Issue 7
Viewpoint
drug development · European Union
Novo Nordisk to use Anthropic's Claude in drug research
Danish company Novo Nordisk and Anthropic announced a collaboration on 16 September 2026 to speed up drug discovery. Novo said the AI tools open up "entirely new scientific possibilities".
Who is affected and how
- pharmaceuticals
- A major drugmaker is publicly building its research on a large language model, which gives competitors a benchmark for their own AI strategies.
regulation · European Union
Von der Leyen: healthcare AI should be European and must not replace doctors
On 16 September 2026, Ursula von der Leyen put AI-powered healthcare on the EU agenda and called for a "European" solution. According to reports, the Commission plans initiatives to support AI…
health policyAhead of the Commission's November initiatives, it is worth mapping the national position and one's own healthcare AI programmes.health ITThe expectation of a "European" solution may affect vendor and data-storage decisions, so procurement plans should be aligned with it.doctorThe emphasis is that AI will not replace doctors, so for professional chambers, securing the supporting role of these tools is the negotiating position.regulation · United KingdomUK commission publishes 44 recommendations on regulating AI in healthcare, from pre-market to lifecycle
The UK's National Commission published 44 recommendations on regulating AI in healthcare on 14 September 2026, proposing a staged framework. The recommendations shift the emphasis from pre-market…
health policyThe staged regulatory model can serve as a template for other countries' frameworks.medtech companyLifecycle-based oversight may foreshadow post-market monitoring obligations.health ITDeployers are likely to face a requirement for continuous performance monitoring.research · globalEvidence for medical AI effectiveness is lacking: only 34 of 1,357 FDA-authorized devices registered for prospective studies
A PLOS Digital Health analysis published in August reviewed 1,357 AI/ML devices authorized by the FDA up to 5 December 2025 and found that most had not been clinically tested; only 34 were registered…
doctorRegulatory authorization alone is not evidence of clinical effectiveness, so when choosing a device it is worth asking for prospective data.hospital managerProcurement should require real-world clinical validation.medtech companyThe lack of prospective evidence is a market and credibility risk.health policyPressure for regulatory requirements on proof of effectiveness may grow.regulation · United StatesUS health officials deploy medical AI as safety concerns persist
The FDA has so far authorized 1,524 AI devices, but no generative AI product for mental health (14 September 2026). According to Haider Warraich, a pilot run by the Trump administration's health…
health policyThe tension between state-level deployment pilots and federal oversight is a regulatory risk.doctorThe move toward autonomous AI raises questions of liability and oversight.medtech companyNo generative AI product for mental health has yet been authorized, which is both a market gap and a regulatory risk.Hungary
caseHungarian private healthcare: strategy, quality and AI at the Private Health Forumhospital managerFor private providers, AI is a tool for supporting staff, so rollout is best tuned to reducing staff workload.doctorAccording to providers, AI assists their work and does not replace it.health ITIn private healthcare, digital integration is the practical question of implementation.researchRomanian researcher joins team developing AI-based child psychiatric diagnosis systemdoctorAI support for child psychiatric diagnostics aims to shorten the long road to a diagnosis.caseHealthcare industry: where does Hungary stand in linking AI and healthcare?health policyThe article points to a lack of regulatory and research readiness as the bottleneck for domestic AI development.caseHospital Association: Hungarian healthcare is transforming, AI spreading in patient carehospital managerAccording to the hospital association's position, AI is one of the main factors in the transformation of patient care, so it should be built into the investment plan.health policySector representatives mention the spread of AI alongside the advance of digitalisation and diagnostics.drug developmentAI and personalised medicines on the agenda at Bosch and Richter conferencepharmaceuticalsA leading player in Hungary's pharmaceutical industry is discussing the link between AI and personalised therapies at a public professional forum.caseHUF 26.55 million raised for AI-based melanoma screening body scanner at a hospitalhospital managerBuying AI equipment with public donations is an example of an alternative funding source for institutional procurement.doctorAI-based dermatological screening could become a new tool for melanoma detection.caseHAI-SO project presented at AI Summit Budapest 2026hospital managerThe health management training centre's project deals with the organisational adoption of AI; details can be followed in the source.caseMedical devices from a One Health perspective: NNGYK IT department head on AImedtech companyThis Hungarian public health forum stresses treating AI as a tool.caseBelgian professor in Budapest: AI is reshaping whole industries, with radiology as an exampledoctorFor radiologists, the message at the Hungarian professional forum was about AI's effect on the structure of the profession.
