The European Union wants stricter laws on medical apps or in some way related to health: App stores, such as the Google Play Store and the Apple App Store, may be forced to impose stricter conditions on third-party developers and even avoid distributing the apps they develop themselves.
The question was raised by a group of researchers in an essay recently published in the scientific journal Nature: the gist is that, given one new European law entered into force in May 2021to be considered “medical” apps must meet all the rules of traditional or “physical” medical devices, and any serious accidents resulting from their use must be reported to the authorities.
The problem is that, almost 24 months after the entry into force of the new laws, it is not at all clear how many are complying with them; also because, further upstream, the very definition of “medical app” is not always clear. The picture is further complicated because, if the developer of an app resides outside the EU, app stores are legally considered their importers.
According to research, Apple is already way ahead of Google in this sense: it satisfies all five main requirements of European law, whereas Google satisfies only one. There are some shortcomings on the Apple side as well, but they are of secondary importance. Naturally, it is easy to understand the dilemma for apps developed directly by the store owners – a dilemma which, moreover, already exists and sparks a rather heated debate. In a nutshell, it’s hard to appear impartial when you’re both a competitor and a controlling authority in an ecosystem like this. In short, in three simple words: conflict of interest.
How to get out of the impasse? According to the researchers, they could set up app stores dedicated to the medical/health category, managed by independent bodies from Apple, Google and company. It seems like an almost ‘sci-fi’ idea given the current state of the app market, but it is also true that pressure from the EU to foster competition on digital app stores is intensifying – and even appears to be about to materialize, with Apple which could be forced to give up on the “monopoly” of the App Store on iPhone, iPad, Mac and so on. At that point, thinking about a “digital pharmacy” just seems like the next logical step.