Challenges ahead for the AI-Powered Future of Life Sciences

The AI Act imposes new obligations for life sciences and healthcare companies using or offering AI systems. Medical devices Class IIa and up are categorised as ‘high risk’ and, as a result, subject to stricter regulations under the AI Act’s stringent requirements for high-risk AI systems. For the medical devices industry, the interaction and overlap between the new high-risk AI requirements and their integration into the requirements under the Medical Devices Regulations is critical, for example with regards to the relevant conformity assessments for these AI powered devices. 

Additionally, for the pharmaceutical industry, change is on the horizon. The European Commission is pursuing to reform the pharmaceutical legislation with technological innovation in mind. Part of this proposal are the ‘regulatory sandboxes’ (a concept also found in the AI Act), which allows for innovation in a temporary regulatory framework – this offers significant opportunities for AI innovations.

The European Medicines Agency (EMA) published its multi-annual AI workplan in November 2023. This workplan aims to minimise risks, while optimizing the benefits of AI for all parties involved. EMA is currently preparing to support the implementation of the EU AI Act, and a significant amount of guidance documents can be expected in the next few years. 

Simultaneously, the Data Act, which will come into force September 2025, will require data access and sharing for connected devices. As a result, medical devices manufacturers must offer “access-by-design” of their products and include terms on fair access and use of data in their contracts. Data access is critical to AI systems and often engages a range of data protection and localisation issues, alongside patient confidentiality rules. Commercial and IP issues also play an important role in data access for AI development and use. 

The forthcoming European Health Data Space (EHDS) Regulation will have a significant impact in this regard providing for a framework regulating secondary use of health data from industry, innovators, policy makers and research. This requires significant preparation from industry, cataloguing all the available health data and ensuring intellectual property rights and trade secrets are identified.

Furthermore, the EHDS will establish novel requirements for manufacturers of electronic health record systems, i.a., with regards to technical aspects in terms of security, identification and authentication and documentation obligations, aiming at streamlining the necessary underlying infrastructure to enable the primary use of health data across member states. For organisations operating in the life science and healthcare industry, it is essential to be aware of these regulatory changes – and the challenges and opportunities that come with this complex legal landscape. 

For further information, please contact: Toby Bond, Nils Lölfing, Hester Borgers, Christian Lindentahl.

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Connected newsletter July 2024: Special AI edition

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