FDA's Regan-Udall Foundation and the ASH Research Collaborative (ASH RC) are launching a collaborative project to gather real-world evidence for sickle cell disease, aiming to establish a consensus on using electronic health record data to better understand clinical outcomes among sickle cell patients and broaden research in the field. The "Real-World Evidence Consortium” will be a collaboration among clinicians, researchers, patients, federal regulators, informaticians and other industry stakeholders, according to the statement announcing the effort Wednesday (April 17). In electronic...

The top Republican on the Senate health committee is criticizing FDA’s approach to regulating clinical decision support (CDS) software, asking the agency for more information about how it crafted its guidance on the technology and whether it has documentation of threats posed to patients. Sen. Bill Cassidy (R-LA), the ranking Republican on the Senate Health, Education, Labor and Pensions Committee, wrote in a letter to FDA Commissioner Robert Califf that FDA’s guidance classifying some CDS software as medical devices subjects...

State insurance regulators have established a multi-state steering group that will look at how February’s cyberattack on Change Healthcare unfolded, assess how insurance carriers and other impacted entities reacted, and facilitate discussions about the response and recovery efforts with UnitedHealth Group and Change Healthcare, as well as ensure the country is better prepared for the next, inevitable attack. The National Association of Insurance Commissioners (NAIC) tells House Energy & Commerce Committee leaders the steering group, which is in its early...