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

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