AI in Life Sciences

As AI innovation in the life sciences sector continues at pace, the Medicines and Healthcare products Regulatory Agency (MHRA) publishes principles and guidance in relation to software-as-a-medical-device which includes the application of AI.

While the AI Act is not applicable to certain research uses of AI, these exemptions do not apply to the use of AI in clinical trials, where a myriad of regulation and guidance has potential application.

The use of real-world evidence data to train AI models is becoming a critical component in advancing research and drug development. We explore how two of the GDPR's guiding principles are more than just regulatory requirements.

Using AI systems in scientific research raises important regulatory considerations. When an AI system is trained with patient data, compliance with GDPR becomes necessary and must undergo a compatibility assessment to ensure it aligns with the purpose limitation principle.

The new Product Liability Directive aims to modernise the product liability rules and remove obstacles for consumers. What should life sciences companies using AI in products know about the new product liability rules.

Manufacturers/providers of medical devices that, according to the EU AI Act, include a high-risk AI system (HRAIS) require a notified body assessment of their technical documentation and/or quality management system should urgently consider which notified body to appoint.

AI has become an integral part of business operations across various industries. Its deployment demands careful legal and strategic considerations. Before integrating AI systems in a company’s workflows, thorough diligence should be conducted.

AI is transforming healthcare and life sciences, by enabling innovations in diagnostics, treatment personalisation, and operational efficiency. This article explores essential considerations for data privacy in pre-contractual AI due diligence, focusing on legal obligations, risk mitigation strategies, and ethical concerns.

As AI models evolve over time, specific considerations will need to be incorporated into any due diligence. These include whether the solution is licensed-in to be licensed-out and has been pretrained/trained with third party or customer data.

Alison Dennis looks at the addition of the EU AI Act to the regulatory framework around medical devices.