Challenges ahead for the AI-Powered Future of Life Sciences
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Artificial Intelligence has been making waves in numerous sectors, including the life sciences and healthcare industry. It is being applied at all stages of medicine development; from the identification and validation of potential targets, predicting efficacy and safety, to its use as a tool for clinical trial design, clinical data monitoring/analysis and patient selection. Production facilities and supply chains are also set to benefit from AI driven innovation. AI is also finding its way into healthcare, speeding up diagnosis, supporting patient engagement and assisting healthcare professionals save time and improve the quality of care they provide to patients. However, this enormous growth in application of AI in the life sciences and healthcare sectors also brings a fast-moving, complex regulatory landscape.
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…
