of care

The relation between the different levels of care related to the cost per day can be

illustrated with the following figure (Wals, 2008).

Figure 10. Cost of care per day

(Source: Jeroen Wals, Philips Research, Seminar ICT for Health & Wellbeing, 5 Nov 2008)

5.3 Technical Devices (Medical Device Directive)

For the medical industry and especially small and medium enterprises, a technological approach

is often the start of an innovation. There are two main approaches to observe the behaviour of

persons with a potential fall risk: dedicated body worn sensor systems, home instrumentation

(smart homes) and smart phones.

Dedicated body worn sensors

Since the late eighties digital and wearable monitoring systems came to the market. The first

activity monitors used piezoelectric sensors which was mainstream in US market. The

processing of the raw signals was in real time using simple algorithms with counts per epoch as

main outcome. These systems were successful in epidemiological studies. Europe research and

industrial development focussed on activity monitors with inertial sensors, raw data collection

and off line analysis. The main aim was to improve the specificity of the analysis. The first

method to identify classes of physical activity (sitting, standing, lying and locomotion) was

developed in The Netherlands in the early nineties and published in 1994 (Veltink PH, 1994).

The uptake of inertial sensors in smart phones further accelerated the development of the

sensors and further lowered the price.

For body worn sensors two different applications have been developed: systems that detect falls

and systems that predict the risk of falling.

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Fall detection This European tradition also made it possible to study the detection of falls using body worn

sensors. This approach seemed very attractive to serve the market of personal alarming systems

developing fall detection systems as add on to personal alarming systems. This is a growing and

potentially huge market. Several products came to the market but clinical application is still

restricted because false positive alarms are not appreciated by the subject as well as the care

giver. The development of valid detection of falls if still continuing worldwide but as far as we

know no valid method has been published in scientific literature.

Fall risk prediction

A new approach of fall risk detection using inertial sensors is recently developed in The

Netherlands (FARAO (VU Medical Centre, 2014)). In this approach older adults wear an

activity monitor for a week and the analysis of instability of gait during free living conditions is

added to the prediction model of falls (Rispens, 2014). This methods makes it possible to supply

specific information about physical activity for better interpretation of the risk behaviour. This

method seems potentially interesting because the method is easy to implement, relatively cheap

and based on objective real life data. This approach will be tested by the VUmc (Amsterdam) in

the mobility outpatient clinic. The method is also recognised as a potential outcome to evaluate

fall prevention interventions.

Smart phones

See FARSEEING.

Instrumentation in the homes (smart homes)

Several technologies are available to detect falls and physical behaviour in the home

environment.

5.4 Services

Cloud servers

Cloud computing is a marketing term referring to a model of network computing where a

program or application runs on a connected server or servers rather than on a local computing

device such as a PC, tablet or smartphone. Like the traditional client-server model or older

mainframe computing, a user connects with a server to perform a task. The difference with

cloud computing is that the computing process may run on one or many connected computers at

the same time, utilizing the concept of virtualization. With virtualization, one or more physical

servers can be configured and partitioned into multiple independent "virtual" servers, all

functioning independently and appearing to the user to be a single physical device. Such virtual

servers do not physically exist and can therefore be moved around and scaled up or down on the

fly without affecting the end user. The computing resources have become "granular", which

provides end user and operator benefits including on-demand self-service, broad access across

multiple devices, resource pooling, rapid elasticity and service metering capability.

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Electronic Health Record

An electronic health record (EHR) is a systematic collection of electronic health information

about an individual patient or population. It is a record in digital format that is theoretically

capable of being shared across different health care settings. In some cases this sharing can

occur by way of network-connected, enterprise-wide information systems and other information

networks or exchanges. EHRs may include a range of data, including demographics, medical

history, medication and allergies, immunization status, laboratory test results, radiology images,

vital signs, personal statistics like age and weight, and billing information.

5.5 Standardisation and interoperability

Standardisation (clinical pathways)

Clinical pathways, also known as care pathways, critical pathways, integrated care pathways, or

care maps, are one of the main tools used to manage the quality in healthcare concerning the

standardization of care processes. It has been shown that their implementation reduces the

variability in clinical practice and improves outcomes. Clinical pathways promote organized

and efficient patient care based on evidence based practice. Clinical pathways optimize

outcomes in the acute care and home care settings. An example of the development of a clinical

pathway COPD in The Netherlands is shown with the picture.

Generally clinical pathways refer to medical guidelines. However a single pathway may refer to

guidelines on several topics in a well specified context.

Figure 11. Clinical pathway COPD

(Source: (Long Alliantie Nederland , 2013)36

36 http://www.longalliantie.nl/files/5113/7994/2952/LAN_Zorgstandaard_COPD-2013-juni.pdf

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Interoperability

The faller’s landscape includes all the different care facilities: primary care, community care as

well as hospital care (Figure 12).

Figure 12. HIC health Informatics

(Source: http://medicine.dundee.ac.uk/)

Interoperability is the ability of making systems and organizations to work together (inter-

operate). While the term was initially defined for information technology or systems

engineering services to allow for information exchange, a more broad definition takes into

account social, political, and organizational factors that impact system to system performance.

Integration profile

An integration profile is a major communication function that allows two or more computer

systems to carry out a succession of coherent exchanges (workflow), previously identified and

specified using globally recognised, operational standards. The figure shows clearly that fall

detection carried out by the home care has to be communicated with the secondary care

(hospital) where the patient will be transported after an injurious fall event. When the patient

will be referred to residential care there is a third party involved in the care process.

Definition of core requirements

Definition of the core requirement first consists, in a given domain (fall alarming at home, fall

risk detection using medical devices, electronic health records), in listing the main exchange

functions that we want to computerise. To do that, users are invited to define the core processes

to be supported.

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Secondary care

The introduction of a new medical device using ICT in a hospital needs to pass several

professionals. First there is a safety check by the department of medical physics. The medical

device has to be accepted by the ICT department of the hospital and outcomes have to be

integrated in the electronic patient record of the hospital.

Homecare

A common procedure in the practice of use of a personal alarming system shows how the

different care givers are involved and should be informed about an injurious fall followed by an

emergency call and transport to the first aid of a hospital. The call centre that handles the alarms

might store data of all contacts with the clients. There are initiatives to use these data to identify

early indicators of functional decline. The Dutch market leader for personal alarming monitors

more than 800.000 persons in Europe with their call centres37

.

Figure 13. Fallers landscape

(source: McRoberts)

5.6 Conclusion

The Healthcare Standardization industry is highly regulated in order to ensure the safety of the

devices and their effectiveness for use. Regulators depend on published international standards

to define the detail that products must comply with in order to satisfy their essential safety and

effectiveness requirements. Since standards are the ‘currency’ or ‘language’ of requirements, it

follows that compliance with standards is a vital means of compliance with requirements of

European Medical Devices Directives and other international regulations.

Most medical devices identified in this project use body worn sensors, often integrated in

personal alarming systems. Those systems are used in the community for independent living as

well as institutional care. In both markets the intended purpose makes that these devices might

37 http://www.verklizan.com/content/

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classify for class 2. Early standardisation in this field can delay and even frustrate the

development of innovations.

Standardisation of the supply chain aims to increase patient safety, improve quality

(implementation of a quality management system) and pursuit of high reliability. Quality

management systems (QMS) should be included in all medical devices that are used in clinical

care. Medical devices of class 2 and higher are obliged to implement a QMS according to the

Medical Device Directive.

The first application for standardisation of collected data are the personal alarming systems.

This market is growing very fast and potentially can collect data about health status and risk of

functional decline including risk of falling. This sector has as far as we know a low level of

regulation cause they are part of home and community care. Standardisation in this market

could be potentially interesting.

Implementation of standards is also related to timing. Fall detection in order to improve

personal alarming systems seems to be ready for standardization because 7 systems are

identified in the market (see D 4.1)are identified in the market. However the validity of the

detection methods is still questionable.

When we look at the different markets the personal alarming systems as part of home and

community care is reaching thousands of older adults in an average European town. Penetration

is fast and therefore standardisation is relevant.

On the other side of the spectrum fall risk assessment using body worn sensors is still in a

preliminary phase of development and clinical testing. Personal alarming systems are often used

for vulnerable older adults still living independent during several months up to several years. A

lot of potential relevant information is collected about functional decline and health status.

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6. ICT Research and Development Perspective

6.1 Research and development on falls and activity monitoring

6.1.1 Current Technologies

Recognizing human activities with sensors next to the body has become an important research

area, which aims to create or improve innovative applications providing activity monitoring.

The ability to record and recognize individual daily activities is essential to determine the

degree of functional performance and general level of activity of a person (Karantonis D. M.,

Narayanan, Mathie, Lovell, & Celler, 2006). In health care field, long term analysis of human

activity could be helpful in early detection of diseases (Czabke, Marsch, & Lueth , 2011) or

even to encourage people to improve their activity level and to prevent the falling events. It

could also be useful for physiotherapy, helping to understand if the recommended exercises are

been correctly performed or even to assist those with cognitive disorders (Lopes, Mendes-

Moreira, & Gama, Semi-supervised learning: predicting activities in Android environment,

2012).

One of the most used approaches to monitor human activity is based on motion capture video

systems that could also be associated with pressure plates in the ground. These methods are

obtrusive, require massive devices and could only be used inside a laboratory environment,

requiring a high set-up and processing time as well as memory space to record it (Czabke,

Marsch, & Lueth , 2011). Motion sensors have become an interesting alternative to video

systems, because of their miniaturization, low cost and capability to record motion signals

within unobtrusive and wearable systems. Accelerometers and gyroscopes were also used in

previously studies for daily activity monitoring (Czabke, Marsch, & Lueth , 2011; Karantonis

D. M., Narayanan, Mathie, Lovell, & Celler, 2006; Salarian, et al., 2004), exercise information,

such as energy expenditure (Lee, Khan, & Kim, 2011), and fall detection (Qiang, et al., 2009).

Most of the commercial systems available in the market for fall detection are wrist bracelets or

pendants that require the user to activate an alarm button in case of falling. The system notifies

a remote monitoring center that responds to the alarm. However, there are also some solutions

for automatic fall detection, mainly based on wearable sensors (Bourke, OBrien, & Lyons,

2007; Bianchi, Redmond, Narayanan, & Cerutti, 2010; Chen, Zhang, Feng, & Li, 2012;

Karantonis D. , Narayanan, Mathie, Lovell, & Celler, 2006; Kangas, Konttila, Lindgren,

Winblad, & Jms, 2008; Bourke & Lyons, 2008). Systems based on wearable devices use body-

attached sensors such as accelerometers, gyroscopes or barometers to acquire kinetic data from

human motion.

In the last years, fall solutions based on the smartphone sensors (Dai, Bai, Yang, Shen, & Xuan,

2010; Abbate, et al., 2012; Sposaro & Tyson, 2009) have been growing due to the development

of inexpensive Micro Electro Mechanical System (MEMS) sensors and their inclusion in

smartphones. Using smartphones avoids the need to acquire other wearable sensors and since

users are perceiving them as personal, smartphones are less obtrusive items (Bianchi, Redmond,

Narayanan, & Cerutti, 2010). Despite the fact that elders today might still not be used to interact

with smartphones, the future older users who have grown up with the technology will probably

become an important market segment for this kind of applications. Smartphones are equipped

with a wide range of internal sensors, including accelerometers and gyroscopes, which can be

used to monitor human daily activities. These devices are practical, small and unobtrusive,

becoming an ideal platform for a pervasive activity recognition system. Other desirable features

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are the possibility to be wearable, always next to the user, work in real-time and be used for

long-term monitoring.

Figure 14. Activity recognition process pipeline (Anguita, Ghio, Oneto, Parra, & Reyes-

Ortiz, 2012)

Although there are some smartphone applications for fall detection (Mosa, Yoo, & Sheets,

2012; Igual, Medrano, & Plaza, 2013), most of them lack a representative dataset and

consensual methodologies for the validation protocol (Noury, Rumeau, Bourke, Laighin, &

Lundy, 2008). iFall application (Sposaro & Tyson, 2009) is an example of the use of the

smartphone built-in accelerometer to detect fall events. The algorithm is based on acceleration

magnitude thresholds, timeouts and long lie detection. If a fall is detected the system sends a

request for help to the caregivers. Abbate et al. (Abbate, et al., 2012) developed a waist mounted

system implemented as a finite state machine followed by a classification engine using a neural

network. Dai et al. proposed PerFallD (Dai, Bai, Yang, Shen, & Xuan, 2010), a pervasive fall

detection system implemented on smartphones. The algorithm is based on accelerometer

thresholds: the total and the vertical acceleration are compared with predefined thresholds,

adjusted with collected data.

6.1.2 Smartphone Based Solutions on Falls and Activity Monitoring

mHealth solutions have been discussed since the end of the 90s. The benefits for patients and

doctors of solutions that ease their daily lives are obvious and well known:

• eases the life of the patient (e.g. don’t have to stay at home)

• allows doctors to reduce regular visits

• enables hospitals to reduce their bed capacities (patients can leave hospital earlier)

• allows health insurance providers to reduce their case related expenses

• improves patient outcomes through improved compliancy

The remaining question is still what impact does the new smartphone application market model

created by Apple in 2008 has on the mHealth market. Will smartphone apps become the killer

application of the mHealth market? To answer the question one has to understand what stopped

the early mHealth market from being successful and determine what impact the new market

model has on those barriers. The following list focus on the main barriers which prevented the

mHealth market from growing in the past and the changes the new model will bring:

• Devices: Early solution providers had to live with limited device capabilities and in

order to achieve successful market entry and profitability had to find hardware partners

to develop the mobile device. Furthermore, reach was very limited for any kind of

smarter phone. Many of the features that early solutions providers had to find special

solutions for are now included as standard on smartphones (e.g. GPS or sensors).

