Australia's Healthcare Pulse

Four separate disputes converged into one structural story. The PBS listing of ublituximab (Briumvi, Neuraxpharm) in January 2026 — at a price the Department of Health required to be 40% lower as a condition of listing — triggered a reference-pricing review of the anti-CD20 class, implying cuts of 40% to 50% for ocrelizumab (Ocrevus, Roche) and ofatumumab (Kesimpta, Novartis). Roche and Novartis refused. The PBAC considered the standoff in a confidential session during its 8–10 July meeting, and on 16 July Health Minister Mark Butler confirmed Ocrevus, Kesimpta and Lemtrada would remain listed while a rapid review is completed by December 2026. Roughly 10,000 Australians use the two main therapies; privately funding Ocrevus costs about $33,000 a year. Separately, AstraZeneca withdrew goserelin 3.6 mg (Zoladex) from both the PBS and the private market effective 1 November 2026, saying the Australian price made supply unsustainable; after a petition gathered more than 42,000 signatures it committed on 30 July to supply the implant free of charge indefinitely to patients with no suitable alternative. Eli Lilly had already withdrawn tirzepatide (Mounjaro) from the PBS listing process for type 2 diabetes in April after price negotiations broke down, and Sanofi-Aventis is discontinuing glibenclamide (Daonil) from 30 November 2026 on commercial grounds.

Butler linked the disputes to United States policy. Companies are increasingly unwilling to accept low ex-factory prices anywhere, because the US “most favoured nation” approach ties American prices to those paid in comparable countries. Paul Cross, a former PBS adviser to the Howard government and former pharmaceutical executive, noted that supplying Zoladex free was probably more financially attractive than setting a low price precedent: a product given away may sit outside the international reference benchmark, while a discounted one does not.

The Grattan Institute's report Future pharmacy: A better deal for patients and taxpayers, released 12 July 2026, recommends ending Community Pharmacy Agreements entirely. It argues the arrangement — negotiated privately between the federal government and the Pharmacy Guild of Australia since 1990, and unlike any other major health funding arrangement in Australia — should be replaced by independent, evidence-based decisions, with the Independent Health and Aged Care Pricing Authority setting rates if agreements are retained. Specific recommendations include scrapping unjustified dispensing fees, redesigning the high-cost medicine stocking fee to save up to $285 million a year, removing pharmacy location rules (including the 10-kilometre separation rule and the prohibition on pharmacies in supermarkets), removing ownership limits, phasing out restrictions on discounting, tightening MedsCheck criteria, and funding pharmacists to work in GP clinics and Aboriginal Community Controlled Health Organisations at roughly $80 million a year. The report notes the Guild donated $2.5 million to political parties over five years, making it the largest political donor in the health sector, and that ownership rules have not prevented consolidation: 44% of community pharmacies now sit within four large banner groups. The eighth agreement runs to 30 June 2029; Grattan argues it should be the last. The Guild rejected changes to ownership and location rules, citing 6,000 community pharmacies and 330 towns where a pharmacy is the only primary healthcare provider. It subsequently wrote to Grattan's financial supporters; Grattan characterised this as pressure over its reform proposals. The RACGP welcomed the report.

On 18 June 2026 Bupa announced an agreement to acquire Partnered Health Group — 68 primary care clinics, three urgent care clinics, and five corporate health and wellbeing brands (Jobfit, Baseline Onsite, New View Psychology, NewPsych Psychology and Australian EAP) — subject to ACCC and Foreign Investment Review Board approval. Bupa currently operates 32 medical centres and 13 Mindplace clinics; the deal would take it to 100 medical clinics and, on Medical Republic's reading of Medius Global's June 2026 operator rankings, make it the fifth-largest general practice operator in Australia behind Amplar Health/Medibank (170 sites), IPN/Sonic (143), Family Doctor (109) and ForHealth (106). Insurers would then sit behind roughly 15% of Australia's group general practices. Partnered Health extends Bupa's footprint into the ACT, Tasmania, South Australia and Perth.

