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Implementing the AI Act in the Portuguese Health Sector

2026-08-03Artigo científico Acesso aberto
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dc.contributor.authorFrutuoso, João
dc.contributor.authorPereira, Juan
dc.contributor.authorPereira, Manuel
dc.contributor.authorDonato, Helena
dc.contributor.authorVaz Carneiro, António
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.pblBiblioteca Nacional de Portugal, Centro de Estudos Históricos, CELOM
dc.date.accessioned2026-09-07T15:23:01Z
dc.date.available2026-09-07T15:23:01Z
dc.date.issued2026-08-03
dc.descriptionPublisher Copyright: Copyright © Ordem dos Médicos 2026
dc.description.abstractThe rapid expansion of artificial intelligence (AI) in the health sector has intensified the need for a robust regulatory framework capable of safeguarding patient safety, professional accountability, and public trust. We aimed to analyse the European Union Artificial Intelligence Act [AI Act, Regulation (EU) 2024/1689] and its implications for the healthcare sector in Portugal, presenting the institutional position of the Artificial Intelligence Committee of the Portuguese Medical Association (CPIA-OM). We conducted a narrative review based on official European legislation [AI Act, General Data Protection Regulation (GDPR), Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)], institutional documents [including the 2025 White Paper on AI in Healthcare in Portugal, published by the Shared Services of the Ministry of Health (SPMS)], and peer-reviewed literature on artificial intelligence in medicine, ethics, and regulatory science. The AI Act introduces a risk-based classification of AI systems, ranging from prohibited “unacceptable risk” applications to minimal risk uses. Most medical AI applications, including diagnostic support, clinical monitoring, and therapeutic decision-making, are classified as “high risk” and are subject to stringent requirements regarding conformity assessment, technical documentation, human oversight, and data governance. The regulation interacts with existing frameworks such as the GDPR and MDR/IVDR, creating complex compliance obligations. Specific challenges include algorithmic bias, liability attribution, and the preservation of the physician-patient relationship. In Portugal, recent institutional initiatives within the National Health Service — including pilot projects in triage, frailty assessment, antibiotic stewardship, and medical imaging — illustrate opportunities for responsible AI integration, while academic reports highlight persistent concerns around transparency, trust, and professional substitution. The AI Act represents a landmark in European health regulation, balancing innovation with fundamental rights protection. For Portugal, its implementation requires coordinated action between the government, regulators, healthcare providers, and professional bodies. The CPIA-OM emphasises the need for continuous medical education in AI, the establishment of clinical oversight protocols, and the creation of observatories to monitor implementation and ensure ethical, safe, and patient-centred adoption.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent7
dc.format.extent575932
dc.identifier.doi10.20344/amp.24588
dc.identifier.issn0870-399X
dc.identifier.otherPURE: 171656675
dc.identifier.otherPURE UUID: 38df98e8-c96d-4f8c-be46-0da7bc67c539
dc.identifier.otherScopus: 105046294738
dc.identifier.otherPubMed: 42556425
dc.identifier.urihttp://hdl.handle.net/10362/206143
dc.identifier.urlhttps://www.scopus.com/pages/publications/105046294738
dc.language.isoeng
dc.peerreviewedyes
dc.subjectArtificial Intelligence ethics
dc.subjectArtificial Intelligence legislation & jurisprudence
dc.subjectDevice Approval
dc.subjectElectronic Health Record
dc.subjectEurope
dc.subjectEuropean Union
dc.subjectMedical Device Legislation
dc.subjectPortugal
dc.subjectGeneral Medicine
dc.subjectSDG 3 - Good Health and Well-being
dc.titleImplementing the AI Act in the Portuguese Health Sectoren
dc.title.subtitleImplications, Challenges and the Perspective of the Portuguese Medical Association's Artificial Intelligence Committeeen
dc.typejournal article
degois.publication.firstPage470
degois.publication.issue8
degois.publication.lastPage476
degois.publication.titleActa Medica Portuguesa
degois.publication.volume39
dspace.entity.typePublication
rcaap.rightsopenAccess

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