Digital Healthcare 2025

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

CHAMBERS GLOBAL PRACTICE GUIDES

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

Contributing Editor Sarah-Jane Dobson Ashurst LLP

Global Practice Guides

Digital Healthcare Contributing Editor Sarah-Jane Dobson Ashurst LLP

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 Sarah-Jane Dobson and Katrin Ruhl, Ashurst p.4

MEXICO Law and Practice p.75 Contributed by Galicia Abogados, SC Trends and Developments p.88 Contributed by Galicia Abogados, SC

BELGIUM Trends and Developments p.11 Contributed by Van Bael & Bellis

SOUTH KOREA Law and Practice p.96 Contributed by Kim & Chang

CHINA Law and Practice p.21

Contributed by Global Law Office Trends and Developments p.37 Contributed by Jingtian & Gongcheng FRANCE Trends and Developments p.45 Contributed by Alchimie Avocats

UK Law and Practice p.117 Contributed by CMS Trends and Developments p.138 Contributed by CMS

USA Law and Practice p.146

ISRAEL Law and Practice p.53 Contributed by Gilat, Bareket & Co., Reinhold Cohn Group

Contributed by Jones Walker LLP Trends and Developments p.164 Contributed by Jones Walker LLP

JAPAN Trends and Developments p.65 Contributed by TMI Associates

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

Ashurst is a global, multi-disciplinary law firm headquartered in London. With a rich history spanning over 200 years, today the firm main- tains 31 offices in nearly 20 countries, as well as several referral relationships that enable it to offer the reach and insight of a global net- work, integrated with the knowledge and com- prehension of the local markets it serves. With more than 1,600 partners and lawyers work-

ing across Asia, Australia, Europe, the Middle East and North America, the firm can respond to its clients whenever and wherever support is required. As a global team, Ashurst has a reputation for successfully managing large and complex multi-jurisdictional transactions, dis- putes and projects and delivering outstanding outcomes for clients.

Contributing Editor

Co-Author

Sarah-Jane Dobson is the global head of product liability and product risk (safety and regulatory compliance) at Ashurst. She specialises in regulatory, litigious and policy

Katrin Ruhl is a German qualified attorney, based in Munich, and part of the global product litigation and product risk practice at Ashurst led by Sarah-Jane Dobson. She

matters across the full product life cycle in product safety, compliance and liability, and in consumer litigation. She has extensive experience in defending corporate clients in high-stakes litigation (including in high-profile class actions), regulatory enforcement actions, inquests, public inquiries and judicial reviews, and she acts on regulatory compliance, advertising issues, global product recalls and corrective actions. Sarah-Jane’s degree in science makes her particularly well placed to navigate clients’ highly technical product matters. Her dual legal qualification in England and Wales and in Australia, her international experience and her language skills make her particularly adept at multi-jurisdictional and multilingual matters.

advises on product safety, compliance and product liability matters across different sectors, with a particular focus on life sciences products. Among other areas, she has vast experience in defending complex consumer mass product liability claims, co-ordinating defence in different jurisdictions and establishing an overall defence strategy.

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

Ashurst LLP Ashurst LLP London Fruit & Wool Exchange 1 Duval Square

London E1 6PW UK Tel: +44 207 859 1519 Email: sarah-jane.dobson@ashurst.com Web: www.ashurst.com/en/people/sarah-jane- dobson/

Context: Digital Healthcare Usage Digital healthcare encompasses a wide array of technologies and applications designed to improve healthcare services, facilitate the inte- gration and exchange of health information, enhance treatment, promote health and prevent the development of diseases. Currently, the main categories of digital healthcare are: • telehealth and telemedicine; • health information technology; • digital/personalised medicine; and • preventative and wellness technologies. Telehealth and telemedicine This involves remote patient monitoring, mobile health applications such as apps that control insulin pumps, and wearable devices such as smartwatches. These tools aim to improve healthcare services by enabling remote consul- tations, real-time data collection, and AI-driven diagnostics to improve diagnosis, treatment and monitoring of patients. Health information technology This includes electronic patient records, and facilitates the integration and exchange of health

information, ensuring that healthcare providers have access to complete sets of data from eve- rywhere, particularly in urgent situations. Digital and personalised medicine This is powered by AI, and offers health recom- mendations and treatments tailored to individual patients, improving treatment outcomes. Preventative and wellness technologies (lifestyle tools) This includes apps promoting health-sustaining behaviours, focusing on promoting health and preventing diseases. These various forms of digital healthcare dif- fer in their operators, purposes and classifica- tions within legal and regulatory frameworks. For instance, telehealth, telemedicine and per- sonalised medicine generally focus on diagno- sis, treatment and monitoring, health informa- tion technology tools enable smooth operation and interconnection, and lifestyle tools aim to promote general well-being. Furthermore, dif- ferent tools and applications fall under differ- ent categories depending on their intended use (eg, lifestyle versus medical app), which might

