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Difference between revisions of "MHWG Consumer Mobile Health Application Functional Framework,"

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'''Project Co-Leads:'''  Nathan Botts and David Tao
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'''Project Co-Leads:'''  Nathan Botts and Frank Ploeg
  
 
== Overview ==
 
== Overview ==
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In particular, cMHAFF will address the following areas:
 
In particular, cMHAFF will address the following areas:
 +
* Transparency of information about the app, its purpose, intended use, target audience, authors, sources, evidence, etc.
 
* User, device, and cross-system authentication
 
* User, device, and cross-system authentication
 
* Authorization to content and features
 
* Authorization to content and features
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* Conditions and agreements, e.g., privacy policy, terms of use, and in-app disclaimers
 
* Conditions and agreements, e.g., privacy policy, terms of use, and in-app disclaimers
  
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The cMHAFF project went through an HL7 Comment-Only Ballot in January 2016; comments were reconciled as of September 2016; a revised cMHAFF document is being developed for balloting in 2017.
+
The cMHAFF project went through an HL7 Comment-Only Ballot in January 2016; comments were reconciled as of September 2016; a revised cMHAFF document is being developed for STU ballot in Jan 2018.
  
 
== Project Scope Statement ==
 
== Project Scope Statement ==
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== Meeting Schedule ==
 
== Meeting Schedule ==
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Standing meetings are every Monday at 5 PM Eastern. Watch for weekly announcement and agenda. Monday meetings will usually be cancelled if cMHAFF meets jointly with Security and CBCC (Tuesday, 2-3pm ET) in any given week.
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Standing meetings are every Thursday at 3 PM Eastern. Watch for weekly announcement and agenda.
  
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WebEx:
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Westat WebEx
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https://westat.webex.com/westat/j.php?MTID=mf163da12b3585dd6f6ffa0e66adfb4bf
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https://westat.webex.com/westat/e.php?MTID=m9411e9dddda3df675ed663ad56fe5816
 
   
 
   
 
Phone:
 
Phone:
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== Documents ==
 
== Documents ==
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===2017 Working Documents===
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===cMHAFF Prep for Ballot Material===
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'''[[File:HL7_cMHAFF_Informative_Ballot_Draft.docx]]''' Copy of cMHAFF as updated after ballot reconciliation, in progress toward next ballot. Updated June 3, 2017
+
'''[[File:cMHAFF_STU_Ballot_Draft.docx]]''' History of cMHAFF drafts, as it evolved toward January 2018 STU ballot. Updated December 14, 2017.
 +
 
 +
[http://www.hl7.org/Special/committees/tsc/ballotmanagement/ViewPastNIB.cfm?ballot_pool_id=1080 Notice of Intent to Ballot (NIB) for January 2018]
 +
 
 +
===Other related documents===
 +
 
 +
'''[[File:cMHAFF_Update_2017-Sept-WGM_16x9.pptx]]''' cMHAFF presentation for September 2017 HL7 Working Group Meeting.
  
 
'''[[File:cMHAFF-HAS_Comparison.docx]]''' Side-by-side comparison of cMHAFF vs French HAS Good Practice Guidelines categories  
 
'''[[File:cMHAFF-HAS_Comparison.docx]]''' Side-by-side comparison of cMHAFF vs French HAS Good Practice Guidelines categories  
  
 
'''[[File:MHAFF_CONS_MHAFF_R1_O1_2016JAN_Consolidated_WG_TRACK_FOR_2017_BALLOT.xlsx]]''' -- Ballot Reconciliation spreadsheet, edited to show work in progress toward next ballot
 
'''[[File:MHAFF_CONS_MHAFF_R1_O1_2016JAN_Consolidated_WG_TRACK_FOR_2017_BALLOT.xlsx]]''' -- Ballot Reconciliation spreadsheet, edited to show work in progress toward next ballot
 +
 +
[[File:HL7_cMHAFF_Informative_Ballot_Draft.docx]] DEPRECATED. Kept as archive of cMHAFF as updated after ballot reconciliation, in progress toward next ballot. Updated June 3, 2017. Superseded by HL7_cMHAFF_STU_Ballot_Draft.docx.
  
