natgillin/translations-raw huggingface dataset:
Cilj predloga naj ne bi bilo le na mobilnosti pacientov (kar zadeva le manjšino), ampak na izboljšanje kakovosti in varnosti oskrbe ter na sodelovanje med državami članicami, torej na vidike, ki bodo koristili vsem državljanom.
The proposal should not focus simply on dealing with patient mobility (which only affects a minority) but on improving healthcare quality and safety, and on cooperation between Member States, all of which will benefit citizens in general.
Ta direktiva se uporablja za izvajanje zdravstvenega varstva v drugi državi članici, ki ni država, v kateri pacient biva ali je v njej zavarovan, ne glede na to, kako je organizirano, zagotovljeno in financirano, oziroma ali je javno ali zasebno.
This Directive shall apply to provision of healthcare in a Member State other than that in which the patient resides or is an insured person, regardless of how it is organised, delivered and financed or whether it is public or private.
Namen te direktive je izboljšati dostop do čezmejnega zdravstvenega varstva.
The purpose of the Directive is to enhance access to cross-border healthcare.
V skladu s sodno prakso Sodišča Evropskih skupnosti ter v okoliščinah, v katerih je treba odobriti zahtevek za odobritev ustreznega zdravljenja v drugi državi članici v skladu s členom 22 Uredbe (EGS) št. 1408/71, se uporabljajo določbe navedene uredbe, določbe iz členov 6, 7, 8 in 9 te direktive pa se ne uporabljajo.
In accordance with the case-law of the Court of Justice of the European Communities and when the circumstances under which an authorisation to go to another Member State in order to receive appropriate treatment under Article 22 of Regulation (EC) No 1408/71 must be granted are met, the provisions of that Regulation shall apply and the provisions of Articles 6, 7, 8 and 9 of this Directive shall not apply.
Izrecno je treba navesti, da v primeru, ko Uredba št. 1408/71 (Direktiva 883/2004) ni v skladu s sodno prakso Sodišča Evropskih skupnosti, prevlada ta sodna praksa.
It should be stated explicitly that where Regulation No 1408/71 (Directive 883/2004) is not in line with the case-law of the Court of Justice of the European Communities, this case-law shall take precedence.
Vse direktive, ki se nanašajo na povračila in pogoje glede zdravstvenega varstva, odobritve in nadzor medicinskih pripomočkov, zaščito osebnih podatkov, ter druge direktive imajo prednost pred to direktivo, razen če so v neskladju s sodno prakso Sodišča, kot je eksplicitno navedeno v odstavku 2.
All directives relating to the reimbursement of and conditions for healthcare, authorisation and monitoring of medicinal products, protection of personal data and other directives shall have precedence over this directive provided they are not at variance with the case-law of the Court of Justice, as is explicitly set out in Paragraph 2.
Člen 4 – točka (a)
Article 4 – point a
(a) „zdravstveno varstvo“ so zdravstvene storitve, zlasti zdravstvena oskrba ali farmacevtske storitve, ter medicinski izdelki in pripomočki , ki jih izvaja , predpiše ali nadzoruje zdravstveni delavec med opravljanjem svojega poklica in ne glede na način, kako so organizirane , zagotovljene in financirane na nacionalni ravni oz. ali so javne ali zasebne .
(a) "healthcare" means health services or products, in particular medical or pharmaceutical services and medicinal products or medical devices, provided by , prescribed by or under the supervision of a health professional in the exercise of his profession, and regardless of the ways in which they are organised, delivered and financed at national level or whether they are public or private;
Dobavljanje medicinskih izdelkov spada med prosti pretok blaga.
The supply of medicinal products is covered by the free movement of goods.
Vendar pa farmacevti ne le prodajajo, temveč tudi pacientom svetujejo in jih oskrbujejo.
Pharmacists do far more than simple distribution, however, as they advise and care for their patients.
Poleg tega medicinski izdelki dopolnjujejo zdravljenje, ki ga je predpisal zdravnik, in so tako pomemben del zdravstvenega varstva.
In addition, the medicinal products they provide supplement the therapy provided by doctors and thus represent a key component of healthcare.
Zato je treba dejavnost farmacevtov vključiti v področje uporabe te direktive.
Their activities should therefore be comprehensively covered by the scope of this directive.
