natgillin/translations-raw huggingface dataset:
Organizacije pacientov se vključijo v sodelovanje z nacionalnimi pristojnimi organi pri postopku zagotavljanja in širjenja informacij pacientom.
Patients' organisations should be involved in cooperating with competent national authorities in the process of providing and disseminating information to patients.
Organizacije pacientov so dragocen vir pri podpori nacionalnih pristojnih organov, vključenih v proces z zagotavljanjem in širjenjem informacij neposredno pacientom.
Patients organisations are a valuable resource in supporting national competent authorities involved in the process of providing and disseminating information directly to patients.
Na podlagi informacij tega centra se bodo pacienti odločili, katero zdravljenje si želijo.
On the basis of the information the counselling centre provides, patients decide which treatment they prefer.
Te nacionalne kontaktne službe je treba vzpostaviti učinkovito in pregledno.
These national contact points should be established in an efficient and transparent way.
Informacije o teh službah morajo biti primerno razširjene v državah članicah, da bodo pacienti zlahka dostopali do teh informacij.
The information about their existence should be appropriately disseminated across Member States, so that patients have an easy access to the information.
Nacionalna kontaktna služba v državi članici pacientovega zdravstvenega zavarovanja v tesnem sodelovanju z drugimi pristojnimi nacionalnimi organi, nacionalnimi kontaktnimi službami v drugih državah članicah, zlasti v državi članici zdravljenja, ter Komisijo:
The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities, and with national contact points in other Member States, in particular in the Member State of treatment, and with the Commission:
Nacionalna kontaktna služba v državi članici pacientovega zdravstvenega zavarovanja v tesnem sodelovanju z drugimi pristojnimi nacionalnimi organi, od katerih je neodvisna, in z nacionalnimi kontaktnimi službami v drugih državah članicah, zlasti v državi članici zdravljenja, organizacijami pacientov ter Komisijo:
The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities , yet independently of same , and with national contact points in other Member States, in particular in the Member State of treatment with patients’ organisations and with the Commission:
Nujno je treba zagotoviti neodvisnost v delovanju med nacionalnimi kontaktnimi službami in drugimi pristojnimi nacionalnimi organi, kot so nacionalne storitve zdravstva, saj bi morda pristojni organi kontaktne službe uporabljali v svojo korist in ne v korist pacientov.
It is imperative to establish functional independence between the national contact points and other competent national authorities, such as national health services, as there may be an incentive for the latter to operate the former subject to its own, rather than patients', prerogatives.
Člen 12 – odstavek 2 – točka (a)
Article 12 – paragraph 2 – point (a)
(a) pacientom zagotavlja in posreduje informacije, zlasti informacije o njihovih pravicah v zvezi s čezmejnim zdravstvenim varstvom, jamstvih kakovosti in varnosti, varstvu osebnih podatkov, javnem ali zasebnem statusu izvajalca oskrbe, postopku in stopnjah povračila, postopkih za pritožbe in pravnih sredstvih, ki so na voljo za zdravstveno varstvo v drugi državi članici, ter o določilih in pogojih;
(a) provide and disseminate information to patients in particular on their rights related to cross-border healthcare and the guarantees of quality and safety, protection of personal data, the public or private status of the care provider, the reimbursement procedure and rates, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable;
Člen 12 – odstavek 2 – točka (d)
Article 12 – paragraph 2 - point d
(d) v sodelovanju z varuhom človekovih pravic olajšujejo razvoj mednarodnega sistema izvensodnih poravnav za spore, do katerih pride pri čezmejnem zdravstvenem varstvu.
(d) facilitate the development of international out-of-court settlement scheme, in cooperation with the Ombudsman, for disputes arising from cross-border healthcare;
Varuh človekovih pravic je neodvisen organ, ki deluje v vseh državah članicah in predvsem preučuje posamezne upravne prakse, opustitve ali stvarne ukrepe organov javnih služb, ki kršijo pravice ali posegajo v legitimne interese fizičnih ali pravnih oseb.
The Ombudsman is an independent authority operating in every Member State, who principally investigates individual administrative practices or omissions or material actions by public service bodies which infringe the rights or prejudice the legitimate interests of natural or legal persons.
Na tej posebni instanci lahko varuh človekovih pravic pomaga pri reševanju sporov.