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• Distribution: In the early days mHealth solutions providers had to seek partnerships

with MNOs in order to gain some support with the distribution of the service or had to

do it on their own. The new market model offers global reach without having to deal

with an MNO. Still, traditional distribution channels like doctors, hospitals and health

insurance providers are not being affected by the new model.

• Patients and doctors: The awareness of mHealth solutions was very limited. The new

market model offers a better user experience along the entire value chain: discovery and

access, billing and usage. The hype for smartphone apps also brings mHealth apps into

the spotlight of its potential users. Still, one of the biggest target groups for mHealth

solutions, the elderly, will have the biggest issues with technology adoption, although

they would benefit most from mHealth application usage. This mismatch will not be

changed by the new market model in the near future.

• Regulations: The new market model has only limited impact on one of the key barriers

– regulation. As long as mHealth solutions and services don’t get clearance from

national regulators and are thus not reimbursable by health insurance providers, patients

must pay expenses themselves. Doctors won’t prescribe e.g. a pill reminder application

and will have no financial incentive to propose such solutions to the majority of their

patients. The market will remain a consumer driven market, which means that the full

potential will remain untapped.

• Another barrier remains the discussion around security and confidentiality of data.

Major projects like electronic health records (EHR) have been mandated a decade ago

in some countries but implementation has been delayed until now mainly because of

security and confidentiality reasons. Section 7.2 will provide further details on the

current status of the Portuguese EHR.

6.1.3 Architecture and Common Standards for Mobile Solutions

The whole process for activity monitoring begins with gathering the raw data, in particular,

motion data. Inertial sensors are an adequate solution to detect motion. These sensors respond to

stimuli by generating signals that can be analyzed and interpreted (Wilde, 2010). Usually,

sensors are placed next to the body and should be comfortable for the user (Lopes , Mendes-

Moreira , & Gama, Semi-supervised learning: predicting activities in Android environment,

2012). The new generation of smartphones are equipped with a wide range of internal sensors,

including accelerometers and gyroscopes, which can be used to monitor human daily activities.

These devices are practical, small and unobtrusive, becoming an ideal platform for an activity

recognition system. Other desirable features are the possibility to be wearable, work in real-time

and be used for long-term monitoring (Lopes , Mendes-Moreira , & Gama, Semi-supervised

learning: predicting activities in Android environment, 2012). These devices can acquire,

process and obtain useful information from raw sensor data (Figo, Diniz, Ferreira, & Cardoso,

2010), but the key difficulty of creating useful context-aware applications is to develop

algorithms that can detect context from noisy and ambiguous sensor data (Bao & Intille, 2004).

Developing a smartphone application has to take into account the limited resources of

smartphone as processing time, limited memory and sample rate and accelerometers are an ideal

sensor because they require low processing power and energy consumption.

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Some setup protocols for human activity data acquisition have been reported in the literature

(Figo, Diniz, Ferreira, & Cardoso, 2010; Bao & Intille, 2004). There are three main concerns

regarding sensors: type, location and number. The majority of motion-aware systems have used

inertial sensors, particularly accelerometers, to estimate the inclination of the body from the

vertical and to determine the orientation and movement of the user (Wilde, 2010). The new

generation of Smartphones is being considered by users as an important personal device,

together with an exponential availability. These devices have an increased potential for an

adequate mean of gathering motion data, to use for building human activity prediction systems.

The perception of their benefits are becoming commonplace, as users have become accustomed

to their ubiquity (Wilde, 2010).

A fragmented approach to solution development is one of the reasons that sustainable

commercial models for mobile health have been slow to develop. To become cost-effective and

commercially-sustainable for the mass-market, mobile health services will need to be based on

standardized, open and interoperable solutions. There is no single standards organization that

covers the complete needs of mobile health. Some organizations, such as the Continua Health

Alliance and the Integrating the Healthcare Enterprise (IHE), are addressing this issue by

providing interoperability guidelines that group standards together into profiles, combining data

standards, security standards, messaging standards and transports together into a single

certifiable solution. However, there is still some way to go before the mobile health sector has a

fully interoperable set of standards that is universally-adopted, and market volumes have yet to

justify the sort of equivalent investment that resulted in the mobile industry offering handsets

that support roaming across multiple network protocols.

6.1.4 Usability Challenges and Recommendations for Mobile Solutions

Technology has the potential to improve the quality of life and well-being of older adults.

However, this audience still has to face several challenges in order to be included in an

increasingly technological society. This fact puts older adults at a disadvantage and it requires

researchers and practitioners to deliver products which are suitable for them, this way ensuring

that they are not excluded from the benefits that technology can provide.

The stereotype that the older population is still unwilling to use computers is deprecated, and

more and more, elders use technology in their daily life. In fact, the main reason for a still lower

acceptance rate of technology among older adults is the disregarding of their characteristics

during the design process. Elders’ characteristics and needs are very different from the

mainstream audience and the number of systems that consider these differences is scarce to non-

existent. This situation brought us to an era of a “Digital Divide” between technology and the

older population (Cresci, Yarandi, & Morrell, 2010). This situation can be modified by using a

more creative approach (Opalinski, 2001) and if developers become “more willing to draw from

gerontologists and elders as they develop, test, refine, and market their products” (Scialfa &

Fernie, 2006). In doing so, the creation of systems and services that address a need or interest

and that users perceive as worthwhile (Hanson, 2010) could more easily appeal to the older

audience, decreasing their qualms towards technology.

Guidelines to increase acceptance

When designing a product for older adults a number of considerations should be taken into

account, in order to increase their acceptance level of the product. These practices are not

directly related to interface design; nevertheless they are of utter importance on the design phase

for a new product or service.

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Provide a humanly rich experience As older adults age, losing family and friends may force them to "reconstitute a

meaningful social world" (APA, 2003). The system’s interface might be a "gate",

connecting them to one of their few human contacts; it is crucial that the older adult feels

satisfied with this communication.

Plan the interaction for the older adult but also for his caregivers

Older adults with chronic conditions probably live accompanied. If a health system

excludes the caregivers, not only it ignores an important piece of the patient’s life, it also

makes the helpers feel useless.

Describe clearly the goal and the outcomes of using your product Dealing with losses – be them physical abilities or even loved ones – brings an awareness

of one's limited opportunities, causing the individual to concentrate on more rewarding

activities (APA, 2003). If the reward is not found relevant, the product won’t be easily

accepted.

Be aware that some older adults will refuse to learn According to (Lindberg, Carstensen, & Carstensen, 2008), the ideas one has of old age

affect the way that individuals learn. In particular, the willingness to learn something new

is known to decrease with age.

Minimize the need to unlearn well "learned" procedures Each time a product changes, one must replace a previous procedure with a new one.

Older adults have shown greater difficulties unlearning procedures (Fisk, Rogers,

Charness, Czaja, & Sharit, 2009), so this should be minimized.

Maximize remote management Older adults may live in rural places with little access to resources like transports (APA,

2003). Because of this, maintenance tasks can be difficult. To deal with these situations,

the system should be prepared to be managed remotely.

Plan carefully the prices of products and services for the user This audience is often coping with economic issues (Smyer, Schaie, & Kapp, 1996). For

this reason, prices for the user should be carefully thought as they also determine

acceptance.

Make use of behaviors developed by older adults to cope with memory loss Older adults will notice that they are losing short-term memory and will start using notes

and other mechanisms to remember things. These procedures can be of great help for the

user, when using a new product for the first times, so they should be encouraged.

Don’t forget older adults did not grow up using computers They may feel more intimidated and will (naturally) face more challenges because they

are not familiar with many metaphors used by such devices.

Give seniors time to learn Cognitive changes are responsible for a decrease in short-term memory and a slower

"processing speed". By holding a smaller amount of information, short-term memory will

likely cause problems in learning.

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Don’t forget older adults wear glasses Recent studies revealed that 92% of the individuals above 70 years wear glasses

(Charness & Schaie, 2003).

Provide redundant channels of communication Because of perception limitations, older adults rely more on the contextual and nonverbal

aspects. Videoconference for example is better than pure-audio communication because

of the visual cues it provides (Fisk, Rogers, Charness, Czaja, & Sharit, 2009).

Guidelines for device manipulation

The following guidelines consider smartphones or tablet devices only. Other mobile phones are

not considered.

Avoid two-handed gestures Older users have been found to hold mobile devices with two hands instead of only one,

unlike their younger counterparts. This could be due to differences in grip strength (Siek,

Rogers, & Connelly, 2005). Avoid specially small devices

Devices that are too small are difficult for older adults to hold comfortably. Joint stiffness

can make it harder to grasp or hold small devices (Kurniawan & Zaphiris, 2005).

Include descriptions of gestures to promote discoverability Gestures that are commonly known and accepted by younger users - such as pinch and

drag - may not be obvious to an older audience (Kobayashi, et al., 2011).

Adjust scrolling speed When scrolling is needed the speed rate should be slower than the standard. Scrolling can

be hard for older adults for various reasons:

- they may not understand the metaphor and be reluctant in using it;

- Fine-motor control might be impaired making it hard, painful or tiresome to perform

multiple flick/drag gestures (Fisk, Rogers, Charness, Czaja, & Sharit, 2009).

Avoid placing important actionable content at:

- The top left corner or bottom right corner (for right handed users)

- Opposite for left-handed users of the touch surface

These sections might be difficult to reach, especially for older users with reduced manual

motor abilities.

Provide UI buttons to complete any task that would be done through gestures

Older adults might have trouble in executing certain gestures, due to losses in manual

dexterity, and therefore should be provided with the option to complete any action by

using buttons. For example, older adults may have difficulty in performing a swipe

gesture to scroll and, in order to compensate for this finding; arrows should be included in

the interface for scrolling purposes.

Provide continuous scrolling When the users keep their fingers on a scrolling arrow, the content should keep scrolling

in order to prevent multiple presses that might be hard or strenuous for older adults to

perform.

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Adjust the tap and long press thresholds to accommodate elderly preferences Older adults generally press longer than their younger counterparts, making most systems

interpret what should be a tap, as a press and hold.

Extend actionable areas (buttons, for example) so that they are larger than the

actual visual target itself This compensates for miscalculations that users tend to have when aiming for a target,

partly because in the case of small screens most of the target is occluded by one’s finger.

Include visual feedback

It might be helpful to include proper visual feedback indicating where the user touched

the screen, even if the target was missed (Kobayashi, et al., 2011).

Provide multimodal feedback Multimodal feedback has been shown to improve interaction perception and accuracy for

older adults. This means that combinations of type of feedback - auditory, haptic, and

visual - can be beneficial. Even though auditory feedback has been found to help most

groups of users, due to the mobile character of smartphones, it might not be the best

option. A combination of visual and haptic feedback may be the best solution for mobile

devices.

When auditory feedback is given, background noise should be taken into account

When speaking of mobile devices, you should probably prepare for loud, noisy

backgrounds and set auditory feedback at 10 db higher than the background noise by

default, but never over 90 db which is the upper limit for security. In addition, always

provide controls that let the users define the volume of auditory feedback.

Vibration frequency should be around 25hz for older adults A significant loss in sensing high frequency vibrations occurs with the aging process

(Fisk, Rogers, Charness, Czaja, & Sharit, 2009).

6.1.5 OS Specific Guidelines

Each mobile platform has unique interface components, capabilities and requirements. If a

product spans multiple platforms, it should function and look as consistently as possible.

Nevertheless, it must also respect platform constraints, and inherit its own unique design and

interaction paradigms.

Android

Further information regarding Android Design Guidelines can be found at:

http://developer.android.com/design/index.html

iOS

Further information regarding iOS Design Guidelines can be found at:

http://developer.apple.com/library/ios/#documentation/UserExperience/Conceptual/MobileHIG/

Introduction/Introduction.html

Windows Phone 7

Further information regarding Windows Phone 7 Design Guidelines can be found at:

http://msdn.microsoft.com/en-us/library/hh202915(v=vs.92).aspx

http://developer.android.com/design/index.html

http://developer.apple.com/library/ios/#documentation/UserExperience/Conceptual/MobileHIG/Introduction/Introduction.html

http://developer.apple.com/library/ios/#documentation/UserExperience/Conceptual/MobileHIG/Introduction/Introduction.html

http://msdn.microsoft.com/en-us/library/hh202915(v=vs.92).aspx

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6.1.6 Design Standards

The standard ISO 9241-210(2010) provides guidance on human-centered design activities

throughout the development life cycle of interactive computer-based systems. According to it,

the activities are carried out in an iterative way, with the cycle being repeated until the design

solutions meet the defined requirements.

Figure 15. ISO 9241-210 (2010) Human-centered design process for iterative systems

(Source: http://www.usabilitypartners.se/about-usability/iso-standards) 38

6.2 Framework of the Portuguese National Health System

6.2.1 Organization of Resources, Provision of healthcare and Funding

The provision of healthcare in Portugal is characterized by the coexistence of a National Health

Service (NHS), public and private subsystems specific for certain professional categories and

voluntary private insurance. The NHS is the main healthcare providing structure, integrating all

aspects of healthcare, from promotion and surveillance to disease prevention, diagnosis and

treatment, as well as medical and social rehabilitation.

The Portuguese Health System simultaneously includes public and private funding. The NHS is

mostly (90%) funded with taxes, with subsystems funded by workers and employees, while

private healthcare funds come from co-payments and direct payments from patients, as well as

from health insurance premiums.

The last decade was marked by a set of reforms on the Portuguese NHS, with particular

incidence on the hospital network and emergency services, on primary healthcare (CSP) and on

long-term care (CCI). The hospital network in Mainland Portugal comprises 212 hospitals, 91

of which are privately-owned. The 363 Primary Care Centers were organized into 74 Groups of

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Primary Care Centers (ACES). In 2012, 342 Family Healthcare Units and 186 Community Care

Units were in operation. The number of available contracted beds as of 31 December 2011 in

the National Long-Term Care Network was 5595. These beds were distributed according to the

following types: 906 for convalescence, 1747 for medium-term and rehabilitation use, 2752 for

long-term and maintenance use, and 190 for palliative care.