More key stories of the week
tool · United States
Oracle Health's clinical AI agent aims to reduce nurses' documentation burden
Oracle Health unveiled its clinical AI agent on 14 September 2026, designed to ease nurses' documentation burden and streamline care. The company is thereby targeting the nursing workflow…
hospital managerInstitutions working in the Oracle environment should assess the rollout and cost terms of the new tool.health ITIntegration of the agent and EHR data flows need to be prepared.drug development · globalGenScript and Twist join Eli Lilly's TuneLab AI platform
On 16–17 September 2026, GenScript Biotech and Twist Bioscience both joined Lilly TuneLab, a collaborative AI-based drug discovery platform. GenScript is contributing large-scale wet-lab validation…
pharmaceuticalsUnder the TuneLab model, contract partners supplying experimental data become integral parts of AI platforms, which matters when selecting CRO partners.drug development · AsiaByteDance AI drug discovery unit Anew Labs raises $290M at $1.5B valuation
Anew Labs, the AI drug discovery unit ByteDance spun off, closed a $290 million funding round on 16 September 2026 at a valuation of $1.5 billion. The funding came after the company's spin-off.
pharmaceuticalsA technology giant's spun-off AI unit is entering drug discovery with substantial capital, a matter for partnership planning and competitor monitoring.research · globalVirtual biotech puts up to 37,000 AI agents to work on drug discovery, with lung cancer candidate
A "virtual biotech" described in Science and Nature uses thousands of AI scientist agents for drug discovery and development (17 September 2026). According to Nature, the system also identified a…
pharmaceuticalsThe multi-agent framework points to automation of target identification and development planning, which makes pilot testing of research workflows worthwhile.researchStudies find AI scribes cut doctors' documentation time and burnout
University of Toronto research and further analyses find that ambient AI scribes reduce doctors' documentation time and may ease burnout (15–17 September 2026). One report says they save 34 minutes a…
doctorThe time savings can be backed with data, so they provide a reference point in applications for institutional rollout.hospital managerThe return on investment and the effect on burnout can be argued in the purchasing decision.health ITIt is worth defining the evaluation metrics in advance.research · globalDrug firms' proprietary data boost AI protein models
Six sources report that drug companies' non-public data significantly improves AI-based protein models (14 September 2026).
pharmaceuticalsProprietary data is a competitive advantage in model training, so data-sharing and federated learning collaborations are worth considering.tool · European UnionTandem Health raises $100M Series B, led by EU's €5bn tech startup fund, for European expansion
Tandem Health announced a $100 million Series B round on 14 September 2026, led by the EU's €5bn tech startup fund. It will use the money to expand across Europe and to build an "AI-native clinical…
health ITA European ambient AI provider is expanding with substantial capital, so it may become a new supplier alternative to US solutions.doctorThe medical assistant may extend to a wider range of the clinical workflow.research · United StatesNearly one in five young people turns to AI for mental health advice
Surveys indicate that almost one in five young people turn to AI for mental health advice (15–17 September 2026). One report says many teenagers treat AI as a therapist.
