Posts Tagged ‘human in the loop’
Designing an Audit Trail for AI in Clinical Trials: Aligning with the EU AI Act
As artificial intelligence (AI) continues to transform clinical trials, ensuring transparency, accountability, and compliance has become critical. Central to achieving these goals is the implementation of a robust audit trail system. While the EU Artificial Intelligence Act (EU AI Act) does not explicitly define audit trail requirements for high-risk AI systems, it emphasizes the need…
Read MoreWho’s Afraid of the Big, Bad EU AI Act?
The European Union’s Artificial Intelligence Act (EU AI Act) has become a significant milestone in the global regulation of artificial intelligence. As the world’s first comprehensive AI regulation, it introduces a risk-based framework designed to ensure the safe and ethical deployment of AI technologies. For industries relying heavily on innovation, like biopharma clinical trials, understanding…
Read MoreBuilding a Compliant Quality Management System for AI in Healthcare
In healthcare and biopharma, ensuring patient safety, product quality, and regulatory compliance has always been paramount. A Quality Management System (QMS) serves as the backbone for these priorities, providing a structured framework for risk management, process standardization, and continuous improvement. As artificial intelligence (AI) becomes more embedded in clinical operations and drug development, traditional QMS…
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