FDA on Thursday released guidelines clarifying how the agency will regulate digital health products, such as mobile apps and tools that use artificial intelligence to help doctors make clinical decisions.

5 imperatives for successful CDS management

In a release, FDA noted that patients and providers increasingly are using digital health tools to inform everyday care decisions. The new guidelines update draft guidance FDA published in 2017 and aim to ensure those devices can be used safely without stifling innovation.

Details on the guidelines

In the guidelines, FDA outlined a risk-based framework which will determine where it will focus its oversight powers for clinical decision support (CDS) products.

FDA said it plans to focus its oversight authority on high-risk products that use AI to help clinicians treat patients with serious or critical conditions and which produce recommendations based on assumptions that clinicians will not independently evaluate.

As an example, FDA offered a CDS tool that sought to identify hospitalized Type 1 diabetes patients at high risk of severe heart problems following surgery. Because clinicians would not know what factors are influencing which patients are identified, this would be a prime example for FDA oversight.

"[I]f the CDS provides information that is not accurate … then any misidentification could lead to inappropriate treatment and patient harm," the agency said. "Since the potential for patient harm is significant, FDA regulation plays an important role in evaluating the software's safety and effectiveness."

FDA said lower-risk products, such as fitness tracker apps and other software not considered a medical device, will not be subject to FDA oversight.

"We're making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA's regulation," the agency said. "Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the health care system."

Bakul Patel, director of FDA's division of digital health, said the agency is "trying to be very clear about where we are focusing our oversight and where we are not. We are working with our stakeholders to create that clarity."

Patel added, "We want manufacturers of these technologies to make products in a way that will actually be useful, and at the same time it's not going to create a situation where people are getting hurt. We're pushing very hard on that" (Ross, STAT News, 9/26; Managed Care Magazine, 9/26).