2019/2804(RSP) | [ParlTrack]

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)356 final);

Amendment 10 #

Citation 6 d (new)

– having regard to the Commission communication of 6 December 2012 - eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century (COM(2012)0736 final);

Amendment 100 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 24

24. Stresses the importance of ~~person- centred approaches to organising~~keeping the national/regional role in the organization of health and care systems, including by using digital solutions and tools which have a great potential in improving the quality, equity and sustainability of health services but also people’s health and well- being;

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 102 #

Paragraph 24

24. Stresses th~~e importance of person- centred approaches to organising health and care, including by using digital solutions and to~~at while the use of digitalisation holds ~~which have a~~ great potential in improving ~~the quality of health services but also people’s health and well-being;~~people's health, person-centred approaches to health and care remains irreplaceable for many patients

Amendment 103 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, César LUENA

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, equity and sustainability of health services but also people’s health and well- being;

Amendment 104 #

Paragraph 24 – point 1 (new)

(1) Stresses the importance of providing information to patients and supporting them to make a meaningful decision regarding their health; pointing out that digital platforms must be user- friendly, digitally accessible and provide barrier free information for patients and health care professionals in multiple languages

Amendment 105 #

Frédérique RIES

Paragraph 25

25. Calls on the Commission to work with relevant actors to support more cooperation across borders and enlarge the deployment of digitally enabled care models; considers, in this respect, that the European Reference Networks can be excellent vehicles to show how digital health can contribute to improve health outcomes and well-being across borders, as they provide a trusted environment in which health professionals and patients are already working together and exchanging health data cross-borders to achieve their goals.

Amendment 106 #

Paragraph 25

25. Calls on the Commission to work with relevant actors to support more cooperation across borders and enlarge the deployment of digitally enabled care models, home care models and assistive home technologies suitable for the elderly;

Amendment 107 #

Paragraph 25

25. Calls on the Commission to support the digitalisation of regulatory agencies and to work with relevant actors to support more cooperation across borders and enlarge the deployment of digitally enabled care models;

Amendment 108 #

Paragraph 25

25. Calls on the Commission to work with the relevant actors to support more cooperation across borders and enlarge the deployment of digitally enabled care models, and to do this without encroaching on Member State competences;

Amendment 109 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS, César LUENA

Paragraph 25

25. Calls on the Commission to work with relevant actors, especially national health systems, to support more cooperation across borders and enlarge the deployment of digitally enabled care models;

Amendment 11 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Citation 7 a (new)

– having regard to Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union

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 111 #

Paragraph 26

26. Calls on the Commission and Member States to ~~ensure tha~~support health professionals i~~mprove competen~~n the context of the digital transformation of healthcare systems, to step up exchanges of relevant good practices and ~~skills~~to consider harmonising training;

Amendment 112 #

Paragraph 26

26. Calls on the Commission and Member States to ensure that health professionals improve competences and skills by means of regular training programmes that take into account the rapid evolution of the IT sector;

Amendment 113 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Demetris PAPADAKIS, César LUENA

Paragraph 26

26. Calls on the Commission and Member States to ensure that health professionals improve the necessary competences and skills to collect, analyse and protect health data;

Amendment 114 #

Paragraph 27

27. Calls on the Commission to work with Member States and the regional and local authorities to develop networks to educate citizens in the use of digital healthcare, enabling universal access; considers that, in order to achieve that goal, there is a need to improve systems’ interoperability and users skills, with the highest possible protection of sensitive data with tools and mechanisms provided by the public health systems;

Amendment 115 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, César LUENA

Paragraph 27

27. Calls on the Commission to work with Member States and regions to develop networks to educate citizens in the use of digital healthcare, enabling universal and equitable access; considers that, in order to achieve that goal, there is a need to improve systems’ interoperability and users skills, with the highest possible protection of sensitive data with tools and mechanisms provided by the public health systems;

