natgillin/translations-raw huggingface dataset:
This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare.
Ta direktiva določa pravila za lažji dostop do varnega in visokokakovostnega čezmejnega zdravstvenega varstva in spodbuja sodelovanje med državami članicami na področju zdravstvenega varstva ter v celoti upošteva nacionalne pristojnosti pri organizaciji in izvajanju zdravstvenega varstva.
This Directive also aims at clarifying its relationship with the existing framework on the coordination of social security systems, Regulation (EC) No 883/2004, with a view to application of patients’ rights.
Namen te direktive je tudi pojasniti njeno povezavo z obstoječim okvirom za koordinacijo sistemov socialne varnosti, Uredbo (ES) št. 883/2004, z namenom uveljavljanja pravic pacientov.
This Directive shall apply to the provision of healthcare to patients, regardless of how it is organised, delivered and financed.
Ta direktiva se uporablja za izvajanje zdravstvenega varstva za paciente, ne glede na to, kako je organizirano, zagotovljeno in financirano.
services in the field of long-term care the purpose of which is to support people in need of assistance in carrying out routine, everyday tasks;
storitve na področju dolgotrajne oskrbe, katerih namen je podpora ljudem, ki potrebujejo pomoč pri opravljanju vsakodnevnih, rutinskih opravil;
allocation of and access to organs for the purpose of organ transplants;
dodelitev in dostop do organov za namene presaditve organov;
with the exception of Chapter IV, public vaccination programmes against infectious diseases which are exclusively aimed at protecting the health of the population on the territory of a Member State and which are subject to specific planning and implementation measures.
z izjemo poglavja IV; javne programe cepljenja proti nalezljivim boleznim, katerih izključni cilj je zaščita zdravja prebivalstva na ozemlju države članice ter ki so v skladu s posebnimi načrtovalnimi in izvedbenimi ukrepi.
This Directive shall not affect laws and regulations in Member States relating to the organisation and financing of healthcare in situations not related to cross-border healthcare.
Ta direktiva ne vpliva na zakone in predpise držav članic o organizaciji in financiranju zdravstvenega varstva v primerih, ki niso povezani s čezmejnim zdravstvenim varstvom.
In particular, nothing in this Directive obliges a Member State to reimburse costs of healthcare provided by healthcare providers established on its own territory if those providers are not part of the social security system or public health system of that Member State.
Nobena določba te direktive ne obvezuje države članice k povrniti stroškov zdravstvenega varstva, ki ga zagotavljajo izvajalci zdravstvenega varstva s sedežem na njenem ozemlju, če ti izvajalci niso vključeni v sistem socialne varnosti ali sistem javnega zdravstva te države članice.
Relationship with other Union provisions
Povezava z drugimi določbami Unije
This Directive shall apply without prejudice to:
Ta direktiva se uporablja brez poseganja v:
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems [18];
Direktivo Sveta 89/105/EGS z dne 21. decembra 1988 v zvezi s preglednostjo ukrepov, ki urejajo določanje cen zdravil za človeško uporabo in njihovo vključitev v področje nacionalnih sistemov zdravstvenega zavarovanja [18];
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [19], Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [20] and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [21];
Direktivo Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [19], Direktivo Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [20] in Direktivo 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih [21];
Directive 95/46/EC and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector [22];
Direktivo 95/46/ES ter Direktivo 2002/58/ES Evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij [22];
Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services [23];
Direktivo 96/71/ES Evropskega parlamenta in Sveta z dne 16. decembra 1996 o napotitvi delavcev na delo v okviru opravljanja storitev [23];
Directive 2000/31/EC;
Direktivo 2000/31/ES;
Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin [24];
Direktivo Sveta 2000/43/ES z dne 29. junija 2000 o izvajanju načela enakega obravnavanja oseb ne glede na raso ali narodnost [24];
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 [25];
Direktivo 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 [25];
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [26];
Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [26];
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components [27];
Direktivo 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi [27];
Regulation (EC) No 859/2003;
Uredbo (ES) št. 859/2003;
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [28];
Direktivo 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic [28];
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [29];
Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [29];
Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems [30];
Uredbo (ES) št. 883/2004 in Uredbo (ES) št. 987/2009 Evropskega parlamenta in Sveta z dne 16. septembra 2009 o določitvi podrobnih pravil za izvajanje Uredbe (ES) št. 883/2004 o koordinaciji sistemov socialne varnosti [30];
Directive 2005/36/EC;
Direktivo 2005/36/ES;
Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) [31];
Uredbo (ES) št. 1082/2006 Evropskega parlamenta in Sveta z dne 5. julija 2006 o ustanovitvi evropskega združenja za teritorialno sodelovanje (EZTS) [31];
Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work [32];
Uredbo (ES) št. 1338/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o statističnih podatkih Skupnosti v zvezi z javnim zdravjem ter zdravjem in varnostjo pri delu [32];
Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) [33], Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) [34] and other Union rules on private international law, in particular rules related to court jurisdiction and the applicable law;
Uredbo (ES) št. 593/2008 Evropskega parlamenta in Sveta z dne 17. junija 2008 o pravu, ki se uporablja za pogodbena obligacijska razmerja (Rim I) [33], Uredbo (ES) št. 864/2007 Evropskega parlamenta in Sveta z dne 11. julija 2007 o pravu, ki se uporablja za nepogodbene obveznosti (Rim II) [34], ter druga pravila Unije o mednarodnem zasebnem pravu, zlasti pravila, ki se nanašajo na sodno pristojnost in pravo, ki se uporablja;
Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation [35];
Direktivo 2010/53/EU Evropskega parlamenta in Sveta z dne 7. julija 2010 o standardih kakovosti in varnosti človeških organov, namenjenih za presaditev [35];
Regulation (EU) No 1231/2010.
