DIGITALEUROPE Position Paper on mHealth

EXECUTIVE SUMMARY

The continued growth of mobile health (mHealth) solutions has the potential to provide countless opportunities for EU citizens, public health services and businesses. DIGITALEUROPE as the voice of Europe’s digital technology industry calls on policy-makers to put in place the right framework conditions that will enable these solutions to thrive in the EU, in order toincrease the competitiveness of Europe in an area that is strongly developing globally as well as to solve the pressing challenges faced by European healthcare systems. While the risks associated with the use of mHealth applications should be clearly addressed, the focus of EU policy makers should be on fostering its opportunities. The European Commission took an important first step in April 2014 through the launch of its public consultation on mHealth to help identify the right way forward to unlock the potential of mHealth in the EU. As the European Commission continues to consider options for future action, DIGITALEUROPE believes any future activities within the field of mHealth should focus on the following measures:

1. Adequacy of Current EU Legal Framework – Resist the temptation to introduce a dedicated legal framework for mHealth in the form of a Directive or Regulation as the existing EU regulatory framework for the safety and performance of medical devices has supplied a sound foundation against which technological innovations can be assessed;

2. Protection of Personal Data – Harmonise privacy rules in the field of healthcare across Member States and follow a risk-based approach in order to both ensure privacy and embrace on-going data innovation; Promote a soft law approach by encouraging codes of conduct and guidelines.

3. Opportunities of Big Data – Adapt the current regulatory framework to the borderless nature of big data while encouraging the use of de-identified, aggregate and properly secured health data;

4. Safety of Applications – Emphasise that only those solutions that meet the definition of a medical device should face additional scrutiny as their potential malfunction could lead to adverse risk on user’s health;

5. Impact on Healthcare Systems – Encourage the European Commission’s to continue its efforts to stimulate the adoption of mHealth technologies in the Member States through Horizon 2020 to create scalable products;

6. Encouraging Interoperability – Promote the need for industry-led standards and certifications to increase the interoperability of Electronic Health Records (EHRs) information collected via mHealth services;

7. International Cooperation – Encourage the European Commission to address any future additional mobile device certification requirements at the international level through the use of guidelines to ensure regulatory predictability for economic operators;

8. Market Access – Promote the use of EU funds coupled with increased confidence in venture capital funding to address some of the weaknesses that hinder the entry of innovative mHealth solution to the EU market.