Changes from report parliamentary committee draft to plenary report

Added129. Stresses that, when appropriately governed, digital tools can also support healthcare systems by enabling continuous evidence generation, quality improvement and adaptive care pathways across populations;

Added130. Calls for strong public governance and safeguards, as well as guidance and standards, for digital health and AI, including as regards privacy, ethical standards, human oversight, transparency, accountability, clinical evidence requirements based on real-world and representative data, clinical validation and post-market surveillance, and measures to prevent bias and undue data use;

Added131. Calls for accessible, secure and interoperable digital health records to support continuity of care, prevention strategies, health preparedness and surveillance; calls for the integration of these digital health records within the European Health Data Space, which should be leveraged for monitoring, quality improvement, research and innovation, with a view to ensuring common standards and equitable participation across all Member States and to enabling cross-border access, improving uptake of preventive measures and supporting evidence-based policymaking, while strictly respecting personal data protection, the meaningful informed consent of patients and transparency over data use, with effective safeguards against misuse; stresses the importance of including data on quality of care and patient-relevant outcomes and disaggregated data by age and gender in these digital health records, with specific requirements for pregnancy-related health data, to capture differences in experiences, needs and outcomes across populations;

Added132. Calls for improved EU-level collection and comparability of data on CVDs and heart conditions, including data disaggregated by gender, age, socio-economic status, education, geography and other relevant characteristics; stresses that high-quality, complete and representative data are essential for effective prevention policies, equitable early detection and the development of reliable and bias-free digital and AI systems;

Added133. Calls for the integration of CVD surveillance and registries into national health information systems, ensuring interoperability, follow-up and linkage with relevant data on risk factors, care pathways and outcomes; stresses that registries should support not only clinical care and research, but also the monitoring of inequalities in access, quality of care and health outcomes;

Added134. Calls on the Commission to support the Member States, including through the European Health Data Space, EU4Health, Digital Europe and technical assistance instruments, in building the digital, governance and workforce capacities necessary for the safe, effective and equitable deployment of digital and AI-based solutions in cardiovascular health, while actively addressing digital exclusion and population-specific needs;

Added135. Recognises that several Member States already have well-functioning and developed registries; calls for the establishment of an EU cardiovascular health knowledge hub to accelerate the integration of existing cardiovascular registries, share best practices and support data harmonisation and accessibility;

VIII. Research and innovation

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Changed42.136. Notes that, despite EU investment under Horizon Europe and other programmes, cardiovascularCVDs diseasesand other interconnected conditions still face a persistent research and innovation gap;gap and structural barriers that require coordinated EU-level solutions; underlines that despite the scale of CVD, EU research funding on CVD accounts for less than 5 % of total health research within Horizon Europe; calls for strengthenedactions independent,to publiclystrengthen fundedindependent cardiovascular research across the continuumcontinuum, from prevention and early detection to treatment optimisation and rehabilitation; calls for research in access to long-term care, community participation and quality-of-life support for people living with the long-standing consequences of CVD; further calls for dedicated research on congenital, inherited and rare cardiovascular conditions in children, adolescents and young adults; recalls the need for digitalisation of EU health data to facilitate AI research;

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Removed43. Calls for EU research and innovation funding to better support interdisciplinary and cross-sectoral approaches, including research on the links between cardiovascular disease, diabetes, obesity, kidney disease and other comorbidities, as well as on the role of nutrition, environmental exposures and social determinants of health;

Added137. Stresses that innovation in the area of cardiovascular therapy should be translated into clinical practice to support the EU’s goals related to prevention and care; calls for stronger support for medical technology innovation, including in mechanisms to accelerate translation into practice, such as pilot programmes, implementation research and investment in cardiovascular research infrastructure;

Added138. Calls for EU research and innovation funding to better support interdisciplinary and cross-sectoral approaches, including through public-private partnerships; stresses that this research and funding should support research on the links between CVD, diabetes, obesity, metabolic dysfunction-associated steatotic liver disease, kidney disease and other comorbidities, as well as on the role of nutrition, environmental exposures, social determinants of health and gender-specific risk factors;

