natgillin/translations-raw huggingface dataset:
The Networks should improve access to diagnosis, treatment and the provision of high-quality healthcare to patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases.
Mreže bi morale izboljšati dostop do diagnoze, zdravljenja in izvajanja visokokakovostnega zdravstvenega varstva za paciente, katerih zdravstveno stanje zahteva posebno koncentracijo virov ali strokovnega znanja, ter bi lahko bile tudi osrednje točke za medicinsko usposabljanje in raziskave, širjenje informacij in ocenjevanje zlasti za redke bolezni.
According to Article 12(2) of Directive 2011/24/EU, each Network is to select at least three objectives from the list laid down in therein 12(2) of Directive 2011/24/EU and demonstrate that it has the necessary competences to pursue them effectively.
V skladu s členom 12(2) Direktive 2011/24/EU mora vsaka mreža izbrati vsaj tri cilje s seznama iz člena 12(2) Direktive 2011/24/EU in dokazati, da ima potrebne kompetence za njihovo učinkovito uresničevanje.
In addition, Networks are required to fulfil the list of tasks or characteristics laid down in Article 12(4)(a)(i)-(vi) of Directive 2011/24/EU.
Poleg tega morajo mreže izpolniti seznam nalog ali značilnosti iz člena 12(4)(a)(i)–(vi) Direktive 2011/24/EU.
This Decision sets out the specific list of criteria or conditions that will ensure the Networks fulfil these tasks.
V tem sklepu je naveden poseben seznam meril oziroma pogojev, s katerimi bo zagotovljeno, da mreže te naloge izpolnjujejo.
These criteria and conditions should provide the basis for the establishment and evaluation of the Networks.
Ta merila in pogoji bi morali zagotoviti podlago za ustanovitev in ocenjevanje mrež.
Among the set of criteria and conditions necessary to enable Networks pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU the Decision provides a list of criteria on the governance and coordination of the Networks that should ensure their transparent and effective functioning.
Poleg niza meril in pogojev, ki so potrebni, da mreže lahko uresničijo ustrezne cilje iz člena 12(2) Direktive 2011/24/EU, je v Sklepu naveden seznam meril za vodenje in usklajevanje mrež, ki bi moral zagotoviti njihovo pregledno in učinkovito delovanje.
Although Networks should be allowed to have different organisation models, it is appropriate to require that they all choose one of their Members as the coordinating Member.
Čeprav bi mrežam moralo biti dovoljeno, da imajo različne organizacijske modele, je primerno zahtevati, da vse izberejo enega izmed svojih članov za člana koordinatorja.
The coordinating Member shall appoint one person acting as the coordinator of the Network (‘Coordinator’).
Ta imenuje eno osebo za koordinatorja mreže (v nadaljnjem besedilu: koordinator).
They should be governed by a board of the Network (‘Board’) composed of representatives from each Member in the Network.
Mrežo bi moral voditi odbor mreže (v nadaljnjem besedilu: odbor), sestavljen iz predstavnikov vsakega člana mreže.
The Board should be in charge of producing and adopting the rules of procedure, work plans and progress reports and any other documents related to the activities of the Network.
Odbor bi moral biti zadolžen za pripravo in sprejetje poslovnika, delovnih načrtov in poročil o napredku ter vseh drugih dokumentov v zvezi z dejavnostmi mreže.
The Coordinator, assisted by the Board, should support and facilitate the internal coordination within the Network and with other healthcare providers.
Koordinator, ki mu pomaga odbor, bi moral podpirati in pospeševati notranje usklajevanje v okviru mreže in z drugimi izvajalci zdravstvenega varstva.
The provision of highly specialised healthcare, one of the criteria to be fulfilled by the Networks, should be based on high quality, accessible and cost-effective healthcare services.
Izvajanje visokospecializiranega zdravstvenega varstva, kar je eno od meril, ki jih morajo izpolnjevati mreže, bi moralo temeljiti na visokokakovostnih, dostopnih in stroškovno učinkovitih zdravstvenih storitvah.
It requires experienced, highly skilled and multidisciplinary healthcare teams and, most likely, advanced specialised medical equipment or infrastructures which commonly imply concentration of resources.
Za to so potrebne izkušene, visokousposobljene in večdisciplinarne zdravstvene ekipe in najverjetneje napredna specializirana medicinska oprema ali infrastruktura, kar običajno pomeni koncentracijo virov.
Healthcare providers who apply for membership of a Network should demonstrate that they fulfil the criteria and conditions laid down in this Decision.
