Historical Development of EU Health Collaboration
The Foundation Period: From Rome to Maastricht (1957-1992)
The Treaty of Rome establishing the European Economic Community in 1957 contained no explicit provisions for health policy. The founding member states conceived of European integration primarily in economic terms, focused on creating a common market and customs union. Health systems, deeply rooted in national traditions and political systems, remained firmly under national control. The early decades of European integration saw health issues addressed only indirectly through provisions related to the free movement of workers and the mutual recognition of professional qualifications.
The primary health-related activities during this period concerned occupational health and safety. The treaty provisions on working conditions provided a legal basis for directives addressing workplace hazards, exposure to dangerous substances, and health protection for specific categories of workers. Additionally, the recognition that healthcare professionals must be able to move freely within the common market led to directives on the mutual recognition of medical, nursing, and other health professional qualifications. These measures, while important, represented a narrow conception of health policy focused on removing barriers to economic integration rather than pursuing health as an intrinsic policy goal.
The Single European Act of 1986 marked a modest expansion of health-related provisions, introducing specific requirements for health and safety protection in the workplace and laying the groundwork for more systematic attention to health matters. However, the act maintained the fundamentally national character of health policy, with Community action limited to supporting and complementing member state initiatives.
The Maastricht Treaty and the Establishment of Health Competence (1992)
The Treaty on European Union, signed at Maastricht in 1992, represented a watershed moment for EU health policy. Article 129 of the treaty, subsequently renumbered as Article 168 in the Treaty on the Functioning of the European Union, established for the first time an explicit legal basis for Community action in public health. The article stated that the Community should contribute to ensuring a high level of human health protection by encouraging cooperation between member states and, if necessary, lending support to their action. Crucially, the treaty specified that Community action should be directed toward improving public health, preventing physical and mental illness, and obviating sources of danger to human health.
The Maastricht provisions incorporated two fundamental principles that continue to shape EU health policy. First, the principle of subsidiarity was explicitly enshrined, establishing that the EU should act only where objectives cannot be sufficiently achieved by member states acting alone and can be better achieved at Union level. This principle reflects the recognition that healthcare organization and delivery remain essentially national responsibilities, shaped by distinct historical traditions, financing mechanisms, and political choices. Second, the treaty explicitly excluded the harmonization of laws and regulations of member states in the health field, meaning that the EU cannot impose uniform health policies or require member states to standardize their health systems.
These limitations notwithstanding, the Maastricht Treaty opened new possibilities for EU action in public health. The establishment of health programs, the collection and analysis of health data, the promotion of research, and the encouragement of cooperation in addressing common health challenges all became legitimate EU activities. The treaty thus created a framework for meaningful EU involvement in health while respecting national prerogatives over healthcare systems.
From Amsterdam to Lisbon: Strengthening Health Protection (1997-2009)
The Treaty of Amsterdam, which entered into force in 1999, built upon the Maastricht foundations by introducing the principle of health protection into all Community policies. The treaty stipulated that a high level of human health protection should be ensured in the definition and implementation of all Union policies and activities, thereby establishing what came to be known as the Health in All Policies approach. This principle recognizes that health outcomes are determined not only by health services but also by social determinants including education, employment, environment, agriculture, transport, and other policy domains. By requiring health considerations to be integrated across all EU policy areas, the Amsterdam Treaty acknowledged the multifaceted nature of health and the need for policy coherence.
Subsequent years saw the gradual expansion of EU health activities within this constitutional framework. Public health programs addressing specific issues such as cancer, AIDS, drug dependence, and health promotion were established and provided funding for collaborative projects between member states. The EU also began to develop regulatory frameworks for cross-border health issues, including standards for blood and blood products, human tissues and cells, and organ transplantation. These measures reflected growing recognition that certain health risks require coordinated action beyond national borders.
The Treaty of Lisbon, which came into force in 2009, consolidated and strengthened EU health provisions. The treaty maintained the core principles established at Maastricht while adding new dimensions to EU health competence. Importantly, Lisbon enhanced provisions related to cross-border health threats, authorizing the Union to adopt measures setting high standards of quality and safety for medicinal products and medical devices, and measures concerning monitoring, early warning, and combating serious cross-border threats to health. The treaty thus provided a stronger legal foundation for EU action on health security and emergency preparedness, though these provisions would not be fully utilized until the COVID-19 pandemic more than a decade later.
The COVID-19 Pandemic and the Push for a European Health Union (2020-Present)
The COVID-19 pandemic that emerged in early 2020 exposed both the strengths and limitations of existing EU health collaboration mechanisms. The initial months of the pandemic saw uncoordinated national responses, including border closures, competition for scarce medical supplies, and varying public health measures that sometimes worked at cross-purposes. The crisis demonstrated that health threats of such magnitude cannot be adequately addressed through voluntary cooperation alone, and that stronger coordination mechanisms and greater EU-level capacity are needed to respond effectively to health emergencies.
In response to these challenges, the EU undertook its most significant expansion of health activities since the Maastricht Treaty. In 2021, the European Commission established the Health Emergency Preparedness and Response Authority, known as HERA, to prevent, detect, and rapidly respond to health emergencies. HERA’s mandate includes threat assessment, intelligence gathering, development and procurement of medical countermeasures, and coordination of emergency response. The establishment of HERA represents a qualitative shift toward greater EU capacity in health security, moving beyond purely coordinating functions to include operational responsibilities for stockpiling, procurement, and ensuring the availability of critical medical supplies.
The pandemic also led to a substantial strengthening of the European Centre for Disease Prevention and Control. Previously limited to providing scientific advice and conducting surveillance, ECDC received an enhanced mandate including the authority to activate the EU Health Crisis and Pandemic Preparedness and Response Plan, conduct epidemiological investigations in member states, and support the development and deployment of medical countermeasures. These changes reflect lessons learned about the need for strong, authoritative scientific guidance during health emergencies.
Perhaps most significantly, the pandemic catalyzed political momentum for what European Commission President Ursula von der Leyen termed a “European Health Union.” This concept envisions a more integrated approach to health policy while maintaining respect for national competences over healthcare organization. The Health Union framework includes not only enhanced emergency preparedness and response mechanisms but also ambitious initiatives in areas such as cancer control, mental health, pharmaceutical policy, and digital health infrastructure. While the legal foundations of this Health Union rest on existing treaty provisions, the political commitment and financial resources dedicated to health have increased dramatically compared to the pre-pandemic era.
