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S Mahomed1, M V Ncube2, A Dhai3

  • 1Department of Jurisprudence, School of Law, University of South Africa, Pretoria, South Africa.

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Area of Science:

  • Healthcare Ethics
  • Artificial Intelligence in Medicine
  • Regulatory Science

Background:

  • Artificial intelligence (AI) is transforming healthcare delivery.
  • The Health Professions Council of South Africa released Booklet 20, an ethical framework for AI in healthcare.
  • This review critically examines Booklet 20 from the perspective of the South African Medical Association AI Task Team.

Purpose of the Study:

  • To evaluate Booklet 20's alignment with South African legislation and policy.
  • To identify operational gaps in the ethical framework for AI in healthcare.
  • To propose recommendations for strengthening AI governance in clinical practice.

Main Methods:

  • Critical review of Booklet 20.
  • Analysis against national legislation (POPIA, SAHPRA guidance, National AI Policy, NHREC guidelines).
  • Examination of ethico-social context, including ubuntu ethics.

Main Results:

  • Identified operational gaps in human oversight, disclosure, data sovereignty, equity, accountability, and risk categorization.
  • Booklet 20 provides a foundation but lacks concrete implementation tools.
  • Need for risk-tiered safeguards, structured consent, governance coordination, and standards for transparency, explainability, and bias mitigation.

Conclusions:

  • Booklet 20 requires practical implementation tools for effective ethical AI integration.
  • South Africa's ubuntu ethic emphasizes relational accountability, fairness, and community participation.
  • Recommendations focus on strengthening ethical governance for safe, equitable AI adoption, patient trust, and professional integrity.