Agenda Items

  • Ballot Reconciliation

Discussion items

3 minIntroductionsAll
  • No new attendees

50 min

cMHAFF Migration

CEN/ISO Gap Analysis a.k.a. cMHAFF - CEN/ISO Harmonization & Conformity Assessment Ad Hoc Group

  • CMHAFF Ballot Reconciliation: 
    • Completed Other-2166. 
    • Go to OTHER-2166 - Getting issue details... STATUS
    • Search = project = OTHER AND issuetype in ("Change Request", Comment, Question, "Technical Correction") AND status = Triaged AND resolution = Unresolved AND Specification = "HL7 Consumer Mobile Health Application Functional Framework (OTHER) [OTHER-cmhaff]" ORDER BY priority DESC, updated DESC
    • Ended on and completed OTHER-2170, OTHER-2150, OTHER-2151, OTHER-2152, OTHER-2149
      • Updated the bullet as follows: 
      • Clinical functionality of health apps (e.g., diabetes monitoring, exercise calculations). The Mobile Health workgroup does not have the subject matter expertise to define clinical-level types of criteria.
    • Addressed OTHER 2164 related to PIM 2.1.4 - need to follow-up on where to put the recommendation. 
      • We propose the following conformance statement to be added to Section PIM.2.1.3: The App SHOULD reference/provide sufficient information so that consumers can easily access evidence for review. This could include clinical, social, technical, and other domains of potential relevance.

    • Working through newly found comments that had not previously been identified thanks to Melva's updated query as follows:
      • project = OTHER AND issuetype in ("Change Request", Comment, Question, "Technical Correction") AND status = Triaged AND resolution = Unresolved AND Specification = "HL7 Consumer Mobile Health Application Functional Framework (OTHER) [OTHER-cmhaff]" ORDER BY priority DESC, updated DESC
    • Contacting Melva Peters to identify next steps in ballot reconciliation
    • Unable to find ballot in JIRA at the moment so that we cannot export reconciliation finalization
    • Trying to follow the steps outlined here: Reconciliation spreadsheets
  • International HL7 Workgroup Meeting Update
  • General Mobile Health Updates
  • JIRA Ballot Transition
  • cMHAFF migrate to EHR-S FM Format:  cMHAFF migrate to EHR-S FM Format
    • EHR-S FM Format updates completed
    • Will not be completing full migration for this ballot round
    • Will plan to pursue when working toward normalization
  • Progress Strategy
    • Frank Ploeg  to put together first draft of HaWa overview, outline of results and gap analysis by  
    • Nathan Botts  to put together first draft of HITEQ Health App analyzer pilot overview, outline of results and gap analysis by  
  • Review of CEN-ISO DTS 82304-2:2020 near final draft for ballot
    • Discussion of gap analysis for next CMHAFF ballot
    • Plan to break up gap findings, conduct review, and add conformance updates or changes to language as appropriate
  • HL7 WGM Meeting Planning
    • Updating slide deck
  • CEN/ISO Progress
    • Frank to follow-up with the meeting request with Charlie
    • Response from Charlie:
      • Many thanks I look forwards to working with HL7, ISO, IEC, CEN and others to avoid fragmentation in this space.

      • How do we progress the statement on differences? -- maybe we could discuss on the monday call and then schedule a call sometime next week with petra to finalise the detail?

    • Frank still working on gap analysis between HaWa and CMHAFF

  • HITEQ Health App Analyzer Review
  • Notes from  8/27/2020
    • General discussion on how best to leverage the CEN/ISO HaWa gap analysis conducted by Frank Ploeg
    • Work toward response to Charlie McCays proposal for collaboration
    • Charlie McCay email text:

      "I think that there is a case for separating the statements describing what cMHAFF is and how it is being maintained alongside 82304-2 from the statements about the relationship between the two specifications from a user perspective.  

      These reads to me as an excellent way to frame the need for HL7/ISO/CEN/IEC to collaborate going forwards, and I would suggest that we take the statement forwards in that context, developing a proposal for the relevant HL7/ISO/CEN/IEC/CENELEC leaderships for how the specifications can be taken forwards.

      It seems to me that the situation is as follows:

      [1] both specifications have been developed to support the assessment of health apps.

