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Tom Martin (HIMSS)John Sharp (HIMSS)

David Collins (HIMSS)Michael J. Kirwan (PCHA-Continua)Michael Brown (Ascend Integrated)

Barry Dickman (AEGIS.net, Inc.)

How to Leverage Emerging Standards & Guidelines for Patient Engagement

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• Business Case– Why should we care?

• How PGHD Benefits Patient Engagement• FDA Standards & Health Devices• Limitations of Data Exchange• Mobile Device & EHR Interactivity• Conclusion

Agenda

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• Patients are playing an increasingly important role in creating relevant healthcare data about themselves using mobile devices and applications. – It is important this data can move with them securely throughout a

healthcare ecosystem.• The increased use of medical devices and mobile applications opens

the dialogue around open source and non-proprietary standards with complementing policies.

• Trust and verification of data and data sources are achieved by implementing the proper information exchange standards from design to implementation.

• Adopting a common framework ensures access to high-quality data and promotes reliability across multiple platforms, enabling an enhanced dialogue between providers and patients.

Executive Summary and Introduction

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Business Case & Opportunities

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Challenges:• Multiple Patient Portals

– Patients having multiple portals to capture/log-in to access their records

– Maintaining difference versions of records– No ability to move data to a single, consolidated EHR/EMR– Does not ensure the functionality of a longitudinal health record– Growing importance of patient access to healthcare data

• Different focus moving from healthcare to health avoidance– Context of healthcare in our everyday lives– Healthcare as perceived as the lack of health– Development of a health scale

Business Case

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Problem:• Patients must have the ability to

collect and share data–Establish baseline of their own

healthcare data points –Ability to want to watch for changes

when healthcare becomes necessary/more expenses

Business Case – Cont’d

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• Limited patient engagement• Transition to alternative payment models which

focus on outcomes• Vendor community building devices that do not

follow open source standards-based technology– As consumers, need devices that are consuming data

in an industry-based way (e.g., EHR, EMR , PHR, etc.)– Not being collected & consumed in a clinically

relevant way for decision-makers/providers

Why Should We Care?

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How PGHD Benefits Patient Engagement

Data from Devices to the EHRHigh risk, high cost patients at risk

for readmission, ER visits benefit from monitoring

Remote patient monitoring devices pass data seamlessly to the EHR

Algorithms identify data trends which show potential deterioration

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How PGHD Benefits Patient Engagement

Based on data from remote patient monitoring, medical team contacts patient and family caregivers to adjust treatment

Ensure true coordination of care for patientsPatients can view data trends through the

patient portalPatients communicate with their provider

team via secure messaging

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Case Example Snapshot

Carolinas Healthcare – apps and devices• Carolinas Tracker enables consumers

in the community to aggregate their health data from apps and devices into one place and view a dashboard to see where they need to focus their attention

• Carolinas Healthcare App – comprehensive patient portal

• Diabetes Coaching App Program

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• Detailed clinical data that can be evaluated for patterns and displayed appropriately for providers.

• Help to determine adverse events/critical clinical indicators

• Precision medicine links data points (clinical events) with real-time self reporting via mobile devices

• Use of standards-based technology could support the multiple use and interpretation of clinical events / real-time self reporting

Benefits

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FDA Standards & Health Devices

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FDA Recognized Standards around Digital Health Devices

• The FDA currently recognizes a wide variety of industry standards related to wireless medical devices which also impact mobile medical applications.

• The current cadre of FDA recognized standards leans toward issues associated with wireless “cross talk” or connectivity. This focus on connectivity issues which has a subsequent and significant impact on the delivery or transport of information. However, the need to timely access to information also presents a need for quality-based standards on patient access.

• The other component of transporting information –aside from connectivity between devices - is the need for the ability to move information between data repositories for effective analysis across platforms. The results in establishing a relational understanding of data between two digital health platforms.

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Impact for Connected Health and Personally Generated Health Data

• Currently, there is limited focus among the FDA on recognizing standards which impact the generation of data and the capability to successfully move this information between “data warehouses” or locations where data is analyzed by different platforms.

• Medical grade devices must address the following:– Location of Care: Acute vs. Ambulatory vs. Home Care, vs

Others– Leverage existing data transport standards

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ONC Meaningful Use Stage 3: Focus on APIs

• Meaningful Use Stage 3 objectives focus largely on the use of APIs for the access of information within programs.

• From - Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017– View their health information;– Download their health information;– Transmit their health information to a third party; and– Access their health information through an API.

• Future efforts by ONC to include API certification programs

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Limitations of Data Exchange

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Current Limitations of Data Exchanges

• According to a survey conducted in 2014 by Research Now, mHealth users get more out of an EHR than traditional desktop applications.

