CMHAFF call, Tuesday June 27

Attendees: David Tao, Frank Pfloeg, Harry Rhodes, Adamu Haruna

Agenda:

• David presented the HAS Categories (14) and the cMHAFF categories (17) side by side, indicating areas of commonality and differences. Posted here cMHAFF-HAS Good Practice Guidelines comparison The green shading indicates areas where the cMHAFF and French categories are reasonably aligned, though there may be lots of differences in the criteria. The yellow shading indicates that the categories aren't well aligned, but the criteria generally exist in both (though they may be in multiple categories or labeled quite differently). The red shading indicates a that a category is not included at all. We need to determine whether red means a "gap" for cMHAFF that should be filled, or whether it is simply out of scope.
• We agreed that not everything in every regional guideline needs to be included in cMHAFF. We should focus on the "Core" and see if anything within the core is missing. Other non-core areas can always be added later.
• We agreed on the following persons to review the potential gaps in cMHAFF ("red" areas in the left column of the comparison chart). They should look at the French guidelines, and recommend which parts, if any, should be considered for inclusion in cMHAFF:
  • Frank -- Usability/Use: Acceptability; Usability/Use: Integration/Import; Health Content: Standardisation; Health Content: Interpreted Content
  • Harry -- Technical Content: Data Flow
  • Adamu -- Security/Reliability: Reliability
  • We should remember that the French guidelines for ASSESSING an app (an existing app) will have areas that are not applicable to someone DEVELOPING a NEW app (e.g., existing of third party reviews).
• Many European guidance documents (from France, Germany, UK, Andalusia) have been posted on Reference Resources on cMHAFF Wiki
• The following persons also agreed to review additional documents (by early August), and compare them to cMHAFF, to see if there is any significant material missing in cMHAFF. These are all on the Wiki under Reference Resources
  • Harry -- German document (File:Charismha abr v.01.1e-20160606 (003) ENG SHORT VERSION.pdf -- GERMAN Chances and Risks of Mobile Health Apps" to compare to cMHAFF.)
  • Adamu -- U.K. document (Guidance: Medical device stand-alone software including apps -- from UNITED KINGDOM Medicines and Healthcare Products Regulatory Agency (MHRA)
  • David -- Andalusian guidelines

• NO MEETING NEXT WEEK (JULY 4th). The meeting time may be changed, but not enough responses to the Doodle poll have been received yet.