natgillin/translations-raw huggingface dataset:
Namen evropskih referenčnih mrež je:
The objective of European reference networks shall be:
(a) uresničevati potencial evropskega sodelovanja na področju visoko-specializiranega zdravstvenega varstva za paciente in sisteme zdravstvenega varstva z izkoriščanjem inovacij na področju medicine in zdravstvene tehnologije;
(a) realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;
(a) pomagati uresničevati potencial evropskega sodelovanja na področju visokospecializiranega zdravstvenega varstva za paciente in sisteme zdravstvenega varstva z izkoriščanjem inovacij na področju medicine in zdravstvene tehnologije;
(a) to help realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;
(aa) prispevati k zbiranju znanja glede preprečevanja obolevanja in glede zdravljenja najpogostejših obolenj;
( aa ) to contribute to the pooling of knowledge regarding sickness prevention and the treatment of major commonly occurring disorders;
(b) olajševati izboljšave pri diagnozi in izvajanju visoko kakovostnega in stroškovno učinkovitega zdravstvenega varstva za vse paciente, katerih zdravstveno stanje zahteva posebno združevanje strokovnega znanja;
(b ) facilitate improvements in diagnosis and the delivery of high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise;
(b) pomagati pri uveljavljanju dostopa in olajševati izboljšave pri diagnozi in izvajanju visokokakovostnega in stroškovno učinkovitega zdravstvenega varstva za vse paciente, katerih zdravstveno stanje zahteva posebno združevanje strokovnega znanja;
(b) to help promote access and facilitate improvements in diagnosis and the delivery of high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise;
(c) zagotavljati najbolj stroškovno učinkovito uporabo virov;
(c) maximise cost-effective use of resources;
(c) zagotavljati stroškovno najučinkovitejšo uporabo virov;
(c) to maximise cost-effective use of resources;
(d) spodbujati raziskave in epidemiološko spremljanje, na primer pri registrih, ter zagotoviti usposabljanje za zdravstvene delavce;
(d) reinforce research, epidemiological surveillance like registries and provide training for health professionals;
(d) spodbujati raziskave in epidemiološko spremljanje, na primer pri registrih, ter zagotoviti usposabljanje za zdravstvene delavce;
(d) to reinforce research, epidemiological surveillance like registries and provide training for health professionals;
(e) olajšati virtualno ali fizično razširjanje strokovnega znanja ter v okviru mrež in zunaj njih razvijati, izmenjavati in širiti informacije, znanje in najboljše prakse;
(e) facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice within and outside the networks;
(e) olajšati virtualno ali fizično razširjanje strokovnega znanja ter v okviru mrež in zunaj njih razvijati, izmenjavati in širiti informacije, znanje in najboljše prakse , zlasti pa spodbujati razvoj diagnosticiranja redkih bolezni ;
(e) facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice and to foster developments of the diagnosis and treatment of rare diseases, within and outside the networks;
(ea) zagotoviti merila kakovosti in varnosti ter pomagati razvijati in širiti najboljšo prakso znotraj in zunaj mreže;
( ea ) to provide quality and safety benchmarks and to help develop and spread best practice within and outside the network;
(f) državam članicam, ki nimajo zadostnega števila pacientov s posebnim zdravstvenim stanjem ali nimajo tehnologije ali strokovnega znanja za zagotavljanje visoko specializiranih storitev.
(f) Member States that have an insufficient number of patients with a particular medical condition or that lack technology or expertise to provide highly specialised services.
(f) državam članicam ki nimajo zadostnega števila pacientov s posebnim zdravstvenim stanjem ali nimajo tehnologije ali strokovnega znanja, pomagati zagotoviti celoten obseg visokospecializiranih storitev najvišje kakovosti;
(f) to help Member States that have an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide a full range of highly specialised services of the highest quality ;
(fa) uvesti instrumente, ki bodo omogočili, da se bodo kar najbolje izkoristile možnosti obstoječega zdravstvenega varstva v primeru nesreč, zlasti na obmejnih območjih.
( fa ) to implement instruments which enable the best possible use to be made of existing healthcare resources in the event of serious accidents, particularly in cross-border areas.
