In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory framework emerges for digital medicine," a commentary appearing in Nature this week, raise several regulatory challenges remaining unanswered.

Background

Since gaining oversight of medical devices through the passage of the Medical Device Amendments of 1976, the US Food and Drug Administration (FDA) has taken various approaches to regulating medical software.

In the past, medical software was regulated using the same risk-based classification as medical devices. However, in recent years, the proliferation of mobile health technology such as cell phones, tablets and personal computers has resulted in "an explosion in the number and diversity of healthcare focused software apps … many of which were developed primarily for the consumer."

Over the last few years, FDA has gone to great lengths to clarify its position on regulating medical apps. Since drafting the Mobile Medical Applications Guidance in 2011, FDA has taken a hands-off approach by stating it would regulate only medical apps making specific health claims and "present the greatest risk to patients."

Subsequent guidance has reaffirmed FDA's approach, and the agency has exempted mobile applications making general wellness claims, medical device data systems (MDDS) and the hardware platforms running medical apps (cell phones, fitness monitors, etc.) from regulation.

For more information on FDA's approach to Medical Apps see our "Regulatory Explainer: Why and How is FDA Regulating Mobile Apps?", and articles "FDA Says it's Not Interested in Regulating Most Mobile Apps or Wearable Devices" and "FDA Confirms it Won't Regulate Apps or Devices Which Store Patient Data".

FDA also has begun exercising enforcement discretion, allowing it to selectively decline to enforce regulations in specific circumstances, to further exempt certain categories of low-risk medical apps that "may meet the definition of a medical device."

Lingering Questions

According to the authors, who represent PureTech, an R&D incubator and investment firm, and Precision for Medicine, a lifesciences consulting firm, FDA has answered "most of the unknowns that have arisen around digital health over the past decade."

However, the authors say several regulatory questions remain uncertain.

First, when it comes to clinical testing, the authors find "blinding a digital medical intervention study is sometimes quite difficult." While they agree "some type of control arm should be included…when a product is making a therapeutic claim," it is still unclear what standards regulators will require in clinical studies. Additionally, the authors raise questions about getting consent from study participants: "[H]ow effectively can a consent form on a mobile phone communicate the study intent and risks? Is tapping 'OK' sufficient to signify consent?"

Second, the authors argue enforcing strict Good Manufacturing Practices (GMP) on software-only products could stifle the "creative culture" to which many software developers are accustomed.

Third, while FDA handles software updates "the same way as any other device change," meaning small changes can be collected and submitted to FDA periodically for review, the authors find this practice to be outdated and "geared toward integral medical device software, not stand-alone mobile medical apps."

Next, the authors question how FDA will regulate combination products involving a drug and medical application. While products combining drugs and devices have been cleared, like Proteus Digital Health's ingestible sensor, FDA has yet to draft specific guidance covering such combinations.

Finally, the authors take a forward look at technology and wonder how FDA might treat already cleared software on entirely new types of hardware, such as virtual or augmented reality platforms. Would a change in user experience brought on by a new platform have regulatory implications for existing software?

Nature – A regulatory framework emerges for digital medicine