CMHAFF call, Tuesday June 13

Attendees:

Agenda

• Revisiting of STU vs Informative. What changes in work, staffing, or dates would be needed for one vs. the other? Have participants in the call been able to review cMHAFF's current draft (available on Wiki Latest Draft), as requested last week. Is it close enough that it can be brought to ballot with reasonable time and staffing? Many of the conformance criteria are "attestation" or "inspection" types of criteria, rather than "testable."
• Debrief on review of European materials (particularly the French guidance) and impact on cMHAFF
• Review the following specific recently changed sections of cMHAFF.
  • 2.3 Lifecycle -- revised based on suggestions from 5/22: 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.
  • 2.3.4 Risk Factors
  • 2.4 Environmental Scan
  • 3.2, (1.2) Product Risk Assessment and Mitigation