Consultations Archive – Page 8

Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node positive early breast cancer

NICE's diagnostics guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (DG34) makes recommendations on tumour profiling tests for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer. This guidance will assess use of the tests for ER-positive, HER2-negative cancer that has spread to the…

DawnNovember 17, 2023

Consultations Consultations Archive

Call for Evidence – National Security and Investment Act

Call for evidence description The Government will use this Call for Evidence to consider changes to the NSI regime. We are looking for views from cross economy stakeholders both in the UK and overseas. In particular, this evidence will help the Government: Hone the scope of the system’s mandatory notification requirements; Improve NSI notification and assessment processes; and Develop the…

DawnNovember 17, 2023

Consultations Consultations Archive External Affairs Working Party External Affairs Working Party Archive Infectious Diseases Working Party Infectious Diseases Working Party Archive Regulatory Affairs Working Party Regulatory Affairs Working Party Archive

NICE guideline on suspected sepsis – consultation

This NICE guideline covers suspected sepsis: recognition, diagnosis and early management – source control, rapid antigen tests, indicators of organ hypoperfusion, intravenous fluids, and vasopressors in the NEWS2 population. You can now comment on this draft scope. The scope defines what the guideline will (and will not) cover. The consultation closes at 5pm, Thursday 23 November 2023.

DawnNovember 10, 2023

Consultations Consultations Archive

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 KempNovember 2, 2023

Consultations Consultations 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 KempNovember 2, 2023

Consultations Consultations 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…

DawnOctober 27, 2023

Consultations Consultations Archive Membership News Membership 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 KempOctober 6, 2023

Consultations Consultations 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…

DawnOctober 6, 2023

Consultations Consultations 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.…

DawnOctober 6, 2023