(Stališče EP– člen 17(2))
(EP position Article 17(2))
PS 103 in 104 iz prve obravnave
1st reading - AM 103+104
Države članice se spodbuja, da olajšajo razvoj evropskih referenčnih mrež tako, da:
Member States are encouraged to facilitate the development of the European reference networks:
Komisija v sodelovanju z državami članicami pomaga pri razvoju evropskih referenčnih mrež, tako da:
In order to facilitate the development of the European reference networks , the Commission, in collaboration with the Member States , shall :
(a) na svojem ozemlju opredelijo ustrezne izvajalce zdravstvenega varstva in strokovne centre;
(a) by identifying appropriate healthcare providers and centres of expertise throughout their national territory;
(a) na njihovem ozemlju opredeli ustrezne izvajalce zdravstvenega varstva in strokovne centre;
(a) identify appropriate healthcare providers and centres of expertise throughout their national territory ;
(b) spodbujajo sodelovanje izvajalcev zdravstvenega varstva in strokovnih centrov v evropskih referenčnih mrežah.
(b) by fostering the participation of healthcare providers and centres of expertise in the European reference networks.
(b) spodbuja sodelovanje izvajalcev zdravstvenega varstva in strokovnih centrov v evropskih referenčnih mrežah.
(b) foster the participation of healthcare providers and centres of expertise in the European reference networks.
Za namene odstavka 1 Komisija :
For the purposes of paragraph 1, the Commission shall:
Komisija v sodelovanju z zadevnimi strokovnjaki in zainteresiranimi stranmi za namene odstavka 1:
For the purposes of paragraph 1, the Commission , in collaboration with relevant experts and stakeholders , shall:
(a) oblikuje in objavi merila in pogoje, ki bi jih evropske referenčne mreže morale izpolnjevati , da bi prejele podporo Komisije ;
(a) develop and publish criteria and conditions that the European reference networks should fulfil in order to receive support from the Commission
(a) sprejme seznam posebnih meril in pogojev , ki jih morajo izpolnjevati evropske referenčne mreže , vključno s seznamom redkejših bolezni, ki jih je treba zajeti, in pogoji in merili, ki jih morajo izpolnjevati izvajalci zdravstvenega varstva, ki se želijo pridružiti evropskim referenčnim mrežam, zlasti za zagotovitev, da evropske referenčne mreže :
(a) adopt a list of specific criteria and conditions that the European reference networks must fulfil , including also a list of rarer disease areas to be covered and the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks:
(i) imajo ustrezne zmogljivosti, da lahko po potrebi postavijo diagnozo, spremljajo in vodijo dosjeje pacientov z dokazi o dobrih rezultatih;
(i) have appropriate capacities to diagnose, to follow-up and manage patients with evidence of good outcomes so far as applicable;
(ii) imajo zadostne zmogljivosti in dejavnosti za zagotavljanje ustreznih storitev in ohranjanje kakovosti storitev;
(ii) have sufficient capacity and activity to provide relevant services and maintain the quality of the services provided;
(iii) imajo zmogljivosti za zagotavljanje strokovnih nasvetov, diagnoze ali potrjevanje diagnoze, oblikovanje in izpolnjevanje smernic za dobro prakso ter izvajanje ukrepov in nadzor kakovosti;
(iii) have capacity to provide expert advice, diagnosis or confirmation of diagnosis, to produce and adhere to good practice guidelines and to implement outcome measures and quality control;
(iv) lahko izvajajo multidisciplinarni pristop;
(iv) can demonstrate a multi-disciplinary approach;
(v) zagotovijo visoko raven strokovnega znanja in izkušenj s pomočjo publikacij, štipendij ali častnih nazivov, poučevanja in usposabljanja;
(v) provide a high level of expertise and experience documented through publications, grants or honorific positions, teaching and training activities;
(vi) pomembno prispevajo k raziskavam;
(vi) provide a strong contribution to research;
(vii) sodelujejo pri epidemiološkem spremljanju, na primer z registri;
(vii) are involved in epidemiological surveillance, such as registries;
(viii) imajo tesne stike in sodelujejo z drugimi strokovnimi središči in mrežami na nacionalni in mednarodni ravni ter zmogljivost povezovanja v mreže;
(viii) have close links and collaboration with other expert centres and networks at national and international level and capacity to network;
(ix) vzdržujejo tesne stike in sodelujejo z združenji pacientov, če obstajajo;
(ix) have close links and collaboration with patients associations where such associations exist;
(x) vzdržujejo ustrezen in učinkovit odnos s ponudniki tehnologij;
(x) have appropriate and effective relationships with technology providers.
