{"slug": "the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation", "title": "The Rrace for healthcare AI: Why Europe needs to move beyond regulation", "summary": "Italy's Law No. 132/2025 made it the first EU Member State to adopt a comprehensive national AI law, but HealthAI CEO Ricardo Baptista Leite said regulatory approval alone is insufficient because an AI tool can clear the EU AI Act and medical device requirements yet still fail to reach patients without a reimbursement code, an HTA process, a procurement mechanism, an implementation budget or a workforce plan. HealthAI's report on the EU AI Act, presented in May with the World Economic Forum, flagged untested divisions of responsibility between horizontal AI authorities and medical device regulators, a shortage of AI and data science expertise in conformity assessment bodies, and Italy's regional fragmentation as barriers to adoption. Leite said Italy must now convert legislative leadership into operational capacity by connecting national AI governance, health data infrastructure and market access mechanisms.", "body_md": "**Ricardo Baptista Leite**, founder and president of the UNITE Parliamentarians Network for Global Health and CEO of HealthAI, approaches artificial intelligence in healthcare from a perspective that brings together governance, innovation and implementation capacity.\n\n**In this interview**, he explains why Europe’s real challenge is not simply to regulate AI, but to translate rules into concrete adoption, making “trusted scale” a competitive advantage. He also identifies Italy as a potential European laboratory for translating regulatory leadership into clinical and economic results.\n\n**Q: The EU AI Act is often discussed from a regulatory perspective. In your view, what are the biggest practical challenges that healthcare systems, healthcare professionals and innovators face in moving from regulatory compliance to real-world implementation?**\n\n**A:** Compliance is often seen as a legal exercise, whereas implementation is a transformation of the healthcare system. The EU AI Act interacts with several regulations, including those concerning medical devices, data protection and the European Health Data Space. The main challenge is establishing responsibility when AI systems are updated, their performance changes, they behave differently across populations or they are integrated into clinical workflows.\n\n- HealthAI’s report on the EU AI Act, presented in May with the World Economic Forum, highlighted several gaps. The division of responsibilities between horizontal AI authorities and medical device regulators has not yet been tested. Conformity assessment bodies need expertise in AI and data science. Smaller healthcare systems and innovators require clear guidance on the different regulatory regimes.\n- Following regulatory approval, an AI tool may comply with the AI Act and medical device requirements but still fail to reach patients without a reimbursement code, an HTA process, a procurement mechanism, an implementation budget or a workforce plan. Regulatory approval is necessary, but not sufficient for adoption.\n- Compliance is only the beginning. Implementing and scaling AI requires institutional capacity, clinical evidence, interoperable data, trained personnel, funding and continuous monitoring. Responsible governance facilitates trust-based adoption and enables AI to move beyond pilot projects.\n\n**Q: Your report identifies Italy as the first EU Member State to adopt a comprehensive national AI law, while also highlighting regional fragmentation and the absence of a structured reimbursement pathway for AI-based clinical tools. What should Italy do now to turn legislative leadership into clinical and economic leadership?**\n\n**A:** Italy has already achieved an important result: it has provided political and legislative direction. Law No. 132/2025 established the first comprehensive national AI regulatory framework adopted by an EU Member State, including specific provisions for the healthcare sector. It establishes that AI must support, rather than replace, healthcare professionals; that clinical responsibility must remain human; and that patients must be informed when AI is used. This human-centric approach is consistent with the European approach and can help strengthen public trust.\n\n- The lesson emerging from Italy, and from the other countries examined in our report, is that legislation is necessary but insufficient. Italy must now turn regulatory leadership into operational capacity. Its decentralised healthcare system makes this transition particularly important. In the absence of common national approaches to assessment, procurement, oversight and post-market monitoring, different regions could adopt different standards and pathways. This can produce inequalities in patient access and make Italy a difficult market for innovators, particularly smaller companies.