Issue 10
Utah lets AI prescribe acne medication without direct physician oversight
In Utah's regulatory sandbox, Nolla Health's AI platform assesses acne from photos and can issue an initial prescription, reportedly for acne treatment only for now. Two physicians must approve the first 100 patients' prescriptions in advance; expert analyses are examining possible conflict with the FDA and the impact on hospitals.
Who is affected and how
- doctor
- Two physicians' approval is required for the first 100 prescriptions, so the supervisory role remains for now, but part of routine prescribing could shift to AI.
- health policy
- Utah's model is a template for the regulatory sandbox and AI prescribing, worth watching because of its relationship with the FDA.
- hospital manager
- It is worth assessing how the reshaping of routine care affects outpatient volumes and liability questions.
- health IT
- Integrating photo-based assessment and prescription issuing raises new vendor and data-handling requirements.
UK government accepts all 44 recommendations of national commission on AI in healthcare regulation
The UK government responded in early October to the National Commission on the regulation of AI in healthcare and, according to reports, backs all 44 of its recommendations. According to Reuters…
medtech companyAI-based devices must stay under continuous oversight after they reach the market, and the company must manage the device's development in line with the regulator.health policyThe new UK framework could serve as a model, so it is worth following the details of the recommendations and the implementation timetable.health ITSuppliers of AI systems used in the NHS should expect changing compliance and monitoring requirements.doctorThe oversight conditions for AI tools used in the NHS are changing, so it is worth following what checks will accompany their clinical use.regulation · United StatesFDA outlines 2027 AI guidance plans; nurses can comment on generative AI framework until October 19
The FDA has set out its AI guidance plans for 2027 and developed a regulatory blueprint for generative AI-enabled devices. The deadline for comments on the draft is October 19.
medtech companyDevelopers of generative AI devices need to follow the FDA framework, as it will shape future authorisation expectations.health policyThe FDA's 2027 plans point to the direction of future oversight of AI devices.insurance · United StatesSenator says Medicare AI prior authorization pilot delays care; documents point to a rushed launch
Patty Murray says the federal pilot covering six states, including Washington, uses AI to delay and deny care for Medicare patients. New documents show the program, called WISeR, which launched in…
doctorIn WISeR states, physicians should prepare for AI-based review of prior authorization requests and for appealing denials.hospital managerAuthorization delays and denials put patient pathways and revenue at risk, and should be tracked.health policyThe pilot's flaws and political pressure may push toward tighter oversight of AI use in Medicare.regulation · United StatesCalifornia law says medicine must be practised by doctors and nurses, not AI
California's new law establishes that medical practice is carried out by doctors and nurses, not AI. Gavin Newsom, however, vetoed a bill that would have protected nurses who override AI.
doctorThe law reaffirms that clinical decisions remain the physician's responsibility, even with AI support.hospital managerWhen deploying AI systems, hospitals must ensure that a qualified professional still makes the clinical decision.health policyThe contrast between the Californian and Utah approaches is a reference point for further state regulation.Hungary
More key stories of the week
AI companies run virtual drug trials to improve success of human studies
Several AI companies are running virtual drug trials with the aim of improving the success rate of human studies. The report was published on 7 October.
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doctorThe AI can take the medical history before the visit, which affects the length and structure of the appointment.hospital managerA pre-screening chatbot could affect how outpatient care and the patient pathway are organised.health ITIntegrating conversational diagnostic systems into patient intake is a new task.clinical deployment · United KingdomAI speeds up skin cancer checks in the NHS, with shorter waits in Sussex and Bradford
AI introduced in Sussex is cutting NHS waiting times for skin cancer checks, and waiting lists have also shortened in Bradford. A study finds the AI also frees up dermatologists' capacity, and the…
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Reports say the teen version of ChatGPT keeps young users talking even during mental health crises. Another report finds that AI chatbots often fail to help users in a mental health crisis.
doctorPsychiatric and primary care practices should expect that patients in crisis may ask a chatbot first.health policyExpected crisis-response behaviour is a key question in regulating mental health chatbots.research · United StatesThree-quarters of FDA-authorized AI medical devices are in radiology; real-world study finds more brain aneurysms detected
A study found that radiology accounts for about three-quarters of AI medical devices authorized by the FDA. A real-world study found that AI used alongside radiologists substantially increases brain…
doctorRadiologists need to judge the accuracy and time savings of AI tools, and the RSNA offers training for this.medtech companyRadiology is the main area of AI authorizations, so competition is strongest here.insurance · United StatesBlue Cross report says AI raises healthcare costs; hospitals dispute it
A Blue Cross Blue Shield report says hospitals' AI documentation tools increase healthcare costs. The AHA's blog and hospital representatives reject the claim.
hospital managerHospital leaders need to be able to argue with data in the dispute with insurers over the cost impact of AI documentation tools.doctorHow insurers view the use of AI documentation may also affect billing practices.health policyThe dispute between insurers and hospitals may influence the reimbursement rules for AI documentation.case · United StatesTech and AI firms lobby federal health officials in CMS-run Slack channel as Medicare promotes commercial health apps
AI and tech companies lobbied Trump administration health officials in a government-run chat channel operated by CMS, according to reports. Meanwhile, Medicare is promoting commercial health apps.
health policyThe informal channel between regulators and industry lobbyists feeds the transparency debate around Medicare apps.health ITCommercial apps backed by Medicare signal market opportunity and growing competition.research · globalAnalysis: AI-enabled drug discovery pipeline is growing but remains largely early-stage
An analysis in ScienceDirect finds that the number of AI-enabled drug discovery candidates is growing, but the pipeline is mostly at an early stage. Other reports discuss the state of the sector and…
pharmaceuticalsThe early-stage nature of the pipeline warrants cautious expectations about the success rates AI promises.research · United StatesMissing chatbot records leave doctors unable to trace harm from AI health advice
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doctorDoctors should ask patients about AI advice, because without documentation they cannot see what was said.health policyThe lack of chatbot logging and traceability points to a regulatory gap.licensing · United StatesFDA clears first AI test predicting breast cancer risk from a pathology slide; another risk tool available nationwide
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doctorPathologists and oncologists may gain access to new risk information based on tissue samples.medtech companyReaching patients directly raises new sales and regulatory questions.tool · United StatesTeladoc adds AI scribe for hospitals as Suki launches UpToDate-based support
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doctorAmbient note-taking and a decision-support question interface both target documentation burden and search time.hospital managerWinning acceptance of AI scribes among late-adopting physicians is a change-management task.health ITIntegrating scribe and decision-support tools with existing systems is a development matter.