Artificial intelligence (AI) is no longer a distant promise in healthcare. It is already redefining the way diseases are detected, treatments are developed and patients are cared for. From enhancing radiology with unparalleled diagnostic accuracy to enabling real-time remote patient monitoring, AI is accelerating medical progress across Europe. In drug discovery, machine learning models are transforming pharmaceutical research, shortening development cycles and unlocking new therapeutic possibilities.
But the legal and regulatory framework is evolving to keep pace. The EU AI Act, GDPR and medical device regulations are laying the foundation for a structured yet innovation-friendly governance model. Legal professionals play a key role in ensuring that AI applications meet the highest standards of safety, transparency and ethical integrity.
A key takeaway from the AI Action Summit in Paris earlier this year was the ongoing tension between regulation and innovation. While perspectives differ, we believe that the core principles remain investment, trust and ethics. Regulation, when well-designed, is not a constraint but a means to foster confidence in AI-driven healthcare.
The challenge for European regulators is then to maintain proportionate oversight, encouraging AI adoption while safeguarding patient safety and European ethical standards without falling into the trap of over-regulating.
This article explores the interplay between AI-driven innovation in healthcare and the evolving European regulatory framework, examining how regulatory compliance acts as a pillar of trust, the classification of AI as a medical device, the complexities of processing sensitive health data, and the evolving legal landscape surrounding liability and accountability.
Regulation as an enabler of trust in the EU
The EU has adopted a structured framework, seeking to align innovation with ethical principles, patient safety and data protection. The EU AI Act, alongside sector-specific regulations such as the Medical Device Regulation (MDR) and directive 2001/83/EC on medicinal products, establishes a layered regulatory environment. The goal is to ensure AI tools comply with strict standards while promoting fairness, accountability and reliability. Protection of sensitive health data remains a priority under GDPR, reinforcing lawful data usage and security measures. The EU recognises that AI, especially in healthcare, is fundamentally about trust.
For high-risk AI systems, the EU AI Act imposes additional requirements. These include transparency and explainability obligations, ensuring AI-generated outputs remain interpretable for clinicians. Risk management and human oversight mechanisms mandate real-time monitoring, bias detection and intervention protocols to prevent errors. Data governance and security provisions align with GDPR and cybersecurity standards, ensuring lawful data processing and patient privacy protection.
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