AMA Calls for Risk-Based GenAI Oversight to Protect Patients and Support Responsible Innovation
As generative AI moves toward performing increasingly consequential clinical functions, the American Medical Association (AMA) is urging the U.S. Food and Drug Administration to address a foundational question: Who is responsible for ensuring that these tools remain safe once they enter clinical practice?
Your Product Works — So Why Does It Still Fail in the Real World?
A patient's automated risk score was reassuringly green. Pulling from a sparse medical record and infrequent acute visits, the model flagged him as low risk and routed him to the default, low-touch outpatient pathway — so why was the patient actively deteriorating?
FDA Official Believes GenAI-enabled Tools Will Need to Be Assessed Like a Physician
Rick Abramson, a radiologist by training and the director of FDA's Digital Health Center of Excellence said, "We ended up putting out this idea that maybe these devices are starting to behave a little bit more like me as a physician than a heart valve or a defibrillator."
Readily Secures $11M for Compliance Intelligence Platform
The Series A round was led by Define Ventures, with participation from Y Combinator and the California Health Care Foundation Innovation Fund.
GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer
The GSK cancer immunotherapy Jemperli is now approved for treating advanced cases of rectal cancer harboring a particular genetic signature. It’s a label expansion for Jemperli, which was initially approved as a treatment for endometrial cancer.