Healthcare AI 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

CHAMBERS GLOBAL PRACTICE GUIDES

Healthcare AI 2025 Definitive global law guides offering comparative analysis from top-ranked lawyers

Contributing Editor Nadia de la Houssaye Jones Walker

Global Practice Guides

Healthcare AI Contributing Editor Nadia de la Houssaye Jones Walker

2025

Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair and Stephen Dinkeldein Content Reviewers Vivienne Button, Lawrence Garrett, Sean Marshall, Marianne Page, Heather Palomino and Adrian Ciechacki Content Coordination Manager Nancy Laidler Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Hannah Leinmüller Head of Production Jasper John Production Coordinator Genevieve Sibayan

Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com

Contents

INTRODUCTION Contributed by Nadia de la Houssaye, Jones Walker LLP p.4 AUSTRALIA Trends and Developments p.8 Contributed by Barry Nilsson

POLAND Law and Practice p.87 Contributed by Kieltyka Gladkowski KG Legal Trends and Developments p.108 Contributed by Kieltyka Gladkowski KG Legal TAIWAN Trends and Developments p.115 Contributed by Lee and Li, Attorneys-at-Law

AUSTRIA Law and Practice p.14 Contributed by Kinstellar

USA Law and Practice p.121

CANADA Trends and Developments p.31 Contributed by Gowling WLG (Canada) LLP

Contributed by Jones Walker LLP Trends and Developments p.141 Contributed by Jones Walker LLP USA – CALIFORNIA Trends and Developments p.149 Contributed by ArentFox Schiff LLP

CHINA Law and Practice p.36

Contributed by Fangda Partners Trends and Developments p.57 Contributed by Fangda Partners

FRANCE Law and Practice p.64 Contributed by Fréget Glaser et Associés Trends and Developments p.82 Contributed by Fréget Glaser et Associés

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INTRODUCTION Contributed by: Nadia de la Houssaye, Jones Walker LLP Jones Walker LLP is among the largest law firms in the United States, with more than 350 lawyers across the Southeast and other strategic locations, includ - ing Miami, New York City and Washington, DC. Led by a core group of veteran healthcare lawyers, the firm’s healthcare industry team includes lawyers from all the firm’s major practice areas, who all have ex - tensive experience in specific practice areas, as well as in-depth knowledge of today’s healthcare market -

place and regulatory environment. The firm’s attor - neys have a deep understanding of the technologies that constitute the world of AI, including generative AI, machine learning, natural language processing, large language models (LLMs) and neural networks. This knowledge enables Jones Walker to better help its clients navigate this complex world, mitigate risks, be strategic and develop approaches to differentiate themselves.

Contributing Editor

Nadia de la Houssaye is a partner in Jones Walker’s litigation practice and co-leads the healthcare industry team. She works extensively with hospitals, health systems, providers and start-up companies to structure

and integrate telemedicine, telehealth, AI and digital health platforms. Nadia’s passion for the expansion and growth of telemedicine began in 1997, when she co-created and helped launch one of Louisiana’s first teleradiology networks. Since 2004, Nadia has provided strategic counsel to healthcare providers and hospital systems on telemedicine service lines, including international telemedicine arrangements involving multi-state and international licensure and scope-of-practice issues, cross- border compliance issues, patient consent requirements, commercial payor reimbursement issues, Medicare and state Medicaid billing requirements, and coverage and reimbursement issues.

Jones Walker LLP 201 St Charles Ave New Orleans LA 70170-5100 USA

Tel: +1 337 593 7634 Fax: +1 337 593 7601 Email: ndelahoussaye@joneswalker.com Web: www.joneswalker.com

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INTRODUCTION Contributed by: Nadia de la Houssaye, Jones Walker LLP

Navigating the Convergence of Innovation, Regulation and Clinical Practice in an Era of Transformation The global healthcare artificial intelligence (AI) land - scape stands at an unprecedented inflection point. As 2025 progresses, the convergence of technologi - cal innovation, evolving regulatory frameworks and mounting healthcare delivery pressures has created both extraordinary opportunities and complex chal - lenges that transcend national boundaries. From Sili - con Valley start-ups to established pharmaceutical giants, and from rural clinics in developing nations to world-renowned academic medical centres, stake - holders across the healthcare AI ecosystem are grap - pling with fundamental questions about how to har - ness the transformative potential of AI while ensuring patient safety, regulatory compliance and equitable access to care. The pace of innovation in healthcare AI continues to accelerate across all major jurisdictions. Machine learning algorithms now assist radiologists in detect - ing cancers, support clinicians in predicting patient outcomes and enable pharmaceutical companies to accelerate drug-discovery processes. Natural lan - guage processing tools automate clinical documen - tation, while predictive analytics optimise hospital operations and resource allocation. This technological revolution extends far beyond diag - nostic applications to encompass therapeutic plan - ning, administrative functions and population health management, fundamentally reshaping how health - care is delivered, managed and regulated worldwide. The Global Regulatory Patchwork Perhaps no aspect of healthcare AI presents greater complexity than the evolving regulatory landscape. Jurisdictions around the world are taking markedly different approaches to AI governance, creating a challenging patchwork of requirements that health - care AI developers and users must navigate. The EU’s Artificial Intelligence Act represents one of the most comprehensive attempts to regulate AI, establishing risk-based classifications that significantly impact healthcare applications. High-risk AI systems used in healthcare face stringent requirements for transpar - ency, human oversight and post-market surveillance,

