Operating AI Tools in Life Sciences: White Paper

AI tools now reach almost every function of a life sciences company, from general assistants to AI features built into the systems your teams already use. Each tool raises two questions: what happens to the data your teams share with it, and what the EU AI Act and GDPR expect of you as a deployer. This white paper answers both, drawing on our experience with pharmaceutical, biotech and healthtech companies.

It sets out our dual approach. AI Governance protects your proprietary and personal data when it is shared with AI tools, which can reuse it to fine tune models and connect it to other systems. AI Compliance covers the obligations that apply to high risk AI systems.

Inside the white paper:

  • Why AI is a data governance question as well as a compliance question
  • What already applies to deployers: the AI Act after the Digital Omnibus, GDPR, US recording and biometric law, and your contracts
  • Four situations from our experience, including an AI assistant reviewing clinical trial data, and twelve recurring pain points
  • The iliomad operating model: roles, triage, a four dimension assessment, a decision register and a permitted use matrix that tells every user what data may go into which tool
  • Practical sheets: six questions for the vendor, eight usage rules, a uniform consent standard and eight conditions before trial data goes into an AI assistant
  • A 90 day plan, the indicators to track and five decisions for your executive team

Written for CEOs, General Counsel, DPOs and Quality, IT Security and Clinical Operations leaders.

Download the Resource

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