The EU AI Act is daunting. When you read the full text, it feels like you need a massive compliance department just to run a clinical trial.
But here is the secret: Not every tool is “High Risk.”
If you try to audit every chatbot, translation tool, and feasibility dashboard with the same scrutiny, you will paralyze your study start-up.
To succeed in 2026, you need to filter the noise. At Accelsiors, we use a 3-Tier Risk Framework to help US sponsors prioritize.
Tier A: Trial-Critical (Highest Scrutiny)
- Definition: AI that influences subject-level decisions (Eligibility), generates endpoints (Imaging/eCOA), or affects safety escalation.
- Action: These require a full Evidence Pack. You must enforce “No Silent Changes” clauses.
- Future-Proofing Tip: Ensure your logs are structured data, not just PDFs. The coming Digital Omnibus will favor automated reporting; unorganized data will become a compliance bottleneck.
- Example: An algorithm that quantifies tumor volume for a primary endpoint.
Tier B: Operational (Moderate Scrutiny)
- Definition: Tools that shape operations but don’t directly touch data integrity.
- Action: Governance, but lighter validation. Focus on configuration control.
- Example: A predictive dashboard that suggests which sites might enroll fastest.
Tier C: Productivity (Lower Scrutiny)
- Definition: Internal efficiency tools.
- Action: Policy and guardrails (e.g., “Don’t put patient data in ChatGPT”).
- Example: A tool used to draft the initial version of a lay summary.
The Takeaway
Don’t ask your vendors “Do you use AI?” Ask them “Does your tool drive a Tier A decision?”
We have created a checklist to help you map your vendors to these tiers in less than an hour.
