33 Amendments of María Soraya RODRÍGUEZ RAMOS related to 2019/2804(RSP)
Amendment 2 #
Citation 1 a (new)
– having regard to the Commission communication of 30 April 2004 - e- Health - making healthcare better for European citizens: an action plan for a European e-Health Area (COM(2004)0356),
Amendment 3 #
Citation 1 b (new)
– having regard to the Commission staff working document of 21 December 2007 - Action plan of the lead market initiative in the area of eHealth - Annex I to the communication - A lead market initiative for Europe (COM(2007)0860,SEC(2007)1730),
Amendment 4 #
Citation 1 c (new)
– having regard to the Commission Recommendation of 2July 2008 on cross- border interoperability of electronic health record systems(notified under document number C(2008) 3282)1a _________________ 1a OJL 190, 18.7.2008, p. 37–43
Amendment 5 #
Citation 1 d (new)
– having regard to the Commission communication of 4 November 2008 on telemedicine for the benefit of patients, healthcare systems and society (COM(2008)0689),
Amendment 6 #
Citation 1 e (new)
– having regard to the Commission communication of 6 December 2012 - eHealth Action Plan 2012-2020 - Innovative healthcare for the21st century (COM(2012)0736),
Amendment 14 #
Recital A
A. whereas Europe’s health and care systems face serious challenges in the context of an aging society that are creating concerns about the sustainability of future provision of healthcare but, on the other hand, are creating new opportunities due to the emergence of new technologies; whereas in this context a paradigm shift is needed towards proactive and responsive health care systems, where maintenance of good health is the prime focus rather than disease management;
Amendment 18 #
Recital B
B. whereas spending on healthcare grows fast and accounts for 9.6% of GDP in the EU as a whole; whereas health systems need to maximise the effectiveness and efficiency of accessible, resilient and sustainable health services and long-term care, deliver seamless care across services and providers, and deliver improvements that matter to patients and their changing care needs;
Amendment 25 #
Recital E
E. whereas the organisation and delivery of health and social care is the responsibility of the Member states; whereas the Union can support the cooperation between Member States in promoting public health and prevention of disease and, improving the complementarity of their health services cross-border, as well as supporting and enabling research and development in smart health in Europe;
Amendment 28 #
Recital F
F. whereas patients’ expectations are rising, and there is a need for more preventive, personalised and responsive ways for people to interact with health services and health professionals;
Amendment 29 #
Recital G
G. whereas in the progressive digitalizsation of the society, will increasingly lead patients, caregivers and, healthcare professionals and potentially all the actors of the healthcare chain to face the challenges of using information technology and the digital infrastructure of patient records in the context, raising questions of personal data security and privacy;
Amendment 30 #
Recital G a (new)
Ga. whereas personal health data are of a particularly sensitive nature and should be subject to strict ethical requirements and the citizens' informed consent with regards to their collection, processing, use and storage;
Amendment 31 #
Recital G b (new)
Gb. whereas the trust of the citizens in the safety and confidentiality of the collection, processing, use and storage of their personal health data is of the utmost importance;
Amendment 33 #
Recital I a (new)
Ia. whereas science, research and innovation play a vital role in Europe’s competitiveness and resilience; whereas exponential leaps in data availability and computing fuel research initiatives to understand, prevent, and treat diseases and medical conditions; whereas data managements techniques can help identify care gaps, risks, trends and patterns in a complementary or more effective way;
Amendment 41 #
Paragraph 2
2. Considers that the actions proposed by the Commission can contribute to provide more preventive, personalised and responsive healthcare to the European citizens, strengthening the resilience and sustainability of Europe’s health and care systems, but also to stimulatinge growth and promotinge the European industry in the domain, in particular by helping to maximise the potential of the digital single market with a wider deployment of digital products and services in health and care;
Amendment 46 #
Paragraph 3
3. Is of the opinion that the digital transformation of health and care needs to be patient-centred, and that digital health should not be a gateway to dehumanised care;
Amendment 49 #
Paragraph 4
4. Believes that there is a need to ensure a key role for public health systems in the governance and the policymaking on digital health and care, at regional, national and European level;
Amendment 60 #
Paragraph 6
6. Stresses that citizens have the right to access and share their personal health data in accordance with the General Data Protection Regulation, and can expect this data to be available in a timely and lay- friendly manner;
Amendment 74 #
Paragraph 14
14. Calls on the Commission and Member States to support projects that use real-world data leading to favourable health outcomes; in this view, further calls on the Commission to develop guidance to promote the secondary use of data for research and ensure fair, transparent and non-discriminatory access to data throughout Europe;
Amendment 76 #
Paragraph 14 a (new)