Legal Framework for EU Health Action
Primary Legal Basis: Article 168 TFEU
The primary legal foundation for EU health policy is Article 168 of the Treaty on the Functioning of the European Union. This article, originally introduced by the Maastricht Treaty as Article 129 and subsequently renumbered, establishes both the scope and the limits of EU competence in health matters. Understanding this article is essential for grasping what the EU can and cannot do in the health field.
Article 168 begins by establishing that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action, which shall complement national policies, is to be directed toward improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. The article specifies several mechanisms through which the Union and member states should foster cooperation, including initiatives to set high standards of quality and safety, measures in veterinary and phytosanitary fields with health protection as a direct objective, and measures concerning monitoring, early warning of, and combating serious cross-border threats to health.
Critically, Article 168 explicitly states that Union action in the field of public health shall fully respect the responsibilities of member states for the definition of their health policy and for the organization and delivery of health services and medical care. The responsibilities of member states include the management of health services and medical care, and the allocation of resources assigned to health services and medical care. The paragraph further specifies that measures adopted pursuant to Article 168 shall not prevent member states from maintaining or introducing more stringent protective measures compatible with the treaties.
The article authorizes the European Parliament and Council to adopt incentive measures designed to protect and improve human health, and in particular to combat major cross-border health scourges, measures concerning monitoring, early warning of, and combating serious cross-border threats to health, and measures setting high standards of quality and safety for medicinal products and devices for medical use. However, the article explicitly excludes any harmonization of laws and regulations of member states in these areas. The Council may also adopt recommendations for the purposes set out in Article 168, though such recommendations are not legally binding.
This legal framework creates a nuanced space for EU action. The EU can establish common standards in specific technical areas such as pharmaceutical regulation and medical device safety, coordinate responses to cross-border health threats, fund health projects and programs, facilitate information exchange and best practice sharing, and promote health considerations across all policy domains. What the EU cannot do is harmonize national health laws, impose uniform health system structures, dictate national healthcare budgets or priorities, or interfere with member states’ fundamental choices about healthcare organization and financing.
Cross-Border Healthcare Legislation
One of the most significant pieces of EU health legislation is Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare. This directive, adopted after years of negotiation and building on case law from the Court of Justice of the European Union, establishes a framework for patients seeking healthcare in member states other than their country of affiliation. The directive recognizes that while healthcare remains a national competence, the principles of free movement require that patients have the right to access healthcare in other member states under certain conditions.
The directive establishes that patients have the right to receive healthcare in another member state and to be reimbursed for that care up to the level that would have been provided by their home member state. Patients are not required to seek prior authorization for most types of care, though member states may maintain prior authorization requirements for hospital care or highly specialized treatments that meet certain criteria. The directive also establishes that the healthcare provider is responsible for the quality and safety of care provided, while the patient’s home member state is responsible for reimbursement.
Beyond individual patient mobility, Directive 2011/24/EU also established frameworks for cooperation between member states on healthcare issues. These include provisions for European Reference Networks, which are virtual networks connecting healthcare providers across Europe to share expertise on rare and complex conditions. The directive also addresses mutual recognition of prescriptions issued in other member states, cooperation on health technology assessment, and mechanisms for sharing information about healthcare providers and patient rights. While the directive has been criticized for complexity and limited impact on actual patient mobility, it represents an important recognition of the cross-border dimensions of healthcare in an integrated Europe.
Pharmaceutical Regulation
The EU has developed extensive regulatory frameworks for medicinal products, reflecting the recognition that the safety, quality, and efficacy of medicines are matters of common interest that benefit from coordinated approaches. The regulatory system operates through two complementary mechanisms: a centralized authorization procedure managed by the European Medicines Agency, and decentralized and mutual recognition procedures coordinated between national medicines agencies.
Regulation 726/2004 establishes the centralized procedure, which is mandatory for certain categories of medicines including those derived from biotechnology processes, orphan medicinal products for rare diseases, advanced therapy medicinal products, and medicines for human use containing new active substances for specific therapeutic areas. For these products, a single marketing authorization granted by the European Commission based on EMA assessment is valid throughout the European Union. This centralized system ensures uniform scientific standards, avoids duplication of assessment efforts, and facilitates access to innovative medicines across the EU.
The Community code relating to medicinal products for human use, codified in Directive 2001/83/EC as amended, establishes comprehensive requirements for the quality, safety, and efficacy of medicines, manufacturing standards, labeling and packaging requirements, advertising restrictions, and pharmacovigilance obligations. The directive has been amended numerous times to address emerging issues such as falsified medicines, the regulation of herbal medicinal products, and enhanced pharmacovigilance requirements following safety scandals.
Clinical trials of medicinal products are governed by Regulation 536/2014, which replaced the previous Clinical Trials Directive. The regulation aims to simplify procedures, harmonize assessment processes across member states, and increase transparency through a publicly accessible EU database of clinical trials. The regulation establishes a coordinated assessment procedure whereby sponsors submit a single application through an EU portal, with one member state serving as reporting member state coordinating the assessment. This system is designed to facilitate multinational clinical trials while maintaining high ethical and safety standards.
Pharmaceutical regulation represents an area where the EU has successfully balanced the need for coordinated action with respect for national competences. While authorization, safety monitoring, and quality standards are significantly harmonized, pricing and reimbursement decisions remain national competences. Member states retain the authority to decide which medicines to include in their national health insurance systems and at what price, though the EU facilitates voluntary cooperation on health technology assessment to support these decisions.
Medical Devices Regulation
The regulation of medical devices underwent comprehensive reform with the adoption of Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices. These regulations, which replaced earlier directives, established significantly more stringent requirements for medical devices based on lessons learned from safety scandals and recognition of gaps in the previous system.
The medical devices regulations introduce more rigorous clinical evidence requirements, particularly for high-risk devices. Manufacturers must provide more extensive clinical data demonstrating safety and performance, and the regulations strengthen requirements for post-market surveillance and vigilance. The regulations establish a Unique Device Identification system to improve traceability of devices throughout their lifecycle, from manufacturing through distribution to use in clinical settings. The regulations also introduced more stringent requirements for notified bodies, the independent organizations that assess device conformity, including more intensive oversight and mandatory unannounced audits.
The medical devices regulations exemplify the EU’s approach to balancing innovation with patient safety. While the regulations are more demanding than their predecessors, they maintain a risk-based approach that avoids unnecessarily burdening lower-risk devices with requirements designed for high-risk implantable devices. The regulations also include provisions to support innovation, such as innovation offices within notified bodies and provisions for custom-made devices and devices manufactured in health institutions.