6.2.2 Portuguese Healthcare Data Platform – Plataforma de Dados de Saúde

The Portuguese Electronic Health Record is based on a web platform, currently in development

by the Comission for Clinical Informatics (CIC, from the Portuguese Comissão para a

Informatização Clínica), created by a dispatch from the Health Secretary of State near the end

of 2011, and the Ministry of Health’s Shared Services (SPMS, from the Portuguese Serviços

Partilhados do Ministério da Saúde), that provides a central clinical information storage and

sharing system in keeping with the requirements of the National Comission of Data Protection

(CNPD, from the Portuguese Comissão Nacional de Proteção de Dados). It allows access to

registered users’ information by health professionals throughout the NHS. Each access to this

information is restricted and registered in an access history.

The Portuguese Healthcare Data Platform, known as Plataforma de Dados de Saúde (PDS),

constitutes the national health record data sharing facility, uses webservice technology to link

old and new existing applications, and by this means, provides information through different

Portals/areas to different stakeholders, namely:

• Citizen Portal (Portal Utente) officially launched in May 2012 – constitutes a Personal

Health Record area and patient online services like ebooking, eordering and health

education; This portal was launched on the 31st of May, 2012 and had on the 19th of June,

2012 over 5000 registered users. It allows the insertion of data such as emergency contacts,

health data, habits, medications, allergies, diseases, authorizations/audits or health

clinic/family health unit contacts. The sharing of information is managed by the user

himself. The information is only be available throughout the country if the patient alows so.

It also enables access to services such as the National Patient Database (RNU), the eAgenda

to book medical appointments or request renewal of prescriptions for chronic patients and

the program SIM-Cidadão to make suggestions, complaints, complements and

acknowledgements to the NJS.

• Health professional area (Portal do Profissional) officially launched in June 2012 – provides

access to patient clinical data to more than 370 institutions. The data is stored in servers and

records of more than 430 institutions and over 5 central repositories, covering all primary

care and all public hospitals. Expansion to social and private sector is undergoing. The

information showed on this portal needs to be granted access by the patient on his PU.

• PDS will allow central institutions acess to anonymized data through the Institutional Area

(Portal Institucional).

• PDS includes the International Portal (Portal Internacional) within the scope of epSOS pilot

project participation. This will enable the pilot to serve as electronic patient’s summary

review for professionals and extended its use cases to include patient interaction for

managing his health wherever he is located in Europe (and beyond) as well as the adoption

of other epSOS approaches. In the context of epSOS II, the platform will be evolved to be

compliant with the epSOS core services of Patient Summary based on the Portuguese

Patient Summary currently being finalised. Portugal receives EU/EEA patients throughout

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all year especially tourists. This seasonal population was 7.3 Million in 2011. Foreign

students and migrant workers are another relevant group.

6.2.3 Architecture, Protocols and Data Protection

The Healthcare Data Platform (PDS) is, as referred previously, a web platform that enables

sharing and recording of clinical information from the patients registered in the Portuguese

Healthcare System. The platform follows the requirements of the Data Protection Commission

(CNPD) and the data is shared straight from the PDS repositories, can be audited and the access

can be restricted by the patient.

Architecturally, PDS is divided in 3 modules:

• Portals and information sharing services;

• Connections between organizations and Patient’s area;

• Information repository (timeline).

The first module has been described previously. The second module is built to work with web

services and Representational state transfer (REST) and PDS uses both as a way to

communicate with other applications or services. It uses POST for the connections between

organizations like Hospitals and Primary Care Centers so it can show the episodes on the

Portals and it uses web services to communicate with external applications. The REST

communication uses HL7 V2 (see Section 8.1.2) in most of the cases and is encrypted using

Data Encryption Standard (DES). The encryption is based on the institution code and acronym

and an encryption key. When accessing patient information stored in another Institution, the

patient information is always validated against the National Patient Database (RNU), to check

for fraud. Also, all communication between PDS and other applications or access to data

through the Portals is logged and the log can be accessed by the patient, the practitioners and the

institutions where the data is recorded.

The third module works as an information repository. The data stored on the PDS is centralized:

the entries on the timeline are links to the description of the episode on the institution where it

occurred. Thus, we have the clinical episodes information recorded locally on the systems

where they occurred and a timeline of links to the local information from the episodes

centralized on the PDS.

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PDS follows the Metropolis Architecture design proposed by Rick Kazman. The core of the

Metropolis is the combination of an enterprise service bus (ESB) and the Portals, as shown

Figure 16.

Figure 16. PDS diagram

Moreover, the PDS platform provides a referencing bridge to healthcare institutions so that they

can share information related to a patient’s care. It handles REST requests in order to provide

access control functionalities and facilitate communication of duly authorized information

between institutions. It does not, therefore, depend on any specific technology to be

implemented by the institutions as long as the defined URL structure for the requests is

followed.

The basic functionality of the protocol used can be described as follows:

• The institution wishing to retrieve information from another institution constructs and

sends a request with encrypted arguments according to its local PDS access

configuration;

• The PDS verifies the authenticity of the request and access authorization;

• The PDS analyses the request by decrypting and validating its arguments;

• The PDS validates the user’s identity through the national patient registry (RNU);

• The PDS constructs and sends the access request to the target institution’s interface with

argument encryption;

• The target institution verifies the authenticity of the request and access authorization;

• The target institution locally validates the user’s identity;

• The target institution provides its own interface for the requested information.

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6.3 Conclusions

Most mobile health solutions are vertically-integrated and closed solutions, which makes it

difficult to integrate devices and products from other providers into the solution. For mobile

health to reach its full potential, healthcare system architectures will need to open up and

become interoperable, both in terms of getting information into the healthcare systems and to

exchange data between back-end solutions.

As described in this document, there are a number of well-defined standards and conformance

profiles, including the Continua Health Alliance designs and the IHE profiles. The component

standards for clinical messaging, clinical coding and communications, such as HL7, IEEE

11073, and various wireless Internet standards, are also clear and well established.

Within the scope of these standards, requirements for development seem clear. Documentation

and examples provide a good starting point. However, it is clear that the scope of these

standards is limited. Nevertheless, adoption of the existing standards does not preclude

upgrading or migrating to more complete standards in the future. Therefore, it would seem

appropriate to encourage new entrants to the mobile health ecosystem to adopt the existing well-

documented standards to expedite the wider deployment of mobile health solutions.


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7. Regulatory Perspective

7.1 Introduction

ICT based fall prevention & intervention devices are relatively new on the European market and

still in a maturing phase. This area is largely driven by SME´s.

The devices are predominantly used in the home setting but may also be used in an out setting

during normal outdoor activities as well as in different care giver settings.

ICT based fall prevention & intervention devices may or may not be classified as medical

devices, they may include alarm functionalities for the user and also for the user’s habitation,

they may incorporate different means of user communication with e.g. care givers and/or

relatives, positioning means, retrieving- storing and transferring of patient data etc. All of which

affects which regulatory requirements will be posed upon them.

The medical and consumer spaces are converging and ICT based fall prevention & intervention

devices challenge the EU regulatory framework and raises new questions and concerns in that it

combines IT, telecom, medical device, home surveillance and several other technologies and

applications.

It is of decisive importance that the legal framework provides means to secure that ICT based

fall prevention & intervention devices are safe and efficacious, but to promote progress and be

supportive of innovation it is also important that the legal framework provides an environment

which does not pose unjustified regulatory burdens on the manufacturers. A balanced and

efficient regulatory approach is necessary to allow for innovation but also for creating

confidence among the different stakeholders.

In this context we will analyze the conditions for the current EU regulatory framework to

provide an effective yet appropriate legal framework for nourishing the further advancement of

ICT based fall prevention & intervention devices.

7.2 Applicable EU Directives

The Package of measures known as the "New legislative framework" was adopted in Council on

9 July 2008 and published in the Official Journal on 13 August 2008. The measures are

designed to help the internal market for goods work better and to strengthen and modernise the

conditions for placing a wide range of industrial products on the EU market (European

Commission, 2014).39

The New legislative framework (NLF), consisting of Regulation (EC) 765/2008 and Decision

768/2008/EC, supersedes the New Approach Directive, 85/C 136/01, which has been in force

since 1985.

39

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-

legislative-framework/index_en.htm

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-legislative-framework/index_en.htm

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-legislative-framework/index_en.htm

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From the NLF it is evident that:

Essential requirements define the results to be attained, or the hazards to be dealt with, but do

not specify the technical solutions for doing so. The precise technical solution may be provided

by a standard or by other technical specifications at the discretion of the manufacturer. This

flexibility allows manufacturers to choose the way to meet the requirements (European

Commission, 2014).40

This is a very important basic principle laid down already in the New Approach Directive and

maintained in the NLF because it prevents the regulatory framework from rapidly becoming

obsolete in the current climate of rapid technical development and is an effort of dealing with

the issue of a fast industry and slow regulators.

Having this said, applying an appropriate standard when available, in full or in part, is usually

the optimal approach for demonstrating compliance with the essential requirements.

If a manufacturer do choose to apply a standard harmonised with a specific Directive,

complying with the standard automatically leads to product compliance with the essential

requirements covered by that standard. This is called the presumption of conformity.

It is estimated that there are some 1838 EU Directives (EUABC, 2014)41

and it is the obligation

of each manufacturer to assess which Directives that are applicable to a specific device and to

demonstrate product compliance with the applicable Directives, a challenging task especially

for SME´s.

In most cases products are covered by more than one Directive. The “New legislative

framework” states that one single Declaration of Conformity (DoC) covering all relevant

Directives has to be issued (Article 5, Decision no. 768/2008/EC) (THE EUROPEAN

PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 2008).42

For medical

devices, this provision has not yet been incorporated in the Medical Devices Directive.

Therefore, for now, the manufacturer has the choice to issue a single combined DoC or to

provide a separate declaration for each relevant Directive (COCIR, 2013).43

If the manufacturer

choose to declare product compliance in a single DoC, the name, address and identification

number of the Notified Body involved per Directive should be specifically declared (Eucomed,

2013).44

The situation is further complicated by the fact that it is not the Directive(s) per se with which

the manufacturer shall demonstrate product compliance, but with the national legal

implementation of the respective Directive in the country in which he will first place the product

on the market. The reason being that Directives relates to EU member states, not to

manufacturers.

40

http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item_id=7326 41

http://en.euabc.com/word/2152 42

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF 43

http://www.cocir.org/site/fileadmin/Publications_2013/COCIR_Guide_on_RoHS_II_Directiv

e_obligations_-_25_April_2013_final.pdf 44

http://www.eucomed.be/publications/download/224/file/130522_paper_on_rohs_ce_marking.

pdf

http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item_id=7326

http://en.euabc.com/word/2152

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF

http://www.cocir.org/site/fileadmin/Publications_2013/COCIR_Guide_on_RoHS_II_Directive_obligations_-_25_April_2013_final.pdf

http://www.cocir.org/site/fileadmin/Publications_2013/COCIR_Guide_on_RoHS_II_Directive_obligations_-_25_April_2013_final.pdf

http://www.eucomed.be/publications/download/224/file/130522_paper_on_rohs_ce_marking.pdf

http://www.eucomed.be/publications/download/224/file/130522_paper_on_rohs_ce_marking.pdf

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A brief overview of some main EU Directives applicable to ICT based fall prevention &

intervention devices is given below:

EU Directive 93/42/EC concerning Medical Devices (MDD) (THE EUROPEAN

PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 1993)45

The Medical Devices Directive will be discussed in detail below.

EU Directive 1999/5/EC on Radio equipment and telecommunications terminal equipment

(R&TTE) (THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN

UNION, 1999)46

eHealth devices quite frequently comprise a radio transmitter e.g. a GSM or Bluetooth

transmitter. The radio transmitter may be incorporated in a third party device such as a mobile

phone which the eHealth device manufacturer intends to place on the market as part of a system.

He should then, as a minimum, exhibit a DoC from the third party manufacturer declaring

product compliance with the R&TTE Directive.

The radio transmitter may also be incorporated in a device which is itself manufactured by the

eHealth device manufacturer. In such case it should either be demonstrated that the eHealth

device manufacturer has closely followed the implementation guide lines from the radio

transmitting chip manufacturer wherein further testing is usually not required, or he should

perform testing of the finished device in conformity with applicable essential requirements of

the R&TTE Directive.

The R&TTE Directive has very few essential requirements and there are harmonised standards

for all of these essential requirements. Demonstrating compliance with the R&TTE Directive

therefore is a quite straightforward process.

EU Directive 95/46/EC on the protection of individuals with regard to the processing of

personal data and on the free movement of such data (THE EUROPEAN PARLIAMENT

AND THE COUNCIL OF THE EUROPEAN UNION, 1995)47

/ The General Data Protection

Regulation (GDPR) (EUROPEAN COMMISSION, 2012)48

The Data Protection Directive which was adopted in 1995 regulates the processing of personal

data within the European Union. Since the Data Protection Directive was adopted in "the year of

the web", it has become increasingly obsolescent. Furthermore, since it is a Directive there is a

patchwork of some 30 national regulations with quite differing requirements.

The current framework remains sound as far as its objectives and principles are concerned, but

it has not prevented fragmentation in the way personal data protection is implemented across

the Union.

