natgillin/translations-raw huggingface dataset:
(a) 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 storitev zdravstvenega varstva, ki se želijo pridružiti evropskim referenčnim mrežam, zlasti za zagotovitev, da evropske referenčne mreže:
(a) 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:
Člen 15 – odstavek 3 – točka a – točka ix a (novo)
Article 15 – paragraph 3 – point a – point ix a (new)
(ixa) imajo ustrezen in učinkovit odnos s ponudniki tehnologij.
(ixa) have appropriate and effective relationships with technology providers.
Poskusna območja
Trial areas
Komisija lahko v sodelovanju z državami članicami določi obmejna območja kot poskusna območja, kjer se lahko inovativne pobude glede čezmejnega zdravstvenega varstva temeljito preskusijo, analizirajo in ovrednotijo.
The Commission, in cooperation with the Member States, may designate border regions as trial areas in which innovative cross-border healthcare initiatives can be tested, analysed and evaluated.
Komisija v skladu s postopkom iz člena 19(2) sprejme posebne ukrepe, ki so potrebni za doseganje medobratovalnosti sistemov informacijske in komunikacijske tehnologije na področju zdravstvenega varstva, ki se uporabljajo, kadar se države članice odločijo, da jo bodo uvedle.
The Commission shall, in accordance with the procedure referred to in Article 19(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 odražajo razvoj na področju zdravstvene tehnologije in medicine ter upoštevajo temeljno pravico do varstva osebnih podatkov v skladu z zakonodajo, ki se uporablja .
Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law .
Zlasti opredelijo potrebne standarde in terminologijo za medobratovalnost zadevnih sistemov informacijske in komunikacijske tehnologije, da se zagotovi varno, visoko kakovostno 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 and efficient provision of cross-border health services.
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.
Države članice zagotovijo, da uporaba e-zdravstva in drugih storitev telemedicine:
The Member States shall ensure that the use of e-Health and other telemedicine services:
(a) spoštuje enake kakovostne in varnostne standarde medicinske stroke, kot veljajo pri nudenju 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 ustrezno zaščito, zlasti z uvedbo ustreznih regulativnih zahtev za zdravnike, ki so podobne zahtevam pri nudenju neelektronskega zdravstvenega varstva.
(b) offer adequate protection to patients, notably through the introduction of appropriate regulatory requirements for practitioners similar to those in use for non-electronic healthcare provision.
Ta nova tehnologija omogoča napredek, vendar bi lahko privedla tudi k zlorabi informacijskih in komunikacijskih tehnologij v zdravstvu, kar bi bilo nevarno za paciente.
This new technology provides not only progress but could also lead to potential misuse of information and communication technologies in healthcare, with associated potential risks to patients.
Zato je treba uporabiti enako raven zagotovil za kakovost in varnost, kot je zagotovljena za standardno zdravstveno nego.
Therefore, the same level of guarantee, in terms of quality and safety, must be applied to these services as compared to “standard” medical acts.
Sodelovanje pri upravljanju nove zdravstvene tehnologije
Cooperation on management of new health technologies
Države članice spodbujajo razvoj in delovanje mreže , ki povezuje nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije.
Member States shall facilitate development and functioning of a network connecting the national authorities or bodies responsible for health technology assessment.
Komisija ob posvetovanju s Parlamentom spodbudi ustanovitev mreže , ki bo povezovala nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije.
The Commission shall, in consultation with the European Parliament, facilitate the establishment of a network connecting the national authorities or bodies responsible for health technology assessment.
Mreža bo temeljila na načelih dobrega upravljanja, torej preglednosti, objektivnosti, poštenih postopkih in polnem sodelovanju vseh zadevnih skupin, razen v primerih, ko nacionalna zakonodaja onemogoča sodelovanje ene ali več teh skupin.
This network shall be based on the principles of good governance including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant groups, except in cases where national law precludes the participation of one or more of those groups.
