The policy already applies to new apps, while existing apps need to undergo verification by “early 2027.”

Seeking “additional transparency to customers,” Apple Store will now show whether an application is a “regulated medical device.”

Apple will require this in the European Economic Area (EEA), the United Kingdom, and the United States.

Regulated medical device apps provide users with medical assistance, “including diagnosis, prevention, monitoring, and treatment of diseases and physiological conditions,” the company states in the Apple Developer blog.

Such applications need to be authorized and registered by regulatory authorities, for example, the US Food and Drug Administration (FDA).

The company notes that apps that operate in the US, the UK, or EEA and fall under the Health & Fitness or Medical category, and frequently refer to “Medical or Treatment Information in the Age Rating questionnaire in App Store Connect,” need to include a regulated medical device status on App Store Connect.

The regulation took effect on March 26th and is already being implemented for new apps.

Existing health and medical apps will be asked to provide the status by early 2027.

Apple notes that applications that fail to declare their status by this date will no longer be able to provide app updates.

Tracking one’s well-being on an app has become mainstream over the years, with more than 350,000 healthcare and medical apps available worldwide.

The stricter regulation of apps is necessary not only to ensure that the information or advice users receive is accurate, but also for data safety, as more users and organizations are moving towards linking their actual medical data.

For example, in Germany, medical professionals are providing patients with state-approved healthcare apps intended to help them better understand their health issues.

Even Apple had been working on an idea of upgrading its Health app to a health coach, an AI-powered “doctor.”

Nevertheless, this wouldn’t be something entirely new, since even AI agents can now access users’ medical data to provide more accurate responses. At least that’s the case for users of OpenAI’s ChatGPT Health.

However, while having your health insights and medical history in one place might be convenient, users shouldn’t forget that it contains sensitive data that, in the event of a breach, could be used against them.

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