 
[http://www.hl7.org/Special/committees/mobile/projects.cfm?action=edit&ProjectNumber=1182 HL7 cMHAFF Project Summary]
 
[http://www.hl7.org/Special/committees/mobile/projects.cfm?action=edit&ProjectNumber=1182 HL7 cMHAFF Project Summary]
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===Reference Resources (including European Guidelines and Good Practices)===
 
===Reference Resources (including European Guidelines and Good Practices)===
  
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'''[[File:French_good_practice_guidelines_on_mHealth_apps.pdf]] -- FRENCH''' "Good Practice Guidelines on Health Apps and Smart Devices" to compare to cMHAFF.
+
*'''[[File:French_good_practice_guidelines_on_mHealth_apps.pdf]] -- FRENCH''' "Good Practice Guidelines on Health Apps and Smart Devices" to compare to cMHAFF. Reviewed by Frank Ploeg, Adamu Haruna, David Tao, and cMHAFF team
  
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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.
+
*'''[[File:charismha_abr_v.01.1e-20160606 (003)_ENG SHORT VERSION.pdf]] -- GERMAN''' Chances and Risks of Mobile Health Apps" to compare to cMHAFF. Reviewed by cMHAFF team
  
−
'''[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.  
+
*'''[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.  
  
−
'''[[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
+
*'''[[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. Reviewed by David Tao.
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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 '''[[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: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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<br>
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**'''[[File:Assessment Questionnaire.xlsx]]''' -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)
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'''[[File:Assessment Questionnaire.xlsx]]''' -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)
 
  
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'''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps Guidance:
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*'''[[File:PAS 277 (2015).pdf]] -- U.K. Health and wellness apps – Quality criteria across the life cycle – Code of practice.''' Includes quality criteria, app project life cycle, risk management, fitness for purpose, etc. Reviewed by Adamu Haruna
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Medical device stand-alone software including apps]''' -- from UNITED KINGDOM Medicines and Healthcare Products Regulatory Agency (MHRA)
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**'''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps U.K. Guidance]''' primarily for medical device stand-alone software, but also including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  
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'''[http://www.calidadappsalud.com/en/listado-completo-recomendaciones-app-salud/ ANDALUSIAN Complete list of recommendations on design, use and assessment of health Apps]''' -- This has four categories: 1. Design and Appropriateness; 2. Quality and Safety; 3. Provision of Services; 4. Confidentiality and Privacy
+
*'''[http://www.calidadappsalud.com/en/listado-completo-recomendaciones-app-salud/ ANDALUSIAN Complete list of recommendations on design, use and assessment of health Apps]''' -- This has four categories: 1. Design and Appropriateness; 2. Quality and Safety; 3. Provision of Services; 4. Confidentiality and Privacy. Reviewed by David Tao
  
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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.  
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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. Reviewed by Nathan Botts
  
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'''[[File:EU_Privacy_CodeofConductfinaldraft.pdf]]''' EU voluntary but authoritative guidelines, to compare to cMHAFF. See [https://ec.europa.eu/digital-single-market/en/privacy-code-conduct-mobile-health-apps Privacy Code of Conduct on mobile health apps] for an overview.
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*'''[[File:EU_Privacy_CodeofConductfinaldraft.pdf]]''' EU voluntary but authoritative guidelines, to compare to cMHAFF. See [https://ec.europa.eu/digital-single-market/en/privacy-code-conduct-mobile-health-apps Privacy Code of Conduct on mobile health apps] for an overview.
  
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'''[https://ec.europa.eu/digital-single-market/en/news/commission-staff-working-document-existing-eu-legal-framework-applicable-lifestyle-and Commission Staff Working Document on the existing EU legal framework applicable to lifestyle and wellbeing apps]''' This is a non-exhaustive description of EU legislation, applicable to lifestyle and wellbeing apps. The aim of this document is to provide guidance for example to app developers.
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*'''[https://ec.europa.eu/digital-single-market/en/news/commission-staff-working-document-existing-eu-legal-framework-applicable-lifestyle-and Commission Staff Working Document on the existing EU legal framework applicable to lifestyle and wellbeing apps]''' This is a non-exhaustive description of EU legislation, applicable to lifestyle and wellbeing apps. The aim of this document is to provide guidance for example to app developers.
  
