Let's see how many die......

Artificial intelligence begins prescribing medications in Utah

Pilot program will test how far patients and regulators are willing to trust AI in medicine.

By Yasmin Khorram and Ruth Reader

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.

It also serves as an early check on how far policymakers and patients are willing to trust AI over trained doctors in decision-making. By inserting algorithms into one of medicine’s most fundamental relationships, Utah’s initiative could represent the first step in upending how care is delivered in the U.S.

That raises new questions about the safety of automating prescription refills, including how they should be regulated. So far, the Food and Drug Administration has not weighed in on Doctronic’s program. If the agency determines it has authority to regulate this use of AI, it could complicate or slow its expansion.

State officials and industry backers say relying more on artificial intelligence lowers costs, reduces medication lapses and improves access to care — while generating data that could shape AI policy beyond Utah.

Health care expenses keep climbing and clinicians — especially in rural areas — are stretched thin, said Margaret Busse, executive director of the Utah Department of Commerce. The state sees automating routine prescription renewals as a way to ease pressure on providers while lowering costs for patients, she said.

It’s also a way to “provide a pathway to innovation for entrepreneurs who are using AI in creative ways that may be bumping up against regulation,” she said.

But doctors’ groups warn that delegating some aspects of prescribing medication to AI could present new hazards.

In a statement, Dr. John Whyte, CEO and executive vice president at the American Medical Association, said: “While AI has limitless opportunity to transform medicine for the better, without physician input it also poses serious risks to patients and physicians alike.”

One concern is misuse or abuse, including the possibility that people struggling with addiction could try to game automated systems to obtain drugs inappropriately. Another concern is missing subtle clinical red flags or drug interactions that a doctor would catch.

“The company has to do that kind of trust building with their patients,” said Busse. “We want it to be done in such a way that people will trust that Utah is looking at this carefully and is not being cavalier about how we granted this regulatory mitigation. In a way it’s a risk for us as we do this.”

Al Carter, CEO and executive director at the National Association of Boards of Pharmacy, said pharmacists already use AI in their prescription fulfillment process and for patient consultations.

However, he cautioned, “the one challenge from a board of pharmacy standpoint is how do you regulate all this technology, and is this technology good for health care?”

In data shared with Utah regulators, Doctronic compared its AI system with human clinicians across 500 urgent care cases. The results showed the AI’s treatment plan matched the physicians’ 99.2 percent of the time, according to the company.

“The AI is actually better than doctors at doing this,” said Dr. Adam Oskowitz, Doctronic co-founder and an associate professor of surgery at the University of California San Francisco. “When you go see a doctor, it’s not going to do all the checks that the AI is doing.”

Oskowitz said the AI is designed to err on the side of safety, automatically escalating cases to a physician if there’s any uncertainty. Human doctors will also review the first 250 prescriptions issued in each medication class to validate the AI’s performance. Once that threshold is met, subsequent renewals in that class will be handled autonomously.

The company has also secured a one-of-a-kind malpractice insurance policy covering an AI system, which means the system is insured and held to the same level of responsibility as a doctor would be.

“In medicine, there’s always going to be potential issues that patients have,” said Oskowitz. “Whether it’s caused by the AI or not — we will take the risk. I think this is going to be infinitely safer than a human doctor.”

Doctronic also runs a nationwide telehealth practice that directs patients to doctors after an AI consultation.

In Utah, patients who use the system will visit a webpage that verifies they are physically in the state. Then the system will pull the patient’s prescription history and offer a list of medications eligible for renewal.

The AI walks the patient through the same clinical questions a physician would ask to determine whether a refill is appropriate. If the system clears the renewal, the prescription is sent directly to a pharmacy.

The program is limited to 190 commonly prescribed medications. Some medications — including pain management and ADHD drugs as well as injectables — are excluded for safety reasons.

Matt Pavelle, the company’s co-founder and co-CEO, said the system would give people easier access to their medications. “It’s hard to get a renewal — if you have a chronic condition and you can’t get your medication, terrible things happen.”

The company will charge $4 per prescription renewal, a price it says is temporary. Pavelle said the cost could drop quickly as the system scales up with renewals ultimately covered by insurance or bundled into a low annual fee.

Pavelle and Oskowitz are in discussion with other states such as Texas, Arizona and Missouri. They’re also weighing a national approval pathway, rather than navigating a patchwork of state-by-state rules.

Getting there will depend on the FDA.

Usually, states are responsible for writing their own rules governing how medicine is practiced. Since Doctronic’s AI is designed to renew patient prescriptions, it’s essentially practicing medicine and could fall under state regulations, according to Lowell Schiller, a former chief counsel for the FDA.

On the other hand, the agency has said it believes it has the authority to regulate AI as a medical device if it is used to diagnose, treat, or prevent disease.

Schiller says the FDA could hold off on taking action against Doctronic, citing medical marijuana as an example of where the agency has deferred to state laws instead of enforcing federal regulation.

But if the FDA does find that Doctronic’s AI is being marketed without appropriate authorization, it may try to bring the technology into compliance. Under President Donald Trump, the agency has shown an appetite for oversight. Earlier this year, the FDA sent a letter to health wearable company Whoop, saying it could not market its blood-pressure estimation technology without FDA approval. The FDA tries to make a decision on a marketing authorization application within 150 days for low to moderately risky devices that have no predicates, but it can take longer.

The FDA declined to comment saying the issue falls outside the agency’s regulatory purview.

In the past, the line has been clear, said Zach Boyd, director of Utah’s artificial intelligence policy office: States regulate the practice of medicine and the FDA regulates devices.

“Now we’re in this weird place where there are devices — maybe you could call them devices — that are purporting to practice medicine,” said Boyd.“Our philosophy has been to just take care of our side — of the state’s authority — and the FDA is going to figure out what it’s going to figure out.”