Official statement on the amendment of the AI Omnibus Regulation
Following the formal adoption of the Council’s and the European Parliament’s positions on the AI Omnibus Regulation, the file has now entered the phase of tripartite negotiations, known as trilogues, between the European Commission, the Council of the EU and the European Parliament, with the aim of reaching an agreement on the final text.
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In this context, the Spanish Federation of Healthcare Technology Companies, Fenin, wishes to state the following:
- Artificial intelligence is already a reality in healthcare and is set to play a key role in addressing some of the main challenges facing the health system, such as the shortage of healthcare professionals, administrative burden, population ageing and the growing complexity of diseases. At Fenin, we are convinced that AI can enhance the capabilities and expertise of healthcare professionals, allowing them to focus on what truly matters: patient care.
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- The healthcare technology industry is aware of the importance of building trust in the use of these technologies, especially when health is at stake. We therefore advocate a responsible approach to AI, supported by a robust regulatory framework that guarantees legal certainty and the protection of patients and users.
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- This regulation represents an opportunity, as it aims to simplify the implementation of the AI Act while establishing harmonised rules that strengthen safety, transparency and trust in the use of AI systems. It also helps to create a level playing field among the different market players and reinforces traceability, data governance and accountability in the development and use of AI systems. It can therefore become a key instrument to foster responsible innovation, aligned with the protection of fundamental rights and patient safety.
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- However, Fenin warns that the implementation of the AI Act, in its current configuration, poses significant challenges for the healthcare technology sector, particularly with regard to AI-based medical devices, which are already subject to strict regulation under the Medical Devices Regulation (MDR). The coexistence of both regulatory frameworks may lead to overlaps, regulatory gaps and a lack of alignment between horizontal rules on AI and vertical rules on medical devices, creating an increasingly complex and unpredictable regulatory environment.
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- This situation may result in delays in European patients’ access to safe and effective innovations, as well as a negative impact on the competitiveness of European companies, by increasing certification timelines, conformity assessment costs and the need for regulatory resources. Fenin believes that these effects could be further aggravated with the full implementation of the AI Act unless adjustments are introduced to ensure greater regulatory coherence.
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- Against this backdrop, Fenin advocates the need to move towards a sector-specific approach to regulatory simplification, aligning the AI Act with the MDR. Specifically, Fenin proposes moving the MDR from Annex I, Section A, to Section B of the AI Act, so that the requirements applicable to high-risk AI systems are directly integrated into the General Safety and Performance Requirements of the MDR.
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- This approach, already provided for in the AI Act itself for other sectors, would make it possible to streamline the regulatory framework, improve its coherence and provide greater clarity for all stakeholders involved, without in any way lowering the levels of patient safety and protection.
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- Fenin also considers it necessary to postpone the date of application of the AI Act, in order to allow sufficient time for an orderly transition towards this sector-specific approach, as well as to ensure a clear, agile and harmonised designation process for Notified Bodies, avoiding bottlenecks that could compromise the certification of AI-based medical devices.
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- Finally, Fenin stresses the importance of maintaining the possibility of evaluating AI systems in medical devices under real-world conditions within the controlled testing environments provided for under the MDR, ensuring that innovation progresses in a responsible, safe and patient-centred manner.