while the EU’s medical device regulations continue to evolve to address AI-specific challenges. In the United States, the Food and Drug Administra - tion has pioneered regulatory pathways for AI-enabled medical devices, authorising over 900 such systems through August 2024 while developing innovative approaches such as predetermined change control plans to accommodate continuously learning algo - rithms. Meanwhile, Asian markets present their own unique regulatory environments, with countries includ - ing Japan, Singapore and South Korea developing specialised frameworks for healthcare AI that balance innovation promotion with patient protection. This regulatory fragmentation creates particular chal - lenges for healthcare AI companies seeking to oper - ate across multiple jurisdictions. What constitutes adequate clinical validation in one country may not satisfy requirements in another. Privacy and data pro - tection standards vary significantly, with the EU’s Gen - eral Data Protection Regulation (GDPR) setting a high bar that other jurisdictions may not match. Health - care AI developers must increasingly design compli - ance strategies that can adapt to multiple regulatory regimes while maintaining product integrity and com - mercial viability. Data Governance and Privacy Imperatives Healthcare AI’s dependence on vast datasets for train - ing and validation creates complex data governance challenges that vary significantly across jurisdictions. The intersection of healthcare data protection laws with AI development requirements presents one of the most pressing compliance challenges facing the industry. In Europe, the GDPR’s strict consent require - ments and data minimisation principles can conflict with AI systems’ need for comprehensive datasets. The right to explanation provisions may challenge the “black-box” nature of certain machine learning algo - rithms, while data portability requirements complicate cross-border AI development efforts. Similar tensions emerge in other jurisdictions with robust healthcare privacy frameworks. The United States’ Health Insurance Portability and Accountabil - ity Act (HIPAA) regulations, while predating modern AI systems, continue to govern how protected health

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INTRODUCTION Contributed by: Nadia de la Houssaye, Jones Walker LLP

information can be used in AI development and deployment. Countries with emerging digital health initiatives must balance the potential benefits of AI innovation against the imperative to protect patient privacy and maintain public trust in healthcare sys - tems. The secondary use of healthcare data for AI training presents particular challenges. Clinical data originally collected for patient care purposes requires careful consideration of consent frameworks, de-identifica - tion standards and cross-border transfer restrictions when repurposed for AI development. Synthetic data generation and federated learning approaches offer promising solutions, but these technologies them - selves raise novel legal and technical questions that The global healthcare AI community increasingly rec - ognises that algorithmic bias represents one of the most significant ethical and legal challenges facing the field. Training datasets that inadequately repre - sent diverse patient populations can perpetuate or exacerbate existing healthcare disparities, potentially undermining the very goals that AI seeks to achieve. This concern transcends geographic boundaries, as healthcare inequities exist in virtually every healthcare system worldwide. The challenge is particularly acute in global contexts where AI systems developed in one region may be deployed in populations with significantly different demographic, genetic or socioeconomic character - istics. An AI diagnostic tool trained primarily on data from European or North American populations may perform poorly when applied to patients in sub-Saha - ran Africa or Southeast Asia. This creates both tech - nical challenges related to algorithm generalisability and ethical obligations to ensure that AI innovation benefits all populations equitably. regulatory frameworks must address. Algorithmic Bias and Health Equity Regulatory responses to algorithmic bias vary sig - nificantly across jurisdictions. Some countries are developing specific requirements for bias testing and mitigation, while others rely on broader anti-discrim - ination frameworks. Healthcare AI developers must increasingly implement systematic approaches to bias

detection and remediation that can meet varying inter - national standards while advancing the broader goals of health equity. Professional Liability in the Age of AI The integration of AI into clinical practice raises novel questions about professional liability and standards of care that legal systems worldwide are struggling to address. Traditional medical malpractice frameworks assume human decision-making processes that may not adequately account for algorithm-assisted care. When AI systems provide diagnostic recommenda - tions or treatment suggestions, determining liability for adverse outcomes becomes complex, particularly when multiple stakeholders – including healthcare providers, AI developers and healthcare institutions – may share responsibility. Different legal systems approach these challenges in varying ways. Common-law jurisdictions may rely on evolving case law to establish standards for AI- assisted care, while civil-law systems may require more explicit legislative or regulatory guidance. Pro - fessional medical organisations across the globe are developing guidelines for responsible AI use, but these standards are not uniform and may not have the force of law. Healthcare providers worldwide must increasingly document their interactions with AI systems, demon - strating appropriate clinical judgment in accepting, modifying or rejecting algorithmic recommendations. This documentation burden varies across jurisdictions but represents a common challenge as healthcare AI adoption accelerates globally. Market Dynamics and Innovation Ecosystems The global healthcare AI market reflects broader pat - terns of technological innovation and investment, with significant activity concentrated in major technology hubs while emerging markets present both opportu - nities and challenges. North American and European companies continue to lead in healthcare AI develop - ment, supported by robust venture capital ecosys - tems and sophisticated regulatory frameworks. Asian markets, particularly China, Japan and Singapore, are rapidly emerging as significant players with substan - tial government support for AI innovation.

