natgillin/translations-raw huggingface dataset:
Izmenjava informacij med organi za ocenjevanje zdravstvene tehnologije predvideva in zahteva, da se pri ocenjevanju, ki ga opravljajo države članice, upoštevajo načela dobre prakse (kot so dobro upravljanje, preglednost in sodelovanje zadevnih akterjev).
The exchange of information between health technology assessment bodies presupposes and requires the implementation of principles of good practice (such as good governance, transparency and stakeholder participation) in the assessments conducted by the Member States.
Zato mora ocenjevanje zdravstvene tehnologije izpolniti merila odprtosti in objektivnosti ter temeljiti na dialogu in vpletenosti zadevnih akterjev, med drugim tudi pacientov in industrije.
Health technology assessments must therefore fulfil the criteria of openness and objectivity and must be based on dialogue and involvement of all stakeholders, including patients and industry.
(45) Komisiji je zlasti treba podeliti pooblastila, da sprejme naslednje ukrepe, in sicer seznam zdravljenj, razen tistih, ki zahtevajo prenočitev pacienta, za katere velja enak režim kot za bolnišnično oskrbo; spremljevalne ukrepe za izključitev posebnih kategorij medicinskih izdelkov ali snovi iz obsega priznavanja zdravniških receptov, izdanih v drugi državi članici, ki ga določa ta direktiva; seznam posebnih meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže, postopek za vzpostavitev evropskih referenčnih mrež.
(45) In particular, power should be conferred on the Commission to adopt the following measures: a list of treatments, other than those requiring overnight accommodation, to be subject to the same regime as hospital care; accompanying measures to exclude specific categories of medicinal products or substances from the recognition of prescriptions issued in another Member State provided for in this Directive ; a list of specific criteria and conditions that European reference networks must fulfil; the procedure for establishing European reference networks .
Navedeni ukrepi so splošnejše narave in so namenjeni spremembi nebistvenih elementov te direktive ali nadomestitvi te direktive z dodajanjem novih nebistvenih elementov, zato jih je treba sprejeti v skladu z regulativnim postopkom s pregledom, določenim v členu 5a Sklepa 1999/468/ES.
Since those measures are of general scope and are designed to amend non-essential elements of this Directive, or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC .
Ta direktiva določa splošen okvir za zagotavljanje varnega, visoko kakovostnega in učinkovitega zdravstvenega varstva in državljanom Evropske unije zagotavlja enak dostop do tega zdravstvenega varstva ter povsem upošteva nacionalno pristojnost pri organiziranju in izvajanju zdravstvenega varstva .
This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare , while ensuring that EU citizens have fair access to this care and respecting national competences as regards the organisation and provision of healthcare .
Ta direktiva se uporablja za izvajanje zdravstvenega varstva, ne glede na to, kako je organizirano, zagotovljeno in financirano oz. ali je javno ali zasebno.
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private .
UL L 166, 30.04.2004, str.
OJ L 166, 30.4.2004, p.
Vsako prekrivanje direktive in uredbe bi lahko omogočilo vzpostavitev dveh vzporednih sistemov za čezmejno zdravstveno varstvo: v skladu s predpisi o koordinaciji socialne varnosti in v skladu z novo direktivo, kar bi povzročilo pravno negotovost.
Any overlapping of the directive and regulations would make it possible to establish two parallel systems for cross-border healthcare: under the regulations on the coordination of social security and under this new directive, which would give rise to legal uncertainty.
Področje uporabe Uredbe št. 883/2004 in te direktive je treba dobro razmejiti.
The borderline between the scope of Regulation 883/2004 and this directive should be well defined.
Ta direktiva ne velja za storitve, ki so usmerjene predvsem na dolgoročno oskrbo.
This Directive shall not apply to services mainly geared to long-term care.
To vključuje zlasti storitve, ki se zagotavljajo v daljšem obdobju in so namenjene pomoči ljudem v vsakdanjem življenju.
These include in particular services provided over an extended period that are designed to assist people with the general organisation of their day-to-day lives.
