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.

1. 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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2. • 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
2

3. • 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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4. Business Case & Opportunities
4

5. 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
5

6. 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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7. • 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?
7

8. How PGHD Benefits Patient Engagement
Data from Devices to the EHR
High 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 8

9. 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 patients
Patients can view data trends through the
patient portal
Patients communicate with their provider
team via secure messaging
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10. 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 10

11. • 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
11

12. FDA Standards & Health Devices
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13. 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. 13

14. 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
14

15. 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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16. Limitations of Data Exchange
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17. 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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18. 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. 18

19. 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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20. 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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21. 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) 21

22. 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. 22

23. 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. 23

24. Mobile Devices & EHR Interactions
24

25. 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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26. Conclusion
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27. 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. 27

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