The Food and Drug Administration today released for comment draft guidance clarifying what types of clinical and patient decision support software would no longer be regulated by the agency as a medical device under the 21st Century Cures Act. FDA Commissioner Scott Gottlieb, M.D., said the guidance generally excludes from regulation software that allows a health care provider or patient to independently review the basis for its treatment recommendations. In addition, FDA released draft guidance clarifying that certain digital health technologies, such as mobile apps intended solely to maintain or encourage a healthy lifestyle, generally fall outside the scope of FDA regulation under the Act, and final guidance adopting international principles for harmonizing the regulation of software with a medical purpose.
HHS’ Health Sector Cybersecurity Coordination Center urged health care organizations to install patches to protect their Windows systems against DejaBlue.
The AHA today proposed additional actions that the Centers for Medicare…
What do New York-Presbyterian, Henry Ford Health System of Detroit, and Children’s Hospital Los Angeles all have in common?
Medicare fee-for-service providers can sign up to participate in a pilot program allow clinicians to access a patient’s Medicare claims data for treatment…
The Centers for Medicare & Medicaid Services late today issued a final rule updating payment rates for skilled nursing facilities for fiscal year 2020.
Insights and Analysis
Hospital and health system leaders should collaborate with radiologists to boost value through AI, said speakers at an AHA Physician Alliance webinar.