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

trigger certain regulatory requirements such as certifications (eg, the CE mark for medical apps available on the EU market). The use and application of digital healthcare is prevalent globally, although it varies from coun- try to country. Telemedicine has become particu- larly prominent, especially during the COVID-19 pandemic. The integration of AI and machine learning is rapidly advancing, with a focus on improving diagnostic accuracy and patient out- comes. Some countries are very advanced in integrating digital technology into healthcare settings, while others have more fragmented systems that are not yet mainstreamed or inter - connected with each other. The different jurisdic- tions therefore have varying regulatory regimes on digital technology. Digital healthcare brings numerous benefits, including enhanced accessibility, efficiency and patient outcomes by enabling remote consul- tations, real-time data collection and AI-driven diagnostics, while also improving interoperability and data sharing among healthcare providers. The benefits of digital healthcare to patient care can be broadly divided into two groups: individu- al treatment improvement and the overall “great- er good” for patient treatment and research. The experience of patients is generally improved with better access to healthcare (reduced need for in-person visits), having greater control over their health data, and smoother transition and access to health data from any location. Health- care professionals benefit from enhanced clinical decision-making, improved diagnostic accuracy, streamlined workflows and more efficient patient care – eg, by everyone, everywhere benefiting from complete sets of data, particularly in urgent situations.

The overall benefit for all is facilitating access to health data for researchers and innovators to improve treatment and to research and develop strategies against diseases. While there are initial investment costs in tech- nology and infrastructure, digital healthcare has the potential to reduce long-term healthcare costs significantly through improved efficiency, early disease detection, remote monitoring and telemedicine. Legal Framework There is no universal regulatory definition of digi- tal healthcare, and in most instances no bind- ing definitions exist within national frameworks. However, practically speaking, digital health- care is broadly understood as an umbrella term encompassing various digital technologies used to improve health. The World Health Organiza- tion (WHO) defines digital health as “the field of knowledge and practice associated with the development and use of digital technologies to improve health”. Similarly, the European Com- mission defines digital health as “a set of tools and services that use information and com- munication technologies (ICTs) to support and improve all stages of healthcare, from preven- tion and diagnosis to treatment, monitoring and management of health conditions”. The new European Health Data Space (EHDS) Regulation provides certain definitions related to personal electronic health data. The regulatory framework for digital healthcare has, for the most part, been developed separate- ly by each country and often lags behind techni- cal progress. Broadly, liability regimes applicable to digital healthcare are more developed (largely as these are general product liability regimes) than bespoke regulatory regimes that address specific digital healthcare issues. For exam-

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

ple, within the EU, the framework is only par- tially harmonised, with regulations such as the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and the Medical Device Regulation (EU) 2017/745 (MDR) providing some level of consistency in respect of the regulatory framework. Key regulatory frameworks generally include requirements for healthcare providers, cost coverage by health insurers, data protec- tion laws, and health data and technology rules, such as HIPAA and HITECH in the United States. Policymakers and lawmakers strive to stay up to date with technological developments and to set up working groups for specific topics. Busi- ness lobby groups also play a significant role in influencing the development of new guidelines, regulations and liability laws. The regulatory (and liability) framework is critical in supporting or hindering digital innovation hubs and the role of domestic enterprises in the global market. The basis for the development of new guidelines or regulatory laws often starts with regulatory sand- boxes and pilot projects. In addition to the usual purpose of ensuring safety and regulatory compliance, adherence to technical standards in the field of digital health particularly addresses unique issues of interop- erability that are increasingly prevalent (with the use of connected devices being on the rise). On the other hand, the rapid technological develop- ments in digital health may not yet be captured by existing technical standards. Instead, they provide the opportunity to set new ones. Issue-specific legal framework Software as a Medical Device (SaMD) is regu- lated in several jurisdictions, under frameworks such as the EU’s MDR and IVDR, Australia’s Therapeutic Goods Act, the US FDA’s guidelines and South Korea’s Digital Medical Products Act

(DMPA), all of which establish specific require- ments for the classification, approval and moni- toring of SaMD, fitting alongside broader digital healthcare regulations to ensure safety, efficacy and compliance. Self-care, wellness and fitness IT products These include IoT and wearables, and have seen rapid growth; they are intended to encourage and monitor health and wellbeing. Nonetheless, there is usually no applicable specific regulato- ry framework, and manufacturers will generally seek to produce products that do not fall under the classification of medical devices. However, the distinction between wellness/healthcare products and medical devices can be very diffi- cult to discern and fluid in nature, potentially trig- gering conformity assessment and label require- ments (eg, CE marking) for products ostensibly intended to be wellness/healthcare products. Cybersecurity and data protection These issues are critical to digital healthcare due to the high sensitivity of collected data (health data in particular). Data protections laws all over the world address related risks for individuals by demanding high protection standards. The approach varies by legislation. Comprehensive models, as the General Data Protection Regula- tion (GDPR) in Europe, provide data protection rules for all personal data, with a particularly high level of protection for health data. Secto- ral approaches, such as in the USA, provide sector-specific data protection. This includes, for example, HIPAA and particular cybersecu- rity regulatory frameworks being introduced in several jurisdictions (eg, the NIS2 Directive and Cyber Resilience Act in the EU).