Člen 4 – točka a a (novo)
Article 4 – point a a (new)
(aa) zdravstveni podatki so vse informacije v zvezi s posameznikovim fizičnim in psihičnim zdravjem ali z zagotavljanjem zdravstvene storitve posamezniku, ki lahko vključujejo: (a) informacije o registraciji posameznika za opravljanje zdravstvenih storitev; b) informacije o plačilih ali upravičenosti posameznika do zdravstvenega varstva; c) številko, znak ali podrobnost, dodeljen posamezniku izključno za njegovo identifikacijo v zdravstvene namene; d) vse informacije o posamezniku, zbrane v času zagotavljanja njegovih zdravstvenih storitev; (e) informacije, pridobljene s testiranjem ali preiskavo dela telesa ali telesnih snovi; in f) identifikacijo osebe (zdravstvenega delavca) kot izvajalca storitev zdravstvenega varstva posamezniku;
(aa) "health data" means any information which relates to the physical or mental health of an individual, or to the provision of health service to the individual, which may include: a) information about the registration of the individual for the provision of health services; b) information about payments or eligibility for healthcare with respect to the individual; c) a number, symbol or particular assigned to an individual to uniquely identify the individual for health purposes; d) any information about the individual collected in the course of the provision of health services to the individual; e) information derived from the testing or examination of a body part or bodily substance; and f) identification of a person (healthcare professional) as provider of healthcare to the individual;
Kakor predlaga evropski nadzornik za varstvo podatkov v svojem mnenju, mora biti opredelitev zdravstvenih podatkov čim širša.
As recommended in the EDPS opinion, the definition of health data should be as broad as possible.
To je opredelitev, skladna s standardom ISO 27799.
This is the ISO 27799 definition.
Člen 4 – točka (d)
Article 4 – point d
(d) „zdravstveni delavec“ je zdravnik ali medicinski tehnik, pristojen za splošno oskrbo, ali zobozdravnik ali babica ali farmacevt 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 zakonito izvaja dejavnosti zdravstvenega varstva v državi članici zdravljenja;
(d) "health professional" means a doctor of medicine or a nurse responsible for general care or a dental practitioner or 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 legally exercising healthcare activities in the Member State of treatment.
Predlog spremembe zaradi skladnosti s področjem izvajanja te direktive (zdravstvene storitve in proizvodi).
Amendment in line with the scope of the Directive (healthcare services and products).
Člen 4 – točka (h)
Article 4 - point h
(h) „država članica pacientovega zdravstvenega zavarovanja“ je država članica, v kateri je pacient zavarovana oseba ;
(h) ‘Member State of affiliation’ means the Member State where the patient is an insured person ;
(h) „država članica pacientovega zdravstvenega zavarovanja“ je država članica, v kateri ima pacient zagotovljeno socialno varstvo v skladu s pravili za usklajevanje iz Uredbe (EGS) št. 1408/71 ;
(h) ‘Member State of affiliation’ means the Member State where the patient has social security affiliation in accordance with the coordination rules laid down in Regulation (EEC) No 1408/71 ;
Člen 4 – točka (i)
Article 4 - point i
(i) „država članica zdravljenja“ je država članica, na ozemlju katere se dejansko izvaja čezmejno zdravstveno varstvo;
(i) ‘Member State of treatment’ means the Member State on whose territory cross-border healthcare is actually provided;
(i) „država članica zdravljenja“ je država članica, na ozemlju katere ali iz katere se dejansko izvaja čezmejno zdravstveno varstvo;
(i) ‘Member State of treatment’ means the Member State on or from whose territory cross-border healthcare is actually provided;
V opredelitvi "države članice zdravljenja" se z besedami "iz katere" pojasni, da je tudi telemedicina vključena v to opredelitev.
- definition ‘Member State of treatment’: ‘or from whose’ should clarify that telemedicine is also included in the definition.
Člen 4 – točka i a (novo)
Article 4 – point i a (new)
(ia) „medicinski pripomoček“ je medicinski pripomoček, kot je opredeljen v direktivah 93/42/EGS, 90/385/EGS ali 98/7/ES;
(ia) ‘medical device’ means a medical device as defined by Directive 93/42/EEC or Directive 90/385/EEC or Directive 98/7/EC;
Nakup blaga, povezanega z zdravstvenim varstvom (npr. medicinskih pripomočkov), je bil predmet sodbe v zadevi Decker (v tej zadevi so bila pripomoček očala), torej bi ga bilo treba vključiti v direktivo, katere namen je kodificirati sodbi v zadevah Kohll in Decker.
