In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Findings indicate that such software can dramatically improve patient safety during surgery. A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General ...

The Class I recall of McKesson's Anesthesia Care software provides clues as to what FDA considers to be high-risk clinical decision-support software and high-risk bugs. By Bradley Merrill Thompson On ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies ...

Can the inefficiencies, wasted resources and costs associated with delayed or misdiagnosis be tolerated and absorbed in the new healthcare paradigm? As the health system migrates from fee-for-service ...

In this special guest feature, Bradley Merrill Thompson, a partner in the Washington DC office of law firm Epstein Becker & Green and Chairman of the Board of the firm’s consulting affiliate EBG ...

The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this ...

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight ...

DAYTON, Ohio--(BUSINESS WIRE)--MedsEngine announced today that Allegheny Health Network’s (AHN) Premier Medical Associates has further expanded its use of its clinical decision support software ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, reveals that computer software that helps inform clinicians’ ...