Issue 9
Viewpoint
insurance · United States
Hospital AI billing tools added $942 million in costs for Blue Cross insurers
Blue Cross insurers say hospitals' AI-based billing tools added $942 million in extra costs, which billing companies dispute. The Texas attorney general has opened an investigation into Blue Cross Blue Shield over the alleged delay and denial of emergency care.
Who is affected and how
- hospital manager
- Hospital executives must review what contestable items AI-assisted coding and billing generate for insurers.
- health IT
- Health IT must demonstrate the auditability and exception handling of billing and coding tools to payers.
- health policy
- Health policymakers must consider how to regulate the cost of the AI arms race between payers and providers.
regulation · European Union
European academies call for stricter rules on AI in healthcare in EASAC–FEAM report
The European Academies' Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) have issued a joint report on the safe use of AI in healthcare. It urges proactive…
health policyShould take the report's recommendations into account in implementing the AI Act and in regulating long-term consequences.doctorShould keep AI safety and liability issues on the professional agenda.hospital managerShould treat AI procurement and deployment as a high-risk system.case · United StatesNurses say AI-driven scheduling and monitoring pose a safety risk
Nurses say AI systems are disrupting work schedules and that this is a patient-safety issue. A survey finds nurses dissatisfied with AI implementation, and a union says AI is pushing out a dozen…
hospital managerHospital executives must involve nurses in rolling out scheduling AI and measure its safety impact.health ITHealth IT must make the scheduling system's decision logic transparent, along with the limits of employee monitoring.regulation · United StatesFDA explores competency-based path for generative AI-enabled medical devices
The FDA is seeking input on a regulatory framework for medical devices that use generative AI, and is floating a competency-based path. The idea fits the lifecycle approach used for AI-based clinical…
medtech companyShould comment on the framework and prepare for stricter evidence of intended use and clinical risk.health ITMust align generative AI CDS development with the lifecycle-based approach.health policyShould follow how the competency-based approach, modelled on the way physicians are assessed, develops.case · globalPatients increasingly turn to AI for health questions instead of their doctors
According to Ipsos, one in three Americans has already talked to a chatbot instead of their doctor, while another study finds that turning to AI may signal anxiety or depression in young adults…
doctorDoctors must expect patients' AI-derived views in consultations and prepare for disputed cases.health ITPatient information and triage tools must account for the risks of unsupervised AI use.Hungary
caseCzech startup Carebot raises record 36m crowns for AI diagnostic toolsmedtech companyIn the regional AI diagnostics market, the funding could mean a competitor or a partner.doctorCentral European AI tools for reading medical scans may become available.clinical deploymentAI supports diagnosis at Szombathely hospital's new CT and MRI scannersdoctorFor radiologists, AI support comes built into the imaging machines.hospital managerWhen buying new imaging equipment, AI features become part of the decision.caseHungary could become a regional meeting point for healthcare AIhealth policyRegional positioning affects national strategic decisions on healthcare AI.caseAI features at the 56th Healthcare Professionals conference
More key stories of the week
incident · United States
AI speeds up hacking while local hospitals' defences remain weak
Security experts say AI is accelerating attacks while local hospitals and smaller organisations struggle to harden their systems. The articles also warn of vulnerabilities in connected medical…
health ITHealth IT must review vulnerabilities in connected devices, shadow AI use and prompt-injection risk.hospital managerHospital executives must treat care continuity and ransom risk as a separate budget item.medtech companyMedtech companies must reduce known critical vulnerabilities in network-connected devices at the manufacturing end.case · United StatesKennedy says AI is "better informed" than doctors; physicians push back
Health Secretary Robert F. Kennedy Jr. says AI can give a second opinion better informed than doctors, and at the MAHA summit an OpenAI representative called avoiding AI health advice malpractice…
doctorDoctors must handle patients' AI-generated "second opinions" and argue professionally for or against them.health policyThe effect of official federal AI endorsement on patient information and trust needs to be monitored.research · globalAI chatbots and mental health: studies warn of psychological harm
A study finds that AI chatbots used for companionship and mental health support can have serious negative consequences, such as dependency. Further articles discuss the impact on young people's…
doctorPsychiatric and primary-care histories should include questions about chatbot use.health ITMental health AI products need risk management and safety controls.clinical deployment · United StatesHCA expands AI nurse handoff tool to 15 more hospitals as Cooper brings ambient AI to the bedside
HCA is extending its AI-based nurse handoff tool to 15 more hospitals. Cooper Norcross Health in New Jersey is the first to bring ambient AI, Microsoft Dragon Copilot, into nurses' bedside work.
