Tag: Government amp; Policy

HIMSS weighs in on FDA software pre-cert program

The FDA's software precertification program aims to take a new approach to regulation for a health technology space that's evolving at dizzying speed. It's meant to offer a voluntary pathway that can keep tabs on the safety and efficacy of new software and devices without stifling innovation or hindering patient access. For vendors that have

As FDA signals wider AI approval, hospitals have a role to play

FDA Commissioner Scott Gottlieb, MD, got a lot of attention this past month when he delivered a speech touting the big promise of artificial intelligence for healthcare, and pledging that the agency has been reconsidering its approach to regulating AI-powered software and devices. "One of the most promising digital health tools is artificial intelligence, particularly

State Department puts out RFI for a new EHR

The U.S. Department of State has released a request for information for a new electronic health record last week, stemming from a failed joint EHR implementation with the Coast Guard. The Coast Guard had attempted to share a hosted EHR with the State Department, known as the Integrated Health Information System, or IHiS. But the