Abram Bailey

📙 The Therapeutic Goods Administration (TGA) has just released its 𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 (𝐀𝐈) 𝐑𝐞𝐯𝐢𝐞𝐰 𝐫𝐞𝐩𝐨𝐫𝐭 – 𝐂𝐥𝐚𝐫𝐢𝐟𝐲𝐢𝐧𝐠 𝐚𝐧𝐝 𝐬𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐞𝐧𝐢𝐧𝐠 𝐭𝐡𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠 𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 (𝐀𝐈), July 2025 🏢 TGA held the consultation with the aim to: ✅ Determine whether Australia existing legislation, regulations and guidance are appropriate to meet the challenges associated with an increasing use of medical software and AI across the healthcare sector, and ✅ Identify measures to clarify and strengthen existing regulation to mitigate risks and leverage opportunities associated with medical software and AI use in the therapeutic goods sector. 📚 The report provides a comprehensive overview of the TGA AI Review process, outcomes and key findings. The 14 Findings covering Legislation, Regulations, Responsibility, Compliance and AI use in AI Healthcare Sectors 🗝️ Key Takeaways: 1️⃣ Existing Australian medical device regulations are robust and largely fit-for-purpose—but with AI evolving rapidly, more refined guidance and continued stakeholder engagement are needed. 2️⃣ Targeted actions recommended to clarify definitions (e.g., "developer," "deployer"), address challenges of software supply via online platforms, and ensure appropriate responsibility for outcomes produced by AI systems. 3️⃣ Stakeholders highlighted urgent need for better compliance support, education, and resources—especially regarding adaptive AI, datasets of unknown provenance, and digital mental health apps. 4️⃣ The TGA is prioritizing international harmonisation (e.g., IMDRF, EU AI Act), dynamic change control, and transparency. Expect future consultations and refinements in 2025 and 2026. 5️⃣ Described emerging risks with AI adoption in healthcare and outlines the TGA’s technology-agnostic, risk-based approach to regulation. 🔗 See link for more background and submissions on the public consultation. If you work in medical AI, health tech policy, risk management, or digital health, this is the report for you! #AIRegulation #TGA #HealthTech #Australia #ArtificialIntelligence #AI #Healthcare #MedicalDevices #Compliance #DigitalHealth 👍𝑳𝒊𝒌𝒆 ♻𝑹𝒆𝒑𝒐𝒔𝒕 ⌨𝑪𝒐𝒎𝒎𝒆𝒏𝒕 &🔖𝑻𝒂𝒈 [15.08.25] cc: Hamed Akhlaghi, Sam Freeman, Robin Mann, Michelle Fitzgerald, Jayne Barclay, Matthew Read, Bryan Tan, Dr Alex Duong, Wei Xiang, Truyen Tran, Paul Cooper Ph.D, David Dembo, Dr Vinayak Smith, Stephanie Chaousis

91

23 Comments

An updated revision of the Australasian Health Facility Guidelines (AusHFG) for Adult Acute Inpatient Units introduces new design and planning principles. This has been informed by extensive consultation with clinical, operational and technical experts, as well as consumer representatives.    The update launches guidance relating to high/close observation units and short stay units, design strategies for accommodating patients with extreme behavioural and psychological symptoms of dementia and information relating to the recommended proportion of single bedrooms.    The AusHFG are developed by the Australasian Health Infrastructure Alliance, a collaboration of public health authorities across all Australian jurisdictions and New Zealand and administered by Health Infrastructure as the lead agency.    Thank you to all the jurisdictional representatives and experts from across Australia and New Zealand for their contribution.    Find out more: https://lnkd.in/gZyRX2XN     NSW Health Victorian Department of Health Victorian Health Building Authority NT Health Health New Zealand | Te Whatu Ora Department of Health, Tasmania Queensland Health ACT Health SA Health Department of Health (WA Health) #AusHFG #healthcaredesign #acuteinpatientunits #healthguidelines #ausnz #healthcare 

95

Australian Digital Health Agency to co-host SNOMED CT Expo 2026 in Sydney The Australian Digital Health Agency will co-host Australia's inaugural SNOMED CT Expo next year. The event will unite global leaders in Sydney in 2026 to explore advancements in clinical terminology and digital health innovation. Co-hosting the event with SNOMED International highlights Australia’s commitment to digital health innovation and global collaboration. As the stewards of digital health standards in this country, the Agency welcomes this opportunity to accelerate collaboration and knowledge-sharing, enabling healthcare professionals worldwide to harness digital technologies that improve patient care and outcomes. SNOMED International CEO Don Sweete highlights Australia's significant contributions to the global SNOMED CT community, particularly in advancing clinicians' adoption of electronic health records, prescribing, and clinical terminology. "From enhancing the patient experience to streamlining how clinicians document and share encounters, Australia is a front-runner in advancing a single global language of health, driving better, more efficient, and safer healthcare," Mr Sweete said. Acting Agency Chief Digital Officer Danielle P. said Australia has been a founding SNOMED International Member since 2007, actively supporting the adoption and advancement of SNOMED CT. “SNOMED CT enables the seamless exchange of clinical information across borders. This event will bring global experts together to progress connected care for the benefit of healthcare consumers and clinicians.” Australia’s National Digital Health Strategy 2023-2028 (https://lnkd.in/gnd7XQhx) positions the country as a leader in digital health, with initiatives like the National Clinical Terminology Service (https://lnkd.in/gg8uTiGq) and Australian Medicines Terminology improving interoperability and consumer access to health records. Australia has been recognised for its leadership in healthcare technology, advancing the nation's commitment in digital health, strengthening interoperability, and enhancing clinical terminology to improve patient care worldwide. SNOMED CT Expo 2026, the premier global event for clinical terminology, will unite international experts to advance data-driven health systems and interoperability. The two-day conference will feature panels, lightning talks, networking, and SNOMED International Business Meetings, fostering collaboration in the evolving digital health landscape. Full media release - https://lnkd.in/gUctvJAA #digitalhealth #clinicalterminology #connectedcare #interoperability #ncts #snomedct #standardsaresexy