On the 25th of January 2012 the European Commission proposed an EU General Data Protection

Regulation. (European Commission, 2012)49

The regulation is planned for adoption in late 2014

and, with a transition period of two years, to become effective in 2016. Since this legal

instrument takes the form of a regulation instead of a Directive, it will reduce legal

45

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF 46

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31999L0005&from=EN 47

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31995L0046&from=EN 48

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0011:FIN:EN:PDF 49

http://europa.eu/rapid/press-release_IP-12-46_en.htm?locale=en

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31999L0005&from=EN


http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0011:FIN:EN:PDF

http://europa.eu/rapid/press-release_IP-12-46_en.htm?locale=en

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fragmentation and provide greater legal certainty by introducing a harmonised set of core rules

for all EU member states.

EU Directive 2012/19/EC on Waste Electrical and Electronic Equipment (WEEE II) (THE

EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 2012)50

Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE II) entered into

force on 13 August 2012 and Member States were required to transpose the Directive into

national law by 14 February 2014. At that time, Directive 2002/96/EC (the “old WEEE

Directive”) was repealed.

The Directive aims to prevent or reduce the negative environmental effects resulting from the

generation and management of WEEE and from resource use.

Medical devices have been excluded from the previous WEEE Directive but the WEEE II

Directive is mandatory for medical device manufacturers. Still excluded are medical devices

that are expected to be infective prior to end of life as well as active implantable medical

devices.

From the entry into force of the WEEE II, medical devices will be subject to a recovery target of

70% and a recycling target of 50%. These targets will be increased on 15 August 2015 to 75%

and 55% respectively. After the introduction of the new equipment categories on 15 August

2018 the recovery and recycling targets for medical devices will become 85% and 80%

respectively for ‘Large’ equipment and remain at 75% and 55% respectively for ‘Small’

equipment. (Eucomed, 2012)51

EU Directive 2011/65/EC on the restriction of the use of certain hazardous substances in

electrical and electronic equipment (RoHS II) (THE EUROPEAN PARLIAMENT AND

THE COUNCIL OF THE EUROPEAN UNION, 2011)52

The RoHS II Directive became mandatory for medical devices on the 22 July 2014.

RoHS II is now a CE-marking Directive which means that the manufacturer must compile the

necessary technical documentation to demonstrate product compliance and draw up an EC

Declaration of Conformity. When addressing compliance to RoHS II, the DoC must contain a

disclaimer stating that it is issued under the sole responsibility of the manufacturer underlining

the manufacturer’s responsibility for compliance with the Directive.

Manufacturers must ensure that components are compliant with RoHS II. Usually, requesting a

certificate from the supplier certifying RoHS II compliance will be sufficient. In case there is

reason to doubt the supplier certificate though, the manufacturer has an obligation to pursue in

the establishment of compliance.

In November 2012, the EN 50581 standard became harmonised with regard to the RoHS II

Directive, why complying with the standard will provide a presumption of conformity to the

relevant provisions of RoHS II.

50


51

http://www.eucomed.be/blog/124/104/The-impact-of-WEEE2-on-the-medical-devices-

industry 52

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0065&from=en


http://www.eucomed.be/blog/124/104/The-impact-of-WEEE2-on-the-medical-devices-industry

http://www.eucomed.be/blog/124/104/The-impact-of-WEEE2-on-the-medical-devices-industry

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0065&from=en

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7.3 Overview of EU Regulatory Framework for Medical Devices

7.3.1 Current Regulatory Framework

The Medical Devices Directive came into force in 1993. It has been amended several times, the

most important amendment was in 2007 with which compliance became mandatory on March

21, 2010.

The MDD is a so called New Approach Directive which means inter alia that the manufacturer

must demonstrate product compliance with applicable essential requirements and choose

conformity assessment route in order to demonstrate compliance.

The MDD has basically four different device classes; Class I, Class IIa, Class IIb and Class III

depending on the criticality of the device i.e. the risks posed to the patients and users.

For medical devices there is no pre-market authorisation by a regulatory authority as is for

pharmaceutical products but instead there is a conformity assessment which, for medium and

high risk devices (Class IIa, IIb, III), involves an independent third party for pre-market

assessment, a so called Notified Body.

For Class I medical devices, the manufacturer must register the device with the Competent

Authority in the country of which he first places the device on the market.

A very common misunderstanding among medical device manufacturers is that the MDD has

different device requirements depending on the classification and most especially that Class I

devices have lower requirements. However, the MDD does not differ in terms of device

requirements for the different classes but only as regards the degree of Notified Body

intervention in the conformity assessment. A Class I device manufacturer must also compile a

complete technical documentation demonstrating product compliance with all applicable

essential requirements which therefore must include e.g. a device risk analysis and a clinical

evaluation.

Having this said, naturally it is usually easier to demonstrate compliance with the essential

requirements for a Class I device than for devices of higher classes, but the same documents

will still be required in the technical documentation.

The MDD has more than 60 essential requirements, all of which are not applicable to a single

medical device, and there isn´t harmonised standards for all of these essential requirements.

Demonstrating compliance with the MDD is therefore a considerably more challenging task

than with e.g. the R&TTE Directive.

In general the MDD has succeeded as a legal instrument for the medical device industry with its

huge spectrum of products, there are around 500,000 or more different types of medical devices

on the market, and with manufacturers ranging from start-ups and SME´s to large enterprises.

Main criticism has referred to differing implementation and application in the different EU

member states leading to uneven competition.

The Competent Authorities have rightfully been criticized for insufficient surveillance and

follow-up of Notified Bodies and of manufacturer’s compliance with the Directive. This in turn

enables non-complying manufacturers cost and time savings in regulatory management which

leads to uneven competition and might lead to patient and user risks.

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The inconsistent performance of Notified Bodies has also been a subject of criticism and is a

concern on EU level.

Proper functioning of notified bodies is crucial for ensuring a high level of health and safety

protection and citizens' confidence in the system which has come under severe criticism in

recent years due to significant differences as regards, on the one hand, the designation and

monitoring of notified bodies and, on the other, the quality and depth of the conformity

assessment performed by them, in particular in their assessment of the manufacturers' clinical

evaluation. (EUROPEAN COMMISSION, 2012)53

Medical devices have e.g. been placed in the market with a wrongfully lower classification,

especially with an incorrect Class I classification in order to avoid Notified Body intervention.

Medical devices have been placed in the market without sufficient clinical evaluation and

products have been placed in the market as non-medical devices although the intended purpose

pronouncedly has been diagnosis and/or treatment of human beings.

Apart from the insufficient and variegated performance of the Competent Authorities and

Notified Bodies, the MDD is an impressively purposeful yet flexible legal framework with an

adaptability to the exceedingly wide scope of medical devices. The MDD is more flexible than

probably most medical device companies and especially SME´s realize.

It is the obligation as well as the privilege of the manufacturer to define the intended purpose of

the device he is about to place on the market. Keeping the MDD definition of a medical device

closely in consideration, the manufacturer is free to choose an intended purpose rendering the

device to be classified as a medical device or not. The intended purpose may or may not affect

the features and characteristics of the device.

If the manufacturer choose an intended purpose rendering the device to be classified as a

medical device, the formulation of the intended purpose may still affect the MDD classification

of the device and the concomitant regulatory burden.

Carefully elaborating the intended purpose of a device is not a question of dodging or

circumventing the regulatory framework, it is a question of a deliberate manufacturer decision

on how he intends his device to be used and which market segments he intends to approach.

The scope of the intended purpose affects potentially available market as well as the regulatory

onus. A more wide scope e.g. including ambulance and helicopter use will increase the

potentially available market but also increase the verification and validation required to

demonstrate product compliance with applicable essential requirements and thereby likely

increase time to market. A more narrow scope on the other hand e.g. restricting to hospital use

only, will decrease the potentially available market but also decrease the verification and

validation required and thereby likely decrease time to market.

As defined already in the New Approach Directive and maintained in the NLF, the application

of standards remains voluntary on behalf of the manufacturer and the manufacturer is free to

choose any other means of demonstrating product compliance with applicable essential

requirements, even to choose parts of standards. This is also a very pragmatic and useful quality

of the Directive.

53

http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

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The MDD is quite pragmatic in how to meet the applicable essential requirements and in how to

demonstrate that the requirements have been met which gives the manufacturer a substantial

degree of freedom. Because of this flexibility, the requirements are not very explicit and it is not

all clear how to meet the requirements or demonstrate how the requirements have been met

which therefore can be quite a challenge especially for SME´s who cannot afford an

experienced regulatory manager.

7.3.2 Proposed Changes

The fact that the MDD is a Directive and that each member state therefore have implemented

their own corresponding national legislation has led to discrepancies. Substantial divergences in

the interpretation and application of the rules have emerged since the introduction, undermining

the legislation's main objectives; the safety of devices and their free circulation within the

internal market. (EUROPEAN COMMISSION, 2012)54

This will be further discussed below as

national barriers.

In order to rectify this situation and to inter alia strengthen the supervision of the Notified

Bodies by the Member States and to guarantee the independency and the quality of pre-market

assessment of devices by clarifying and enhancing the position and powers of notified bodies

vis-à-vis the manufacturers, the European Commission published, on 26 September 2012,

proposals for two new regulations on medical devices and in vitro diagnostic devices which will

replace the existing three Directives currently regulating medical devices in the European

Union. (European Commission, 2014)55

The Commission proposals will be discussed in the European Parliament and in the Council.

They are expected to be adopted in 2014 and would then gradually come into effect from 2015

to 2019. As with the General Data Protection Regulation, this legal instrument also takes the

form of a regulation instead of a Directive and will therefore reduce legal fragmentation and

provide greater legal certainty by introducing a harmonised set of core rules for all EU member

states.

7.4 Two Alternative Regulatory Pathways to the Market for ICT

Based Fall Prevention & Intervention Devices

This chapter addresses the following questions:

• Are ICT based fall prevention devices necessarily medical devices?

• When do they become medical devices?

As discussed above, the manufacturer freely determine the intended purpose of his device. For

manufacturers of typical medical devices, this opportunity may seem as a mare's nest but for

manufacturers of eHealth devices such as ICT based fall prevention devices, this is very much

real. By carefully elaborating the intended purpose of their device, a manufacturer of ICT based

fall prevention devices may decide whether his device will be regulated as a medical device or

not. This is not an obvious choice but most certainly a trade-off.

If he choose an intended purpose (and possibly features of the device) in order to avoid a

medical device classification, he must carefully avoid describing any features involving

diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap in

54http://ec.europa.eu/health/medical-devices/files/revision_docs/com_2012_540_revision_en.pdf 55 http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm

http://ec.europa.eu/health/medical-devices/files/revision_docs/com_2012_540_revision_en.pdf

http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm

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human beings. Furthermore he must carefully avoid any descriptions of a medical purpose in

the marketing of the product that would render the device a medical device classification. This

will highly affect the potentially available market by reducing the market segments he may

approach. On the other hand he will have less to prove during the verification & validation

phase of the product design which will most likely save costs and reduce time to market.

In the case the manufacturer choose an intended purpose in order not to have his device

classified as a medical device, it is likely that other regulations will be applicable such as the

General Product Safety Directive, 2001/95/EC (THE EUROPEAN PARLIAMENT AND THE

COUNCIL OF THE, 2002)56

, which may have more stringent safety requirements.

If the manufacturer on the other hand choose to have his device classified as a medical device,

new segments of the market will be available, segments where product margin is usually higher

inter alia because of the increased regulatory management costs. His verification & validation

burden though will increase and most likely his time to market.

This is a situation these manufacturers share with many other manufacturers of products on the

borderline of medical purpose e.g. health or lifestyle products and certainly eHealth products.

In recent years though, the trend from the regulators has been to include more devices within the

scope of the MDD. Devices such as standalone software or apps (EUROPEAN COMMISSION,

2012)57

and electronic patient records have now been considered to be medical devices which

was not evident previously. This is partly reflected in the 2007 amendment of the MDD where

in the definitions for the classification rules; “Stand alone software is considered to be an active

medical device” was added to rule 1.4 but also in guidance’s from Competent Authorities.

(Medical Products Agency, 2014)58

A manufacturer of ICT based fall prevention and

intervention devices must keep this in mind when elaborating the product intended purpose in

case he wants to avoid a medical device classification of his product.

7.5 Is the MDD an appropriate regulatory framework for ICT based

fall prevention & intervention devices?

This chapter addresses the following questions:

• ICT based fall prevention & intervention devices are often low risk products. Is there a

tendency to over-regulate these kind of devices?

• Is the MDD a barrier for the deployment of innovative ICT-based fall prevention and

intervention solutions or is it merely a question of applying the MDD correctly?

ICT based fall prevention & intervention devices which are classified as medical devices may

still differ quite considerably in terms of features and applications with concomitant differing

associated user risks. Some devices may have rather few and uncritical features rendering them

a Class I classification while others may include different degrees of patient monitoring and

alarm functionality such as call for ambulance, rendering them a higher risk classification.

This is not unique for ICT based fall prevention & intervention devices. The vast scope of

medical devices range from e.g. simple bandages to the most sophisticated life-supporting

56 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0095&from=EN 57 http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf 58 http://www.lakemedelsverket.se/malgrupp/Foretag/Medicinteknik/Klassificering/Sakerhetskrav-pa-medicinska-

informationssystem/


http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf

http://www.lakemedelsverket.se/malgrupp/Foretag/Medicinteknik/Klassificering/Sakerhetskrav-pa-medicinska-informationssystem/

http://www.lakemedelsverket.se/malgrupp/Foretag/Medicinteknik/Klassificering/Sakerhetskrav-pa-medicinska-informationssystem/

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devices. This is the root-cause for the intrinsic flexibility of the MDD and should be equally

applicable to ICT based fall prevention & intervention devices as for other medical devices.

It would therefore seem as if the main issue for manufacturers of ICT based fall prevention

devices is whether to classify the device as a medical device or not and if so, to decide the

product features with respect to criticality and concomitant MDD classification.

The MDD itself seem to be as an appropriate legal instrument for ICT based fall prevention

devices as for other devices currently in the market.

