BOSTON – Health experts are applauding the U.S. Food and Drug Administration’s work to regulate digital health and view new guidelines as ways to advance innovation and improve health care.
“There is a huge opportunity here,” said Dr. Fatima Paruk, chief medical officer, analytics, of Allscripts, at the Bridge to Pop Health conference in Boston this week. “We finally have a framework that outlines a way to get a lot of this technology developed at scale.”
Under the 21st Century Cures Act, some technology—including certain software that supports administrative functions, encourages a healthy lifestyle, serves as electronic patient records, assists in displaying or storing data, or provides limited clinical decision support—is no longer considered to be a medical device, nor regulated as such.
Building on the Cures Act, the FDA’s Digital Health Innovation Plan reimagines its approach to digital health medical devices with pragmatic approaches to advance the development of high-quality, safe and effective devices, while assuring timely patient access.
“We’ve historically been careful about what we deliver to a patient because of past regulations,” said Dr. Gowtham Roa, chief medical informatics officer, Blue Cross Blue Shield of South Carolina, at the conference. “The FDA’s work will only help facilitate progress in this space. “
The FDA also recently introduced the Medical Device Safety Action Plan, which outlines how the FDA can continue to enhance its programs and processes, while assuring the safety of medical devices.
“Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.