FDA Introduces New Rules For Wearables And AI-Enabled Devices
The agency announced Tuesday that it is reducing oversight of digital health products. Commissioner Marty Makary unveiled the news in a speech at the Consumer Electronics Show. Also: Utah is allowing AI to prescribe medications; telehealth reimbursement is in limbo; and more.
Stat:
FDA Relaxes Oversight Of AI-Enabled Devices And Wearables
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. (Lawrence, Aguilar, Palmer and Trang, 1/6)
In related news from the FDA —
MedPage Today:
First In-Ear EEG Device Gets FDA Clearance
The FDA cleared an electroencephalography (EEG) system based on a small sensor worn in the ear, allowing patients to be monitored outside of hospital settings, Naox Technologies in Paris, announced on Tuesday. The Naox Link in-ear EEG platform is the first of its kind to be cleared for prescription use at home or in healthcare settings, the company said. It uses wired earbuds with electrodes on the tips to acquire, record, and transmit one channel of EEG data. (George, 1/6)
More news about AI —
Politico:
Artificial Intelligence Begins Prescribing Medications In Utah
In a first for the U.S., Utah is letting artificial intelligence — not a doctor — renew certain medical prescriptions. No human involved. The state has launched a pilot program with health-tech startup Doctronic that allows an AI system to handle routine prescription renewals for patients with chronic conditions. The initiative, which kicked off quietly last month, is a high-stakes test of whether AI can safely take on one of health care’s most sensitive tasks and how far that could spread beyond one AI-friendly red state. (Khorram and Reader, 1/6)
Bloomberg:
AI Faces Threat Of New Regulations In California, Despite Trump
This year, many of the world’s most powerful artificial intelligence companies face a pitched battle over government regulation on their home turf — California. And even President Donald Trump’s threat to punish states that regulate AI may not stop the fight. California lawmakers, dominated by Democrats, are determined to place guardrails on the homegrown industry, saying unfettered AI poses a mental health risk to children and adults alike. (Kamisher, 1/5)
Modern Healthcare:
Telehealth, AI Reimbursement Has Digital Health In Limbo For 2026
Companies providing virtual health services are in reimbursement limbo for the sixth straight year. In November, Congress extended flexibilities that allow providers using telehealth and hospital-at-home care to get reimbursed at the same rate as in-person care through January. That means virtual health advocates didn’t get the reimbursement certainty they’ve long sought. (Perna, 1/6)
Stat:
AI Started Making Drug-Like Antibodies. When Will It Revolutionize Biopharma?
One day, probably in the next year or two, a company will claim it has put the first artificial-intelligence-designed antibody in the clinic. But the industry is divided on what “AI-designed” really means, and how close we are to the technology truly being able to design a medicine. (Trang, 1/6)
KFF Health News:
Listen To The Latest 'KFF Health News Minute'
Katheryn Houghton reads the week’s news: AI voices can help patients who have had their voice boxes sound like themselves again, and many state-run psychiatric hospitals don’t have enough beds to treat patients unless they’ve been charged with a crime. (1/6)
