Devices

Healthcare Opposition to Cybersecurity Reg Change

The American College of Cardiology has joined the American Medical Association, the College of Healthcare Information Management Executives, and many other healthcare organizations in opposing a proposed change to U.S. cybersecurity policy. Cardiovascular Business reports the proposal, first developed under the Biden administration, claimed it would “better protect the confidentiality, integrity, and availability of electronic protected health information.”

The opponents say that, in fact, the proposal would increase costs, waste valuable resources, and require extensive infrastructure redesigns. They also argue that the proposed rule’s requirements are not nearly as flexible as required for such sweeping changes. They say its one-size-fits-all approach could have a negative impact on patient care.

In a letter to HHS secretary Robert F. Kennedy, Jr., the organizations said, “We support updating cybersecurity standards for healthcare, and they must be flexible enough to accommodate the wide range of provider organizations. Standards should set strong protections while allowing innovation so providers can respond effectively to evolving cybersecurity risks.” The groups also said the proposal “runs counter to President Trump’s robust deregulatory agenda,” and called on HHS to withdraw the proposal as soon as possible.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome