Changelog

​

v2.8 — 19 August 2026

• Choosing Your Model gains a fourth selection axis: resource cost. Cost, quality and latency are what you trade against on a single task; at team scale, energy and water move alongside them. The new section covers why over-powered model choice compounds — the tasks already listed as reasoning-model overkill are the ones where the saving is free — why CSRD-driven environmental questions are starting to reach agency RFPs through procurement, and the proportionality point: a frontier model on a high-stakes regulatory document is a good use of resources, the same model generating fifty social captions is not. Sized with the AI Water and Energy Footprint Calculator.
• Agentic Workflows — new entry under “When an agent is the wrong tool”: a single instruction becomes many model calls, so a loop that is not earning its keep multiplies the same overkill rather than causing a different one
• Homepage rewritten above the fold — the hero subhead now leads with the accountability tension rather than listing lifecycle stages, and the description, og:description and twitter:description tags are decoupled from it into a single keyword-bearing line, synced with the homepage entry in product/SEO-METADATA.md (the two had drifted, so the SEO copy had never reached the page it was written for)

​

v2.7 — 16 August 2026

• AI Regulation in Pharma updated for Article 50 coming into force. The EU AI Act’s transparency obligations became enforceable on 2 August 2026, and foundation model providers have begun marking their output at source — Anthropic watermarking Claude’s text output globally, Google’s SynthID doing the same for Gemini, and C2PA content credentials on generated image files. The page previously described detectability as a future obligation; it now describes what has actually shipped and what it means for writers:
  • New Provider-side content marking section — what text watermarking is, which providers have deployed it, and the limits of detection: there is no public cross-provider detector, Anthropic’s detection API is announced but unreleased, and the signal is weakest on short, factually constrained or heavily rewritten text, which describes most medical writing after author review and MLR
  • The marking obligation sits on the provider, not on you — a watermark is not a disclosure and changes nothing about what you declare
  • Article 50(4)‘s human editorial review exemption made explicit — text published under a named person holding editorial responsibility is not, in the Act’s own terms, undisclosed synthetic content, which puts the named-reviewer model the playbook argues for throughout on a statutory footing
  • Implementation timeline corrected to present tense, with the 2 December 2026 grace period for machine-readable marking of synthetic content added

​

v2.6 — 11 August 2026

• Disclosure guidance updated for JAMA Network’s tightened AI policy (editorial, 10 August 2026, doi:10.1001/jama.2026.16613). JAMA has moved three categories from “disclose” to “not permitted”: AI-generated or AI-formatted references, AI-drafted Opinion articles, Letters to the Editor and online Comments, and AI-created or AI-manipulated clinical images, illustrations, video and audio. The playbook’s disclosure pages assumed any use could be disclosed into acceptability; that framing no longer holds, so the change is threaded through five pages rather than confined to the policy table:
  • Declaring AI Use — JAMA row rewritten with the full set of prohibitions and the expanded disclosure fields (tool, version, manufacturer, dates of use, portions affected, statement of author responsibility); new framing on the shift from disclosure to prohibition; the “what counts as AI use” table revised, with new rows for Opinion drafting and for permitted adjustment of existing scientific images; two new Common Mistakes entries
  • Disclosure Language Template — reference verification (still acceptable) separated from reference generation (now prohibited); figure snippet scoped to conceptual visuals, with a new snippet for uniform adjustment of existing scientific images; manufacturer and dates of use added throughout; new section documenting the uses that deliberately have no template because they are barred
  • Pre-Submission QC Checklist — new checks for prohibited uses, AI-free reference compilation, clinical-image provenance, uniform image adjustment and retained originals, plus a sign-off row
  • AI in Peer Review — notes that journals are now responding upstream with policy, not only at the automated screening gate
  • Generate Concept Visuals — reality check extended to cover journal submissions, not just regulatory and MLR-bound materials

​

v2.5 — 26 July 2026

• The Description–Discernment Loop added to Principles — applying concepts from the AI Fluency Framework (Dakan & Feller, as taught in Anthropic’s AI Fluency courses) to medical writing:
  • Description — briefing AI like you’d brief a writer: approved prior work as voice examples, injecting the context AI can’t know (client sensitivities, MLR history, audience realities), and describing the approach (source-grounding rules) not just the output — with a confidentiality warning on what may be uploaded
  • Discernment beyond accuracy — an explicit “does it sound like us?” voice check, and process-level discernment (recurring corrections belong in the brief, not in another round of edits)
  • Closing the loop — a specific-vs-vague revision instruction table, plus two safety rules: pin what must not change, and re-verify anything the model touched
  • Briefing packs — a reusable per-client/per-product context document that accumulates what each project teaches you
• Voice and Authenticity Check added to Review Prompts — compares a draft against approved reference examples for generic AI register, vocabulary drift, and register mismatch
• Final Human Review checklist extended with a voice check under AI-specific checks

