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Lect. Mircea Focsa, MD, PhD University of Medicine and Pharmacy Timisoara Prorec Romania Association Certification of Electronic Health Record Systems - EHRQ TN POLAND 2012

Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

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Page 1: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Lect. Mircea Focsa, MD, PhD University of Medicine and Pharmacy Timisoara

Prorec Romania Association

Certification of Electronic Health Record Systems - EHRQTN POLAND 2012

Page 2: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Romanian Health IT market

Legislative and organizational framework

Steps to certification of EHR systems

Tools and Methodology supporting the Eurorec Seal

The assessment of the functional criteria

The lesson learned

Page 3: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Basic facts about ROMANIA

◦ Population: 21,504,442 (2002) ) – 19,042,936 (preliminary results 2011)

◦ Life expectancy at birth: 73.4 y (WHO 2009)

Basic facts about the romanian health care system

◦ HC expenditure: 5.5% of GDP (WHO 2008)

◦ Public sector hc expenditure as % of total hc expenditure: 81.7% (OECD 2007)

◦ Organization: central / district auth./ local units

Ministry of Health (MoH) / 41 District Health Authorities

National Health Insurance House (NHIH) / 41 District HIH

Page 4: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Simplified version (SIUI) = 100% (mandatory) in both primary care and hospitals

Extended version:

◦ primary care ~ 50% (from small companies)

◦ hospitals ~90% large hospitals, ~30% small hospitals

Number of applications on the market

◦ Primary care: ~20, but only ~10 have acceptable quality

◦ Hospitals: 5 better known applications

◦ Pharmacies: ~10

◦ Dentistry: 8-10

Empirica 2010

Page 5: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Any legislation / regulation: Yes [1]

◦ about the use of EHR systems? - Not explicit

◦ about functionalities of the systems

related to functional system requirements? No

related to data-exchange and/or interoperability? No (*)

(*) Note: it does exist only related to protection of personal data [2]

[1] Ministry of Health: Strategic Plan of the Ministry of Public Health

for 2008-2010

[2] Law no 677 on the Protection of individuals with regard to Processing

of Personal Data and onthe Free movement of such Data, November 2001

Page 6: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Dissemination and promotion of EHR certification: EFMI – Special Topic Conference 2006 - Timisoara

Workshops: ◦ Present and Future of EHR in Romania Bucuresti 2007 ◦ The quality of EHR systems – developers perspectives

Bucuresti 2009 ◦ First step validation of the Eurorec Seal criteria

Timisoara 2010 ◦ Validation of the Eurorec Seal tools and methodology

Timisoara 2011

Letter for authorities and decision bodies

Emails to the major EHR systems developers

Online announcements (www.prorec.ro, www.paginamedicala.ro, Google map)

Page 7: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Romanian Medical Science Academy –session dedicated to EHR certification ( Apr. 2012)

Romanian eHealth strategy - amendment regarding the necessity of a quality certification mechanism

Prorec.ro website – online resources for evaluating the quality of EHR systems: ◦ Full documentation ◦ Registration for applicants ◦ Online tools for self-assessment ◦ Online assistance during the whole process

Page 8: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Procedure of granting the Eurorec Seal:

The session opening announcement followed by the online registration

Access to the informative resources

Request for evaluation and payment

Personalized calendar of assessments

Self-evaluation and online documenting the requirement’s accomplishment

Testing session by the Prorec Romania experts and collecting the documentation

[Re-testing during the same session]

Final resolution

Page 9: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD
Page 10: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

General information

Eurorec Seal criteria

Evaluation request form

Page 11: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD
Page 12: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Focused on validation of the repository ◦ Content wise:

EuroRec Seal Level 2

◦ Translations:

Terminology – Definitions

Consistency - sometimes an issue

Page 13: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Issues quality related: ◦ Formulation: correct and understandable

◦ Content acceptable (not normative!)

◦ Completeness (of the set)

◦ Technically correct (doubles, not granular…)

Issues usage related ◦ Importance

◦ Feasibility

Page 14: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

http://www.prorec.ro/sondaj

Page 15: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Requirements included in Eurorec Seal Level 2 covers basic functionality

Some criteria are derived from the very model of a DBMS - ease accepted by the developers

Other criteria - too specific or too vague

The necessity of ◦ Clear definition of terms

◦ Explanations to be included with the criteria

◦ Headings for grouping the criteria

Page 16: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

GS001611.01: The system is able to present all the documentation associated to a contact for that patient. ◦ SS000595. 01 - CCHIT-06 - 55 - The system

shall display documentation

GS002243.1 Security service issues and operation of the system are well documented.

GS002625.1 The system enables the user to modify patient's administrative data.

Page 17: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

GS001550.6 The system presents a current medication list associated with a patient.

GS001559.2 The system presents a medication history associated with a patient.

GS002638.1 The system distinguishes actual or active medication items from past medication items when including and displaying medication items in lists or in a journal

Page 18: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD
Page 19: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Workshop: Validation of the Eurorec Seal tools and methodology - Timisoara, April 2011

Medins ◦ EMR for GPs, patient oriented

◦ Data grouping by SOAP and by episodes

◦ Coding system: ICPC-2 and ICD-10

Assessment data collected on a framework build based on Danish and Slovenian templates

Page 20: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD
Page 21: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD
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Present state regarding the certification:

◦ lack of “motivation” for the developers

◦ Lack of awareness for the clinicians

Implementing the certification mechanism took time and need a proper preparation

Need of “pressure” for accepting the necessity of EHR certification

Create incentives for the use of EHR certified systems

Page 27: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Don't reinvent the wheel – use existing methodology

Share expertise and resources Work in small groups and try to involve

various stakeholders Always display the English version of the

statement near the translated one. Reference statements could bring clarity Identify unclear situations about the criteria

accomplishment and consult as many opinions

Page 28: Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

Questions?

[email protected]