Google Fit Health datas and Medical devices Application

tantepetunia

Starting to get Involved
As a Medical Device Manufacturer under the FDA (513k) and Class IIa under MDR, Hipaa compliant, a few years ago we assessed that we could not use Google Fit APIs because of HIPAA constraints. Reading again their T&Cs I’m not quite sure about that: Terms and Conditions | Google Fit | Google Developers.
The Google Fit has some limitations; for example, When you look at the terms of service for Google Fit for developers, Google Fit is only a fitness tracking app; it does not allow you any help on controlling the medical parameters. You are also not allowed to use Google Fit along with any other medical gadgets or services under Section 201(h) of the US Federal Food, Drug, and Cosmetic Act. Google Fit is not to be seen as a medical device, the app does not need extra security measures that are crucial for custom healthcare software development. Google insists that it makes no representation that Google Fit meets HIPAA requirements. So when an app developer is a covered entity or business associate under HIPAA, they should use Google Fit in their app only after getting written consent to such use from Google.

Do you think we can get around that by using google fit data as a source, as long as the review from the healthcare professional is made on a copy of the data and clinical annotations/processing done on that copy and not fed back to Google Fit ?


Thanks! Best
 

yodon

Leader
Super Moderator
I don't see this as being particularly defensible. You would be using data collected from a system that is not validated to provide that information in a way to allow clinicians to (presumably) make medical decisions.

You could possible request a presub meeting with the FDA.
 
Top Bottom