Compliance & trust
ProClinic is designed around POPIA, HPCSA record-keeping, the Medicines Act, and the Medical Records Act. Data lives on AWS. Nothing goes to a patient, a medical aid, or the medico-legal record without your signature.
ProClinic is registered with the Information Regulator. Louis Basson serves as our appointed Information Officer (Reg 2026-011081). We process personal information under the eight POPIA conditions — accountability, processing limitation, purpose specification, further processing limitation, information quality, openness, security safeguards, and data subject participation. Full data subject rights (access, correction, deletion, objection) are honoured via basson@proclinicai.com.
All patient and personal data is stored and processed on AWS. We do not transfer patient data offshore without explicit contractual and consent-based justification.
Every clinical, patient-facing, and financial output waits for the treating clinician's signature. Notes are not recorded, prescriptions are not printed, claims are not submitted, until the dentist approves. Every approval is timestamped and logged.
Clinical generation is grounded in a verified, clinician-authored knowledge base. If the knowledge base cannot support a claim with a cited source, ProClinic states what is missing rather than fabricating an answer. Treating clinicians remain accountable for every final decision.
Cite-or-refuse in action
The scenario below is from a live consultation on ProClinic. The patient had a documented severe penicillin allergy. The initial prescription drafted for a dental infection would have included Amoxicillin. ProClinic's prescription agent, grounded in the verified knowledge base, blocked the draft and demanded a substitution before the dentist could approve the script. This is what safety by design looks like at the chair — not a warning banner, a signature gate.
Grounded, not guessed
The allergy comes from the patient's verified record, retrieved by get_patient_documents.
Halts before signature
The prescription cannot be signed while the contraindication is unresolved. Substitution is required first.
Logged for audit
The safety-flag event, tool calls, and clinician response are all recorded in the audit log.
Encryption at rest and in transit. Role-based access. Every agent call, every retrieval, every approval, every claim — logged, timestamped, and searchable. Access is scoped per practice and per role.
Note structure, retention, and audit trails are designed against HPCSA record-keeping guidance and the National Health Act. Records are retained for the periods required by South African law.
SAHPRA positioning
ProClinic Dental AI is a software-only clinical decision support (CDS) platform. It does not diagnose, prescribe, or execute clinical decisions. The registered dental practitioner remains the sole decision-maker at every step. On that basis, ProClinic sits outside the Software-as-a-Medical-Device (SaMD) classification under SAHPRA-aligned SaMD principles.
To provide clinical decision support to qualified dental practitioners by facilitating the review of relevant clinical information. The platform is not intended for autonomous diagnosis, treatment-plan selection, prescription authorisation, or execution of clinical decisions.
Software is regulated as SaMD only where it is intended to be used for a medical purpose and performs that purpose without reliance on a healthcare professional. ProClinic does not perform a medical function independently of a practitioner, does not drive or determine clinical outcomes, and requires active professional interpretation at all times.
All outputs require practitioner review before any clinical action. No diagnosis, prescription, or treatment decision can be generated or implemented by the software alone. The platform cannot function as a stand-alone medical or diagnostic solution.
The practitioner remains the sole decision-maker in respect of diagnosis, prescribing, and treatment; retains full professional and ethical responsibility for patient care; and exercises independent clinical judgment irrespective of any software output. ProClinic expressly disclaims clinical authority.
Communications & labelling
All user interfaces, platform workflows, contractual documentation, and marketing materials are structured to reflect that the software (a) provides clinical decision support only; (b) does not constitute a medical device; and (c) does not provide diagnostic or therapeutic determinations. No representations are made that ProClinic Dental AI replaces, overrides, or automates professional dental judgment.
Ongoing regulatory posture
SaMD frameworks may evolve, and software functionality can change over time. If ProClinic's intended purpose or technical capabilities are expanded in a way that may bring it within the scope of regulated SaMD, we will reassess the regulatory classification and proactively engage with SAHPRA to ensure full compliance. This positioning is reviewed periodically to remain aligned with applicable legislation and SAHPRA guidance.
Signed off by
Dr Louis Trichardt
Chief Executive Officer, ProClinic AI Solutions
HPCSA DP0116726
Trademark & intellectual property
The PROCLINIC brand and the multi-agent orchestration technology are held by ProClinic IP (Pty) Ltd, the group IP-holding entity, and licensed to the operating company. Filings are handled by De Klerk & Van Gend Incorporated, Bellville.
Word mark
PROCLINIC
South African trade mark application no. 2026/17044-7, filed 14 May 2026.
Classes
09 · 35 · 42 · 44
Software (09), business services (35), technology and hosted services (42), and medical & dental services (44).
Patent
ZA 202602343
SA provisional patent filed February 2026 covering multi-agent orchestration for clinical practice management and the verified knowledge methodology.
Applications receipted; examination and registration pending on standard SA trade-mark prosecution timelines.