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INTRODUCTION Contributed by: Nadia de la Houssaye, Jones Walker LLP

However, the global nature of healthcare challenges creates opportunities for AI solutions to address uni - versal needs. Telemedicine platforms enhanced by AI can extend specialist expertise to underserved regions, AI-powered diagnostic tools can support healthcare delivery in resource-constrained environ - ments and drug discovery platforms can accelerate the development of treatments for neglected diseases that disproportionately affect developing world popu - lations. Cross-border collaboration in healthcare AI develop - ment is becoming increasingly common, but these partnerships must navigate complex regulatory, intellectual property and data transfer requirements. Academic medical centres are forming international research consortia to develop AI solutions, while tech - nology companies are establishing global partnerships to access diverse datasets and clinical expertise. Intellectual Property and Technology Transfer Healthcare AI innovation raises complex intellectual property questions that vary significantly across juris - dictions. Patent protection for AI algorithms and appli - cations differs among countries, with some offering robust protection for software innovations while oth - ers maintain more restrictive approaches to algorithm patentability. Copyright protection for training data, code and AI-generated outputs presents additional challenges that intellectual property frameworks are still adapting to address. The global nature of AI development complicates tra - ditional intellectual property strategies. Training data - sets may incorporate information from multiple coun - tries, AI algorithms may be developed collaboratively across international teams and deployment may occur in jurisdictions with varying IP protections. Healthcare AI companies must develop comprehensive intellectual property strategies that account for these complexities while protecting their competitive advantages. Future Horizons and Strategic Considerations As healthcare AI continues to evolve, several trends will likely shape the global landscape over the coming years. Regulatory harmonisation efforts may reduce some of the current fragmentation, but significant differences in national approaches to AI governance

are likely to persist. International standards organisa - tions are working to develop common frameworks for healthcare AI, but adoption will depend on national regulatory agencies and may not be uniform. The emergence of more sophisticated AI technolo - gies, including large language models and genera - tive AI applications, will create new regulatory and ethical challenges that existing frameworks may not adequately address. Healthcare organisations must prepare for continuous adaptation as both technology and regulation evolve. Conclusion: A Call for Co-Ordinated Action The global healthcare AI revolution presents unprec - edented opportunities to improve patient outcomes, enhance healthcare delivery efficiency and address pressing public health challenges. However, realis - ing this potential requires co-ordinated action among healthcare providers, technology developers, regula - tors and legal professionals worldwide. Legal practitioners serving healthcare AI stakeholders must develop a deep understanding of AI’s technolog - ical capabilities and regulatory requirements across multiple jurisdictions. This requires ongoing educa - tion about emerging technologies, active monitoring of regulatory developments and collaboration with technical experts to ensure that legal advice reflects current realities. Success in this environment demands proactive com - pliance strategies that can adapt to evolving require - ments while supporting innovation goals. Healthcare AI stakeholders must invest in robust governance frameworks, comprehensive risk management pro - grammes and ethical development practices that meet international standards while advancing patient care objectives. As the articles in this guide demonstrate, the chal - lenges facing healthcare AI are both jurisdiction-spe - cific and globally interconnected. Legal professionals who can navigate this complexity while supporting responsible innovation will play crucial roles in shap - ing the future of healthcare AI and ensuring that its benefits are realised safely, equitably and sustainably worldwide.

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AUSTRALIA Trends and Developments Contributed by:

Australia

Sydney

Tasmania

Robert Samut Barry Nilsson

Barry Nilsson has an insurance and health practice with expertise across all lines of insurance, from pol - icy drafting to claims management. The firm partners with insurers, brokers, self-insureds and re-insurers – in Australia and overseas – to tailor legal strate - gies that achieve the best possible outcomes. The team of over 220 specialist insurance lawyers across Australia combines deep industry knowledge with lo - cal expertise and the highest standards of client ser - vice. Barry Nilsson’s national health and life sciences practice advises public and private hospitals, medi -

cal clinics, medical practitioners, allied health profes - sionals and aged care facilities on matters involving medical negligence, life sciences, product liability, complaints and regulatory investigations, coronial in - quests, clinical trials and policy reviews, across Aus - tralia and internationally. The team of over 50 health law specialists in all six states has a formidable track record of devising innovative and rapid solutions to complex, high-profile disputes involving close con - sultation with senior stakeholders.

Author

Robert Samut leads Barry Nilsson’s national health and life sciences practice, bringing over 20 years’ experience in insurance and health law. He acts for insurers, hospitals, medical defence organisations, health

organisations, self-insureds and government in the areas of medical negligence, professional indemnity, and public and products liability. Rob has a particular focus on medical negligence litigation and disputes, acting for public and private hospitals, doctors and allied health practitioners. He also provides advice in noncontentious matters and is sought after to advise on insurance contract issues in the health sector, including third-party liability insurance and insurance cover for pharmaceutical and medical device manufacturers and suppliers.

