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 thousan...

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Main Authors: Olamide Sadare, Tom Melvin, Hugh Harvey, Erik Vollebregt, Stephen Gilbert
Format: Article
Language:English
Published: Nature Portfolio 2023-01-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-023-00754-6
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author Olamide Sadare
Tom Melvin
Hugh Harvey
Erik Vollebregt
Stephen Gilbert
author_facet Olamide Sadare
Tom Melvin
Hugh Harvey
Erik Vollebregt
Stephen Gilbert
author_sort Olamide Sadare
collection DOAJ
description 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.
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spelling doaj.art-94ba760c16174cfa88419046f2ad70dc2023-12-02T22:57:28ZengNature Portfolionpj Digital Medicine2398-63522023-01-01611710.1038/s41746-023-00754-6Can Apple and Google continue as health app gatekeepers as well as distributors and developers?Olamide Sadare0Tom Melvin1Hugh Harvey2Erik Vollebregt3Stephen Gilbert4Else Kröner Fresenius Center for Digital Health, Technische Universität DresdenSchool of Medicine, Trinity College, University of DublinHardian HealthAxon LawyersElse Kröner Fresenius Center for Digital Health, Technische Universität DresdenAbstract 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.https://doi.org/10.1038/s41746-023-00754-6
spellingShingle Olamide Sadare
Tom Melvin
Hugh Harvey
Erik Vollebregt
Stephen Gilbert
Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
npj Digital Medicine
title Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
title_full Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
title_fullStr Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
title_full_unstemmed Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
title_short Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
title_sort can apple and google continue as health app gatekeepers as well as distributors and developers
url https://doi.org/10.1038/s41746-023-00754-6
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