Communicable Disease Control and Health Security
The legal framework for communicating disease control and health security has evolved significantly, particularly in response to new and emerging health threats. Decision 1082/2013/EU on serious cross-border threats to health establishes mechanisms for coordination, early warning, and response to health threats including communicable diseases, threats of biological, chemical, environmental, or unknown origin, and other events that may constitute public health emergencies of international concern.
The decision establishes the Early Warning and Response System, through which member states must notify the Commission and other member states of serious cross-border threats to health. The system enables rapid exchange of information and coordination of response measures. The decision also provides for risk assessment by relevant EU agencies, development of preparedness and response plans, and coordination of risk communication. While member states retain primary responsibility for protecting public health on their territories, the decision creates obligations for notification and cooperation that strengthen collective capacity to address threats that transcend borders.
The COVID-19 pandemic led to further strengthening of health security provisions. Regulations adopted in 2022 expanded the mandate of the European Centre for Disease Prevention and Control to include enhanced surveillance capabilities, authority to conduct epidemiological investigations in member states in coordination with national authorities, and responsibilities for supporting preparedness planning and response coordination. These regulations also established the EU Health Crisis and Pandemic Preparedness and Response Plan, providing a framework for coordinated EU-level action during health crises while respecting member state competences.
Standards for Blood, Tissues, Cells, and Organs
The EU has established comprehensive quality and safety standards for substances of human origin used in medical treatments. Directive 2002/98/EC sets standards for the collection, testing, processing, storage, and distribution of human blood and blood components. The directive aims to ensure high standards of protection for blood donors and recipients while facilitating exchange of blood and blood components between member states where necessary to meet clinical needs.
Similarly, Directive 2004/23/EC establishes standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells. The directive covers a wide range of applications from reproductive medicine to bone and skin grafting, establishing requirements for tissue establishments, donor selection, testing protocols, and traceability systems. Directive 2010/53/EU extends similar frameworks to organ transplantation, establishing quality and safety standards for organs intended for transplantation.
These directives reflect the recognition that substances of human origin present unique regulatory challenges, combining medical device and pharmaceutical characteristics with ethical considerations specific to human-derived materials. The EU framework aims to ensure safety and quality while respecting principles such as voluntary unpaid donation, anonymity of donors and recipients, and solidarity in the allocation of scarce organs.
Tobacco Control
Tobacco control represents an area where the EU has pursued relatively ambitious regulatory action, justified by the overwhelming evidence of tobacco’s health harms and the cross-border nature of tobacco marketing and trade. The Tobacco Products Directive 2014/40/EU establishes comprehensive requirements for tobacco products marketed in the EU.
The directive mandates that health warnings cover 65% of the front and back of cigarette packages, establishes standardized formats for warning messages, and requires graphic warnings depicting health consequences of smoking. The directive prohibits misleading descriptors such as “light” or “mild” and restricts characterizing flavors that make tobacco products more attractive, particularly to young people. The directive also establishes regulatory frameworks for electronic cigarettes and refill containers, including maximum nicotine concentrations, safety and quality requirements, and restrictions on advertising.
Member states have implemented the directive’s minimum standards while some have adopted more stringent measures permitted under EU law, including plain packaging requirements and display bans at point of sale. The EU framework on tobacco control demonstrates how public health considerations can justify significant regulatory intervention in a commercial sector, though always within the bounds of treaty provisions and subject to scrutiny regarding proportionality and evidence basis.
Health Data Protection
The protection of health data is governed primarily by the General Data Protection Regulation, which applies across all sectors but includes specific provisions for health data as a special category of personal data requiring additional safeguards. Health data is defined broadly to include information about physical or mental health, including the provision of healthcare services, that reveals information about health status.
Processing of health data is generally prohibited unless specific conditions are met, including explicit consent, necessity for healthcare provision, public health purposes, research under appropriate safeguards, or other specified legal grounds. The regulation imposes stringent requirements for data security, transparency about data use, rights for data subjects to access and control their information, and accountability mechanisms including data protection impact assessments for high-risk processing activities.
The GDPR framework reflects the need to balance health data protection with legitimate uses of health information for healthcare delivery, research, public health surveillance, and health system management. The regulation provides flexibility for member states to adopt more specific provisions for health data processing while establishing a common floor of protection across the EU. As health systems become increasingly digital and data-driven, the GDPR framework plays an increasingly central role in shaping how health information can be collected, used, and shared.
Institutional Architecture for EU Health Policy
The European Commission and DG SANTE
The European Commission serves as the executive branch of the European Union, with responsibilities including proposing legislation, implementing decisions, upholding EU treaties, and managing the day-to-day business of the EU. Within the Commission, the Directorate-General for Health and Food Safety, known as DG SANTE, is responsible for EU policy on food safety, health, and animal welfare.
DG SANTE develops and implements policies to ensure that food in the EU is safe, that outbreaks of animal and plant diseases are prevented and controlled, that high standards of human health protection are maintained in all EU policies, and that EU citizens can take informed decisions about their health. The directorate-general is organized into directorates covering public health, health systems and products, crisis management and preparedness in health, and food and veterinary matters. The structure reflects the breadth of health-related issues falling within EU competence, from pharmaceutical regulation to disease prevention to food safety.
The Commissioner for Health and Food Safety, a member of the College of Commissioners appointed by the European Council and approved by the European Parliament, provides political leadership for EU health policy. The Commissioner proposes new legislation, represents the Commission in health matters, and works with the Council and Parliament in the legislative process. The political priorities of successive Commissioners shape the EU health agenda, though always within the legal constraints of the treaties and subject to the agreement of member states through the Council.
The European Parliament
The European Parliament, directly elected by EU citizens every five years, serves as the co-legislative authority for most EU health legislation alongside the Council. The Parliament’s Committee on Environment, Public Health and Food Safety, known as ENVI, is the parliamentary committee with primary responsibility for health matters. ENVI examines legislative proposals in the health field, drafts reports with proposed amendments, holds hearings with experts and stakeholders, and votes on whether to recommend adoption of legislation to the full Parliament.
The Parliament has gradually expanded its role in health policy as successive treaty reforms have extended the co-decision procedure to more policy areas. Under the ordinary legislative procedure now applied to most health legislation, the Parliament and Council must agree on identical texts for legislation to be adopted. This gives the Parliament significant influence over the content and direction of EU health policy, though always within the framework of Commission proposals and in negotiation with member states through the Council.
Members of the European Parliament from different member states and political groups bring diverse perspectives to health policy debates. While the Parliament generally supports ambitious health initiatives and often pushes for stronger provisions than proposed by the Commission or sought by the Council, MEPs must also be attentive to concerns about subsidiarity and national competences. The Parliament’s health deliberations thus reflect tensions between the desire for stronger EU action on health and respect for the primacy of national health systems.