Barry Nilsson Level 14, 345 Queen Street Brisbane QLD 4001 Australia

Tel: +61 7 3395 7326 Fax: +61 7 3099 7399 Email: robert.samut@bnlaw.com.au Web: www.bnlaw.com.au

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AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson

Healthcare in Australia is undergoing a significant transformation, having to adapt to an ageing popula - tion, dealing with an increasing prevalence of chronic diseases and benefitting from many and varied tech - nological advancements. Australian healthcare providers continue to provide a high standard of care to patients and consumers. The industry is well regulated, with the care being provided by a highly trained workforce. It is, however, an indus - try that is under constant pressure, with both private and public healthcare providers having to do more on tightening budgets, and with many care providers being stretched to the point of exhaustion. AI in healthcare is rapidly evolving, with significant research and investment focused on integrating AI into patient-focused care and creating systemic effi - ciencies. Over the past few years, there have been changes in the frequency, severity and nature of claims being made against healthcare providers. The industry relies heavily upon both local and overseas insurers to meet the cost of these claims. Lloyds syndicates continue to play an important role in providing cover for the larger healthcare operations. This overview looks at recent trends and develop - ments in the claims and regulatory environment affect - ing healthcare providers, and what the next disrup - tions to the market might include. Claims Against Healthcare Providers Secondary psychiatric claims arise where a person suffers a psychiatric injury or illness as a result of witnessing, or being informed of, a traumatic event involving another person. They are also referred to as “nervous shock claims”. There is a requirement of close ties of love and affection between the injured person and the person seeking damages for nerv - ous shock. There has been a continuing increase in the frequency of secondary psychiatric claims being made against healthcare providers. In addition, the damages awards are also increasing. Where a number of family members are seeking compensation from the healthcare provider, the quantum of the secondary

victim claims may exceed the damages being claimed by the injured party. The amounts being claimed for gratuitous care and paid care are increasing due to higher hourly rates being allowed for in gratuitous care claims, and to providers increasing their service fees for paid care. In part, this is due to the National Disability Insurance Scheme (NDIS) distorting the costs of the care market with the rates that care providers have been charg - ing the fund. A widespread practice developed where NDIS participants were being charged more for sup - port than non-NDIS participants, which created a two- tier system, and these higher costs have been filtering into medical negligence claims costs. Another concerning trend is the extension of limitation periods. The limitation of actions legislation across the country generally provides that you have three years from the day the cause of action arises to issue proceedings against a defendant. There is the ability to issue proceedings outside this three-year period where the claimant is only made aware of facts that give rise to the claim later in time, including after the limitation period has expired. The courts are quite amenable to extending the limitation period by finding that a plaintiff had not discovered, or was not aware of, a material fact of a decisive character until some time after the negligent act or omission. COVID-19 continues to have an impact on claims in two ways: • firstly, in the way that claims against healthcare providers are managed – technology allows for bet - ter engagement with experts and witnesses, where you can share documents on your screen and have multiple people involved in the meeting; and • secondly, in the way that COVID-19 disruption also saw a spike in claims for missed diagnoses and delayed diagnoses, which are still working their way through the system. More recent times have seen the rise of the medical expert. There are now a number of companies with stables of medical experts. The plaintiff expert and the defendant expert divide is locked in, notwithstand - ing the acknowledged and obvious benefits of par -

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AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson

ties resolving a dispute by the engagement of joint experts. Not only are there more experts to choose from, but the number of experts being retained in cas - es is increasing. With the rise of AI and technology, new experts will emerge as claims include allegations relating to the failure of a product and/or software. The rise of the peer opinion defence is also being seen – ie, where legislation codifies the Bolam test and provides that a professional does not breach a duty arising from the provision of a professional service if it is established that they acted at the time in a way that was widely accepted by a significant number of their peers as being competent and professional prac - tice. Two recent Supreme Court of New South Wales (“NSW Supreme Court”) decisions have provided added guidance and assistance with regard to raising this type of defence. In April 2025, the NSW Supreme Court decided in favour of an ophthalmologist in the matter of Busa v Eastern Sydney Local Health District t/as Sydney Eye Hospital (2025 NSWSC 130) on the basis of peer opinion supporting a finding that the doctor had not breached his duty of care. In May, the same court made a similar finding in Nemes v South Eastern Sydney Local Health District (2025 NSWSC 418) – ie, finding in favour of the defendant hospital on the basis of peer opinion. How is the Law Responding to Claims Involving New Technology Such as Robotic Surgery, AI Tools and Virtual Care Platforms? As healthcare providers integrate more advanced technologies and personalised treatment, the medical negligence risks evolve and will be different to some extent to what they are today. There will be more prod - uct and software claims – and more tech claims. With AI tools, it will rarely be the case that the doctor and/or hospital will escape all liability in the event of product failure. The doctor’s non delegable duty of care remains. Healthcare providers must apply human oversight and judgement when using AI and any out - puts. They will also need to carefully guard patient privacy when using AI in healthcare. In the context of AI and technology in medicine, the healthcare professional will bear the ultimate respon - sibility for patient safety and wellbeing. It is no answer

to a claim to blame the product or the software. The patient may choose to sue only the healthcare pro - vider, and it will then be up to the provider to seek recovery from the AI or product manufacturer/sup - plier. As a consequence, the contracts that healthcare providers have with the manufacturers or suppliers of these products or technology will become increasingly important. Healthcare providers need to be careful and ideally avoid assuming liabilities under the contract by indemnifying, releasing or agreeing to insure these providers. Insurance policies will probably not provide insurance cover for such pure contractual liabilities. Jurisdictional issues will arise from time to time with telemedicine claims. The relevant jurisdiction will gen - erally be the place where the harm is suffered. The next big disruptor for healthcare litigation has to be the evolution of more personalised care using advanced technology, and the rise of telemedicine- and AI-driven diagnostics. This is going to disrupt healthcare more generally. The nature and subject of the claim will generally be the same. For example, a medical negligence claim will still be a claim for dam - ages for injury and loss made against the healthcare provider. However, the cause of the injuries or adverse event will increasingly change over time; whereas pre - viously it may have been at the hands of a surgeon, it may now be a malfunctioning robot or failure of tech - nology. Healthcare lawyers will need to ensure that they are able to deal with these emerging causation issues. The law will need to catch up with AI and provide some much-needed guidance and regulation. This applies across the board, not just in relation to healthcare. There are some laws that capture AI in a general way, as follows: • the Privacy Act 1988 and the Australian Privacy Principles apply to AI systems that handle personal information, which includes health information; • data protection laws cover the collection, use and storage of data used by AI systems; and • importantly, in healthcare, if an AI system or tool is a “medical device” as defined in the Therapeutic