Izvajalci zdravstvenega varstva, ki zaprosijo za članstvo v mreži, bi morali dokazati, da izpolnjujejo merila in pogoje, navedene v tem sklepu.
These criteria and conditions should guarantee that the services and healthcare are provided according to the highest possible quality criteria and available clinical evidence.
Ta merila in pogoji bi morali zagotoviti, da se storitve in zdravstveno varstvo izvajajo v skladu z najvišjimi možnimi merili kakovosti in kliničnimi dokazi, ki so na voljo.
The required criteria and conditions for a healthcare provider would vary depending on the diseases or conditions specifically addressed by the Network of which they want to become a Member.
Zahtevana merila in pogoji, ki naj bi jih izpolnjeval izvajalec zdravstvenega varstva, bi bili odvisni od bolezni ali stanj, ki jih posebej obravnava mreža, katere člani želijo postati.
It therefore appears necessary to establish two sets of criteria and conditions: a first set of horizontal criteria and conditions that should be fulfilled by all healthcare providers wishing to join a Network, regardless of the field of expertise or the medical procedure or treatment they perform, and a second set of criteria and conditions that may vary depending on the scope of the concrete area of expertise, disease or condition addressed by the Network they wish to join.
Zato se zdi potrebno vzpostaviti dva niza meril in pogojev, in sicer prvi niz horizontalnih meril in pogojev, ki bi jih morali izpolnjevati vsi izvajalci zdravstvenega varstva, ki se želijo pridružiti mreži, ne glede na strokovno področje ali medicinski postopek ali zdravljenje, ki ga izvajajo, in drugi niz meril in pogojev, ki se lahko razlikujejo glede na obseg konkretnega strokovnega področja, bolezen ali stanje, ki jih obravnava mreža, ki se ji želijo pridružiti.
Among the first set of horizontal and structural criteria and conditions, those related to patients empowerment and patient-centred care; organisation, management and business continuity; research and training capacity appear to be essential in order to ensure that the objectives of the Networks are met.
V okviru prvega niza horizontalnih in strukturnih meril in pogojev se zdi, da so tisti, povezani s krepitvijo vloge pacientov in v pacienta usmerjene oskrbe, organizacijo, upravljanjem in neprekinjenim poslovanjem, raziskavami in zmogljivostmi v zvezi z usposabljanjem, bistvenega pomena za zagotovitev izpolnjevanja ciljev mrež.
Further horizontal and structural criteria and conditions related to the exchange of expertise, information systems and eHealth tools should help developing, sharing and spreading information and knowledge and fostering improvements in the diagnosis and treatment of diseases within and outside the Networks and to collaborate closely with other centres of expertise and networks at national and international level.
Nadaljnja horizontalna in strukturna merila in pogoji v zvezi z izmenjavo strokovnega znanja, informacijskimi sistemi in orodji e-zdravja bi morala pomagati pri razvoju, izmenjavi in širjenju informacij in znanja ter podpiranju izboljšav na področju diagnosticiranja in zdravljenja bolezni v okviru mrež in zunaj njih ter prispevati k tesnemu sodelovanju z drugimi strokovnimi centri in mrežami na nacionalni in mednarodni ravni.
Interoperable and semantically compatible information and communication technology (ICT) systems would facilitate the exchange of health data and patients' information, and the establishment and maintenance of shared databases and registries.
Interoperabilni in pomensko združljivi sistemi informacijske in komunikacijske tehnologije (IKT) bi pospeševali izmenjavo zdravstvenih podatkov in podatkov o pacientih ter vzpostavitev in vzdrževanje skupnih zbirk podatkov in registrov.
The ability to have an efficient and secure exchange of health data and other patient information as well personal data of the healthcare professionals in charge of the patient is a crucial aspect for the successful functioning of the Networks.
Zmožnost učinkovite in varne izmenjave zdravstvenih podatkov in drugih podatkov o pacientih ter tudi osebnih podatkov o zdravstvenih delavcih, odgovornih za pacienta, je ključen vidik za uspešno delovanje mrež.
The exchange of data should in particular take place in accordance with the specified purposes, necessity and legal grounds for the processing of data and be accompanied by appropriate safeguards and rights of the data subject.
Izmenjava podatkov bi morala potekati zlasti v skladu z določenimi nameni, potrebami in pravnim ozadjem pri obdelavi podatkov, pri čemer bi se morali izvajati ustrezni zaščitni ukrepi in upoštevati pravice posameznika.
Personal data should be processed in compliance with Directive 95/46/EC of the European Parliament and of the Council [3].
Osebne podatke bi bilo treba obdelati v skladu z Direktivo 95/46/ES Evropskega parlamenta in Sveta [3].