On 23 June — five days after the announcement — a malicious actor accessed Partnered Health's data. The company disclosed the breach on 15 July, more than three weeks after becoming aware of it. Twenty-one clinics across Sydney, Melbourne, Brisbane, Perth and Canberra were affected. Stolen information included names, dates of birth, addresses, contact details, Medicare numbers, private health insurance and concession card details, alongside consultation notes, referral letters and pathology or diagnostic results. Partnered Health obtained an interim injunction in the NSW Supreme Court restraining use or publication of the data, and reported the incident to the Australian Cyber Security Centre, the Office of the Australian Information Commissioner and law enforcement. It declined to state how many patients were affected. A University of Melbourne information systems academic, Dr Suelette Dreyfus, noted an injunction is unlikely to prevent sale on closed markets. The OAIC received 1,205 data breach notifications in calendar 2025, up 8% on 2024.

On 2 July 2026 the Australian Government passed legislation allowing designated registered nurse prescribers to prescribe PBS medicines, implementing a recommendation of the Scope of Practice Review. The reform is available to registered nurses who have completed studies required by the Nursing and Midwifery Board of Australia, building on the NMBA registration standard for designated registered nurse prescribers that commenced in 2025 (in Western Australia from 30 September 2025) and on the national registration standard approved by all health ministers in December 2024. Changes to PBS administrative systems will be ready from 1 October 2026. ANMAC's Registered Nurse Prescribing Accreditation Standards 2025 provide the national framework for accrediting the education programs. Which medicines will be prescribable is still being determined: the PBAC's 8–10 July meeting agenda included items on designated registered nurse prescribing across several therapeutic groups of PBS-listed medicines.

Speaking at the Australian Institute of Digital Health's HIC2026 conference in Sydney on 3 August 2026, Tracey Duffy, first assistant secretary of the TGA's Medical Devices and Product Quality Division, said the regulator's year-long review of digital scribes had “moved into compliance action”. In her words: “We've had 12 months of reviewing and discussing with various companies around Australia, but we are now moving into compliance for those organisations who have deployed a scribe that's operated as a medical device and have not sought medical device regulatory approval.” The review identified scope creep, AI features influencing clinicians' decisions, a general lack of transparency and post-market feedback, and inadequate monitoring controls including unmitigated foreseeable risks. Duffy said action could be expected over the following twelve months, and that the review findings and updated developer guidance would be published “in the coming weeks”. She also said the TGA's broader AI review had concluded the existing legislative framework remains fit for purpose, requiring refinements rather than new laws, and that any future streamlining of approval would depend on post-market monitoring mechanisms that do not yet exist. Software as a medical device is one of twelve priority focus areas for TGA compliance and enforcement in 2026 and 2027.

The regulatory position is unchanged but now being enforced: a scribe that only transcribes or translates a consultation is not a medical device, while one that analyses or interprets the conversation and generates a diagnosis, differential diagnosis or treatment recommendation not stated by the clinician is. No AI scribe product is currently included in the Australian Register of Therapeutic Goods. Adoption, meanwhile, is substantial — an RACGP poll found use among Australian doctors nearly doubled from 22% in August 2024 to 40% in November 2025.

Two parallel findings sharpen the commercial picture. First, a Department of Health, Disability and Ageing briefing obtained by Guardian Australia under freedom of information and reported on 4–5 July warned that scribes “have little oversight”, that some suppliers may be unaware their cloud platforms send data offshore, and that there is limited broad-scale peer-reviewed evidence of benefit. The same document records that some suppliers advertise a 30% revenue increase for health professionals with no additional hours or consultations, “which has implications for [Medicare Benefits Schedule] costs”, and that departmental analysts estimated ten minutes saved per primary care GP per day would be equivalent to 4,295,918 additional consultations a year. Second, Digital Rights Watch's report Off the Record found that of 60 privacy policies reviewed from Australian medical providers using scribes, only four explained that use; that no Australian-based vendor it reviewed discloses the underlying AI models; and that some clinics withdraw care from patients who decline consent.