(a) „zdravstveno varstvo“ je zdravstvena storitev, ki jo izvaja ali nadzoruje zdravstveni delavec med opravljanjem svojega poklica in ne glede na način, kako je organizirana, zagotovljena in financirana na nacionalni ravni oz. ali je javna ali zasebna;
a) "healthcare" means a health service provided by or under the supervision of a health professional in exercise of his profession, and regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private ;
(a) „zdravstveno varstvo“ je zdravstvena storitev, ki se zagotavlja pacientom za oceno, ohranitev ali obnovitev zdravstvenega stanja .
a) "healthcare" means a health service provided to patients to assess, maintain or restore their state of health .
Za namene členov 6 do 11 „zdravstveno varstvo“ pomeni zdravljenje, ki spada med koristi zdravstvenega varstva, ki ga zagotavlja zakonodaja države članice pacientovega zdravstvenega zavarovanja;
For the purpose of Articles 6 to 11, "healthcare" means treatments that are among the healthcare benefits provided for by the legislation of the Member State of affiliation ;
(b) „čezmejno zdravstveno varstvo“ je zdravstveno varstvo v državi članici, ki ni tista država, v kateri je pacient zavarovana oseba , ali zdravstveno varstvo v državi članici, ki ni tisti država, v kateri ima izvajalec storitev zdravstvenega varstva stalno prebivališče, je registriran ali ustanovljen ;
(b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established ;
(b) „čezmejno zdravstveno varstvo“ je zdravstveno varstvo v državi članici, ki ni tista država, v kateri je pacient zavarovana oseba;
(b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person;
Pojem čezmejno zdravstveno varstvo bi vključeval mobilnost pacienta v ožjem smislu in mobilnost zdravstvenih storitev, ki jih je mogoče zagotavljati na daljavo, kot pri uvodni izjavi št 10; ocenjuje se, da sklicevanje na izvajalce zdravstvenega varstva v tem členu ni ustrezno.
As in the case of recital 10, the concept of cross-border care would include both patient mobility in the narrower sense and the mobility of health services which can be provided remotely; the reference in this article to healthcare providers is not considered appropriate.
Člen 4 – točka g
Article 4 – point g
(g) „zavarovana oseba“ je:
(g) ‘insured person’ means
(g) „zavarovana oseba“ je oseba, ki je zavarovana v skladu z opredelitvijo iz člena 1(c) Uredbe (EGS) št. 883/2004;
(g) ‘insured person’ means a person who is insured in accordance with the definition in Article 1(c) of Regulation (EC) 883/2004;
Uredba (ES) št. 883/2004 začne veljati 1. januarja 2009.
Regulation (EC) No 883/2004 comes into force on 1 January 2009.
Poglavje II – naslov
Chapter II – title
ORGANI DRŽAV ČLANIC, PRISTOJNI ZA USKLADITEV S SKUPNIMI NAČELI ZA ZDRAVSTVENO VARSTVO
MEMBER STATE AUTHORITIES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
DRŽAVE ČLANICE , PRISTOJNE ZA USKLADITEV S SKUPNIMI NAČELI ZA ZDRAVSTVENO VARSTVO
MEMBER STATES RESPONSIBLE FOR COMPLIANCE WITH COMMON PRINCIPLES FOR HEALTHCARE
V primeru uporabe izraza „organi“ je treba ta izraz opredeliti.
If used, the term ‘authorities’ would need to be defined.
Pristojnosti države članice zdravljenja
Responsibilities of the Member State of treatment
Zaradi usklajenosti s predlogom spremembe o naslovu Poglavja II.
To be consistent with the amendment to the title of Chapter II.
Če se zdravstveno varstvo zagotovi v državi članici, ki ni država članica pacientovega zdravstvenega zavarovanja, se zdravljenje izvede v skladu z zakonodajo države članice, kjer se zdravljenje zagotovi.
Where healthcare is dispensed in a Member State other than that in which the patient is affiliated, treatment shall take place in accordance with the legislation of the Member State where the treatment is dispensed.
Zdravstveno varstvo se zagotavlja v skladu s standardi kakovosti in varnosti ter s smernicami, ki jih določi država članica, v kateri poteka zdravljenje.
Healthcare shall be provided in accordance with the quality and safety standards and guidelines defined by the Member State in which the treatment takes place.
Država članica mora zagotoviti:
That Member State must ensure that:
Popravek besedila poudarja načelo, da organizacija in zagotavljanje zdravstvenega varstva spadata med nacionalne pristojnosti držav članic.
This rewording reinforces the principle that the organisation and provision of healthcare falls within the national competence of the Member States.