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

Artificial intelligence (AI) and machine learning (ML) The EU’s new AI Act is the first-ever standalone governance of AI from a regulatory perpsective. However, the EU AI Liability Act was withdrawn in February 2025, as the member states were unable to agree on a sufficient common basis. In other jurisdictions, such as Switzerland, legisla- tors have not yet managed to develop a regula- tory framework, or have only a partially enacted relevant regulatory framework (eg, South Korea’s AI Act, and China’s regulations on AI-assisted diagnosis technology and Al-assisted treatment technology). Telehealth Despite the increased use of telehealth following the COVID-19 pandemic, some jurisdictions lack specific telemedicine legislation. They instead rely on general healthcare rules. Others, like the USA and India, have implemented specific tel- ehealth regulations. Overall, in dealing with the topic generally and in respect of the discrete issues that arise with digital healthcare, the regulatory framework for digital healthcare is seen as lagging behind tech- nological advancements, with gaps in regulation and enforcement. Existing liability laws, in par- ticular, may need to be amended to take into account the new types of products and services emerging in digital healthcare contexts. Usu- ally, marketing authorisations by US and ROW authorities provide for the safety and conformity of the product. However, considering the num- ber and variety of digital health technologies, no similar comprehensive regulatory framework has been developed yet, leading to regulatory gaps and uncertainties.

Regulatory Oversight The oversight of digital healthcare typically falls under the remit of the usual healthcare regula- tory agencies (such as the FDA in the USA, and the FAMHP in Belgium), being responsible for oversight and providing regulatory advice. In some cases, non-healthcare regulatory agen- cies may also be involved in digital healthcare oversight. For example, the Competition and Consumer Protection Commission (CCPC) in Ireland is responsible for consumer protection, including digital healthcare applications. The enforcement of laws and regulations in digital healthcare varies by jurisdiction and can range from educating infringing parties and issuing warning letters to pre-market assess- ments, routine monitoring and the imposition of penalties (even criminal penalties). Data protec- tion violations are particularly liable to stricter enforcement. The current regulatory frameworks are evolving but still face challenges in fully addressing the risks posed by digital technologies in health- care. For instance, in Australia, the Therapeutic Goods Administration (TGA) has made strides with recent amendments to the Medical Device Regulations, yet cybersecurity and data privacy remain critical issues needing further regula- tory attention. In the USA, while the FDA and other agencies have established guidelines and enforcement mechanisms, the rapid pace of technological advancement often outstrips regulatory updates. In Switzerland, the decen- tralised approach and lack of a coherent data management environment highlight the neces- sity for a more integrated and robust regulatory framework to effectively manage the complexi- ties of digital healthcare technologies. Proposed reforms in the USA, for example, may address

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

telehealth fraud and over-utilisation by practi- tioners following the expanded use of telemedi- cine services. Liability Digital healthcare poses several legal risks, including privacy and security challenges, inter- operability issues, and the increased involve- ment and reliance on third parties, which can lead to intended or unintended responsibility gaps. Legal issues also arise from the lack of comprehensive and harmonised pre-market regulatory frameworks, resulting in inconsistent enforcement and gaps in protection. The rapid pace of technological advancements often out- strips existing regulations, creating challenges in ensuring that new digital health solutions com- ply with current legal standards and adequately protect patient safety and privacy. Companies not specialised in healthcare but tapping into healthcare services/products may face signifi- cant regulatory challenges. Fragmented and inconsistent regulatory land- scapes, which complicate the enforcement of standards and protections across different juris- dictions, might be very unclear to, for example, manufacturers of digital healthcare applications. Additionally, the lack of specific regulations for emerging technologies, such as AI and machine learning in healthcare, further complicates enforcement efforts, as authorities struggle to apply existing frameworks to new and com- plex digital health solutions. If the digital health product leads to damage to consumers, typically the “enforcement” will be imposed by affected consumers’ or competitors’ claims via litigation. There is often great complexity in determining responsibility among multiple stakeholders, such as healthcare providers, technology devel- opers and manufacturers. This can complicate

