What are the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences? Mike King, Senior Director at IQVIA and Alex Denoon, Partner at Bristows Law Firm examine how the EU AI Act, a new regulation for artificial intelligence, could pose risks to innovation within Europe’s life sciences sector.
Similar to the introduction of GDPR in 2018, there are concerns that the regulatory complexity and inconsistency may discourage companies from operating in Europe.
The EU AI Act’s lack of precise definitions mirrors issues seen in the early days of the GDPR. Undefined terms like “undue delay” and “disproportionate effort” add layers of uncertainty. Enforcement by 27 national authorities adds further challenges for companies operating across borders. Moreover, the mandatory dual certification for medical devices and their AI components increases costs and delays, deterring innovation in Europe.
The authors also indicate that there is a shortage of AI-specific expertise among notified bodies responsible for assessing AI-powered medical devices. This could lead to delays in approvals, mirroring the issues experienced with the MDR and IVDR regulations.
Furthermore the Act overlaps with GDPR, complicating compliance. While GDPR emphasizes data minimization and limited retention, the AI Act requires comprehensive and representative datasets. This creates conflicting obligations, particularly around privacy and transparency.
To maintain innovation, some suggestions in the article are:
- Harmonizing existing quality management processes allowing companies to build on certifications like ISO 13485.
- Clear guidelines and transition periods to facilitate compliance without stifling innovation.
- Streamlined processes to avoid duplicative efforts and operational inefficiencies.
Much like GDPR, the EU AI Act is poised to set international standards. While this could promote global harmonization, overly stringent regulations risk driving companies to less burdensome markets.
Conclusion
The EU AI Act is an ambitious step that could position Europe as a leader in AI regulation. However, without improvements in consistency, expertise, and support, the Act may inadvertently push life sciences innovation outside Europe. A balanced approach could foster innovation while ensuring safety and transparency, enabling the life sciences sector to thrive within the EU.