Will Apple & Google tame the health app wild west??
I recently co-authored a paper, published in Nature: Digital Medicine, exploring the role of Apple and Google’s app stores in the health and wellness app sector, and how these companies should comply with new EU medical device regulations and digital EU laws to resolve a cycle of conflicts that currently prevent them from fulfilling their legal obligations.
Consumers primarily access digital health and wellness software through mobile health apps, and it is fast becoming an attractive way to receive and deliver healthcare. With an estimated 350,000 health and wellness apps worldwide, this number is increasing dramatically year on year as healthcare becomes further digitalised. It’s easy to see why digital health apps are so popular - everyone wants information and support at their fingertips, and anyone can develop an app and submit it to an app store for global distribution. Apple and Google have become a de facto duopoly in this market, with 92% of all apps available for download through the Apple App Store and Google Play Store.
However, health and wellness app developers are not all aware of the blurry lines that divide the regulation of medical device (MD) based apps – those that can diagnose, prevent, monitor, or treat a condition – from general wellbeing apps which are currently not formally regulated.
Since developers can bring general wellness products to market without being subjected to the stringent regulations applied to MD apps, the barrier to market entry is minimal – and many developers are getting better at exploiting and skating this fine line to bring products to market quickly, but sometimes illegally if their claims enter medical device territory.
MD apps can only be marketed in the EU with a CE mark, indicating that they are in conformity with compulsory regulations and quality management standards, otherwise there is a real risk of medical apps not being safe or effective. A 2020 assessment of regulatory standards of paediatric drug calculator MD apps, found that only 1.4% have the required regulatory approval. In contrast to MD apps, wellness apps only perform simple health data handling tasks or simple searches of medical information.
It comes as no surprise that the world of health and wellness apps has become a wild west (see figure 1 from the paper), with no clear distinction in the app stores whether the product is regulated, and the associated clinical evidence, or lack thereof.
The recently updated EU regulations have been significantly tightened to increase transparency and protect users and their data, and under these, app stores have a substantial regulatory role in governing the 'wild west' health app market.
What role do Apple and Google play in the health app market?
With great power comes great responsibility. App stores now have a legal and moral obligation to assess and continually monitor the apps that they develop and distribute. Within this global market, they now have three key roles:
Distributors and Importers: If an MD app developer not based in the EU, makes its app available in the EU via an app store, then the app store is not only the distributor of the MD app, but also its importer. Additionally, apps stores now have the legal responsibility to ensure apps with medical claims are appropriately CE marked and labelled.
Gatekeepers: Under the Digital Markets Act (2022) Apple and Google are recognised as gatekeepers in digital markets as they “have the capacity to affect a large number of end users and businesses, which entails a risk of unfair business practices”.
Developers: Apple and Google both develop their own health and wellness apps hosted on the app stores.
Sounds straightforward enough? We wish it was. In May 2021, changes in EU law (see table 1 from the paper below) require app stores to ensure that the apps distributed or imported via the store are medically and regulatory compliant, and to inform authorities of serious harm arising from use. However, Apple and Google have trouble meeting these legal requirements in practice, perhaps due to their role as gatekeepers.
To make this a little bit clearer, here are the three major challenges:
Responsibility of oversight: Apple and Google have a legal responsibility under increasing regulation pressure to police and oversee the monitoring of user complaints and ensure apps meet required regulations.
Role as gatekeepers: Under the European Digital Markets Act, as two dominant players in the digital app market Apple and Google cannot discriminate against other apps.
Conflict of interest: Apple and Google are both developers of their own health and wellness apps, creating a stark conflict of interest with the apps they act as distributors and importers of.
I hope it’s clearer to see how this cycle of conflicting responsibilities creates a considerable problem for Apple and Google. Our paper, led by Prof. Stephen Gilbert, Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health at Technische Universität Dresden, and published in Nature: Digital Medicine, explores how the two companies have tried thus far to alleviate this issue, but the bottom line is they need to do better.
Lead author Professor Stephen Gilbert summarises this well:
"The EU, in the 2017 Medical Devices Regulation has wisely introduced requirements not only for the app developers but also for the app stores, who have the legal role of 'distributors'. Google and Apple dominate as app stores, and they effectively provide every medical app to every user, be they a patient or a health care provider. With great power comes great responsibility, but thus far the app stores are fulfilling their compliance oversight duties in a patchwork fashion. The app stores need to do better, but their ability to fulfil their legal duties is compromised by stark conflicts of interest. They develop their own competitor apps, as well as being the gatekeepers of the digital domain. Under the 2022 EU Digital Markets Act 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. This calls into question the sustainability of a model where a critical aspect of health care infrastructure, the app stores, is provided in such a duopolistic and conflicted fashion.”
Digital health app stores of the future
Taking Apple and Google’s roles in the market into consideration we’ve outlined how these challenges could be overcome and legal obligations met. The paper explains these concepts in more depth, but here’s an overview of the different potential futures:
There will be no change in structure or behaviour of the status quo duopoly between Apple and Google, and the wild west remains, despite the new laws.
Apple or Google are forced to allow competing health app stores on their operating systems to remove conflicts of interest. For example, independent, accredited and regulatory compliant digital app ‘pharmacies’ could provide curation, oversight, triage, documentation, and complaint handling for health apps, linked to regulatory databases.
The current duopoly remains but Apple and Google’s approach evolves significantly to create greater separation of both companies’ individual roles. Doing so would resolve the developing regulatory pressures, enabling them to meet legislative requirements fully and transparently. This could occur through the separation of app stores into clear segregated domains where each provides clearly labelled MD apps and wellness apps, a bit like over-the-counter vs prescription drugs.
Digital health apps have an increasing role in clinical medicine and the way we look after our health and wellness. The evolution of health and wellness app stores would benefit all stakeholders in the industry to foster safer, better and fairer provision of digital health applications in the EU – if we are to reach this goal we must resolve these issues now.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