contractual and statutory obligations and make determination of resultant liability more difficult. Liability frameworks for digital healthcare are generally based on general liability regimes, including contractual claims, tort, common law principles, and strict product liability. In the EU, the Product Liability Directive (PLD) harmo- nises liability across the member states and falls under the Representative Actions Directive (RAD) regime currently being brought into effect across the EU. This means that product liability claims can be brought on behalf of consumers in some form of class action system. Some of the jurisdictions (eg, Germany) enabled “class actions” aimed at redress for the first time, with the implementation of the RAD in October 2023. This might increase the exposure of manufac- tures of digital health products in the EU member states significantly, as the RAD further provides for the possibility of cross-border claims. To mitigate against legal exposures, companies can: • adhere to industry standards (where avail- able); • obtain necessary regulatory approvals; • document testing against standards; • enable proper quality surveillance systems; • implement robust compliance systems; and • include contractual safeguards such as indemnity clauses, warranties and clear allo- cation of responsibilities. Emerging Legal Issues and Reform Recent developments in digital healthcare tech- nology include a continued focus on: • AI and ML; • virtual and augmented reality; • automation of administrative processes;

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INTRODUCTION Contributed by: Sarah-Jane Dobson and Katrin Ruhl, Ashurst

• data interoperability and standardisation; and • the Internet of Medical Things (IoMT). These advancements are transforming the healthcare landscape, offering new opportuni- ties for improving patient care and operational efficiency. Several jurisdictions are undertaking reforms to address the evolving digital healthcare land- scape. On the EU level, the revised PLD aims to keep pace with new stakeholders and prod- uct types, overcoming the “black box” effect for consumers. In Switzerland, the “DigiSanté” ini- tiative aims to advance digitalisation within the healthcare sector. These reforms and initiatives reflect the ongoing efforts to create a more integrated and robust regulatory framework that can effectively man- age the complexities of digital healthcare tech- nologies.

In conclusion, digital healthcare offers signifi- cant benefits in terms of accessibility, efficiency and patient outcomes. However, the regulatory framework must evolve to keep pace with tech- nological advancements, address legal risks, and ensure the safety and privacy of patients. In the face of continuing digital progress, regard- less of the regulatory framework (or its introduc- tion), stakeholders will face uncertainties and will need to closely monitor the changing regulatory landscape. Moreover, even with existing and fur- ther developed liability regimes, the complexity of legal issues arising in the context of digital healthcare means liability determination for these products is particularly complex.

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BELGIUM

Netherlands

Brussels Belgium

Germany

Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini Van Bael & Bellis Van Bael & Bellis is a leading independent inter- national law firm, headquartered in Brussels with additional presence in London and Geneva. For nearly 40 years, the firm has been at the heart of the EU and Belgian legal and regulatory eco- system, representing some of the world’s larg- est pharmaceutical, biotechnology and medical device companies. Its multi-disciplinary digital healthcare team combines longstanding life sci- ences and healthcare, data privacy, competition and regulatory expertise with experience advis-

Luxembourg

France

ing on new and emerging technologies. The firm advises multiple clients on issues related to the access and use of data in the digital healthcare field and the impact of new and proposed com- petition and sectoral regulation and policy on existing practices. These include advising on the data protection implications of the use of new technologies, cloud-based services and analysis of Big Data and the re-use of personal data for AI, in particular machine learning.

Authors

Thibaut D’hulst heads the Van Bael & Bellis (VBB) privacy and data protection team and is a certified data protection officer. His practice has a strong data protection, intellectual property,

Ilham Irgiou is an associate in the Van Bael & Bellis commercial team, with a strong focus on pharmaceutical and healthcare law. She also advises on competition law and intellectual

life sciences and healthcare and competition focus. He leads VBB’s AI taskforce and has a particular interest in emerging technologies and the interplay of data protection, IP and competition issues. Thibaut’s experience includes advising on regulatory and data protection requirements for platforms hosting clinical trial information; impact assessments for medtech and pharma solutions; and dealing with data subject requests and data breaches in the life sciences context.

property rights. Ilham advises Belgian and international clients across a wide range of sectors, with particular expertise in the pharmaceutical industry. Her experience includes advising on regulatory matters and representing clients in litigation before commercial courts and administrative authorities.

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

Ossama M’Rini is an associate in the Van Bael & Bellis commercial team. He advises domestic and international clients on a wide range of commercial law issues, with a

focus on IT/IP, data protection, pharmaceuticals and healthcare. A member of the firm’s AI taskforce, Ossama has a particular interest in issues at the intersection of law and technology, including the potential impact of AI and data-driven tools on the pharmaceutical and healthcare sectors.