Cilj ocenjevanja zdravstvene tehnologije je:
The objective of the health technology assessment network shall be:
Namen ocenjevanja zdravstvene tehnologije je:
The objective of the health technology assessment network shall be:
(a) podpiranje sodelovanja med nacionalnimi organi ali telesi;
(a) to support cooperation between national authorities or bodies;
(a) podpirati sodelovanje med nacionalnimi organi ali telesi;
(a) to support cooperation between national authorities or bodies;
(aa) iskati trajne načine, kako uravnovesiti cilje dostopa do zdravil, nagrajevanja inovacij in upravljanja proračuna za zdravstveno varstvo;
(aa) to find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets;
(b) podpiranje zagotavljanja objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih informacij o kratkoročni in dolgoročni učinkovitosti zdravstvene tehnologije ter omogočanje učinkovite izmenjave teh informacij med nacionalnimi organi ali telesi.
(b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies.
(b) podpirati zagotavljanje objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih informacij o kratkoročni in dolgoročni učinkovitosti zdravstvene tehnologije ter omogočati učinkovito izmenjavo teh informacij med nacionalnimi organi ali telesi.
(b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies.
(ba) preučiti naravo in vrsto informacij, ki se lahko izmenjujejo.
(ba) to analyse the nature and type of information that can be exchanged;
Države članice določijo organe ali telesa, ki sodelujejo v mreži, kot je določeno v odstavku 1, ter Komisiji sporočijo imena in kontaktne podatke navedenih organov ali teles.
Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies.
Države članice določijo organe ali telesa, ki sodelujejo v tej mreži, kot je določeno v odstavku 1, ter Komisiji sporočijo imena in kontaktne podatke navedenih organov ali teles.
Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies.
Komisija v skladu s postopkom iz člena 19(2) sprejme potrebne ukrepe za vzpostavitev in upravljanje te mreže ter opredelitev narave in vrste informacij za izmenjavo .
The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.
Komisija v skladu s postopkom iz člena 19(2) sprejme potrebne ukrepe za vzpostavitev , upravljanje in pregledno delovanje te mreže.
The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment , the management and the transparent functioning of this network.
Države članice zbirajo statistične in druge dodatne podatke, potrebne za spremljanje izvajanja čezmejnega zdravstvenega varstva, zagotovljene oskrbe, izvajalcev in pacientov, stroškov in rezultatov.
Member States shall collect statistical and other additional data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes.
Takšne podatke zbirajo kot del svojih splošnih sistemov za zbiranje zdravstvenih podatkov v skladu z nacionalnimi zakonodajami in zakonodajo Skupnosti za pripravo statistike in o varstvu osebnih podatkov.
They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data.
Države članice zbirajo statistične podatke, potrebne za spremljanje izvajanja čezmejnega zdravstvenega varstva, zagotovljene oskrbe, izvajalcev in pacientov, stroškov in rezultatov.
Member States shall collect statistical data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes.
Takšne podatke zbirajo kot del svojih splošnih sistemov za zbiranje zdravstvenih podatkov v skladu z nacionalnimi zakonodajami in zakonodajo Skupnosti za pripravo statistike in o varstvu osebnih podatkov , zlasti pa s členom 8(4) Direktive 95/46/ES .
They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data , and specifically Article 8(4) of Directive 95/46/EC .
Člen 8(4) Direktive 95/46 določa posebne zahteve glede naknadne uporabe zdravstvenih podatkov.
Article 8(4) of Directive 95/46 lays down specific requirements relating to subsequent use of health data.
Komisiji pomaga odbor, ki ga sestavljajo predstavniki držav članic in ki mu predseduje predstavnik Komisije.
The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative.
Pri tem Komisija zagotovi ustrezno posvetovanje s strokovnjaki iz zadevnih skupin pacientov in zdravstvenih delavcev, zlasti glede na izvajanje te direktive, in pripravi utemeljeno poročilo o tem.