The Council of the European Union
The Council of the European Union, representing member state governments, is the co-legislative authority alongside the Parliament for most EU health legislation. Health matters are addressed primarily by the Employment, Social Policy, Health and Consumer Affairs Council, known as EPSCO, which brings together ministers responsible for employment, social protection, consumer affairs, health, and equality from all member states.
The EPSCO Council examines legislative proposals, agrees on the Council’s position through negotiations in working parties and COREPER (the Committee of Permanent Representatives), and participates in trialogue negotiations with the Parliament and Commission to reach final agreement on legislation. The Council also adopts conclusions on health policy issues, providing political guidance on priorities and approaches. While conclusions are not legally binding, they reflect agreements among member states and influence the development of EU health policy.
The Council Working Party on Public Health, composed of national health ministry officials, conducts detailed examination of health policy proposals and prepares the ground for EPSCO discussions. The working party provides a forum for member states to discuss health policy issues, share national experiences, and identify common positions. The technical expertise of working party members, combined with their understanding of national contexts, shapes the practical implementation of EU health initiatives.
Decision-making in the Council on health matters generally uses qualified majority voting, meaning that proposals can be adopted without unanimous support if they receive support from member states representing at least 55% of member states and 65% of the EU population. However, particularly sensitive health issues may require consensus, and member states that object strongly to particular provisions can seek to protect national interests. The Council thus serves both as a forum for cooperation and as a guardian of member state prerogatives in health policy.
European Medicines Agency
The European Medicines Agency, established in 1995 and currently based in Amsterdam, is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. The agency coordinates a network of national medicines regulatory authorities, facilitating collaboration and harmonization while benefiting from diverse scientific expertise across member states.
EMA’s core responsibilities include evaluating applications for marketing authorization through the centralized procedure, providing scientific opinions on medicines, monitoring the safety of medicines through pharmacovigilance activities, providing scientific advice to medicine developers, and publishing information about medicines for healthcare professionals and patients. The agency operates through scientific committees that assess medicines based on quality, safety, and efficacy data provided by applicants.
The Committee for Medicinal Products for Human Use evaluates medicines for human use, while the Pharmacovigilance Risk Assessment Committee assesses safety issues, and the Committee for Advanced Therapies evaluates novel therapies based on genes, tissues, or cells. Additional committees address orphan medicines, pediatric medicines, and herbal medicinal products. These committees comprise experts nominated by member states, ensuring that authorization decisions benefit from the best available scientific expertise across Europe.
EMA’s role extends beyond initial authorization to include monitoring medicines throughout their lifecycle. Post-authorization safety monitoring through the European pharmacovigilance system collects and analyzes adverse reaction reports from healthcare professionals, patients, and pharmaceutical companies. When new safety concerns arise, EMA can require label changes, impose restrictions on use, or in serious cases recommend suspension or withdrawal of marketing authorization. This comprehensive approach to medicine regulation aims to ensure that medicines available in Europe meet consistently high standards.
The agency also plays an important role in facilitating access to medicines. Scientific advice programs provide guidance to developers on clinical trial design and data requirements, potentially accelerating development of promising therapies. Accelerated assessment procedures allow faster evaluation of medicines addressing unmet medical needs, while conditional authorizations enable early access to promising medicines when comprehensive data are not yet available. These mechanisms reflect efforts to balance rapid access to innovation with maintenance of high safety and efficacy standards.
European Centre for Disease Prevention and Control
The European Centre for Disease Prevention and Control, established in 2005 and based in Stockholm, serves as the EU’s specialized agency for communicable disease prevention and control. ECDC strengthens Europe’s defenses against infectious diseases by providing scientific advice, surveillance and monitoring, epidemic intelligence, and support for preparedness and response planning.
ECDC operates the European Surveillance System, known as TESSy, which collects surveillance data on communicable diseases from member states using standardized case definitions and data formats. This harmonized surveillance enables identification of trends, detection of outbreaks, and monitoring of disease burden across Europe. ECDC publishes regular surveillance reports, outbreak investigations, and risk assessments that inform public health decision-making in member states and at EU level.
The centre’s epidemic intelligence activities combine surveillance data with information from multiple sources to detect and assess public health threats as early as possible. This includes monitoring media reports, analyzing airline passenger data during disease outbreaks, and maintaining networks of specialists who can rapidly provide expertise on emerging threats. During outbreaks, ECDC can deploy rapid assistance teams to support affected member states with field epidemiology, laboratory investigation, and control measures.
The COVID-19 pandemic led to significant expansion of ECDC’s mandate and resources. Regulations adopted in 2022 enhanced ECDC’s capacity to coordinate surveillance, strengthened its role in preparedness planning including reviews of national preparedness plans, and provided authority to activate the EU Health Crisis and Pandemic Preparedness and Response Plan during emergencies. These changes reflect recognition that stronger central scientific capacity is needed to support coordinated responses to major health threats while respecting member state authority over public health measures.
ECDC also supports training of public health professionals through the European Programme for Intervention Epidemiology Training, which provides practical training in outbreak investigation and applied epidemiology. This fellowship program helps build capacity across Europe while creating networks of professionals who can collaborate effectively during cross-border health threats. The centre additionally provides guidance on prevention measures, publishes technical documents on disease-specific topics, and conducts research on emerging public health challenges.
Health Emergency Preparedness and Response Authority
The Health Emergency Preparedness and Response Authority, known as HERA, was established in 2021 as part of the EU response to lessons learned from the COVID-19 pandemic. Unlike traditional EU agencies, HERA is established within the European Commission structure but operates with significant autonomy and dedicated resources for health emergency preparedness and response.
HERA’s mandate encompasses the full cycle of health emergency management from prevention and preparedness through response and recovery. In preparedness mode, which represents its normal operating state, HERA conducts threat assessments, gathers intelligence on potential health threats, supports research and development of medical countermeasures, addresses potential supply chain vulnerabilities, and maintains strategic stockpiles of critical medical supplies. The authority works with member states, EU agencies, industry, and international partners to strengthen Europe’s collective preparedness for health emergencies.
A key innovation of HERA is its focus on medical countermeasures, including vaccines, therapeutics, diagnostics, and personal protective equipment. HERA aims to avoid the supply shortages, competition between member states, and dependence on external suppliers that characterized early pandemic response. The authority facilitates advance purchase agreements with manufacturers to secure supplies, supports development of novel countermeasures through research funding, and works to maintain European manufacturing capacity for critical medical products through the EU FAB network concept.
