*Already in 2015 the range of health apps in Appstore and Google Play exploded. Both major global players and small startups have promoted the further development. Together with the success of “wearable tech,” it is possible to soon analyse and share all physical movement, from running steps to pulse, blood pressure and health status. While the opportunities appear to be endless and an increasing number of individuals want to reap the benefits of the positive health effects, there is a downside in the form of a risk of relying on an often unsafe source.
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MEDICAL PRODUCTS AGENCY EXAMINES
At the end of 2015 the Medical Products Agency (“MPA”) attracted a relatively high degree of attention when it started an examination of apps within eHealth. The regulations are clear, if the app has a medical purpose it is a medical device. The app should then be CE marked to fulfil the requirements in the legislation for medical technology and to be marketed on the whole. However, the distinction between when an app has a medical purpose or only provides general health or lifestyle information is more difficult. The examination resulted in adjustments being imposed for one of the examined apps. However, in an updated and CE marked version this specific app, Natural Cycles, shows that there are still opportunities of success within the framework of the regulation – or perhaps in particular because the CE marking is a quality marker.
THE EUROPEAN COMMISSION IS WORKING ON GUIDANCE AND THE SWEDISH eHEALTH AGENCY LAUNCHES “HEALTH FOR ME”
MPA does not only impose requirements. In 2017 we will see more of the European Commission’s work on guidance and the code of conduct for health apps as well as the Swedish initiative “Health for me” which connects public health care to the world of health apps by means of a personal health account with the Swedish eHealth Agency.
WOULD YOU LIKE MORE INFORMATION?
PLEASE FEEL FREE TO CONTACT US AT MORRIS LAW
HENRIK ALMSTRÖM
Associate
Telephone: +46 10 722 36 12
Mobile: +46 738 26 47 75
E-mail: henrik.almstrom@morrislaw.se