Uredbo (EU) št. 1231/2010.
‘healthcare’ means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices;
„zdravstveno varstvo“ pomeni zdravstvene storitve, ki jih za paciente opravljajo zdravstveni delavci, da bi ocenili, ohranili ali obnovili njihovo zdravstveno stanje, vključno z izdajo in zagotovitvijo zdravil in medicinskih pripomočkov ter izdajanjem receptov zanje;
‘insured person’ means:
„zavarovana oseba“ pomeni:
persons, including members of their families and their survivors, who are covered by Article 2 of Regulation (EC) No 883/2004 and who are insured persons within the meaning of Article 1(c) of that Regulation; and
osebe, vključno z njihovimi družinskimi člani in njihovimi preživelimi družinskimi člani, ki jih zajema člen 2 Uredbe (ES) št. 883/2004 in ki so zavarovane osebe v smislu člena 1(c) navedene uredbe, ter
nationals of a third country who are covered by Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010, or who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits;
državljane tretje države, ki jih zajema Uredba (ES) št. 859/2003 ali Uredba (EU) št. 1231/2010, ali ki izpolnjujejo pogoje zakonodaje države članice zdravstvenega zavarovanja za upravičenost do dajatev;
‘Member State of affiliation’ means:
„država članica zdravstvenega zavarovanja“ pomeni:
for persons referred to in point (b)(i), the Member State that is competent to grant to the insured person a prior authorisation to receive appropriate treatment outside the Member State of residence according to Regulations (EC) No 883/2004 and (EC) No 987/2009;
za osebe iz točke (b)(i) – državo članico, ki je pristojna za predhodno odobritev ustreznega zdravljenja zavarovani osebi izven države članice, v kateri ima pacient stalno prebivališče, v skladu z Uredbo (ES) št. 883/2004 in Uredbo (ES) št. 987/2009;
for persons referred to in point (b)(ii), the Member State that is competent to grant to the insured person a prior authorisation to receive appropriate treatment in another Member State according to Regulation (EC) No 859/2003 or Regulation (EU) No 1231/2010.
za osebe iz točke (b)(ii) – državo članico, ki je pristojna za predhodno odobritev ustreznega zdravljenja zavarovani osebi v drugi državi članici, v skladu z Uredbo (ES) št. 859/2003 ali Uredbo (EU) št. 1231/2010.
If no Member State is competent according to those Regulations, the Member State of affiliation shall be the Member State where the person is insured or has the rights to sickness benefits according to the legislation of that Member State;
Če v skladu z navedenima uredbama ni pristojna nobena država članica, je država članica zdravstvenega zavarovanja država članica, v kateri je oseba zavarovana ali ima pravico do storitev v primeru bolezni v skladu z zakonodajo te države članice;
‘Member State of treatment’ means the Member State on whose territory healthcare is actually provided to the patient.
„država članica zdravljenja“ pomeni državo članico, na ozemlju katere se pacientu dejansko zagotavlja zdravstveno varstvo.
