Consulting
Compliance & Governance
Australian healthcare regulatory compliance — TGA, AHPRA, state real-time prescription monitoring, Privacy Act — translated from primary instruments into practical operating systems.
What this covers
In regulated healthcare the rules are not optional and they are not generic. The TGA Special Access Scheme, AHPRA registration and advertising standards, state-based real-time prescription monitoring (SafeScript VIC, CanniScript NSW, ScriptCheck WA, QScript, ScriptCheckSA, ACT Online, NT real-time, TASmart-Rx), the Privacy Act 1988 with the Australian Privacy Principles, and emerging Software as a Medical Device classifications all interact. I help operators read the primary instruments, translate them into workflows their clinicians and software can actually follow, and prepare the audit trail before someone asks for it.
Who it is for
- Medicinal cannabis operators expanding under post-December-2024 AHPRA and state-regulator scrutiny — including platforms like Montu, Alternaleaf, Sirius Green, Dispensary Plus, and adjacent groups.
- Telehealth platforms operating across multiple state RTPMs and prescribing in jurisdictions where the practitioner and patient may sit in different schemes.
- Health-tech startups preparing for ISO 13485 quality systems or TGA Software as a Medical Device classification.
- Investors and acquirers running clinical or regulatory due diligence on Australian healthcare targets.
Typical deliverables
- TGA Special Access Scheme (Cat A and Cat B) and Authorised Prescriber pathway design.
- AHPRA advertising, testimonials, and registration-standard compliance reviews.
- State RTPM integration and prescribing-policy alignment across multiple jurisdictions.
- Privacy Act 1988 and APP compliance frameworks for clinical and identifiable health data.
- Documentation, consent, and record-retention frameworks defensible at audit and at Notification.
- Vendor-side regulatory diligence packs for partners, lenders, and acquirers.
Why Dr Rob
Active TGA Authorised Prescriber for medicinal cannabis. Day-to-day operator under all major Australian state RTPMs through telehealth and in-person practice. Reads primary instruments — for example the WA Monitored Medicines Prescribing Code Part 4 introduced on 12 December 2024, which set the first numeric daily-dose triggers for THC prescribing in Australia — rather than relying on summary commentary. Founder of an operator subject to the same compliance load that consulting clients face, which keeps the advice practical rather than theoretical.
Engagements are delivered through Health Data Research Pty Ltd. For enquiries, use the contact page and select the business or partnerships route.