The HPCSA has introduced significant ethical rule changes effective in late 2025 and 2026, focusing on Artificial Intelligence (AI) in healthcare, end-of-life decisions, and corporate employment of practitioners.
Key updates include new guidelines for AI use (Booklet 20), revised rules for withholding treatment (Booklet 7), and strict pre-approval requirements for unregistered employers (Rule 18).
• Booklet 20 – Artificial Intelligence (AI) in Health Care (New, 2025/2026): Establishes
ethical guidelines for using AI, emphasizing that accountability remains with the
practitioner, not the technology. It requires transparency with patients regarding AI tools
in their care, data privacy adherence, and ethical training for practitioners.
o Accountability: Explicitly states that AI cannot replace professional clinical
judgment; practitioners remain ultimately responsible for all clinical decisions
and interpretations of AI output
o Transparency: Patients must be informed if AI tools are being used to inform their care.
o Validation: Only AI systems validated for reliability and cultural appropriateness in South Africa should be used, aligning with SAHPRA regulatory requirements.
• Booklet 7 – Withholding/Withdrawing Treatment (Updated): Strengthens patient autonomy, requiring consultation with patients or their representatives on end-of-life decisions. It now codifies a “hierarchy of consent” for when patients cannot make decisions themselves and allows for withdrawing treatment if it brings little benefit, even if family requests it.
o Patient Representatives: Formally recognises a person nominated by the patient to make healthcare decisions if the patient loses capacity.
o Hierarchy of Consent: Provides a clear order of authority for decision-making (e.g., spouse first, then parent, etc.) if no representative was appointed.
o Futility and Best Interests: Reaffirms that practitioners may withhold or withdraw treatment they deem futile, provided the decision is grounded in the patient’s best interests and dignity …Read More