Software and artificial intelligence (AI) as a medical device
2025年2月3日 · MHRA announced plans for an extensive change programme and supporting roadmap to drive regulatory changes including key reforms across the software as a medical device lifecycle, from...
MHRA’s AI regulatory strategy ensures patient safety and industry ...
2024年4月30日 · The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2024) set out its strategic approach to artificial intelligence (AI). The MHRA welcomed the publication of...
AI Airlock: the regulatory sandbox for AIaMD - GOV.UK
2024年5月9日 · The MHRA AI Airlock was launched in Spring 2024 and is the MHRA ’s first regulatory sandbox for AI as a Medical Device (AIaMD) products. The project will enhance our understanding and...
MHRA ‘sandbox’ to pilot AI regulation will go live soon
4 天之前 · The MHRA's regulatory sandbox for artificial intelligence as medical device technologies, AI-Airlock, will go live this spring, according to a new strategy document.
The MHRA is fully committed to ensuring equitable access to safe, effective, and high-quality medical devices for all individuals who use them. As Dame Margaret Whitehead notes, the advance of...
英国MHRA发布关于人工智能对医药产品监管影响的政策文件 - 识林
英国药品和保健产品监管局（MHRA）于 4 月 30 日发布 “人工智能（AI）对医药产品监管的影响”的政策文件，制定了 AI 战略方针。 文件讨论了从三个角度看待 AI：作为 AI 产品的监管者，作为提供时间紧迫决策的公共服务组织，以及作为做出影响公众和患者安全的基于证据的决策组织，这些证据通常由第三方提供。 MHRA 表示，“许多 AI 产品目前处于最低风险分类，这意味着它们可以在没有独立合规评估的情况下投放市场，但这些产品将被升级。 这将通过在整个产品 生命周 …
Artificial intelligence (AI) - the use of machines to do complex tasks that we associate with human intelligence – is one of the most exciting areas of development in health, with...
MHRA Outlines New Strategic Approach to Artificial Intelligence
2024年5月1日 · The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.
Medicines and Healthcare products Regulatory Agency pilot new ...
The Medicines and Healthcare products Regulatory Agency (MHRA) continue work on transforming the regulatory approach for innovative AI technologies. The AI Airlock pilot scheme is helping test and improve the rules for AI medical devices to streamline their route to market.
UK: MHRA trials five AI technologies as part of pilot scheme to …
2024年12月5日 · Focus on Transformative Technologies: Five innovative devices targeting cancer, chronic respiratory diseases, and radiology diagnostics were selected to explore their potential to revolutionize patient care.
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