EU AI Act elements to consider in 2026:
This is not a EU only matter. In times of global datasets, where data is heterogeneous and deriving from different jurisdictions, compliant global data governance is needed. The EU AI Act is the first of its kind, but Brazil, Canada and the ASEAN region are already following and implementing EU standards into their local legislations. More to come.
Establish clear “human oversight mechanisms” now. This is one of the central concepts of the Act, mentioned 17 times and shall ensure robustness and accuracy on the data output level at any time.
Be aware of the fines. In a nutshell we are looking at up to €35M or 7% global turnover for breaches.
Conduct due diligence and inventory on existing data governance now. 2025 saw a peak in budget allocation for AI experts in pharma and biotech companies. Inventory diligence on LLM systems already in place are running at full speed until August 2026.
Collaborate with compliant AI vendors. Due diligence is key to be ready to scale compliant AI clinical trial solutions.
The EU AI Act is publicly available, and the EU has already published many guidelines on AI system definition and risk evaluation approaches. More guidance is expected to come. We’ll share any updates once new guidelines have been published. Stay tuned!
