Digital health pioneer Paul Sonnier takes a look at the FDA’s stance on mobile medical apps.
I was recently reminded of the US FDA’s stance on “mobile medical apps” after coming across an op-ed with the alarmist title, “The New Health App on Apple’s iOS 8 is Literally Dangerous.” Yes, as astonishing as it may seem, that's the title verbatim. The impression one gets is that a health app on your smartphone is dangerous to the health of the average person. While that’s of course not the case, the gist of the author's argument is that this particular consumer health-tracking app — one of thousands available in the app stores — is “dangerous” because people with obsessive-compulsive disorder (OCD) are often obsessed with self-tracking and, since the app can’t be removed, they would experience a “temptation to fall back into self-destructive habits” that is “worse by orders of magnitude” than if they had an app they could remove. Granted, one could still download the app from one of the app stores. But the logic is that this doesn’t present the same severity of issues.
While I don’t doubt that this scenario is unfortunately true for some individuals, it should be noted that the U.S. Food and Drug Administration (FDA) addressed the consumer and patient safety issues related to health, fitness, and medical apps a little over a year ago. The FDA’s “Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff” spells out where they will exercise “enforcement discretion” on digital health apps that pose a very small risk of harm to consumers and patients. Moreover, the guidance makes clear that apps of the HealthKit variety typically do not require premarket clearance in order to be marketed.
According to the FDA website:
The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery. Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it.
For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:
1. Help patients/users self-manage their disease or condition without providing specific treatment suggestions
2. Provide patients with simple tools to organize and track their health information
3. Provide easy access to information related to health conditions or treatments
4. Help patients document, show or communicate potential medical conditions to health care providers
5. Automate simple tasks for health care providers
6. Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems
It’s clear here that the FDA is using a light and deft touch in how it regulates consumer digital health apps, the numbers of which continue to grow rapidly. While the FDA guidance is primarily intended to help app developers (who are often unfamiliar with medical device product development and marketing requirements) to better understand and navigate the regulatory environment, it also serves to inform the public, press, and pundits. When considering apps that fall within the “discretionary enforcement” category, we should keep in mind the very low risk posed to consumers but still remain vigilant as to how an app is marketed to the public. There have been a handful of companies that have made claims tantamount to medical diagnostics or therapeutics. But, significantly, this isn’t the case with Apple’s HealthKit or the vast majority of consumer digital health apps in the app stores.
The digital revolution’s impact on our health, living, and society is diverse in its applications and benefits. The populations that can benefit are often just as numerous and varied. And while the rising tide of news coverage for the digital health revolution is great, it’s important that caution be exercised in using article titles that are exaggerated or overreaching in scope. Scrutiny is important, but equally important is clear communication and an understanding of the regulations designed to ensure public safety.
Paul Sonnier is a digital health evangelist, pioneer, and strategic advisor to nuviun. He is best known as the founder of the 30,000+ member Digital Health group on Linkedin. For more of his expert insights, you can follow him on Twitter: @Paul_Sonnier or through his website: The Story of Digital Health.
The nuviun blog is intended to contribute to discussion and stimulate debate on important issues in global digital health. The views are solely those of the authors.
