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By Sascha Marschang, Policy Manager, EPHA

Following concerns about the ability of consumers to assess the usefulness of the large number of health apps now available on the market, the European Commission’s DG CONNECT set out to develop guidelines for a “framework of safety, quality, reliability and effectiveness criteria to improve the use, development, recommendation and evaluation of mHealth apps.” EPHA took part in the consultation on the guidelines, due to be published at the end of 2016.

The guidelines cover apps not classified as medical devices (regulated by existing EU legislation) used in a health and social care context, as well as health & wellbeing apps aimed at prevention.  The Commission argues that controlled use of these apps could lead to “better use of better apps for better healthcare”.

The scope of the guidelines should be expanded to include other apps that could impact health and wellbeing. This would prevent manufacturers from deliberately placing products on the market disguised as something else, since apps are classified based on their “intended use”.

Users download apps to suit their activities, which involve infrequent and “modified” uses. Consideration should thus also be given to “off-label uses” and to the distinction between prevention apps and other types. For example, features such as ‘push notifications’ can be harmful if apps are used by novice athletes before seeking advice from health professionals prior to the start of any training.

Health and well-being apps, which process personal data not deemed as “sensitive”, are not required to comply with the stricter rules that apply to medical devices. Data collected by them could however provide insights into physical or mental health status, which could be exploited for targeted advertising.

“Explicit consent” also remains problematic as users do not have the time or capacity to read pages of legal small print, often unavailable in a user-friendly format. The appeal of apps is that they are quickly available ‘on the go’; complex consent rules do not fit this business model. Clear messages or warnings could be beneficial, in particular for people with poor health literacy.

Regarding health professionals, the guidelines should look beyond clinicians and recognise that nurses, pharmacists and others are also well placed to provide advice on apps where appropriate. It is essential that apps correspond to health professionals’ practical needs.

mHealth can expand access to healthcare in a cost-effective way and the guidelines should recognise apps as tools to overcome existing health inequalities.

Proper implementation cannot depend on voluntary mechanisms alone.  Although evidence is building as the market matures, more oversight and regulation are required as long as the potential effects are not yet known.

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