“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).
Leyes | 🇬🇧 Laws
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.
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
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
“The artificial intelligence (AI) landscape has evolved significantly from 1950 when Alan Turing first posed the question of whether machines can think. Today, AI is transforming societies and economies. It promises to generate productivity gains, improve well-being and help address global challenges, such as climate change, resource scarcity and health crises. Yet, as AI applications are adopted around the world, their use can raise questions and challenges related to human values, fairness, human determination, privacy, safety and accountability, among others. This report helps build a shared understanding of AI in the present and near-term by mapping the AI technical, economic, use case and policy landscape and identifying major public policy considerations. It is also intended to help co-ordination and consistency with discussions in other national and international fora”. (OECD)