Van Bael & Bellis Glaverbel Building Chaussée de La Hulpe 166 Terhulpsesteenweg 1170 Brussels Belgium

Tel: +32 2647 7350 Fax: +32 2640 6499 Email: brussels@vbb.com Web: www.vbb.com

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

The Latest in Digital Healthcare in Belgium The digital healthcare landscape in Belgium has experienced profound changes in recent years, propelled by technological advancements, evolving patient needs, and challenges brought on by the COVID-19 pandemic. The heightened need for remote care, telemedicine, and data- driven decision-making has underscored the importance of a robust and adaptable digital healthcare infrastructure. Amid these evolving dynamics, a new fed- eral government, formed in January 2025, has set a clear policy direction through its federal coalition agreement for 2025–2029 (“Coalition Agreement”). While the Coalition Agreement places digital transformation, especially within healthcare, at the heart of its vision for public service modernisation, it largely maintains the course set by previous administrations, with no major shift in healthcare policies. The Coali- tion Agreement recognises the potential added value of technology for patients and healthcare providers, provided it complements rather than replaces in-person care. Digital tools are viewed as a means to strengthen existing care relation- ships and support more personalised services. The federal government also recognises the growing role of artificial intelligence (AI). Belgium aims to complement EU legislation with nation- al rules that safeguard medical confidentiality, therapeutic freedom, and patient safety, while leaving space for experimentation and innova- tion. A national AI and data strategy for public health is being developed, with cybersecurity as a core priority. Similarly, the National Institute for Health and Disability Insurance (RIZIV/INAMI – NIHDI) has introduced its new interfederal eHealth Action Plan (2025–2027) (eHealth Plan) for integrated healthcare by establishing eHealth architecture

in which the hundreds of existing ICT compo- nents and platforms are shared transparently with a wide range of stakeholders. This review explores the key trends shaping Bel- gium’s digital healthcare ecosystem and high- lights the main challenges faced by healthcare organisations and policymakers. Integrating Care and Advancing Data Sharing Systems in Belgium The growing emphasis on healthcare data shar- ing and interoperability has emerged as a key trend in Belgium’s digital healthcare landscape. Historically, Belgium’s healthcare system was very fragmented, marked by minimal co-ordi- nation across different providers and care set- tings. Patients frequently encountered gaps in care when moving between healthcare provid- ers or settings, such as transitioning from hos- pital to home care. This lack of co-ordination and data sharing led to inefficiencies, and less- than-ideal patient outcomes. Interoperability efforts now aim to enhance continuity of care and improve communication across healthcare environments, facilitated by the rapid expansion of digital health technologies such as electronic health records (EHRs) and telehealth platforms (eg, myconsultation.be, Doctena, and Doktr). EHRs allow healthcare professionals to access and share patient information securely, ensur- ing continuity of care, while telehealth platforms enable remote consultations and monitoring, facilitating care co-ordination. National strategy and the Belgian integrated health record The eHealth Plan’s central pillar is strengthening the core services of the federal eHealth platform and accelerating the rollout and operationalisa- tion of the Belgian Integrated Health Record (BIHR). The BIHR is conceived as a comprehen-

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

sive, national electronic health record accessible to authorised healthcare professionals across the country. Its primary goal, supported by the Coalition Agreement, is to ensure continuity of care for every patient by providing a unified and secure platform for health data. The aim is for the BIHR to achieve full national interoperability by 2026–2027. Existing Belgian initiatives illustrate this push for better data integration. For example, the Brus- sels Health Network (BHN) connects all public and private hospitals in the Brussels region, as well as the French and Dutch-speaking associa- tions of general practitioners (GPs) in Brussels. These platforms allow healthcare providers to access and share relevant patient information, eg, medical history, test results, and medication lists, helping avoid unnecessary repeat tests. The federal eHealth platform, with its MaSanté patient portal and the eHealthBox secure mes- saging system, remains a cornerstone. A recent concrete development is the Mult-eMe- diatt application. Developed by NIHDI in collabo- ration with the eHealth Platform, Medex (a fed- eral agency responsible for conducting medical assessments for sick leave or workplace acci- dents), and the National Intermutualistic College (CIN/NIC), it allows GPs to electronically trans- mit medical certificates directly to health insur- ance funds or Medex, streamlining an important administrative process. Alignment with European Health Data Space (EHDS) Belgium’s national data sharing initiatives are closely aligned with the broader European agenda, particularly the EHDS. The EHDS Reg- ulation (2025/327), which entered into force on 26 March 2025, aims to give individuals great- er control over their health data and facilitate

secure cross-border data exchange for primary care purposes, as well as for secondary uses such as research, innovation, and health poli- cymaking. The eHealth Plan includes the planned intercon- nection of the BIHR with the EHDS, commenc- ing in 2025. Belgium’s proactive engagement is further demonstrated by Sciensano’s involve- ment in preparatory projects such as the TEH- DAS2 Joint Action (aimed at developing con- crete guidelines for EHDS implementation) and the EHDS2 PILOT project (which concluded in October 2024 and focused on establishing infra- structure for secondary data use). The Belgian Health Data Agency (HDA) and data governance A key institutional development mandated by the Coalition Agreement is the formalisation of the HDA as a federal agency. HeDERA, a project co-ordinated by the Belgian Federal Public Ser- vice Health, Food chain safety and Environment ( Service public fédéral Santé publique, Sécurité de la chaîne alimentaire et Environnement/Fed- erale Overheidsdienst Volksgezondheid, Veilig- heid van de Voedselketen en Leefmilieu – FPS Health) in partnership with Sciensano, supports the HDA’s mission to facilitate secondary use of health, healthcare and well-being data in a safe, uniform, and transparent environment, compli- ant with privacy regulations like the General Data Protection Regulation (2016/679) (GDPR) and the principles of the EHDS. Furthermore, health data managed by the Intermutualistic Agency (IMA/AIM) will be made accessible to authorised public and research institutions upon request, to support scientific research and inform health policy decisions.

