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CMHAFF call, Monday, May 22

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Attendees: David Tao, Nathan Botts, Matthew Graham, Vanessa Batoon

Agenda:

  • Debrief from Madrid WGM about priorities and direction for cMHAFF, scope
    • STU vs Informative -- stay with Informative
    • Guidance vs "certification" target --- stay with "guidance" approach.
    • Timeline -- Still aim for September ballot
    • International vs US-realm -- International still, but OK to have US examples
  • Review highlighted changes in cMHAFF draft
    • 2.2.1 scope
    • 2.3 Lifecycle -- suggested addition: publishing on app store, meeting the app store requirements; app enhancements and maintenance after initial release; frequency of updates; keeping current with OS, etc.
    • 2.3.2 Use Case B -- say "regulated" vs "unregulated" and the criteria for what's regulated varies by realm (e.g.,FDA.) European example is in materials Matt sent me. Clarify if examples are realm-specific.
    • We ran out of time before covering these:
      • 2.3.4 Risk Factors
      • 2.4 Environmental Scan
      • 3.2, (1.2) Product Risk Assessment and Mitigation
  • Other resources to incorporate or reference -- European materials. French guidance received; Matt to send info from Netherlands; Finnish PHR presentation at Madrid will also be reviewed (posted on HL7 webpage).
  • HITRUST review/limited license, final decision -- defer until future.