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

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

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 m...

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Published in:NPJ digital medicine 2023-01, Vol.6 (1), p.8-8, Article 8
Main Authors: Sadare, Olamide, Melvin, Tom, Harvey, Hugh, Vollebregt, Erik, Gilbert, Stephen
Format: Article
Language:eng
Subjects:
Digital technology
Medical equipment
Medical technology
Regulation
Software
Telemedicine
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title Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
format Article
creator Sadare, Olamide
Melvin, Tom
Harvey, Hugh
Vollebregt, Erik
Gilbert, Stephen
subjects Digital technology
Medical equipment
Medical technology
Regulation
Software
Telemedicine
ispartof NPJ digital medicine, 2023-01, Vol.6 (1), p.8-8, Article 8
description 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.
language eng
source PubMed Central (Open access); Publicly Available Content Database; Alma/SFX Local Collection; Coronavirus Research Database
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