There’s a Medical App for That: Recent FDA Guidance Should Allow for Dramatic Growth in Medical Apps

September 23, 2015

This is the second in a four-part series of articles on consumer-focused health care. These articles are adapted from a Health Law Update presentation Attorney Tyler Wilkinson gave at the State Bar of Wisconsin’s annual Health, Labor and Employment Law Institute in August 2015.

If you heard cheers from San Francisco, Austin and Madison earlier this winter, they were probably from hoodied coders working to create medical applications for mobile devices. In January and February, the Food and Drug Administration issued guidance to medical app developers indicating that it did not intend to regulate large segments of the medical and mobile application fields. The FDA’s decision should make it much easier and cheaper for medical app developers to bring products to market.

Patients and health care providers nationwide are using mobile technology to improve patient health and the overall delivery of health care. Certain companies and products are already publicly available and well-known. For instance, mobile apps and wearable devices from companies like Fitbit and Jawbone can help people manage their own health and wellness. Websites like MyFitnessPal.com can help people count calories and share data with providers. Apple and Epic Systems are working together to provide HealthKit, a data repository which collects information from various devices (connected scales, fitness trackers, food diaries, etc.) and shares it with providers. For every large company identified above, there are countless mobile medical app start-ups trying to develop the next hit product.

The promise of these medical apps was tempered by the dreaded development process. In layman’s terms, the development process is an FDA-required process to determine whether medical devices are safe and effective. It can involve extensive clinical trials and FDA review. One inventor we work with called the development process “long, arduous and expensive.”

That’s why it was big news when the FDA announced that it would not regulate certain medical applications. In January 2015, the FDA issued draft guidance on “low-risk products that promote a healthy lifestyle” and indicated it does not intend to examine them to determine whether they are “devices” subject to regulation. Health and activity monitors similar to those produced by Fitbit and Jawbone fell into this category and will not be subject to review. In February, the FDA announced it would not regulate mobile medical applications that pose low risks to the public, such as mobile apps that help patients maintain positive behaviors, use GPS location to alert patients to environmental conditions, implement video games to motivate patients to exercise, and apps that track asthmatic attacks.

In short, the FDA removed a large hurdle for many medical app developers to take their products to the public. App developers should carefully review the FDA guidance before deciding their product is not subject to FDA review. Developers should also be mindful of privacy laws as they may create apps subject to HIPAA or state privacy laws.

The FDA’s decision to forego regulatory review of certain products and mobile medical apps was great news for clusters of developers in cities like San Francisco and Madison. It’s also great news for consumers and patients looking for new ways to monitor their health and to engage with their physician.

Want to know whether your mobile medical app is subject to FDA regulation or privacy laws? Contact Tyler Wilkinson at 608.283.6783 or at twilkinson@axley.com.

For more information about "There’s a Medical App for That: Recent FDA Guidance Should Allow for Dramatic Growth in Medical Apps," contact Tyler K. Wilkinson at twilkinson@axley.com or 608.283.6783.