When is an mHealth App Subject to FDA Regulation?


fda logoWith new FDA regulations in the works for the mHealth and medical device space, it’s important to understand the distinction between a consumer-friendly mHealth app and a regulated medical device.


We really like this article because it breaks down the differences between the two and defines what features can push an mHealth app towards the FDA regulatory process.


The bottom line is that if an mHealth app is for consumers and does not collect or provide medical information and advice, it will not be subject to FDA regulation. If you can answer yes to any of the following questions, your mHealth app might be subject to FDA guidelines:


  • Does the app diagnose a medical condition or provide information that allows a doctor to make a diagnosis?
  • Is the app designed to help a patient monitor a chronic medical condition?
  • Does it transmit information between a patient and a healthcare provider?
  • Does it provide data or advice to help patients or healthcare providers make decisions about medication or other treatment options?


The article also goes on to describe some of the risk factors to be aware of when creating and managing your mHealth apps:


  • Human error – Make sure your interface is simple and tailored to your specific users.
  • Hardware failure – Are there risks associated with a compete failure of the patient’s device? Is there a contingency plan if they lose their phone?
  • Software failure – Similar to above, is there a plan if your app crashes or if the patient’s phone gets a virus?
  • Malicious tampering – What kind of security plan do you have in place? Are you keeping up with best practices to mitigate risk?


At Smart Clinic, we stay on top of mHealth best practices to make sure our application (and its data) is safe, secure and in line with any appropriate FDA guidelines.


We would love to hear your thoughts on the future of our industry, so please get in touch or leave a comment on our blog. And remember, if you’d like to learn more about the great benefits Smart Clinic brings to patients and providers alike – sign up for a demonstration today!