1. Mobile Health (MH) Working Group – Projects Update
HL7 May 2019 WGM
By Matthew Graham (Mayo Clinic)
May 7, 2019
® Health Level Seven and HL7 are registered trademarks of Health Level Seven International, registered with the United States Patent and Trademark Office.

2. Mobile Health Work Group Co-Chairs
Gora Datta
Matt Graham
Nathan Botts
Frank Ploeg

3. MH Sessions Wednesday Q1 – Introduction & Overview
State of Mobile Health
Wednesday Q2 – cMHAFF – Deep Dive
Wednesday Q3 – mLabel Brainstorming Session
Thursday Q1 – cMHAFF Working Session
Thursday Q2 – cMHAFF Working Session
8/19/2019

4. Mobile Health - Projects
Consumer Mobile Healthcare Application Functional Framework (cMHAFF)
mLabel – Consumer Labeling for Mobile Health Applications
School Healthcare Information Framework utilizing Technology (SHIFT)
® Health Level Seven and HL7 are registered trademarks of Health Level Seven International, registered with the United States Patent and Trademark Office.

5. Consumer Mobile Healthcare Application Functional Framework (cMHAFF)
Mobile Health May 2019 HL7 Montreal Canada WGM cMHAFF Project (HL7 Confluence)
® Health Level Seven and HL7 are registered trademarks of Health Level Seven International, registered with the United States Patent and Trademark Office.

6. cMHAFF Scope and Goals
Provide a framework for assessment of the common foundations of mobile health apps
Product Information (disclosures/transparency)
Security
Privacy / consent / authorization
Risk assessment/analysis
Data access privileges
Data exchange / sharing
Usability & Accessibility
Assessment could include attestation, endorsement, testing, voluntary or regulatory-driven certification
Out of scope: specific clinical content or functionality
cMHAFF is scoped towards general-purpose standards and guidelines that span most mobile apps, such as privacy, security, data export, and transparency.
Because of the huge range of potential functionality, cMHAFF does not attempt to provide specific guidance for functionality, such as data and capabilities for disease management, fitness, etc.
Assessment methods are to be determined, but most likely private sector testing, endorsement, and certification, rather than regulation.
8/19/2019

7. Why cMHAFF? What’s the Need?
Target Audience: mobile health app developers needing guidance on building apps
Beneficiaries: consumers, providers, caregivers
Consumers need protection, transparency and assurance regarding mobile apps. Some examples:
What does the app do? What evidence supports it?
What security protections exist behind that “cloud?”
Who can the app share data with?
What does the app know about me (location, microphone, camera, contacts, etc.), and what can it do on my device?
Can I access my app data like I can under HIPAA?
To refresh your memory on why this project exists, we believe there are unmet needs that exist in the marketplace, as health IT is increasingly moving to mobile delivery platforms, for consumers as well as clinicians. There is much attention at the Federal level as well, including ONC and FTC, on the need for better guidance for MH apps.
While some of the results of cMHAFF may benefit clinicians as well, its scope of guidance is targeted towards developers who build mobile apps for consumers, while the benefiiciaries of apps following that guidance should be the consumers who use those apps. And, of course, if assessment programs arise such as voluntary certification or endorsements, cMHAFF can be a baseline for those.
8/19/2019

8. Project Updates Review of initial Pilot Project Implementations
mLabel Brainstorming
Normative Ballot May 2020
8/19/2019

9. CMHAFF Pilots Children’s Health Fund
Universitair Medisch Centrum Groningen
Children's Hospital of Philadelphia (CHOP)
CMHAFF Health App Certifier

10. Sample of U.S. Policies & Guidelines Assessed
ISO TC215> ISO/TR 17522:2015 Provisions for health applications on mobile/smart devices
Health Insurance Portability and Accountability Act
FDA Playbook on Medical Device Cybersecurity
NIST Special Publication:
FTC Cross-Device Tracking Considerations
FTC Guidance for mHealth Developers
8/19/2019

11. CMHAFF Web Guide!
Check out our first draft of the CMHAFF web guide and pilot site at:

12. Sample of European Guidelines Assessed
French mHealth Good Practice Guidelines
German Mobile Health Assessment Criteria
Andalusian App Recommendations
U.K. PAS277 Quality Criteria
Finland PHR Cert Criteria
Other EU initiatives
8/19/2019

13. School Healthcare Information Framework utilizing Technology (SHIFT)
New Mobile Health Project White Paper /PSS
Birds of a Feather Session – Tuesday 5:15 PM - Salon 8
SHIFT Project (HL7 Confluence)
® Health Level Seven and HL7 are registered trademarks of Health Level Seven International, registered with the United States Patent and Trademark Office.

14. SHIFT - SCOPE
The scope of the SHIFT Project is to create a Framework that addresses the needs of various stakeholders who are involved in the health and well-being of students to facilitate learning and activities in the school environment. The White Paper envisions the set of healthcare standards that will support the Framework.
® Health Level Seven and HL7 are registered trademarks of Health Level Seven International, registered with the United States Patent and Trademark Office.

15. Meetings / Questions Mobile Health Fridays – Weekly Meeting
Every Friday at 11 am EST
cMHAFF Project – Weekly Meeting
Every Thursday at 3 pm EST
SHIFT Project – Weekly Meeting
TBD
8/19/2019