The European Union is eager to be on the forefront of regulation of data and digital technologies. In particular, the risk-based approach of the Artificial Intelligence Act is expected to have broad ramifications and to establish the standards for AI governance structures within business organizations beyond the geographical scope of the EU market. This was the theme of our recent panel which included Pascal Hofer, Head of Legal Digital & IT, Roche Diagnostics GmbH, Kyle Thomson, Product Counsel, Verily Life Sciences and Dr. Heather Evans, Deputy Assistant Secretary for Manufacturing, Industry & Analysis, International Trade Administration of the U.S. Department of Commerce, moderated by our Partner Arne Thiermann.

The AI Act will be directly applicable to providers and deployers of AI systems that are marketed or used in the EU, irrespective of whether such operators are located inside or outside the EU. The Act will implement a horizontal, cross-sector approach across (almost) all industry sectors. Our panelists discussed a variety of anticipated challenges with how the AI Act will impact compliance and market access issues in the context of the overall health ecosystem. In the context of medical devices, for example, the panelists discussed some concerns regarding the need to align the AI Act with the existing Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and analyzed a few scenarios where the AI Act might apply to some technologies even where the MDR/IVDR might not apply, and vice versa. The challenge, they noted, will be in finding the right balance to ensure safe and responsible AI without having a negative impact on innovation. For global companies seeking to market and deploy their products in Europe, there may be some general uncertainty at the outset that could have a negative impact on product launch timelines.

On the positive side, the panelists described a number of opportunities where EU and U.S. regulators and technical experts may be able to work together to deepen collaboration. Preparations for the AI Act should be seen as part of the overall governance measures that a company must take to address the development and deployment of AI. Generally, it is essential for businesses to swiftly and meticulously evaluate the impact of the AI Act – and to prepare for the transformation that AI will bring to every aspect of the business operations.

Authored by Arne Thiermann.