Amendment 116 #

Paragraph 27

27. Calls on the Commission to work with Member States and regions to develop networks to educate citizens in the use of digital healthcare, enabling universal access; considers that, in order to achieve that goal, there is a need to improve systems’ interoperability and users skills, with the highest ~~possible~~ protection of sensitive data with tools and mechanisms provided by the public health systems;

Amendment 117 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, César LUENA

Paragraph 27 a (new)

27a. Calls on the Commission and Member States to ensure that all measures to improve citizens digital skills and access to and use of their health data take into consideration sensitive groups such as older citizens, info- excluded people and people with disabilities;

Amendment 118 #

Cristian-Silviu BUŞOI

Paragraph 28 a (new)

28a. Patients should benefit from the most up to date information regarding their medicines, therefore urges the Commission to develop further electronic product information, including thee- leaflet to improve regulatory efficiency and empower patients with up to date information on medicines.

Amendment 119 #

Paragraph 29

29. Calls on the Commission to assist Member States and regions in raising awareness about innovative procurement and investment possibilities for digital transformation in public health and ~~care and in leveraging public and private investment for the large-scale deployment of digitally enabled, integrated person- centred~~ care;

Amendment 12 #

Citation 7 a (new)

– having regard to Special report no 7/2019 of the European Court of Auditors: EU actions for cross-border healthcare: significant ambitions but improved management required

Amendment 120 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 29

29. Calls on the Commission to assist Member States and the regional authorities in raising awareness about innovative procurement and investment possibilities for digital transformation in public health and care and in leveraging public and private investment for the large-scale deployment of digitally enabled, integrated person- centred care;

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 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 30

30. Calls on the Commission to assist Member States in creating contingency strategies to a~~void 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 126 #

Paragraph 30

30. Calls on the ~~Commission to assist~~ Member States into creat~~ing~~e strategies to avoid total dependency on electronic data, in the event of blackouts;

Amendment 127 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 30 a (new)

30a. Supports the efforts of the European Centre for Disease Prevention and Control (ECDC) to develop strategies to make better use of existing computerised systems, to use data to limit the spread of infectious diseases, and to help Member States gather and process 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;

Amendment 129 #

Paragraph 31 a (new)

31a. Calls on the Commission and Member States to establish a clear timetable of the changes planned in order to create a digital health Europe, with mid-term assessments, and to set targets;

Amendment 13 #

Citation 7 b (new)

– having regard to Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format,

Amendment 130 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 31 b (new)

31b. Calls on the Commission and the Member States to implement the Commission's recommendations of February 2019 on a European Electronic Health Record exchange format;

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 15 #

Recital A

A. whereas Europe’s health and care systems face serious challenges in the context of an ageing society ~~that are~~, with an ever- increasing threat from infectious illnesses as a result of growing resistance to antibiotics, 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;

Amendment 16 #

Esther DE LANGE

Recital A

A. whereas Europe’s health and care systems face serious challenges in the context of an aging society, higher life expectancy and consistently lower birth rates 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;

Amendment 17 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Recital A

A. whereas ~~Europe’s health and~~the emergence of new technologies care ~~sys~~atems ~~face serious~~both opportunities and challenges into the ~~context of an aging society that are creating~~development of better health care, as concerns about the sustainability of future provisions of healthcare ~~but, on the other hand, are creating new opportunities due to the emergence of new technolog~~are rising due to Europe's aging societies;

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 19 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Recital B

B. whereas health systems need to maximise the effectiveness and efficiency of 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; considering their differences in internet connectivity, digital competences and health literacy

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 20 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS

Draft motion for a resolution
Recital B

B. whereas health systems need to maximise the effectiveness and efficiency, equitable access and sustainability of 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~~and growing health and care needs, well-being and quality of life;

Amendment 21 #

Recital B

B. whereas health systems need to maximise the effectiveness and efficiency of health services and long-term care, provide new services in line with the evolution of society, deliver seamless care across services and providers, and deliver improvements that matter to patients and their changing care needs;

Amendment 22 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS, César LUENA

Recital C

C. whereas innovative digital solutions for health and care can boost ~~health and quality of life of citizens~~prevention of diseases and promotion of healthy lifestyles, improve citizens’ quality of life and enable more efficient ways of organiszing and delivering health and care services;