Načela univerzalnosti, kakovosti, enakosti in solidarnosti zdravstvenega varstva je treba vključiti v člen 1 o ciljih direktive.
The principles of universality, quality, equity and solidarity of healthcare should be included in Article 1 on the objectives of the directive.
(a) da so uvedeni mehanizmi za zagotovitev, da so izvajalci storitev zdravstvenega varstva zmožni izpolniti takšne standarde, ob upoštevanju mednarodne medicine in splošno priznane dobre zdravniške prakse;
a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices;
(a) da so uvedeni mehanizmi za zagotovitev, da so izvajalci storitev zdravstvenega varstva in nujnih zdravstvenih storitev zmožni izpolniti takšne standarde, ob upoštevanju razvoja mednarodne medicine in splošno priznane dobre zdravniške prakse;
a) mechanisms are in place for ensuring that healthcare providers and emergency medical services are able to meet such standards, taking into account developments in international medical science and generally recognised good medical practices;
Standardi kakovosti morajo zajemati tudi službe nujne medicinske pomoči.
It is important for quality standards to also cover emergency medical services.
(b) da se uporaba takšnih standardov s strani izvajalcev storitev zdravstvenega varstva v praksi redno spremlja in da se sprejmejo korektivni ukrepi, kadar niso izpolnjeni ustrezni standardi, ob upoštevanju napredka na področju medicine in zdravstvene tehnologije;
b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
(b) da se uporaba takšnih standardov s strani izvajalcev storitev zdravstvenega varstva in nujnih zdravstvenih storitev v praksi redno spremlja ter ocenjuje in da se sprejmejo korektivni ukrepi, kadar niso izpolnjeni ustrezni standardi, ob upoštevanju napredka na področju medicine in zdravstvene tehnologije;
b) the application of such standards by healthcare providers and emergency medical services in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology;
Zaželeno je, da se ta odstavek črta, ker način oblikovanja smernic Komisije neposredno ovira izključne nacionalne pristojnosti na področju organizacije in zagotavljanja zdravstvenega varstva.
It is preferable to delete this paragraph, given that the way in which the guidelines have been developed by the Commission interferes directly with exclusive national competencies in the area of the organisation and provision of healthcare.
Pacienti so upravičeni do povračila stroškov za načine zdravljenja, če v državi članici gostiteljici povračilo obstaja in je te načine zdravljenja priznala mednarodna medicina, čeprav v njihovi državi članici zanje ni povračila stroškov;
Patients shall be entitled to reimbursement for methods of treatment, even where those methods are not reimbursed in their own Member State, provided that this is the case in the host Member State and that the method is recognised by international medical science;
Države članice morajo imeti pravico, da same oblikujejo svoje sisteme socialne varnosti.
Member States must have the right to design their own social security systems.
Vendar pa je način zdravljenja pogosto odvisen od prakse znotraj določenega zdravstvenega poklica, ki temelji na usposabljanju in specializaciji.
However, the method of treatment used is often a question of practice within the medical profession based on its training and specialisation.
To ne sme biti vodilno načelo pri določanju povračila, ki mora biti odvisno od učinkov, ki jih ima storitev na pacientovo stanje.
This should not be a guiding principle in determining reimbursement, which should be dependent on the results achieved for the patient.
To ne vpliva na višino povračila, ampak le omogoča pacientu večjo svobodo izbire, kar je zlasti pomembno za paciente z novimi ali redkimi boleznimi.
This does not affect the level of reimbursement but simply gives patients greater freedom of choice, which is particularly important for patients with new or rarer diseases.
( 1a) Državljan države članice je lahko zavarovanec sistema zdravstvenega zavarovanje v državi, ki ni njegova država stalnega bivališča pod pogojem, da plačuje prispevke temu sistemu.
(1a) A national of a Member State may be affiliated to a health insurance scheme of a Member State other than that of residence, by paying contributions to that scheme.
V podporo interesov državljanov, ki so v državi članici, ki ni njihova država stalnega bivališča, da bi imeli dostop do sistema zdravstvenega varstva v državi, ki ni država njihovega stalnega bivališča.
Supporting the interests of citizens who are in a Member State other than that of residence means allowing them access to a health scheme of a Member State other than that of residence.
