Published February 24, 2020
Feeling sick? Grab your smartphone!
Normally we’re used to hear and read about potential health risks connected to the excessive use of smartphones and mobile devices. But this time it’s the other way around: Germany recently passed a digital health act (“Digitale Versorgungsgesetz”) allowing doctors to prescribe to patients the use of certain health applications, whose costs will be covered by public health insurances.
Apps medical devices
The explicit recognition of “software” as medical device directly derives from art. 2 of the European Regulation on medical devices (2017/745/EU), that – inter alia – divides medical devices in general in several classes based on their function and on their inherent risks. The German law allows for the recognition of software applications as medical devices (“health apps”) only if included in the two lowest risk-classes (i.e. I and IIa).
Practical examples of how an app could be implemented as a medical device are apps allowing for the tracking of certain health data (e.g. daily glucose values for diabetes patients, or general health data of pregnant women), apps providing psycological assistance, apps helping to measure reactions, such as sight or hearing etc. etc.
Also, the government’s goal is to improve the access to medical aid by allowing for online consultations via apps.
How to get an app approved
There are two aspects in the planned approval process for medical apps:
just as any other traditional medical device, medical apps must in future be approved by the Federal Agency for Pharmaceuticals and Medical Devices (BfArM) in order to be marketed as such (i.e. as “medical”)
once a health app has been approved, doctors may prescribe its use and the costs connected thereto are covered by the public (and private) health insurances
The approval process will consist in checking that the health app complies with a list of requirements of both medical, technological and legal nature.
From a legal perspective, the most important issue deinitely is protection and security of data, which has to be ensured in numerous ways. Also, consumer protection and liability (in particular in connection with the health claims the app is presented under) will play a major role. Currently, a draft regulation concerning the application process in being circulated: although this version is not final yet, it gives already a pretty specific insight into what the approval process will most likely look like, and already allows interested app owners to move into the outlined direction.
The development and approval of health apps represents a major opportunity both for established pharmaceutical enterprises and for smaller companies, that are often faster and more flexible in adopting new technology also in this branch. The approval process in Germany will be open app owners from all over the world, if the current regulation is not amended in that respect. In any case, due to the principle of non-discrimination, owners based elsewhere within the EU could hardly be excluded.