European Society of Cardiology, France

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European Society of Cardiology, France 1.1 Please indicate the type of organisation on behalf of which you are responding to this consultation: 1. Respondent Profile Health professionals' organisations (e.g. doctors, nurses, managers) Please indicate level: European Union umbrella organisation Please indicate Member States representation: Pan European Please indicate for what the administration is responsible: 1.1.1. Other (please specify): 1.2 Please indicate the name of your organisation or centre: European Society of Cardiology 1.3 Please indicate the country where your organsation/centre is located/has its headquarters or main representative office in Europe: 1. Please indicate the number of EU Member States and EEA countries (Norway, Iceland, Lichtenstein) and accessing country (Croatia) in which your organisation conducts business/is represented: 1. If need be, can we contact you by e-mail to obtain further information on your submission? 1..1 Please provide an e-mail address where we can contact you: ileggeri@escardio.org FR 31

1.6 Please provide us with a contact person (incl jobtitle and daytime phone number): Ilaria Leggeri EU Policy Advisor European Affairs Department Advocacy & Representation Division European Society of Cardiology (ESC) Tel: +33 (0) 92 9 7638 Fax: +33 (0) 92 9 77 1 Email: ileggeri@escardio.org 1.7 Please provide additional contact details if needed: Sophie O'Kelly Head of European Affairs Advocacy & Representation Division European Society of Cardiology (ESC) Tel: +33 (0) 92 9 86 62 Fax: +33 (0) 92 9 77 1 Email: sokelly@escardio.org 2. Involvement of your organisation in the matter of centres of excellence/reference (COE) and healthcare networks in highly specialised healthcare (HSHC). 2.1 How would you describe your organisation's knowledge of CoE and HSHC? 2.1.1 Space for further comments: 2.2. What aspects or domains related to the topic of CoE and HSHC would correspond to your organisation's key knowledge? (cross any that applies) Very high Highly specialised healthcare provision Priorities, description and characteristics of CoE and HSHC Management and organisational aspects of highly specialized healthcare Professional performance, clinical practice, quality and safety of specialized healthcare 2.2.1. Space for further comments: 2.3 Is highly specialised healthcare a priority in your organisation's strategies and work plans? High

2.3.1 Space for further comments: The European Society of Cardiology fosters high standards of training in cardiology across Europe in order to ensure high standards of care. Centers of Excellence may also contribute to this endeavour 2.. What specific field of healthcare services/specialities are most relevant for your centre/organisation's field of work? Medical/Surgical speciality Please specify: 2.. Has your organisation/centre been directly involved in the design or assessment of professional standards and criteria related with highly specialised healthcare? Cardiology Frequently 2..1 Please describe your role in such actions/projects: ESC develops an array of tools aimed at training and certification of individuals and at defining the criteria that training centers need in order to provide appropriate training. 2.6. Has your organisation been involved in projects/activities supported by the Commission in relation with HSHC or professional and technical criteria/standards in highly specialised healthcare? No 2.7. Do you have concrete examples based on your own organisation's experience or could you provide us with references or links to documents related with professional criteria and standards in highly specialised healthcare/coe or HSHC (e.g. quality criteria, guidelines, consensus documents)? 2.7.1 Space for further comments: Core Curriculum Clinical Practice Guidelines 2.13. What is the scope of the network? 2.1. Which kind of network? 2.1.1 Space for further comments:

2.1. Would you be interested in applying to the process to be considered Centre of Excellence of the future European Reference Network? (1 = not interested at all, = very interested) 2.1.1 Space for further comments: 3. Proposed criteria for ERN (scope, general and specific criteria) 3.1 Criteria related with diseases or conditions in order to be considered under the scope of the ERN 3.1.1. Need of highly specialised healthcare 3.1.1.1. Complexity of the diagnosis and treatment 3.1.1.2. High cost of treatment and resources 3.1.1.3. Need of advanced/highly specialised medical equipment or infrastructures 3.1.2. Need of particular concentration of expertise and resources 3.1.2.1. Rare expertise/need of concentration of cases 3.1.2.2. Low prevalence/incidence/number of cases 3.1.2.3. Evaluated experiences of Member States 3.1.3. Based on high-quality, accessible and cost-effective healthcare 3.1.3.1. Evidence of the safety and favourable risk-benefit analysis

3.1.3.2. Feasibility and evidence of the value and potential positive outcome (clinical) 3.1.. Do you recommend any additional criteria or option that would effectively address the issue? 3.1..1 Explain your proposal in free text: - collaboration in the definition of the targeted diseases and in establishing the rules for auditing the selected centers - JCI quality label" (Joint Commission International) to be extended to EU 3.1.. Would you prioritise or suggest any concrete disesase or group of diseases to be addressed by the future ERN according to the above criteria? 3.1..1 Explain your proposal in free text: Noncommunicable diseases (including cardiovascular disease), which are linked by common risk factors and often occur together. A concentration of expertise/resources would bring health/economic gains. 3.2. General criteria of the centres wishing to join a European Reference Network 3.2.1. Organisation and management 3.2.2. Patients empowerment and centered care 3.2.3. Patient care, clinical tools and health technology assessment 3.2.. Quality, patient safety and evaluation framework policies 3.2.. Business continuity, contingency planning and response capacity

3.2.6. Information systems, technology and e-health tools and applications 3.2.7. Overall framework and capacity for research and training 3.2.8. Specific commitment of the management/direction of the centre/hospital to ensure a full and active participation in the ERN 3.2.9. Do you recommend any additional option that would effectively address the issue? 3.2.9.1. Space for further comments: - JCI quality label" (Joint Commission International) to be extended to 3.3. Specific criteria regarding the areas of expertise 3.3.1. Competence, experience and good outcomes and care 3.3.2. Specific resources and organisation: 3.3.2.1. Human resources 3.3.2.2. Team/centre organisation 3.3.2.3. Structural conditions 3.3.2.. Specific equipment 3.3.2.. Presence and coordination with other required complementary units or services 3.3.3. Patient care pathways, protocols and clinical guidelines in the field of expertise

3.3.. External coordination, care management and follow-up of patients 3.3.. Research, training, health technology assessment in the field of expertise 3.3.6. Specific information systems 3.3.7. Do you recommend any additional criteria or option that would effectively address the issue? 3.3.7.1. Space for further comments: none No