When the Commission activates emergency mode in response to a recognized health crisis, HERA shifts to emergency operations with enhanced authority and resources. In emergency mode, HERA can trigger rapid procurement procedures, activate emergency medical countermeasure development, coordinate distribution of supplies, and mobilize additional financing. This dual-mode structure aims to ensure sustained attention to preparedness while enabling rapid response when emergencies occur.
HERA’s establishment represents a significant evolution in EU health policy, moving beyond purely coordinating functions to include operational capacity for ensuring medical supply security. This reflects recognition that effective pandemic preparedness requires not only coordination but also concrete measures to maintain manufacturing capacity, secure supplies, and support innovation. The authority’s success will depend on sustained political and financial commitment beyond the immediate post-pandemic period.
Other Relevant Agencies
The European Food Safety Authority, based in Parma, provides independent scientific advice and communication on risks associated with the food chain. EFSA conducts risk assessments on food safety issues ranging from additives and contaminants to zoonotic diseases and nutrition. While EFSA does not make regulatory decisions, its scientific opinions inform legislation and guidance on food safety matters. The authority’s work links closely to health protection, addressing issues such as foodborne pathogens, chemical contaminants in food, and nutritional aspects of public health.
The European Monitoring Centre for Drugs and Drug Addiction, located in Lisbon, serves as the EU reference point for information on drugs and drug addiction. EMCDDA monitors the drug situation in Europe, collecting and analyzing data on drug use, consequences, and responses. The centre publishes annual reports on the state of the drug problem in Europe, threat assessments on new psychoactive substances, and guidance on prevention and harm reduction approaches. While member states retain primary responsibility for drug policies, EMCDDA facilitates evidence-informed policymaking and cooperation.
The European Health and Digital Executive Agency, established through merger of previous executive agencies, implements EU health programs including EU4Health. As an executive agency, HaDEA is responsible for managing calls for proposals, evaluating applications, signing grant agreements, monitoring project implementation, and ensuring effective use of EU health funding. The agency serves as the operational arm for implementing Commission health policies, enabling the Commission services to focus on policy development while specialized staff manage program implementation.
EU4Health Programme: The Current Framework (2021-2027)
Genesis and Objectives
The EU4Health programme, formally established by Regulation 2021/522, represents the most ambitious EU health programme to date both in terms of budget and scope. With €5.3 billion allocated for 2021-2027, EU4Health commands resources more than tenfold greater than the previous health programme. This dramatic increase reflects the political momentum generated by the COVID-19 pandemic, which exposed vulnerabilities in health systems and prompted recognition that stronger EU-level capacity is needed to address cross-border health challenges.
The programme emerged from the Commission’s proposal in May 2020 for a €9.4 billion health programme as part of the recovery from COVID-19. After negotiations between the Parliament, Council, and Commission, the final budget was set at €5.3 billion, still representing unprecedented investment in EU health activities. The increase reflects both the urgent need to strengthen health security following pandemic experiences and political will to develop a stronger health dimension to European integration.
EU4Health establishes four general objectives that structure all programme activities. First, protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination between member states to address such threats. Second, improving the availability in the Union of medicines, medical devices, and other crisis-relevant products and contributing to their accessibility and affordability. Third, strengthening health systems by improving their resilience and resource efficiency, including through supporting digital transformation, integrated work between care sectors, primary care, disease prevention, and health promotion. Fourth, contributing to protecting people from serious cross-border threats to health and supporting actions in third countries and international health organizations.
Crisis Preparedness and Response
The first pillar of EU4Health addresses strengthening crisis preparedness, surveillance, early detection, and response capacity. Actions funded under this pillar include building stockpiles of medical countermeasures, expanding production capacity for crisis-relevant products, supporting surveillance and early warning systems, developing and testing preparedness and response plans, and building capacity for coordination during health crises.
Specific initiatives include support for the rescEU medical reserve, which maintains stockpiles of medical equipment including ventilators, personal protective equipment, laboratory supplies, and therapeutics that can be rapidly deployed to member states during emergencies. The programme funds advance purchase agreements for medical countermeasures, ensuring that vaccines, therapeutics, and diagnostics can be procured rapidly when threats emerge. Support for the EU FAB initiative aims to maintain European manufacturing capacity for essential medical products, reducing dependence on external suppliers demonstrated to be problematic during the pandemic.
The programme strengthens surveillance capacity through support for the European Surveillance System and other monitoring networks coordinated by ECDC. Enhanced surveillance includes genomic sequencing capacity for pathogen characterization, environmental surveillance for early detection of biological threats, and integrated surveillance approaches linking human, animal, and environmental health data consistent with One Health principles.
Preparedness planning receives support through assessment and testing of national and EU-level preparedness plans, development of response protocols, and exercises that test coordination mechanisms. The programme funds capacity building for surge capacity in healthcare systems, including training of healthcare workers in emergency response, development of mobile medical teams, and planning for rapid expansion of hospital capacity during crises.
Health Systems Strengthening
Strengthening health systems represents a major focus of EU4Health, addressing structural challenges including workforce shortages, digital transformation needs, integration of care across sectors, and quality improvement. The programme funds initiatives to support primary care development, recognizing that strong primary care systems improve outcomes while controlling costs. Support includes training for primary care professionals, development of integrated care models, and implementation of digital tools supporting primary care delivery.
Digital transformation receives substantial investment, including support for electronic health record systems, telemedicine infrastructure, artificial intelligence applications in healthcare, and digital tools for patient engagement and self-management. The programme funds development of interoperability standards enabling exchange of health information across borders and between systems. Cybersecurity for health systems also receives attention given increasing digitalization and emerging threats.
Health workforce initiatives address recruitment, retention, and training of healthcare professionals. The programme supports development of innovative training programs, continuing professional development, exchanges that facilitate learning across member states, and initiatives to improve working conditions and prevent burnout. Particular attention addresses shortages of specific professions including nurses, pharmacists, and mental health professionals.
Quality and patient safety initiatives funded include implementation of clinical guidelines, patient safety protocols, quality indicators for health systems, and mechanisms for learning from adverse events. The programme supports accreditation systems, quality improvement collaboratives, and research on effective quality improvement strategies. Patient engagement and empowerment receive support through initiatives promoting shared decision-making, patient-reported outcome measures, and patient involvement in quality improvement.
Medicines and Medical Devices
EU4Health addresses challenges related to availability, accessibility, and affordability of medicines and medical devices. Medicine shortages receive particular attention through support for monitoring systems, diversification of supply chains, and incentives for production of critical medicines at risk of shortage. The programme funds research on causes of shortages and pilot initiatives testing solutions such as buffer stocks, contractual requirements for continuity of supply, and incentives for production of less profitable but medically important medicines.
