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 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 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.

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).

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.

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.

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

torna all'inizio