Added139. Insists that publicly funded research must deliver clear public benefit, including open access to results, affordable resulting innovations and equitable access for patients across all Member States;

Added140. Recognises the contributions of the life science sector to strengthening the EU’s research capacity on CVDs and its importance for European competitiveness; calls for the Member States and the Commission to work together with the EU life science sector to promote research and innovation, mobilising public and private capital to support research and development targeting CVD; emphasises that research and innovation must translate into clinical use, supporting the transition from research to commercialisation for the innovative EU life science sector and providing more effective treatments to patients;

Added141. Calls on the Commission and the Member States to support research, innovation, production and marketing of nutritious foods, in order to improve dietary quality and reduce the burden of CVD;

Added142. Calls on the Commission and the Member States to make the One Health approach (research, health data, prevention) central to CVD policy, including by strengthening cross-sectoral collaboration and monitoring across human, animal and environmental health to better prevent and reduce CVD risks linked to cumulative exposures; calls for an ambitious exposome research and innovation agenda, including through Horizon Europe, to improve evidence on cumulative exposures and their links to CVDs, and stresses that the results should be translated into prevention-oriented policymaking, aligned with zero-pollution goals, the implementation and enforcement of environmental and health standards, and the precautionary principle, as appropriate;

Added143. Welcomes the Commission’s proposal for a European Biotech Act; notes that providing for increased regulatory flexibility, simpler bureaucracy and strong intellectual property rights is essential in order to spur further research and innovation in the EU, including in the field of CVD;

Added144. Calls for cooperation between the Member States to be strengthened on the clinical assessment of new health technologies through the EU regulation of health technology assessment, especially for high-risk medical devices and implantable devices designed for treatment of CVDs;

Added145. Underlines that increased investment in cost-effective public health and prevention research has significant potential to reduce the incidence of CVDs, delay disease onset and prevent complications; stresses that prevention-oriented research remains structurally under-prioritised compared to therapeutic innovation, despite its high societal, economic and healthcare returns;

Added146. Calls on the Commission, in cooperation with Member States and relevant stakeholders, to develop a coherent EU cardiovascular research and innovation roadmap that aligns funding instruments, reduces fragmentation, targets unmet needs across the full disease continuum, and accelerates the translation of research into prevention, diagnosis, care and rehabilitation, while complementing existing initiatives such as the Innovative Health Initiative and Horizon Europe partnerships;

IX. Governance, implementation and funding

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Changed44.147. Calls on all Member States to develop or update national cardiovascular health plansplans, coveringwhich should cover prevention, early detection, treatment, rehabilitation and long-term care, as well as all major risk factors, and should be aligned with the Safe Hearts Plan, EU objectives and international commitments;commitments, including the political declaration of the fourth high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases and the promotion of mental health and well-being, and the EU Global Health Strategy; stresses that such plans should encourage structured coordination between public authorities, healthcare providers, patient organisations and responsible private-sector partners, with clear governance, transparency and accountability mechanisms;

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Removed45. Stresses that effective cardiovascular disease prevention, preparedness, care and research require ring-fenced, stable and long-term EU public funding; underlines that cardiovascular health is a public good and calls for dedicated EU health funding, including adequate support under the next multiannual financial framework, the Union Civil Protection Mechanism and cohesion instruments, in order to strengthen prevention, preparedness and equity across the EU;

Added148. Calls on the Commission to develop guidelines, including on the identification and exchange of best practice, to support Member States in the design and implementation of effective, evidence-based measures aimed at promoting participation in preventive health services and screening programmes;

Removed46. Calls for clear targets, indicators and milestones, transparent monitoring and regular public reporting, including equity objectives and targeted measures for high-risk and underserved groups;

Added149. Calls on the Commission to support Member States in the development and implementation of national cardiovascular health plans through EU-level guidance, appropriate funding, exchange of best practice and technical assistance, and to facilitate coordination between national strategies in order to help reduce disparities in cardiovascular outcomes across the EU;