doctorWhen questioning young patients, it is worth mapping their AI use as well.health policyWidespread chatbot use among young people strengthens the case for regulation.research · AsiaAlibaba open-source AI model detects nearly 150 conditions, outperforming 23 of 26 radiologists
Alibaba has released as open source an AI model that detects nearly 150 conditions from CT images (18–19 September 2026). In results published in Science, 23 of 26 radiologists performed worse than…
doctorOpen models that outperform radiologists warrant local validation.medtech companyAn open-source model with broad coverage may put pricing pressure on closed vendors.regulation · United StatesFDA order keeps radiology AI under 510(k) premarket review
According to two trade sources, an FDA order keeps radiology AI under 510(k) review (17–18 September 2026). A separate analysis says the regulatory risks are already present.
medtech companyRevenue for radiology AI remains tied to premarket clearance, so the 510(k) plan and documentation need to be maintained.doctorCheck the authorization status of radiology AI tools before adopting them.regulation · United StatesConnecticut bans AI-based health insurance denials for state employees
Connecticut announced AI rules for state employee health plans between 16 and 18 September 2026. The rule bans AI-based health insurance denials.
health policyA state-level AI rule could serve as a model for other states.doctorDoctors can cite the rule against denials that rely on AI.clinical deployment · United States25 health systems build AI agents with Epic; Epic announces real-time prior authorization
Twenty-five health systems are building AI agents in Epic's "Agent Factory" program (15 September 2026). According to Suki's chief executive, Epic's real-time prior authorization announcement also…
health ITAn EHR vendor's own agent platform also affects the position of independent suppliers.hospital managerIn an Epic environment, the role of third-party scribes needs rethinking alongside in-house agent development.In brief
toolChatGPT Health: solution or experiment? OpenAI's privacy and usage guidancedoctorPatients can increasingly use the chatbot together with their own health data, so it is worth asking about information that comes from AI.health ITHandling data uploaded by patients raises data-protection questions.researchAI can also detect common cardiovascular diseases from mammogramsdoctorScreening mammography could provide an additional risk signal, which affects cooperation between radiologists and cardiologists.researchAI tool predicts lung cancer immunotherapy outcomes; human-AI collaboration also testeddoctorFor oncologists, AI can supplement therapeutic decisions; the study also measured human-machine collaboration.regulationWatchdog says patients should be told when NHS uses AI in their carehospital managerPatient-information rules and the flagging of AI use are worth building into the consent process.doctorInforming patients about the use of AI has to be handled in everyday practice.licensingPowerful Medical's 'Queen of Hearts' AI ECG model wins FDA De Novo authorizationdoctorA new, authorized AI ECG tool is entering cardiac diagnostics.medtech companyThe De Novo pathway creates a new product category, which serves as a reference for similar devices.licensingFDA clears RadNet's foundation model-based chest X-ray AI tooldoctorFoundation model-based X-ray AI is a new option to evaluate in the radiology workflow.medtech companyClearance of a foundation model-based tool sets a precedent for similar developments.regulationFDA weighs changes to clinical trial design, drug development and use of AI in trialspharmaceuticalsChanges to trial-design and AI-use rules may affect development plans, so they are worth tracking.health policyRules on the use of AI in clinical trials could serve as a guide.insuranceCMS WISeR AI prior authorization pilot hit by delays and technical failures, documents showhospital managerDenials and delays affect the revenue cycle, so hospitals in pilot regions should have their appeals process ready.health policyResults from AI-based prior authorization are feeding the regulatory debate.incidentLawsuit claims ChatGPT became teenager's "illicit drug coach" before his deathdoctorDrug and medication advice that patients get from chatbots is an area to ask about when taking a medical history.health policyThe case feeds the debate on liability and regulation for consumer AI.clinical deploymentOura and Counsel Health join CMS ACCESS modelhealth policyThe ACCESS model is an official test of wearable- and AI-based chronic care.doctorChronic care models built on remote data may affect everyday practice.incidentMost