−
'''[[File:Draft_White_Paper_PGHD_Policy_Framework_HL7_MH_Comments.pdf]]''' Draft whitepaper on PGHD, written by Accenture for ONC.
+
*'''[[File:Draft_White_Paper_PGHD_Policy_Framework_HL7_MH_Comments.pdf]]''' Draft whitepaper on PGHD, written by Accenture for ONC.
  
 
===Old documents===
 
===Old documents===
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== Minutes==
 
== Minutes==
−
===2017 Meetings===
+
===2018 Meeting Minutes===
−
'''NO MEETING the week of July 3-7. Next meeting tentatively set for week of July 10th, pending results of Doodle poll sent to the MH Listserv (please respond if you want to continue participating in cMHAFF).'''
+
 
 +
For all current minutes please go to [https://cmhaff.healtheservice.com/Workgroup/tabid/1043/Default.aspx HL7 CMHAFF Standard Web Portal]
 +
 
 +
===2017-2018 Meetings===
 +
 
 +
*[[cMHAFF call, Thursday, January 25, 2018]]
 +
*[[cMHAFF call, Thursday, December 14]]
 +
*[[cMHAFF call, Thursday, December 7]], including FINAL PLAN to complete ballot materials
 +
*[[cMHAFF call, Thursday, Nov 30]], including WEEKLY PLAN for completion of ballot materials
 +
*[[cMHAFF call, Thursday, Nov 16]]
 +
*[[cMHAFF call, Thursday, Nov 9]],
 +
*[[cMHAFF call, Thursday, Nov 2]], including WEEKLY PLAN for completion of ballot materials
 +
*[[cMHAFF call, Thursday, Oct 26]]
 +
*[[cMHAFF call, Thursday, Oct 19]]
 +
*[[cMHAFF call, Thursday, Oct 12]]
 +
*[[cMHAFF call, Thursday, Oct 5]]
 +
*[[cMHAFF call, Thursday, Sept 21]]
 +
*[[cMHAFF call, Thursday, Sept 7]]
 +
*[[cMHAFF call, Thursday, August 31]]
 +
*[[cMHAFF call, Thursday, August 24]]
 +
*[[cMHAFF call, Thursday, August 17]]
 +
*[[cMHAFF call, Thursday, August 10]]
 +
*[[cMHAFF call, Thursday, August 3]]
 +
*[[cMHAFF call, THURSDAY, July 20]]
 +
*[[cMHAFF call, Tuesday July 11]]
 
*[[cMHAFF call, Tuesday June 27]]
 
*[[cMHAFF call, Tuesday June 27]]
 
*[[cMHAFF call, Tuesday June 20]]
 
*[[cMHAFF call, Tuesday June 20]]

Latest revision as of 01:21, 13 September 2018

Project Co-Leads: Nathan Botts and Frank Ploeg

Overview

This project (Consumer Mobile Health Application Functional Framework, (a.k.a. cMHAFF) will define security, privacy and data standards and guidelines for mobile health applications (apps), as well as other aspects of transparency and consumer protection through the life cycle of such apps (from purchase, download, installation, use, and deletion). The intent is to provide industry guidance and common methods to enable the development of mobile health apps targeted to consumers/citizens that use protected health information (PHI) and personally identifiable information (PII). These standards will not address the clinical content of such apps (e.g., "Does it give good advice?"), but will provide a framework for security, privacy and the integration of data generated from apps into Personal Health Record (PHR) and Electronic Health Record (EHR) systems as well as into other types of data repositories (e.g., personal data stores, population care systems). "Mobile Health Apps" include apps running typically on smartphones, but also on other consumer devices such as watches and tablets.

cMHAFF may reuse conformance criteria already available within the HL7 PHR-S and EHR-S Functional Models, augmenting with new conformance criteria specific to mobile platforms (e.g., use of geolocation services, accelerometers, cameras, microphones, contacts). It will also use existing HL7 principles for security and privacy risk assessment. It will not attempt to replicate standards, regulations, and guidelines defined elsewhere, but will reference them where possible.