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AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson

Goods Act 1989, it will need to be approved by the Therapeutic Goods Administration (TGA). In August 2024, the Australian Health Practitioner Regulation Agency (AHPRA) published guidelines on “Meeting your professional obligations when using artificial intelligence in healthcare”. In these guide - lines, AHPRA referred to the following, amongst other things. • AI being defined as computer systems able to perform tasks that normally require human intel - ligence. • Some AI tools used in healthcare being regulated by the TGA. The TGA regulates therapeutic goods that meet the definition of a “medical device”, which includes software if it has a therapeutic use and meets the definition. • Emphasising the principle that, regardless of what technology is used in providing healthcare, the practitioner remains responsible for delivering safe and quality care, and for ensuring that their own practice meets the professional obligations set out in their codes of conduct. • Healthcare practitioners must apply human judge - ment to any output of AI. • Healthcare practitioners should inform patients and clients about their use of AI and consider any concerns raised. • Healthcare practitioners must obtain informed con - sent from the patient and ideally note the patient’s response in the health records. • When using an AI scribing tool that uses generative AI involving the input of personal data, the health - care practitioner will require informed consent from the patient. Informed consent is particularly impor - tant in AI models that record private conversations, as there may be criminal implications if consent is not obtained before recording such conversations in some Australian states and territories. • The need to ensure confidentiality and privacy of patient/client information, as required by privacy and health record legislation. • The need to ensure that healthcare practitioners understand the inherent bias that can exist in data and algorithms in AI applications, for example in relation to Aboriginal and Torres Strait Islander people.

• The need to have and be aware of governance arrangements in place to oversee the implementa - tion, use and monitoring of AI. Are There Any Signs of Australia Heading Towards Higher Damages or More Litigious Jurisdiction, Similar to the USA? The cost of claims in Australia has increased signifi - cantly in the past few years, mostly due to economic factors. Ten years ago, the inflation rate in Australia was 1.5%, and wage growth was minimal. The coun - try has since moved to a higher inflation economy with rising wages. These changes eventually flow into the cost of claims. In addition, the amounts being claimed by plaintiff lawyers for legal costs – and the amounts charged by experts and other providers – have increased, on occasion significantly, in recent years. The relatively recent and often significant rise of claims reserves in Australia will, however, never extend to the claims reserves that one needs to hold in the USA. The high watermark in the USA was reached last year in the case of Michael E Sanchez v NuMale Medi - cal Centre LLC. The case involved Mr Sanchez, a 66-year-old widower visiting NuMale for fatigue and weight management, and ultimately being convinced into having a penile injection for erectile dysfunction. This procedure was botched. NuMale were found to have been negligent, and their conduct was found to have been unconscionable. Mr Sanchez received USD412 million, of which USD375 million was punitive damages. This type of result will never, and can never, happen in Australia. There are prohibitions in place in most Australian states and territories on punitive damages awards. There are some exceptions, however, including cases of intentional conduct and unlawful sexual assault. In Victoria, there is no statutory prohibition, but common law effectively restricts punitive damages to intention - al or reckless misconduct. Except for Victoria, Australian states and territories do not have jury trials in civil claims. Most states and territories also do not allow plaintiff lawyers to charge contingency fees (US trial lawyers can demand con -

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AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson

tingency fees, which may extend to 30–40% of the damages award). Again, there is an exception here in Victoria, where plaintiff lawyers can charge on a con - tingency fee basis in class actions if a court makes an

There have recently been a number of new law firms entering the legal market that specialise in healthcare claims. The bigger firms tend to still dominate. Few claims go to trial. Most trials take place in New South Wales and Victoria. In other Australian states and territories, there may only be a handful of health- care trials in any one year. Access to justice in personal injury claims is arguably open to most with the proliferation of no-win-no-fee lawyers. That is not seen to be controversial, and the community and insurance industry accept that people who do not have the means to pay legal fees upfront should not be denied access to justice, particularly where the alleged negligence has impacted their abil - ity to earn an income. This has been balanced by tort law reform legislation that places downward pressure on claims costs, par - ticularly with the more minor and speculative claims. In Queensland, for example, there are restrictions on a claimant’s ability to claim for legal costs and out - lays where the value of their claim is below a certain amount. Following the release of the Personal Injuries Proceedings Indexation Notice 2025, if an adverse event were to happen post-1 July 2025 and a plain - tiff made a personal injury negligence claim against a healthcare provider, the plaintiff would have no enti - tlement to costs and outlays if the claim was worth AUD58,089 or less, and would only be entitled to claim AUD4,860 for costs and outlays if the damages were between AUD58,090 and AUD96,870, beyond which there are no restrictions. Life Sciences In the life sciences area, medical device product liabil - ity litigation continues to feature prominently. There appear to be signs that the wave of litigation against orthopaedic device manufacturers is finally begin - ning to slow. Much of this litigation was precipitated by data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), which was established in the early 2000s. By 2010, there was a decade of data from this registry avail - able publicly, including statistics indicating prostheses that had a “higher-than-anticipated date of revision”. The data was used by lawyers to identify products