​

v2.4 — 16 May 2026

• Playbook now available as a downloadable PDF — every page of the playbook (cover, principles, workflows, prompt patterns, tools, templates) bundled into a single A4 PDF with auto-generated table of contents and section dividers. Linked from the homepage hero (“Download as PDF”) and the Start Here page. Rebuilt automatically on every content update via GitHub Actions and published to GitHub Releases so the download URL always serves the latest version.

​

v2.3 — 4 May 2026

• Five new Principles pages covering the 2025–26 AI landscape:
  • Declaring AI Use — journal, regulator, and sponsor disclosure expectations, with mid-2026 policy snapshot for ICMJE, NEJM, Lancet, JAMA Network, BMJ, Nature, Science/AAAS, and WAME (each linked to the publisher’s actual AI policy page)
  • AI Regulation in Pharma — the EU AI Act’s risk-tier system, Article 50 transparency obligations, foundation model provider obligations, with brief notes on FDA, EMA, MHRA, WHO, PMDA, and NMPA frameworks
  • Choosing Your Model — when to reach for a reasoning model vs. a standard LLM vs. a frontier model, with a practical decision matrix and a worked example of mixing model classes across a manuscript workflow
  • Agentic Workflows — generalising the closed-loop pattern (RefCheckr) to other agent applications, with five agent patterns and the failure modes specific to agentic systems
  • AI in Peer Review — what publishers run on submissions before peer review, where the screens work well vs. where they don’t, and a pre-submission QC checklist
• Glossary expanded with twelve recent AI terms — Computer use, Frontier model, Grounding, Guardrails, Harness, Human-in-the-loop (HITL), Open-loop AI, Prompt injection, Reasoning model, Skill, System prompt, and Tool use
• Homepage hero added — gradient-background block with the playbook headline, subtitle, and primary/secondary CTAs replacing the previous doc-page intro; auto-rendered title suppressed via project-level CSS scoped to the homepage only

​

v1.24 — 4 May 2026

• RefCheckr rearchitected as closed-loop AI — RefCheckr now runs a Verify (Perplexity) → Fix (Claude) → Re-check (Perplexity + MedCheckr ABPI compliance) loop, re-running on failure. It no longer just flags mismatches: it rewrites claims using only evidence from the paper (with guardrails — no new numbers, no new endpoints, no stronger language) and re-verifies the rewrite before returning it
• RefCheckr tool page rewritten with a “How the closed loop works” table covering Verify, Fix, and Re-check steps and the underlying stack
• Closed-loop AI added to the glossary, anchored to RefCheckr as the working example
• Playbook-wide language refresh — workflow tool-stack tables, the Verify Claims Against References workflow header diagram and steps, the Tool decision tree, the PubCrawl comparison table, the Source grounding principle, the homepage card, the Start guide, and the about page all updated to describe RefCheckr’s closed-loop behaviour rather than the old verify-only framing

​

v1.23 — 20 April 2026

• Generate Concept Visuals with AI workflow page added under Drafting — when to use AI image generation (conceptual figures, visual abstracts, slide visuals, social graphics), the tool landscape (Nano Banana 2, Midjourney, ChatGPT, Adobe Firefly), four prompting patterns, and a “Reality check” section covering what AI images must not be used for (exact scientific figures, data visualisations, regulatory-facing materials without review, patient depictions implying outcomes, identifiable people or products)
• Nano Banana 2 and Midjourney added to the Tool ecosystem under a new AI image generation section, with an explicit pointer that AI image tools are not substitutes for BioRender or a medical illustrator on scientific figures
• Decision tree updated with a new row for concept images, visual abstracts, slide visuals, and social graphics

​

v1.22 — 18 April 2026

• Claude Design added to the Tool ecosystem under a new Design and brand concepting section — Anthropic Labs’ design surface for pitch decks, leavepieces, marketing collateral, and prototypes, framed for medical writers who are increasingly being asked to generate visual concepts before a designer takes over
• Decision tree updated with a new row mapping brand concepts, leavepieces, ad mockups, and pitch deck visuals to Claude Design

​

v1.21 — 15 April 2026

• AI Failure Modes in Medical Writing page added to Principles — ten predictable ways AI fails when working with scientific evidence, each with example, why it matters, and how to catch it, plus a summary table