Amendment 23 #

Recital D

D. whereas data concerning the health of EU citizens is a key enabler for digital transformation, and must be strictly protected against misuse; whereas the availability of data varies greatly across Member States, and whereas, due to the lack of interoperability and market fragmentation across health systems, citizens cannot yet fully benefit from the digital single market;

Amendment 24 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Recital D a (new)

Da. whereas healthcare digitalisation will not be limited to greater use of mobile health apps, but also include analysing large data sets also known as data mining, that serve as a foundation for artificial intelligence (AI) and machine learning;

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 26 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS

Recital F

F. whereas patients’ expectations are rising, and there is a need for an empowerment of citizens regarding their health through user-centred services and more ways for people to interact with health services and health professionals;

Amendment 27 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Recital F

F. whereas patients’ expectations a~~re rising, and the~~nd desire to monitor one’s own health are ris aing, the need for more ways for people to interact with health services and health professionals are rising accordingly;

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 #

Frédérique RIES, Fredrick FEDERLEY, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ

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 3 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 30 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 32 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Recital H

H. whereas the implementation and use of digital health are at different levels between Members States, including the use of updated technology, support infrastructures to digital transformation and the use of electronic health records in healthcare services; whereas the establishment of a comprehensive digital healthcare system will be hugely expensive in many countries;

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 34 #

Recital I a (new)

Ia. whereas people along lower social gradients tend to have higher health needs, they are also more vulnerable to become excluded by the digitalisation of health care

Amendment 35 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Demetris PAPADAKIS, César LUENA

Paragraph 1

1. Welcomes the Commission communication on enabling the digital transformation of health and care in the Digital Single Market which aims to promote health, prevent and control disease, help address pacitizents’ unmet needs, represent an opportunity to improve the sustainability of health systems and make it easier for citizens to have equal access to high quality care through the meaningful use of digital innovations;

Amendment 36 #

Paragraph 1

1. Welcomes the Commission communication on enabling the digital transformation of health and care in the Digital Single Market which aims to promote health, prevent and control disease, help address patients’ unmet needs and make it easier for citizens to have equal and affordable access to high quality care through the meaningful use of digital innovations;

Amendment 37 #

Paragraph 1 – point 1 (new)

(1) Points out that while digital health holds a lot of potential, it also has a lot of unresolved issues when it comes to privacy, security and safety

Amendment 38 #

Paragraph 1 – point 2 (new)

(2) Underlines that to fully benefit from the potential of digital health tools it is of upmost importance to implement digital health elements with a high consideration of data privacy, security, accuracy and inclusion of patient needs

Amendment 39 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 1 a (new)

1a. Notes that compliance with EU legislation on data protection should be the precondition to this digital transformation of health and care in the Digital Single Market;

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 40 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 2

2. Considers that the actions proposed by the Commission can contribute to strengthening the resilience and sustainability of Europe’s health and care systems but also to stimulating growth and promoting 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, as well as the deployment of new services, especially for isolated and inaccessible areas with inadequate medical staff and services;

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, strengthen~~ing~~ the resilience and sustainability of Europe’s health and care systems, but also to stimulat~~ing~~e growth and promot~~ing~~e 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 42 #

Paragraph 2

2. Considers that the actions proposed by the Commission can contribute to strengthening the ~~resilience and sustainability~~efficiency, equitable access, sustainability and resilience of Europe’s health and care systems but also to stimulating growth and promoting 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 43 #

Paragraph 3

3. Is of the opinion that the digital transformation of health and care needs to be patient-centred; that this transformation should allow for the exchange of information on patient records, electronic prescriptions, laboratory test results, medical imaging and discharge summaries, as well as information on the cost of medicines in each Member State and, in particular, how they are covered and reimbursed;

