I attended a small conference today in the Netherlands about eHealth. It was great to great to see how many people were trying to throw their weight behind eHealth initiatives in every possible way: remote monitoring of demented senior citizens by means of picture interpreting software, decision support systems, you name it. It was strange however that basically none of the persons presenting or discussing had considered the possibility that software with an important role in a medical process would need to be validated on another than a purely technical basis (does it work?).
Another case in point is the recently launched online “Health risk test” launched by the Dutch Bronovo hospital. For a mere € 19,95 (for the expert test, there’s a free version too) you can fill in a bunch of information about your yourself, your medical history and your lifestyle and the test will provide you with an overview of risks of you getting a number of the most prevalent diseases. A lot of doctors seem to have cooperated, given the number of pictures of people in white coats on the website.
So, I think: this is a medical device. There is a piece of software running on a server somewhere that applies a model or decision tree and produces a result based on that and serves up the information for medical purposes (diagnosis of health risks) that it obtained directly from a human subject. In other words: fits the definition of software as standalone medical device. So I start looking for the CE sign on the website. No CE sign. I took the test, maybe I overlooked something somewhere. Still no CE sign witnessing that the manufacturer of the test had taken the trouble to properly test the thing and compile a technical file supporting the way the software reaches its conclusions and presents them, for example: does it render the same way in all browsers (I was using Safari, who knows how my results may have been distorted)? Then I heard a radio program on BNR Nieuwsradio saying the Dutch Healthcare Inspectorate (IGZ) also had its doubts about this test because apparently had not been properly validated and might be contrary to the Act on Population Investigation (Wet op het Bevolkingsonderzoek). Apparently the possibility of other infringements, like the Act on Medical Devices, has not occurred even to the Inspectorate yet, or the press has not picked up on it. I couldn’t locate an official statement of IGZ on the subject, so I can’t be sure on this.
It is strange to see how clinicians that are working on eHealth solutions outside a medical devices company seem to have a tendency to completely overlook the possibility that they are putting medical devices on the market and risk being charged with illegal behaviour. In this particular case they may also have contravened some other rules in the process. Maybe I have met the wrong clinicians so far and my impression is incorrect. However, it seems to me that for eHealth to truly take off in a legally compliant fashion, the Dutch medical profession has some serious catching up to do.