Development & Verification
Fairness
Data & digital tools:
Where patient data is used in the design/operation of the digital CMC tool (typically involving AI), ensure that the system is designed not to undermine the legal rights of individuals or organisations, discriminate unfairly against individuals or create adverse market outcomes. System requirements analysis identifies risks posed by the system, impact to identified stakeholders has been assessed and stakeholder levels of engagement defined (ISO 24027).
Personnel Training:
If applicable, ISO 24027 Artificial intelligence (AI) — Bias in AI systems and AI aided decision making.
Links:
ICH Q7: https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
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
ISPE GAMP Guide: Artificial Intelligence: https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence
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
NIST Special Publication 1270: Towards a Standard for Identifying and Managing Bias in Artificial Intelligence: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.1270.pdf
NIST AI RMF Playbook: https://airc.nist.gov/airmf-resources/playbook/
NIST Artificial Intelligence Risk Management Framework (AI RMF 1.0): https://doi.org/10.6028/NIST.AI.100-1
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
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024: laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
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