• EHR and Mobile standards allow for both push and pull notifications to occur between an enterprise EHR and a mobile device.

• Many healthcare providers have developed Application Programming Interfaces (APIs), allowing a mobile device to push certain data sets into an EHR.

• Accessing EHR data repositories through a single mobile interface is an industry next step.

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Current Limitations of Data Exchanges

• Platforms must enable true interoperability (push and pull data securely) between medical and non-medical devices and EHR systems.– Engineers are working to transform traditionally defined healthcare data

into JSON, a consumable format for mobile devices. – HL7 Fast Healthcare Interoperability Resources (FHIR) is a healthcare

information exchange standard that provides a method for mobile devices to pull & push (Bi-directional information exchange) from an enterprise EHR.

• Secure SMS messaging standards, such as HL7 mFHAST allows EHRs to push secure text notifications to patient – Restricted to 140 characters per message. – One-way communication, not intended for sending large quantities of data.

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Security Standards and Recent Developments

• The National Institute of Standards and Technology (NIST) released mobile device security guidelines for comment from the public. The guidelines provide a framework for the following:– Networking Infrastructure Services– Backup & Disaster Recovery (DR)– Configuration Management– Intrusion Detection Systems (IDS)– Certificate Authorities (Secure Socket Layer (SSL))– Identity and Access Control – Operating Systems

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International Standards for Mobile Devices

• The International Organization for Standards (ISO) and International Electrotechnical Commission (IEC) regulates all standards internationally for medical devices and mobile healthcare.

• They are international standards, subsequently any region or country can adopt these standards.

• Several of the international standards around mobile & medical devices include:– ISO 14971:2007: Medical Devices – Application of Risk Management to Medical

Devices– ISO 13485:2003: Medical Devices – Quality Management Systems –

Requirements for Regulatory Purposes– IEC 62366-1:2015: Medical devices — Part 1: Application of usability

engineering to medical devices– ISO/IEEE 11073-20601: Optimized Exchange Protocol

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U.S. Standards for Medical Devices

• The U.S. uses the American National Standards Institute (ANSI), the U.S. representative to the ISO.

• There are two organizations approved by ANSI specifically for Medical Device standards definitions:– Advancement of Medical Instrumentation (AAMI)– American Society for Quality (ASQ)

• Below are examples of standards used for Medical Devices:– ANSI/AAMI/ISO 13485:2003 (R2009): Medical devices — Quality

management systems - Requirements for regulatory purposes– ANSI/AAMI/ISO 14971:2007 (R2010): Medical devices — Application of risk

management to medical devices– ANSI/ISO/ASQ Q9001-2008: Quality management systems —

Requirements (U.S. version of ISO 9001:2008)

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European Union Standards

• The EU has two standards organizations, European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC). Examples include:– EN ISO 13485:2012: Medical devices — Quality management

systems — Requirements for regulatory purposes– EN ISO 14971:2012: Medical devices — Application of risk

management to medical devices• The Medical Device Directive (MDD), Active Implantable

Medical Device Directive (AIMDD), and the In Vitro Diagnostic Directive (IVDD) define requirements for particular types of medical devices.

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Additional Standards Considerations

• A region or country may adopt an international standard and place certain constraints on the standard. – The U.S. may adopt medical device / mobile health

standards. – Many of the standards defined at the International (ISO)

level may be modified from the original standard to fit a specific country (much like ANSI).

• U.S. standards organizations may adopt various standards, however regulatory authorities such as the FDA are not required to recognize these standards.

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Mobile Devices & EHR Interactions

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Standards Enabling the Effective Transportation of Healthcare Information

• Devices– IEEE 11073 (Currently covers 16 device specializations)– Bluetooth (Classic basic rate and Smart covering an additional 6 device

specializations)– Devices (Weighing Scale, Body Comp. Analyzer, Heart Rate, Blood Pressure,

Insulin Pump, Continuous Glucose Monitor,

• Services– HTTPS / SOAP / XML– REST / hData / JSON– HL7 FHIR – Also HL7 3.0 via the Personal Health Monitoring Record Also via IHE’s new

Remote Patient Monitoring Profile (which is nearly an approved IHE Profile that will be tested within the next IHE Connectathon in January 2016).

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Conclusion

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Conclusion

• Patients need more accessibility over their data.– Engineers are challenged to enable secure and

reliable data transfer / exchange between existing systems and mobile devices.

– Engaging patients via mobile devices improves health outcomes and quality of care.

• Engaging patients will occur through the use of mobile devices and industry standards / best practices.

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Acknowledgements

• David Haddad, Executive Director, Open mHealth (www.openmhealth.org)