7.6 National Barriers for Deployment of Services/Products Resulting

from falls ICT-based Solutions

This section answers the following questions:

• Are there national regulatory barriers within the EU for ICT based fall prevention &

intervention devices?

• To what extent are national barriers preventing deployment of ICT based fall prevention

& intervention devices?

7.6.1 Requirements for National Registration of Medical Devices

One of the main objectives of the European Union is to promote the free movement of goods

and to prevent trade barriers.

Although every medical device is registered with the Competent Authority in the country where

the device is first placed on the market, Article 14 of the MDD states:

For all medical devices of classes IIa, IIb and III, Member States may request to be

informed of all data allowing for identification of such devices together with the label and

the instructions for use when such devices are put into service within their territory.

The Italian Ministry of Health (MOH) implemented mandatory procedures for an Italian

registration of medical devices as of 1 May 2007.

Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking

which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the

Italian market will go through a Device registration process. This process is similar to the

pre-market notification requirement for Class I Medical Devices (as stated in the European

Directive MDD 93/42/EEC Article 14); however, in Italy it is applicable for all classes, not

only Class I. Local legislations, such as this one, are growing rapidly in Europe…...The

registration can only be done with granted access to the Italian Database, and with the

required “smart card” for the actual registration. (Wikipedia, 2014) 59

Unfortunately, the bad example of Italy has since been followed by countries such as France

(Afssaps, 2010)60

, Spain (AEMPS, 2010)61

and Poland (Qmed, 2014)62

and is envisaged to be

followed by other member states.

59 http://en.wikipedia.org/wiki/Italian_Device_Registration 60http://ansm.sante.fr/var/ansm_site/storage/original/application/70db8dfb9035e3aa365c04b238e1287d.pdf 61http://www.aemps.gob.es/en/publicaciones/publica/regulacion_med-PS/docs/folleto-regulacion_Med-PS.pdf 62 http://www.qmed.com/consultants/new-registration-requirements-medical-devices-poland

http://en.wikipedia.org/wiki/Italian_Device_Registration

http://ansm.sante.fr/var/ansm_site/storage/original/application/70db8dfb9035e3aa365c04b238e1287d.pdf

http://www.aemps.gob.es/en/publicaciones/publica/regulacion_med-PS/docs/folleto-regulacion_Med-PS.pdf

http://www.qmed.com/consultants/new-registration-requirements-medical-devices-poland

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Currently, only entities which have a registered place of business on Polish territory are

permitted to register medical devices resulting in non-Polish manufacturers being forced to have

a distributor or importer with a registered office in Poland. This must be deemed an exceedingly

extensive interpretation of Article 14, MDD.

Member states requiring registration of Class IIa, IIb and III medical devices for market

clearance in their respective country is a nuisance and annoyance and in direct contrary to the

principle of free circulation of goods within the European community. For medical device

manufacturers, this is turning back the clock 20 years to the time before the introduction of the

MDD. It considerably increase costs and workload on medical device manufacturers, especially

SME´s, without any gain whatsoever in patient safety or device efficacy and with the risk of

impeding the development of innovative uses of new technologies.

Hopefully this situation will be remedied by the European Commission proposal for new

regulation on medical devices:

Article 1, EC/764/2008; “The aim of this Regulation is to strengthen the functioning of the

internal market by improving the free movement of goods.”

The establishment of a central registration database will not only provide a high level of

transparency but also do away with diverging national registration requirements which

have emerged over recent years and which have significantly increased compliance costs

for economic operators. It will therefore also contribute to reducing the administrative

burden on manufacturers.

[‘Economic operators’ shall mean the manufacturer, the authorized representative, the importer

and the distributor]

7.6.2 Requirements for Standards Compliance

Requiring compliance with standards in the procurement specifications for medical devices is a

bad habit by many purchasers.

Since there are national standards, requiring compliance with standards in the procurement

specifications of medical devices forces European medical device manufacturers to be

knowledgeable about these national standards. This poses a major effort especially for SME´s,

delays product launches and is directly contradictory to one of the fundamental ideas of the EU,

the New Approach/NLF and to the MDD.

Since the manufacturer is free to choose to apply standards in whole, in part or not at all when

demonstrating product compliance with the essential requirements of the MDD, the purchaser in

a public procurement cannot and must not request compliance with any standards whatsoever.

From a regulatory point, the purchaser should only request that the device is CE marked as a

medical device in accordance with the MDD. How the manufacturer has demonstrated

compliance with the MDD is a matter between the manufacturer and the Notified Body or, in

the case of a Class I devices, the Competent Authority of the country in which the product is

first placed on the market.

Having this said, of course the purchaser is free to request any features necessary for the

intended use he has in view and to determine whether the manufacturer stated intended purpose

of the device correlates with his intended use.

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National implementation of the Data Protection Directive

Since ICT based fall prevention & intervention devices are often retrieving-, storing and

transferring patient data, although not specific for but highly affecting those devices is the

different national implementation of the Data Protection Directive.

Close to 30 different legislations regarding data protection is quite a challenge for an SME to

comply with. Hopefully the General Data Protection Regulation will overcome this issue.

7.7 Summary

From a regulatory point, a manufacturer of ICT based fall prevention & intervention devices has

the choice to define his product as a medical device or not. The choice is his and both

alternatives has their pros and cons.

The MDD is a quite flexible regulatory framework and given that manufacturers of ICT based

fall prevention & intervention devices choose to classify their products as medical devices, the

MDD should be as applicable for them as for other medical devices.

Directives have the disadvantage of being implemented somewhat differently in different EU

member states. To some extent there seems to be a trend from EU to compose regulations

instead of Directives, having the advantage of reducing or eliminating different legislation in

different EU member states which highly facilitates the functioning of the internal market for

goods. In some instances, manufacturers of ICT based fall prevention & intervention devices

will benefit from this trend.

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8. Standardization perspective

8.1 Existing Standards in eHealth and mHealth

In order to share and aggregate data electronic information systems rely on standards. ICT based

fall prevention and management solutions that collect, use and share electronic information need

to collect data using standard definitions and formats. In order to exchange health data and to

make use of the information, systems must include syntax and semantic content that is clear and

unambiguous to both sender and receiver. Due to the broad scope of health information and

multiple (and often imprecise) terminologies in common use, this can pose a significant

challenge (WHO, 2012)63

.

As soon as health information data are stored and exchanged a series of health informatics

standards become relevant. Standards can assist to meet the requirements set by users,

healthcare professionals, industry and legislation. This section describes some of the existing

standards that can be used in ICT solutions for fall prevention. According to their objectives

standards can be grouped into three relevant categories:

• Medical record standards specify the structure, content, and organization of individual

patient medical records.

• Messaging standards describe protocols to communicate data.

• Vocabulary standards define the terms used to describe health conditions and events.

8.1.1 Medical Record Standards

Health information is sensitive, particularly when it comes to individual health information.

Therefore it is important to comply to international or national regulations and standards for the

collection, storage, use and disclosure of health information.

ISO’s Technical Committee (TC) 215 and CEN Technical Committee 251 work on health

information and communications technology to facilitate interoperability of health data. The

Technical Committees develop standards on various aspects of electronic health records. The

ISO and CE standards address a wide range of interoperability issues for patient information

and device communication as well as privacy and security issues related to patient data.

Information security: ISO 27002 and ISO 27799

ISO/IEC 27002 (ISO/IEC, 2013)64

is a broad and general standard on information security.

ISO/IEC 27799 (ISO/IEC, 2008)65

provides guidance for the implementation of ISO 27002

within the healthcare sector.

The ISO 27002 and 27799 standards assist healthcare organizations to ensure that the

confidentiality, integrity and availability of data in their care is preserved:

• confidentiality is essential when the privacy of subjects of care is to be safeguarded;

• integrity of health information must be protected to ensure patient safety;

63 WHO 2012. Management of patient information. Trends and challenges in Member States

http://apps.who.int/iris/bitstream/10665/76794/1/9789241504645_eng.pdf?ua=1 64 ISO/IEC 27002: 2013 Information technology — Security techniques —Code of practice for information security

controls 65 EN/ISO 27799: 2008 Health informatics – information security management in health using IEC/ISO 27002

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• availability of health information is critical to effective healthcare delivery. Different

healthcare providers need to have access to the health information data when needed.

Health informatics systems must meet the demands to remain operational when facing

system failures, natural disasters and denial-of-service attacks.

The need for effective IT security management in healthcare is made all the more urgent by the

increasing use of wireless and Internet technologies in healthcare delivery. If not implemented

properly, these technologies will increase the risks to the confidentiality, integrity and

availability of health information.

Regardless of size, location and model of service delivery, all healthcare organizations need to

have stringent controls in place to protect the health information entrusted to them.

There are several types of information whose confidentiality, integrity and availability need to

be protected:

a. personal health information,

b. pseudonymised data derived from personal health information via a certain methodology

for pseudonymous identification,

c. statistical and research data, including anonymised data derived from personal health

information by removal of personally identifying data,

d. clinical / medical knowledge not related to any specific subjects of care, including clinical

decision support data (e.g., data on adverse drug reactions),

e. data on health professionals, staff and volunteers,

f. information related to public health surveillance,

g. audit trail data, produced by health information systems, that contain personal health

information or pseudonymous data derived from personal health information, or that

contain data about the actions of users in regard to personal health information, and

h. system security data for health information systems, including access control data and

other security related system configuration data, for health information systems.

The extent to which confidentiality, integrity and availability need to be protected depends upon

the nature of the information, the use to which it is put, and the risks to which it is exposed.

Risk assessment can properly determine the level of effort needed to protect confidentiality,

integrity and availability.

ISO 27799 provides guidelines on data security issues like data storage, information

classification, access control management, logging and authentication, incident management

and business continuity.

Interoperability

The AALIANCE2 report (AALIANCE2, 2013) provides a number of reasons that

standardization and interoperability is a key requirement for the success of ambient assisted

living solutions. The reasons are adapted for ICT solutions for fall prevention and management

based on the results of the survey:

• Variety of user requirements and preferences: The elderly people, the main customer

group for fall prevention solutions, have a large variety of needs and preferences. This

is on the one hand due to possible physical or cognitive limitations and chronic diseases

that may or may not be present, and on the other hand due to the individual experience

with, and acceptance of technical systems in general, and computers in particular. This

means that a “one size fits all” product will hardly be accepted on the market.

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Successful solutions will have to be modular and adaptable to individual user needs and

preferences.

• Need for “future proof” systems: As a user’s health status and individual limitations

change over time, an ICT based fall prevention solution will have to be extended or

complemented with additional modules whenever a new need arises. It is unlikely that

users will accept that in each of these cases a system needs to be completely exchanged

by a different one (with possibly different user interfaces).

• Integration with existing infrastructure: ICT based fall prevention solutions that

make use of sensors or actors embedded in the environment need to be adapted for the

layout of each individual living environment. Depending on the number of rooms,

doors, electrical appliances etc. the number and location of components will vary.

Furthermore, in apartments where a home automation infrastructure (such as a KNX,

LON or BACnet field bus) is already available, users will probably not accept that the

complete network (including all cables in the walls) need to be exchanged only because

the ICT based fall prevention system only supports a different home automation

network. Again, this requires a significant amount of modularity in product design.

• Integration with local service providers: ICT based fall prevention and management

solutions will most often have to integrate with local service providers delivering

services such as GP, physiotherapist, nursing care, alarm service, concierge services etc.

Therefore, in each city or region the system will have to interact with different

providers. Interoperability is a prerequisite as health care organizations can not and are

not willing to cope with a variety of systems.

• No comprehensive product program: Unlike markets such as the medical device

market, where a few “big players” offer comprehensive product programs covering all

needs of a potential customer, the ICT fall prevention solution sector is rather

dominated by small and medium-sized enterprises (SMEs) offering innovative products.

It is (AALIANCE2, 2013) unlikely that in this situation a single vendor will be able to

offer a comprehensive product program covering all needs of the customer base. This in

turn makes it necessary to combine products from different vendors in order to address

users’ needs.

• Freedom of choice: From the user perspective, interoperability is very much desirable

because it enables the user to choose over different products and services, and adapt a

system according to the current needs, but also to the available financial and material

means, which is especially important. This is where standards come „into play“: If the

interfaces between systems and system Interoperability can be addressed on several

layers or levels.

ISO 11073 series of standards

The 11073 series of standards are targeted at personal health and fitness devices (such as

glucose monitors, pulse oximeters, weighing scales, medication dispensers and activity

monitors) and at continuing and acute care devices (such as pulse oximeters, ventilators and

infusion pumps). They comprise a family of standards that can be layered together to provide

connectivity optimized for the specific devices being interfaced.

There are five main types of ISO 11073 standards:

• Communication Protocols;

• Medical Devices;

• Personal Health Records;

• Terminologies and Semantics;

• Medical Terminology

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For ICT based fall prevention and management solutions the following could be useful:

• ISO/IEEE 11073- 10101:2004 Health informatics – Point-of-care medical device

communication – Part 10101: Nomenclature,


communication – Part 10201: Domain information model,

• ISO/IEEE 11073-10421:2012 Health informatics – Personal health device

communication – Part 10421 Device specialization – Peak expiratory flow monitor

(peak flow),

• ISO/IEEE 11073 - 10442 Health informatics—Personal health device communication -

Part 10442: Device specialization— Strength fitness equipment,

• ISO/IEEE 11073- 10471:2010 Health informatics – Personal health device

communication – Part 10471: Device specialization - Independent living activity hub,

• ISO/IEEE FDIS 11073-10472 Health Informatics – Personal health device

communication – Part 10472: Device specialization – Medication monitor,


communication –Part 20101: Application profiles – Base standard,

• ISO/IEEE 11073- 20601:2010 Health informatics – Personal health device

communication – Part 20601: Application profile – Optimized exchange protocol,

• ISO/IEEE 11073-30200:2004 Health informatics – Point-of-care medical device

communication – Part 30200: Transport profile – Cable connected,


communication – Part 30300: Transport profile – Infrared wireless,

• ISO/IEEE FDIS 11073-30400 Health informatics – Point-of-care medical device

communication – Part 30400: Interface profile – Cabled Ethernet,

• ISO 11073- 90101:2008 Health informatics – Point-of-care medical device

communication – Part 90101: Analytical instruments – Point-of-care test,

• ISO/TS 11073- 92001:2007 Health informatics – Medical waveform format – Part

92001: Encoding rules.

