These guidelines are in response to work begun in 2014 when the EC asked for public comment on challenges facing the mobile health market in Europe and ways to address them. The results of that were published last year and one of the themes was the need for clear guidance on a range of issues including data security, liability & legal issues, and interoperability.
According to the EC’s statement, the working group has some pretty ambitious aims,
The group will seek to provide common quality criteria and assessment methodologies that could help different stakeholders (users, developers, vendors of electronic health record systems, payers etc.) in assessing the validity and reliability of mobile health applications.
In order to fully benefit from the mobile health apps that people increasingly use to monitor their lifestyle and health status or to manage their chronic disease, it should be possible in the future to link data from these apps to the electronic health records. This means that patients would be able to give access to their health professionals to consult the data collected by the apps. Also, health professionals need the reassurance about the reliability of the apps, in order to be able to recommend apps to their patients and take apps’ data into consideration in a treatment/monitoring process.
We’ve talked before about the challenges in developing a single set of medical app guidelines that can not only address the entire market but also cover a broad areas like validity and reliability. Then there’s the technology itself. It took two years for the EC to just say it was going to create guidelines – who knows what the digital health landscape will look like by the time these medical app guidelines actually come out?
In the United States, the FDA has decided to address only a sliver of the medical apps as described in their medical app guidelines. Efforts to broadly cover the medical app space, like Happtique, have stalled in large part because of the scope and size of the market they tried to cover with a single set of guidelines.
That’s not to say guidance is impossible or not worth trying to develop. mHIMSS put out medical app guidelines focusing on usability a few years ago. Others have developed privacy guidelines for medical apps.
Comprehensive medical app guidelines are, however, a whole different ball game – the range of apps out there, whether you’re talking about the area they cover or the functionality they offer, is immense. The European Commission isn’t the only one taking on that challenge. The American Medical Association recently adopted a resolution declaring their intent to develop similar medical app guidelines.
Clearly, there is an unmet need in the market for more guidance on how to manage the many unique features of the healthcare sector, from protecting privacy to complex regulatory & legal responsibilities. It will be interesting to see whether efforts like these offer answers.