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

Enhancing interoperability and data harmonisation

of digital health and data sharing strategies in Belgium. Data donation for research The concept of “data donation” for scientific research is being actively promoted, support- ed by the Coalition Agreement. This aims to enable citizens to voluntarily share their health data, including anonymised or pseudonymised information from medical records, genetic data, and lifestyle information, for scientific research. This practice must be in full compliance with the GDPR, the EHDS Regulation, and the Data Gov- ernance Act (2022/868) (the Belgian implement- ing law for which was adopted on 15 May 2024). Such data is viewed as a valuable resource for advancing medical understanding and innova- tion. Initiatives like the European Brain Data Hub, in which Belgium participates, already exemplify data altruism for specific research areas like brain health. Belgian authorities continue to study and refine the legislative framework surround- ing medical data donation to ensure adequate safeguards, patient control, and transparency. The Role of Multi-Stakeholder Partnerships Another essential factor driving healthcare inno- vation in Belgium is the rise of multi-stakeholder partnerships. Diverse stakeholders play a role: government bodies such as FPS Health and the Walloon Agency for a Life of Quality (AVIQ), healthcare providers from hospitals to primary care centres and individual professionals, tech- nology companies from multinational corpora- tions to local startups, and research institutions including universities and academic medical centres. Patient organisations also play a pivotal part, advocating for patient needs. These stakeholders combine to co-create digi- tal health solutions that address real-world chal-

Despite significant progress, the full harmonisa- tion of health data and comprehensive interoper- ability of digital systems remain ongoing objec- tives. Difficulties in exploiting data persist due to a lack of standardised data input and system compatibility, a concern highlighted by Belgian hospitals and research institutions. The Belgian government encourages the adoption of har- monised systems for structuring and encrypting medical data, such as SNOMED CT. To address these challenges, FPS Health has launched initiatives like the “cross-over” call for projects. This programme is designed to finance projects aimed at strengthening the interoper- ability of digital systems within Belgian general and psychiatric hospitals. It seeks to overcome limitations of previous pilots, such as prototypes not reaching operationalisation, restricted scope, and insufficient transferability of solutions. Data protection and patient trust The protection of sensitive health data is par- amount and is governed by a comprehensive regulatory framework in which the GDPR plays a central role. Public concern over data privacy remains a significant consideration in the devel- opment and implementation of data sharing initiatives. This sensitivity was underscored in February 2025 when patient associations, sev- eral psychologists’ associations, and the League of Human Rights (LDH) lodged an appeal with the Belgian Council of State. The appeal raised concerns regarding the government’s manage- ment of digitalised health data sharing, medical confidentiality, and the processes for informed consent. Ensuring robust data security meas- ures, transparent governance structures, and maintaining public trust are therefore critical preconditions for the successful advancement

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

AI and personalised medicine The integration of AI into healthcare will also shape the future of digital health in Belgium. While Belgian companies and hospitals are actively developing and deploying AI-driven solutions, the establishment of a comprehensive national data and AI strategy specifically for the public health sector is an ongoing commitment for the Belgian federal government, as per the Coalition Agreement. The aim is to leverage AI for administrative simplification and care improve- ment, with an important emphasis on ensuring cybersecurity and ethical oversight. The new EU AI Act will significantly influence this, imposing stringent requirements on high-risk AI applica- tions in healthcare. Belgian companies are actively developing AI- driven solutions for personalised medicine, particularly in oncology and infectious diseas- es, promising improved patient outcomes and more efficient use of healthcare resources. For example, a Leuven-based company has devised AI algorithms for analysing brain scans, aiding neurological disorder diagnosis and monitor- ing. Hospitals like AZ Delta are being recog- nised for their innovative use of AI, and others, such as AZ West, are employing AI-equipped video capsules for digestive examinations. AI is also being developed for rapid diagnostic tests, for instance, to detect urinary infections more quickly. As digital health solutions become more user- centric, patient engagement is expected to increase, leading to better health outcomes and a more sustainable healthcare system. Digital tools, such as patient portals, mobile health apps, and online communities, enable patients to take a more active role in managing their health and well-being. Initiatives like “C’est quoi, Doc?” aim to create accessible medical literacy