14a. Calls on the Commission to support projects aiming at developing technologies needed to anonymise or pseudo-anonymise data to allow for their exploitation without risks of compromising the privacy of patients, as well as technologies needed to create synthetic data for Artificial Intelligence algorithm training;
Amendment 78 #
Paragraph 14 b (new)
14b. Calls on the Commission to launch a wide European reflection on the ethical aspects of the digital transformation of health and care, actively involving the citizens and all other actors of the healthcare chain, with a view to develop ethical standards and regulations to protect the citizens’ rights while providing security to researchers and the medical technology industry, in particular with regards to the exploitation of health data and the use of Artificial Intelligence;
Amendment 79 #
Paragraph 15
15. Calls on the Commission and Member States to ensure the establishment of appropriate training and skills development in privacy and security measures for those processing personal health data, which are in line with prevailing standards and data processing techniques; further calls on the Commission to launch an EU-wide educational campaign on the benefits of and mechanisms for health data sharing to break down misconceptions and support the actions put forward by its Communication on enabling the digital transformation of health and care in the Digital Single Market;
Amendment 81 #
Paragraph 17 a (new)
17a. Calls on the Commission to set up a platform for Competent Authorities, Notified Bodies and the pharmaceutical and medical technology industry regarding the application of the Medical Devices Regulation to digital therapeutics and combination products with specific attention to the needs of start-ups and SMEs;
Amendment 86 #
Paragraph 20
20. Considers that the move towards digitalisation is an opportunity to launch an ambitious capacity-building programme for citizens; further considers that promoting the development of skills for the uptake and effective use of smart health products and services is of the utmost importance at all levels of the health value chain (patients, health professionals, regulatory bodies, payers and authorities);
Amendment 91 #
Paragraph 21
21. Believes that the development of a shared framework to harmonise the collection of health data, storage and use in the EU could improve the quality of research and health services provided to citizens, also facilitationg universal access;
Amendment 98 #
Paragraph 23
23. Considers that digital healthcare tools are well positioned to address challenges of accessibility to health information and health literacy, both essential for health promotion, better disease prevention and more effective disease management; considers that these tools, when built with the contribution of the appropriate health professionals and civil society end-users, allow for more accuracy and completeness of information enabling the promotion of healthy habits and prevention activities, as well as the support to co- decisions in health-related matters and patient adherence to treatments.
Amendment 101 #
Paragraph 24
24. Stresses the importance of person- centred approaches to organising health and care, including by using digital solutions and tools which have a great potential in improving the quality of health services but also people’s health and well- being, while increasing patient empowerment;
Amendment 110 #
Paragraph 26
26. Calls on the Commission and Member States to ensure that health professionals improve competences and skills, including by defining requirements for digital health curricula for healthcare professionals, creating life-long training centres of excellence for specific digital skillsets, and building up the capacity of regulatory bodies to assess smart health products and services in a rapidly evolving technology environment;
Amendment 121 #
Paragraph 29 a (new)
29a. Calls on the Commission and the Member States to support the scaling up of smart health pilot and demonstration projects to accelerate learning curves;
Amendment 122 #
Paragraph 29 b (new)
29b. Calls on the Commission to study the possibility of setting up a European smart health innovation hub to assess and promote smart health initiatives, and provide a platform for all actors of the health chain to establish consortia to realise ambitious large-scale projects;
Amendment 123 #
Paragraph 29 c (new)
29c. Calls on the Commission and the Member States to promote the sharing of best practices and evidence of early adopters of innovative solutions in healthcare, in particular by making a full use of Interreg Europe projects and its Policy Learning Platform;
Amendment 124 #
Paragraph 29 d (new)
29d. Calls on the Commission to continuously monitor, benchmark, and promote the sharing of good practices between Member States and regions to incentivise effective reforms and track progress towards value-based healthcare and sustainable healthcare systems;
Amendment 125 #
Paragraph 30
30. Calls on the Commission to assist Member States in creating contingency strategies to avoid total dependency on electronic data, in the event of blackouts; ddress any potential temporary or permanent unavailability of health data resulting from an accident or attack on the infrastructure, systems or software used for the collection, processing or storage of said data;
Amendment 128 #
Paragraph 30 a (new)
30a. Stresses that a successful digital healthcare transition will require strong political leadership, a long-term vision, and sustained investments at both national and European levels;