Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...

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 ...

In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.

Epic and Oracle submit policy recommendations to HHS to guide AI adoption in clinical care with vendor-agnostic validation ...

The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to exclude certain medical software functions, including certain decision support software, from the definition ...

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 ...

The FDA granted a De Novo request for DreaMed Diabetes’ artificial intelligence-based decision support software Advisor Pro, the Israeli diabetes management solutions developer confirmed June 18.

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). 1 The ...

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 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 ...

BOSTON--(BUSINESS WIRE)--Etiometry, a leader in clinical decision-support software for critical care, announced today that the company has obtained the CE Mark under the European Union's medical ...

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’ ...