8.1.2 Messaging Standards

Citizens have a right to expect safe and quality care throughout their lives and need systems that

can work together. Health and care professionals are in need of systems able to represent and

communicate relevant information. Concurrent Use (CEN/TC 251, 2014) of the messaging

standards ContSys, HISA and EHRcom makes multi-disciplinary care planning possible.

Furthermore it helps healthcare organizations to be more efficient and effective in delivering

care by eliminating data silos and removing vendor lock-in. The video

http://tinyurl.com/CENConUse explains the role of each of these standards.

In addition to these messaging standards that describe messaging at a higher level, the HL7

standards are used to make up the message.

EN ISO 13940 (ContSys)

This standard for a system of concepts is a high level description of how health and social care

operates to achieve continuity of care, which is an important aspect of quality and safety in

healthcare. It describes a generic clinical process, which is focused upon the subject of care and

the context in which that care takes place. This standard establishes a common conceptual

framework across national, cultural, organizational and professional barriers; by doing so,

ContSys provides the basis for all information and computational models necessary to deliver

semantic interoperability for what is, in essence, a person-centric domain (CEN/TC 251, 2014).

http://tinyurl.com/CENConUse

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An example of use: The County Council of Skåne, Region Skåne in Sweden, has created

clinical reference models from ContSys concepts to develop coherent clinical applications. The

process used was to make an XML scheme/service for each reference structure, to document the

specialization and to use it in an implementation.

EN ISO 12967 (HISA)

This 3 part standard for Health Informatics Service Architecture enables integration and

interoperability of IT systems in healthcare. It underpins a middleware of information services

that are technology independent, handling the common information asset and business logic

relevant for a healthcare enterprise. HISA is based on the ISO/IEC reference model for Open

Distributed Processing using Enterprise, Information and Computational viewpoints and permits

plug-and-play exchange of data through many types of deployment interface (e.g. web-

services). In particular, HISA specifies the architecture and services for continuity of care,

enabling access to, and the sharing of, the patient’s record (CEN/TC 251, 2014).

An example of use: The Italian Region of Molise is engaged in creating an integrated HISA-

based regional repository containing patient’s healthcare information, unified and accessible

through services, allowing the implementation of a new regional healthcare information system

and the integration of multi-vendor applications.

EN ISO 13606 (EHRcom)

This standard for Electronic Health Record (EHR) Communication defines the way in which

clinical applications, electronic health record systems and national EHR repositories can

exchange health and care records. It therefore helps to support shared patient care between

healthcare and social care organizations, and enables care providers to be informed by a

patient’s life-long history whenever and wherever he or she next needs care. The standard

importantly also supports information about who should be allowed to access the data in each

record, for example to comply with national regulations and the wishes of the patient, and

enables patients to view who has been accessing their health record (CEN/TC 251, 2014).

The standard is organized in parts: Part 1: Extended architecture, Part 2: Domain term list, Part

3: Distribution rules, Part 4: Messages for the exchange of information and Part 5 interface

specification.

An example of use: Every week over 11,000 patients change their general practice in England in

the safe knowledge their complete life general practice record will be available at their first

consultation with their new GP thanks to 13606 based messages.

Concurrent use of ContSys, HISA and EHRcom

The following figure, developed by CEN/TC 251 Heath informatics, shows the landscape and

interrelationship between the different standards in eHealth. The HL7 standards in this figure

are represented by the ‘templates-’ and ‘archetypes-’ fields.

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Figure 17. Concurrent use landscape

Source (CEN/TC 251, 2014)

HL7 (Health Level 7: Standard for communication transfer of medical data) (HL7, 2014)66

Just as people from different countries with completely different native tongues are only able to

communicate with each other if they can speak a common language, computer applications can

only share data if they communicate with a common protocol. For people or computers to be

able to share clinical information with one another, they must both:

1. have functions to be able to physically communicate, e.g. speak & hear, send and

receive documents and data files, share data and information. This is called "functional

interoperability".

2. speak a common language (in terms of nouns, verbs, grammatical structure, etc.) and

share the same vocabulary that allows them to understand complex medical conditions

and processes. This is called "semantic interoperability".

A group of healthcare computer systems users started developing the HL7 protocol in 1987 to

create a common "language" that allows healthcare applications to share clinical data with each

another. Over time the HL7 interoperability protocol became a nationally, internationally and

globally accepted and accredited standard.

66 http://www.hl7.com.au/FAQ.htm

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The term ‘Health Level 7’ (HL7) is used both for the organizations involved in developing and

supporting the healthcare standards as well as for the Version 2.x and Version 3 Standards

themselves and other standards developed by the HL7 local organizations in some30 countries.

HL7 version 3 is expressed in XML encoding syntax and allows the HL7 model to expand

beyond messaging by including vocabularies from other sources.

The following HL7 standards are published by ISO:

• ISO/HL7 10781:2009 (cor. 2012) Electronic Health Record-System Functional Model,

Release 1.1

• ISO/HL7 21731:2006 Health informatics – HL7 version 3 – Reference information

model – Release 1

• ISO/HL7 27931:2009 Data Exchange Standards – Health Level Seven Version 2.5 – An

application protocol for electronic data exchange in healthcare environments

• ISO/HL7 27932:2009 Data Exchange Standards – HL7 Clinical Document

Architecture, Release 2

• ISO/HL7 27953-1:2011 Health informatics – Individual case safety reports (ICSRs) in

pharmacovigilance – Part 1: Framework for adverse event reporting

• ISO/IEEE 11073-10103:2014 (Cor. 2014-05) Health informatics - Point-of-care

medical device communication - Part 10103: Nomenclature - Implantable device,

cardiac

• ISO 11073-90101:2008 Health informatics - Point-of-care medical device

communication - Part 90101: Analytical instruments - Point-of-care test

• ISO/TS 11073-92001:2007 EHealth informatics – Medical waveform format – Part

92001: Encoding rules

• ISO 13606-3:2009 Health informatics – Electronic health record communication – Part

3: Reference archetypes and term lists

• ISO/TS 15000- 2:2004 Electronic business eXtensible Markup Language (ebXML) –

Part 2: Message service specification (ebMS)

• ISO 21090:2011 Health informatics – Harmonized data types for information

interchange.

Clinical Document Architecture (CDA) The Clinical Document Architecture (HL7, 2014)

67 is a HL7 standard for the representation and

machine processing of clinical documents in a way which makes the documents both human

readable and machine process-able and guarantees preservation of the content by using the

eXtensible Markup Language (XML) standard. It is an approach to the management of

documents which make up a large part of the clinical information processing arena.

Continuity of Care Document (CCD) The Continuity of Care Document (CCD) is an HL7 XML standard for the exchange of

electronic clinical records. The CCD is based on the Clinical Document Architecture (CDA) in

use in the USA. The CCR (Clinical Care Record) is developed to facilitate transfer of the

essential health record of an individual patient from one care provider to another through the use

of a standard format and vocabulary.

The CCD represents a merger of the CCR (ASTM) and the CDA (HL7) and replaces both of

these (CCD=CCR+CDA). The CCD is both “human readable” (via browser) and “machine

readable” (import into EHR system) and has wide healthcare industry support.

67 http://www.hl7.org.au/CDA.htm

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The CDA and CCD documents standards are specific to the US health care system but can be

adopted for use elsewhere.

8.1.3 Vocabulary Standards

Vocabularies provide a standard method of expressing health information. For clear

communication it is vitally important to have each given health term precisely defined so that it

will not lead to confusion or be subject to corruption when received.

Vocabularies such as SNOMED or ICD are designed for specific descriptive purposes. A

country may adopt these completely or agree to use subsets. Countries might find it useful to

define their own vocabulary for a data set that is used within the country such as national health

indicators, routine facility reporting, or monitoring and evaluation reporting.

International Classification of Diseases (ICD)

The ICD is a list of codes to classify diseases, signs, symptoms, abnormal health findings and

external causes of illness or injury. It has been maintained by WHO since the first World Health

Assembly in 1948. This effort built on earlier classifications going back to the late 19th century.

The current version of the ICD is 10 although version 9 is still in widespread use, particularly in

the USA. There have been several extensions and modifications of the ICD to provide better

coverage of clinical conditions, health care procedures, and morbidity. The USA maintains the

ICD-9-CM (Clinical Modifications) and is working on developing ICD-10-CM. ICD-9 contains

approximately 17 000 codes whereas ICD-10 contains approximately 155 000 codes. WHO is

currently working on ICD-11.

Systematized Nomenclature of Medicine (SNOMED)

SNOMED (IHTSDO, 2014) is designed to provide a comprehensive nomenclature of clinical

medicine for the purpose of describing records of clinical care in human medicine. It is a multi-

axial and hierarchical classification system. It is multi-axial in that any given clinical condition

can be described through multiple axes such as topography (anatomy), morphology, organisms

such as bacteria and viruses, chemicals such as drugs, function (signs and symptoms),

occupation, diagnosis, procedure, physical agents or activities, social context, and syntactic

linkages and qualifiers. SNOMED is hierarchical in that each of the axes has a hierarchical tree

that proceeds from general terms to more specific ones. For example topography (anatomic)

terms are first divided into major organs such as lung, heart, and then into the smaller

components of each.

The SNOMED CT is a collection of medical terms covering most areas of clinical information

that is systematically organized to be processed by computer. It provides a terminology,

developed by the International Health Terminology Standards Development Organization

(IHTSDO) that is optimized to index, store, and retrieve clinical data across care boundaries and

sites. SNOWMED CT consists of over a million medical concepts.

SNOMED CT contributes to the improvement of patient care by underpinning the development

of Electronic Health Records that record clinical information in ways that enable meaning-based

retrieval. This provides effective access to information required for decision support and

consistent reporting and analysis. Patients benefit from the use of SNOMED CT because it

improves the recording of EHR information and facilitates better communication, leading to

improvements in the quality of care (IHTSDO, 2014).

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Logical Observation Identifiers Names and Codes (LOINC)

LOINC10 is a standard for identifying medical laboratory observations. Developed by the

Regenstrief Institute in the USA, it is specifically designed for use as an electronic database for

clinical care and management that is suitable for use in an electronic health record. It has

expanded from the original laboratory codes to include nursing diagnoses and interventions,

outcomes classification, and a patient care data set.

LOINC is the preferred code set for HL7 laboratory test names in transactions. It currently

contains over 58 000 observation terms.

Pofound Taxonomy

ProFaNE' project published a taxonomy (Profane, 2007)68

(naming and classification system)

for falls prevention interventions, as presented in chapter 4.

8.2 Use of Standards in ICT Solutions for Fall Prevention and

Management

8.2.1 Use of Standards in eHealth and mHealth

WHO is monitoring the use of standards in eHealth (WHO, 2012).

Individual patient data standards

Thirty-eight per cent of responding countries have standards for individual patient data. This

can be anything from a small data set of demographic and basic clinical information to a

complete longitudinal electronic medical record (EMR or PHR) with full professional,

laboratory, radiology and ancillary service input. Most commonly, countries have defined some

set of individual patient data that is useful for continuity of care, monitoring and evaluation, or

aggregate data for planning or research.

Examples of international individual patient data standards are the Continuity of Care Record

(CCR) and the Continuity of Care Document (CCD);

Figure 8.2 shows the uptake of international standards for eHealth across responding countries,

according to a WHO survey (WHO, 2012).

68 http://www.profane.eu.org/taxonomy.html

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Figure 18. Adoption of international standards in eHealth in WHO survey

(Source: (WHO, 2012) Management of patient information. Trends and challenges in Member

States http://apps.who.int/iris/bitstream/10665/76794/1/9789241504645_eng.pdf?ua=1) Note: Most of the mentioned standards in figure 8.1 are discussed in the sections above (in this chapter). The

metadata standards: Dublin Core Metadata Initiative (DCMI), Data Documentation Initiative (DDI) and

Statistical Data and Metadata eXchange (SDMX) are not explained in this chapter as the metadata standards

at this state of implementation may be less relevant for the ICT solutions in fall prevention and management.

Use of SNOWMED

Vocabularies such as SNOMED or ICD are designed for specific descriptive purposes. A

country may adopt these completely or agree to use subsets. Countries might find it useful to

define their own vocabulary for a data set that is used within the country such as national health

indicators, routine facility reporting, or monitoring and evaluation reporting. Almost one third

of the responding countries (32%) have adopted vocabularies in addition to ICD for use in their

health sectors.

Twenty-five per cent of the responding countries (in the WHO survey) have adopted SNOMED.

This is less than the ICD coding system and may be due to SNOMED’s complexity. Cost is also

likely to be an important factor in the relatively low uptake seen – the ICD is free and

SNOMED is not (WHO, 2012).

The following European countries are member of the International Health Standards

Development Organisation (IHTSDO) (IHTSDO, 2014)69

. In each country hospitals, vendors,

researchers and public administrations can become licensees. The following list gives an

overview of the deployment of SNOWMED and priorities in each country:

Belgium (0 licensees)

Belgium has developed an e-health roadmap for 2013-2018, in which an important strategy is

the adoption of SNOMED CT as the main health system’s clinical terminology.

69 http://www.ihtsdo.org/members/xxxx/2014-update/

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The strategic goal to use SNOMED CT in the entire Belgian healthcare system is still in the

initial planning stages and a schedule is set to be determined in 2014. Efforts to work on

translation and limited implementations are gaining momentum.

