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ISO/PWI 24051-2 Medical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysis

Deadline: 28 November Scope This document specifies requirements and gives recommendations for the digitalization of slidemounted, stained sections, processing of digital whole slide images, and artificial intelligence (AI) based image analysis to support anatomical pathology examination. This document focuses on sections from formalin-fixed paraffin-embedded (FFPE) tissues (derived e.g. from surgical resection, biopsy or autopsy). It is also applicable to paraffin-embedded…
Ben Kemp
November 2, 2023
ConsultationsConsultations Archive

ISO/PWI 24051-1 Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories

Deadline: 28 November Scope This document specifies general principles for the application of artificial intelligence in the medical laboratory. This document is applicable to methods commonly considered subsets of artificial intelligence, including fuzzy logic, Bayesian networks, supervised and unsupervised machine learning, deep learning, neural networks, expert systems, robotics, natural language processing and image analysis.   Purpose Artificial intelligence refers to…
Ben Kemp
November 2, 2023
ConsultationsConsultations Archive

Health Protection (Notification) Regulations 2010: proposed amendments

  Consultation description This consultation seeks relevant stakeholder’s views on proposed additions to schedule 1 and 2 of the Health Protection (Notification) Regulations (HPNR) 2010 and amendments to diagnostic laboratory reporting requirements in England. The Department of Health and Social Care (DHSC) will publish a response to this consultation in due course. The HPNR (which apply to England only) place a statutory…
Dawn
October 27, 2023
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Medical Devices in Primary Care: Proposals for updating Part IX of the Drug Tariff – medical devices available for prescribing in primary care.

The government has today released the anticipated consultation on Medical Devices in Primary Care: Proposals for updating Part IX of the Drug Tariff – medical devices available for prescribing in primary care. Following the publication DHSC’s Medical Technology Strategy in February 2023, they have set out a series of proposals to modernise Part IX of the Drug Tariff to ensure…
Ben Kemp
October 6, 2023
ConsultationsConsultations Archive

ISO/NP 23421 Medical devices — Terminology — Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices

You can access the consultation here. Comment period end date: 03/11/2023 Scope This document defines terms in the field of quality management and corresponding general aspects for products with a health purpose including medical devices. Purpose This document will provide the fundamental terminology used in quality management and the corresponding general aspects for products with a health purpose including medical…
Dawn
October 6, 2023
ConsultationsConsultations Archive

ISO/NP TS 23918 Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

You can access the consultation here. Comment period end date: 08/10/2023 Scope This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971.…
Dawn
October 6, 2023
ConsultationsConsultations Archive

Consultation: The disclosure of industry payments to the healthcare sector

Consultation description We want to seek views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. This consultation aims to address the second part of recommendation 8 contained in the Independent…
Ben Kemp
September 22, 2023
ConsultationsConsultations Archive

Provision of Services Regulations 2009: proposed reforms

The Provision of Services Regulations 2009 (“the Regulations”) provide a framework of rules for how services are regulated in the UK. They ensure that authorisation schemes (for example, licences that businesses or individuals must secure before providing a service) which are administered by competent authorities (for example, government departments and independent regulators) are proportionate, justified in the public interest, and…
Ben Kemp
September 21, 2023
ConsultationsConsultations Archive

UK SMI ID 06: identification of Neisseria species

Consultation description UK Health Security Agency (UKHSA) has opened a consultation in joint partnership with professional organisations. This consultation asks for feedback in relation to the UK Standards for Microbiology Investigations (UK SMI) ID 06: identification of Neisseria species. We have refined the process so that UK SMI users can comment more easily if they see no requirement for amendments to the…
Dawn
September 15, 2023
ConsultationsConsultations Archive

UK SMI ID 15: identification of Actinomyces and reclassified species

Consultation description UK Health Security Agency (UKHSA) has opened a consultation in joint partnership with professional organisations. This consultation asks for feedback in relation to the UK Standards for Microbiology Investigations (UK SMI) ID 15: identification of Actinomyces and reclassified species. Please note that the title has been changed from ‘Identification of Anaerobic Actinomyces species’ to ‘Identification of Actinomyces and…
Dawn
September 15, 2023
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