In particular, cMHAFF will address the following areas:

  • Transparency of information about the app, its purpose, intended use, target audience, authors, sources, evidence, etc.
  • User, device, and cross-system authentication
  • Authorization to content and features
  • Proxy designations
  • Use of location services, camera, accelerometers and other smartphone services
  • Security of data at rest (local and cloud)
  • Security of data in transit (wired and wireless)
  • Minimum data standards for device generated and device transmitted information
  • Record system reliability; record authenticity (it is what it represents to be)
  • Data provenance
  • Audit
  • Discontinuation of use of an app
  • Conditions and agreements, e.g., privacy policy, terms of use, and in-app disclaimers

The cMHAFF project went through an HL7 Comment-Only Ballot in January 2016; comments were reconciled as of September 2016; a revised cMHAFF document is being developed for STU ballot in Jan 2018.

Project Scope Statement

File:PSS Consumer Mobile Health App Framework 20150217.pdf

Meeting Schedule

Standing meetings are every Thursday at 3 PM Eastern. Watch for weekly announcement and agenda.

Westat WebEx https://westat.webex.com/westat/e.php?MTID=m9411e9dddda3df675ed663ad56fe5816

Phone: +1 770-657-9270 Participant Passcode: 465623

Documents

cMHAFF Prep for Ballot Material

File:CMHAFF STU Ballot Draft.docx History of cMHAFF drafts, as it evolved toward January 2018 STU ballot. Updated December 14, 2017.

Notice of Intent to Ballot (NIB) for January 2018

Other related documents

File:CMHAFF Update 2017-Sept-WGM 16x9.pptx cMHAFF presentation for September 2017 HL7 Working Group Meeting.

File:CMHAFF-HAS Comparison.docx Side-by-side comparison of cMHAFF vs French HAS Good Practice Guidelines categories

File:MHAFF CONS MHAFF R1 O1 2016JAN Consolidated WG TRACK FOR 2017 BALLOT.xlsx -- Ballot Reconciliation spreadsheet, edited to show work in progress toward next ballot

File:HL7 cMHAFF Informative Ballot Draft.docx DEPRECATED. Kept as archive of cMHAFF as updated after ballot reconciliation, in progress toward next ballot. Updated June 3, 2017. Superseded by HL7_cMHAFF_STU_Ballot_Draft.docx.

HL7 cMHAFF Project Summary

Reference Resources (including European Guidelines and Good Practices)

  • File:PAS 277 (2015).pdf -- U.K. Health and wellness apps – Quality criteria across the life cycle – Code of practice. Includes quality criteria, app project life cycle, risk management, fitness for purpose, etc. Reviewed by Adamu Haruna
    • U.K. Guidance primarily for medical device stand-alone software, but also including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Old documents

The following are old, but are included for historical purposes
File:MHAFF CONS MHAFF R1 O1 2016JAN.pdf -- Original cMHAFF as balloted in January 2016

File:HL7 MH Out of Cycle intro v20150427.pptx

File:HL7 Consumer Mobile Framework Overview v20150406.pptx

Minutes

2018 Meeting Minutes

For all current minutes please go to HL7 CMHAFF Standard Web Portal

2017-2018 Meetings

2016 and Earlier Meetings

Most meetings in 2016 were dedicated to ballot reconciliation, and the results were reflected in the Ballot Reconciliation Spreadsheet (see link under 2017 Workng Documents above).

File:HL7 Consumer Mobile App Framework Minutes v20150818.docx

File:HL7 Consumer Mobile App Framework Minutes v20150810.docx

File:HL7 Consumer Mobile App Framework Minutes v20150615.docx

File:HL7 Consumer Mobile App Framework Minutes v20150601.docx

File:HL7 Consumer Mobile App Framework Minutes v201500518.docx

File:HL7 Consumer Mobile App Framework Minutes v201500504.docx

File:HL7 Consumer Mobile App Framework Minutes v20150427 28.docx

File:HL7 Consumer Mobile App Framework Minutes v20140413.docx

File:HL7 Consumer Mobile App Framework Minutes v20140406.docx

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