On 15 July 2026 the Prime Minister announced the establishment of an Office of AI within the Department of the Prime Minister and Cabinet, effective immediately, to coordinate the design of Australian Standards for AI. The standards will include mandatory requirements for large AI data centres covering energy and water, alongside copyright protections; the approach was to be considered by National Cabinet in August, with standards expected to be legislated early next year. The government has described this as the first single national AI framework in the world. It follows the National AI Plan of December 2025, which committed about $30 million to an AI Safety Institute established in early 2026.

One week later, on 22 July, the Australian Alliance for Artificial Intelligence in Healthcare launched Don't Walk. Run., the third National Policy Roadmap for AI in Healthcare, developed with the Australian Institute of Health Innovation at Macquarie University, the Digital Health CRC, CSIRO's Australian e-Health Research Centre and RMIT University. It makes 28 recommendations across eight priority areas and draws on input from more than 96 organisations, around 90 questionnaire responses and roughly 20 focus groups and interviews with agencies and peak bodies. Its first recommendation is a government-led national AI in healthcare strategy, supported by a National Health AI Expert Group. Other recommendations include building sovereign technological independence to reduce reliance on international technology providers; national access to locally governed generative AI capabilities optimised for Australian healthcare; investment in privacy-preserving data ecosystems such as federated learning; AI localisation so tools are calibrated to specific Australian populations and services; national best-practice guidance for clinical implementation and procurement guidance at state and federal levels; national “Beacon sites” offering routine AI-enabled care; an AI-enabled “front door” to help people navigate services such as 1800 Medicare and My Aged Care; a national Chief AI Officer training program; dedicated AI review panels within the MRFF and NHMRC; and one or more large-scale Centres of Research Excellence in Healthcare AI. Lead author Professor Enrico Coiera told The Medical Republic that ownership should sit with the Department of Health, Disability and Ageing working with the new Office of AI, and warned that global technology companies were moving to position themselves between consumers and traditional health services.

ABC News reported on 8 September 2026 that Harrison.ai has made Australian roles redundant and is expanding into the United States with Frontier Radiology, a Delaware-registered AI-enabled teleradiology service that employs American doctors to read scans using the company's technology. Redundancies were communicated to Australian employees in April, with at least two staff confirming cuts publicly in May. An internal restructure recast every employee as a “player-coach” of AI agents — company messaging quoted by the ABC described every team member as an “agent orchestrator” — which a company leader said also prompted staff to leave. Harrison.ai received $32 million from the federal government's National Reconstruction Fund Corporation last year so that it could, in the NRFC's framing, continue to base its operations in Australia. The NRFC said it was aware of the shift, attributed it to the company moving from product development into commercialisation, said the mix of skills and roles needed for this phase is evolving, and said it remains confident about the company's long-term future and its commitment to scaling globally while remaining in Australia. The company's tools are used by about 3,500 clinicians across more than 1,000 sites for chest and brain imaging. It was valued at close to $400 million in a 2025 round; investors include I-MED, Sonic Healthcare, Aware Super and Blackbird, and a June job advertisement referred to working towards IPO readiness and ASX listing controls. Professor Wendy Rogers, a clinical ethics academic at Macquarie University, raised the concern that radiologists employed to work with a single AI system may find it harder to challenge that system's output. Harrison.ai has said its system supports radiologists rather than replacing them and that Frontier's doctors exercise independent clinical judgement. The company previously drew criticism over training models on Australian medical scans supplied through its I-MED partnership; it said the data was de-identified.

In adjacent news from the same market, Jardine Matheson agreed to acquire I-MED Radiology Network — Australia's largest diagnostic imaging provider, with 215 clinics across Australia and New Zealand and more than 7 million procedures a year — from funds advised by Permira at an enterprise value of approximately $2.4 billion, with completion expected by the end of 2026. I-MED holds a minority stake in Harrison.ai.

