Difference between revisions of "MHWG Consumer Mobile Health Application Functional Framework,"
| Line 47: | Line 47: | ||
===Reference Resources (including European Guidelines and Good Practices)=== | ===Reference Resources (including European Guidelines and Good Practices)=== | ||
| − | '''[[File:French_good_practice_guidelines_on_mHealth_apps.pdf]]''' | + | '''[[File:French_good_practice_guidelines_on_mHealth_apps.pdf]] -- FRENCH''' "Good Practice Guidelines on Health Apps and Smart Devices" to compare to cMHAFF. |
| − | '''[[File:charismha_abr_v.01.1e-20160606 (003)_ENG SHORT VERSION.pdf]]''' | + | '''[[File:charismha_abr_v.01.1e-20160606 (003)_ENG SHORT VERSION.pdf]] -- GERMAN''' Chances and Risks of Mobile Health Apps" to compare to cMHAFF. |
| − | '''[https://appcheck.de/kriterienkatalog | + | '''[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mhealth apps_not for publication_DTao_Comments.docx]]''' Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution). While not completed, there was a report on the work '''[[File:ReportofmHealthWorkingGroup-June2017cleanpdf.pdf]]''' | + | '''[[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apps_not for publication_DTao_Comments.docx]]''' -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution). While not completed, there was a report on the work '''[[File:ReportofmHealthWorkingGroup-June2017cleanpdf.pdf]]''' |
<br> | <br> | ||
| − | '''[[File:Assessment Questionnaire.xlsx]]''' Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution) | + | '''[[File:Assessment Questionnaire.xlsx]]''' -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution) |
| − | '''[ | + | '''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps Guidance: |
| + | Medical device stand-alone software including apps]''' -- from UNITED KINGDOM Medicines and Healthcare Products Regulatory Agency (MHRA) | ||
| − | '''[ | + | '''[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 |
| − | + | ||
'''[[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. | '''[[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. | ||
Revision as of 17:41, 27 June 2017
Project Co-Leads: Nathan Botts and David Tao
Contents
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:
- 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 balloting in 2017.
Project Scope Statement
File:PSS Consumer Mobile Health App Framework 20150217.pdf
Meeting Schedule
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.
WebEx: https://westat.webex.com/westat/j.php?MTID=mf163da12b3585dd6f6ffa0e66adfb4bf
Phone: +1 770-657-9270 Participant Passcode: 465623
Documents
2017 Working Documents
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: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
Reference Resources (including European Guidelines and Good Practices)
File:French good practice guidelines on mHealth apps.pdf -- FRENCH "Good Practice Guidelines on Health Apps and Smart Devices" 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.
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). While not completed, there was a report on the work File:ReportofmHealthWorkingGroup-June2017cleanpdf.pdf
File:Assessment Questionnaire.xlsx -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)
[https://www.gov.uk/government/publications/medical-devices-software-applications-apps Guidance: Medical device stand-alone software including apps] -- from UNITED KINGDOM Medicines and Healthcare Products Regulatory Agency (MHRA)
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
File:EU Privacy CodeofConductfinaldraft.pdf EU voluntary but authoritative guidelines, to compare to cMHAFF. See Privacy Code of Conduct on mobile health apps for an overview.
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.
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
2017 Meetings
- cMHAFF call, Tuesday June 20
- cMHAFF call, Tuesday June 13
- cMHAFF call, Tuesday June 6
- cMHAFF call, Monday, May 22
- cMHAFF calls Monday, April 24, May 1 and 8 -- CANCELLED (travel, Madrid). May 15 cancelled (lack of attendance and technical problems)
- cMHAFF call, Monday, April 17
- cMHAFF call, Monday, April 10
- cMHAFF call, Monday, March 27
- cMHAFF call, Monday, March 13
- cMHAFF call, Monday, March 6
- cMHAFF call, Monday, February 20
- cMHAFF call, Monday, February 6
- cMHAFF joint with Security/CBCC, Tuesday, January 31
- Joint with Security/CBCC at San Antonio WGM, January 17, 2017
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
