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Technical draft deliverable issued by the ITU-T Focus Group on AI for Health presenting structured good machine learning practice guidelines and regulatory considerations for manufacturers and regulators of AI-based medical devices across the product life cycle.
Organization:
International Telecommunication Union (ITU), Telecommunication Standardization Sector (ITU-T)
Focus Group:
ITU-T Focus Group on AI for Health (FG-AI4H)
Study Period:
2017–2020
Document Code:
FG-AI4H-J-039
Deliverable:
DEL2.2
Version:
0.2.0
Draft Date:
20-09-2020
Meeting:
E-meeting, 30 September – 2 October 2020
Source:
Editors
Editors:
Luis Oala; Christian Johner; Pradeep Balachandran
Contributors:
Alixandro Werneck Leite; Andrew Murchison; Anle Lin; Juliet Rumball-Smith; Pat Baird; Peter G. Goldschmidt; Shan Xu; Sven Piechottka; Zack Hornberger
Purpose:
Discussion
Type of Document:
Technical paper / Draft deliverable
Keywords:
Regulatory Checklist; Software-as-a-Medical Device; AI based Medical Devices
Scope:
Good machine learning practice guidelines for AI-based health solutions
Regulatory References:
IMDRF; FDA
Lifecycle Coverage:
Pre-market and post-market requirements for AI-based medical devices
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Year:
2020
Region / city:
Geneva
Topic:
AI-based medical devices
Document type:
Technical paper
Organization / institution:
International Telecommunication Union (ITU)
Author:
Luis Oala, Christian Johner, Pradeep Balachandran
Target audience:
AI solution developers/manufacturers
Period of validity:
Draft document
Approval date:
April 2020
Date of changes:
April 2020
Year:
2021
Region / city:
Firth of Forth
Theme:
Environmental Regulations, Habitat Conservation, Development Impact Assessment
Document Type:
Guide
Organization / Institution:
European Union
Author:
Unknown
Target Audience:
Developers, Regulators, Environmental Impact Assessors
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Contextual Description
Year:
2026
Organization:
NAIC Innovation, Cybersecurity and Technology (H) Committee
Type of document:
Regulatory guidance / Supplementary tool
Audience:
State insurance regulators
Topics:
Artificial intelligence, machine learning, insurance risk assessment, consumer protection
Sections:
Exhibit A – Quantify Regulated Entity’s Use of AI Systems; Exhibit B – AI Systems Governance Risk Assessment Framework; Exhibit C – AI Systems High-Risk Model Details; Exhibit D – AI Systems Model Data Details
Scope:
Financial and consumer risk evaluation of AI systems usage in insurance companies
Year:
2023
Region / City:
United States
Subject:
Artificial Intelligence, Insurance, Risk Management
Document Type:
Regulatory Tool
Institution:
National Association of Insurance Commissioners (NAIC)
Author:
Big Data and AI Working Group (BDAIWG)
Target Audience:
State Regulators, Insurance Companies
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2015
Region / city:
Western Interconnection
Subject:
Reliability Standards, Automatic Voltage Regulators
Document type:
Compliance Audit Worksheet
Organization / institution:
WECC
Author:
WECC Compliance Staff
Target audience:
Entities subject to compliance audits for VAR-002-WECC-2
Period of validity:
Ongoing
Approval date:
July 2011
Revision date:
July 2015
FROM:
NAIC Staff
RE:
Information Regarding the Transition to TeamMate+
Year:
2023
Region / city:
NA
Subject:
Pricing and transition details for TeamMate+ implementation
Document type:
Memorandum
Author:
NAIC Staff
Target audience:
State regulators and procurement officers
Period of validity:
Ongoing transition
Approval date:
January 2023
Date of changes:
None specified
Note:
Year
Organization / institution:
Energy Intensive Users Group (EIUG)
Year:
2016
Region / City:
UK
Topic:
Business regulation
Document type:
Impact Assessment
Organization / Institution:
Department for Business Innovation and Skills / Cabinet Office
Author:
Margot James
Target audience:
Regulators, policymakers, businesses
Period of validity:
Not specified
Approval date:
25/11/2016
Date of amendments:
Not specified
Year:
2021
Region / city:
South Asia
Topic:
Telecommunication and ICT Regulation
Document Type:
Action Plan
Organization:
South Asian Telecommunication Regulators’ Council (SATRC)
Author:
South Asian Telecommunication Regulators’ Council (SATRC)
Target Audience:
Telecommunication regulators
Period of Action:
2022 – 2023
Approval Date:
3 November 2021
Modification Date:
N/A
Year:
2023–2025
Location:
ICAR- National Institute of Abiotic Stress Management, Malegaon, Baramati, Maharashtra, India
Crop:
Mango (Mangifera indica L.) cv. Kesar
Subject:
Plant growth regulators, biostimulant and deficit irrigation
Irrigation Regimes:
100% ETc and 75% ETc
Experimental Design:
Split plot design with three replications
Treatment Combinations:
Fourteen (T1–T14)
Plant Growth Regulators:
Salicylic acid (200 ppm), CPPU (2.5 ppm)
Biostimulant:
Seaweed extract (4 ml/litre)
Phenological Stages of Application:
Flowering (December–January), Fruit development (February–March), Maturity (April–May)
Parameters Studied:
Vegetative growth, canopy characteristics, yield attributes, biochemical traits
Key Measurements:
Plant height, canopy spread, canopy volume, fruit number, fruit yield, TSS, ascorbic acid, titrable acidity
Document Type:
Experimental research study
Year:
2026
Region / Country:
United Kingdom
Topic:
Technology regulation and economic growth
Document type:
Written evidence
Organization:
ACT | The App Association
Authors:
ACT members and small technology companies
Target audience:
House of Lords Industry and Regulators Committee