110

2 Comments

A note to The Rt. Hon. Wes Streeting MP on designing the Single Patient Record (SPR). (And why I believe it will work - with the right focus.) There’s been a lot of noise lately around the SPR. Some see it as another NPfIT. Others worry it's too ambitious, too vague, or too driven by political theatre. I see something else: a genuine opportunity - if we ground it in what already works, and build with, not for the people who use and contribute to care every day. Let me explain 👇 1. Don’t rip and replace - build from what exists Shared Care Records (Gen 1) are live across England. Many have proven value, interoperability, and clinician support - especially where they've been shaped locally. SPR shouldn't start from scratch. It should connect, unify, and elevate what’s already delivering outcomes. 2. A record isn’t a platform. It’s part of a system. Let’s stop chasing the mythical "single source of truth". Clinical reality is messier than that - and it’s OK. What we do need is a federated, queryable, and writable ecosystem where structured data flows, but provenance and context are preserved. That’s a system. Not a database. 3. Patients first. But not just in principle. Digital health has come a long way in shifting toward patient-centredness. But SPR could be a leap forward, if we reframe it not just as infrastructure, but as an enabler of longitudinal, participatory care. Think: shared plans, modular interfaces, personalised nudges, open APIs. 4. Involve people who actually know how care is delivered This is where the optimism gets tested. But if NHSE really does want to engage constructively, then frontline clinicians, CIOs, CCIOs, and technologists (many of whom are already building the future on the ground) must be at the table - not just vendors or policy authors. 5. My ask: Let’s build the SPR like we’d build any good product This means solving a focused problem first, starting small, and proving value early. It means real user research, regular iteration, and a relentless focus on usability. Most importantly, it means resisting the urge to boil the ocean. Simpler, clearer, and better beats "all things to all people" every time. The Single Patient Record could be the connective tissue that makes personalised, coordinated, data-driven care truly possible. But it will require humility. It will require listening. And above all, it will require designing for reality, not fantasy. Let’s not waste the moment. I’d love to hear people's thoughts - especially if you're working on shared records, infrastructure, or frontline systems. What’s one principle we can all agree on? #DigitalHealth #Interoperability #NHS #SinglePatientRecord #HealthTech #SPR #EHR #SharedCareRecords #PatientCentredCare

98

41 Comments

🗎🩺 New AI Pragmatic Guidance for Clinicians Artificial intelligence (AI) has the potential to enhance the quality of care in Australia. The Commission has developed new resources for health professionals with practical guidance on how to use AI technologies safely and responsibly when providing care. These include: 🔹 AI Clinical Use Guide 🔹 AI Safety Scenario - AI Scribe 🔹 AI Safety Scenario - Interpretation of Medical Images Understand your professional responsibilities in using AI, including what transparency, consent and AI evaluation procedures are used in your health service organisation. Visit safetyandquality.gov.au/AI #AI #AI4Clinicians #ArtificialIntelligence #DigitalHealth #healthcare #AI4Clinicians Australian Government Department of Health, Disability and Ageing

82

The SA Virtual Care Service team is researching how Australia's digital health strategies align with value-based healthcare principles. "Providing consumers with high-quality care, whether in-person or digital, is a growing trend," says Dr Melanie Smith, Co-Clinical Lead at SA Virtual Care Service. "For South Australians who need or prefer care from home or local clinics, digitally delivered healthcare – known as virtual care - is game-changing. It provides value to individual patients and our broader healthcare system." The SA Virtual Care Service team worked with SA Health's Chief Clinical Information Officer Rhys Parker to map strategies from state, territory, and national organisations. The authors identified 10 key processes that health services can use to ensure digital innovations improve patient care and system efficiency. "These ten processes guide healthcare organisations embedding virtual care," says Paul Tait, Senior Program Manager (Research) at SA Virtual Care. "They include co-design principles and building leadership at all government levels." "As digital solutions develop at a local level, we must ensure equitable access and demonstrate real improvements in health outcomes. We need evidence-based processes that put patient results at the centre of virtual care delivery." To learn more, visit brnw.ch/21wW4x6

