This was the clear message of yesterday’s hearing on mHealth in the European Parliament.
Commissioner Andriukaitis, Members of the European Parliament Peterle and Boni and participants all agreed that mHealth, and in particular health apps, have the power to transform the relationship between patients and doctors. Speakers stressed that mHealth has a tremendous potential when it comes to improving the management of chronic diseases, giving citizens the possibility to monitor and evaluate their health and to make more informed decisions. There is also a huge potential for mHealth to feed real-world data into the medical research community.
Privacy and data protection issues implicit in the use of mHealth continue to be of concern, but participants agreed that the General Data Protection Regulation (GDPR) and the recently approved Medical Devices Directive provide the legal framework to protect patients’ rights. Now that a good level of consumer protection in mHealth is being developed, privacy and safety should no longer be seen as obstacles to mHealth.
The Code of Conduct on privacy for mobile health was highlighted as an important example of the Commission’s ongoing work in the development of soft law addressing privacy concerns. The draft Code seeks to provide app developers with practical guidelines on user’s consent, privacy and data retention. This could be an important tool to improve trust in the market, which in turn would allow mHealth to flourish.
The Commission has now submitted the Code for approval to the Article 29 Data Protection Working Party, an independent advisory group composed of experts from Member States. The Working Party is expected to approve the Code by the end of the year and in the course of 2017 app developers should have clear guidelines at their disposal providing them with legal certainty.
The Code, together with binding law in the soon-to-be implemented GDPR are good news for the whole mHealth Community – developers, patients, healthcare professionals and also the institutions paying for healthcare such as insurers, mutualities and tax payers. Europe’s populations are aging, prevalence of non-communicable diseases is rising, and healthcare budgets are shrinking. Now is the moment to harness the potential of mHealth to move towards more sustainable European health systems which recognise the patient as a key driver of her/his own wellness.
The time to fully unleash the potential of mHealth has finally arrived!
The views expressed herein are those of the author(s) and not necessarily the views of FTI Consulting LLP, its management, its subsidiaries, its affiliates, or its other professionals, members or employees.