Charles Lowe, DHACA’s Managing Director, was invited to this event on 26th March as the editor of DHACA’s comprehensive EC mHealth Green Paper response. This is his summary of the event and the follow-on actions from it
The event was very well attended – the EC’s engagement with mHealth is clearly an area of considerable interest to commerce as most of the big firms working in this area attended the event last week.
Particular points of relevance to DHACA members were:.
- Wearables and apps are increasingly seen as providing a single health-related service, together, yet currently are often treated for regulatory purposes as separate (the concept of ‘accessory’ can help here);
- The issue of health & wellness apps vs medical apps continues to be cause of potential confusion so the EC recognises the need to clarify the borderline between the two;
- By far the two biggest areas of concern expressed in the responses to the consultation were trust in privacy & security, and people’s ability to interpret their own data correctly;
- Separately, from a “recent survey” (Mobiquity, The Appification of Health and Fitness, April 2014) the EC has concluded that privacy, at 61%, is the major blocker to adoption of mHealth (note that this editor disagrees on this one as there appear to have been a number of options not offered, like efficacy, plus the percentage refers to both health & fitness apps);
- The EC recognises the need for greater clarity on: definition of a medical device (so they will be adding examples to the upcoming Medical Device Regulation that will replace the current Directive), and how digital health fits into the EU’s General Product Safety Directive which is now 14 years old (so they are assessing the changes required);
- EC takes safety concerns very strongly, however they are uncertain just now whether to strengthen initiatives underway in Member States (both the NHS Apps Library & BSI’s PAS 277 were quoted among the examples) or to tackle it centrally;
- However privacy and security is their number one concern, so they are kicking off the development of a code of conduct on the topic and inviting all those who provided comment on the original Green Paper to participate (DHACA has confirmed participation);
- During discussions, the EC representatives agreed that evidence (notably of efficacy, for medical apps) was also a key requirement and that they would be starting on this in September 2015 (DHACA has expressed a particular interest in participating)’.
DHACA members with a particular interest in developing the code of conduct are asked please to contact Charles as soon as possible so DHACA can put together its own internal team to engage with the EC. Likewise, Charles would be delighted to expand further on the above if required.