Have your say on impending EU Guidelines for Mobile Health Applications

By Nicolas Carbonnelle, Maria-Paz Martens, Marc Martens


The European Commission released a first draft of what will become mHealth apps assessment guidelines at an open stakeholder meeting the 5th of May.

How does this affect you?

The guidelines are designed to address the handling and assessment of the health and safety risks related to mHealth apps, with a particular focus on 

  1. clinical evidence,
  2. claims on the purpose and functions of mHealth apps and
  3. test and validation of the performance.

The guidelines will eventually form the soft law reference framework for mHealth apps in Europe.

What does the first draft contain?

Here is an overview of the most important aspects of the first draft guidelines:

Scope of the guidelines: the guidelines are intended to apply to non-CE marked (read: non-medical devices) apps used in medical settings and health & wellbeing apps; an indicative list of "in scope" apps is included in the guidelines

Definitions: the draft guidelines provide definitions of the most important terms, including of mHealth apps, and refer already to certain ISO standards in relation to certain terms.

Target audience: the draft guidelines are intended for use by

(i) citizens,(ii) app developers, (iii) healthcare professionals, (iv) private and public healthcare providers, (v) public authorities and (vi) health insurance providers

Structure of the guidelines: the guidelines provide for a 3-stages approach in the apps evaluation process :

  1. initial validation
  2. risk assessment
  3. scrutiny

The intention is that for each stage, the final guidelines will include a list of questions intended to assist the developer/supplier in its evaluation process.

The questions for the (i) the initial information gathering and validation and (ii) scrutiny stage are already quite developed in the first draft.

The questions relating to app scrutiny for instance are divided in several subsections, namely (i) usable and accessible, (ii) desirable to use, (iii) credible, (iv) transparent, (v) reliable, (vi) technically stable, (vii) safe, (viii) effective, (viv) private and secure.

The Risk Assessment stage is still currently under discussion and the list of questions is still to be drafted.

Methodology: The draft guidelines mention several app assessment approaches, including (i) scoring, (ii) a pass/fail system, (iii) certification, (iv) or simply providing a list of questions to run through which can be considered when developing/commissioning/acquiring an app.

What are the next steps?

The first draft guidelines are currently under public consultation that closes Monday, 16 May. Based on the comments received during that consultation, the Commission will prepare a second version of the draft guidelines (release expected by the end of May).

Have your say!

Even though the consultation on the first draft closes Monday 16 May, it is possible to submit comments after that date‎. These comments will be taken into account for the next version of the draft, of which the release is scheduled for June.

This is an opportunity not to be missed as it is clear that these guidelines will have a huge impact on the mHealth industry and the future development of apps.

A final version of the guidelines is anticipated by the end of 2016.