Supporting innovative medicines and devices includes funding for regulatory science, facilitating clinical trials, and supporting health technology assessment to inform coverage and reimbursement decisions. The programme funds development of real-world evidence generating systems that provide information on medicines performance in routine practice. Support for orphan medicines development and medicines for pediatric use addresses market failures in these areas.
Rational use of medicines is promoted through prescribing guidelines, pharmacist-led medicines review services, and patient education about appropriate use of medicines. Antimicrobial stewardship receives particular emphasis given the AMR challenge. The programme also supports environmentally sustainable pharmaceutical production and use, addressing pollution from pharmaceutical manufacturing and disposal.
Medical devices initiatives address safety monitoring, support for innovative devices, and facilitating small and medium enterprise access to regulatory processes. The programme funds post-market surveillance systems, training for notified bodies, and development of standards supporting device safety and performance. Patient registries for implantable devices enable long-term monitoring of device performance and early detection of safety issues.
Implementation Mechanisms
EU4Health is implemented through various mechanisms tailored to different types of actions and objectives. Direct grants to member states support implementation of priority actions including strengthening health systems, expanding screening programs, implementing disease prevention initiatives, and building crisis preparedness capacity. Direct grants are also awarded to international organizations, particularly WHO, for global health initiatives.
Joint actions represent a distinctive EU4Health mechanism, bringing together multiple member states to implement collaborative projects. Joint actions typically address issues requiring coordinated approaches across countries, such as cross-border health threat preparedness, health workforce planning, or implementation of health technology assessment cooperation. By pooling resources and expertise, joint actions enable member states to achieve objectives that would be difficult to accomplish individually.
Public procurement under EU4Health addresses acquisition of medical countermeasures, vaccines, and other health products for crisis response or disease prevention. Joint procurement enables member states to negotiate better prices through collective purchasing power while ensuring smaller member states have access to products they might struggle to obtain independently. Advanced purchase agreements provide guaranteed markets for manufacturers, reducing risk of investment in production capacity.
Operating grants support organizations contributing to EU4Health objectives, including non-governmental organizations working on health issues, professional associations, patient organizations, and research networks. Operating grants provide core funding supporting organizational capacity, enabling these bodies to engage in EU health policy processes and implement projects aligned with programme priorities.
Prizes and procurement of services represent additional implementation tools. Prizes incentivize innovation by awarding financial rewards for achievements such as developing novel diagnostic tools, implementing innovative care models, or creating effective health promotion campaigns. Procurement of services enables the programme to contract for technical expertise, studies, or services supporting programme implementation.
Future Directions in EU Health Policy
The Evolving European Health Union
The concept of a European Health Union, articulated by Commission President von der Leyen in 2020, represents an aspiration for deeper health integration while respecting the fundamental principle that health systems remain national competences. The Health Union concept encompasses several dimensions including enhanced capacity for health emergency preparedness and response, stronger EU agencies with clearer mandates, more systematic cooperation on health challenges transcending borders, and greater investment in health innovation and research.
The practical development of the Health Union proceeds through incremental steps rather than dramatic treaty changes. Strengthened mandates for ECDC and EMA, the establishment of HERA, increased budgets for health programs, and new legislative proposals on issues such as health data and pharmaceutical regulation all contribute to building the Health Union in practice. However, tensions persist between ambitions for stronger EU health capacity and concerns about preserving national autonomy in healthcare decisions.
Future evolution of the Health Union may include further strengthening of emergency response mechanisms, potentially including binding EU decisions during serious cross-border health crises. Some envision development of EU health system benchmarking and performance assessment, though this raises sensitivity about implicit comparisons and potential pressure on healthcare organization. Enhanced financing mechanisms for health, potentially including EU health bonds or expanded health budgets, could provide resources for more ambitious initiatives. However, all such developments must navigate the tension between perceived need for stronger EU action and member state insistence on preserving national competences.
European Health Data Space
The European Health Data Space represents one of the most significant upcoming developments in EU health policy. The proposed regulation, published in 2022 and under legislative negotiation as of 2025, aims to create a comprehensive framework for health data use supporting both healthcare delivery and research while ensuring robust data protection.
The EHDS distinguishes between primary use of health data for healthcare provision and secondary use for research, innovation, policymaking, and regulatory purposes. For primary use, the regulation would establish rights for individuals to access and control their electronic health records, requirements for health data interoperability enabling records to be shared across borders, and frameworks for electronic prescriptions and patient summaries that work throughout the EU. These provisions aim to support patient mobility, enable cross-border healthcare, and improve care coordination.
Secondary use provisions establish frameworks for researchers, innovators, policymakers, and regulators to access health data in privacy-preserving ways. Health data access bodies in each member state would provide secure access to health datasets for approved uses, applying consistent criteria for access and implementing technical and organizational safeguards. A permit system would authorize data users, and a catalogue would enable discovery of available datasets across the EU.
The EHDS proposal addresses multiple challenges. Interoperability standards would enable different health information systems to exchange data effectively, overcoming current fragmentation where health data is locked in incompatible systems. Data quality requirements would ensure that data used for secondary purposes meets standards for completeness, accuracy, and documentation. Governance frameworks would balance access for legitimate uses against privacy protection, preventing unauthorized use or breaches.
Implementation of the EHDS will require substantial technical, organizational, and cultural changes. Health information systems must adopt common standards and incorporate interfaces enabling data portability. Health data access bodies must be established with appropriate expertise and resources. Healthcare providers, researchers, and policymakers must adapt to new frameworks for data access and use. Most fundamentally, trust must be built that health data will be used responsibly, with benefits flowing back to individuals and society while risks of misuse or privacy violations are mitigated.
The timeline for EHDS implementation anticipates adoption of the regulation in 2024-2025, with gradual implementation over several years as technical standards are developed, national infrastructures are built, and stakeholders adapt to new requirements. The EHDS represents an ambitious vision of health data as a resource supporting better healthcare and research while respecting individual rights and privacy.
Cancer Mission and Future Cancer Initiatives
The Cancer Mission, part of the Horizon Europe research framework, complements Europe’s Beating Cancer Plan through focused research investment aimed at achieving the goal of saving three million additional lives by 2030. With €1.25 billion dedicated to cancer research over 2021-2027, the mission funds projects addressing prevention, early detection, treatment, and quality of life for cancer patients and survivors.
Mission priorities include understanding cancer biology to identify new therapeutic targets, developing precision medicine approaches matching treatments to individual tumor characteristics, improving early detection through novel screening approaches and technologies, and addressing cancer inequalities. The mission emphasizes translational research bridging from laboratory discoveries to clinical application, recognizing that many scientific advances do not reach patients due to barriers in translation and implementation.