hospital managerThe HCA and Cooper examples can serve as a benchmark for pilots.health ITMust integrate ambient and handoff tools into nursing workflows.regulation · European UnionEU AI Act in healthcare: high-risk rules and deadlines in 2027 and 2028
Analyses summarize which healthcare AI counts as high-risk under the EU AI Act and what already applies. For medical AI covered by the MDR/IVDR, the key date is 2 August 2028.
medtech companyMust align MDR/IVDR conformity assessment with the AI Act's August 2028 deadline.pharmaceuticalsShould assess which of its internal AI tools fall into the high-risk category.hospital managerShould prepare for deployer obligations for triage AI and other systems under Annex III.health ITShould schedule documentation and compliance work around the deadlines.tool · United StatesEverlywell offers Clairity's FDA-authorized AI breast cancer risk assessment nationwide
Everlywell is making Clairity's FDA-authorized AI-based breast cancer risk assessment available nationwide in the United States. The announcement was published on October 1.
doctorPatients may come with the result before a mammography screening decision, so physicians need to know the tool's limitations.medtech companyThe distribution partnership offers a model for taking authorized AI tools to the consumer channel.research · globalMedical AI devices should be tested in real-world settings, but most in hospitals are not
Articles say medical AI is already in hospitals, but most devices have not been properly tested. Authors call for studies in real clinical settings.
hospital managerWhen procuring, it should ask the manufacturer for validation data from real-world conditions.medtech companyIt should collect performance data in clinical settings, including after authorisation.health policyPost-market evaluation based on real-world use is a regulatory question.regulation · United StatesANA adds AI to nursing scope and standards; NCSBN launches survey
The American Nurses Association (ANA) has added AI to its scope and standards of practice. The NCSBN and nurse scientists are launching a survey on how AI affects nursing practice.
hospital managerHospital executives must align nurses' AI-use policies with the ANA standards.clinical rollout · European UnionLunit wins contract for AI-supported breast cancer screening in Stockholm
South Korea's Lunit has secured the contract for AI support in citywide breast cancer screening in Stockholm. The company's breast diagnostic AI is used for screening.
doctorRadiologists must work alongside AI in screening reads.hospital managerThe Stockholm contract can serve as a reference for region-wide screening AI deployment.medtech companyThe large public procurement shows European demand for screening AI.research · globalAI plus one radiologist matches two radiologists in breast cancer screening, analysis finds
An analysis found that double reading by one radiologist and AI is no worse than double reading by two radiologists. In the MASAI trial, AI-supported screening increased detection without increasing…
doctorReplacing the second reader with AI could mean a change in screening protocols for radiologists.hospital managerReorganising screening with AI could help address radiology capacity shortages.health policyThe study is an argument for reviewing screening guidelines to allow AI-supported reading.regulation · United StatesNewsom vetoes bill protecting nurses who override AI, but signs clinical judgment law
California's governor vetoed a bill that would have protected nurses who override AI recommendations. He did, however, sign a law on clinical judgment.
hospital managerHospital executives must set out in internal policy that clinical judgment takes precedence over AI.health policyCalifornia's twin decision may offer a model for other states' regulation.research · United KingdomNHS study: AI skin cancer tool reduces number of biopsies
Research at Chelsea and Westminster Hospital found that an AI-based medical tool can clear benign cases from further investigation. This reduces the biopsy rate.
doctorFor dermatologists, the AI tool can help safely triage benign cases.hospital managerFewer biopsies can free up capacity.In brief
regulationWHO warns health AI research is outpacing ethics oversighthealth policyEthics committee oversight of AI research needs to be strengthened.doctorClinicians taking part in research must check ethical compliance more closely.clinical deploymentVA signs $775 million contract to bring ambient AI into clinical documentationdoctorAI note-taking, which replaces typing during visits, is becoming widespread in US public care.health ITFor ambient AI vendors, the VA contract is a reference for integration into large systems.hospital managerThe contract could serve as a cost benchmark for reducing documentation burden with AI.regulationFour ARPA-H initiatives aim to modernize US clinical trialspharmaceuticalsAI-driven modernization of trial processes could change development timelines.health policyThe government programs are instruments for competitiveness against China.incidentFake disease fools Copilot, Gemini and a medical journaldoctorClaims in AI summaries and the literature must be checked against a primary source.health ITClinical AI tools need built-in source verification and hallucination handling.toolHeidi launches AI agents to automate clinical administrative tasksdoctorAutomating administrative tasks could free up time, but the agents' output has to be checked.health ITAgent-based tools must be fitted into existing systems and data-protection requirements.toolNYU Langone