Google Play’s Health apps declaration

Google Play Console documents the requirement on its own Health apps declaration help page: every developer with an app published on Google Play — on closed testing, open testing, or production tracks — must complete it. Google is explicit that this includes developers whose apps offer no health features whatsoever; they still have to certify that. The only documented exceptions are system services apps and private apps.

What the form actually covers

The declaration lives on the App content page of Play Console, under Policy → App content → Health Apps. It asks you to declare all the health features your app offers. One of the selectable categories is Medical Device Apps — Google describes this as apps regulated as medical devices, which “may be subject to additional regulatory scrutiny, such as FDA (or another relevant authority) approval,” and gives examples including diagnostic tools, treatment recommendation systems, and software that interfaces with medical device hardware. If more detail is needed for a feature you have selected, Google asks for it on a second page. If you are unsure about something, the form lets you click Save as draft and come back to it later — that is a way to pause, not a final “unsure” answer, so an incomplete item should not be submitted as a No.

How it relates to Health Content and Services

The declaration form sits alongside a separate, broader page: Google’s Health Content and Services policy. The policy page sets the rules for health-related content and features generally; the declaration form is where you certify, feature by feature, which of those apply to your app. They are two different pages serving two different purposes — a policy and the form that operationalizes part of it — not the same document under two names.

A phrase that means something different at the FDA

Google’s own feature taxonomy includes a category literally called Clinical Decision Support, described as tools that assist healthcare professionals in clinical decisions, leveraging data analysis, patient information, clinical knowledge, and algorithm-driven insights — including drug-dosage calculators and risk-assessment tools. This is worth flagging on its own, because US federal law has a statutory exclusion (FD&C Act §520(o)(1)(E)) with its own specific, narrower conditions that is commonly called the CDS exclusion — the statute itself describes the function without ever using the phrase “clinical decision support,” and the name comes from FDA’s guidance on that exclusion, not the statutory text. These are two unrelated systems that happen to share a name: whether Google classifies a feature under its own Clinical Decision Support category has no bearing on whether that feature meets the FDA’s exclusion, and the reverse is equally true.

If your app is regulated as a medical device

Whether that box applies to you is a separate, prior question — whether your app actually qualifies as a medical device in the markets you distribute to. Our companion guide, “Is my app a medical device? US, UK, and EU,” covers how that question is answered in each market. An app declared as a medical device is identified as such on its Play Store listing — Google states these apps “will be identified as a ‘Medical Device’ on Google Play.” Rather than requiring the supporting documentation upfront the way some of Apple’s fields do, Google asks for proof of approval, clearance, or certification only upon request.

There is one more layer specific to a particular region. If your app is available to users in the EEA and Northern Ireland and is regulated under the EU Medical Devices Regulation or In Vitro Diagnostic Medical Devices Regulation, Google requires you to make six pieces of information publicly available: the device’s name or trade name; the manufacturer’s name, registered trade name, and place of business along with its Single Registration Number (SRN); a description of the device and its intended purpose; warnings or precautions for the user; a link to the electronic Instructions for Use; and the Unique Device Identification number (UDI-DI). Two further bundles apply where relevant — Legal Compliance Information (authorized representative details, notified body number, certificate number) and Operating Requirements (particular operating instructions, whether a manufacturer hardware device is also required, and minimum hardware/setup/connection/security requirements). In the documentation we have reviewed, this specific EEA-and-Northern-Ireland disclosure block does not carry over to Great Britain in the same form — the same app can face a public-disclosure requirement distributed into Northern Ireland that it does not face distributed only into Great Britain.

If your app touches health but is not a device

Google requires apps that are not medical devices, but still touch health or medical content, to carry a clear disclaimer in the app description — that the app is “not a medical device and does not diagnose, treat, cure, or prevent any medical condition” — and to remind users to consult a healthcare professional for medical advice, diagnosis, or treatment. Worth remembering: that boilerplate describes your app; it does not change what your app actually does. Under GB’s MHRA guidance, for instance, a general disclaimer is explicitly treated as insufficient if a medical claim is made or implied elsewhere in the product — a principle worth keeping in mind here too, since a store disclaimer and an actual qualification result are not the same fact.

Sources

• Google Play Console HelpProvide information for the Health apps declaration form
• Google Play Console HelpHealth Content and Services · related policy page

This guide is general information, not legal advice, and not an assessment of your app.