Concept & Risk Analysis

Fairness

Data & digital tools: 

Evaluate defined data sources to identify any containing patient data. (Ref. ISO 22989 section 5.15.9 AI bias and fairness)

Personnel Training:

For AI systems development where defined data sources include patient data, training on ISO 22989 Artificial intelligence concepts and terminology.

Links:

ICH Q8(R2): https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf

ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

ICH Q12: https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf

ICH M15: https://database.ich.org/sites/default/files/ICH_M15_EWG_Step2_DraftGuideline_2024_1031.pdf

ISO/IEC TS 12791:2024 (Information technology — Artificial intelligence — Treatment of unwanted bias in classification and regression machine learning tasks): https://www.iso.org/standard/84110.html

ISO/IEC TR 24027:2021 (Information technology — Artificial intelligence (AI) — Bias in AI systems and AI aided decision making): https://www.iso.org/standard/77607.html

ISO/IEC TR 24368:2022 (Information technology — Artificial intelligence — Overview of ethical and societal concerns): https://www.iso.org/standard/78507.html

WHO Data Principles: https://www.who.int/docs/default-source/world-health-data-platform/who-data-principles-10aug-%283%29.pdf

WHO Annex 4: Guideline on data integrity: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf?sfvrsn=6218a4e6_4&download=true

ASME VV40: https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices

FDA Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

EMA and FDA set common principles for AI in medicine development: https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0

EMA Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle: https://www.ema.europa.eu/system/files/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle-en.pdf

AI Playbook for the UK Government: https://www.gov.uk/government/publications/ai-playbook-for-the-uk-government

UK Government Implementing the UK’s AI regulatory principles: initial guidance for regulators: https://www.gov.uk/government/publications/implementing-the-uks-ai-regulatory-principles-initial-guidance-for-regulators

UK Government A pro-innovation approach to AI regulation: https://www.gov.uk/government/publications/ai-regulation-a-pro-innovation-approach/white-paper