The purchase of goods in connection with healthcare (e.g. medical devices) was the subject of the Decker judgment (the device to which that case applied being spectacles), and should therefore also be incorporated into a directive intended to codify the Kohll and Decker judgments
Člen 4 – točka i (b) (novo)
Article 4 – point i b (new)
(ib) „blago, povezano z zdravstvenim varstvom“ je blago, ki se uporablja za ohranjanje ali izboljšanje zdravja ljudi, na primer medicinski pripomočki in zdravila;
(ib) ‘goods used in connection with health care’ means goods which are used to preserve or improve a person’s health, such as medical devices and medicines;
Člen 5 – naslov, odstavek 1 in točka (a)
Article 5 - title and paragraph 1 and point a
Pristojnosti organov države članice zdravljenja
Responsibilities of authorities of the Member State of treatment
Pristojnosti organov držav članic
Responsibilities of the authorities of the Member States
V okviru tega in na podlagi načel univerzalnosti, geografskega in finančnega dostopa do oskrbe dobre kakovosti, učinkovitosti in uspešnosti, stalnosti, enakosti in solidarnosti, opredelijo jasne standarde kakovosti in varnosti za zdravstveno varstvo na njihovem ozemlju ter zagotovijo:
In such a context and on the basis of the principles of universality, geographical and financial access to good quality care, efficiency and effectiveness, continuity, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that:
(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 , ki zagotavljajo visokokakovostno sistematično izobraževanje in usposabljanje za zdravstvene delavce , da bi bili izvajalci storitev zdravstvenega varstva zmožni izpolniti takšne standarde, ob upoštevanju mednarodne medicine in splošno priznane dobre zdravniške prakse;
(a) mechanisms which deliver high quality systematic education and training for healthcare professionals, are in place toensure that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices;
Člen 5 – odstavek 1 – točka (b)
Article 5 – paragraph 1 – point b
(b) da se zdravstveno varstvo iz odstavka 1 zagotovi v skladu s standardi in smernicami o kakovosti in varnosti, ki jih določi država članica zdravljenja, da se zagotovi:
(b) the healthcare referred to in paragraph 1 is provided in accordance with the standards and guidelines on quality and safety defined by the Member State of treatment ensuring that:
(i) da imajo pacienti in izvajalci storitev zdravstvenega varstva iz drugih držav članic na voljo informacije o teh standardih in smernicah, vključno z določbami o nadzoru, med drugim z elektronskimi sredstvi;
(i) patients and healthcare providers from other Member States are provided with information on such standards and guidelines, including provisions on supervision, inter alia by electronic means;
(ii) Da imajo pacienti in izvajalci storitev zdravstvenega varstva iz drugih držav članic na voljo informacije o oblikah zdravljenja, ki so na voljo, razpoložljivosti, povprečnih ali po možnosti obveznih cenah zdravstvenega varstva ter podatke o predpisih v zvezi z zavarovanjem izvajalcev storitev zdravstvenega varstva ali o drugih oblikah osebne ali kolektivne zaščite glede poklicne odgovornosti izvajalcev teh storitev;
(ii) patients and healthcare providers from other Member States are provided with information on available treatments, availability, average or, if applicable, mandatory prices of the healthcare provided and details on the rules regarding insurance cover or other means of personal or collective protection with regard to the professional liability of healthcare providers;
V člen 5 je treba vključiti določbe člena 11, saj obravnavata enako vprašanje.
The provisions of Article 11 should be incorporated into Article 5 as they deal with the same subject matter.
Lahko se pretehta črtanje člena 11.
The deletion of Article 11 can be considered.
Zaradi subsidiarnosti in sorazmernosti je treba opredelitev standardov za kakovost in varnost obravnavati kot izključno vprašanje veljavnega prava.
For reasons of subsidiarity and proportionality, the definition of quality and safety standards should be treated exclusively as a matter for the applicable law.