(b) oblikuje in objavi merila za ocenjevanje evropskih referenčnih mrež;
(b) develop and publish criteria for evaluating European reference networks;
(b) oblikuje , sprejme in objavi postopke za določanje in ocenjevanje evropskih referenčnih mrež;
(b) develop, adopt and publish the procedures for establishing and evaluating European reference networks;
(c) olajša izmenjavo informacij in strokovnega znanja v zvezi z vzpostavitvijo evropskih referenčnih mrež in oceno o njih.
(c) facilitate the exchange of information and expertise in relation to the establishment of European reference networks and the evaluation of them.
ca) deloma financira vzpostavitev teh mrež.
c a) part-finance the establishment of the said networks.
(Stališče EP– člen 17(3))
(EP position Article 17(3))
PS 106 in 107 iz prve obravnave: Komisija bi morala pomagati financirati vzpostavljanje teh mrež.
1st reading - AM 106 and 107 The Commission should help finance the establishment of the networks in question.
Merila in pogoji iz odstavka 4 se sprejmejo v skladu z regulativnim postopkom iz člena 15(2).
The criteria and conditions referred to in paragraph 4 shall be adopted in accordance with the regulatory procedure referred to in Article 15(2).
Komisija sprejema ukrepe iz odstavka 4 z delegiranimi akti ter v skladu s členom 16 in pod pogoji iz členov 17 in 18.
The Commission shall adopt, by means of delegated acts in accordance with Article 16 and subject to the conditions of Article 17 and 18, the measures referred to in paragraph 4.
Z ukrepi, sprejetimi v skladu s tem členom, se ne usklajujejo zakoni ali predpisi držav članic in se v celoti spoštujejo odgovornosti držav članic pri organizaciji in opravljanju zdravstvenih storitev in zdravstvene oskrbe.
Measures adopted pursuant to this Article shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.
Komisija podpira države članice pri doseganju trajnostnih gospodarskih in družbenih koristi evropskih sistemov in storitev ter interoperabilnih aplikacij E-zdravja, z namenom, da se doseže visoka raven zaupanja in varnosti, izboljša stalnost oskrbe ter zagotovi dostop do varnega in kakovostnega zdravstvenega varstva .
The Commission shall support the Member States towards delivering sustainable economic and social benefits of European e-health systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and quality healthcare.
Komisija v skladu s postopkom iz člena 15(2) sprejme posebne ukrepe, ki so potrebni za doseganje medobratovalnosti sistemov informacijske in komunikacijske tehnologije na področju zdravstvenega varstva, ki se uporabljajo, če se države članice odločijo, da jo bodo uvedle .
The Commission shall , in accordance with the procedure referred to in Article 15(2) , adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them.
Navedeni ukrepi so v skladu z zakonodajo, ki se uporablja za varstvo podatkov v posamezni državi članici, in odražajo razvoj na področju zdravstvene tehnologije in medicine, tudi telemedicine in telepsihiatrije, ter upoštevajo temeljno pravico do varstva osebnih podatkov.
Those measures shall conform to the applicable data protection laws in each Member State and shall also reflect developments in health technologies and medical science, including telemedicine and telepsychiatry, and respect the fundamental right to the protection of personal data.
Zlasti opredelijo potrebne standarde in terminologijo za medobratovalnost zadevnih sistemov informacijske in komunikacijske tehnologije, da se zagotovi varno, visokokakovostno in učinkovito izvajanje čezmejnih zdravstvenih storitev.
They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high-quality, accessible and efficient provision of cross-border health services.
Države članice zagotovijo, da se pri uporabi e-zdravstva in drugih storitev telemedicine:
The Member States shall ensure that the use of e-Health and other telemedicine services:
(a) spoštujejo enaki kakovostni in varnostni standardi medicinske stroke, kot veljajo pri zagotavljanju neelektronskega zdravstvenega varstva;
(a) adhere to the same professional medical quality and safety standards as those in use for non-electronic healthcare provision;
(b) pacientom omogoča ustrezna zaščita, zlasti z uvedbo ustreznih regulativnih zahtev za zdravnike, ki so podobne zahtevam pri zagotavljanju neelektronskega zdravstvenega varstva.
