Key to digital health innovations that deliver: Early feedback

Innovation is a popular buzzword in the digital health space. Before the latest gizmo is released to the market, work is done to ensure that it is safe and effective, and that its use will not burden medical practices.

“The AMA works to ensure that new technologies become assets for physicians and solutions that improve patient care,” said Susan Wilson, vice president of sales and marketing for healthcare solutions at the AMA.

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“We believe that the physician perspective is a key ingredient in realizing the potential of healthcare innovation,” she added. “We facilitate collaboration across the healthcare ecosystem to ensure the physician perspective is represented in the design, implementation and evaluation of new healthcare technologies and digitally enabled care.”

Wilson spoke during an AMA webinar examining the key role the Food and Drug Administration (FDA) plays in regulating medical devices, and how the FDA’s work precedes and intersects with the Current Procedural Terminology (CPT®) set of codes. (Webinar available on demand. Registration required.)

The code set plays an important role in fostering innovation, Wilson explained.

“We prepare, maintain and distribute the current set of codes for procedural terminology – or the language of medicine – that provides the basis for communication in many critical areas of care, including innovation, research, interoperability and health equity,” she said.

The FDA is seeking early information about the devices

For its part, the FDA also encourages earlier input on medical technology, according to Douglas E. Kelly, MD, chief scientist and deputy director of the FDA’s Center for Devices and Radiological Health. He outlined the FDA’s device approval process and emphasized the importance of physician input.

“The Food and Drug Administration does not tell doctors how to practice medicine — we listen to doctors when we determine whether a device is safe or effective for a given indication,” said Dr. Kelly. “We also use advisory committees when technologies are new and try to understand what the larger community thinks about it — especially the medical community.”

FDA relies on input from 50 committees and panels to obtain expert advice on scientific, technical, and policy issues.

Among those cited by Dr. Kelly were the FDA’s Payer Communication Task Force, the Medical Device Innovation Consortium, and the Product Lifecycle Advisory Program, which he helped launch with the goal of helping innovators avoid “failures in late stage” after receiving FDA approval.

These failures could have occurred because patient advocacy groups did not like the “endpoints the company chose” or had a different risk-benefit analysis, or physician associations sought different evidence to evaluate the device’s utility, or needed of guidance on what coding was needed.

“It’s much better to know what these issues are early in the development of medical devices, then later,” said Dr. Kelly. “The hope is that by including stakeholder input early in the process, you can come up with a much more holistic strategy for generating evidence.”

“Ultimately, we think you may end up with a larger study, but with much less risk and much more transparent and faster time to commercialization and profitability — all in the service of patients,” he added.

In addition to the FDA’s historic role in protecting consumers from unsafe products, the agency also seeks to “catalyze innovation” and facilitate “patients’ timely access to safe and effective medical devices,” Dr. Kelly said.

Digital health tool developers can now use the CPT Smart App to submit requests for new codes or revisions. The app also has online training materials that provide instructions and information about the CPT editorial panel process.

The CPT® 2024 Professional Edition and CPT® Changes 2024: An Inside Look are available from Amazon’s AMA Storefront.

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