This section collects the legislative and regulatory materials related to the use of AI in medicine and healthcare.
AHEAD - Legislative and regulatory framework
Italy – Senate of the Republic – Bill No. 1146: “Provisions and Delegations to the Government on Artificial Intelligence”
20 marzo 2025
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On 20 March 2025, the Senate approved Bill No. 1146 on artificial intelligence (“AI Bill”), originally presented by the Government on 20 May 2024, aimed at harmonizing Italian national legislation with the European Regulation 1689/2024 (“AI Act”).
European Union - Regulation 2024/1689 on artificial intelligence (AI Act)
13 giugno 2024
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On 1 August 2024, the Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (also known as the Artificial Intelligence Act or AI Act) entered into force. The aim of the Regulation is to create a harmonised horizontal regulatory framework for the development, introduction into the EU market and use of artificial intelligence (AI) products and services, with a focus on managing risks to health, safety and fundamental rights.
Council of Europe - Framework Convention on artificial intelligence, human rights, democracy and the rule of law
17 maggio 2024
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The Council of Europe has adopted the Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law. The Convention represents the first legally binding international treaty on artificial intelligence and focuses on the protection of human rights, democracy, and the rule of law in relation to all activities involving the AI system life cycle.
UK - Department of Health and Social Care – Equity in Medical Devices: Recommendations to Promote Equity in Medical Devices
Anno 2024
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This document analyzes potential inequalities arising from the use of certain types of medical devices, including those incorporating artificial intelligence systems, and offers recommendations to eliminate or mitigate them, with the aim of ensuring equity within the English National Health Service (NHS).
WHO - Regulatory considerations on artificial intelligence for health
Anno 2023
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The WHO has published key recommendations that developers, manufacturers, policymakers, regulators, legislative bodies, and healthcare professionals should follow and adopt in the production and application of artificial intelligence (AI) systems within the healthcare sector.
European Union - European Parliament, Council and European Commission - European Declaration on Digital Rights and Principles for the Digital Decade
Anno 2023
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On January 23, 2023, the European Parliament, the Council, and the European Commission jointly adopted the European Declaration on Digital Rights and Principles for the Digital Decade, with the aim of promoting a model of digital transformation centered on human beings, European values, and fundamental rights.
WHO – Ethics ad Governance of Artificial Intelligence for Health: WHO Guidance
Anno 2021
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The World Health Organization (WHO) has developed a set of guidelines, recommendations, and directives regarding the development, application, and use of artificial intelligence (AI) technologies in the field of medicine.
Pubblicato il: Lunedì, 14 Aprile 2025