This Decision respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, as referred to in Article 6 of the Treaty on European Union and notably the right of human dignity, the right to the integrity of the person, the right to the protection of personal data and the right of access to healthcare.
V tem sklepu so upoštevani temeljne pravice in načela, priznani zlasti z Listino Evropske unije o temeljnih pravicah, kot je navedeno v členu 6 Pogodbe o Evropski uniji, in zlasti pravica do človekovega dostojanstva, pravica do osebne celovitosti, pravica do varstva osebnih podatkov in pravica do zdravstvenega varstva.
This Decision must be applied by the Member States in accordance with the rights and principles guaranteed in the Charter.
Ta sklep morajo države članice uporabljati v skladu s pravicami in načeli, ki jih zagotavlja Listina.
In particular, the Charter requires that in the field of biology and medicine the free and informed consent of the person concerned must be respected.
V Listini se zlasti zahteva, da je treba na področju biologije in medicine spoštovati svobodno privolitev po predhodni seznanitvi prizadete osebe.
As Clinical Trials could likely be one of the areas of work of the Networks it is important to recall that an extensive set of rules for the protection of subjects in clinical trials is foreseen in Directive 2001/20/EC of the European Parliament and of the Council [4].
Ker bi klinična preskušanja verjetno lahko bila eno izmed področij dela mrež, je pomembno opozoriti, da je v Direktivi 2001/20/ES Evropskega parlamenta in Sveta [4] predviden obsežen niz pravil za varstvo posameznikov pri kliničnih preskušanjih.
In order to ensure the exchange of personal data in the context of the Networks, procedures concerning informed consent for processing this data could be simplified by using one single common consent model that needs to be subject to the requirements set out in Directive 95/46/EC with regard to the consent of the data subject.
Da bi se zagotovila izmenjava osebnih podatkov v okviru mrež, bi bili lahko postopki v zvezi s svobodno privolitvijo po predhodni seznanitvi pri obdelavi teh podatkov poenostavljeni z uporabo enega samega modela privolitve, ki mora biti v skladu z zahtevami iz Direktive 95/46/ES glede privolitve posameznika, na katerega se nanašajo osebni podatki.
The criteria and conditions related to expertise, clinical practice, quality, patient safety and evaluation should help in developing and spreading the best practices for quality and safety benchmarks.
Merila in pogoji v zvezi s strokovnim znanjem, klinično prakso, kakovostjo, varnostjo pacientov in ocenjevanjem bi morala pomagati pri razvoju in širjenju najboljših praks na področju meril kakovosti in varnosti.
They should also thus ensure the offer of a high level of expertise, produce good practice guidelines, implement outcome measures and quality control and follow a multi-disciplinary approach as required by Article 12(4) of Directive 2011/24/EU.
Prav tako naj bi torej zagotovila ponudbo strokovnega znanja na visoki ravni, pripravo smernic o dobrih praksah, izvajanje merjenja izidov in nadzora kakovosti ter izvajanje večdisciplinarnega pristopa, kot je zahtevano v členu 12(4) Direktive 2011/24/EU.
Member States with no Member of a given Network may decide to designate healthcare providers with a special link to a given Network, following a transparent and explicit procedure.
Države članice, ki nimajo člana v določeni mreži, se lahko odločijo imenovati izvajalce zdravstvenega varstva s posebno povezavo z določeno mrežo v skladu s preglednim in natančnim postopkom.
Those providers might be designated as Associated National Centres focusing in the provision of healthcare or as Collaborative National Centres focusing in the production of knowledge and tools to improve the quality of care.
Te izvajalce lahko imenujejo za povezane nacionalne centre, ki se osredotočajo na izvajanje zdravstvenega varstva, ali za sodelujoče nacionalne centre, ki se osredotočajo na pridobivanje znanja in orodij za izboljšanje kakovosti oskrbe.
Member States may also wish to designate a national coordination hub with all types of Networks.
Države članice lahko imenujejo tudi nacionalno koordinacijsko središče z vsemi vrstami mrež.
That might help Member States to pursue Article 12(3)(a) of Directive 2011/24/EU particularly if the objectives of the Network are among those listed under Article 12(2)(f) and (h) of Directive 2011/24/EU.
To bi lahko pomagalo državam članicam, da uresničijo zahteve iz člena 12(3)(a) Direktive 2011/24/EU, zlasti če so cilji mreže med tistimi s seznama v členu 12(2)(f) in (h) Direktive 2011/24/EU.
The Coordinator should facilitate the cooperation with these healthcare providers linked to a Network.