Czech Republic (0 licensees)

In joining IHTSDO in 2012, the Czech Republic will make SNOMED CT available throughout

the Czech Republic for use in electronic health records, health research, and other applications.

Denmark (29 licensees)

There is a growing interest and understanding in Denmark of the possibilities for using

SNOMED CT. Two of the five Danish regions have chosen a common EHR system, Epic. In

connection with this, they have shown interest in knowing more about SNOMED CT. On the

municipal level, the Danish municipalities are planning to use parts of SNOMED CT for the

terminology in their healthcare systems.

Development of the Danish drug terminology is expected to move forward in 2014 in the

following ways:

Danish drug data will be added to SNOMED CT in a Danish Drug Extension;

The new IHTSDO pharmacy model, which includes strength, will be implemented in

the drug terminology, making Danish trade products fully defined;

Establishment of a national allergy register containing SNOMED CT allergy codes is

expected to start in 2014; and

A number of knowledge databases – Max Dose, Risk Situation, Interactions Database

and medicin.dk (drug information site) – will start using SNOMED CT substance codes

Estonia (9 licensees)

SNOMED CT will be of primary focus in Estonia in 2014-2015. The overall aim is to begin

implementing and using SNOMED CT nationally. The extent to which SNOMED CT will be

translated and implemented is currently under evaluation.

Iceland (0 licensees)

The eHealth policy in Iceland includes the implementation of an integrated EHR at a national

level, which is securely accessible to authorized professionals at point of care. Furthermore, it

allows people in the general public access to their own health data. This is achieved by

integration of regional databases and the development of a national patient portal.

A nationwide surveillance system on communicable diseases for the office of the Chief

Epidemiologist of Iceland has been in use for some years. Recently, the system was updated to

allow for real-time reporting on communicable diseases. SNOMED CT terminology is utilized

in the system to ensure correct registration of pathogens. Another milestone includes the

launching of real-time data collection to the nationwide hospital discharge registry of the

Directorate of Health. Furthermore, all prescription drugs are reported to a nationwide

prescription database, which is now updated in real-time and can provide practicing physicians

direct access to their patients’ prescriptions. This access, along with up to 70% of all drug

prescriptions currently being delivered electronically, will support increased patient safety and

surveillance of drug prescriptions.

Lituania (17 licensees)

At the start of 2014, Lithuania initiated national projects in an effort to complete the translation

and translation quality assurance of the majority of 40,000 concepts by year’s end. At the same

time, it also began moving through the various SNOMED CT projection and development

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phases, to be completed by the close of 2015. In the second half of 2014, the pilot project

SNOMED CT utility will be launched together with the polyclinic Centro Poliklinika.

A selection process took place in 2013 to choose 40,000 SNOMED CT concepts, at which time

the main implementation priorities were added due to various practicalities and national e-health

project requirements, such as the Tele-cardiology Project and MedVAIS. Future priorities are

likely to be: primary care, cardiology, encoded cancer checklists, translation of attribute

relationships, and supplementation of subsets for the quality assurance. We also implemented

the main SNOMED CT translation procurement procedures and signed contracts with suppliers

in 2013.

Malta (4 licensees)

During 2014, the eHealth Office in Malta’s Ministry for Energy and Health will continue to

evaluate the feasibility of implementing SNOMED CT on a wide basis in government health

information systems. Malta’s second official language, English, remains the standard in health

documentation, so there is no plan to translate SNOMED CT into Maltese.

Netherlands (51 licensees)

Increasing awareness of SNOMED CT remains one of the most important activities of the NRC

team. Our direction of focus is the implementation of terminology and code systems and the use

of SNOMED CT in particular. Creating cross-maps between SNOMED CT and the Dutch code

systems is currently one of the most useful approaches for coping with translation issues. The

code systems for billing purposes in the Netherlands will be the first to be mapped to SNOMED

CT.

The National IT Institute for Healthcare (Nictiz) emphasizes that mapping is only a temporary,

in-between step on the way to using SNOMED CT in EHR systems and for generating billing

and statistical information. The NRC does not translate SNOMED CT directly into Dutch, but it

does enable users to interface with SNOMED CT in Dutch, in addition to supporting various

solutions to accommodate that. Domain experts can add translations to the RefSets they create.

The NRC actively supports the mapping of SNOMED CT to other code systems, such as the

Dutch version of ICD-10.

Poland (0 licensees)

In December 2011 Poland became an Ordinary Member of IHTSDO. In joining IHTSDO, the

CSIOZ (National Centre for Health Information Systems) will make SNOMED CT available

throughout Poland for use in electronic health records, health research, and other applications.

Users of the terminology in Poland will also have access to new resources as they are

developed. The NRC plans to conduct a tender, select a contractor and translate at least part of

SNOMED CT into Polish in 2014.

Portugal (0 licensees)

In January 2014 Portugal became a Member of IHTSDO.

Slovakia (0 licensees)

The National Health Information Center (NHIC) faced economic constraints and organizational

changes in 2012 that greatly affected continuation of the eHealth project and medical

terminology work regarding the adoption of SNOMED CT in the Slovak Republic.

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Nevertheless, the Center for Medical Terminology and Standards, which is part of the NHIC

and staffed by experts from the field of medicine and science, continued its terminology work,

especially on translation of ICD-10 (German version), which will be used for implementing the

Diagnosis Related Group system in Slovakia.

Slovenia (0 licensees)

In January 2010 the Republic of Slovenia became a Member of IHTSDO.

Spain (273 licensees)

In 2014, Spain’s SNOMED CT goals include development of formal ontologies for clinical

safety, deployment of terminology services for the National Health System (NHS) and support

for quality efforts regarding e-prescription national nomenclature and RefSets. Of central

importance is the development of new software tools for improving production processes of the

Spanish Extension and continued validation of archetypes and terminology binding for

modeling EHR components and user interface implementation elements.

Our organization expects considerable improvement and tangible progress concerning the use of

SNOMED CT assets within the NHS and the National Health System’s Digital Health Records

Project (HCDSNS).

2013 activities focused on supporting development of the Spanish Drug Extension and related

ontological models. We succeeded in initiating publication of the Extension and ensuring

sustainable maintenance. In addition, more than 30 related specific Subsets for different clinical

variables within the HCDSNS content models were published. We also completed the

Extension for semantic standardization of HCDSNS dataset variables (elements for registry and

observable entities).

Translation efforts involved the inclusion of new descriptions for more than 1,500 terms in the

Spanish of Spain (es-ES) Extension. Ongoing translation work represents a strategic approach

to ensuring adequate use and clinical acceptability of SNOMED CT within the NHS.

Sweden (215 licensees)

The ongoing formalization of communication with Swedish users of SNOMED CT has meant

the establishment of reference groups from different health and social care sectors. One

important step to cementing this interaction was the first annual forum for the users of eHealth

resources provided by the National Board of Health and Welfare (NBHW), held in March 2014.

Over the course of the year, the NRC will mainly focus on user support and training

stakeholders.

The NBHW has been commissioned to further develop the decision-making support doctors use

to determine appropriate sickness benefits for patients. The project is studying if and how

SNOMED CT might be able to play a role in this.

The task of developing a national source for reasons for prescribing a medicine, with SNOMED

CT serving as the foundation for the terminology, has begun and is expected to continue in

2014. Integration of SNOMED CT concepts into national clinical guidelines published by the

NBHW has been initiated, starting with breast cancer care guidelines. Other clinical areas will

follow.

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United Kingdom (1500 licensees)

Clinical applications incorporating SNOMED CT continue to be deployed into all healthcare

sectors. For example, over three million electronic prescription messages are transacted monthly

using SNOMED CT.

The UKTC is responsible for managing and distributing the UK Edition of SNOMED CT, with

additional products and services to support implementation. The UK Clinical Edition is released

every six months and UK Drug Extension is released every four weeks. UKTC runs a help desk

for user enquiries and an online request portal for new UK Edition concepts and terms.

Shared electronic patient records remain a strategic milestone. Inclusion of SNOMED CT is

required in information standards considered for national approval.

The UK Edition is now available in both RF1 and RF2 formats, with around 75,000 UK clinical

concepts and 300,000 UK drugs.

8.2.2 Which standards are used in the ICT based fall prevention solutions?

From one ICT based fall solution we have made a case study. Sona is an ICT based fall

prevention solution that stimulates elderly people to become more active. The Sona is used in

care homes in the Netherlands and is developed by Yalp (Yalp, 2014). This case study focusses

on the use of and the reasons for not using standards. The Sona pictures are provided by Yalp.

8.2.3 Case Study Sona

Sona is an interactive sound device that is specifically designed for the outdoor area. A motion

camera in the top of the big orange arch registers the movements of players on the specially

designed play-floor beneath. Despite all the technology Sona remains simple. With the press of

a button one out of the ten games can be easily chosen. The games use music and sound as

feedback. The camera registers which person moves the most active and chooses a game

winner.

The Sona is also accessible with a wheelchair. The Sona is publicly accessible and is suited for

deployment in activities for seniors at a nursing home or to play with the visiting grandkids.

Moving with Sona has a strong social character as it encourages

people to move together.

Eleven care facilities in the Netherlands 2013 and 2014 have

installed an interactive Sona or are planning to.

Requirements from user perspective

The Sona is used by different user groups that each have their own

user requirements:

- inactive seniors: Elderly people in nursing homes

structurally move insufficient. 86% to 96% of elderly,

depending on the type of care (nisb, 2010), do not meet the

moving standard of 30 minutes a day. For health reasons it

is important that this group of elderly becomes more

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active. Movement contributes to improved balance, coordination, increases independent

living and is in that way a perfect solution in fall prevention. The Sona is an attractive

initiative to encourage movement.

- seniors with dementia: Fun is important to get elderly

people more active. Besides the ‘fun factor’ Sona has more

beneficial effects. Music has a special effect in people with

dementia. Sensitivity to music continues well into the

dementia process. The music of Sona helps to break

passivity and encourages elderly to move together. Moving

outdoors works out especially positive. People with

dementia are at increased risk for depression. Exercise and

outdoor work is both preventive and curative.

- grandkids (additional user group): The games of Sona are

also fun for grandchildren who come to visit their

grandparents. People of different age can play together

under the arch, making the device connecting generations.

Meeting usability requirement

Sona was originally developed for children in 2006. With 100 placed Sona's the electronics

have proven their suitability for the outdoor area. In 2013 Sona was adapted for use in health

care:

• the games are optimized and tested in healthcare facilities;

• the pace of Sona is optimized to movement of seniors;

• music choice is based on the taste of the seniors and music known from the past;

• the choice of word in the games is adapted and tested with seniors.

Playing games on Sona is exercising in a fun way and it will improve the moving abilities of the

seniors. Four additional games will be developed in the coming year, where the seniors act as

"test group".

Meeting accessibility requirements

The gaming floor is flat and accessible for seniors who

have difficulty walking, walk with walkers or use

wheelchairs. It is advised to place benches next to Sona,

so that seniors who do not participate in the game can

rest and watch.

As Sona is often placed in the public space of a nursing

home, free play is always possible. To encourage the

use of Sona, activity counsellors should add Sona to their weekly schedule with billiard,

dancing classes etc. People should at first be encouraged to participate on Sona. We know from

practice that the elderly are enthusiastic after the first use of Sona and for example make use of

the facility with their grandchildren by themselves.

Clinical perspective

The overall project activities will be carried out by healthcare innovation agency DAZ and

Yalp. Yalp is the developer of the device Sona. DAZ supports by implementing Sona in health

care organizations, as they have experience with the introduction of innovations in care and

communication.

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The games focus on practicing the following competencies: reaction, balance, concentration,

agility, move, speed and competition. The games offer seniors a fun way to exercise. For

example, seniors can dance to music they are familiar with from the past and should stop when

the music stops. The person who moves last is off the game. In another game everyday life

situations are simulated, such as sweeping with a broom, climbing stairs or picking up

something from the ground. And there is a game that focuses on training the memory by

remembering numbers. In total there are 10 games available. All games have different

competence levels.

After the test period it is clear how the device is used by different groups of users, such as

people with various illnesses and seniors with and without care. Sona monitors the use if the

different games and users. The healthcare institutions involved are supporting this project.

Management, physical therapists, occupational therapists, nurses and other staff provide

residents with relevant activities around the Sona, whether or not in conjunction with

municipalities, local welfare organizations or the elderly.

Payer/stakeholder perspective

Healthcare institutions bear the cost of purchasing the Sona (€ 22.000) and the service

subscription (€ 500 per year). The institutions get access to remote support, get technical

support from Yalp and updates on new games.

To make the Sona a success after placement, a good approach is essential. Seniors will not start

moving on Sona themselves. Especially at the beginning dedication and support is needed from

all staff, such as physiotherapists, carers, management, etc.); someone needs to be responsible

for the use of Sona and ensure that Sona is part of the exercise program and invest in it.

Industrial perspective.

Sona is not a medical device. CE marking is not applicable. The Sona is equipped with an

inspection certificate as required in ‘Warenwetbesluit Attraction and Play (WAS)’ – a

certification method for playgrounds.

Data exchange, -protection and -security

The Sona uses programmed games. The camera in the Sona registers movement. These images

are not saved. Sona has a remote support system where the administrator of Sona can login to

select games, set the volume or see game statistics. The advice is to select just a couple of

games at once, to allow the elderly time to explore Sona. The game statistics are saved (how

much time is played, what games are the most popular, etc) and visible to the administrator.

There is no storage of private information. It is not possible to track the activity profile of

individual players.

Conclusion Sona

Sona is a creative ICT based fall prevention and management solution that is very unlike most

devices earlier discussed, such as fall detectors and personal activity monitors. Sona does not

make use of any health informatics standard and is not interoperable with any other devices.