In doing so, the Commission shall ensure the consultation of experts from the relevant patient and professional groups in an appropriate manner especially in the context of the implementation of this Directive and shall provide a reasoned report on these consultations.
Izvajanje te direktive se lahko doseže le z vključitvijo vseh zainteresiranih strani.
The implementation of this directive can only be achieved through the involvement of all relevant parties.
Zato je treba pripraviti ustrezen mehanizem posvetovanja, ki bo odboru za čezmejno zdravstveno varstvo v pomoč.
Therefore, an appropriate mechanism of consultation should be set up in order to assist this “cross-border healthcare committee".
Pri sklicevanju na ta odstavek se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 navedenega sklepa.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 of that Decision.
Obdobje iz člena 5(6) Sklepa 1999/468/ES znaša 3 mesece.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months.
Če so izvedbeni ukrepi povezani z obdelavo osebnih podatkov, je potrebno posvetovanje z evropskim varuhom osebnih podatkov.
Where implementing measures relate to the processing of personal data the European Data Protection Supervisor may be consulted.
Kot je priporočeno v mnenju evropskega nadzornika za varstvo podatkov, se je treba pri teh vprašanjih posvetovati z njim.
As recommended in the EDPS opinion, it is important the EDPS is consulted on these matters.
Komisija v petih letih po datumu iz člena 22(1) pripravi poročilo o izvajanju te direktive ter ga predloži Evropskemu parlamentu in Svetu.
The Commission shall within five years after the date referred to in Article 22(1) draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council.
Komisija v petih letih po datumu iz člena 22(1) pripravi poročilo o izvajanju te direktive , skupaj s statistiko o odtekanju in pritekanju virov pacientov, ki izhajajo iz te direktive, ter ga predloži Evropskemu parlamentu in Svetu.
The Commission shall within five years after the date referred to in Article 22(1) draw up a report on the operation of this Directive , including statistics on patient outflows and inflows resulting from this Directive, and submit it to the European Parliament and to the Council.
(Še noben pesnik ni narave interpretiral tako svobodno kot pravnik resnico.)
(No poet ever interpreted nature as freely as a lawyer interprets the truth.)
Razsodnost in rahločutnost
Sense and Sensitivity
Pravniki ali politiki.
Lawyers or politicians.
Zadnjih deset let, odkar je leta 1998 Sodišče Evropskih skupnosti razsodilo v zadevah Kohll in Decker, so politiko o mobilnosti pacientov krojili evropski pravniki, ker se evropski politiki s tem niso ukvarjali.
For the past ten years, since the 1998 Kohll and Dekker judgement at the European Court of Justice (ECJ), the lawyers of Europe have been deciding policy on patient mobility, because the politicians of Europe have failed to do so.
Če ne bomo storili ničesar, bo Sodišče pravice s področja mobilnosti pacientov tudi v prihodnje tolmačilo na podlagi ustanovnih pogodb.
If we do nothing, the Court will continue to interpret the Treaties, where patient mobility rights are concerned.
Jasnost, za katero nismo uspeli poskrbeti politiki, bosta zagotovili pogodbi.
They will provide the clarity that we politicians have failed to provide.
Če se zadovoljimo s tem, da oblikovanje politike prepustimo pravnikom, nam ni treba storiti ničesar – razen seveda plačati nastale nepredvidljive račune.
If we are content to leave policymaking to lawyers, then we need do nothing - except of course pay the resulting unpredictable bills.
Če pa verjamemo, da je delo nas izvoljenih politikov poskrbeti za pravno in politično gotovost, potem moramo to storiti nemudoma.
But if we believe it is our job, as elected politicians to give legal and policy certainty, then we should do so without further delay.
Zamisel o mobilnosti pacientov je kot možnost našim volivcem všeč, vendar želijo in pričakujejo, da bo ustrezno vodena, želijo in pričakujejo pa tudi dobre smernice za politiko in postopke.
