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Difference between revisions of "CMHAFF call, Thursday, August 10"

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Attendees: ____
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Attendees: David Tao, Adamu Haruna, Gary Dickinson, Nathan Botts, Vanessa Batoon
  
 
AGENDA
 
AGENDA
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*Review of recommendations re French Good Practice Guidelines: Reliability (Adamu)
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*Review of recommendations re French Good Practice Guidelines: Reliability (Adamu) -- Adamu's recommendations were discussed, and dispositions were agreed upon. David will incorporate them into the next draft of cMHAFF.
 
*Review latest draft of cMHAFF: '''[[File:cMHAFF_STU_Ballot_Draft.docx]]'''  
 
*Review latest draft of cMHAFF: '''[[File:cMHAFF_STU_Ballot_Draft.docx]]'''  
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**Section 3.3.1.1, Informing Consumers/Users section, review conformance statements. Logically group them, decide upon conformance strength and whether there are too many (currently 24). When trying to add ideas from many sources, cMHAFF grows larger and larger.
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**Section 3.3.1.1, Informing Consumers/Users section, review conformance statements. Logically group them, decide upon conformance strength and whether there are too many (currently 24). When trying to add ideas from many sources, cMHAFF grows larger and larger. Decision was to consolidate some duplicates that were noticed, and to group them into subcategories (e.g., General Info, Payment, Limitations, Evidence/Credentials, etc.) so there is not just one long undifferentiated list.  
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**Specific comment numbers to discuss:
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**Specific comment numbers discussed:
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***DKT4 decision tree
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***DKT10  narrative introductions for each category? YES, this should be added.
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***DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
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***DKT20  style/wording decision throughout -- refer to "app," "product," or...?  Explain that they are synonymous, but change wording to consistently use "App" in conformance statements.
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***DKT10  narrative introductions for each category?
 
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***DKT14  reference for "secure coding practices?"
 
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***DKT20  style/wording decision throughout -- refer to "app," "product," or...?
 
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***DKT30 granularity vs precision -- are both needed?
 
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***DKT39 and DKT40  "syncing" data and "pairing" of devices?
 
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***DKT42  decision on what to do with provenance discussion
 
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***DKT43  new "Interoperability" section
 
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***DKT51  revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
 
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***DKT56  Glossary: build it, or refer to external glossary?
 
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***DKT46  Should Windows platform considerations be included or not
 
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*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).
 
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**'''[[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)
 
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**'''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps UNITED KINGDOM Guidance]''' Guidance for medical device stand-alone software, including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA) (ADAMU)
 
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**'''[https://appcheck.de/kriterienkatalog 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)
 
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**'''[[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)
 
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**'''[[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)
 
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***'''[[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.
 
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***'''[[File:Assessment Questionnaire.xlsx]]''' -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)
 

Latest revision as of 20:21, 10 August 2017

Attendees: David Tao, Adamu Haruna, Gary Dickinson, Nathan Botts, Vanessa Batoon

AGENDA

  • Review of recommendations re French Good Practice Guidelines: Reliability (Adamu) -- Adamu's recommendations were discussed, and dispositions were agreed upon. David will incorporate them into the next draft of cMHAFF.
  • Review latest draft of cMHAFF: File:CMHAFF STU Ballot Draft.docx
    • Section 3.3.1.1, Informing Consumers/Users section, review conformance statements. Logically group them, decide upon conformance strength and whether there are too many (currently 24). When trying to add ideas from many sources, cMHAFF grows larger and larger. Decision was to consolidate some duplicates that were noticed, and to group them into subcategories (e.g., General Info, Payment, Limitations, Evidence/Credentials, etc.) so there is not just one long undifferentiated list.
    • Specific comment numbers discussed:
      • DKT10 narrative introductions for each category? YES, this should be added.
      • DKT20 style/wording decision throughout -- refer to "app," "product," or...? Explain that they are synonymous, but change wording to consistently use "App" in conformance statements.
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