Research2guidance mHealth App Developer Economics 2017 Study
EU draft mHealth app assessment guidelines: Open ...€¦ · on mHealth app assessment & seek...
Transcript of EU draft mHealth app assessment guidelines: Open ...€¦ · on mHealth app assessment & seek...
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EU draft mHealth app assessment guidelines:
Open Stakeholder Meeting 9th June
Andrew Ruck & Charles Lowe
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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
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1. Rationale and Process
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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?
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3. Review of contents of 2nd draft Guidelines
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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
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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…
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The criteria
Quality
Credible
Safe
Transparent
Transp
aren
t
Secure
Stable
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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
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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
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2. Open Issues
Scope
Dovetailing
User perspectives and needs
Form
Risk Assessment
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4. Tell us what you think
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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.
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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.
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Thank you