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Difference between revisions of "CMHAFF call, Thursday, August 17"

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AGENDA:
 
AGENDA:
 
*Review specific comments in latest draft '''[[File:cMHAFF_STU_Ballot_Draft.docx]]'''  
 
*Review specific comments in latest draft '''[[File:cMHAFF_STU_Ballot_Draft.docx]]'''  
−
**DKT4 decision tree
+
**DKT4 decision tree. Agreed that the decision tree diagram format is helpful. Decided to also look at the Children's Health decision tree Nathan sent me, as perhaps closer to what we want.
−
**DKT6 and DKT8 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
+
**DKT6 and DKT8. Decided NOT to impose criticality levels in any formal sense, at least not at this point. Conditional SHALL[IF] statements provide enough flexibility. If necessary, levels can be added later for conformance statements that need them.
−
**DKT13 -- How do we find authoritative references for things like "secure coding" or do we just leave it open-ended?
+
**DKT13 -- How do we find authoritative references for things like "secure coding" or do we just leave it open-ended? Nathan will look for appropriate reference.
−
**DKT22 reorganization of "Informing Users" section. Does it make sense?
+
**DKT22 reorganization of "Informing Users" section. Does it make sense? Yes, it helps. It's possible we will
−
**DKT29-30  granularity vs precision -- are both needed?
+
**DKT29-30  granularity vs precision -- are both needed? Not sure we understand the distinction. David will look again at the French guidelines and other sources to see if the meaning can be clarified.
−
**DKT38-39  "syncing" data and "pairing" of devices: should they be within the same section?
+
**The following were not discussed, as we ran out of time
−
**DKT41  decision on what to do with provenance discussion
+
***DKT38-39  "syncing" data and "pairing" of devices: should they be within the same section?
−
**DKT42-44  new "Interoperability" section
+
***DKT41  decision on what to do with provenance discussion
−
**DKT50  revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
+
***DKT42-44  new "Interoperability" section
−
**DKT57  Should Windows platform considerations be included or not
+
***DKT50  revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
−
*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).
+
***DKT57  Should Windows platform considerations be included or not
−
**'''[[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)
+
*Nathan agreed to recommend which (if any) criteria from Finland should be added to cMHAFF. This will be done on August 31st.  
−
**'''[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)
 
−
**'''[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. (DAVID reviewed, found nothing major to add to cMHAFF)
 
 
**'''[[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: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 (DAVID TAO -- done)
 
−
***'''[[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)
 

Revision as of 20:13, 17 August 2017

Attendees: ____

AGENDA:

  • Review specific comments in latest draft File:CMHAFF STU Ballot Draft.docx
    • DKT4 decision tree. Agreed that the decision tree diagram format is helpful. Decided to also look at the Children's Health decision tree Nathan sent me, as perhaps closer to what we want.
    • DKT6 and DKT8. Decided NOT to impose criticality levels in any formal sense, at least not at this point. Conditional SHALL[IF] statements provide enough flexibility. If necessary, levels can be added later for conformance statements that need them.
    • DKT13 -- How do we find authoritative references for things like "secure coding" or do we just leave it open-ended? Nathan will look for appropriate reference.
    • DKT22 reorganization of "Informing Users" section. Does it make sense? Yes, it helps. It's possible we will
    • DKT29-30 granularity vs precision -- are both needed? Not sure we understand the distinction. David will look again at the French guidelines and other sources to see if the meaning can be clarified.
    • The following were not discussed, as we ran out of time
      • DKT38-39 "syncing" data and "pairing" of devices: should they be within the same section?
      • DKT41 decision on what to do with provenance discussion
      • DKT42-44 new "Interoperability" section
      • DKT50 revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
      • DKT57 Should Windows platform considerations be included or not
  • Nathan agreed to recommend which (if any) criteria from Finland should be added to cMHAFF. This will be done on August 31st.
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