Upload
others
View
11
Download
0
Embed Size (px)
Citation preview
EU draft mHealth app assessment guidelines:
Open Stakeholder Meeting 9th June
Andrew Ruck & Charles Lowe
Purpose of this presentation
• To update stakeholders on the development of the voluntary EU guidelines on
mHealth app assessment & seek feedback
• This presentation will:
1. Describe the context of the guidelines
2. Review the contents of the second draft guidelines
3. Give a flavour of open issues
4. Invite your feedback, for inclusion in the next iteration
• NB the second draft of the guidelines can be seen on the Commission website at
https://ec.europa.eu/digital-single-market/en/news/mhealth-ehealth-week-2016
Then download the guidelines at the bottom of the page
1. Rationale and Process
First Iteration in March, followed by stakeholder engagement and written feed-back
Second Iteration – as presented today, then feedback
Third Iteration – targeted for mid October, then feedback
Fourth (and Final) Iteration – targeted for end December
Final draft guidelines sent out for written comments to the extended stakeholder group.
• When feedback received, final draft guidelines produced and discussed with
Commission.
• Included in final report (2017-01-25)
Development of the draft guidelines;
Where are we?
3. Review of contents of 2nd draft Guidelines
Existing privacy legislation
“The grey zone”
The EU context - a possible future
GDPR
Guidelines on app assessment (voluntary)
App Code of Conduct on privacy (voluntary)
MDD/IVDD/IDDD MDR/IVDR/IDDR
Possible legislation/Code of Conduct on safety following current consultation
2016 2017 2018 2019
Possible legislation/Code of Conduct on usability following consultation shortly
2020
Guidance for app developers
High medical risk Low medical risk
Constructing the first draft
• Original remit to cover reliability & validity
• All WG members invited to suggest assessment models; many provided
• Included those from Andalucia, Catalonia, DMD Santé, UK, plus academic
papers from many other countries
• Combining all these produced nine criteria, plus risk assessment to ensure
proportionality
• Graphically…
The criteria
Quality
Credible
Safe
Transparent
Transp
arent
Secure
Stable
Proportionality
• WG wants the Guidelines to cover everything from ‘grey area’ apps down
to simple apps with minimal medical content, eg doctors’ appointment
apps
• Propose therefore to stratify to three risk levels that in turn will drive the
importance of the questions under each criterion – lowest risk would only
engage a small subset of questions
• Welcome views on what risks to consider, remembering these are apps
that are already comparatively low risk
The second draft
• Much changed from the earlier draft, and shorter - the rationale for the
criteria is now in an annex, as is the original discussion on origins
• Now includes details of the existing/future regulatory environment, &
relevant standards
• …adds a stakeholder analysis & discussion on uses
• …has a more detailed set of definitions
• Areas still requiring significant work include:
– Agreement on the handling/number of criteria
– The dimensions of risk to consider
– How best to make the scrutiny questions as objective as possible
2. Open Issues
Scope
Dovetailing
User perspectives and needs
Form
Risk Assessment
4. Tell us what you think
Where are the guidelines?
The latest draft of the guidelines are available to stakeholders for download from the
Commission website.
Go to: https://ec.europa.eu/digital-single-market/en/news/mhealth-ehealth-week-2016
Then download the guidelines at the bottom of the page.
Your feed back
• Stakeholder feed-back is captured via series of questionnaires
– (allows for accurate identification of draft
– and republication of all feed-back received in structured manner).
• Please go to
https://www.surveymonkey.co.uk/r/TYRSX2K
to provide your feed back before 31st August
• A summary of feed back received on each iteration will be prepared,
• A summary of all feed-back received to be published by end January 2017.
Thank you