Specific initiatives under the cancer mission include development of cancer diagnostic tools enabling earlier and more accurate detection, creation of a European Cancer Imaging Initiative providing training datasets for AI-based diagnostic tools, and research on cancer prevention addressing modifiable risk factors. The mission also funds research on rare cancers where small patient populations impede traditional research approaches, and on childhood cancers where distinct biology requires specialized research efforts.
Looking beyond the current mission, future cancer initiatives may include expanded screening programs as new technologies enable effective screening for additional cancer types. Immunotherapy approaches continue to evolve, with research on combinations, biomarkers predicting response, and mechanisms of resistance. Cancer survivorship receives growing attention, addressing long-term effects of cancer and treatment, psychosocial support needs, and prevention of recurrence.
Integration of cancer care with other health priorities also emerges as important. The intersection of cancer with cardiovascular disease, diabetes, and mental health conditions requires coordinated approaches. Addressing cancer disparities between and within countries remains a priority, requiring research on determinants of inequalities and interventions to reduce gaps in outcomes.
Mental Health Strategy Implementation
The comprehensive approach to mental health adopted in 2023 establishes a framework for action over coming years through twenty flagship initiatives. Implementation of this ambitious agenda requires sustained commitment, adequate resources, and coordination across multiple sectors given that mental health is influenced by factors far beyond healthcare.
Key implementation challenges include integration of mental health into primary care and general healthcare settings, addressing fragmentation that often results in people with mental health needs falling through gaps in services. Training of primary care providers in mental health assessment and basic interventions can improve access while reducing pressure on specialized services. Integration of mental health and physical health care is particularly important given high rates of comorbidity.
Workforce development represents a critical need, with shortages of mental health professionals including psychiatrists, psychologists, psychiatric nurses, and social workers in many member states. Expanding training capacity, improving working conditions to enhance retention, and developing new professional roles such as peer support workers and mental health coaches can help address workforce gaps.
Suicide prevention requires comprehensive approaches including primary prevention addressing risk factors, training of healthcare and other professionals in suicide risk assessment, ensuring access to crisis services, implementing means restriction, and supporting those bereaved by suicide. Evidence-based interventions exist but implementation remains inconsistent across Europe.
Digital mental health tools offer potential to improve access particularly in areas with provider shortages, but quality assurance is essential. Regulatory frameworks must ensure that apps and online services meet evidence standards, protect user data, and integrate appropriately with traditional services. Questions about reimbursement for digital mental health interventions and their place in treatment pathways require attention.
Addressing mental health stigma and discrimination remains foundational, as stigma deters help-seeking and contributes to social exclusion of people with mental health conditions. Public campaigns, contact-based interventions bringing people into direct contact with those who have experienced mental health challenges, and anti-discrimination legislation all contribute to stigma reduction.
Cardiovascular Disease Action
Cardiovascular diseases remain the leading cause of death in Europe, accounting for more deaths than all cancers combined. Despite reductions in cardiovascular mortality over recent decades, CVD burden remains high and disparities persist. An EU cardiovascular disease plan is in development, expected to establish priorities and actions analogous to those in the Beating Cancer Plan.
Anticipated priorities include prevention of cardiovascular risk factors, particularly hypertension, elevated cholesterol, diabetes, smoking, obesity, and physical inactivity. Population-level interventions addressing social determinants of cardiovascular health, including urban environments, food systems, and economic factors, complement individual-level risk factor management.
Early detection and screening for cardiovascular disease receives attention, with consideration of systematic screening for hypertension, diabetes, and elevated cholesterol in defined populations. Atrial fibrillation screening could prevent strokes through early anticoagulation. Abdominal aortic aneurysm screening in older men demonstrates cost-effectiveness. However, questions persist about optimal screening strategies, age ranges, and integration with existing healthcare services.
Improving acute cardiovascular care includes ensuring timely access to reperfusion for heart attacks and strokes, as outcomes are highly time-dependent. Networks ensuring rapid transport to centers capable of providing advanced interventions can save lives and reduce disability. Cardiac rehabilitation following heart attacks improves outcomes but remains underutilized, suggesting need for expanded capacity and access.
Chronic disease management for people with established cardiovascular disease aims to prevent complications, optimize quality of life, and reduce healthcare utilization. Integrated care models coordinating across primary and specialist care, including nurses and other professionals in care teams, and using digital tools for monitoring can improve outcomes while controlling costs.
Addressing cardiovascular inequalities between countries, regions, and population groups requires research on determinants and interventions to reduce gaps. Cardiovascular mortality varies several-fold across Europe, with higher rates in eastern and southeastern Europe. Within countries, cardiovascular risk follows social gradients with higher rates among disadvantaged populations.
Strengthening Antimicrobial Resistance Response
Antimicrobial resistance continues to worsen despite actions to date, indicating need for intensified efforts. A proposed Council Recommendation on strengthening EU action against AMR through a One Health approach, published in 2023, aims to enhance coordination and ambition across member states.
The recommendation proposes national targets for reduction of antimicrobial consumption in human and veterinary medicine, recognizing that reduced consumption slows resistance development. Targets would be differentiated based on current consumption levels, with high-consuming countries expected to achieve larger reductions. Implementation of targets requires monitoring systems tracking consumption, stewardship programs promoting appropriate use, and policy measures such as restrictions on antibiotic prescribing and use.
Infection prevention and control receives emphasis as a means to reduce need for antimicrobials by preventing infections. Healthcare-associated infections represent a significant source of antibiotic-resistant infections. Strengthening IPC programs, ensuring adequate staffing and resources, implementing evidence-based practices, and monitoring IPC performance can reduce infection rates and consequently antimicrobial use.
The pull incentive question for new antimicrobials remains contested. Without new mechanisms, market failure will persist as the commercial returns on antimicrobials do not justify development costs, particularly given that new antibiotics should be reserved for resistant infections. Proposed approaches include subscription models where health systems pay fixed fees for access to antibiotics regardless of volumes used, transferable exclusivity vouchers providing market exclusivity for other products as reward for antibiotic development, and direct grants supporting clinical development.
Environmental dimensions of AMR receive growing attention, as antimicrobial contamination of water systems from pharmaceutical manufacturing and agriculture contributes to resistance development. Standards for wastewater from pharmaceutical manufacturing, regulations on veterinary antimicrobial use, and treatment of agricultural runoff can reduce environmental antimicrobial concentrations.
