Healthcare and medicine Archives

DSF M399201

Medical laboratories – Part 1: General principles for the application of artificial intelligence in medical laboratories

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System lifecycle Process, management and governance

This document specifies general principles for the application of artificial intelligence in the medical laboratory.This document is applicable to methods…

Draft

Last Updated: 27 Apr 2026

ANSI/HSI 2800

Artificial Intelligence (AI) Governance in Healthcare Operations

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Healthcare and medicine AI-specific Accountability Organisational governance

Risk management System lifecycle Process, management and governance

Establish guidelines for integrating AI in healthcare system operations, both clinical and administrative. This should include its place in strategy…

Published

Last Updated: 27 Apr 2026

Frameworks and principles

Good machine learning practice for medical device development: Guiding principles

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Topic:

Good practice for development and use

Domain:

Healthcare and medicine - Medical devices

Organisation: International Medical Device Regulators Forum

Last Updated: 15 Jan 2025

Strategies and roadmaps

Impact of AI on the regulation of medical products

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Topic:

Adoption and commercialisation Good practice in development and use

Domain:

Healthcare and medicine - Medical devices

This document summarises the MHRA’s strategic approach to AI regulation following the UK Government request for an update from regulators…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 15 Jan 2025

BS EN IEC 63310

Functional performance criteria for robots used in AAL connected home environment

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Healthcare and medicine - Care and support Internet of things AI-specific Product and performance requirements See more

Published

Last Updated: 31 Oct 2024

ISO 13482:2014 BS EN ISO 13482:2014

Robots and robotic devices. Safety requirements for personal care robots

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Healthcare and medicine - Care and support AI-enabling - Non-intelligent robotics and autonomous systems AI-enabling - Risk management Human-computer interaction

Risk management Safety Process, management and governance Product and performance requirements

What is this standard about? It supplies the latest guidelines and specifications to ensure the safe design and use of…

Published

Last Updated: 18 Jul 2024

ISO/TS 22287:2019 PD ISO/TS 22287:2019

Health informatics. Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)

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Healthcare and medicine - Health informatics AI-enabling - Corporate governance AI-enabling - Information management Skills and readiness

Process, management and governance

What is ISO/TS 22287 – Terminology services in healthcare about? The use of terminology service helps in understanding and sharing…

Published

Last Updated: 18 Jul 2024

PAS 277:2015 from BSI

Health and wellness apps. Quality criteria across the life cycle. Code of practice

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Healthcare and medicine AI-enabling Project management Risk management

System lifecycle System quality Process, management and governance

What is PAS 277 – Health and wellness apps – Code of practise with quality standards for all stages of…

Published

Last Updated: 18 Jul 2024

Strategies and roadmaps

Roadmap towards the future regulatory framework for medical devices

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Domain:

Healthcare and medicine - Medical devices

“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

Strategies and roadmaps

Medical technology strategy

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Topic:

Data Security and resilience

Domain:

Healthcare and medicine

Building on the broader Life Sciences Vision, this high-level document reviews the current UK medtech landscape and identifies and prioritises…

Organisation: Department of Health & Social Care

Last Updated: 23 Jan 2024

Regulation and official guidance

Clinical decision support software: Guidance for industry and Food and Drug Administration staff

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Topic:

Bias Data collection

Domain:

Healthcare and medicine

Organisation: U.S. Food and Drug Administration

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance on GxP data integrity

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Topic:

Data

Domain:

Healthcare and medicine

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

Content Type

Medical laboratories – Part 1: General principles for the application of artificial intelligence in medical laboratories

Artificial Intelligence (AI) Governance in Healthcare Operations

Good machine learning practice for medical device development: Guiding principles

Impact of AI on the regulation of medical products

Functional performance criteria for robots used in AAL connected home environment

Robots and robotic devices. Safety requirements for personal care robots

Health informatics. Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)

Health and wellness apps. Quality criteria across the life cycle. Code of practice

Roadmap towards the future regulatory framework for medical devices

Clinical decision support software: Guidance for industry and Food and Drug Administration staff

Guidance on GxP data integrity

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