CMHAFF call, Tuesday June 6

Agenda:

• Re-orientation to project timeline and goals for next ballot. STU vs Informative? Revisit last week's decision. Gora strongly feels it should be STU to have more impact.
  • Timeline -- Still aim for September ballot, but assess impact on content if changing to STU
  • STU requires some implementers to agree to try it. These would probably be app developers who are willing to try to conform to cMHAFF, and provide feedback on their efforts.
  • EHR Functional Model had large groups working on it early on. It was published as DSTU, then evolved to Normative. It was not published as Informative.
  • Gora and all participants are asked to review the document as it now stands (available on Wiki Latest Draft). 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."
  • Should cMHAFF have different "levels of assurance" (e.g., 3 levels?). It is not structured that way now. There are 3 Exemplary Use Cases, but no definition of levels.
• Some European materials have been made available
  • French guidance
  • Draft material from EC (Frank Pfloeg). The project was cancelled and material is not for publication, but there may still be some helpful material to inform cMHAFF.
  • Finnish PHR presentation at Madrid (posted on HL7 webpage): are any draft certification criteria available?
  • Spanish (Andalusia region) materials -- Gora will look into them.
• The following were on agenda to review changes in cMHAFF draft, but defer till next week.
  • 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