Queensland's Metro South Health has been rolling out Heidi's ambient AI scribe across its health service since June 2026, in what it describes as the largest AI scribe deployment in Australia to date. The rollout spans five hospitals plus mental health, community health and oral health services, covering a catchment of 1.2 million residents on Brisbane's southside and in Logan, Redlands and the Scenic Rim, and is open to a workforce of more than 10,000 clinicians. It is expected to take more than a year. The scribe is deployed on Microsoft Azure, and Metro South plans to integrate Heidi with its electronic medical record under a multi-year contract; the service says it is the first in Australia to implement a full-stack EMR. The rollout follows a 2025 trial in which 92% of participating clinicians reported spending less time on administration, documentation time savings averaged 59 minutes per doctor per day, and more than 70% of patients reported feeling their clinician spent more time with them, heard them and cared for them.

Medicines Australia published a sequence of reports through the quarter — Access Denied (18 May 2026), Bitter Pill (July 2026) and Access unlocked (September 2026) — each returning to the same finding: the 50 recommendations of the Health Technology Assessment Policy and Methods Review, published in September 2024, remain unimplemented as at July 2026. The industry body reports that 84% of its member companies say Australia has deteriorated, or is expected to deteriorate, in their global launch sequence. It states that around 25% of medicines launched globally over the past decade have been reimbursed in Australia, against 88% in the United States and 46% in the United Kingdom, and that at January 2026 only 15% of highly innovative US-approved cell and gene therapies were registered here. Medicines listed on the Life Saving Drugs Program between 2016 and 2025 faced delays of just under four years. It also notes that the PBAC's base discount rate of 5% was set in 1990 with reference to Canada and has not changed since, while the HTA Review recommended 3.5% for a selected group of technologies. Its priority asks are the recommendations covering high unmet clinical need and high added therapeutic value pathways (44 and 45), the valuation of incremental clinical advances (32–36), and an explicit qualitative values framework (26). The government established an Implementation Advisory Group which delivered a roadmap in 2025; Medicines Australia's May statement criticised a further round of departmental consultation as an additional hurdle. Separately, the Generic and Biosimilar Medicines Association pressed in August for PBS pricing reform on the opposite argument — that prices set too low risk undermining the supply of off-patent medicines.

The PBAC held a three-day meeting from 8 to 10 July 2026 covering a final total of 78 items, of which 25 required external evaluation — including 13 cost-effectiveness or cost-utility analyses and 9 cost-minimisation analyses. Its published update records that the agenda included non-submission items considering listing changes arising from recent commercial decisions of various sponsors, matters relating to designated registered nurse prescribing across several therapeutic groups, and departmental referrals on the implementation of pricing policy measures. Median time from first PBAC submission to outcome was one standard cycle for both recommended and not recommended items, and three quarters of submissions received an outcome within two cycles. Outcomes were published on 21 August 2026, and include a recommendation to list belantamab mafodotin (Blenrep) in combination with bortezomib and dexamethasone for relapsed or refractory multiple myeloma.

A separate out-of-session meeting on 30 July addressed the consequences of the Zoladex delisting directly. The PBAC's August update notes that more than 51,000 Australian women currently use goserelin and that prescribing data shows fewer than 1% of goserelin prescriptions are private, confirming heavy reliance on subsidy across hormone receptor-positive breast cancer, endometriosis and prevention of chemotherapy-induced premature ovarian failure. To preserve continuity of care, the committee recommended that the General Benefit listing for triptorelin 3.75 mg intramuscular injection (Diphereline, Ipsen) be made unrestricted, cost-minimised against goserelin 3.6 mg subcutaneous implant, with a utilisation review about two years after the amendment. Those outcomes were published on 17 August 2026.

On 5 August 2026 the Australian Digital Health Agency announced it will mandate AU Core and the Australian Core Data for Interoperability (AU CDI) as the national baseline for all FHIR-based connections to My Health Record, and begin retiring legacy technology. Together the two define the core clinical information that should be exchanged and how it should be represented consistently across systems. The indicative transition timetable, subject to consultation, would see final My Health Record FHIR conformance profiles published by mid-2027; no new conformance assessments against existing Clinical Document Architecture standards from mid-2028; no new CDA-based connections from the end of 2028; and existing CDA connections retired entirely by mid-2029, leaving FHIR profiles as the only option. The Agency will immediately sunset 11 of the 80 conformance profile versions currently active across the ecosystem, retire outdated healthcare identifiers, and stage a transition to version 9.1 of its Healthcare Information Provider Service — with HIPS 6.x reaching end-of-access on 31 March 2027, versions 7.x and 8.2.1 on 31 August 2027, and versions 8.3.0 and 8.3.1 on 30 November 2027. Agency CEO Amanda Cattermole framed the reforms as reducing variation in how health information is captured, shared and used; Chief Digital Officer Peter O'Halloran said vendors “would be foolish” not to move now.