\n- The most immediate opportunity lies in connecting national AI governance, health data infrastructure and market access mechanisms. AGENAS (National Agency for Regional Healthcare Services) is developing a national AI platform for primary and community care, designed to provide non-binding support for clinical decision-making and prevention while maintaining professional responsibility. Italy has also launched its national 2026–2028 Health Technology Assessment (HTA) programme for medical devices, which explicitly identifies AI platforms and digital therapeutics as areas of focus. These are promising foundations, but HTA must be linked to procurement, funding and adoption, rather than becoming another layer of isolated assessment.\n- Italy could become a European laboratory for the implementation of trustworthy AI in healthcare: by testing forms of joint oversight between authorities, establishing nationally recognised evidence requirements, using value-based procurement and evaluating AI across different regional populations and care settings. Its success, ultimately, will not be judged by the number of strategies or pilot projects launched, but by the ability of safe technologies to improve care throughout the country.\n\n**Q: As AI in healthcare becomes part of the geopolitical competition for technological leadership, how can Europe strengthen its strategic autonomy without fragmenting international cooperation? What distinctive role could Italy play?**\n\n**A:** AI in healthcare is already part of the broader geopolitical competition for technological leadership. The relevant assets are no longer limited to algorithms. They include computing capacity, cloud infrastructure, health data, foundation models, semiconductor supply chains, scientific talent, clinical validation capacity, pharmaceutical research, regulatory expertise and the ability to implement technology at healthcare-system scale.\n\n- However, I would avoid framing all this as a simple zero-sum competition between Europe, the United States and China. Healthcare is inherently interdependent. Diseases cross borders, scientific knowledge is global, and safety signals associated with an AI system deployed in one country can be extremely relevant to patients in another.\n- European strategic autonomy does not imply technological isolation or complete self-sufficiency. It means that Europe can make sovereign and informed choices: independently assess AI systems, protect and responsibly use health data, maintain critical infrastructure, support European innovators and avoid dependence on technologies it cannot inspect, govern or replace.\n- The European Commission itself increasingly links AI adoption in strategic sectors, including healthcare, biotechnology and pharmaceuticals, to competitiveness and technological sovereignty. Its Apply AI Strategy and AI Continent Action Plan aim to combine computing capacity, data, investment, skills and support for adoption.\n- Italy can make a distinctive contribution through applied AI: clinical validation, biomedical research, pharmaceutical and medical technology innovation, advanced manufacturing, community and primary care, and regulatory science. It can also act as a bridge between European institutions and the wider Mediterranean region.\n- The winners of the geopolitical competition will not necessarily be those who produce the largest number of models. They may be those who know how to safely integrate AI into healthcare, produce reliable evidence, strengthen their workforce and generate measurable benefits for their populations.\n\n**Q: There is growing concern that regulation could slow innovation compared with competitors such as the United States and China. How can Europe ensure that responsible AI governance becomes a source of competitive advantage, rather than a constraint on its healthcare systems and life sciences sector?**\n\n**A:** Europe’s problem is not that it regulates. The greater risk is that it regulates without creating the operational conditions that make compliance predictable and adoption possible.\n\n- Well-designed governance can provide legal certainty, reduce investment risk and give doctors, patients and healthcare systems the confidence needed to use new technologies. In healthcare, trust is not an abstract ethical benefit. It is a practical condition for market adoption. A technology that doctors do not trust, that regulators are unable to assess or that citizens are unwilling to accept cannot achieve widespread deployment, regardless of how sophisticated it is.\n- But Europe will only be able to turn governance into a competitive advantage if it addresses fragmentation. An innovator should not be forced to deal with substantially different interpretations, evidence requirements, procurement rules and reimbursement systems in every Member State. Europe needs a single market for trustworthy healthcare innovation in practice, not just in law.