FDA Expands Digital Health Efforts: Gottlieb

FDA commissioner Scott Gottlieb says the agency has issued two draft and one final guidance to “continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to FDA’s regulatory framework.”

In a statement, Gottlieb reviews progress made thus far under the agency’s Digital Health Innovation Action Plan, including launching a digital health software precertification pilot program and choosing nine diverse companies to participate in the pilot.

The three guidances released 12/7, he said, address, in part, important provisions of the 21^st Century Cures Act by offering additional clarity about where the agency sees its role in digital health and where it does not see a need for FDA involvement. “We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress,” he says. The guidances are: 

•          Clinical and Patient Decision Support Software that outlines the agency approach to clinical decision support software (CDS). Gottlieb says the draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device and thus not regulated by the agency. Generally, he says, CDS that allows a provider to independently review the basis for the recommendations are excluded from FDA regulation. This can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.
  FDA says it will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as there remain medical devices under the Cures Act.
  The guidance proposes not to enforce regulatory requirements for lower-risk decision support software, known as patient decision support software, intended to be used by patients or caregivers to independently review a treatment recommendation’s basis.
•          Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21^st Century Cures Act outlining the agency’s interpretation of the types of software that are no longer considered medical devices. Gottlieb says the guidance makes clear that certain digital health technologies, such as mobile apps intended only for maintaining or encouraging a healthy life style, generally fall outside the scope of FDA regulation. “Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system,” he says.
•          Software as a Medical Device: Clinical Evaluation to fulfill international harmonization efforts in this area. A draft was issued 10/2016 and was finalized with global and domestic comments. Gottlieb says the final version establishes common principles for regulators to use in evaluating the safety, effectiveness, and performance of software as a medical device. “The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health,” he says.

“Through this comprehensive approach,” Gottlieb concludes, “we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited.”