Amendment 44 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS

Paragraph 3

3. Is of the opinion that the digital transformation of health and care needs to ~~be patient-centred~~support citizen-centred services as well as empowering citizens to play a more active role in disease prevention and promotion of health, as well in health and care services, answering the needs of citizen;

Amendment 45 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 3

3. Is of the opinion that the digital transformation of health and care needs to be patient-centred; stresses, at the same time, that the needs of patients who are unable to keep up with the digital transformation must not be disregarded;

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 47 #

Paragraph 3 a (new)

3a. Highlights that national health systems are the main providers of the fundamental right to access to health and are based on the principle of solidarity whereby "healthy people finance the care of sick people", and that is key to make possible an efficient and equitable system; states therefore that there is a shared property of these systems and of what is produced in them;

Amendment 48 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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; stresses, in this regard, the importance of cooperation and interconnectedness between the databases of healthcare establishments and insurance companies with municipal authorities and social security and social welfare bodies;

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 5 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 50 #

Paragraph 4

4. Believes that there is a need to ensure a key role for patient organisations and networks, public health systems in the governance and the policymaking on digital health and care;

Amendment 51 #

Paragraph 4 a (new)

4a. Believes that public health systems are the best-placed authorities to manage and/or supervise the collection, anonymization and pseudonymization, custody and exploitation of health data while protecting patients’ privacy as well as the efficiency, equitable access and sustainability of health and care sector;

Amendment 52 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS, César LUENA

Paragraph 4 a (new)

4a. Stresses that the future of digital health will need to develop secure and effective anonymization and pseudonymization techniques enabling sensible data to be used in health research;

Amendment 53 #

Paragraph 5

5. Stresses that health data could be used for research, to implement evidence based health policies and for a better understanding of diseases and early detection of events that threaten public health, whilst complying with the principles of patient confidentiality;

Amendment 54 #

Paragraph 5

5. Stresses that health data could be used for scientific health research, to implement evidence based health policies and for a better understanding of diseases and early detection of events that threaten public health;

Amendment 55 #

Paragraph 5

5. Stresses that fully anonymised health data could be used for research, to implement evidence based health policies and for a better understanding of diseases and early detection of events that threaten public health;

Amendment 56 #

Paragraph 5 a (new)

5a. Stresses that the use of anonymised health data should be favoured; Points out that if anonymization is not possible, data should be pseudonymised, so that it can not be directly connected to a specific person

Amendment 57 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS, César LUENA

Paragraph 5 a (new)

5a. Stresses that a Commission proposal on sharing information and data governance is necessary to tackle the implications for national health systems;

Amendment 58 #

Subheading 2

The need to secure access to and sharing of personal health data, whilst applying the GDPR rules thoroughly

Amendment 59 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 for better health care; points out that the recent regulation on data protection of the EU improves the right of patients to access information on aspects of their health and protect their privacy; regrets, however, that this regulation does not go further on data property or other new rights for patients; remarks that the aim of a patient-based system is to improve citizens` health, and that the national health systems must guarantee it for the sake of common interest;

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 60 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

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 61 #

Paragraph 6 a (new)

6a. Stresses that it is indispensable that secure and effective anonymization and pseudonymization techniques are developed, which enable sensitive data to be used in health research without compromising the privacy of patients; draws attention to the importance of pseudonymization techniques allowing the re-identification of the data donors in cases where their health is at risk;

Amendment 62 #

Paragraph 6 b (new)

6b. Considers that due to the sensitive nature of health data, the right to protection of privacy must be specially regulated, which requires special measures to avoid not only cyberattacks but also an inadequate use of such data by utilities;

Amendment 63 #

Paragraph 6 c (new)

6c. Acknowledges that there are significant economic interests in the exploitation of data from the health and care sectors; calls therefore on the Commission and Member States to clearly define responsibilities in data governance, putting in place a new public-private paradigm;

Amendment 64 #

Paragraph 7

7. Regrets that, at present, many citizens in Europe have limited electronic access to their personal health data, in particular ~~in cross-border -healthcare provision~~when they need to have recourse to cross-border medical care;

