AI playbook for pharmaceutical, biotech and medical device companies

The six playbooks

What each playbook contains

Frequently asked questions

Who is the Digital Pharma Lab AI playbook for?

Pharmaceutical and biotech companies, and medical device manufacturers (including in vitro diagnostics and software as a medical device), from SMEs and start-ups to large groups and the French affiliates of international groups. Each chapter states its audience: management, managers, AI leads, quality and legal, HR, or all employees.

Why six playbooks rather than one?

Priorities change with the type of company (medicines or medical devices) and its size: SME or start-up (fewer than 250 employees), mid-sized company (250 to 4,999 employees), large group or affiliate (5,000 employees or more). Each playbook adapts the typical situation, the three priorities, the common mistakes and the actions to start in the next two weeks.

Does the playbook cover the EU AI Act?

Yes. Chapter 4 sets out the European and French framework: the EU AI Act and its application timeline, GDPR and health data, health data hosting in France (HDS) and HAS good practice. For medicines, it adds the EMA positions, the draft GMP Annex 22, pharmacovigilance and promotional information. For medical devices, it covers how MDR/IVDR and the AI Act fit together, software as a medical device and vigilance. Sources are cited with links. The framework was checked on 16 October 2026.

Is the regulatory framework specific to France?

The playbook covers the EU rules that apply in every Member State (AI Act, GDPR, MDR/IVDR, EMA positions, GMP) and adds the French requirements (HAS, ANSM, HDS, CNIL). Companies in other countries can use the EU part and check their national rules.

What does a role sheet contain?

Uses to start this week, ready-to-use prompts, use cases to propose, points to watch and indicators to track. Each playbook has 14 role sheets, from management to regulatory affairs, quality and sales teams.

Does the playbook replace legal advice?

No. It gives practical guidance: it does not replace legal, regulatory or quality advice.

How can Digital Pharma Lab help further?

Digital Pharma Lab offers an AI diagnostic (review of uses, tools, governance and compliance, then prioritisation of use cases with the playbook grid), training and workshops by role (nearly 4,000 healthcare industry employees trained across Europe by DPL Academy), deployment of the playbook in the company with DPL support, and AI Compass, the AI governance platform developed by Digital Pharma Lab for pharmaceutical companies.