Pacienti in izvajalci storitev zdravstvenega varstva morajo biti obveščeni o standardih za kakovost in varnost države članice.
Patients and providers must be informed about Member States' quality and safety standards.
Pacienti morajo biti obveščeni o terapevtskih možnostih, da se lahko odločijo.
However, patients must also be informed about therapeutic options in order to be able to make a choice.
(c) da izvajalci storitev zdravstvenega varstva zagotovijo vse pomembne informacije, tako da lahko pacienti sprejemajo utemeljene odločitve, zlasti informacije možnostih zdravljenja, o razpoložljivosti, cenah , potrjevanju kakovosti in tveganjih, povezanih z zagotovljenim zdravstvenim varstvom ter podatke o njihovem zavarovanju ali drugih oblikah osebne ali kolektivne zaščite v zvezi s poklicno odgovornostjo;
(c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on treatment options, availability, prices and quality certifications and risks inherent in the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Pacienti morajo biti obveščeni o različnih možnostih zdravljenja, da se lahko ozaveščeno odločijo.
Patients must be told about the different therapeutic options in order to be able to make an informed choice.
Člen 5 – odstavek 1 – točka (d)
Article 5 - paragraph 1 – point d
(d) da imajo pacienti možnost vložiti pritožbo in da so jim zagotovljena pravna sredstva in odškodnina, kadar utrpijo škodo, nastalo pri zdravstvenem varstvu;
(d) patients have a means of making complaints and are guaranteed remedies and compensations when they suffer harm arising from the healthcare they receive;
Člen 5 – odstavek 1 – točka (e)
Article 5 – paragraph 1 – point e
(e) da so za zdravljenje na ozemlju vzpostavljeni sistemi zavarovanja poklicne odgovornosti ali jamstva ali podobne ureditve, ki je enakovredna ali v bistvu primerljiva glede na njen namen ter ustreza naravi in obsegu tveganja;
(e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on the territory;
Člen 5 – naslov in odstavek 1 – točki (f) in (g) ter odstavka 1a in 1b
Article 5 - title and paragraph 1 – point f and g and paragraph 1a and 1b
(f) da ima pacient pravico do stalne oskrbe s posredovanjem potrebnih zdravstvenih podatkov, ki ga zadevajo.
(f) there is a right to continuity of care by means of the forwarding of relevant medical data concerning the patient.
V zvezi s tem je treba zaščititi temeljno pravico do zasebnosti pri obdelavi osebnih podatkov v skladu z nacionalnimi ukrepi o izvajanju določb Skupnosti o varstvu osebnih podatkov, zlasti direktiv 95/46/ES in 2002/58/ES;
In this context the fundamental right to privacy with respect to the processing of personal data must be protected in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC;
(g) pacientom iz drugih držav članic je zagotovljeno enako zdravljenje kot državljanom države članice zdravljenja, vključno z zaščito pred diskriminacijo, zagotovljeno v skladu z zakonodajo Skupnosti in veljavno zakonodajo države članice zdravljenja .
(g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment.
(g) pacientom iz drugih držav članic je zagotovljeno enako zdravljenje kot državljanom države članice zdravljenja, vključno z zaščito pred diskriminacijo, zagotovljeno v skladu z zakonodajo Skupnosti in veljavno zakonodajo države članice zdravljenja ;
(g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment;
(ga) sistematično in stalno prizadevanje, da se zagotovi izboljšanje teh standardov, v skladu s sklepi Sveta o skupnih vrednotah in načelih zdravstvenih sistemov Evropske unije*, ter ob upoštevanju prednosti mednarodne medicinske znanosti, splošno priznane dobre prakse in novih zdravstvenih tehnologij;
(ga) systematic and continuous efforts shall be made to ensure that these standards are improved, in accordance with the Council Conclusions on common values and principles in European Union health systems*, and taking into account advances in international medical science, generally recognised good practice and new healthcare technologies;
(gb) javni organi držav članic zdravljenja redno spremljajo dostopnost, kakovost in finančni položaj njihovih zdravstvenih sistemov na osnovi podatkov, zbranih v skladu s členom 18; redno sprejemajo ustrezne ukrepe za ohranjanje ravni javnega zdravstva in finančne vzdržnosti njihovih sistemov socialnega zavarovanja;
(gb) the public authorities of the Member States of treatment shall regularly check the accessibility, quality and financial state of their healthcare systems on the basis of the data gathered in accordance with Article 18; they shall, on a regular basis, take appropriate measures to maintain the level of public health and the financial viability of their social security systems;
gc) ta direktiva od izvajalcev storitev zdravstvenega varstva ne zahteva, da sprejmejo načrtovano zdravljenje ali dajo prednost pacientom iz drugih držav članic v škodo drugih pacientov s podobnimi zdravstvenimi potrebami, zlasti s podaljševanjem čakalnih dob za zdravljenje;
gc) healthcare providers shall not be required under this Directive to accept planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, in particular through increasing waiting times.
