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UK approach to regulating 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.
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Selecting your AIA notified body
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.
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Re-use of patient data in scientific research to train AI systems - important GDPR considerations
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.
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Data privacy in AI due diligence
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.
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The regulation of clinical trials in which AI is deployed
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.
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FinTech Matters - March 2025
Fishing for evidence: when courts say no to cross-border requests
The UPC: a new rocket docket for life sciences patent litigation
Data privacy in AI pre-contractual due diligence
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.
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