In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established;
Pri telemedicini se šteje, da se zdravstveno varstvo zagotavlja v državi članici, v kateri ima sedež izvajalec zdravstvenega varstva;
‘cross-border healthcare’ means healthcare provided or prescribed in a Member State other than the Member State of affiliation;
„čezmejno zdravstveno varstvo“ pomeni zdravstveno varstvo, ki se zagotovi ali predpiše v državi članici, ki ni država članica zdravstvenega zavarovanja;
‘health professional’ means a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment;
„zdravstveni delavec“ pomeni zdravnika, medicinskega tehnika, pristojnega za splošno oskrbo, zobozdravnika, babico ali farmacevta v smislu Direktive 2005/36/ES ali drug strokovnjak, ki izvaja dejavnosti v sektorju zdravstvenega varstva, omejene na regulirane poklice, kot je določeno v členu 3(1)(a) Direktive 2005/36/ES, ali oseba, ki velja za zdravstvenega delavca v skladu z zakonodajo države članice zdravljenja;
‘healthcare provider’ means any natural or legal person or any other entity legally providing healthcare on the territory of a Member State;
„izvajalec zdravstvenega varstva“ pomeni vsako fizično ali pravno ali katero koli drugo osebo, ki zakonito izvaja zdravstveno varstvo na ozemlju države članice;
‘patient’ means any natural person who seeks to receive or receives healthcare in a Member State;
„pacient“ pomeni vsako fizično osebo, ki želi prejeti ali prejme zdravstveno varstvo v državi članici;
‘medicinal product’ means a medicinal product as defined by Directive 2001/83/EC;
„zdravilo“ pomeni zdravilo, kot je opredeljeno v Direktivi 2001/83/ES;
‘medical device’ means a medical device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC;
„medicinski pripomoček“ pomeni medicinski pripomoček, kot je opredeljen v Direktivi 90/385/EGS, Direktivi 93/42/EGS ali Direktivi 98/79/ES;
‘prescription’ means a prescription for a medicinal product or for a medical device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC who is legally entitled to do so in the Member State in which the prescription is issued;
„recept“ pomeni zdravniški recept za zdravilo ali medicinski pripomoček, ki ga izda imetnik reguliranega zdravstvenega poklica v smislu člena 3(1)(a) Direktive 2005/36/ES, ki je do tega zakonsko upravičen v državi članici, v kateri se recept izda;
‘health technology’ means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare;
„zdravstvena tehnologija“ pomeni zdravilo, medicinski pripomoček ali medicinski ali kirurški postopek ter ukrepi za preprečevanje bolezni, diagnosticiranje ali zdravljenje, ki se uporabljajo v zdravstvenem varstvu;
‘medical records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process.
„zdravstvena dokumentacija“ pomeni vsak dokument s kakršnimi koli podatki, ocenami ali informacijami o pacientovem stanju in razvoju njegovega zdravstvenega stanja v procesu oskrbe.
RESPONSIBILITIES OF MEMBER STATES WITH REGARD TO CROSS-BORDER HEALTH CARE
PRISTOJNOSTI DRŽAV ČLANIC V ZVEZI S ČEZMEJNIM ZDRAVSTVENIM VARSTVOM
Responsibilities of the Member State of treatment
Pristojnosti države članice zdravljenja
Taking into account the principles of universality, access to good quality care, equity and solidarity, cross-border healthcare shall be provided in accordance with:
Ob upoštevanju načel univerzalnosti, dostopa do dobre kakovosti oskrbe, enakosti in solidarnosti se čezmejno zdravstveno varstvo zagotavlja v skladu:
the legislation of the Member State of treatment;
z zakonodajo države članice zdravljenja;
standards and guidelines on quality and safety laid down by the Member State of treatment; and
s standardi in smernicami glede kakovosti in varnosti, ki jih določi država članica zdravljenja; ter
Union legislation on safety standards.
z zakonodajo Unije o varnostnih standardih.
The Member State of treatment shall ensure that:
Država članica zdravljenja zagotovi, da:
patients receive from the national contact point referred to in Article 6, upon request, relevant information on the standards and guidelines referred to in paragraph 1(b) of this Article, including provisions on supervision and assessment of healthcare providers, information on which healthcare providers are subject to these standards and guidelines and information on the accessibility of hospitals for persons with disabilities;
pacienti na zahtevo od nacionalne kontaktne točke iz člena 6 prejmejo ustrezne informacije o standardih in smernicah iz točke (b) odstavka 1 tega člena, vključno z določbami o nadzoru in oceno izvajalcev zdravstvenega varstva, in informacije o tem, za katere izvajalce zdravstvenega varstva veljajo ti standardi in smernice, ter informacije o dostopnosti bolnišnic za invalidne osebe;
healthcare providers provide relevant information to help individual patients to make an informed choice, including on treatment options, on the availability, quality and safety of the healthcare they provide in the Member State of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration status, their insurance cover or other means of personal or collective protection with regard to professional liability.
