What does HPCSA Booklet 20 ask of a practice that uses AI, such as an AI scribe?

Booklet 20 asks the practitioner to stay the final decision maker, to tell patients before an AI tool is used and when it assisted a diagnosis or treatment, and to protect the patient's information. The HPCSA does not regulate or approve AI tools, so the practitioner stays accountable for the ones they choose.

What Booklet 20 asks

Booklet 20, published in September 2025, names voice recognition for clinical documentation and language processing of clinical notes among the AI uses already in daily care.¹ It says the HPCSA does not regulate or approve new technologies, that health practitioners always make the final decision on patient care, and that it is contrary to good practice for AI to be the final decision maker.¹ Patients must be told when a diagnosis or treatment recommendation was assisted by AI, and a patient who declines AI may not be disadvantaged or refused care.¹

How to adopt AI under Booklet 20

1. Assess the tool. Check it suits its purpose, is reliable and explainable, and how it learns from data, as section 4 asks.
2. Tell the patient first. Before use, explain the tool's capabilities and limits and the safeguards in place, and record the patient's agreement.
3. Keep the decision human. The clinician reviews and signs every AI output, and never lets the tool decide.
4. Protect the data. Use the tool under POPIA and the practice's confidentiality controls, with access logged.
5. Train the team. Booklet 20 makes skill in AI tools part of continuing professional development.

1. Tool ______ Purpose ______ Introduced on ______
2. Assessed for fit, reliability and data use by ______
3. How patients are told ______ Agreement recorded where ______
4. Who reviews and signs the output ______
5. Data stored in ______ Access logged ______
6. Next review ______

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Telehealth, and what is proposed

Booklet 10 asks that the consent for telehealth cover the secure storing and encryption of any recordings of consultations, and says no practitioner may render services exclusively through telehealth.² Draft 1 of revised Norms and Standards Regulations, out for consultation and not in force, proposes chapters on digital health, artificial intelligence and telemedicine, with human oversight and clinical accountability.³ Consent itself still follows Booklet 4, set out in the guide to informed consent.⁴

Questions

Is Booklet 20 binding?

The HPCSA's booklets are the standard against which a registered practitioner's conduct is evaluated, and Booklet 20 is listed on its Ethics page as the guideline on AI.

Must patients consent to an AI scribe?

Booklet 20 asks for disclosure of an AI tool before it is used, and Booklet 10 asks that consent for telehealth cover how any recordings are stored, so most practices record consent at booking.

Who is liable when AI gets it wrong?

The practitioner remains accountable for clinical decisions, and Booklet 20 adds that developers are also liable with the user for adverse events caused by malfunction or inaccurate output.

Sources

1. 1Health Professions Council of South Africa, 2025Booklet 20, Ethical guidelines on the use of artificial intelligence, September 2025Read source
2. 2Health Professions Council of South Africa, 2021Booklet 10, General ethical guidelines for good practice in telehealth, revised December 2021Read source
3. 3Office of Health Standards Compliance, 2026FAQs, Review of the 2018 Norms and Standards Regulations, stakeholder consultation on Draft 1Read source
4. 4Health Professions Council of South Africa, 2021Booklet 4, Seeking patients' informed consent, the ethical considerations, revised December 2021Read source

Written by the wai team from Health Professions Council of South Africa and Office of Health Standards Compliance guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the OHSC nor the HPCSA endorses wai or any software.