lenges. An example is HeDERA or at a more local level, the Antwerp Health Harbour initiative (AHHI), whose partners aim to share data, net- works, and applications and to develop innova- tive health projects such as an integrated medi- cal and socio-economic data platform. Advancing Patient-Centric Care: Empowerment, Remote Technologies, and Personalised Medicine Enhancing patient control and engagement The digital healthcare revolution in Belgium continues to enhance patient empowerment. The introduction and expansion of telemedicine platforms, remote monitoring devices and wear- able technologies have given patients greater control over their health information, allowing them to actively participate in their care journey. These tools enable remote access to healthcare services, monitor health metrics in real-time, and engage more effectively with healthcare providers. The Coalition Agreement supports the development of digital skills for citizens and psychosocial support to help them manage the influx of health data, further promoting patient empowerment. Belgian startups remain at the forefront of this movement, developing innovative solutions for remote patient monitoring and disease manage- ment. For instance, smartphone apps employing photoplethysmography to detect atrial fibrillation have received CE marking and are now used by patients and healthcare providers nationwide. Similarly, wearable platforms capturing a wide array of physiological parameters continue to be tested in clinical trials and real-world settings, demonstrating the impact of continuous moni- toring on patient outcomes.

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

videos, further supporting patient understanding and engagement. In conclusion, while Belgium shows promising advancement in AI-driven personalised medi- cine, significant challenges remain. The absence of a comprehensive national data and AI strategy creates regulatory uncertainty. Ethical concerns around algorithmic bias and equitable access persist, potentially widening healthcare dis- parities if not properly addressed. Additionally, healthcare professionals face a steep learning curve in integrating these technologies into clini- cal workflows, requiring significant investment and resources in training and in developing skills to interpret AI outputs while maintaining their professional judgement. Without proper sup- port, even the most promising AI technologies may face resistance or implementation chal- lenges. For Belgium to fully realise the potential of AI in healthcare, these technical, ethical, and practical challenges must be addressed through thoughtful policy development and multi-stake- holder collaboration. Regulatory Landscape Efforts to cultivate a robust digital health eco- system in Belgium are often challenged by the need to comply with complex European Union (EU) legal and regulatory frameworks, alongside national implementation and specific Belgian rules. Evolving EU and national regulatory frameworks Compliance with the EU Medical Device Regula- tion (2017/745) (MDR) and the EU In-Vitro Diag- nostic Medical Devices Regulation (2017/746) (IVDR) continues to be particularly challenging for digital health companies, especially small and medium-sized enterprises. These regula- tions demand comprehensive clinical evidence,

robust quality management systems, and con- tinuous monitoring, which can be both resource- intensive and time-consuming. In recognition of these difficulties, the European Parliament adopted a resolution in October 2024 calling for urgent revisions to the MDR and IVDR to ensure the availability and safety of medical devices. The European Commission has subsequently initiated a targeted evaluation of these regula- tions, which closed for feedback on 21 March 2025, to identify areas for improvement and simplification. The European Medicines Agen- cy (EMA) is also playing a growing role, having established a procedure for scientific advice on certain high-risk technologies and an ongo- ing pilot programme (until the end of 2025) for orphan medical devices. A highly significant development is the EU AI Act, with enforcement projected to start mid- 2025 and the Belgian Institute for Postal Ser- vices and Telecommunications as the desig- nated national regulator. The AI Act introduces a risk-based framework for regulating AI sys- tems, imposing stringent requirements for high- risk applications, a category that includes many healthcare AI systems used for diagnosis, treat- ment, or as medical devices. This legislation will notably influence the Belgian digital health sector, mandating specific controls for such sys- tems. The Coalition Agreement sets out the plan to develop national frameworks to complement the AI Act, particularly focusing on care quality, medical confidentiality, and cybersecurity, while also creating safe spaces for experimentation through initiatives like AI regulatory sandboxes. A public tender was launched in late 2024 to study the framework for these sandboxes. The GDPR continues to shape the sector by enforcing strict rules on personal data process- ing, particularly health data. Digital health com-

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

panies must design their solutions with robust data protection and privacy measures. Com- plementing this, the EU Data Governance Act facilitates data altruism and the creation of com- mon data spaces, including in health. The EHDS Regulation, adopted in January 2025, will further revolutionise the landscape by governing cross- border health data exchange and secondary use for research and policy. Belgium’s strong position in clinical research (approximately 20% of all European clinical trials for cancer drugs occur in Belgium, with compa- nies investing EUR15 million daily in R&D) high- lights the importance of understanding these evolving regulatory frameworks. Challenges such as participant mobility and ensuring trust in medical research persist. Cybersecurity: a critical imperative Cybersecurity is another critical component of digital health regulation and a growing concern. The enactment of the NIS2 Belgian law (Law of 26 April 2024, effective 18 October 2024), align- ing with the EU’s NIS2 Directive (2022/2555), mandates stricter cybersecurity risk manage- ment measures, incident management, and supervision for entities in critical sectors, includ- ing healthcare. In-scope entities were required to identify themselves using tools like the Scope Test Tool and register via the Safeonweb@work platform by 18 March 2025. The Belgian Fed- eral Agency for Medicines and Health Products (AFMPS/FAGG – FAMHP) acts as a sectoral authority for relevant health entities under this law. This framework is closely linked to the EU Directive on the resilience of critical entities (CER Directive, 2022/2557); entities designated as critical under the future Belgian CER law (for which the FAMHP will also be a sectoral author- ity) will automatically be considered essential

