Leyes | ?? Laws
COCIR analyses application of medical device legislation to Artificial Intelligence
“The European Commission has shown its ambition in the area of artificial intelligence (AI) in its recent White Paper on Artificial Intelligence – a European approach to excellence and trust. This White Paper is at the same time a precursor of possible legislation of AI in products and services in the European Union. However, COCIR sees no need for novel regulatory frameworks for AI-based devices in Healthcare, because the requirements of EU MDR and EU IVDR in combination with GDPR are adequate to ensure that same excellence and trust.” (COCIR paper).
Guideline for AI for medical products
The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the notified bodies are, to promote step-by-step implementation of safety of medical devices, that implement artificial intelligence methods, in particular machine learning, to compensate for the lack of a harmonized standard (in the interim) to the greatest extent possible.
III CONGRESO AUDITORÍA Y GRC (ISACA Madrid Chapter)
Este congreso, motivado por la creciente sensibilidad de las compañías en materia de Gobierno, Riesgo y Cumplimiento, se enfoca en generar una visión global de los procesos, gestión de riesgos, fraude, control interno y cumplimiento normativo y legislativo, sin dejar de lado la metodología y ejecución de revisiones y auditorías de los mismos
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition