EU draft mhealth app assessment guidelines: Open Stakeholder Meeting 9 th June. Andrew Ruck & Charles Lowe

Transcription

1 EU draft mhealth app assessment guidelines: Open Stakeholder Meeting 9 th June Andrew Ruck & Charles Lowe

2 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 Then download the guidelines at the bottom of the page

3 1. Rationale and Process

4 Development of the draft guidelines; Where are we? First Iteration in March, followed by stakeholder engagement and written feedback 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 ( )

5 3. Review of contents of 2 nd draft Guidelines

6 The EU context - a possible future High medical risk Existing privacy GDPR legislation Low medical risk App Code of Conduct on privacy (voluntary) MDD/IVDD/IDDD MDR/IVDR/IDDR The grey Guidelines on app zone assessment (voluntary) Guidance for app developers Possible legislation/code of Conduct on safety following current consultation Possible legislation/code of Conduct on usability following consultation shortly

7 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

8 The criteria Transparent Stable Credible Quality Safe Transparent Secure

9 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

10 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

11 2. Open Issues Scope Dovetailing User perspectives and needs Form Risk Assessment

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17 4. Tell us what you think

18 Where are the guidelines? The latest draft of the guidelines are available to stakeholders for download from the Commission website. Go to: Then download the guidelines at the bottom of the page.

19 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 to provide your feed back before 31 st 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.

20 Thank you