To monitor individual activity patterns of elderly wearable activity monitoring devices could be

added.

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8.2.4 Case Study Standardization Initiative Service Chain Social Care Alarms

Excerpts from the business plan of CEN/TC 431 show the interesting standardization project

offering a working (and in Sweden tested) open internet protocol for service chain processes for

technology enabled care. This is also very relevant for ICT based fall prevention solutions.

Scope

CEN/TC 431 is to be responsible for the standardization of the service chain processes for

technology enabled care. The firm focus is on the users; ensuring them an improved level of

quality of life by enabling the users to stay longer in their own homes, remain independent and

be able to participate actively in society. CEN/TC 431 achieves this by working with all

interconnected parts in the entire service chain for social care alarms. All parts in the service

chain are equally important.

Benefits

The benefits of standardization of the service chain are multiple. Next to the benefits

demonstrated in the work plan, stakeholders add through their Standardization Institutes:

• Increased safety, quality of life and security for millions of elderly and people with

special requirements - and their relatives - providing users the opportunity to stay in

their own homes longer;

• Stimulated growth in innovation and business activity due to a coordinated,

comprehensive and radical technology shift of a non-sustainable analogue

communication platform into a digital Internet Protocol (IP) based platform;

• Decreased costs for society.

• Today the market of “Protocols used in Home Care Systems” is dominated by

proprietary and closed protocols, owned by the big players for Home Care Systems and

Centrals. An attempt to create a standardized protocol is a big step forward. The Alarm

Protocol uses open standards like XML and SIP (ASI).

Resistance

The initiative has met resistance from established Technical committees (through the national

standardization institutes):

• The scope of attached working draft has overlap with the EN standard developed by

CLC/TC 79 Alarm systems: EN 50136-1 Alarm systems - Alarm transmission systems

and equipment - Part 1: General requirements for alarm transmission systems. CLC TC

79 WG4 already develops the specifications for the implementation of an open IP

(Internet Protocol) based protocol for social care alarms. Plan of CEN/TC 431 has to be

adapted to avoid overlapping or redundant work (NEN, BSI, DIN).

• The work appears to overlap at least in part with the IEEE 11073 originated EN ISO

11073-10471:2011 Health Informatics - Personal health device communication - Part

10471: Device specialization - Independent living activity hub (ISO/IEEE 11073-

10471:2010). It looks like we should be aware of what is happening in TC 431 and let

them be informed of existing standards from the Health informatics area which may

have connection points to their area (CEN/TC 251)

• Standardization of interfaces to products for homecare (e. g. work programme of

ISO/TC 121 "Anaesthetic and respiratory equipment" and of ISO/TC 215 "Health

informatics" (DIN, NEN).

Despite all comments and resistance the CEN/TC 431 has had its first meetings in 2014,

additional meetings are scheduled and the participating stakeholders are determined to make the

work a success.

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8.3 Conclusions discrepancy between existing standards and use of

these standards in ICT solutions for fall prevention and

management

Despite the many advantages of interoperability and the use of standards many of the ICT based

fall prevention and management solutions have not chosen to be medical devices and hardly

comply to the requirements in the standards, its data do not follow a standardized data

architecture and therefore cannot be exchanged with the electronic health record. As also

concluded in chapter 5 most activity monitors and fall detectors are at a stage of validating the

data they gather with the actual activities and falls. Most ICT based fall prevention and

management solutions are ‘not yet’ or ‘in the process of thinking of the need of’ complying with

standards and interoperability.

The challenges to the use of standards are multiple. The respondents from our survey mention a

number of challenges. The AALIANCE2 (AALIANCE2, 2013) project confirms some of these

challenges and adds some others:

Complexity: Communication standards are often designed to support a wide range of

possible use cases. This comes at a price, which is the greatly increased complexity of

the specification. For example, a training device measuring strength in elderly would

require a number of ISO/IEEE 11073 (interoperability) standards: ISO/IEEE 11073 part

10442 Health informatics—Personal health device communication - Part 10442: Device

specialization— Strength fitness equipment”, which in turn is based on ISO/IEEE

11073- 20601 “Health informatics — Point-of-care medical device communication —

Part 20601: Application profile — Optimized exchange protocol”. Together these two

standards have a volume of about 166 pages and they define a highly complex

communication protocol. It is understandable that implementers shy away from

implementing such complexity unless this is absolutely needed or made compulsory.

Implementation cost: Since implementing a standard is expensive, the final product

may be more expensive than a comparable product with a simple, proprietary interface.

This problem is increased when an expensive external certification of the standards

compliance of the interface is needed – this may be one of the factors limiting the

market uptake of Continua based products.

Competition: Vendor-independent, standard interfaces are a double-edged sword from

the perspective of a manufacturer of the device. On the one hand it may create new

markets where a product can now be combined with components of other vendors, on

the other hand it may permit the competition to produce compatible, and perhaps

cheaper, alternatives that may threaten the market position of a product. This may be a

danger especially for small enterprises producing high-quality, high-priced products,

who fear of being overwhelmed by cheap competitor products mass-produced if they

open their devices by standardising the interfaces. In such cases, “vendor lock-in”,

while in general undesirable from the end-user perspective, is an integral part of the

business model.

Interoperability problems: Different developers may well read the same standard

differently and produce incompatible implementations. Opening a product’s interface to

the competition makes it much more difficult for a vendor to guarantee to the customer

that the product will always work as intended when combined with other products

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offering the same interface. Having a product portfolio that just “causes no trouble”

may well be a reason for customers to prefer a proprietary product family.

Slow standard development process compared to the fast innovation process: The

preparation and publication of a standard mostly takes about 3 years. This means that a

standard, once published, by definition will be somewhat outdated in technical fields

that see a rapid technological development. Furthermore, doing things “the standard

way” may prevent implementation of innovative ideas not (yet) supported by the

standard. Illustrative is the development of the smart watches (Box 8.1).

Slow implementation of ICT based solutions: For manufacturers and researchers to

develop devices that can communicate with the Electronic Health Record is an almost

impossible task as long as the Electronic Health Records between the different

European countries and often within one single country are not standardized and use

different clinical data architecture and semantics. The paragraph on the use of

SNOWMED shows that even the use of a common vocabulary is still in the process of

being implemented.

In the Medical sector the ‘evidence base’ is the paradigm to develop guidelines:

Medical practitioners and researchers are looking for evidence based care for patients.

The consensus model used by the standardization bodies is not appreciated, especially

because health insurers and industrialists are allowed to join the Technical Committees.

As a result there seems to be a lack of interest and a lack of knowledge about available

standards and the standardisation processes within the research community in general

and the medical research community in particular. Our chapter 6 (researcher

perspective) is illustrative in this respect as it mainly draws its information from

scientific publications rather than from standards.

Difficult to know which standards to use: The AALIANCE2 project has developed a

490 page repository (AALIANCE2, 2013) that lists (name of the standards with

abstract) for Ambient Assisted Living. Most of these standards are relevant for ICT

based solutions in fall prevention and management. The medical standards are not

included in the list. The length of the list alone already discourages potential users of

the relevant standards. The cost of the standards, even if negligible compared to the cost

of developing the device, is inhibitive especially if it is not clear which package of

standards are essential for the ICT based fall prevention and management solution.

Not all challenges are solved in the standards, f.i. mapping from one standard (e.g.

ISO/IEEE 11073) to a different standard (e.g. HL7) is not defined in either standard.

The standardization communities do not like initiatives that offer alternatives to the

standards, as they claim the alternatives are overlapping or not complying with existing

initiatives or standards. Illustrative is the case study presented in 8.2.3.

The number and seriousness of the risks and challenges may cause developers/manufacturers of

new devices to prefer closed, proprietary solutions over open standards-based ones.

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BOX 8.1

Smartwatches will revolutionise treatment for chronic conditions

Google, Apple, and Samsung are racing to develop wearable technology that could be used to

to monitor and track personal health and diagnose disease Smartwatches can monitor and store

fitness statistics, check vital signs and remind you to take medication. The advancements in

wearable technology, specifically smartwatches and their biosensors make it possible that

people seek self-knowledge through self-monitoring. Health and technology are converging to

become ubiquitous in patients' and physicians' lives. This intersection of health and technology

is changing the way on how long-term chronic conditions can be monitored and treated.

Exponential growth

Smartwatches have explosive potential in the healthcare space thanks to their sensors, ability to

sync to mobile health platforms and transmit sensor data to the cloud. Smartwatches will start

to go beyond just monitoring and tracking personal wellness and will help to predict and

diagnose disease.

The next generation of smartwatches will employ additional technology including the

accelerometer, magnetometer, gyroscope, compass, heart-rate monitor, altimeter and an

ambient light sensor, to name a few. Inside their wearable’s, Samsung and Google are already

detecting body temperature as well as location, and integrating voice commands. Apple's vision

is to find a way to load more into its new devices and platforms.

According to IMS Research, the wearable’s market is poised to grow from 14m devices

shipped in 2011 to as many as 171m units shipped by 2016. In a more recent estimate, ABI

Research foresees the wearable’s market at 485m annual devices shipped annually by 2018.

The urge for wearable’s and smartwatches is fuelled by the more than 75% of all patients

expected to use digital services in the future.

Excerpt from The Guardian, 25 July 2014 (Duffey, 2014)70

Note Chapter 6 discusses the wearable’s.

70 http://www.theguardian.com/healthcare-network/2014/jul/25/smartwatches-revolutionise-treatment-chronic-

conditions

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9. Conclusions

To achieve significant prevention/detection and reduction of falls incidence, a holistic life-long

approach combining cognitive, psychosocial and physical activities will be required. The

challenges are significant, but with close collaboration between fallers, falls experts and

technical experts they may be also achievable.

The actually ageing generations will have the needed technical skills and desire to educate

themselves and to self-manage their falls risks, but technology must be in place for them in

order to do so.

Primary care staff requires screening technology to identify elders who are at risk to fall. A

multitude of methods for assessing the risk of fall are used and accepted in the clinical practice.

All countries use a variety of protocols and tools to assess fall risk.

Fall risk assessment using body worn sensors is still in a phase of development and clinical

testing. Personal alarming systems are often used for vulnerable older adults still living

independent during several months up to several years. Body worn sensors potentially can

collect useful information about physical activity patterns of elderly.

From a regulatory point, a manufacturer of ICT based fall prevention & intervention devices has

the choice to define his product as a medical device or not. Both alternatives have their pros and

cons.

The MDD is a quite flexible regulatory framework and given that manufacturers of ICT based

fall prevention & intervention devices choose to classify their products as medical devices, the

MDD should be as applicable for them as for other medical devices.

Standardization and interoperability are key requirements for the success of ICT solutions for

fall prevention and management: variety of user requirements and preferences, need for “future

proof” systems, integration with existing infrastructure, integration with local service providers;

no comprehensive product program, and freedom of choice.

The challenges of the use for standards and interoperability are multiple as well: complexity,

implementation cost, competition, unsolved interoperability issues, slow standard development

process compared to the fast innovation process and slow implementation of ICT based

solutions. In the medical sector the ‘evidence base’ is the paradigm to develop guidelines and it

may be difficult to know which standards to use.

Despite the many advantages of interoperability and the use of standards many of the ICT based

fall prevention and management solutions have not chosen to be medical devices and hardly

comply to the requirements in the standards, its data do not follow a standardized data

architecture and therefore so far cannot be exchanged with the electronic health record. Most

activity monitors and fall detectors are at a stage of validating the data they gather with the

actual activities and falls. Most ICT based fall prevention and management solutions are ‘not

yet’ or ‘in the process of thinking of the need of’ complying with standards and interoperability.

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11. Annex

Questionnaire ICT based fall prevention and intervention solutions

The aim is to make an inventory and analyze best practices in standardization and

interoperability from different perspectives:

User perspective


Payers perspective

Industrial perspective

What ICT solution for fall prevention have you developed?

name

explanation

Please answer the following questions for this ICT based fall prevention solution

User perspective

What user needs/requirements have you taken into account, please identify different

user groups if appropriate

How have you addressed these user requirements

What did you do to meet usability needs

What did you do to meet accessibility needs

What did you do to meet interoperability needs

Did you use any existing standards to meet the user requirements

Which ones

Why or why not

How useful were these standards

Have you missed any standards, on which subjects


What clinical requirements have you taken into account, please identify different

clinical purposes if appropriate

How have you addressed these clinical requirements

Did you make use of international clinical tests/guidelines/protocols? Which ones

Why or why not

How does the ICT based fall prevention solution fit in the clinical

test/protocol/guideline

What is the clinician’s attitude to ICT based fall prevention & intervention devices or

services? What is the uptake of the ICT based fall prevention solution?

Payer perspectives

How is your device/assistive technology and its service paid for

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Please describe the payment/reimbursement pathway and the roles of end-users

(elderly), health care institutions, health insurances, others

Industrial perspectives

Your ICT based fall prevention & intervention device

o is it available in the market with a CE marking?

o is it classified as a Medical Device?

Is the ICT based fall prevention solution designed for interoperability?

o Protectionism/proprietary solutions

o Customer driven requirements for interoperability

Can the fall risk measure or falls monitoring results be exchanged with the electronic

patient health record? Why or why not?

Did you use any existing standards with regards to

o Semantics

o Clinical data architecture

o Data protection and security

Why or why not?

How useful were these standards?

Have you missed any standards, on which subjects?

Since the application of harmonized or other standards remains voluntary, standards in

this area must offer the manufacturer an added value in order to be applied, would the

industry perceive certified interoperability as an added value?

Standardization perspective

What existing standards have been useful?

Is there a need for specific standardization in the area of ICT based fall prevention &

intervention devices or is this area already covered by existing standards?

How can standards and interoperability support/promote this field?

Which areas of standardization would be beneficial to the industry?