FDA Releases New Guidance to Advance Digital Medical Tech

We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.

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Digital tool use is growing, and rapidly. To keep up with these changes, the Food and Drug Administration released a Digital Health Innovation Action Plan over the summer. It aimed to redesign medical device regulation to effectively address new tools, while also making way for innovation in the field.

The FDA quickly followed up the plan with several initiatives, including the launch of its Digital Health Software Precertification Pilot Program, which looks to fast-track the development and uses of digital health technologies. The FDA chose nine companies to participate in the program in September, including Fitbit, Samsung and Apple, among others.

Now, to close out the year, the agency has released three policy documents that will shape future health IT oversight and innovation.

“We recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” FDA Commissioner Scott Gottlieb said in a statement. “Moreover, we must always lean in the direction of enhancing access to more information — not restricting information flow — given the ability of reliable information to positively impact daily life.”

Aside from encouraging innovation, the three new guidances — two drafts and one final — also address key provisions of the 21st Century Cures Act that seek to lay out the FDA’s role in digital health — where it is needed and where it is not.

These three new guidances include:

A Clarifying Look at Clinical Decision Support Software

As the pool of health data grows thanks to technologies such as wearables that collect data on everyday activities, the need to sift through data and use it to create actionable insights is rising. Backed by machine learning, clinical decision support (CDS) software aggregates and digests healthcare data to help inform or support clinician decisions on treatment options, diagnostic tests and more.

“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision-making,” Gottlieb said. “We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”

The FDA hopes to do this by releasing a new draft guidance that will clarify which types of CDS will not qualify as medical devices, and therefore not fall under FDA regulation.

Essentially, the guidance outlines that CDS or similar patient decision support (PDS) software that allow the clinician to “independently review the basis for the recommendations” will not fall under FDA guidance. Software that analyzes or processes “images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram” and uses these analyses to make treatment recommendations will fall under FDA oversight.

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