order to that effect. Medicinal Cannabis

Medicinal cannabis continues to attract the attention of regulators due to widespread poor practices. The Medical Board of Australia (the “Board”), overseen by AHPRA, has specific guidelines regarding telemedi - cine and online prescribing. Concern has recently been expressed by the Board about the practices of medical cannabis companies, including their online prescribing. On 9 July 2025, AHPRA published a guidance report on the professional responsibilities of medical can - nabis organisations. In this guidance, they referred to the following issues: • there is evidence of poor practice in prescribing medical cannabis that is leading to patient harm; • most medical cannabis products prescribed in Australia are not approved by the TGA; • a high number of medical cannabis products in Australia contain tetrahydrocannabinol (THC), which makes them Schedule 8 medicines (con - trolled drugs in Australia) due to the risks of mis - use/abuse and potentially addictive properties; • the Board is concerned that profits are being prioritised over patients in some medical cannabis prescribing practices; • business models have emerged that appear to use aggressive and sometimes misleading advertising that targets vulnerable people; • there is an inherent conflict of interest for doctors and nurses working in an organisation that pre - scribes and dispenses a single product (ie, brand); and • AHPRA and the Board will work with other regula - tors to better understand prescribing patterns, and may investigate the practices of practitioners with high rates of prescribing of any scheduled medi - cine, including medicinal cannabis.

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AUSTRALIA Trends and Developments Contributed by: Robert Samut, Barry Nilsson

for mass tort litigation against orthopaedic device manufacturers, and as evidence in the case. In par - ticular, “metal-on-metal” hip replacements produced by several manufacturers were targeted for both class actions and individual actions. While registry-based litigation in relation to orthopae - dic devices is slowing, there are signs that a simi - lar phenomenon is happening in relation to breast implants in Australia. In 2016, the Australian Breast Device Registry (ABDR) was established. Similar to the AOANJRR, the ABDR tracks the implantation and revision surgery dates of breast prostheses in patients in Australia, including identifying implants with higher- than-anticipated rates of revision. There is now almost a decade a data in the ABDR, and this data is begin - ning to be used by lawyers to identify particular pros - theses as targets for litigation – in a similar way to the data in the AOANJRR was used for hip and knee replacement litigation. It remains to be seen whether this will be on the same scale as the hip replacement litigation of the last decade. Product liability in relation to pharmaceuticals in Aus - tralia has been sporadic over the last decade. This can be partly attributed to the outcome of the Australian Vioxx litigation, which was not particularly success -

ful for the plaintiffs, especially when compared with other jurisdictions around the globe that experienced large settlements and verdicts in similar cases. This was at least partly due to the strict causation tests under Australian law, making it difficult for plaintiffs to establish that adverse outcomes were the result of a particular medication. At the same time, there was “lower hanging fruit” as a target for product liability litigation in the form of medical devices, along with products in other industries. However, there are signs that this too is changing, and that pharmaceuticals are back in the litigation cross - hairs. This has been partly prompted by the competi - tive litigation market in Australia. The litigation funding industry in Australia contin - ues to grow. Similarly, the plaintiff class action law firm market which previously had only a handful of players, now has several participants, including law firms, which would traditionally operate solely on the “defence” side. With more competition, both funders and law firms are looking further afield for targets for mass tort litigation and class actions. While no sig - nificant pharmaceutical product liability class actions have yet commenced, a number are currently under investigation.

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AUSTRIA Law and Practice Contributed by: Harald Strahberger and Florian Sesztak Kinstellar

Czech Republic

Germany

Slovak

Vienna

Austria

Hungary

Italy

Slovenia

Croatia

Contents 1. Use of Healthcare AI p.17 1.1 Types and Applications of Healthcare AI p.17 1.2 Key Benefits and Challenges p.17 1.3 Market Trends p.18 2. Legal Framework for Healthcare AI p.19 2.1 Regulatory Definition and Classification of Healthcare AI p.19 2.2 Key Laws and Regulations p.19

2.3 Approval and Certification Processes p.20 2.4 Software as a Medical Device (SaMD) p.20 2.5 Data Protection and Privacy p.21 2.6 Interoperability and Standards p.21 3. Regulatory Oversight of Healthcare AI p.21 3.1 Regulatory Authorities p.21 3.2 Pre-Market Requirements p.21 3.3 Post-Market Surveillance p.22 3.4 Enforcement Actions p.22 4. Liability and Risk in Healthcare AI p.22 4.1 Liability Framework p.22

4.2 Patient Harm and Malpractice p.23 4.3 Risk Management Requirements p.23 4.4 Defences and Limitations p.23 5. Ethical and Governance Considerations for Healthcare AI p.24 5.1 Ethical Frameworks p.24 5.2 Transparency and Explainability p.24

