Researchers have published a scientific article in the prestigious journal NPJ Digital Medicine today (Tuesday, January 31st, 2023) on the conflict of interest of app store operators Google and Apple, who are both legal distributors and importers of health apps into the European market and developers of those same apps.
Google and Apple dominate as a “duopoly” with their app stores. They distribute and import many thousands of health and wellness apps into the EU, some of which are approved as medical devices. New ones are added daily. Under EU rules, those who distribute health apps are also responsible for ensuring that they meet certain regulatory requirements.
Contributing author, Dr Tom Melvin, Associate Professor of Medical Device Regulatory Affairs at the School of Medicine, Trinity College, said:
“There are thousands of health apps available through the ‘Apple App Store’ and the ‘Google Play Store’ and health apps are changing the way in which healthcare can be delivered in important ways.
At the same time, the rules we apply to app stores under the Medical Device Regulation for roles such as distributors were developed with physical products in mind. When these rules are applied to apps, they can lead to challenges and potential conflicts of interest as distributors are required to assess aspects of compliance of the apps they distribute. As both distributors and developers, there can be potential conflicts of interest in carrying out these roles. This can present issues relating to fairness and competition in the digital market in Europe.“
The EU – in the 2017 Medical Devices Regulation – introduced requirements not only for app developers, but also for app store operators, who have a legal role of distributors. Since then, these have had to ensure that apps comply with medical device regulations in the EU and inform the authorities about serious incidents related to their use. Under the 2022 EU Digital Markets Act (which determines how large online platforms operate in the decades to come to ensure fair competition and more choice for users) they will have to walk a tightrope between enforcement and oversight and making sure they do not act unfairly to the apps for which they are the duopoly platform providers.
Researchers say this brings into question the sustainability of a model in which a crucial aspect of healthcare infrastructure, namely app stores, is provided in such a duopolistic and conflicted manner. The EU has powers to legally enforce changes to this model. 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. The authors explore the implications of these new regulations and propose alternative models that could resolve the apparent conflicts.
To enable the health and wellness app sector to further develop safely, researchers believe that these ‘wild west’ aspects of the market must be resolved. 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.
Publication: O. Sadare, T. Melvin, H. Harvey, E. Vollebregt, S. Gilbert: Can Apple and Google continue as health app gatekeepers as well as distributors and developers? NJP Digital Medicine. 2023 Jan 31: https://www.nature.com/