Koordinator bi moral pospeševati sodelovanje s temi izvajalci zdravstvenega varstva, ki so povezani z mrežo.
Those healthcare providers shall support the objectives and respect the rules of the Network and share the work related with the cooperation activities of the Network,
Navedeni izvajalci zdravstvenega varstva naj bi podpirali cilje in spoštovali pravila mreže ter si delili delo v zvezi s sodelovanjem mreže –
This Decision lays down:
Ta sklep določa:
the criteria and conditions that the Networks referred to in Article 12 of Directive 2011/24/EU must fulfil; and
merila in pogoje, ki jih morajo izpolnjevati mreže, navedene v členu 12 Direktive 2011/24/EU, in
the criteria and conditions required from healthcare providers wishing to join a Network referred to in Article 12 of Directive 2011/24/EU.
merila in pogoje, ki jih morajo izpolnjevati izvajalci zdravstvenega varstva, ki se želijo pridružiti mreži, navedene v členu 12 Direktive 2011/24/EU.
For the purpose of this Decision and in addition to the definitions laid down in Article 3 of Directive 2011/24/EU the following definitions shall apply:
V tem sklepu se poleg opredelitev pojmov iz člena 3 Direktive 2011/24/EU uporabljajo naslednje opredelitve:
‘Member of a Network’ means healthcare providers that are in compliance with the list of criteria and conditions laid down in Article 5 of this Decision and have been awarded with the membership of a given Network;
„član mreže“ pomeni vsakega izvajalca zdravstvenega varstva, ki izpolnjuje merila in pogoje s seznama v členu 5 tega sklepa in mu je bilo dodeljeno članstvo v določeni mreži;
‘Highly specialised healthcare’ means healthcare that involves high complexity of a particular disease or condition in its diagnosis or treatment or management and high cost of the treatment and resources involved;
„visokospecializirano zdravstveno varstvo“ pomeni zdravstveno varstvo, ki se nanaša na diagnosticiranje, zdravljenje ali obravnavanje precej zapletene oblike določene bolezni ali stanja ter vključuje visoke stroške zdravljenja ter uporabljenih virov;
Complex disease or condition' means a particular disease or disorder which combines a number of factors, symptoms, or signs that requires a multidisciplinary approach and well-planned organisation of services over time because it implies one or several of the following circumstances:
„zapletena bolezen ali stanje“ pomeni posebno bolezen ali motnjo, pri kateri gre za kombinacijo številnih dejavnikov, simptomov ali znakov, ki zahtevajo večdisciplinarni pristop in dobro načrtovano organizacijo storitev v daljšem časovnem obdobju, saj to pomeni eno ali več od naslednjih okoliščin:
a large number of possible diagnoses or management options and comorbidity,
veliko število možnih diagnoz ali možnosti obravnavanja in sočasnih obolenj,
difficult interpretation of clinical and diagnostic tests data,
težavno razlago podatkov iz kliničnih in diagnostičnih preskusov,
a high risk of complications, morbidity, or mortality related to either the problem, the diagnostic procedure or the management;
visoko tveganje zapletov, obolenj ali umrljivosti, povezanih s problemom, diagnostičnim postopkom ali obravnavanjem;
‘Multidisciplinary healthcare team’ means a group of health professionals from several fields of healthcare, combining skills and resources, each providing specific services and collaborating on the same case and coordinating the healthcare to be provided to the patient;
„večdisciplinarna zdravstvena ekipa“ pomeni skupino zdravstvenih delavcev z različnih področij zdravstvenega varstva, ki združuje sposobnosti in vire, pri čemer vsak izvaja določene posebne storitve in sodeluje pri istem primeru ter se usklajuje pri zagotavljanju zdravstvenega varstva pacientu;
‘Informed consent under the framework of European Reference Networks’ means any freely-given, specific, informed and explicit indication of a subject's wishes by which he or she, either by a statement or by a clear affirmative action, signifies agreement to the exchange of her or his personal and health data between healthcare providers and Members of a European Reference Network as provided in this Delegated Decision.
„svobodna privolitev po predhodni seznanitvi v okviru evropske referenčne mreže“ pomeni vsako prostovoljno podano, konkretno in izrecno navedbo želja po predhodni seznanitvi osebe, na podlagi katere z izjavo ali z jasnim pritrdilnim dejanjem ta izrazi soglasje za izmenjavo svojih osebnih in zdravstvenih podatkov med izvajalci zdravstvenega varstva in člani evropske referenčne mreže, kot je predvideno v tem delegiranem sklepu.