Stroške za zdravstveno varstvo v drugi državi članici povrne država članica pacientovega zdravstvenega zavarovanja v skladu z določbami te direktive do višine stroškov, ki bi bili prevzeti za enako ali podobno zdravstveno stanje v državi članici pacientovega zdravstvenega zavarovanja, ne da bi bili preseženi dejanski stroški za prejeto zdravstveno varstvo.
The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed in respect of the same medical condition in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Podatki se prenesejo le ob izrecnem pisnem dovoljenju pacienta ali pacientovih sorodnikov.
Data shall be transmitted only with the express consent in writing of the patient or the patient’s relatives.
Bistveno je, da se prenos podatkov omogoči le ob izrecnem pisnem dovoljenju pacienta ali pacientovih sorodnikov.
It is essential to ensure that data may only be transmitted with the explicit consent in writing of the patient or the patient’s relatives.
Sprejmejo se potrebni ukrepi, ki državljanom EU, ki doživijo nesreče ali potrebujejo drugo nujno medicinsko pomoč v drugih državah članicah, omogočijo dostop do visoko kakovostne nujne medicinske pomoči.
The necessary measures shall be taken to enable EU citizens who suffer accidents or other medical emergencies in other Member States to receive high ‑quality emergency medical care.
Sodelovanje ne sme biti omejeno samo na nesreče, ampak bi moralo veljati tudi za nujno medicinsko pomoč.
Collaboration should not be restricted to accidents, but should also apply to other medical emergencies.
Za namene povrnitve stroškov zdravstvenega varstva v drugi državi članici v skladu s to direktivo je bolnišnična in specialistična oskrba v skladu z opredelitvijo v zakonodaji države članice zdravstvenega zavarovanja, storitev zdravstvenega varstva, za katero je potrebna visokospecializirana in draga medicinska infrastruktura ali medicinska oprema , ali zdravstveno varstvo, ki predstavlja posebno tveganje za pacienta ali prebivalce.
For the purposes of reimbursement of the costs of healthcare provided in another Member State in accordance with this Directive, hospital care and specialised care shall mean, as defined in the legislation of the Member State of affiliation, healthcare that requires use of specialised and cost-intensive infrastructure or equipment , or healthcare involving treatments presenting a particular risk for the patient or the population.
(a) storitev zdravstvenega varstva, ki zahteva prenočitev zadevnega pacienta vsaj za eno noč ;
a) healthcare which requires overnight accommodation of the patient in question for at least one night.
(b) storitev zdravstvenega varstva, vključena v poseben seznam, ki ne zahteva prenočitve pacienta vsaj za eno noč.
b) healthcare, included in a specific list, that does not require overnight accommodation of the patient for at least one night.
– zdravstveno varstvo, ki zahteva uporabo visoko specializirane in drage medicinske infrastrukture ali medicinske opreme , ali
- healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment ; or
zdravstveno varstvo, ki predstavlja posebno tveganje za pacienta ali prebivalce.
- healthcare involving treatments presenting a particular risk for the patient or the population.
Ta seznam sestavi Komisija, ki ga lahko tudi redno posodabljajo vse države članice, ki so države zavarovanja ali njihovi pristojni organi, glede na posebnosti njene organizacije.
This list shall be set up and may be regularly updated by each Member State of affiliation or by the competent authorities of that Member State, depending on its specific organisational arrangements.
(b) namen sistema je obravnavati obsežno prehajanje pacientov zaradi izvajanja tega člena in preprečiti, da bi odhod pacientov ogrožal ali verjetno ogrožal:
(b) the purpose of the system is to address significant patient flow due to the implementation of the present Article and to prevent it from undermining, or being likely to undermine:
(ii) načrtovanje in racionaliziranje, ki se izvajata v sektorju zdravstvenega varstva v izogib preobremenjenosti, neuravnoteženosti zagotavljanja zdravstvenega varstva ter logistični in finančni izgubi, vzdrževanje vsem dostopne uravnotežene zdravniške in bolnišnične storitve ali vzdrževanje zmogljivosti zdravljenja ali zdravniških kompetenc na ozemlju zadevne države članice.
(ii) the planning and rationalisation carried out in the healthcare sector to avoid overcapacity, imbalance in the supply of healthcare and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State.
