Can Apple and Google continue as health app gatekeepers as well as distributors and developers?

Abstract

Mobile apps are the primary means by which consumers access digital health and wellness software, with delivery dominated by the 'Apple App Store' and the 'Google Play Store'. Through these virtual storefronts Apple and Google act as the distributor (and sometimes, importer) of many thousands of health and wellness apps into the EU, some of which have a medical purpose. As a result of changes to EU law which came into effect in May 2021, they must now ensure that apps are compliant with medical devices regulation and to inform authorities of serious incidents arising from their use. The extent to which these new rules are being complied with in practice is uneven, and in some areas unclear. In light of EU legislation related to competition, which came into effect in November 2022, it is also unclear how conflicts of interest can be managed between Apple and Google's roles as gateway duopoly importers and distributors whilst also developers of their own competitive health products. Finally, with the proposed European health data space regulation, wellness apps will be voluntarily registered and labelled in a fashion more like medical devices than consumer software. We explore the implications of these new regulations and propose future models that could resolve the apparent conflicts. All stakeholders would benefit from improved app store models to sustainably evolve safer, better, and fairer provision of digital health applications in the EU. As EU legislation comes into force it could serve as a template for other regions globally.

Fig. 1. Categories of apps in the health, wellness, and lifestyle area.

MD Medical Devices, CE Conformité Européenne. *health apps: this group includes apps that must be CE-marked, and simple data handling apps (**) for the transfer, communication, compression, storage, conversion, formatting, archive, display or simple search of medical information, which must only be CE-marked if they have overlapping MD functionalities.

Fig. 2. App stores approval processes.

Historical, new, and proposed app store approval requirements in the EU, described in the context of general apps, wellness apps (W-apps), and medical device-apps (MD-apps). This is based on processes used by the Apple App Store, as reported in. Currently similar requirements do not extend to W-apps, but this is under consideration as part of the European Health Data Space (EHDS) proposal.

Fig. 3. The roles of app stores in compliance.

Overview of the challenges for app stores in balancing their medical device compliance role, their role as MD app developers and their obligations as gatekeepers in the EU digital market. Similar app store responsibilities for wellness apps may be introduced under the proposed legislation. MD Medical Devices, CE Conformité Européenne.