The mandate lands five weeks after the Sharing by Default reforms commenced on 1 July 2026, requiring pathology and diagnostic imaging reports authored by or on behalf of a pathologist or radiologist to be uploaded to My Health Record by default unless an exception applies or an extension has been granted. The Agency reported that consumer views of pathology and diagnostic imaging reports had risen 433% to over 3 million weekly, on the back of a 105% increase in uploads to over 5 million weekly.

The Australian Institute of Health and Welfare released Australia's health 2026, the twentieth edition of its flagship report, on 8 July 2026. Australia spent an estimated $270.5 billion on health goods and services, with hospital care the largest share at 42% ($113.8 billion), up from 39% a decade ago. Spending was just over $10,000 per person in 2023–24 — 17% higher than a decade earlier after inflation, and about a quarter above the average among wealthy nations. Chronic conditions cost the health system around $98 billion in 2023–24, more than half (54%) of all disease spending. More than three in five Australians (61%) have at least one chronic condition and almost two in five (38%) have two or more. Dementia is now the leading cause of death. Cancer causes the greatest burden of disease, with five-year survival rising from 50% in 1987–1991 to 72% in 2017–2021; mental and substance use disorders are the second largest cause of healthy life lost, and mental illness has increased among young people. Life expectancy for a boy born in 2022–2024 was 81.1 years and for a girl 85.1 years. Average out-of-pocket fees were $1,634, nearly $200 higher than a decade earlier in today's dollars; 8% of Australians said they delayed or avoided a GP visit in 2024–25 because of cost, and 16% skipped dental care, where patients fund 61% of total costs. The AIHW estimates 36% of ill health and premature death could be prevented by changes to lifestyle and environmental factors. Childhood immunisation rates have fallen over the past five years, and hospital wait times are increasing.

A study published in PLOS Digital Health on 19 August 2026 analysed all 1,357 AI/ML-enabled medical devices cleared or approved by the US FDA through 5 December 2025, using the FDA device database and the American College of Radiology Data Science Institute catalogue, with linked searches of ClinicalTrials.gov and PubMed. Of those devices, 34 (2.5%) were linked to registered prospective trials, 12 (0.9%) posted results, 12 (0.9%) reached peer-reviewed publication, and 3 (0.2%) evaluated patient-centred outcomes such as mortality, morbidity or readmissions. Radiology accounts for 78% of cleared devices (1,059 of 1,357); anaesthesiology has 22 cleared devices and no registered prospective trials at all. Of the 34 trials, 62% of studies used observational designs with small, homogenous cohorts, 68% ran only in the United States, and 32 of 34 (94%) were industry-led. The authors identify the predicate chain as the mechanism: a 510(k) submission demonstrates substantial equivalence to an existing device rather than independent clinical effectiveness, so a device cleared against a predicate that was never prospectively validated inherits and passes on that gap. They propose a staged framework — retrospective validation on representative datasets, then prospective workflow-embedded studies of at least 500 participants, then multi-centre trials of at least 2,000 evaluating patient-centred outcomes. The authors are explicit about limitations: the census counts only publicly registered evidence and may undercount proprietary validation, and it has no non-AI device comparator, so it cannot establish whether the gap is specific to AI devices or reflects device regulation generally.

Two related developments landed in the same week. On 13 August, CMS approved a Medicare add-on payment for Aidoc's CT triage AI, extending reimbursement to a device cleared on the same pathway. On 18 August, Axios reported an FDA discussion paper proposing that generative AI-enabled medical devices might be assessed through a “competency-based approach” similar to how doctors are evaluated, seeking feedback on risk assessment, premarket evaluation and post-market monitoring.