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Our abstract, “Current GenAI Policy In HTA: The Missing Mandate And Implications For Industry,” has been accepted for poster presentation at ISPOR Europe 2026 in Vienna.
Resources · AI Brief

Current AI news meets peer-reviewed research — every week.

A free weekly brief for professionals in pharma, market access, health economics and HTA. Four themed news sections with a plain-English "So what?", plus three recent PubMed papers, lay-summarised. AI moves faster than peer review — this tracks both.

Format
PDF — free, no sign-up
Frequency
Weekly
Audience
Pharma · market access · HEOR · HTA
№21 Latest issue 25 Aug 2026
Standout story

Epic unveils Agent Factory and a sweeping AI expansion at UGM 2026 — commanding 43.7% of the acute-care EHR market, its AI layer will shape how real-world evidence is generated and how patient pathways are algorithmically formed across the dominant US clinical data platform.

01Regulatory & HTA Signals
02Regulation & Policy
03Healthcare & Life Sciences
04Models & Research
Inside this issue
Four themed sections, each story with a "So what?" · three PubMed papers, lay-summarised.
Download Issue №21 (PDF) ↓

Earlier issues

IssueDateStandout storyDownload
№20 19 Aug 2026 NICE moves from AI position statement to practice — running parallel pilots on AI-assisted evidence submission and review through its HTA Innovation Laboratory, alongside a 2026/27 delivery plan confirming AI adoption across its internal processes. PDF ↓
№19 12 Aug 2026 UK PM Andy Burnham abolishes DSIT and appoints Kanishka Narayan as the UK's first Cabinet-level AI Minister — elevating AI's political standing while fragmenting its delivery machinery across three departments, testing whether the UK can govern AI coherently. PDF ↓
№18 5 Aug 2026 Eighteen months after the FDA's first draft AI guidance, there is still no binding AI standard anywhere in US and EU drug regulation — the FDA-EMA ten-point principles and EMA's reflection paper remain explicitly non-binding, leaving sponsors to interpret non-converged frameworks across jurisdictions. PDF ↓
№17 30 Jul 2026 Regulation (EU) 2026/1744 — the Digital Omnibus on AI — enters into force, deferring high-risk AI compliance to December 2027 (standalone systems) and August 2028 (embedded products), while transparency obligations remain binding from August 2026. PDF ↓
№16 24 Jul 2026 EU HTACG adopts General Principles on AI use in JCA dossier preparation — Health Technology Developers remain fully accountable for the completeness, validity, and methodological rigour of any AI-assisted evidence submitted. PDF ↓
№15 15 Jul 2026 EU consultation on classifying high-risk AI under the AI Act closes 23 July — draft guidelines read the conformity test broadly, pulling more medical devices and health pricing tools into scope. The Omnibus deferred the deadlines, not the scope. PDF ↓
№14 8 Jul 2026 Rentosertib enters Phase III — the first drug where AI identified the target, designed the molecule, and guided clinical development end-to-end. HTA frameworks for AI-originated drugs are now urgently needed. PDF ↓
№13 1 Jul 2026 EU Council formally adopts AI Act Omnibus — high-risk AI deadlines confirmed, medical devices extended to August 2028. Transparency obligations remain 2 August 2026. PDF ↓
№12 24 Jun 2026 MHRA National Commission finalising AI medical device regulatory framework and NICE formalising AI evidence-generation guidance — the UK's AI health governance standards are being written now. PDF ↓
№11 17 Jun 2026 Anthropic's Claude Fable 5 launched and pulled by US government directive within three days — the first government-mandated takedown of a publicly deployed frontier AI model, raising new vendor risk questions for regulated AI workflows. PDF ↓
№10 9 Jun 2026 More than 200 AI-discovered drugs now in clinical development — 94 in Phase 1, 56 in Phase 2, 15 in Phase 3 — with analysts projecting a 60% probability that the first AI-discovered drug receives FDA approval in 2027 or 2028. PDF ↓
№9 3 Jun 2026 Nature publishes Robin — a multi-agent AI system that autonomously identified a novel drug repurposing candidate for macular degeneration, analysing 551 papers in 30 minutes with a 200-fold reduction in scientist time. PDF ↓
№8 26 May 2026 NIHR i4i £10m funding call closes — the direct-funded route for companies with AI-enabled diagnostics holding a NICE Early Value Assessment to generate the RWE required for full NICE guidance and NHS-wide reimbursement. PDF ↓
№7 20 May 2026 European Commission's stakeholder consultation on AI transparency obligations closes 3 June — disclosure for interactive AI, deepfake labelling and biometric categorisation under Article 50 of the EU AI Act. PDF ↓
№6 12 May 2026 EU AI Act high-risk deadline confirmed — 2 Dec 2027 for standalone systems, 2 Aug 2028 for medical devices. Pharma and healthcare AI finally have a definitive planning horizon. PDF ↓
№5 6 May 2026 EU AI Act's high-risk obligations are scheduled for 2 Aug 2026 — 13 weeks away. A Digital Omnibus proposal may push this to Dec 2027, but it isn't formally adopted: 2 August remains the current legal obligation. PDF ↓
№4 28 Apr 2026 New UK clinical trial regulations came into force today — post-Brexit regulatory divergence from EU frameworks is now a live consideration for AI-enabled diagnostics seeking UK market entry. PDF ↓
№3 21 Apr 2026 Novo Nordisk partners with OpenAI to accelerate drug discovery — as drugmakers increasingly turn to AI partnerships at scale, the implications for evidence generation and HTA submissions are growing harder to ignore. PDF ↓
№2 14 Apr 2026 Eli Lilly commits $2.75bn to Insilico Medicine for AI-discovered candidates — the first compound from target identification to Phase I in under 30 months, raising questions for HTA bodies evaluating shorter evidence histories. PDF ↓
№1 31 Mar 2026 Pilot issue — Insilico's ISM001-055 becomes the first AI-designed drug against an AI-discovered target to show positive Phase IIa results; over 60% time reduction from initiation to preclinical candidate. PDF ↓