Removed47. Calls for evaluation and accountability, including a Parliament implementation study and a Commission evaluation report within two years of adoption;

Added150. Calls for the Commission to develop a Safe Hearts Plan implementation roadmap, based on clear and strong political commitment, supporting innovation and flagship initiatives throughout the Member States and at EU level;

Added151. Stresses that effective CVD prevention, preparedness, care and research require adequate, dedicated, stable and long-term EU public funding from all relevant EU programmes; underlines that cardiovascular health is a public good and that adequate funding should allow prevention, preparedness and equity to be strengthened across the EU, including support to reduce access barriers to diagnosis, affordable medicines, medical interventions and treatment; calls for EU funding, data collection and research to include a gender dimension, including targeted support for innovation addressing women’s specific cardiovascular risks and care pathways;

Added152. Calls on the Commission to set clear and comprehensive targets, indicators and milestones for cardiovascular risk reduction and control, including for the effective management of major risk factors and comorbidities; calls for transparent monitoring and regular public reporting, including on equity objectives and targeted measures for high-risk and underserved groups, and calls for clear targets for reducing mortality from CVDs;

Added153. Emphasises that national cardiovascular health plans should explicitly address health inequalities by incorporating equity objectives and targeted actions for populations at higher risk;

Added154. Calls on the Commission to include data on cardiovascular health, its determinants and public attitudes in Eurobarometer surveys and statistics;

Added155. Calls for evaluation and accountability; in that respect, commits to undertaking an implementation study assessing the progress, coherence and effectiveness of the Safe Hearts Plan across the Member States, paying particular attention to prevention, equal access, early detection and action on the social and environmental determinants of health; calls on the Commission, in parallel, to present an evaluation report on the implementation of the EU cardiovascular health plan no later than four years after its adoption, assessing progress against stated objectives, identifying gaps and barriers to implementation and proposing solutions where necessary, in order to ensure accountability, transparency and continuous improvement; calls on the Commission to continuously monitor the situation and present regular evaluation reports after the first report;

X. International dimension

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Changed48.156. Stresses that the EU’s role in global action on CVDs and NCDs should be consistent with the EU Global Health Strategy;Strategy and the political declaration of the fourth high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases and the promotion of mental health and well-being; underlines that this should support the strengthening of CVD prevention, preparedness and care systems, with a view to enhancing resilience;

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Added157. Stresses that the EU’s role in global action should also include strengthened cooperation with candidate and potential candidate countries, to support the strengthening of CVD prevention, preparedness and care systems, with a view to enhancing resilience and facilitating gradual alignment with EU objectives and standards; highlights that such cooperation could include participation in EU health programmes, cross-border projects and technical assistance aimed at strengthening healthcare systems and reducing cardiovascular mortality;

Added158. Stresses that CVD mortality is a key driver of premature mortality from NCDs globally and that reducing cardiovascular mortality is essential to achieving SDG 3.4 by 2030; underlines the EU’s commitment, in line with its external action objectives, to contribute actively to global efforts to reduce the burden of CVDs through prevention, early detection and healthcare system strengthening; calls, therefore, for internal and external policy alignment, including the consideration of populations in low- and middle-income countries in research activities to tackle CVD and related risk factors such as adverse pregnancy outcomes, given the high burden of maternal morbidity;

Added159. Calls for the alignment of EU action on cardiovascular health with international frameworks and commitments, including strategies and action plans developed by the WHO, in order to promote policy coherence, comparability of data, mutual learning and the exchange of best practice between the EU, neighbouring countries and global partners; further encourages the Commission and the Member States to strengthen cooperation with relevant international organisations and partners to support CVD prevention, surveillance, research collaboration and healthcare system resilience globally;

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Changed49.160. Instructs its President to forward this resolution to the CouncilCouncil, the Commission and the Commission.governments and parliaments of the Member States.