AI Act, European Health Data Space and new rules divide opinion between strengthening security and slowing down agility in the sector
Europe is at a decisive moment in its healthcare innovation journey. With the approval of the AI Act and the rollout of the European Health Data Space, the continent seeks to strike a balance between two often conflicting objectives: protecting its citizens and stimulating technological progress.
For many experts, regulation can act both as a driver and as a brake. On one hand, the regulatory framework ensures privacy, data protection and cybersecurity, creating an environment of trust that is essential for the adoption of digital health solutions in hospitals, clinics and everyday patient care. Certification for AI-powered medical devices, for example, strengthens quality standards and reduces the risk of errors that could compromise lives.
On the other hand, excessive bureaucracy and the lack of interoperability between national systems risk slowing the arrival of innovative technologies to the European market. Healthtech start-ups, often operating with limited resources, face major hurdles in complying with complex regulatory demands, which restricts their capacity to expand and compete globally.
Hospitals and research centres also struggle with implementation. The European Health Data Space promises secure sharing of medical information across countries, enabling faster diagnoses, personalised treatments and scientific breakthroughs. Yet until national systems are properly aligned, fragmentation remains a significant obstacle.
For citizens, the impact is tangible. Regulation can accelerate access to safer and more effective treatments, but it can also delay the introduction of innovations already available in markets such as the United States and Asia.
Europe must therefore find a delicate balance: preserving its tradition of consumer protection without undermining its competitiveness in a sector that is transforming at unprecedented speed. The future of digital health across the continent will depend on turning regulation into a platform for trust rather than a barrier to progress.
