AI Medical Scribes Face Calls for Regulation
Synopsis
Digital Rights Watch wants AI scribes regulated as medical devices and patients given the right to refuse their use.
Australia's increasing adoption of AI medical scribes is attracting the regulatory spotlight, prompting privacy advocates to demand greater protections as health practices turn to AI for patient interactions.
The debate arises as new data reveals that general practitioner adoption of AI has almost doubled over the course of just over a year, and the nation's medicines regulator is considering whether some AI scribe products are medical devices.
The Royal Australian College of General Practitioners (RACGP) reported that by the end of 2025, approximately 40% of Australian GPs would be using an AI scribe, compared to 22% of the total in August 2024.
The surge has raised concerns about patient confidentiality, the security of the data, and liability for AI-generated clinical notes.
Patient Rights and Privacy Take Centre Stage
The discussion is based on the publication of Off the Record: AI Scribes in Australian Healthcare by Digital Rights Watch. Patients should have the legal right to opt out of using AI medical scribes during consultations without losing access to medical care, the report states.
Additionally, some patients have stated that they were encouraged to go elsewhere for care if they refused to accept the care documentation by AI. It suggests more explicit consent procedures, increased transparency regarding data collection and handling, and improved regulation of AI scribe providers.
AI medical scribes record patient-clinician interactions and create preliminary notes. While the technology is supposed to cut administrative burdens, clinicians will still need to check and approve each record before it gets added to a patient's medical history.
Regulators Review Expanding AI Scribe Market
Around 200 AI scribe products are currently being evaluated by the Therapeutic Goods Administration (TGA) to assess whether they fall within Australia's definition of a regulated medical device. The review is part of a wider debate on the need for more rigorous regulation of AI systems generating information for clinical decision-making.
Australia is not the only country that is evaluating the technology. In the United States, Canada and the United Kingdom, healthcare organisations and regulators have also provided guidance or commenced to examine the governance of AI medical scribes.
Clinicians in the United States have been advised by legal experts that it is their responsibility to ensure that the accuracy of the medical record is maintained, even if the documentation is done with the assistance of AI.
The healthcare AI industry's growth is getting bigger. The global artificial intelligence in healthcare market is estimated to have reached a value of US$26.57 billion in 2024, and is expected to rise when healthcare organizations invest more in digital clinical solutions.
With the rapid pace of adoption, regulators in various countries are now prioritizing patient privacy, informed consent, and the trustworthiness of AI-generated documentation.
Source: InformationAGE
Pooja Malik is a business journalist with over six years of experience covering startups, entrepreneurship, and emerging trends. She has previously worked with leading media platforms such as YourStory Media and BW BusinessWorld, where she reported on business, policy, and market developments. Currently, she serves as Editor at The Inspirepreneur Magazine, where she writes and edits stories across business, lifestyle, and travel, with a focus on clarity, accuracy, and reader relevance.