health systems deploy AI tools without formal IT approvalhealth ITAuditing unauthorised AI tools and putting data-security governance in place is an urgent task.hospital managerA regulated framework for AI use should be developed together with the departments.researchMost oncology nurses have had limited AI training but want to learn; 92% of nursing students have used ithospital managerThe lack of AI education for nurses is a risk for deployments.regulationFDA publishes discussion paper on regulating generative AI-enabled medical devicesmedtech companyThe discussion paper is an opportunity to give feedback, so it is worth submitting expert comments.health policyDevelopments in the regulatory framework for generative AI devices should be followed.regulationLegislative moves target use of mental health chatbotshealth policyState-level chatbot regulation is taking shape.health ITProviders offering a mental health chatbot are advised to prepare for compliance.clinical deploymentCharité builds central AI platform for use across the hospitalhospital managerA central platform provides unified governance in place of scattered AI pilots.health ITDesigning and operating central AI infrastructure becomes a task.regulationEU AI Act high-risk deadline: medical devices follow the sector-specific conformity routemedtech companyFor devices that contain AI, the sector-specific conformity process and the high-risk deadline are part of the design.health ITIt is worth requesting suppliers' declarations of conformity.researchMulticentre mammography study: adjunctive AI raises breast cancer detection by more than 10 percentdoctorThe result supports AI assistance in screening programmes, but the short follow-up calls for caution in interpreting it.drug developmentInsilico's AI-discovered drug rentosertib enters phase 3 in idiopathic pulmonary fibrosispharmaceuticalsOne of the most closely studied AI-discovered molecules has reached the pivotal stage, which may serve as a benchmark for evaluating AI-derived pipelines.drug developmentModerna and Merck's AI-built cancer vaccine clears phase 3, PYMNTS reportspharmaceuticalsIn personalised mRNA therapy development, the role of AI may be validated at the pivotal stage, so platform strategy deserves reassessment.incidentHealthcare watchdog raises concerns over errors in AI scribe notesdoctorChecking and signing the generated note remains the doctor's responsibility, so it is worth building a routine for reviewing it.hospital managerError-reporting and quality-assurance procedures are needed around AI-generated notes.researchMicrosoft study: AI diagnosed complex cases better than experienced physiciansdoctorThe value of differential-diagnosis support is demonstrable, but performance in a hospital setting needs to be measured separately.toolKairon Health raises $5 million for AI execution in value-based carehospital managerA new AI tool has appeared to support the fulfilment of value-based contracts.drug developmentInsilico launches AI-driven longevity vaccine research for age-related diseasespharmaceuticalsA new therapeutic area opens for AI researchers, but the programme is at an early stage.regulationCognita wins $1.29 million FDA contract to evaluate radiology AImedtech companyThe FDA is developing its methodology for evaluating radiology AI, which may shape future expectations.researchIs AI accelerating drug discovery? Two-molecule data and a JCIM analysispharmaceuticalsThe findings offer a critical benchmark for internally validating AI promises in lead optimisation.researchNew AI-based test predicts breast cancer recurrence risk more accuratelydoctorA more accurate estimate of recurrence risk can support treatment decisions.regulationHealth and social care regulators coordinate their response to AIhealth policyCoordination between regulators may signal more consistent expectations towards providers.researchElse Kröner Fresenius Center for Digital Health presents on-premise medical AI agent for clinical decision supporthealth ITFrom a data-protection standpoint, an on-premise model is an alternative to cloud-based solutions.clinical deploymentUS Department of Veterans Affairs to expand AI scribe gradually after successful pilotshospital managerThe rollout of a large public care system can serve as a model for a phased expansion.doctorRecording patient consent is part of the practice.regulationNHS AI procurement should require ethnicity performance data, say calls for race equity focushealth ITProcurement documents must ask suppliers for performance data broken down by ethnic group.health policyAn equity requirement can become a condition of procurement.licensingRadiology accounts for 76% of FDA