Google clinical director on AI and mental health

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In early April, Google offered a response, of sorts, to calls for the company to take greater accountability for the mental health impacts of its products. It introduced several updates to how its Gemini chatbot behaves in situations where users show signs of mental health issues and $30 million in funding for crisis lines.

I spoke with Google clinical director Megan Jones Bell about the updates, and why she believes it's important to let people in crisis talk to chatbots instead of cutting them off from conversations.

policy

Utah Medical Board blasts Doctronic experiment

On Friday I broke the news that the Utah Medical Licensing Board has called for an immediate suspension of the state's plan to allow the startup Doctronic to use a chatbot renew medication prescriptions without clinician review. A majority of the board wrote in a letter that they only learned about the pilot after it had been announced and that it poses risks to patients. The experiment was authorized by the Utah Office of AI Policy under a program that allows that state to temporarily waive regulations for AI developers under controlled circumstances.

This is the latest sign of discomfort with the AI experiment, which experts told me undermines ongoing clinical care and may run afoul of Food and Drug Administration regulations. In response to the letter, the Office of AI Policy wrote that of course it consulted medical experts before authorizing the pilot. It said it would not suspend the project because it's still in an early phase where all renewals are being supervised by clinicians.

medical devices

No automatic reimbursement for FDA breakthroughs

The FDA and the Centers for Medicare and Medicaid Services last week announced a new RAPID coverage pathway they believe will accelerate access to innovative medical devices deemed breakthroughs by FDA. The announcement comes just weeks after Medicare regulators proposed repealing a coverage pathway that made it easier for breakthrough devices to qualify for supplemental payments.

Under the new plan, developers of breakthrough devices will receive guidance from CMS on how to run pivotal trials that will collect the evidence necessary so that they can be covered shortly after receiving FDA marketing authorization. On a press call, a CMS official estimated that some 40 devices currently in its pipeline may be eligible.

As I reported with Katie Palmer, the plan does not deliver what industry has been hoping for: automatic reimbursement for breakthrough devices upon FDA approval. Industry observers noted similarities to an existing "parallel review" program, which hasn't proven a huge boon to manufacturers.

It will be interesting to see this unfold, and whether it actually delivers faster coverage and patients access. I'm very curious what details will come out in the Federal Register notice about RAPID when it comes out.

Zap in a cap?

FDA on Friday approved a request from Motif Neurotech to start gathering data on the safety of their device, a brain implant that treats depression by zapping the brain.

As O. Rose Broderick reports, scientists have used transcranial magnetic stimulation, or TMS, to alleviate depression for decades. Motif is putting their own spin on the therapy, including the use of a hat to spark the daily therapy, a task Jacob Robinson, Motif's founder and CEO, likened to charging your phone every day. Rose talked with Robinson about the trial and why Motif is zigging (treating depression) while the rest of the field is zagging (treating ALS).

digital therapeutics

New pharma deal for digital 'hybrid' cancer drugs

Remepy, a digital health startup developing "hybrid drugs" announced a new deal with Germany-based Merck (not to be confused with the U.S.-based pharma company). All that's been disclosed is that the deal surrounds a software and drug treatment under development for rare cancer.

Remepy is also about to begin a pivotal trial for a combination treatment for Parkinson's disease that uses a digital intervention developed by the company and carbidopa-levodopa, a common drug treatment for Parkinson's.

If all goes well, Remepy may be the first to market with an FDA-approved software-drug combination product that takes advantage of guidance the FDA released several years ago on Prescription Drug Use Related Software. Specifically, the guidance offers a way for companies to make medical claims about software used with drugs. Pfizer is also working on PDURS.

Health tech news roundup

In other digital therapeutics news, Floreo announced it had submitted a De Novo authorization request to FDA for its virtual reality autism therapy.
Stanford professor James Zou is in talks to raise about $100 million "to build artificial intelligence models to improve research about the human body," B loomberg reports.
Viz.ai a nnounced a new deal with Johnson & Johnson to boost commercialization of Viz's subdural hemorrhage imaging technology that FDA cleared last year.
TruBridge, which provides EHR and RCM services to rural and community health care providers, was acquired by IKS Health, an AI health administration platform company that's public on India's stock exchange.
Zócalo Health, "a tech-enabled, community-based primary care provider," raised a $15 Million Series A round led by EO Ventures.
Spring Health, a large provider of behavioral health benefits for employers, announced Guide, an AI platform meant to enhance the continuity of its services between clinical visits.
Tava Health, which develops technology infrastructure for mental health care, announced a $40 million Series C round led by Centana Growth Partners.