AI tool finds and fixes training gaps for radiology residentsdoctorIn resident training, the tool could provide personalised learning material targeted at the gaps.hospital managerAI-based gap analysis can be applied in training programmes.caseGE HealthCare hires Medtronic's AI leader as chief AI officermedtech companyElevating AI strategy to the executive level signals competition among leading manufacturers.regulationAI drug discovery tools carry risky contract terms as USPTO inventorship rules changepharmaceuticalsAI vendor contracts and the handling of inventorship rights must undergo legal review.researchRadiology: generative AI compared with physicians, and wrong AI suggestions bias readersdoctorAI suggestions can steer decisions in the wrong direction, so AI should not be used as an automatic anchor.clinical deploymentWest Virginia invests in AI voice recording technology for rural hospitalshospital managerAI documentation may become available to small-town hospitals with state support.doctorDocumentation workload for rural doctors may fall.drug developmentTremont AI emerges from stealth with AI platform for preclinical drug safetypharmaceuticalsAI-based safety prediction can be built into the preclinical toxicology workflow.drug developmentAbbVie partners with IPO-bound Iambic as Insilico picks another AI-designed obesity drug candidatepharmaceuticalsAI-led research partnerships and AI-designed candidates are also appearing in large companies' portfolios.researchFDA grant funds an LLM "jury" to evaluate AI-generated radiology reportsdoctorAssessing the quality of generated radiology reports could become standardized.medtech companyThe FDA's interest in evaluating report-generating AI signals future expectations.caseHealth AI lab launches with $500M backing; OpenEvidence raises $250MpharmaceuticalsThe new, well-capitalized players in drug-development AI may become competitors or partners.doctorThe business model of clinical decision-support tools is expanding toward drug development.licensingFDA clears AI devices: Tempus ECG tool, kidney stone surgery robot, CapsoCam featuredoctorNew ECG, endoscopy and surgical AI tools are becoming clinically available.medtech companyThe clearances are model cases for AI devices going through the FDA pathway.insuranceUtilization management and prior authorization among AI's hardest healthcare problemshealth ITIn prior-authorization automation, it must be clear who makes the final decision.caseDYAD raises $10M to expand healthcare AI for the NHShospital managerThe market of AI providers tied to the NHS is growing, and procurement should be weighed with this in mind.researchHospitals team up to speed advances in diagnostic AIhospital managerJoining hospital consortia may help with access to data and validation.regulationFDA to prioritize guidance on AI and surgical robots next yearmedtech companyMust align AI and robotics product plans with the upcoming guidance.health ITShould watch for new draft guidance on compliance of software-based devices.researchAI detected esophageal cancer on CT scans months before diagnosis, study findsdoctorOpportunistic AI analysis of routine CT scans could allow earlier detection, if the result is confirmed clinically.researchNew AI test aims to diagnose diabetes in seconds from voicedoctorVoice-based screening could offer pre-screening without blood draws, but clinical confirmation is needed.clinical deploymentUW Health uses AI to help guide intubation of newbornsdoctorFor neonatologists, AI guidance for intubation could help in a high-risk procedure.regulationAI recommendations could help Britain carve its own path on medical device regulationmedtech companyCompanies entering the UK market must align with the distinct British regulatory route.health policyDifferences between the British and EU regulatory paths need to be weighed.drug developmentIndependent analysis: Medable's AI agent saves millions in clinical trial costspharmaceuticalsMonitoring trials with an AI agent could bring cost and time savings.drug developmentRoche plans move towards autonomous AI-driven laboratories in drug developmentpharmaceuticalsLinking laboratory automation with AI-based design could become a competitive factor.drug developmentHow does an AI pathology tool become a companion diagnostic?pharmaceuticalsFor companion-diagnostic AI, the path from research use to clinical access requires accreditation.medtech companyThe companion-diagnostic route opens a market opportunity for AI pathology tools.regulationNew rules for AI-generated real-world evidence in Canadian health technology assessmentspharmaceuticalsAI-generated RWE in Canadian HTA submissions must be submitted under the new rules.clinical deploymentAI-native radiology practices promise greater efficiencydoctorThe organisation of radiologists' work may shift toward AI-native models.clinical deployment22 clinics, one stroke network: the role of AI at BG Klinikum Unfallkrankenhaus BerlindoctorNetwork-wide AI triage may speed up the recognition of stroke patients.regulationNew EU product liability rules extend to innovative medical devices and AImedtech companyMust reassess liability exposure and the provability of its documentation.health ITLogging and explainability of AI system operation gain legal significance.incidentClinicians cause "well-meaning" data leakage by using AI toolshealth ITIt must reduce clinicians' unauthorized AI use through policy and approved tools.doctorPatient data must not be entered into unapproved AI tools.clinical deploymentLake County, Ohio, 911 center uses AI to review all medical calls