      [2] where possible they use common definitions and criteria

      [3] there are differences in the number of criteria, and focus of the criteria, so a direct mapping between the criteria is not possible in the current versions of the specifications

      [4] the PSDO relationship between HL7 and ISO opens up opportunities for more direct and formal collaboration in the maintenance of the specifications going forwards

      I suggest that in the TS we include (a paraphrasing of) the statements [1], [2] and [3] with a reference to the HL7 cMHAFF product page.  

      fwiw my preference for a future collaboration would be:

      [1] ISO/IEC is the home for a base set of criteria

      [1.1] ISO/IEC maintain the links into the suite of health software and software-as-a-medical-device standards 

      [1.2] HL7 maintains the links through to the HL7 functional specification frameworks 

      [1.3] HL7 maintains the links through to SMART on FHIR and similar relevant interoperability specifications

      [2] HL7, HL7 Affiliates, CEN, and National Member bodies can define and ballot profiles for specific geographies or usecases.  This may be done collaboratively between HL7 national affiliates and national member bodies.

      Both specifications are in a "pre-standard" state... 82304-2 is a TS, and cMHAFF and STU .. and it is clear that there is more to learn about what he market needs and how to best drive adoption at scale... and I think that we need to keep the momentum up on those conversations"

      Response to email: 
      • Overall agreement with statements outlined in the email
      • Need to work on the description of differences as discussed in 3
      • In principle, we fully agree with this proposed way forward. Discussion on the obvious need to walkout the proposed collaboration elements and work through the respective procedures for each organization.
      • Plan to circle back to discuss next steps in the future collaboration after the respective products are in the public domain

  • Notes from 7/19 Meeting
  • Final review of cMHAFF/ISO harmonization text for inclusion within ISO TS82304-2 
    • Approved by subworkgroup  
  • Need to get ballot NIB in order by  to meet the January 2021 WGM deadline.
    • Need to get the workgroup vote on approval to ballot by early October so that it has time to be passed on to the steering division for approval afterwards
    • For projects other than investigative and reaffirmations, to submit a NIB, your PSS must have been approved by TSC a minimum of four weeks before the start of the WGM that precedes the NIB deadline. 
  • Notes from 6/25 Meeting
    • CEN/ISO and CMHAFF Inclusion Discussion
      • Discussion on certification need and impact in relation to global software as a medical device
      • First step in integration between ISO and HL7 - How to collaborate?
        • As the two efforts evolve within standardization cycles each will benefit from each others formal progress
  • Notes from 6/11 Meeting
    • Focused this meeting primarily on how to harmonize cMHAFF and CEN/ISO and what our views should be on how the CEN/ISO Technical Specification will co-exist with the cMHAFF Framework.
      • As of now cMHAFF is reverenced in the TS in Annex E (Informative) "relationship to HL7 Consumer Mobile Health Application Functional Framework"
      • The idea was to have the CEN/ISO specs as a overall TS and cMHAFF as the profiled version - as in realm specific, health topic specific - of the TS
      • This requires mapping of the TS to cMHAFF and vv
      • This mapping process is almost finished in the since that where applicable cMHAFF has been incorporated in the TS. In cooperation and adjustment form the TS point of view in cMHAFF has not been undertaken yet. 
    • Basically the main question in the meet was how do we envisage the co-existence of cMHAFF to the CEN/ISO specs. This led to an invitation to Gora to help us define this co-existence, also in relation to the Conformity Assessment Ad Hoc Group which is founded by the initiative of Gora (which is the understanding by Frank). Ther invite to Gora reads as follows:
      • Hi Gora, From the CEN/ISO perspective (as relayed by Frank) it sounds as though there are some questions on the ongoing “relationship” between HaWa and CMHAFF and how formal that continues to be moving forward. Members of the conformance assessment adhoc group (that you helped to intiate as we understand it) seem to be having questions about this and the benefits or not. We are not completely sure we understand all of the implications/politics involved between CEN/ISO and HL7 CMHAFF and think we could benefit from some of your background/guidance on this. Would you be available to join the CMHAFF meeting next week (6/18) to discuss this and formulate a position of sorts that can be communicated to that team. Thanks, -Nathan

2 minNew Business: mHealth Hub and HL7 Foundation involvementFrank
  • Frank informed the team about HL7 foundation joining in with the mHealth Hub. By the initiative of Catherine Chronaki, Giorgio Cangioli, Gora Datta & Frank have been asked to join the initative (and have accepted (smile)).

Action items

  • Nathan Botts - plug in CMHAFF ballot into similar outline as the phrs-fm release example  
  •   Frank Ploeg - confirm with Michael if there is an open template or whether the tooling is what drives the ballot documentation (and also how this would work with the new JIRA balloting method)  
  • Nathan Botts and Frank Ploeg finalize project descriptions and analysis gaps   
  • Nathan Botts Frank Ploeg Add the following to the updated ballot: Comment: Change SHOULD TO SHALL. Consider requiring the developer to disclose whether any SDKs allowing for data siphoning are included the app.