Clifford Chance

Healthtech

The Impact of the new EU AI Act on the Healthcare Sector: Part One - Scope and a Risk-Based Approach

Almost three years after the publication of the EU Commission's proposal for a Regulation on Artificial Intelligence (AI Act), the EU institutions involved in the legislative process have finally reached a consensus. With its vote on the AI Act, the Permanent Representatives Committee presented a compromise text on 26 January 2024. On the 13th March 2024 the European Parliament adopted the AI Act, with final confirmatory votes by all institutions to be taken in April 2024 - before the European elections in June 2024 – to pass what will be the world's first comprehensive regulation on AI. The AI Act shall enter into force on the 20th day after publication in the EU Official Journal and generally apply 24 months later (i.e. by 2026), except for a few provisions that shall become applicable six and 12 months after the AI Act will have entered into force, respectively. To facilitate compliance with the new legal framework for AI in Europe, the Commission has recently launched an AI Pact, a voluntary initiative that calls on AI developers from Europe and beyond to make themselves acquainted and comply with the key obligations under the AI Act ahead of time. But what exactly are these obligations? We will focus on various key aspects of the new AI Act and its impact on the healthcare sector in several posts over the coming weeks, starting with the scope of application and the risk-based approach of the new European law.