under NIS2, even if they are not caught within the NIS2 scope. As digital health technologies proliferate, ensur- ing strong cybersecurity protocols and manda- tory notification of significant incidents to the Centre for Cybersecurity Belgium (CCB) are essential for protecting patient data, maintain- ing trust, and adhering to the evolving regulatory framework. Further supporting these efforts, the European Commission launched an action plan in January 2025 to strengthen cybersecurity in hospitals and healthcare providers across the EU, proposing that the EU Agency for Cyberse- curity (ENISA) establish a pan-European support centre. The Belgian Data Protection Authority (DPA) stressed the importance of adequate security measures in a decision of 17 December 2024, imposing a EUR200,000 fine on a Belgian hospi- tal. This fine followed a 2021 ransomware attack that compromised the personal data of 300,000 people. The DPA found significant deficien- cies in the hospital’s data protection measures, including a lack of an appropriate data protec- tion impact assessment (DPIA) and inadequate technical security. The Belgian healthcare sector remains a prime target for cyberattacks, with reports in the sec- ond quarter of 2024 indicating a 31% increase compared to the same period in 2023, and the healthcare sector being the most targeted. High- profile incidents at various hospitals in recent years illustrate the persistent threat and the sub- stantial financial and operational impact of such attacks, with recovery costs sometimes running into millions of euros.

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BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis

Reimbursement and Funding: Persistent Challenges and Future Directions One of the most significant remaining barriers in Belgium is the reimbursement and funding of digital health solutions. Reimbursement is for many digital health companies key to success and sustainable growth. Although certain inno- vations have seen progress in securing support, many others still struggle to obtain adequate reimbursement, hindering their broader adop- tion and integration into the healthcare system. Scaling the pyramid: reimbursement of mobile health apps in Belgium Belgium is one of the few countries in Europe that provides for reimbursement for mobile health apps. The mHealthBelgium validation pyramid, introduced in 2018, was designed to facilitate their reimbursement. It categorises apps into three levels: M1 (CE marking as a medical device), M2 (meeting interoperability and connectivity criteria), and M3 (demonstrat- ing socio-economic value for reimbursement). Level M3 has remained a high hurdle, with only a few apps able to demonstrate sufficient socio- economic impact. As of April 2025, eight health apps have reached Level 3+, entitling them to regular reimbursement – a significant increase in comparison with last year. While recent progress is encouraging, significant challenges remain. In October 2024, the Belgian House of Representatives introduced a draft resolution aimed at improving the accessibility and affordability of digital health applications. The resolution suggests that a process such as that of the German “ Fast-Track-Verfahren ”, a fast-track procedure which allows digital health applications to be approved for reimbursement within three months, could be a significant improvement on the current approach proposed by the NIHDI, marked by unclear timelines and

non-binding deadlines. This is particularly rel- evant given the challenges in demonstrating the socio-economic value of health applications, which often takes considerable time. The Ger- man model addresses this by allowing immedi- ate approval and reimbursement if patient ben- efit is proven or granting companies up to 12 months post-inclusion in the central register to demonstrate added value. New reimbursement framework for telemonitoring The NIHDI has implemented a new reimburse- ment framework to support the use of telem- onitoring in the follow-up care of patients hos- pitalised for heart failure. Under this initiative, hospitals that have established agreements with the NIHDI are eligible for reimbursement when providing remote monitoring services through dedicated telemonitoring teams. As of April 2025, 30 healthcare institutions had such agree- ments, and eight telemonitoring applications (FibriCheck, Remecare, moveUp, Healthen- tia, Comunicare, and BeWell@Home, CareLink System and Comarch), the majority of which are Belgian-developed, are approved for reimburse- ment under this scheme. This policy is based on the NIHDI’s assessment that integrating telem- onitoring into the care continuum for heart failure patients can significantly improve both the qual- While other areas are moving forward, telecon- sultations have seen a setback. As of 15 Febru- ary 2025, telephone consultations by GPs are no longer reimbursed. Video consultations remain permitted but are strictly regulated under the Royal Decree of 27 March 2025 which sets out the legal basis and guidelines for remote medi- cal care under the compulsory health insurance scheme. This decision, made primarily for budg- ity and efficiency of care delivery. Setback for teleconsultations

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