​

v1.20 — 14 April 2026

• Which tool when decision tree added to the Tools section — a Mermaid flowchart plus fast-reference list mapping common medical writing tasks to the right tool, covering both third-party options and the PharmaTools.AI suite

​

v1.19 — 14 April 2026

• Claude Cowork section on the Tool ecosystem page expanded with a practical example workflow, example prompt, and a short “Why this workflow matters” explainer

​

v1.18 — 13 April 2026

• Patiently AI tool page updated with OpenClaw installation option — Patiently AI is now available as a skill on ClawHub (clawhub install patiently-ai)

​

v1.17 — 9 April 2026

• Tool ecosystem page added to the Tools section — single consolidated reference covering all 16 third-party tools the playbook points to (Claude Cowork, NotebookLM, Elicit, Consensus, Perplexity, Scite.ai, Zotero, EndNote, Claude, ChatGPT, Microsoft Copilot, BioRender, Napkin, Gamma, Otter.ai, Fireflies.ai)
• Tools grouped by job-to-be-done (multi-document workflows, single-paper exploration, literature search, reference management, general-purpose AI, enterprise productivity, figures, presentation generation, transcription)
• Each entry links to the playbook workflows and tool pages that already reference it, so readers can jump from the directory back into context
• The Tools sidebar group now contains the seven PharmaTools.AI products plus a single ecosystem entry, preserving the section’s role as a product surface while giving readers one place to discover external options

​

v1.16 — 9 April 2026

• BioRender added (Slide Deck, Manuscript) — publication-quality biological figures
• Microsoft Copilot added (Slide Deck, Manuscript, Regulatory Document) — in-Word/PowerPoint drafting for enterprise pharma environments
• Otter.ai / Fireflies.ai added (Extract Key Messages) — transcription for advisory boards, KOL interviews, and focus groups
• Scite.ai added (Verify Claims, Find Evidence, RefCheckr complementary tools) — citation context analysis

​

v1.15 — 9 April 2026

• Claude Cowork added as a third-party tool across 6 pages (Find Evidence, Extract Study Data, Extract Key Messages, Write a Manuscript, Draft a Regulatory Document, PubCrawl)
• Positioned for structured workflows involving multiple source documents (analysing papers together, comparing trials, drafting from multiple sources)
• Distinct from NotebookLM (single-paper exploration) and inline Claude/ChatGPT (pasted text)
• Glossary expanded from 27 to 48 terms — added DOI, EMA, EudraCT, FDA, HEOR, IB, ICH, MCP, MedDRA, MeSH, MOA, MSL, ORR, OS, PFS, PICO, PMCPA, PMID, PRISMA, QALY, SAP, TFL
• PubCrawl tool page updated with MCP server explanation and installation details

​

v1.14 — 9 April 2026

• NotebookLM added as a third-party tool across 6 pages (Find Evidence, Summarise a Paper, Extract Study Data, Extract Key Messages, Write a Manuscript, PubCrawl)
• Positioned for source-grounded summarisation, paper familiarisation, and theme identification
• Homepage intro rewritten for clarity and directness
• Meta description simplified

​

v1.13 — 8 April 2026

• Risk Levels renamed to Understanding AI Risk in Medical Writing and rewritten as a conceptual page (why risk varies, failure modes, risk factors)
• AI Risk Framework tightened as the operational page (tier model, workflow mapping, review expectations)
• Overlap between the two pages reduced: conceptual content lives on Understanding AI Risk, operational content lives on the Framework
• Cross-links added between the two pages
• All references to “Risk Levels” updated across the playbook

​

v1.12 — 8 April 2026

• AI Risk Framework added to Principles: a 4-tier governance framework (Assistive → Structured Transformation → Evidence-Critical → Human Authority Required)
• Maps all 17 workflows to risk tiers with notes on context-dependent classification
• Includes review expectations by tier and practical guidance for writers, teams, and stakeholder conversations

​

v1.11 — 8 April 2026

• Workflows grouped in sidebar into 5 lifecycle stages: Evidence & Insight, Drafting, Adaptation, Validation, Delivery
• Reduces visual clutter of the 17-item flat list and reinforces the lifecycle structure

​

v1.10 — 8 April 2026

• 3 new regulatory-adjacent workflows added: Draft a Regulatory Document, Convert Statistical Outputs to Narrative, Check Document Consistency
• Integrated into existing lifecycle: regulatory drafting sits in the Draft stage, document consistency sits in the Validate stage
• Homepage lifecycle map and card grid updated with new workflows
• Cross-links added from Write a Manuscript, Extract Study Data, Build an Outline, and Verify Claims to the new workflows
• Playbook now covers 17 workflows across publications, medical affairs, medcomms, regulatory writing, and promotional content