(b) offer adequate protection to patients, notably through the introduction of appropriate regulatory requirements for health professionals similar to those in use for non-electronic healthcare provision.
(Stališče EP– člen 19)
(EP position Article 19)
Predlog spremembe 110 iz prve obravnave.
1st reading - AM 110
Člen 13 – odstavek 2 – točka a – točka i
Article 13 – paragraph 2 – point a – point i
(i) neizčrpen seznam podatkov, ki se vključijo v povzetke o pacientih in ki si jih lahko izmenjujejo zdravstveni delavci, da bi tako zagotovili stalnost čezmejne oskrbe in varnosti pacientov; ter
(i) a non-exhaustive list of data that are to be included in patients' summaries and that can be shared between health professionals to enable continuity of care and patient safety across borders, and
(i) neizčrpen seznam podatkov, ki se vključijo v elektronske zdravstvene kartone in ki si jih lahko izmenjujejo zdravstveni delavci, da bi tako zagotovili stalnost čezmejne oskrbe in varnosti pacientov; ter
(i) a non-exhaustive list of data that are to be included in Electronic Health Records and that can be shared between health professionals to enable continuity of care and patient safety across borders, and
Člen 13 – odstavek 2 – točka b
Article 13 – paragraph 2 – point b
(b) podpira države članice pri oblikovanju skupnih ukrepov za identifikacijo in ugotavljanje avtentičnosti, na podlagi katerih se spodbudi prenosljivost podatkov v čezmejnem zdravstvenem varstvu.
(b) support the Member States in developing common identification and authentication measures to facilitate transferability of data in cross-border healthcare.
(b) sprejme ukrepe za identifikacijo in ugotavljanje avtentičnosti, na podlagi katerih se zagotovi prenosljivost podatkov v čezmejnem zdravstvenem varstvu ter visoka raven varstva in zaščite osebnih podatkov .
(b) adopt identification and authentication measures to ensure transferability of data in cross-border healthcare while guaranteeing a high level of security and the protection of personal data .
Ti ukrepi se sprejmejo v skladu z regulativnim postopkom iz člena 15(2).
These measures shall be adopted in accordance with the regulatory procedure referred to in Article 15 (2) .
Člen 13 – odstavek 2 – pododstavek 1 a (novo)
Article 13 – paragraph 2 – subparagraph 1 a (new)
Ukrepi iz točk (a) in (b) se začnejo pripravljati najkasneje dve leti po začetku veljavnosti direktive.
Work on the measures referred to in points (a) and (b) shall start no later than two years after entry into force the Directive.
Unija podpira in olajšuje sodelovanje in izmenjavo znanstvenih informacij med državami članicami v okviru prostovoljne mreže, ki povezuje nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije, ki jih imenujejo države članice.
The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States.
Člani mreže sodelujejo pri dejavnostih mreže ter prispevajo k njim v skladu z zakonodajo države članice, v kateri imajo svoj sedež.
The members of the network shall participate in, and contribute to, the network's activities in accordance with the legislation of the Member State where they are established.
Mreža temelji na načelih dobrega upravljanja, vključno s preglednostjo, objektivnostjo, strokovno neodvisnostjo, poštenimi postopki in širokim ter polnim sodelovanjem vseh zainteresiranih strani, tudi – vendar ne izključno – zdravstvenih delavcev, predstavnikov pacientov, socialnih partnerjev, znanstvenikov in industrije, ob upoštevanju pristojnosti držav članic na področju ocenjevanja zdravstvene tehnologije.
That network shall be based on the principles of good governance including transparency, objectivity, independence of expertise, fairness of procedures, and broad stakeholder participation from all relevant groups, including - but not limited to - health professionals, patients' representatives, social partners, scientists and industry, whilst respecting Member States' competence in the area of health technology assessment.
Imena strokovnjakov in posameznikov, ki sodelujejo pri dejavnostih mreže, morajo biti objavljena skupaj z njihovo izjavo o interesu.
Names of experts and individuals participating to the network's activities should be publicly available, together with their declaration of interest.
