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New product liability risks for AI products
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.
5 of 10 Insights
Purpose limitation and data minimisation: key considerations for AI training in the life sciences sector
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.
3 of 10 Insights
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.
1 of 10 Insights
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.
6 of 10 Insights