Health Department, Campania Region, Italy

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Health Department, Campania Region, Italy 1.1 Please indicate the type of organisation on behalf of which you are responding to this consultation: Please indicate for what the administration is responsible: 1. Respondent Profile Healthcare public administration at regional level National/regional health service provider 1.1.1. Other (please specify): 1.2 Please indicate the name of your organisation or centre: Health Department, Campania Region - Italy 1.3 Please indicate the country where your organsation/centre is located/has its headquarters or main representative office in Europe: 1.4 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: l.natale@maildip.regione.campania.it IT 20 Yes 1.6 Please provide us with a contact person (incl jobtitle and daytime phone number): Dott.ssa Lara Natale Tel. + 39 081 7969273 Fax + 39 081 7969377 1.7 Please provide additional contact details if needed: Dott.ssa Laura Filomena Russo Tel. + 0828 67439 Fax + 39 0828 34621 e-mail: russo.filomenalaura@virgilio.it

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 Costs and economic evaluation Ethical analysis Management and organisational aspects of highly specialized healthcare Social aspects Professional performance, clinical practice, quality and safety of specialized healthcare Legal aspects Assessment/evaluation/certification of clinical practice and healthcare providers 2.2.1. Space for further comments: 2.3 Is highly specialised healthcare a priority in your organisation's strategies and work plans? 2.3.1 Space for further comments: 2.4. What specific field of healthcare services/specialities are most relevant for your centre/organisation's field of work? Very high High tech diagnostic and treatment services (radiology, nuclear medecine, electrophysiology, radiotherapy etc.) Please specify: Campania has a relevante number of providers

2.. Has your organisation/centre been directly involved in the design or assessment of professional standards and criteria related with highly specialised healthcare? Frequently 2..1 Please describe your role in such actions/projects: Coordinator of Struttura Commissario ad Acta for the Campania Region Recovery Plan; Campania Region Referent of the Progetto Mattone Internazionale 2.6. Has your organisation been involved in projects/activities Yes supported by the Commission in relation with HSHC or professional and technical criteria/standards in highly specialised healthcare? 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)? Yes 2.7.1 Space for further comments: 2.13. What is the scope of the network? 2.14. Which kind of network? 2.14.1 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 4 3.1.2.1. Rare expertise/need of concentration of cases 3.1.2.2. Low prevalence/incidence/number of cases 4 3.1.2.3. Evaluated experiences of Member States 4 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) 3.1.4. Do you recommend any additional criteria or option that would effectively address the issue? 4 No

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: AIDS, tubercolosis and malaria due to migratory fluxes from non-eu Countries. Yes 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 4 3.2.3. Patient care, clinical tools and health technology assessment 3.2.4. Quality, patient safety and evaluation framework policies 2 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 2 3 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? No 3.2.9.1. Space for further comments: Geographical location is a critical issue: frontier locations (for example Southern Italy) are more exposed to the recrudescence of some specific diseases (ie from Africa and eastern EU).

3.3.1. Competence, experience and good outcomes and care 3.3. Specific criteria regarding the areas of expertise 3.3.2. Specific resources and organisation: 3.3.2.1. Human resources 3 3.3.2.2. Team/centre organisation 3 3.3.2.3. Structural conditions 3 3.3.2.4. Specific equipment 3 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 3.3.4. 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 4 3 3.3.7. Do you recommend any additional criteria or option that would effectively address the issue? No 3.3.7.1. Space for further comments: Expertise, protocols, best practice and disease registers should be shared through a common ICT platform to improve the performances of all member States.