Saturday, 26 September 2026
My Health Record security enforcement, Multicancer blood test backed, Heroin use frequency hits record
- 01
My Health Record security rules face 1 October enforcement
Healthcare organisations using My Health Record must comply with updated security and access policy rules when enforcement begins on 1 October. The deadline affects organisations registered before 1 April 2026 and applies to all healthcare provider organisations, including solo practitioners. The rules add requirements covering user account management, annual refresher training, data breach processes, cybersecurity measures and access policy documentation. New record-keeping obligations require specified policy and training documents to be retained for between two and five years. Non-compliant organisations may have their My Health Record registration revoked, while the Office of the Australian Information Commissioner may also consider regulatory action.
- 02
FDA advisers back Grail multicancer blood test despite data concerns
An FDA expert panel found the probable benefits of Grail’s Galleri multicancer blood test outweighed its risks in a 7–2 vote, with one abstention. The test analyses methylation patterns in cell-free DNA from a single blood sample to detect a cancer signal and identify its likely tissue or organ of origin. Panel members unanimously supported its safety but narrowly backed its effectiveness by six votes to four, amid concerns about false results and limited data for some cancer types. They stressed that Galleri should supplement, not replace, guideline-recommended screening for breast, cervical, colorectal and lung cancers. The test failed to meet the primary endpoint in the NHS-Galleri trial, while Grail’s premarket approval application remains before the FDA; no FDA-authorised device currently screens for multiple cancer types.
via BioPharma Dive
- 03
Heroin use frequency reaches record high in Australian monitoring
Heroin use reached a daily average among surveyed users in 2026, the highest frequency recorded since national monitoring began in 2000, despite the proportion reporting recent use falling from 79% in 2000 to 51%. Researchers also recorded a significant increase in participants likely to have opioid dependence, while preliminary figures showed heroin-involved overdose deaths approaching the previous peaks of 2018 and 2019. Among surveyed ecstasy and stimulant users, 84% reported recent cocaine use, the highest proportion in 20 years, while eight in ten surveyed people who inject drugs reported methamphetamine use. Reported illicit tobacco use increased year-on-year, although overall tobacco use and frequency remained stable in both samples. Nitrous oxide use also remained stable, but larger canisters overtook small bulbs as the most commonly reported format, a shift associated internationally with serious neurological harms.
- 04
Cohealth pay and communications spending draws urgent scrutiny
Cohealth faces fresh scrutiny over reported payments of $3000 a day to part-time transition chair Paul Geyer, $488,000 a year to interim chief executive Kate Gillan and $288,000 for eight months of external crisis communications. The spending emerged after the federal government committed two $1.5 million funding packages to keep Cohealth’s Collingwood, Fitzroy and Kensington GP services open. A confidential draft of an independent review said salary expenses represented between 121% and 130% of total income across all periods reviewed. Victorian Premier Ben Carroll said he would examine the remuneration as a matter of urgency. Cohealth said the remuneration was independently benchmarked, the first funding package went directly to the three clinics, and contractual obligations would be independently audited.
- 05
US judge orders removal of community integration disability protections
A federal judge in Texas ruled that the US Department of Health and Human Services must remove every mention of community integration from a landmark disability rule. The decision reversed a decades-long federal priority for people with disabilities to live and receive services in their communities rather than in nursing homes or other facilities. It came weeks after the Justice Department joined a lawsuit brought by 17 states against the Biden administration’s 2024 update to Section 504 of the Rehabilitation Act, which prohibits disability-based discrimination by recipients of federal funding. The ruling does not alter community protections contained in other laws, including the Americans with Disabilities Act.
- 06
Healthcare AI regulation risks stifling Australian innovation, opinion argues
Poorly informed regulation risks suppressing the productivity and clinical benefits of healthcare AI in Australia, according to an opinion piece in The Medical Republic. The piece cited the TGA’s classification of Heidi Health’s decision-support layer, Heidi Evidence, as a medical device and said the regulator was considering imposing an outdated governance model. It argued that clinicians were already widely using AI scribes, sometimes without formal IT approval, while recognising and working around their limitations and hallucinations. The author warned that political panic after an adverse AI event could lead regulators to restrict credible innovation without stopping clinicians from using the technology.
MDDR is a news digest for medical professionals. It is not medical advice and should not be relied on for clinical decision-making.