Regulatory body Archives - AI Standards Hub

Regulatory body

Strategies and roadmaps

Roadmap towards the future regulatory framework for medical devices

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Domain:

Healthcare and medicine - Medical devices

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“This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 29 Feb 2024

Reports, resolutions, and position papers

Overview of the CMA’s provisional approach to implement the new Digital Markets competition regime

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“This overview responds to a request from ministers from the Department for Business and Trade (DBT) and the Department for…

Organisation: Competition and Markets Authority

Last Updated: 29 Feb 2024

Regulation and official guidance

How to use AI and personal data appropriately and lawfully

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Topic:

Bias and discrimination Explainability and transparency Risk management Safety

Domain:

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Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to…

Organisation: Information Commissioner's Office

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance on GxP data integrity

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Domain:

Healthcare and medicine

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The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Software and artificial intelligence (AI) as a medical device

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Domain:

Healthcare and medicine - Medical devices

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Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Frameworks and principles

Predetermined change control plans for machine learning-enabled medical devices: Guiding principles

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Topic:

Risk management Safety

Domain:

Healthcare and medicine

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In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…

Organisation: Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

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Topic:

Safety Trustworthy AI

Domain:

Healthcare and medicine - Medical devices

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Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…

Organisation: Medicine & Healthcare products Regulatory Authority

Last Updated: 30 May 2023

Research and analysis item

The benefits and harms of algorithms: a shared perspective from the four digital regulators

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Topic:

Adoption and commercialisation Ethical considerations

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In 2021 the DRCF established an Algorithmic Processing workstream to explore the impact of algorithms across our industries and regulatory…

Last Updated: 12 Oct 2022

Research and analysis item

Auditing algorithms: the existing landscape, role of regulators and future outlook

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Topic:

Assurance and testing

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In 2021 the DRCF established an Algorithmic Processing workstream to explore the impact of algorithms across our industries and regulatory…

Last Updated: 12 Oct 2022

Research and analysis item

Using machine learning in diagnostic services: a report with recommendations from CQC’s regulatory sandbox

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Topic:

Accuracy and performance Bias and discrimination Good practice for development and use

Domain:

Healthcare and medicine - Clinical medicine

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This report presents the findings from the Care Quality Commission’s (CQC’s) regulatory sandbox pilot. Regulatory sandboxing is a way of…

Last Updated: 12 Oct 2022

Strategies and roadmaps

Online safety bill: Ofcom’s roadmap to regulation

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Topic:

Accountability Ethical considerations Safety Skills and readiness

Domain:

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Last Updated: 12 Oct 2022

Official policy proposals and consultations

Call for evidence: first phase of online safety regulation

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Topic:

Accountability Ethical considerations Safety Skills and readiness

Domain:

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Last Updated: 12 Oct 2022

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