izvajalci zdravstvenega varstva zagotavljajo ustrezne informacije, da posameznim pacientom pomagajo pri sprejemanju ozaveščenih odločitev, vključno o možnostih zdravljenja, o razpoložljivosti, kakovosti in varnosti zdravstvenega varstva, ki ga zagotavljajo v državi članici zdravljenja, in da predložijo tudi jasne račune ter jasne informacije o cenah, pa tudi o njihovi odobritvi ali registracijskem statusu izvajalcev zdravstvenega varstva, njihovem zavarovanju ali drugih oblikah osebne ali kolektivne zaščite v zvezi s poklicno odgovornostjo.
To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on these subjects, this Directive does not oblige healthcare providers to provide more extensive information to patients from other Member States;
Če izvajalci zdravstvenega varstva pacientom s prebivališčem v državi članici zdravljenja že sedaj zagotavljajo ustrezne informacije, ta direktiva izvajalcev zdravstvenega varstva ne obvezuje, da bi morali pacientom iz drugih držav članic zagotavljati obširnejše informacije;
there are transparent complaints procedures and mechanisms in place for patients, in order for them to seek remedies in accordance with the legislation of the Member State of treatment if they suffer harm arising from the healthcare they receive;
so vzpostavljeni pregledni pritožbeni postopki in mehanizmi za paciente, da ti uveljavljajo pravna sredstva v skladu z zakonodajo države članice zdravljenja, kadar utrpijo škodo, nastalo pri zdravstvenem varstvu;
systems of professional liability insurance, or a guarantee or similar arrangement that is equivalent or essentially comparable as regards its purpose and which is appropriate to the nature and the extent of the risk, are in place for treatment provided on its territory;
so za zdravljenje na njenem ozemlju vzpostavljeni sistemi zavarovanja poklicne odgovornosti ali jamstva ali podobne ureditve, ki so enakovredni ali v bistvu primerljivi glede na njihov namen ter ustrezajo naravi in obsegu tveganja;
the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC;
je temeljna pravica do zasebnosti pri obdelavi osebnih podatkov zaščitena v skladu z nacionalnimi ukrepi o izvajanju določb Unije o varstvu osebnih podatkov, zlasti direktiv 95/46/ES in 2002/58/ES;
in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic medical record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.
imajo, za zagotovitev neprekinjenosti oskrbe, pacienti, ki se zdravijo, pravico do zdravstvene dokumentacije v pisni ali elektronski obliki in dostop vsaj do kopije te dokumentacije v skladu z nacionalnimi ukrepi o izvajanju določb Unije o varstvu osebnih podatkov, zlasti direktiv 95/46/ES in 2002/58/ES.
The principle of non-discrimination with regard to nationality shall be applied to patients from other Member States.
Načelo nediskriminacije zaradi nacionalne pripadnosti se uporablja za paciente iz drugih držav članic.
This shall be without prejudice to the possibility for the Member State of treatment, where it is justified by overriding reasons of general interest, such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources, to adopt measures regarding access to treatment aimed at fulfilling its fundamental responsibility to ensure sufficient and permanent access to healthcare within its territory.
S tem se ne posega v možnost države članice zdravljenja, kjer to temelji na prevladujočih razlogih v splošnem interesu, kot so potrebe za načrtovanje v zvezi z zagotavljanjem zadostnega in stalnega dostopa do uravnoteženega obsega visokokakovostnega zdravljenja v zadevni državi članici, ali z namenom obvladovanja stroškov in, kolikor je mogoče, preprečevanja odvečne porabe finančnih, tehničnih in človeških virov, da sprejme ukrepe o dostopu do zdravljenja, katerih cilj je izpolnitev temeljne odgovornosti države članice, da na svojem ozemlju zagotovi zadosten in stalen dostop do zdravstvenega varstva.
Such measures shall be limited to what is necessary and proportionate and may not constitute a means of arbitrary discrimination and shall be made publicly available in advance.
Takšni ukrepi so omejeni na to, kar je nujno in sorazmerno, in ne smejo predstavljati sredstva samovoljne diskriminacije, ter so vnaprej javno dostopni.