EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…
On Friday 8 December, after intense negotiations, EU lawmakers reached a major political agreement on the EU Artificial Intelligence (AI) Regulation. This is the bloc’s landmark legislation regulating the development and use of AI in Europe and one of the world’s first comprehensive attempts to regulate the use of AI. More details on this agreement and on the Regulation are available here. In this blog, we have been following the Regulation’s legislative process closely and…
Introduction Following our post here on the EMA’s consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, which is open for public consultation until 31 December 2023, it is the turn of the World Health Organization (WHO) to release a publication outlining key considerations for regulation of artificial intelligence for health. In the same line as the EMA’s reflection paper that aims to initiate dialogue with all groups of stakeholders in…