Devices

A Distributed Approach to Regulating Clinical AI

Researchers from several Harvard University schools and departments and in other international institutions are suggesting the need for an amalgam of centralized and decentralized regulation of clinical artificial intelligence (AI). The researchers discuss the benefits and challenges of such an approach in a report in the open-source journal PLOS Digital Health.

“In the long run,” the report concludes, “we believe that the best approach to regulating clinical AI in practice is to not regulate it centrally, in most instances, but rather to delegate the regulation of clinical AI to local health systems.”

The paper says that while a distributed process involving a robust decentralized process as an adjunct to a centralized regulatory process is optimal, the researchers accept that it is not currently possible. “Such an approach requires the establishment of a specialty of clinical AI and an accountability framework, as well as the development of open data assets, AI registries, and a robust process for public engagement,” they write. “It will also require a shift in regulatory mindset and an acceptance of changes in institutional responsibilities from existing regulatory organizations.”

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