AI device authorizationsmedtech companyRadiology is the most crowded authorization area, and the FDA list can be used for competitor analysis.doctorRadiologists are the professional group most affected by AI.toolAbridge enters the revenue cycle with AI-powered pre-bill claim reviewhospital managerCoding and documentation workflows may move onto the same platform, which affects cost and revenue metrics.health ITThe ambient platform becomes a revenue cycle tool, so an integration plan is needed.toolChatGPT 'trusted contact' feature for people in crisis has flawsdoctorMental health professionals should know about the AI crisis features their patients use.researchAI scores lung cancer treatment response on par with pathologistsdoctorPathology scoring could be partly automated, while validation remains the pathologists' task.researchAI spatial analysis of standard pathology slides predicts pancreatic cancer recurrencedoctorRoutine slides can yield additional prognostic information without a separate test.researchKorean-US multinational study: AI improves stroke diagnosisdoctorIn emergency stroke diagnosis, AI support can save time.clinical deploymentNew South Wales hospitals to trial AI model for faster sepsis detectionhospital managerEarly sepsis warning can improve measurable patient outcomes, and the pilot's results deserve close attention.regulationAMA publishes guidance on ethical questions about health AIdoctorThe AMA guidance is a reference point for the ethical assessment of AI use.regulationAI in life sciences: ten legal considerations for drug discoverypharmaceuticalsThe legal risks of AI use should be addressed in internal compliance checks.researchPatients use AI to interpret symptoms and prepare for medical appointmentsdoctorPatients arrive at the surgery with information obtained from AI, and this needs to be handled in the consultation.regulationThird meeting of the Global Initiative on AI for Health heldhealth policyInternational coordination can help align regulatory approaches.regulationAI use policy template and companion guide published for health departmentshealth policyA ready-made policy template speeds up the development of institutional AI guidelines.toolMedicai introduces AI voice dictation for faster clinical reportingdoctorDictation can shorten reporting time, but the tool's accuracy should be checked in a pilot.caseRadiology embraces AI for speed but hesitates on diagnosisdoctorRadiologists already use productivity AI, while adoption of diagnostic support is slower.clinical deploymentKenyan maternity clinic network uses AI chatbot to answer pregnancy text messagesdoctorThe automated messaging service can substitute for direct contact in resource-constrained settings.clinical deploymentManipal Hospitals seeks acquisitions and bets on AI-led healthcare strategyhospital managerHospital chains are introducing AI as part of expansion, building on a unified hospital information system (HIS).toolAustralian AI receptionist startup raises another $3.5 million in seed fundingdoctorThe AI receptionist tool, aimed at administration in specialist practices, is a new option for providers.caseThree health systems on AI's real ROI: a transplant, fewer readmissions, 20 minutes savedhospital managerPractical return-on-investment examples support the business case for adoption.drug developmentAnthropic sets up a biology lab, says it is not specifically for drug researchpharmaceuticalsAn AI developer is building its own laboratory, which could reshape the division of labour between model providers and pharmaceutical companies.toolGE HealthCare launches AI-driven operations systemhospital managerAI-based optimization of hospital capacity and operations is a new procurement option.medtech companyDevice makers are also entering the market with operations-optimization software.clinical deploymentProximie, AWS, Deloitte and NHS launch largest NHS AI operating theatre evaluationhospital managerAI-based analysis of theatre utilisation can be a tool for reducing waiting lists.tool$1,365 Chinese AI mattress claims to detect sleep apnea, but FDA has not cleared itdoctorPatients may bring results from uncleared consumer devices, which should be treated with caution.toolIncluded Health launches Dot AI guide with human escalationhealth ITCombining an AI assistant with human escalation is a model for designing patient journeys.researchVirtual cell model predicts effective drug for triple-negative breast cancerpharmaceuticalsCell-model-based prediction can support candidate selection and trial design.clinical deploymentTaiwanese hospital builds its own agentic AIhospital managerThe in-house AI agent is an example of the build-or-buy decision.