The rapidly evolving world of mHealth has resulted in some ambiguity regarding regulations that apply to apps. To alleviate some of the confusion, the FDA and FCC have collaborated to create an interactive tool for developers of mHealth apps. The intent is to inform them of which federal laws they will need to follow based on whether the app collects, creates or shares consumer information; or diagnoses or treats a disease or condition, for example. It’s also possible that regulations from more than one agency will apply.
The mHealth app tool asks whether the app maintains or transmits identifiable health information, if a prescription is required to access the app, and whether the app poses “minimal risk” to users. For example, if your app is intended to diagnose a disease or condition, or is used in the process of curing, mitigating, treating, or preventing a disease, then it is a medical device subject to the FD&C Act, according to the tool. From there, the tool directs you to a question that will help you decide if FDA regulatory oversight applies to the app.
The site also includes a glossary of terms that defines a medical device, protected health information (PHI), personal health records (PHR), HIPAA covered entities, and mobile medical app.