5.3 Bias and Fairness p.24 5.4 Human Oversight p.25 6. Data Governance in Healthcare AI p.25

6.1 Training Data Requirements p.25 6.2 Secondary Use of Health Data p.25 6.3 Data Sharing and Access p.26 6.4 De-Identification and Anonymisation p.26 7. Intellectual Property Issues Regarding Healthcare AI p.26 7.1 Patent Protection p.26 7.2 Copyright and Trade Secrets p.26 7.3 Ownership of AI Outputs p.27 7.4 Licensing and Commercialisation p.27

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AUSTRIA CONTENTS

8. Specific Applications of Healthcare AI p.27 8.1 Clinical Decision Support p.27 8.2 Diagnostic Applications p.27

8.3 Therapeutic and Treatment Planning p.27 8.4 Remote Monitoring and Telemedicine p.27 8.5 Drug Discovery and Development p.28 9. Future Trends and Regulatory Developments in Healthcare AI p.28 9.1 Pending Legislation and Regulation p.28 9.2 Regulatory Sandboxes and Innovation Programmes p.28

9.3 International Harmonisation p.28 9.4 Emerging Legal Challenges p.29 10. Practical Considerations in Healthcare AI p.29 10.1 Compliance Strategies p.29 10.2 Contracting and Liability Allocation p.29 10.3 Insurance Considerations p.29 10.4 Best Practices for Implementation p.30 10.5 Cross-Border Considerations p.30

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AUSTRIA Law and Practice Contributed by: Harald Strahberger and Florian Sesztak, Kinstellar

Kinstellar is a leading independent law firm with over 300 lawyers across 13 offices in Central and East - ern Europe and Central Asia, including key locations such as Vienna, Prague, Bucharest, Budapest, and Istanbul. Opened in January 2025, Kinstellar’s Vienna office launched with 21 lawyers (6 partners, 15 law - yers), quickly becoming a strategic hub for cross-bor - der legal advice. The firm has deep sector expertise in healthcare and life sciences, advising clients on M&A, growth capital, regulatory strategy, ESG compliance,

and IP structuring. Recent highlights include advising Kerry Group on the acquisition of a biotech business from a Vienna-based startup and Trill Impact on the acquisition of Komet Austria and TT medic. The team regularly acts for pharmaceutical and medtech inves - tors, funds, and corporates on market entry, carve- outs, and clinical data/privacy compliance across the region. With planned expansion in IP/IT, and employ - ment, the Vienna office further strengthens Kinstel - lar’s full-service healthcare offering in CEE.

Authors

Harald Strahberger is a partner in Kinstellar’s Vienna office. Harald regularly advises national and international clients in all fields of public law, including physicians, hospitals, pharmaceuticals, medical

Florian Sesztak is an associate in in Kinstellar’s Vienna office. He advises national and international clients, especially in the life sciences and healthcare sectors. His work includes regulatory guidance on

devices and data protection law. Besides preparing legal opinions and statements in these areas of law, eg regarding the establishment and/or acquisition of hospitals or the reimbursement of a new medicinal product, he also represents his clients in the corresponding administrative proceedings as well as in proceedings in front of administrative courts, the Supreme Administrative Court, the Austrian Constitutional Court and in front of the Austrian civil courts.

pharmaceutical advertising, market authorisation of pharmaceuticals and medical devices, as well as legal support for clinical trials and the licensing of healthcare institutions. He frequently advises on issues at the intersection of medical research, digital health innovation and reimbursement strategies. As part of his ongoing postgraduate studies, Florian conducts academic research on emerging legal challenges in health and medical law.

Kinstellar Dominikanerbastei 11 1010 Vienna Austria Tel: +43 1 3860 700 Email: vienna.office@kinstellar.com Web: www.kinstellar.com

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AUSTRIA Law and Practice Contributed by: Harald Strahberger and Florian Sesztak, Kinstellar

1. Use of Healthcare AI 1.1 Types and Applications of Healthcare AI In Austria, the use of AI in the healthcare setting is already quite advanced, with the technology being employed in a variety of ways to improve patient care and safety. AI is used in the following areas of health - care. Diagnostic Tools AI is widely used in Austria for medical diagnostics, particularly in radiology, pathology, and dermatology. These systems support physicians in identifying dis - eases such as cancer, lung infections, and skin con - ditions through automated image analysis. Hospitals across the country have also integrated these tools into routine workflows, making diagnostics one of the most mature and widely adopted areas of AI in Aus - trian healthcare. Treatment Planning and Clinical Decision Support AI applications are increasingly used to support clinical decision-making and personalised treatment planning. These tools analyse patient data, including genetic and clinical indicators, to identify optimal ther - apies and predict outcomes. AI is particularly valuable in oncology and chronic disease management, where it helps in tailoring interventions to individual patients. While still in development in some areas, these sys - tems are expanding in research hospitals and are emphasised in Austria’s national eHealth strategy. Drug Discovery and Development In Austria’s strong biotech and pharmaceutical sec - tors, AI is being applied to accelerate drug discov - ery and clinical research. Tools are used to identify potential drug targets, simulate molecule behaviour, and design more efficient clinical trials. Universities and life science companies frequently integrate AI into preclinical research and development, supported by national and EU-level funding initiatives. Operational and Administrative Applications AI is also being deployed in hospital administration to improve efficiency. Applications include automated patient scheduling, triage systems, documentation, billing, and fraud detection. Furthermore, chatbots are used for patient communication and basic inquir -

