FDA Does Not Regulate Smartphone Apps, But Courts and FTC Do  
​[Posted on: Thursday, April 6, 2017]

FDA does not treat most healthcare related smart-phone apps as medical devices, leaving it to the FTC and state regulators to regulate apps based on claims and complaints. Healthcare apps, mostly hosted on Smartphones, smart watches and other wearable devices, are popular due to high acceptance by consumers and seemingly endless possibilities. Apps can be used for simple things such as to monitor general health and wellness by measuring vital signs, or for sophisticated diagnosis. It is ironic that while FDA regulates blood pressure monitors and temperature monitors as medical devices, it decided to not regulate smart watches that do the same measurements and potentially have a higher impact on a person’s general health awareness. FDA’s decision to not regulate phone apps had the desired impact of encouraging developers to create thousands of new apps without worrying about FDA approval or registration. However, FDA worked with FTC to create a pathway to potentially regulate apps if they make medical claims or if they could potentially mislead in their marketing. There are three ways an app may be considered: 1. Not regulated based on use in fitness and general health awareness, 2. Regulated as a medical device requiring formal FDA approval, or 3. Apps that may be regulated as a device based on the claims they make but subject to enforcement discretion. The third kind of devices is the ones that developers need to worry about. FTC created an online tool for developers to understand if their proposed app would or would not require FDA approval. There are primarily two concerns for regulators: FDA and FTC. First the protection of private health information that is otherwise covered under HIPAA rules, and second, false advertisement for apps that do not work as claimed. The FTC tool focuses mostly on the privacy protection aspects of an app. It recommends that an app should limit the amount of private information it collects to the bare minimum needed for the functionality, include robust security measures, control access to the collected information, evaluate the claims to assure that those claims meet FDA definition of a wellness app or a regulated app. A consumer reserves the right to take legal action against an app owner if found to be harmed by the app or for breach of privacy protection. That said, the current laws for healthcare apps are generally very lax and developer-friendly. Of the 156,000 healthcare apps available for iPhone and Android phones, only 4 have so far been taken to courts by the users and those also lead to relatively tiny fines. But it may change. Many apps tread the fine line between medical diagnosis and wellness. For example an app that claims to evaluate if a user as any genetic syndromes based on a selfie seems to make a medical claim. Similarly, there are apps for diagnosing if a user has bone damage in an accident by taking a picture of the limbs. With regards to privacy, apps that collect general health information may be used by insurance companies and providers to evaluate coverage, cost, and reimbursement issues. The main factor keeping FDA out of the app world is the popularity of a given app. So far, very few apps garner respectful following over a significant time period, making them slip under FDA’s radar but as we get more used to using apps for everything health, first FTC, then courts and finally FDA may not be far behind to clamp up the market.