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Difference between revisions of "CMHAFF call, Thursday, August 17"
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AGENDA: | AGENDA: | ||
*TO BE ADDED | *TO BE ADDED | ||
| − | *Review specific comments in latest draft | + | *Review specific comments in latest draft '''[[File:cMHAFF_STU_Ballot_Draft.docx]]''' |
**DKT4 decision tree | **DKT4 decision tree | ||
**DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps | **DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps | ||
Revision as of 15:35, 11 August 2017
Attendees: ____
AGENDA:
- TO BE ADDED
- Review specific comments in latest draft File:CMHAFF STU Ballot Draft.docx
- DKT4 decision tree
- DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
- DKT21 reorganization of "Informing Users" section. Does it make sense?
- DKT28-29 granularity vs precision -- are both needed?
- DKT37-38 "syncing" data and "pairing" of devices: should they be within the same section?
- DKT40 decision on what to do with provenance discussion
- DKT41-43 new "Interoperability" section
- DKT49 revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
- DKT56 Should Windows platform considerations be included or not
- Check status, set schedule for recommendations from additional European documents. Look for 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- File:Draft guidelines mhealth apps not for publication DTao Comments.docx -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines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)