International cooperation remains essential given that AMR spreads globally. The EU supports capacity building in partner countries for surveillance, laboratory capacity, stewardship programs, and infection control. Global governance mechanisms through WHO, FAO, and OIE provide frameworks for coordinated action. Access to antibiotics in low-income countries must be balanced against stewardship imperatives, requiring nuanced approaches that ensure access to essential antibiotics while promoting appropriate use.
Health Workforce Initiative
Demographic changes, increasing complexity of care needs, high burnout rates, and uneven distribution of healthcare professionals make health workforce sustainability a priority concern. A comprehensive EU health workforce initiative is under development to support member states in addressing these challenges while respecting their competence over healthcare organization.
Priority areas include workforce planning and forecasting, improving data on current and projected healthcare workforce needs considering demographic trends, technological changes, and evolving models of care. Better forecasting enables proactive training adjustments, reducing cycles of shortage and oversupply. Cooperation on workforce planning can help anticipate cross-border movements of healthcare professionals.
Training and education initiatives address both quantity and quality of healthcare workforce preparation. Expanding training capacity where shortages persist, ensuring curricula prepare professionals for evolving practice including digital health competencies, and developing continuing education systems maintaining competence throughout careers all require attention. Interprofessional education preparing professionals to work effectively in teams can improve care coordination.
Retention of healthcare professionals requires addressing working conditions contributing to burnout and attrition. High workloads, inadequate staffing, difficult working conditions, lack of professional development opportunities, and insufficient recognition all contribute to healthcare professionals leaving the profession or migrating to other countries. Improving working conditions, ensuring adequate compensation, providing professional development, and creating supportive work environments can enhance retention.
Ethical recruitment practices are essential given that many EU member states recruit healthcare professionals from third countries. WHO Global Code of Practice on International Recruitment of Health Personnel establishes principles for ethical recruitment, including discouraging active recruitment from countries with critical shortages, ensuring transparent employment contracts, and supporting source countries in building their health workforce capacity.
Deployment of healthcare professionals during emergencies, highlighted by COVID-19, requires mechanisms for rapid mobilization, clear legal frameworks for cross-border deployment, and systems supporting deployed professionals. The European Medical Corps and similar mechanisms provide frameworks, but expansion and strengthening could enhance capacity for future crises.
Climate Change and Health
Climate change represents a growing threat to health through multiple pathways including extreme heat events, changing patterns of vector-borne diseases, air pollution, impacts on food and water security, and climate-related migration and conflict. An integrated approach to climate and health is emerging as a priority for EU health policy.
Heat-health action plans represent an immediate adaptation priority, as extreme heat events are increasing in frequency, intensity, and duration. Effective plans include early warning systems triggering protective actions when dangerous heat is forecast, guidance for vulnerable populations, cool spaces where people can escape heat, and monitoring of heat-related morbidity and mortality. Urban planning incorporating green space and water features can reduce urban heat island effects.
Vector-borne diseases including those transmitted by mosquitoes and ticks may expand their geographic range as climate change shifts species distributions. Enhanced surveillance for vectors and diseases, control programs targeting vector populations, and clinical capacity to recognize and treat vector-borne diseases can mitigate risks. Invasive mosquito species already established in southern Europe could spread northward with climate warming.
Air pollution, closely linked to climate change through shared sources in fossil fuel combustion, causes significant mortality and morbidity. Policies reducing greenhouse gas emissions simultaneously improve air quality and health. EU air quality standards set limits on pollutants, though evidence suggests that health effects occur at levels below current standards, suggesting need for stricter standards over time.
Climate resilience of health systems requires attention to both physical infrastructure and operational preparedness. Healthcare facilities must be able to maintain operations during extreme weather events, which may require backup power, water storage, structural resilience to flooding or storms, and cool facilities during heat waves. Supply chains for medicines and medical supplies require redundancy given vulnerability to climate impacts on production and transport.
The health co-benefits of climate action represent an important framing, as policies to mitigate climate change often yield immediate health benefits. Active transport infrastructure promoting walking and cycling reduces both emissions and chronic diseases. Plant-rich diets have lower environmental impact while reducing cardiovascular disease risk. Energy-efficient housing reduces both emissions and respiratory disease from indoor air pollution. Emphasizing health co-benefits can strengthen political support for climate action.
Digital Health Transformation
Digital technologies offer potential to transform healthcare delivery, but realizing this potential while avoiding harms requires thoughtful governance. Beyond the European Health Data Space, multiple digital health initiatives advance.
Artificial intelligence applications in healthcare span diagnosis support, treatment planning, drug discovery, and health system management. AI diagnostic tools for radiology, pathology, and other specialties show promise for improving accuracy and efficiency. Treatment recommendation systems can support clinical decision-making by synthesizing evidence and patient-specific factors. However, AI also raises concerns about algorithmic bias, lack of transparency in decision-making, unclear liability when AI contributes to adverse outcomes, and potential deskilling of healthcare professionals.
Regulation of AI in healthcare is addressed through the EU Artificial Intelligence Act, which classifies most healthcare AI as high-risk requiring conformity assessment before market introduction. Requirements include data quality standards, transparency and explainability, human oversight, and robustness. Healthcare-specific AI guidance may provide additional detail on appropriate development, validation, and deployment of AI in clinical settings.
Telemedicine expanded dramatically during COVID-19 and much of this expansion is likely to persist. Telemedicine offers convenience for patients, improves access in underserved areas, and can reduce healthcare costs. However, telemedicine also raises questions about quality of care when physical examination is not possible, data protection for consultations conducted remotely, and reimbursement policies. Ensuring telemedicine complements rather than replaces in-person care where the latter is clinically indicated remains important.
Remote patient monitoring using wearables and sensors enables continuous monitoring of chronic conditions, potentially enabling earlier intervention and reducing hospitalizations. Digital therapeutics providing evidence-based interventions through apps or software are emerging for conditions including mental health disorders, diabetes, and substance use. However, evidence standards for digital health interventions, reimbursement frameworks, and integration with traditional care all require development.
Cybersecurity for health systems is increasingly critical as digitalization creates new vulnerabilities. Ransomware attacks on healthcare facilities disrupt care delivery and compromise patient data. Medical devices connected to networks may be vulnerable to hacking with potentially life-threatening consequences. Building cybersecurity capacity, implementing security standards, and planning for cyber incidents all require attention and resources.
Digital inclusion must be considered to ensure that digital transformation does not widen health inequalities. Older adults, people with disabilities, those with limited digital literacy, and populations with poor internet access risk being left behind by digital health. Maintaining non-digital alternatives, designing inclusive digital interfaces, and providing support for digital health use can promote equity.