\n- Clearer coordination is needed between the EU AI Act, medical device regulations and the European Health Data Space. Regulators and conformity assessment bodies must have adequate capacity. Innovators must receive early scientific and regulatory advice. Regulatory sandboxes and real-world testing environments are necessary. More harmonised pathways from authorisation to reimbursement and procurement are essential. The EHDS can become a competitive asset, but its operational components will come into effect gradually. Meanwhile, decisions are being made on AI compliance and investment. Regulatory sandboxes, early scientific advice and data-sharing agreements between healthcare systems can reduce fragmentation and strengthen the system once the EHDS becomes operational.\n- Europe should not try to win by lowering safety standards or imitating every feature of the American or Chinese models. It should compete through “trusted scale”: clear rules, high-quality evidence, access to diverse health data, strong public institutions and the capacity to implement safe innovations in a continent-sized market.\n- As I have argued publicly, governance is not an obstacle to innovation. Without safety, evidence, accountability and trust in regulation, AI will remain trapped in pilot projects. With the right governance, it can enter healthcare systems and generate real value.\n- In summary, I would say that Europe should not be forced to choose between speed and safety. Its competitive advantage should lie in its ability to achieve both.\n\n**Q: Over the next two to three years, what should governments, regulators and industry prioritise to ensure that AI delivers measurable improvements in patient outcomes, workforce capacity, equity and healthcare system sustainability, while maintaining public trust?**\n\n**A:** I would prioritise three areas.\n\n1. First, governments must invest in implementation capacity. This means clarifying institutional responsibilities, training regulatory and health authorities, expanding AI and data science expertise within conformity assessment bodies and testing oversight mechanisms before real-world incidents expose their shortcomings. Rules without institutions capable of enforcing them will neither protect patients nor support innovators.\n2. Second, Europe must build credible pathways from approval to impact. Governments should connect regulation with HTA, reimbursement, public procurement, interoperability and clinical implementation. Success should not be measured by the number of AI strategies, pilot projects or procurement initiatives announced. It should be measured through patient outcomes, earlier diagnoses, access, equity, workforce experience, productivity and healthcare system sustainability.\n3. Third, we need lifecycle governance. AI is different from a static drug or a conventional device because its performance can change as models are updated, data environments evolve and systems are deployed across different populations. Governments therefore need registries, version traceability, real-world performance monitoring, clear incident-reporting mechanisms and international exchange of safety signals. This is one of the main reasons why HealthAI is developing mechanisms for regulatory collaboration and adverse event monitoring among the countries that are part of the HealthAI Global Regulatory Network.\n\n**The bottom line:** “These priorities must involve patients and healthcare professionals from the outset. Participation cannot be purely formal. People affected by AI must have a meaningful role in defining acceptable risks, relevant outcomes and conditions of use,” said Leite.\n\n- “Finally, we should avoid what I have called the *AI Saviour Complex* . Simply introducing AI into a dysfunctional system will not solve the underlying problems of leadership, organisation or incentives. Technology can amplify human and institutional capabilities, but it cannot replace clarity of objectives.”\n- “The goal, therefore, should not be to automate today’s healthcare systems. It should be to use AI to help redesign them towards greater prevention, personalisation, accessibility and human connection.”", "url": "https://wpnews.pro/news/the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation", "canonical_source": "https://decode39.com/16915/16915/", "published_at": "2026-10-09 08:00:51+00:00", "updated_at": "2026-10-09 08:23:07.522509+00:00", "lang": "en", "topics": ["ai-policy", "artificial-intelligence", "ai-ethics"], "entities": ["Ricardo Baptista Leite", "HealthAI", "UNITE Parliamentarians Network for Global Health", "European Union", "EU AI Act", "Italy", "Law No. 132/2025", "World Economic Forum"], "also_reported_by": [], "alternates": {"html": "https://wpnews.pro/news/the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation", "markdown": "https://wpnews.pro/news/the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation.md", "text": "https://wpnews.pro/news/the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation.txt", "jsonld": "https://wpnews.pro/news/the-rrace-for-healthcare-ai-why-europe-needs-to-move-beyond-regulation.jsonld"}}