On September 12, the tech giant released its Apple Watch Series 4, which features an electrical heart rate sensor that can take an electrocardiogram (ECG) via an ECG app—an app, Apple officials reveal, that has been granted a De Novo classification by the U.S. FDA.
In a statement, FDA Commissioner Scott Gottlieb, MD, and Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, discussed this development and spoke out about the agency’s work to spur digital health innovation. “The FDA worked closely [Apple] as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.”
Although the healthcare sector has been slow to implement new technologies in the past—due, in large part, to the stringent regulatory environment—the FDA is trying to change its approach. Last summer, the government agency announced its Digital Health Innovation Action Plan, which transforms how the FDA regulates digital medical devices.
“In establishing our regulatory approach to emerging technologies, such as digital health, we have recognized that we must—first and foremost—maintain our scientific gold standard for assuring product safety and effectiveness,” Gottlieb and Shuren said in a statement. “We must always put protecting patients at the forefront of what we do.”
By facilitating a more “flexible and risk-based approach” to device regulation, Gottlieb and Shuren expect to see the development of more digital health products, such as the latest Apple Watch. “Based on the substantial number of applicants to our software precertification pilot program, including traditional medical device companies, large tech companies and small start-ups, we understand more developers are interested in investing and creating products that can impact health care,” they add.
So, how will digital tools transform the healthcare sector? Share your thoughts in the comments section.