Our electors like the idea of patient mobility as an option; but they want and expect it to be properly managed and they want and expect to be offered sound guidance on policy and procedures.
Pozdravljamo dolgo pričakovani predlog Komisije, ki je sledil poročilu Parlamenta o mobilnosti pacientov iz leta 2005 ( A6-0129/2005 ), sprejetemu z veliko večino, pa tudi domiselne določbe o evropskih referenčnih mrežah za redkejše bolezni, kar presega sodbe Sodišča Evropskih skupnosti.
The Commission’s long-awaited proposal, following the overwhelmingly majority in the Parliament for our Patient Mobility Report of 2005 ( A6-0129/2005 ), is welcome, including its imaginative provisions that go beyond the ECJ judgements on European Reference Networks for rarer diseases.
Vendar ostaja negotovost na nekaterih področjih, ki jih obravnava in skuša pojasniti to poročilo.
It does however leave some areas of uncertainty that this Report seeks to clarify and address.
Priložnost za paciente.
Opportunity for Patients.
Popolnoma jasno mora biti, da je to priložnost za paciente.
We should make it crystal clear that this is an opportunity for patients.
Predlog tudi jasno navaja, da ne spreminja poti socialne varnosti ali kakor koli posega vanje; te bodo veljale tudi v prihodnje, čeprav bi morda bilo treba razjasniti, kdaj se katera od njih uporablja.
Nor, as it makes clear, does this proposal amend or touch the Social Security route, which remains in place, although perhaps we need greater clarity as to when each would apply.
Prav tako bi moralo biti jasno, da ta priložnost za paciente izhaja iz njihovih potreb, ne finančnih sredstev, ter temelji na utemeljenih odločitvah, ne na prisili.
We should make it no less clear that it is an opportunity for patients, based on need and not means and on informed choice and not compulsion.
Sodbe Sodišča.
Court Judgements.
Jasno je tudi, da ne začenjamo iz nič in da sedaj ni čas za oblikovanje teoretičnih predlogov.
It is equally clear we are not starting with a clean sheet of paper; this is not a time for 'blue sky' drafting.
Pogodbi sta bili Sodišču Evropskih skupnosti pravna podlaga za sodbe in s tem je Sodišče ustvarilo osnutek politike.
The Treaties have provided the ECJ with the legal basis for its judgements and the Court has written its draft of consequent policy.
Začel se je proces, ki lahko pacientom omogoči večji vpliv in okrepi zdravje evropskih državljanov.
They have set in motion a process which has the potential to empower patients and enhance the health of Europe’s citizens.
Prvotno je Sodišče Evropskih skupnosti potrdilo, da imajo pacienti v primeru nepotrebnega odlašanja zdravljenja pravico, da gredo na zdravljenje v drugo državo članico in da račun poravna zdravstvena blagajna v domači državi, če sta izpolnjena dva pogoja: zdravljenje mora biti v domači državi običajno razpoložljivo in stroški morajo biti primerljivi.
In its original ECJ essence, this confirmed that patients, facing 'undue delay' for treatment, have the right to go to another Member State for treatment and have the bill paid by the home country’s health funder, so long as two conditions apply :- the treatment must normally be available in the home country and the cost must be comparable.
Sodišče Evropskih skupnosti je z vrsto sodb določilo, da se od pacienta ne sme zahtevati, da mora pridobiti predhodno dovoljenje za nebolnišnično zdravljenje ali druge zdravstvene ugodnosti, kot so na primer očala ali ortodontske storitve.
In a series of ECJ judgements it has been established that there can be no requirement on the patient to seek prior approval for non-hospital treatment or other health benefits, such as the original spectacles and orthodontics.
Dopušča pa možnost nekakšne predhodne odobritve ali priglasitve, ko gre za bolnišnično zdravljenje pacienta, če lahko domača država (država članica pacientovega zdravstvenega zavarovanja) dokaže, da bi brez tega trpelo upravljanje zdravstvenega varstva drugih pacientov.