EUROPEAN REFERENCE NETWORKS
EVROPSKE REFERENČNE MREŽE
Criteria and conditions for Networks
Merila in pogoji, ki jih morajo izpolnjevati mreže
Networks shall fulfil the criteria and conditions necessary to enable them pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU set out in Annex I.
Mreže izpolnjujejo merila in pogoje, ki so potrebni, da lahko uresničijo ustrezne cilje iz člena 12(2) Direktive 2011/24/EU, navedene v Prilogi I.
Membership of the Networks
Članstvo v mrežah
Networks shall be composed of healthcare providers identified as Members of the Network.
Mreže sestavljajo izvajalci zdravstvenega varstva, ki so opredeljeni kot člani mreže.
For each network, one Member will act as Coordinator.
V okviru vsake mreže bo en član deloval kot koordinator.
HEALTHCARE PROVIDERS
IZVAJALCI ZDRAVSTVENEGA VARSTVA
Criteria and conditions for applicants of membership of a Network
Merila in pogoji, ki jih morajo izpolnjevati kandidati za članstvo v mreži
All applicants wishing to join a given Network must have knowledge and expertise or offer a diagnosis or a treatment that focusses on a disease or condition falling within the field of specialisation of the Network and shall fulfil the criteria and conditions set out in Annex II.
Vsi kandidati, ki se želijo pridružiti določeni mreži, morajo imeti znanje in izkušnje ali izvajati diagnosticiranje ali zdravljenje, ki je osredotočeno na bolezni ali stanja, ki spadajo na področje specializacije mreže, in izpolnjujejo merila in pogoje iz Priloge II.
This Decision shall enter into force on the 10th day following that of its publication in the Official Journal of the European Union.
Ta sklep začne veljati 10. dan po objavi v Uradnem listu Evropske unije.
OJ L 88, 4.4.2011, p. 45.
UL L 88, 4.4.2011, str. 45.
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
PRILOGA I
ANNEX I
MERILA IN POGOJI, KI JIH MORAJO IZPOLNJEVATI MREŽE
CRITERIA AND CONDITIONS TO BE FULFILLED BY THE NETWORKS
Da bi mreže uresničile cilje iz člena 12(2) Direktive 2011/24/EU, vsaka izmed njih:
In order to enable Networks pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU, each Network shall:
izvaja visokospecializirano zdravstveno varstvo za zapletene bolezni ali stanja z redko ali nizko stopnjo razširjenosti;
provide highly specialised healthcare for rare or low prevalence complex diseases or conditions;
ima jasno strukturo upravljanja in usklajevanja, ki vključuje vsaj naslednje:
have a clear governance and coordination structure including at least the following:
predstavnike članov, ki jih bodo zastopali v mreži.
the Members' Representatives who will represent them within the Network Each Member shall choose its representative from among the health professionals belonging to its staff;
Vsak član izbere svojega predstavnika izmed zdravstvenih delavcev, ki so del njegovega osebja;
the Board of the Network that will be responsible for its governance.
odbor mreže, ki bo odgovoren za upravljanje mreže.
All Members of the Network must be represented on the Board;
V odboru morajo biti zastopani vsi člani mreže;
the Coordinator of the Network, chosen from among the health professionals belonging to the staff of the coordinating Member, who will chair the meetings of the Board and represent the Network.
koordinatorja mreže, izbranega izmed zdravstvenih delavcev, ki so del osebja člana koordinatorja, ki bo predsedoval sejam odbora in zastopal mrežo.
To fulfil the requirement set out in point (i) of Article 12(4)(a) of Directive 2011/24/EU (‘have knowledge and expertise to diagnose, follow up and manage patients with evidence of good outcomes’), the Networks must:
Za izpolnjevanje zahteve iz točke (i) člena 12(4)(a) Direktive 2011/24/EU („imajo znanje in strokovne izkušnje, da lahko, kolikor je to izvedljivo, z dokazi o dobrih rezultatih postavljajo diagnozo, spremljajo in obravnavajo paciente“) morajo mreže:
promote good quality and safe care to patients suffering from certain diseases and conditions by fostering proper diagnosis, treatment, follow-up and management of patients across the Network;
spodbujati kakovostno in varno oskrbo pacientov z določenimi boleznimi in stanji, in sicer s podpiranjem pravilnega diagnosticiranja, zdravljenja, spremljanja ter obravnavanja pacientov v okviru mreže;
empower and involve patients in order to improve the safety and good quality of the care they receive.
krepiti vlogo pacientov in njihovo vključevanje, da bi izboljšale varnost in kakovost prejete oskrbe.