CMHAFF call, Thursday, August 3

Attendees: David Tao, Frank Pfloeg, Adamu Haruna, Nathan Botts, Gary Dickinson, Gora Datta.

AGENDA

• Review of recommendations re French Good Practice Guidelines.
  • Frank completed his recommendations for four categories from the French Guidelines (Usability/Use: Acceptability; Usability/Use: Integration/Import; Health Content: Standardisation; Health Content: Interpreted Content). Frank will send his recommendations (currently in Mind Map) in Word format, and David will incorporate. "Data Granularity" was discussed at length. We decided that assessing whether a given app's data granularity is "right" is out of scope for us; however, it is reasonable to require transparency and justification about the granularity and how it is appropriate. Also, for Usability, we will have a placeholder to refer to HL7 EHR Usability Functional profile, where applicable, rather than including specific usability criteria within cMHAFF.
  • Adamu started presenting his recommendations for the Reliability Category, which he sent two weeks ago. It was agreed that Contraindications should be included (David has already incorporated it into cMHAFF). Will continue with Adamu's additional recommendations next meeting.
• Consider comment points in latest draft of cMHAFF: File:CMHAFF STU Ballot Draft.docx (RAN OUT OF TIME, NOT DISCUSSED)
• Check status and/or assign reviewers to remaining European guidelines (see below). The goal is to review these over the next month, to identify gaps (missing in cMHAFF, but within scope), or contradictions (recommendations that run counter to cMHAFF).
  • File:Charismha abr v.01.1e-20160606 (003) ENG SHORT VERSION.pdf -- GERMAN Chances and Risks of Mobile Health Apps" to compare to cMHAFF. (HARRY RHODES)
  • UNITED KINGDOM Guidance Guidance for medical device stand-alone software, including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA) (ADAMU)
  • GERMAN Assessment Criteria for health-related apps These are mostly intended for developers to use in self-assessment, but the assessments also contain reviews by a third party. (UNASSIGNED)
  • File:National authorisation criteria of Finnish PHR v2.2 Nokia Translation.xlsx -- FINNISH National Authorisation (Certification) Criteria for PHR (unofficial translation into English) Contains approximately 80 criteria in 6 categories. (NATHAN BOTTS)
  • File:Draft guidelines mhealth apps not for publication DTao Comments.docx -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines for assessing the validity and reliability of the data that health apps collect and process." While the project was never completed, there was a report on the work (UNASSIGNED)
    • File:ReportofmHealthWorkingGroup-June2017cleanpdf.pdf of which page 6 summarizes 13 categories for assessment that were discussed, of which six had a higher degree of consensus than others.
    • File:Assessment Questionnaire.xlsx -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)