It leaves open however the possibility of some form of prior authorisation or notification when in-patient hospital treatment is concerned, if the home country ('Member State of Affiliation') can show that, without it, the management of healthcare for other patients would suffer.
Sodbe se niso toliko osredotočale na postopek odobritve, temveč bolj na nerazumno rabo tega postopka za zavrnitev pravice do potovanja zaradi zdravljenja ali za postavljanje ovir pri izkoriščanju te pravice.
The judgements were not so much about the authorisation process but about the use of this process unreasonably to decline or place obstacles in the way of a person’s right to travel for treatment.
Zato smo skušali vzpostaviti sistem predhodne odobritve, ki do pacientov ne bi bil prezahteven, upravljavcem zdravstvenega varstva pa bi omogočil razumno vnaprejšnje opozorilo o izrednih stroških.
For that reason we have sought to put in place a system of prior authorisation that has a light touch, where patients are concerned, but a sensible advance warning of exceptional costs, where healthcare managers are concerned.
Potrebe, ne finančna sredstva.
Needs not Means.
Ko govorimo, da bi morala politika obravnavati paciente s potrebami in ne pacientov s finančnimi sredstvi, mora biti jasno, da si ne želimo pacientov, ki bi potovali z gotovino ali kreditno kartico v rokah, da bi vnaprej plačali pogosto zelo drago bolnišnično zdravljenje.
When we say the policy should be about patients with needs, not patients with means, we should make it clear we do not wish to see patients having to travel, clutching cash or credit card to pay upfront for often expensive in-hospital treatment.
Vzpostaviti bi morali neposreden sistem za povračilo stroškov med domačo zdravstveno blagajno in bolnišnico, ki pacienta sprejme, bodisi prek osrednje klirinške hiše, ki bi reševala čezmejne, medvalutne, medsistemske (Beveridge/Bismarck) zaplete, bodisi s sistemom prostovoljnih predhodnih obvestil, ki bi jim sledila pisna izjava o maksimalnem plačilu.
We should put in place a system of reimbursement direct from home funder to receiving hospital, either through a Central Clearing House to manage the cross-border, cross-currency, cross-system (Beveridge/Bismark) complications, or a system of voluntary prior notification, followed by a written confirmation of the maximum amount that will be paid.
Ta izjava bi se potem lahko predložila bolnišnici, ki bi izvajala zdravljenje, država članica pacientovega zdravstvenega zavarovanja pa bi nato neposredno povrnila stroške zdravljenja.
That written confirmation could then be taken to the hospital of treatment and reimbursement would then be made directly to that hospital by the Member State of affiliation..
Pojavlja se vprašanje, ali sodbe Sodišča Evropskih skupnosti glede stroškov pomenijo, da država članica pacientovega zdravstvenega zavarovanja nosi zgolj stroške zdravljenja.
The question arises of whether the ECJ's ruling with regard to cost means a Member State of Affiliation can only be liable for the actual cost of treatment.
Paketi zdravljenja z dodatki, kot sta rekonvalescenca ali fizioterapija, se lahko ponujajo za nižjo skupno ceno od tiste, ki bi jo doma plačali zgolj za zdravljenje.
A package of treatment, with extras such as convalescence or physiotherapy, could be offered at a total cost less than would have been paid for the treatment alone at home.
Če paketi pomenijo dodatne zdravstvene ugodnosti za pacienta, na primer manjšo možnost za ponoven pojav bolezni, so gotovo pozitivni in dobrodošli, pod pogojem, da cena celega paketa ne presega stroškov, ki bi jih plačali za zdravljenje v domači državi.
If such packages bring added health benefit to the patient, for example making relapse less likely, that must be good and should be welcomed, so long as the whole package is within the cost that would have been paid for treatment in the home country.
Na tem področju bi morale biti države članice kar se da prožne.
Member States should be as flexible as possible on this.
Zdravstveni posredniki.
'Health Brokers'.