LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.

FDA Commissioner Marty Makary indicated that one of the agency’s priorities is fostering an environment that’s good for investors, and that FDA regulation needs to move “at Silicon Valley speed.” He announced the changes during an address to conference attendees at the Consumer Electronics Show.

The agency will soften its approach to the regulation of clinical decision support software, which include AI-enabled products that help doctors navigate diagnoses and treatment options. The agency previously considered products that delivered a single recommendation as FDA-regulated medical devices. Now, those products can enter the market without FDA review as long as they fulfill the agency’s other criteria for escaping regulation. 

Continue to STAT+ to read the full story…

BERLIN — The leading professional organization for European oncologists has rolled out its first set of guidance on how its members should use large language models, a type of artificial intelligence, in cancer medicine. 

“The oncology community cannot ignore the potential benefits which AI technology can provide to cancer patients,” the authors of the guidance wrote, while simultaneously acknowledging that there aren’t enough evaluations of the chatbots available to patients or tools available to doctors to address the risks associated with generative AI in medicine.

The guidance’s release — it was published last Saturday in the Annals of Oncology — coincided with the annual meeting for the European Society for Clinical Oncology in Berlin. The American Society of Clinical Oncology has issued its own set of principles for the responsible use of AI in cancer medicine, but has not released recommendations specific to large language models (LLMs).

Continue to STAT+ to read the full story…