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
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
The Senate overwhelmingly approved the VA Mission Act on Wednesday, overhauling private sector care options for veterans. Passing with a 92-5 vote, the bill cleared just one week after passing in the House with a 347-70 vote. Its passage meets the White House’s deadline to act on the issue before Congress leaves for a week-long
In a 5-4 decision decided by the conservative justices of the U.S. Supreme Court and handed down on May 21, Epic Systems – along with two other employers – came out on top in a labor law case experts say will have a significant impact on American workers' rights. The case, Epic Systems Corporation v.
A bipartisan bill cleared the U.S. Senate on Tuesday, which gives the Centers for Medicare and Medicaid Services the authority to offer incentives for behavioral health providers who implement electronic health records. The legislation now heads to the House where it will be reconciled with similar legislation. The Improving Access to Behavioral Health Information Technology
The meaningful use EHR incentive program served its purpose of getting hospitals to implement electronic health records platforms. Now, renamed as promoting interoperability, the next phase is to advance the federal government’s approach to enabling those organizations to actually share health data more effectively. “The job of meaningful use is done, now it’s a rebranding
The Food and Drug Administration released its plan to improve medical device safety, which includes a reorganization of its medical device center and a Congressional plan to launch a public-private partnership focused on cybersecurity. The five-point plan released Tuesday outlines a plan to consolidate offices within its device center, which oversees pre- and post-market activities.
The U.S. Coast Guard announced on Monday that it would join the Department of Defense on its EHR project to transition the patient records of its service members and clinics to the DoD’s MHS Genesis platform. The Coast Guard’s needs will be incorporated into the DoD’s $4.3 billion contract with Leidos, rather than signing a
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
U.S. Department of Health and Human Services Chief Information Security Officer Chris Wlaschin will leave his role on March 31, just 15 months in the position. Centers for Medicare and Medicaid Services Chief Information Officer Janet Vogel will take his place. Reports have circulated regarding the circumstances around his departure, as it comes amid a