Amendment 65 #

Paragraph 7

7. Regrets that, at present, many citizens in Europe have limited or no electronic access to their personal health data, in particular in cross-border - healthcare provision;

Amendment 66 #

Paragraph 8

8. Calls on the Commission to continue improving cybersecurity, reducing the risk of privacy breaches and unauthorised use of health data across the Union;

Amendment 67 #

Paragraph 9

9. Agrees with the Commission that citizens should have secure access to a comprehensive electronic record of their health data, and should remain in control of and be able to share their personal health data securely with authorised parties, while unauthorised access should be pr~~even~~ohibited in accordance with data protection legislation;

Amendment 68 #

Paragraph 10

10. Calls on the Commission to continue promoting the cooperation of Member States’ health authorities to connect to the eHealth digital infrastructure in order to extend its use to also cover the interoperability of Member States’ electronic record systems by supporting the development and adoption of a European electronic health record exchange format, particularly when patients have recourse to gross-border medical care;

Amendment 69 #

Paragraph 10

10. Calls on the Commission to continue promoting the cooperation of Member States’ health authorities to connect to the eHealth digital infrastructure in order to extend its use to also cover the interoperability of Member States’ electronic record systems by supporting the development and adoption of a European electronic health record exchange format, which, in order to serve the patients' interest, ought to contain the most comprehensive information possible concerning health status;

Amendment 7 #

Citation 6 a (new)

Amendment 70 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, César LUENA

Paragraph 10

10. Calls on the Commission to continue promoting the cooperation of Member States’ health authorities to connect to the eHealth digital infrastructure in order to extend its use to also cover the interoperability of Member States’ electronic record systems by supporting the development and adoption of a European electronic health record exchange format, taking into account the Union’s multilingualism as well as user with disabilities;

Amendment 71 #

Paragraph 10

10. Calls on the Commission to continue promoting the cooperation of Member States’ health authorities to connect to ~~the~~a public eHealth digital infrastructure in order to extend its use to also cover the interoperability of Member States’ electronic record systems by supporting the development and adoption of a European electronic health record exchange format;

Amendment 72 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 13

13. Calls on Member States’ health authorities to make use of EU financing instruments, such as the European Structural and Investment Funds and the European Fund for Strategic Investments, for the deployment of interoperable electronic health records at national and regional level which will enable citizens to access their personal health data for investment in building solid and more reliable infrastructure which supports the digital transformation, and helps to reduce the digital divide between all Member States; calls for the benefits brought by the digitisation and digitalisation of health records to help improve access to and the quality of medical care in both urban and rural areas;

Amendment 73 #

Esther DE LANGE

Paragraph 13

13. Calls on Member States’ health authorities to make use of EU financing instruments, such as the Active and Assisted Living (AAL) programme that aims to create better quality of life for older people, the European Structural and Investment Funds and the European Fund for Strategic Investments, for the deployment of interoperable electronic health records at national and regional level which will enable citizens to access their personal health data for investment in building solid and reliable infrastructure which supports the digital transformation, and helps to reduce the digital divide between all Member States;

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 75 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 14

14. Calls on the Commission and Member States to support projects that use real-world data ~~leading to~~and develop criteria for the quality of data gathered in a non- controlled environment in order for real- world data to help achieve favourable health outcomes;

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 77 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 14 a (new)

14a. Calls for the Commission and Member states' use of real world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials.

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 #

Frédérique RIES, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ

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 8 #

Citation 6 b (new)

– having regard to the Commission Recommendation of 2 July 2008 on cross- border interoperability of electronic health record systems (notified under document number C (2008) 3282)1a; _________________ 1a OJ L 190, 18.7.2008, p. 37–43

Amendment 80 #

Frédérique RIES, Fredrick FEDERLEY, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ

Paragraph 17

17. Stresses the importance of standardising regulation of connected healthcare ~~devices, such as mHealth and eHealth~~ devices, assuring their data accuracy ~~and~~, precision and safety;