ies. These tools help reduce administrative workload and streamline hospital operations. While adoption is not yet universal, many public hospitals are piloting or implementing these technologies. Remote Monitoring and Telemedicine AI-enabled remote monitoring is gaining momentum, particularly in the management of chronic diseases and elderly care. Wearables and smart devices track patients’ vital signs and behaviour in real time, trig - gering alerts when needed. Telemedicine services, enhanced by AI triage tools, allow for virtual consul - tations and follow-up care. These technologies gained prominence during the COVID-19 pandemic and are now a central focus of Austria’s long-term digital health strategy. 1.2 Key Benefits and Challenges Several key benefits drive the use of AI in the Austrian healthcare sector. One of the most notable impacts is the improvement of patient outcomes by enabling early diagnosis and personalised treatment, particu - larly in fields such as oncology, radiology, and chronic disease management. It is also assumed that the use of AI can lead to better results in patient studies, since it can analyse vast amounts of data quickly and accu - rately. At the same time, AI increases system efficien - cy by automating administrative tasks (eg, scheduling and documentation, billing, etc) and optimising clinical workflows, resulting in a reduced workload for health - care professionals and improved resource utilisation. AI also enhances clinical decision-making by integrat - ing vast amounts of medical data to support therapy selection and risk prediction. In the pharmaceutical sector, AI accelerates drug development by expedit - ing processes such as target identification, molecule screening and clinical trial design. Finally, AI is driv - ing the expansion of scalable digital health solutions, eg, telemedicine, remote monitoring and patient self- management tools. Despite the growing potential of AI and digital tech - nologies in healthcare, several key challenges and concerns remain. A significant challenge is the ongo - ing lack of data integration. Despite the availability of existing systems, interoperability between different healthcare sectors and digital platforms remains lim - ited, hindering the seamless exchange of information.

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AUSTRIA Law and Practice Contributed by: Harald Strahberger and Florian Sesztak, Kinstellar

Another pressing challenge is the disparity in digital literacy and access to technology. Both patients and healthcare providers frequently encounter challenges in utilising digital tools effectively. The integration of AI disrupts existing workflows, requiring healthcare pro - fessionals to adapt to new roles and develop additional skills. Regulatory and ethical considerations also pose significant concerns. As digital technologies become increasingly embedded in clinical settings, clear legal frameworks are necessary to address issues related to data protection, transparency, and accountability. Finally, the absence of suitable reimbursement mod - els constitutes a substantial challenge. Many digital health tools have yet to receive formal approval or secure funding pathways, which limit their integra - tion into routine care and slow broader system-wide adoption. 1.3 Market Trends Austria is experiencing steady growth in the appli - cation of artificial intelligence in healthcare, with key trends emerging in diagnostics, digital health services, and pharmaceutical research. AI is increasingly used in clinical decision support and diagnostic imaging – particularly in radiology, oncology, and pathology – where it enhances the accuracy and speed of disease detection and supports the shift toward personalised treatment approaches. In parallel, the expansion of AI-enabled telemedicine and remote monitoring is a national priority, supported by Austria’s eHealth Strat - egy 2024–2030, which emphasises a “digital before ambulant before inpatient” approach to healthcare delivery. AI is also being used in the analysis of real- world health data and predictive modelling for popula - tion health management. Additionally, the integration of AI into pharmaceutical research and clinical trial design is advancing, contributing to more efficient drug development and supporting Austria’s growing position as a centre for life science innovation. The development and adoption of AI in Austrian healthcare are driven by a broad network of stakehold - ers, including healthcare providers, public institutions, research organisations, and private sector innovators. Hospitals and university medical centres are leading adopters, especially in applying AI for diagnostics, clinical decision-making, and operational optimisa - tion. Public institutions such as the Federal Ministry

of Health, the Austrian Research Promotion Agency ( Österreichische Forschungsförderungsgesellschaft mbH – “FFG”), and the Austrian Business Service Agency ( Austria Wirtschaftsservice Gesellschaft mbH – “aws”) play a crucial role by offering funding, regula - tory guidance, and strategic coordination. Research institutions contribute through foundational AI and medical research, often in partnership with clinical facilities. Technology developers and digital health startups, many of which are supported by national innovation programs, provide AI solutions tailored to healthcare use cases. While insurance companies are not yet primary drivers, they are increasingly involved in discussions around reimbursement models and regulatory pathways for digital health tools and AI- supported care. Austria has also established a strong foundation for collaboration between healthcare institutions and technology developers, particularly in the context of public–private partnerships and coordinated innova - tion platforms. The healthcare AI ecosystem ben - efits from national initiatives that connect academic research, clinical practice, and the development of digital technology. For example, new interdisciplinary institutes focused on AI in biomedicine have been launched in collabo - ration with academic and public research bodies, reflecting a long-term commitment to integrating AI into personalised and predictive medicine. Coordina - tion platforms, such as LISAvienna, and innovation hubs, like the Future Health Lab, promote active col - laboration among hospitals, researchers, startups, and public agencies to co-develop and implement AI- driven healthcare solutions. These efforts are further supported by EU-level networks, such as EIT Health Austria, which facilitates cross-border knowledge exchange and access to innovation funding. Together, these collaborations demonstrate Austria’s strategic focus on building an integrated, innovation-friendly environment for healthcare AI.

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