(gd) da se varuje pravica do pisne ali elektronske zdravstvene kartoteke z namenom stalnosti oskrbe;
(gd) the right to written or electronic medical records, with a view to continuity of care, must be safeguarded;
(ge) da izračun stroškov zdravstvenega varstva, ki ga pacienti prejmejo v drugih državah članicah, ustreza dejanskim povprečnim stroškom, ki se zaračunajo pacientom ali njihovim zdravstvenim zavarovalnicam v državi članici zdravljenja.
(ge) the calculation of the costs of healthcare provided to patients from other Member States corresponds to the actual average costs charged to patients or to their health insurance companies in the Member State of treatment;
Države članice zdravstvenega zavarovanja za kar največjo varnost pacientov zagotovijo, da:
In order to maximise patient safety the Member States of treatment and affiliation shall ensure that:
(a) imajo pacienti možnost vložiti pritožbo, zlasti Evropskemu varuhu človekovih pravic, v zvezi s predhodno odobritvijo, kakovostjo zdravljenja in plačili, in da imajo zagotovljena pravna sredstva in odškodnino, kadar pri zdravstvenem varstvu utrpijo škodo;
(a) patients have a means of making complaints notably to a European Ombudsman who will treat patient complaints as regards prior authorisation, the quality of treatment and payments, and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive;
(b) se objavijo standardi kakovosti in varnosti v jeziku in obliki, ki sta državljanom jasna in razumljiva;
(b) the quality and safety standards of the Member State of treatment are made public in a language and format that is clear and accessible to all citizens;
(c) imajo pacienti pravico do stalne oskrbe, zlasti s posredovanjem potrebnih zdravstvenih podatkov, ki jih zadevajo, ob ustreznem upoštevanju določb iz odstavka 1(e) ter v skladu s členom 13, pacienti, ki so se zdravili, pa pravico do zdravstvenega kartona v pisni ali elektronski obliki s podatki o zdravljenju in vsemi zdravniškimi priporočili za nadaljnje zdravljenje;
(c) there is a right to continuity of care of notably by means of the forwarding of relevant medical data concerning the patient with due respect to provisions of paragraph 1 - point (e) and pursuant to article 13 and patients who have received treatment are entitled to a written or electronic record of such treatment and of any medical advice for the continuity of their care;
(d) v primeru zapletov, nastalih med izvajanjem zdravstvenega varstva v tujini, ali kadar je potrebno posebno zdravniško spremljanje, država članica zdravstvenega zavarovanja zagotovi enako zdravstveno varstvo, kot je predvideno na njenem ozemlju;
(d) in the event of complications resulting from healthcare provided abroad or if a particular medical follow-up proves necessary, the Member State of affiliation guarantees to provide healthcare equivalent to that received on its territory;
(e) se med seboj takoj in proaktivno obveščajo o izvajalcih zdravstvenega varstva ali zdravstvenih delavcih, če je proti njihovi registraciji ali pravici do zagotavljanja storitev vložen ureditveni ukrep.
(e) they immediately and proactively inform each other about health providers or health professionals when regulatory action is taken against their registration or their right to provide services;
Komisija v skladu s postopkom iz člena 19(2) sprejme ukrepe, ki so potrebni za enotno raven varstva zdravstvenih podatkov na nacionalni ravni, ob upoštevanju obstoječih tehničnih standardov na tem področju.
The Commission shall in accordance with the procedure referred to in Article 19(2), adopt measures necessary for achieving a common security level of health data at national level, taking into account existing technical standards in this field.
*UL C 146, 22.6.2006, str.
* OJ C 146, 22.6.2006, p.