Člen 8 – odstavek 3 – točka b a (novo)
Article 8 – paragraph 3 – point b a (new)
(ba) Pristojni organi države članice pacientovega zdravstvenega zavarovanja postavijo merila za ugotavljanje, kdaj je ali bi lahko bilo ogroženo finančno ravnotežje sistema socialnega varstva države članice ali načrtovanje in racionaliziranje njenega sektorja zdravstvenega varstva.
(ba) The competent authorities of the Member State of affiliation shall establish criteria to identify when the financial balance of the Member States social security system, or the planning and rationalisation carried out in its healthcare sector, is undermined or is likely to be undermined.
Sistem predhodne odobritve je omejen na tisto, kar je nujno in sorazmerno, ter ne predstavlja sredstva za samovoljno diskriminacijo.
The prior authorisation system shall be limited to what is necessary and proportionate, and shall not constitute a means of arbitrary discrimination.
Črtanje zaradi skladnosti s predlogom spremembe člena 8(3).
To be consistent with the amendment to Article 8(3).
Država članica pacientovega zdravstvenega zavarovanja javnosti omogoči dostop do seznama vseh bolnišnic in storitev specialističnega zdravstvenega varstva ter vseh pomembnih informacij o sistemih predhodne odobritve, uvedenih v skladu z določbami iz odstavka 3.
The Member State of affiliation shall make publicly available the list of hospitals and specialised healthcare services and all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.
Sistem predhodnih odobritev ne velja za primere akutnih bolezni in nujnih primerov, ko je takojšnje ukrepanje bistveno.
The system of prior authorisation should not apply in cases of acute illnesses and emergencies where prompt action is essential.
Poleg tega se je treba predhodnem dovoljenju odpovedati v primeru selitve iz ene bolnišnice v drugo, ki je v drugi državi članici.
In addition, the requirement for prior authorisation shall be waived in the event of transfer from one hospital to another hospital in a different Member State.
Predhodno dovoljenje ni izvedljivo v nujnih primerih.
Pre-authorisation is not feasible in acute cases.
Nujne primere je treba obravnavati ločeno, saj se predhodno dovoljenje v teh primerih ne more pridobiti.
Emergencies must be treated separately, since pre-authorisation cannot be obtained in these cases.
Isto velja za hospitalizirane bolnike, pri katerih običajno ni mogoče čakati na odločitev, kdo bo prevzel stroške.
Likewise, in the case of hospitalised patients it is not usually possible to wait for the costs to be assumed.
Pri vseh zahtevkih za odobritev, ki jih vloži zavarovana oseba z namenom prejeti zdravstveno varstvo v drugi državi članici, država članica pacientovega zdravstvenega zavarovanja preveri, ali so izpolnjeni pogoji iz Uredbe (ES) št. 883/2004, in v tem primeru odobri predhodno odobritev v skladu z navedeno uredbo.
In the event of any requests for authorisation by an insured person to receive healthcare in another Member State, the Member State of affiliation shall ascertain whether the conditions laid down by Regulation (EC) No 883/2004 have been met and, if so, shall grant the prior authorisation in accordance with that Regulation.
Predlog uredbe je v nasprotju z veljavno uredbo o usklajevanju sistemov socialne varnosti.
The proposal for a directive is at odds with the existing rules on coordination of social security schemes.
Če bi se direktiva pokrivala z obstoječo uredbo, bi to omogočilo vzpostavitev dveh vzporednih sistemov čezmejnega zdravstvenega varstva.
If the directive were to overlap with existing regulations, this would allow two parallel systems for cross-border healthcare to be established.
Dvodelni sistem se namreč ustvari ker predlog ne opredeli območij, ki jih uredba ne pokriva, in se osredotoča na tista območja, ki so že pokrita.
In fact a dual system is being created because the proposal not only fails to identify the areas not covered in the regulation, but focuses essentially on those areas which it does already cover.
Člen 8 – odstavek 5 c (novo)
Article 8 – paragraph 5 c (new)
Država članica lahko kadar koli zavrne odobritev predhodne odobritve, če se enako zdravljenje lahko zagotovi na njenem ozemlju v medicinsko utemeljenem časovnem obdobju, ob upoštevanju pacientovega trenutnega zdravstvenega stanja in verjetnega razvoja bolezni.
In any event, the Member State may refuse to grant prior authorisation if the same treatment can be provided within its territory within a medically justifiable timeframe, taking into account the current state of health of the patient concerned and the probable development of his or her illness.