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 82 #

Paragraph 18

18. Calls on the Commission to ~~facilitate~~step up European coordinated action to support ~~pooling and~~the secure exchange in practice of genomic and other health data in order to advance the progress of researchers and personalised medicine and thereby identify the best treatments, while ensuring full compliance with data protection legislation and ethical principles;

Amendment 83 #

Frédérique RIES

Paragraph 18

18. Calls on the Commission to facilitate European coordinated action to support pooling and secure exchange and linkage of genomic and other health data in order to advance research and personalised medicine, while ensuring full compliance with data protection legislation and ethical principles;

Amendment 84 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Demetris PAPADAKIS, César LUENA

Paragraph 19

19. Calls on the Commission together with the Member States to proceed with the testing of specific applications for cross-border health data exchange for research and health policy to improve prevention, diagnosis and treatment of diseases in order to help health systems to meet current and future challenges;

Amendment 85 #

Frédérique RIES, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ, Fredrick FEDERLEY

Paragraph 19

19. Calls on the Commission, together with the Member States and accredited institutions, to proceed with the testing of specific applications for high-security cross-border health data exchange for research and health policy to improve prevention, diagnosis and treatment of diseases;

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 87 #

Esther DE LANGE

Paragraph 20

20. Considers that the move towards digitalisation is an opportunity to launch an ambitious capacity-building programme for citizens and to strengthen industrial opportunities in the field of healthy ageing technology and innovation;

Amendment 88 #

Paragraph 20

20. Considers that the move towards digitalisation is an opportunity to launch an ambitious capacity-building programme for citizens and to improve access to medical care, especially in rural areas;

Amendment 89 #

Cristian-Silviu BUŞOI

Paragraph 20 a (new)

20a. Is of the opinion that ensuring a fit for purpose regulatory environment is a key element to protect public health and provide access to high quality medicines. The effective use of Information Technology systems will improve regulatory efficiency across Europe; therefore, urges the Commission to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and inter- dependency of the European regulatory framework.

Amendment 9 #

Frédérique RIES, Fredrick FEDERLEY, María Soraya RODRÍGUEZ RAMOS, Irena JOVEVA, Susana SOLÍS PÉREZ

Citation 6 c (new)

– having regard to the Commission communication of 4 November 2008 on telemedicine for the benefit of patients, healthcare systems and society (COM(2008)689 final);

Amendment 90 #

Sara CERDAS, Carlos ZORRINHO, Monika BEŇOVÁ, Biljana BORZAN, Manuel PIZARRO, Nicolás GONZÁLEZ CASARES, Simona BONAFÈ, Tudor CIUHODARU, Demetris PAPADAKIS, César LUENA

Paragraph 21

21. Believes that the development of a shared ~~framework~~standards 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 facilitation universal access;

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 92 #

Paragraph 22

22. Considers that there is a need to better advance health promotion, prevent disease and deliver integrated services based on people’s needs, especially during pandemics, and that the European Centre for Disease Prevention and Control (ECDC) must play a central role in these efforts;

Amendment 93 #

Paragraph 22

22. Considers that there is a need to better advance health promotion, prevent disease and deliver integrated services based on people’s needs, especially ~~during pandemic~~in the event of pandemics or medicine shortages;

Amendment 94 #

Paragraph 22 a (new)

22a. Calls on the Commission and Member States to consider setting up a dedicated and protected IT system for the purpose of exchanging information between national authorities on the cost of medicines in each Member State in order to shed light on patients' decision- making in this regard;

Amendment 95 #

Edina TÓTH, András GYÜRK

Paragraph 23

23. Considers that digital healthcare tools armay be 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 users and are in conformity with all the relevant legislation, allow for more accuracy and completeness of information enabling the promotion of healthy habits and prevention activities, as well as the support to decisions in health and patient adherence to treatments.

Amendment 96 #

Paragraph 23

23. Considers that digital healthcare tools, such as portable patient information cards, 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 users, allow for more accuracy and completeness of information enabling the promotion of healthy habits and prevention activities, as well as the support to decisions in health and patient adherence to treatments.

Amendment 97 #