AI Regulation in Pharmacy: The New Rules and What Is Coming

This article is general information, not legal advice. AI regulation in Australia is developing quickly, and some measures below are proposed rather than in force. For decisions about your pharmacy, get advice specific to your situation.

AI regulation sounds like a problem for big technology companies, not a community pharmacy. But because pharmacy sits in health, a regulated and trust-sensitive field, the rules matter here sooner than in most industries. The reassuring part is that the direction is clear, and choosing the right kind of AI keeps you on the safe side of it.

This guide explains where AI regulation in Australia stands, the two rulebooks most relevant to a pharmacy, and what they mean when you choose an AI tool.

Australia is moving to regulate AI

Australia does not yet have a single, dedicated AI law. Instead, AI is governed by existing laws, such as privacy and consumer law, with new AI-specific measures being layered on top. The clearest signal came in September 2024, when the government released a Voluntary AI Safety Standard and, alongside it, a proposals paper on mandatory rules for higher-risk uses of AI.

For a pharmacy, two rulebooks matter most: the health-specific rules from the TGA, and the general AI rules taking shape for high-risk settings.

When is pharmacy software a medical device?

The Therapeutic Goods Administration regulates software-based medical devices, under rules that took effect in 2021. The key question is what the software does.

Software that performs a clinical or diagnostic function, such as clinical decision support that recommends a treatment, can be regulated as a medical device. Software that only handles administrative tasks is not. An AI receptionist that answers routine calls about hours, prices, and script status is administrative. It is not diagnosing or advising on treatment, so it sits outside the medical-device rules.

The line to watch is clinical advice. An AI that starts giving patients clinical recommendations could cross into medical-device territory, which is a strong reason to choose tools that escalate clinical questions to a pharmacist rather than answer them.

The proposed AI guardrails for high-risk settings

The second rulebook is broader. In September 2024 the government proposed 10 mandatory guardrails for AI in high-risk settings, mirrored by a voluntary standard that businesses can adopt now.

The guardrails focus on sensible expectations: testing AI before and during use, being transparent with the people affected, keeping a human accountable and able to oversee the system, and maintaining records. Health-related uses are the kind of setting these rules are aimed at, so a pharmacy adopting AI is wise to expect that direction of travel, even while the mandatory version is still being finalised.

What this means when choosing an AI receptionist

You do not need to become a regulatory expert to make a good choice. A few principles keep you aligned with where the rules are heading:

Favour tools that keep clinical judgement with the pharmacist and escalate anything clinical, so you stay clearly on the administrative side of the medical-device line. Prefer providers who are transparent about how the system works and what data it uses. And look for Australian hosting and clear accountability, which support both privacy and the emerging AI standards.

How Krepko approaches this

Krepko built Emily as an administrative tool by design. It answers routine pharmacy calls and escalates clinical or complex ones to your team, so it is not making clinical decisions. It runs on a private, Australia-based server, and it is built to be transparent about what it does.

Regulation will keep evolving, and the responsibility to comply sits with your pharmacy. But choosing AI that is scoped to routine work, keeps a human in charge of clinical calls, and is hosted locally is a practical way to stay on the right side of both today’s rules and tomorrow’s. For your obligations around patient data specifically, see our guide to AI, privacy and compliance for pharmacies.