Healthcare Innovation September 27, 2019
The federal agency also wants to modernize its regulatory oversight of these technologies
The U.S. Food and Drug Administration (FDA) has issued a suite of new guidances aimed to encourage innovative approaches to the development of digital health tools—including fresh guidance around clinical decision support software.
The FDA, an agency within the U.S. Department of Health and Human Services, also wants to ensure that its internal approach to overseeing these technologies advances along with the development of digital health tools, according to a statement from the federal agency.
FDA officials noted that digital health technologies— such as tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation—are increasingly being embraced...