AHEAD - Legislative and regulatory framework / AHEAD OBSERVATORY / AI Legal Atlas / Biodiritto

AHEAD - Legislative and regulatory framework

This section collects the legislative and regulatory materials related to the use of AI in medicine and healthcare.

On 4 December 2025, the European Union Agency for Fundamental Rights (FRA) published a report on the risks to fundamental rights associated with artificial intelligence.

In November 2025, the European Commission enacted the “Guidelines on the scope of the obligations for providers of general-purpose AI models established by Regulation (EU) 2024/1689 (AI Act)”, with the aim of explaining how the Commission interprets the AI Act rules for general-purpose AI models, especially the obligations that began applying from 2 August 2025. The guidelines are non-binding, but they describe the Commission’s intended approach to supervision and enforcement.

On September 23, 2025, the Parliament approved Law No. 132, titled “Provisions and Delegations to the Government on Artificial Intelligence”, which had been introduced by the Government on May 20, 2024, and aims to regulate the development and use of artificial intelligence (AI) within the Italian legal system.

In July 2025, the European Commission enacted the “Commission Guidelines on prohibited artificial intelligence practices established by Regulation (EU) 2024/1689 (AI Act)”, with the aim of explaining how to interpret and expect practical implementation of the AI Act’s Article 5 prohibitions, which target AI practices considered to pose an “unacceptable risk”. The guidelines are non-binding, but they are intended to guide providers, deployers, regulators, and market surveillance authorities.

On 24 July 2025, the European Commission published a template for the public summary of the training content used by general-purpose AI models, in accordance with Article 53(1)(d) of the AI Act, which has been in force since 2 August 2025.

In February 2025, the European Commission adopted a set of guidelines aimed at supporting stakeholders—including policymakers, companies, and developers—in defining whether a system qualifies as AI under the legal framework of the Regulation (EU) 2024/1689, which came into force in August 2024.

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.

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.

The document outlines the strategies that the Medicine and Healthcare products Regulatory Agency (MHRA) has implemented, and will implement, in order to effectively regulate AI medical products (AIaMED).

The National Academy of Medicine (USA), as part of its AI Code of Conduct initiative, has presented a proposed Code of Conduct for the use of AI in healthcare, care delivery, and the biomedical sector.

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Pubblicato il: Lunedì, 14 Aprile 2025

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