Cilja podpore Unije iz odstavka 1 sta:
The objectives of the Union support referred to in paragraph 1 shall be to:
Cilj ocenjevanja zdravstvene tehnologije je:
The objective s of the health technology assessment network shall be to :
(a) podpora državam članicam pri njihovem sodelovanju prek nacionalnih organov ali teles iz odstavka 1 ; ter
(a) support Member States in their cooperation through the national authorities or bodies referred to in paragraph 1; and
(a) podpora sodelovanju med nacionalnimi organi ali telesi ;
(a) support cooperation between national authorities or bodies;
(aa) iskanje trajnih načinov, kako uravnovesiti cilje dostopa do zdravil, nagrajevanja inovacij in upravljanja proračuna za zdravstveno varstvo;
(aa ) find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets;
(b) podpora državam članicam pri zagotavljanju objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih znanstvenih informacij o kratko- in dolgoročni učinkovitosti zdravstvene tehnologije ter omogočanje učinkovite izmenjave teh informacij med nacionalnimi organi ali telesi.
(b) support Member States in the provision of objective, reliable, timely, transparent and transferable scientific information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between the national authorities or bodies.
(b) podpora državam članicam pri zagotavljanju objektivnih, zanesljivih, pravočasnih, preglednih , primerljivih in prenosljivih znanstvenih informacij o sorazmerni učinkovitosti v dejanskih pogojih uporabe ali izvajanja, pa tudi o kratko- in dolgoročni učinkovitosti zdravstvene tehnologije, ter omogočanje učinkovite izmenjave teh informacij med nacionalnimi organi ali telesi.
(b) support Member States in the provision of objective, reliable, timely, transparent , comparable and transferable scientific information on the relative efficacy as well as on the short- and long-term effectiveness when applicable, of health technologies, and to enable an effective exchange of this information between the national authorities or bodies.
(ba) preučitev narave in vrste informacij, ki se lahko izmenjujejo.
( b a ) analyse the nature and type of information that can be exchanged.
(bb) preprečitev podvajanja sklepov in ocen evropskih regulativnih organov, zlasti, ko se odločajo o varnosti, učinkovitosti, kakovosti in upravičenosti populacije pacientov;
(bb) avoid duplications of assessments made by the European regulatory bodies, particularly in so far as these bodies take decisions with regards to safety, efficacy, quality and eligible patient populations;
(Stališče EP– člen 20(2))
(EP position Article 20(2))
Države članice določijo organe ali telesa, ki sodelujejo v mreži, kot je določeno v odstavku 1, ter Komisiji sporočijo njihova imena in kontaktne podatke.
Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission the names and contact details of those authorities or bodies.
(Stališče EP– člen 20(3))
(EP position Article 20(3))
PS 135 iz prve obravnave
am 135 of first reading
Komisija v skladu z regulativnim postopkom iz člena 15(2) sprejme potrebne ukrepe za vzpostavitev, upravljanje in preglednost te mreže.
The Commission shall, in accordance with the regulatory pro cedure referred to in Article 15 (2), adopt the necessary measures for the establishment, management and transparent functioning of th at network.
(Stališče EP– člen 20(4))
(EP position Article 20(4))
Komisija dovoli sodelovanje v mreži le organom, ki izpolnjujejo načela dobrega upravljanja, kot je določeno v odstavku 1.
The Commission shall only allow such authorities to join the network which fulfil the principles of good governance as defined in paragraph 1.
(Stališče EP– člen 20(5))
(EP position Article 20(5))
Ukrepi, sprejeti v skladu s tem členom, ne vplivajo na pristojnosti držav članic za odločitve o izvajanju ugotovitev ocenjevanja zdravstvene tehnologije, z njimi se tudi ne usklajujejo zakoni ali predpisi držav članic in se v celoti upoštevajo pristojnosti držav članic pri organizaciji in izvajanju zdravstvenih storitev in zdravstvene oskrbe.
Measures adopted pursuant to this Article shall not interfere with Member States' competences in deciding on the implementation of health technology assessment conclusions and shall not harmonise any laws or regulations of the Member States and shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.
Pri tem Komisija zagotovi ustrezno posvetovanje s strokovnjaki iz zadevnih skupin pacientov in zdravstvenih delavcev ter socialnimi partnerji, zlasti v okviru izvajanja te direktive.
In that process, the Commission shall ensure the consultation of experts from the relevant patient and professional groups, as well as the social partners, in an appropriate manner, especially in the context of the implementation of this Directive