![]() ![]() The Apple App Store currently features a category of “Health and Fitness” covering a range from simple wellness apps that play white noise or sleep diaries all the way up to more clinically relevant apps such as a self-harm tracker, heart rate monitors, and mental health counselling platforms. Both companies also sell a range of products with health implications such as the Apple Watch, which in its latest version includes a heart rate sensor, an electrocardiogram, and an irregular heart rhythm notification. For example, in 2019 apps associated with e-cigarettes or “vapes” were removed and in 2021 during the height of the COVID-19 pandemic the app of an online dating community for people who chose not to be vaccinated against the coronavirus was removed 6. Today, Apple and Google selectively assess apps with a health impact. In the health domain this quickly became problematic, as a 2015 review of asthma apps and insulin calculators found, which identified a range of potentially harmful errors and privacy issues 3, 4, 5. Barriers to submitting an app were originally low, which meant amateurs or small developer groups could easily make apps. ![]() The Apple App Store first opened in 2008 and the Google Play Store in 2012, with an emphasis on games, utility apps, and social networks. The number of health and wellness apps available in the app store has been estimated to be 350,000 apps worldwide with as many as 90,000 new health apps added in 2020 alone 2. The success of their vertically integrated mobile platforms relies heavily on the sales and marketing functionality of their respective app stores. As EU legislation comes into force it could serve as a template for other regions globally.Īpple and Google dominate the provision of apps through the ‘Apple App Store’ and the ‘Google Play Store’ respectively, accounting for around 92% of the mobile app distribution business 1. All stakeholders would benefit from improved app store models to sustainably evolve safer, better, and fairer provision of digital health applications in the EU. We explore the implications of these new regulations and propose future models that could resolve the apparent conflicts. 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. 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. The extent to which these new rules are being complied with in practice is uneven, and in some areas unclear. 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. 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. 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’. ![]()
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