Relevant legislation:
Digital Markets, Competition and Consumers Act 2024; EU Digital Markets Act
Key issues:
Regulatory impact on SMEs, AI policy, standard-essential patent licensing, mobile ecosystem security
Date submitted:
16 January 2026
Appendices included:
Appendix 1 – Mobile Ecosystem SMS designations and roadmaps, 22 December 2025
Document type:
Research proposal section
Research area:
Systems biology and epigenetics
Scientific field:
Gene regulatory network modeling
Research focus:
Integration of epigenetic regulators into gene network inference
Model organism:
Arabidopsis thaliana
Key regulator studied:
SET Domain Group 8 (SDG8)
Homologous human protein:
SETD2
Epigenetic mechanism:
H3K36 histone methylation
Biological processes referenced:
Gene regulation and chromatin modification
Methodological approaches:
Time-course transcriptome analysis, predictive network modeling, dynamic Bayesian networks, state-space modeling
Data sources referenced:
Epigenomics datasets and ENCODE resources
Research objectives:
Identification of genomic targets of epigenetic regulators and evaluation of their role as predictors in gene regulatory network models
Proposed framework:
EpiNet
Research components:
Significance, Innovation, and Approaches
Experimental strategy:
Integration of experimental perturbation data with computational network inference
Year:
2017
Region / City:
Milsons Point, NSW, Australia
Subject:
Financial services regulation, credit card debt, consumer protection
Document type:
Letter
Organization / Institution:
Australian Broadcasting Corporation (ABC)
Author:
PJ Scribe
Recipients:
Sam Lipski, Robert Raymond
Target audience:
Executive Producers of Four Corners
Period covered:
2001–2017
Reference:
Proposed Four Corners programme "Nobody Cares in a Christian Country"
Key topics:
Persistent revolvers, financial literacy, Reserve Bank of Australia, ASIC, predatory credit card practices
Year:
2026
Date:
3 February 2026
Time:
10.30 am
Location:
London, United Kingdom
Institution:
House of Lords Industry and Regulators Committee
Type of document:
Uncorrected oral evidence transcript
Evidence session number:
10
Questions:
118–130
Hearing format:
Public evidence session
Witnesses:
John Fingleton CBE; Dan Corry OBE; Rebecca Shrubsole
Committee Chair:
Baroness Hayter of Kentish Town
Committee members present:
Lord Barber of Ainsdale; Lord Best; Baroness Carberry of Muswell Hill; Baroness Drake; Lord Fuller; Baroness Harding of Winscombe; Lord Teverson; Viscount Thurso; Viscount Trenchard; Lord Udny-Lister; Baroness Valentine
Subject:
Regulation and economic growth
Policy areas discussed:
Regulatory policy; nuclear sector regulation; environmental regulation; governance and public administration
Government departments referenced:
Department for Environment, Food and Rural Affairs
Publication status:
Uncorrected transcript of oral evidence
Broadcast:
Parliamentlive.tv
Year:
2024
Region / City:
Global
Theme:
Plant growth regulators, Seed production, Cherry tomato
Document Type:
Research Review
Author:
Various
Target Audience:
Agricultural researchers, Crop scientists, Horticulturists
Period of Action:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Journal:
Journal of Applied Life Sciences International
Manuscript Number:
Ms_JALSI_151529
Article Title:
Dietary Bioactives as Genomic Regulators: A Critical Review of Gene Control, Biomarker Validation, and Translational Barriers in Nutrigenomics
Article Type:
Review Article
Document Type:
Peer Review Report
Reviewer:
Sumon Rahman Chowdhury
Reviewer Affiliation:
Chittagong Diabetic General Hospital
Country:
Bangladesh
Subject Area:
Nutrigenomics; Nutrigenetics; Epigenetics; Precision Nutrition
Key Scientific Topics:
Gene regulation by dietary bioactives, biomarkers, molecular mechanisms, obesity-related genes, translational barriers
Genes and Pathways Mentioned:
NRF2, NF-κB, FFAR1, FTO, GLUT4, PPARγ, leptin
Methodological Note:
Recommendation to describe methodology as “a narrative critical review using structured literature search”
Ethical Issues Statement:
No ethical issues reported
Purpose of Document:
Evaluation and revision recommendations for a submitted scientific manuscript
Year:
2021
Organization:
International Telecommunication Union
Sector:
Telecommunication Standardization
Study period:
2017-2020
Working Group:
WG2
Document type:
Input document / Report
Title:
Report of FG-AI4EE Working Group 2, 25 January 2021
Purpose:
Information
Contact:
Leonidas Anthopoulos, WG2 Co-chairman FG-AI4EE
Keywords:
Report; FG-AI4EE; Working Group 2
Meeting date:
25 January 2021
Next meeting date:
25 February 2021
Participants:
9
Location:
Online / e-meeting
Year:
2022
Region / City:
N/A
Topic:
Environmental Efficiency, AI, Emerging Technologies
Document Type:
Report
Organization:
International Telecommunication Union (ITU)
Author:
FG-AI4EE Working Group 1
Target Audience:
Experts, Researchers, Policymakers
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2020
Region / city:
Geneva
Topic:
Radiocommunication
Document Type:
Report
Body / Institution:
ITU - Working Party 5A
Author:
Chairman, Working Party 5A
Target Audience:
Telecommunications professionals, stakeholders in radiocommunication
Period of Effectiveness:
November 2020
Approval Date:
15 December 2020
Date of Changes:
N/A
Year:
2020
Region / City:
International
Theme:
Environmental Efficiency, AI, Emerging Technologies
Document Type:
Meeting Report
Organization:
International Telecommunication Union (ITU)
Author:
Joel Alexander Mills, Co-Chairman
Target Audience:
Experts, ITU Members
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified