A prescription refill programme that launched in the US state of Utah this year has triggered a debate on whether artificial intelligence is actually ready to take over tasks that, until now, could only be performed by doctors, reports CNN.
The programme allows Utah residents to skip the doctor’s office and get their prescriptions refilled online by an AI chatbot called Doctronic – a seemingly simple step toward making healthcare more convenient for patients and prescribers.
But it has set off alarm bells for doctors, lawyers and public health experts. The pilot programme has laid bare various questions about the role of AI in medicine, including how it should be regulated, whether doctors should be able to veto it, and what kinds of safety measures are needed to protect patients.
At the centre of the debate is that state and federal laws limit prescribing to licensed medical professionals only. Proponents say those laws, which have underwritten American medicine for more than a century, should be updated to include AI chatbots and other new technologies.
“We have crossed a threshold in terms of giving something – that is not human – a medical licence, whether or not we want to call it that,” said Dr Eric Bressman of the University of Pennsylvania.
AI cannot practise medicine under current laws
Bressman and other experts say they aren’t opposed to AI prescribing, but it should have to meet rigorous standards akin to human doctors, who undergo years of testing and training before being licensed.
In Utah, Doctronic was able to launch thanks to a “regulatory sandbox” allowing state officials to waive laws for AI companies offering promising technology.
The refill programme is currently overseen by a five-member board of AI specialists, none of whom is a doctor, but who say they have implemented numerous safeguards. During the programme’s initial phase, for example, human doctors review all Doctronic refill orders.
The company expects to soon transition to fully automated refills.
The head of the state’s medical licensing board said he and his colleagues only learned of the programme when its January launch was reported in the news. In a March letter to the state, 11 board members called for the programme to be halted, citing the risks of automatically renewing medicines that can have side effects or drug interactions.
“We were essentially told: ‘Yes this is going on. And no, you don’t have a say in it’,” said Dr Alan Smith, a family physician who heads the board but said he was speaking only for himself.
Complicating the picture is the fact that medical technology is traditionally regulated at the federal level, while medical professionals are overseen by states.
Doctronic executives consider their AI as part of the state-regulated practise of medicine. But the Food and Drug Administration is supposed to oversee AI that directly affects medical care or decision-making, a line some experts believe Doctronic has crossed.
Doctronic’s executives wouldn’t tell CNN whether they had sought permission from the FDA.
“Our goal here is really just to meet patients where they need healthcare,” said Dr Adam Oskowitz, who co-founded the company with a tech industry entrepreneur.
“We try not to get too deep into the weeds on the regulatory side.”
In Utah, residents can visit a Doctronic website built for the refill programme. After confirming their identity, the AI chatbot asks users about their prescriptions and medical history, verifying that they have a valid prescription by tapping into a national pharmacy database.
If there are no issues, the AI can renew the prescription and send it to a local pharmacy. If the request requires more attention, the chatbot transfers the patient to a doctor who works for Doctronic’s telehealth service.
Oskowitz envisions a future where many routine medical tasks, including ordering tests and analysing results, can be offloaded to Doctronic, allowing doctors to manage thousands more patients than they can today.
Haphazard
The current approach to AI mirrors the haphazard medical standards of the early 20th century, Bressman said, before medical schools, medical boards and other authorities agreed on national benchmarks for training and licensing.
National guidelines on medical technology would typically come from the FDA, but the agency has indicated it plans to take a hand-off approach, at least under the current administration.
An FDA spokesperson said the agency has not authorised any AI chatbots but “is committed to encouraging medical innovation and helping bring promising new technologies to patients, while keeping safety at the centre of every decision”.
For now, Doctronic and other companies are likely to expand across states with different regulatory approaches.
“Companies may benefit in the short term by expanding their business models and kind of having the technology go beyond the evidence,” said Daniel Aaron of University of Utah’s law school. “But in the long-term, I think they risk compromising public trust and fuelling backlash.”
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