On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...

The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical ...

A new study by investigators from Massachusetts General Hospital reveals that computer software that helps inform clinicians' decisions about a patient's care can prevent 95% of medication errors in ...

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 ...

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 ...

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 ...

The Blueprint for an AI Bill of Rights the White House recently published didn’t come a moment too soon for the health care industry. Most of the AI-driven applications in health care are known as ...

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 ...

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 ...

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’ ...