​

v1.9 — 8 April 2026

• Workflow lifecycle map added to homepage: a 6-stage table (Evidence → Insight → Draft → Adapt → Validate → Deliver) linking all 14 workflows
• Card grid reordered to match the lifecycle sequence
• Cards grouped by lifecycle stage using natural CardGroup breaks (3-2-3-2-2-2 layout)
• Two navigation modes now supported: lifecycle overview (table) and task-based access (cards)

​

v1.8 — 8 April 2026

• Sidebar reordered: Congress Summary moved after Summarise a Paper (reflects the evidence-first lifecycle)
• Slide deck sidebar title changed to “Create a Slide Deck” for verb consistency
• Cross-links improved: Find Evidence → Congress Summary, Congress Summary → Extract Study Data, Extract Key Messages → outline/deliverable context
• Minor consistency fixes across workflow Next steps sections

​

v1.7 — 8 April 2026

• 4 new workflows added: Find Evidence, Extract Study Data, Create a Medical Slide Deck, Write a Manuscript
• Workflow sidebar reordered to follow the medical writing project lifecycle: Evidence → Insight → Draft → Adapt → Validate → Deliver
• Homepage decision section updated to include all 14 workflows
• Cross-links added between related workflows (summarise → extract data, outline → manuscript/slides)
• Playbook now covers 14 workflows across publications, medical affairs, medcomms, and promotional writing

​

v1.6 — 8 April 2026

• External tool ecosystem integrated across the playbook (Claude, ChatGPT, Elicit, Consensus, Zotero, EndNote, Napkin, Gamma)
• PharmaTools remain the primary workflow tools; external tools added as alternatives or complements
• Ecosystem note added to the homepage
• Complementary tools sections added to PubCrawl and RefCheckr tool pages
• MedCheckr compliance section kept focused with no external competitors

​

v1.5 — 8 April 2026

• Reduced em dash density by ~30% across all published content to improve writing naturalness

​

v1.4 — 8 April 2026

• Serif headings — Newsreader font for headings (matches PharmaTools.AI brand), cleaner editorial feel
• Risk-tier callout system — Low risk workflows use green Tip, Medium use blue Info, High/Critical use amber Warning. Visual colour coding reinforces the risk framework.
• Workflow flow diagrams — Every workflow now shows a compact one-line flow summary (e.g., “Full paper → AI summary → Data verification → Final summary”) inside the risk callout

​

v1.3 — 8 April 2026

• Time estimates added to all 10 workflow info callouts (e.g., “~10 min with AI, ~45 min without”)
• Worked examples added to 3 key workflows: Summarise a Paper, Extract Key Messages, Verify Claims — showing source → AI output → issues caught → reviewed final
• Glossary page — single-page reference for abbreviations used across the playbook (ITT, MLR, SmPC, etc.)
• Changelog page — version history for the playbook
• Search enabled with custom prompt
• OG metadata configured for social sharing

​

v1.2 — 8 April 2026

• Removed checkbox syntax from review checklists — cleaner bullet formatting
• Renamed all content files from .md to .mdx for full Mintlify component support

​

v1.1 — 8 April 2026

Major playbook redesign.

• New homepage — “What do you need to do?” decision-based entry replaces the V1 pipeline visualisation
• Standardised workflow template — all 10 workflows now follow a consistent structure: risk tier callout, Steps component, Output section, Why this works, Common mistakes (accordions), Review checklist (accordion), Tool stack with links
• Progressive disclosure — detailed risk tables and review checklists moved into expandable accordions
• Tighter copy — removed redundant sections, merged “Where AI helps” and “Where human judgement is essential” into a single “Why this works” section
• Tool links — all tool references in workflow pages now link directly to tool pages
• Start page reworked with cleaner heading hierarchy

​

v1.0 — 6 April 2026

Initial release of the Medical Writing AI Playbook.

• 10 workflows covering summarisation, messaging, outlining, adaptation, compliance, verification, and final review
• 4 core principles: human-in-the-loop, source grounding, risk levels, review accountability
• 20+ prompt patterns across 4 categories
• 7 PharmaTools.AI tool pages with workflow integration
• Role-based Start Here guide for medical writers, agency teams, and pharma stakeholders
• Four-tier risk framework (Low, Medium, High, Critical)