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

aren

t

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