99

2 Comments

The New Zealand Dental Association (NZDA) has just released their Roadmap Towards Better Oral Health for New Zealand. It is an ambitious document that recognises the significant burden of oral disease that exists, and at the same time the persisting inequities in the oral health of New Zealanders. The view of the NZDA is that all New Zealanders have a right to good oral health, but in order to achieve that there needs to be a concerted effort to enact change across a number of systems. Are there lessons in this roadmap to help chart a better course for Australia? https://lnkd.in/gDuCdan4

60

6 Comments

🤖 At the Caring General Hospital, innovation and clinical care work hand in hand to better health. The CGH Centre for Healthcare Assistive & Robotics Technology (CHART) - which commemorates a decade of transforming healthcare delivery this July - supports CGH and the healthcare sector in redefining traditional care models through the implementation of assistive technologies and robotic solutions that complement our care team in a wide range of areas. To date, there are over 80 robots on CGH home ground, roaming the corridors, wards, operating theatres (and more!) autonomously to transform care at the Caring General Hospital. Some of our smart care team members include: ✨ Autonomous guided vehicles that deliver thousands of meals, linen, and supplies daily ✨ Pepper, our social robot who engages patients in therapy and exercise ✨️ MEDi, BLANKi and EDi - our robot trio that provides medication and blanket delivery, and wayfinding at our Emergency Department ✨️Robotic therapy and automated gait assessment that helps patients get back on their feet With these smart care team members (and more) handling the heavy lifting, our colleagues at the Caring General Hospital can focus on what they do best – delivering quality patient care. This is the future of healthcare – where technology enhances human touch! Here's to our continued journey in building a sustainable, future-ready healthcare system and innovating healthcare for tomorrow! 💙 #CGHcares #CaringGeneralHospital #ChangiGeneralHospital #YourTrustedCarePartner #InnovatingHealthcareForTomorrow #HealthcareRobotics #FutureofHealthcare #Singapore #WorldsBestSmartHosptials2025 #NewsweekWorldsBestSmartHospitals2025

74

5 Comments

Streamlining patient care in the emergency department: how can technology make vital patient information instantly accessible? 🏥💡 In this interview, Peter Birch chats with Lily Liu from Western Health, about the game-changing capabilities of their Care Connect tool. As part of the hospital’s current EMR system, Care Connect addresses a common pain point: the tedious and fragmented process clinicians face while searching for patient records during critical moments. Lily discusses how Care Connect consolidates essential patient information like demographics, allergies, appointment history, diagnoses, and more into a single-page summary. This innovation reduces time spent clicking through multiple screens and allows clinicians to immediately focus on high-quality patient care. Future updates will integrate radiology and pathology data, further enhancing care coordination and decision-making. Key takeaways: Care Connect provides a unified patient overview within the EMR, optimising workflow for clinicians in time-sensitive environments like the ED. Quick access to outpatient records and patient history improves treatment accuracy and safety. The transition from traditional EMRs to platforms like Care Connect marks a significant step in digital healthcare transformation for providers and patients alike. Check out the full discussion on the Talking HealthTech Podcast. #DigitalHealth #EMR #HealthcareInnovation #TalkingHealthTech Oracle Health

54

2 Comments

A Brisbane-based startup linked to the co-founders of edtech unicorn Go1, one of whom is a doctor, is pioneering a new form of preventative health around the country and eventually the globe with a whole-of-body MRI scan solution designed for the early detection of more than 500 conditions. Co-founded in October last year by Go1 co-founders Dr Vu Tran and Andrew Barnes alongside entrepreneur and electrical engineer Gopi Sara, OneMRI has raised $2.5 million in seed capital to accelerate its expansion. The heavily oversubscribed round attracted investment from OIF Ventures, TEN13, Antler, Salus Ventures, AfterWork Ventures, Archangel Ventures, Black Sheep Capital, Prtnr, Larsen Ventures, Tribe Global Ventures, and a select group of clinicians and radiologists. https://lnkd.in/g47H_gun

29

2 Comments

Early-bird registrations are now open for the 26th International Conference on Digital Image Computing: Techniques and Applications (DICTA2025) which will be held at the Adelaide Convention Centre from 3–5 December 2025. DICTA2025 is proudly sponsored by AIML, the Institute of Electrical and Electronics Engineers (IEEE), and the Australian Pattern Recognition Society (APRS). AIML Director Professor Simon Lucey is this year’s conference co-chair. As Australia’s premier conference in the field of digital image processing, DICTA2025 will bring together leading researchers and industry professionals to exchange ideas, foster collaboration, and showcase cutting-edge research and applications. The program will include keynotes from distinguished leaders in digital image processing, including: • Georgia Institute of Technology Associate Professor James Hays • National University of Singapore Associate Professor Angela Yao • Carnegie Mellon University Professor Alex John London And more to be announced. Early bird discounts on registrations are available until 30 September 2025 via: https://lnkd.in/ginbYqCF For more information on the conference, please visit: https://lnkd.in/g83xME4f #DICTA2025 #DigitalImageProcessing #IEEE #APRS

27