Explore how FDA's risk-averse approach to clinical decision support software regulation reveals challenges in balancing innovation and patient care.

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 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 ...

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 United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...

The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...

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 ...

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 ...

Dr. Eve Cunningham is group vice president and chief of virtual care and digital health at health system Providence and founder of MedPearl. And Providence is getting ready to spin off MedPearl.

Israel-based DreaMed Diabetes announced this week that it has raised $3.3 million from Norma Investments, Russian businessman Roman Abramovich and one other unnamed angel. The funds will mainly be ...

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’ ...