Assurance and testing Archives - Page 4 of 10

Strategies and roadmaps

Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan

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Domain:

Healthcare and medicine - Medical devices

The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action…

Last Updated: 12 Oct 2022

Strategies and roadmaps

Software and AI as a medical device change programme

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Assurance and testing Safety

Domain:

Healthcare and medicine - Medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical…

Last Updated: 19 Dec 2022

Official policy proposals and consultations

Consultation on the future regulation of medical devices in the United Kingdom

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Topic:

Assurance and testing Explainability and transparency Safety

Domain:

Healthcare and medicine - Medical devices

Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory…

Last Updated: 15 Dec 2022

Official policy proposals and consultations

Guidance on the AI auditing framework: draft guidance and consultation

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Topic:

Assurance and testing Data Data collection Data processing Data protection Data quality Ethical considerations Good practice for development and use

Domain:

Horizontal

Applications of artificial intelligence (AI) increasingly permeate many aspects of our lives. We understand the distinct benefits that AI can…

Last Updated: 19 Dec 2022

Regulation and official guidance

Code of practice: automated vehicle trialling

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Topic:

Assurance and testing Good practice for development and use Safety

Domain:

Transport and autonomous vehicles - Road vehicles

This Code is primarily intended to be used by organisations or individuals planning to trial or pilot automated vehicle technologies…

Last Updated: 15 Dec 2022

Regulation and official guidance

A guide to good practice for digital and data-driven health technologies

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Adoption and commercialisation Assurance and testing Ethical considerations Good practice for development and use Procurement

Domain:

Healthcare and medicine - Medical devices

This guide is designed to support innovators in understanding what the NHS is looking for when it buys digital and…

Last Updated: 15 Dec 2022

Regulation and official guidance

A buyer’s guide to AI in health and care

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Topic:

Adoption and commercialisation Assurance and testing Ethical considerations Procurement

Domain:

Healthcare and medicine - Medical devices

The exciting promise of artificial intelligence (AI) to transform areas of health and care is becoming a reality. Prospective vendors…

Last Updated: 12 Oct 2022

Frameworks and principles

Evidence standards framework (ESF) for digital health technologies

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Topic:

Assurance and testing Good practice for development and use Standardisation for AI

Domain:

Healthcare and medicine - Medical devices

Last Updated: 12 Oct 2022

Legislation

Regulation laying down harmonised rules on artificial intelligence (EU AI Act)

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Topic:

Accountability Adoption and commercialisation Assurance and testing Data Ethical considerations Human rights Procurement Risk management Safety

Domain:

Horizontal

The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework…

Last Updated: 9 Aug 2024

Frameworks and principles

Deliverable 1: principles for the evaluation of artificial intelligence or machine learning-enabled medical devices to assure safety, effectiveness and ethicality

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Topic:

Assurance and testing Ethical considerations Good practice for development and use

Domain:

Healthcare and medicine - Medical devices

As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…

Last Updated: 19 Dec 2022

Frameworks and principles

Deliverable 2: principles to support the development and deployment of artificial intelligence or machine learning-enabled medical devices across jurisdictions

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Topic:

Assurance and testing

Domain:

Healthcare and medicine - Medical devices

As part of the G7’s health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of…

Last Updated: 19 Dec 2022

Content Type

Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan

Software and AI as a medical device change programme

Consultation on the future regulation of medical devices in the United Kingdom

Guidance on the AI auditing framework: draft guidance and consultation

Code of practice: automated vehicle trialling

A buyer’s guide to AI in health and care

Evidence standards framework (ESF) for digital health technologies

Regulation laying down harmonised rules on artificial intelligence (EU AI Act)

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