In this specific instance, the Ombudsman could help towards the settlement of disputes.
Člen 12 – odstavek 2 – točka (e a) (novo)
Article 12 – paragraph 2 – point e a (new)
(ea) Glavni izvajalci oskrbe obvestijo paciente o razpoložljivosti in delovanju nacionalnih kontaktnih točk v državah članicah njihovega zdravstvenega zavarovanja.
(ea) Primary care providers shall inform patients of the availability and function of the national contact points in their Member State of affiliation.
Glavni izvajalci oskrbe, kot so družinski ali splošni zdravniki, so v večini primerov prvi stik med pacientom in zdravstvenimi službami.
Primary care providers, such as family doctors/general practitioners, are in most cases the first point of contact between patient and health service.
Da bi bili pacienti seznanjeni s svojimi pravicami do čezmejnega zdravstvenega varstva, bi morali biti glavni izvajalci oskrbe zavezani usmeriti paciente k nacionalnim kontaktnim točkam, kjer bodo dobili popolne informacije o možnostih zdravljenja.
Therefore, in order to make patients aware of their rights to cross-border healthcare, primary care providers should be obliged to point patients in the direction of national contact points to give them the fullest information possible on their treatment options.
Člen 13 – odstavki 2a, 2b in 2c (novo)
Article 13 - paragraphs 2a, 2b and 2c (new)
Države članice zagotovijo sodelovanje med svojimi pristojnimi organi, da bi zagotovile zanesljivost informacij, ki so dane na voljo pacientom v skladu z določbami člena 10.
Member States shall ensure that their various competent authorities cooperate in order to guarantee that the information made available to patients in accordance with the provisions of Article 10 is reliable.
Države članice sodelujejo, da bi zagotovile zdravniško spremljanje in/ali zdravljenje možnih zapletov, ki nastanejo med izvajanjem zdravstvenega varstva v tujini.
Member States shall cooperate to ensure the medical follow-up and/or treatment of any complications resulting from healthcare provided abroad.
Država članica zdravljenja državi članici zdravstvenega zavarovanja, ki je odgovorna za prevzem stroškov spremljanja in/ali zdravljenja zagotavlja možnosti pravnih sredstev v primeru škode in zagotavlja dostop do zdravstvenih podatkov.
The Member State of treatment shall ensure that the Member State of affiliation responsible for providing that follow-up and or treatment has the possibility of redress in the event of harm and shall provide access to the medical file.
Vzpostavi se evropski register poklicnih kvalificiranih zdravnikov, ki so bili izbrisani iz zdravniškega registra ali proti katerim so ustrezni organi katere koli države članice v EU uvedli disciplinski postopek oziroma predpisali omejitve za opravljanje njihove dejavnosti;
There shall be an EU register of professional medical practitioners who have been struck off the medical register or are subject to restrictions or disciplinary procedures by the relevant authorities of any Member State in the EU.
Obveznost sodelovanja velja za nove določbe členov 5 in 10.
The duty to cooperate should apply to the new provisions of Articles 5 and 10.
Člen 14 – odstavek 1 – uvodni del
Article 14 – paragraph 1 – introductory part
Če je medicinski izdelek odobren za trženje na ozemlju držav članic v skladu s členom 6(1) Direktive 2001/83/ES, države članice zagotovijo, da se zdravniški recepti, ki jih za ta medicinski izdelek izda pristojna oseba v drugi državi članici za imenovanega pacienta, lahko uporabljajo na njihovem ozemlju in da so omejitve priznavanja posameznih zdravniških receptov prepovedane, razen če:
If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued for that medicinal product by an authorised person in another Member State for a named patient can be used in their territory and that any restrictions on recognition of individual prescriptions are prohibited unless they:
Člen 14 – odstavek 1 – točka b
Article 14 – paragraph 1 – point b
(b) temeljijo na legitimnih in utemeljenih dvomih o verodostojnosti ali vsebini posameznega zdravniškega recepta ali o pravici osebe, ki ga je predpisala, do izdaje recepta .
(b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the prescribing party's right to issue the prescription .
Člen 14 – odstavek 2 – uvodni del
Article 14 – paragraph 2 – introductory part
Komisija za olajševanje izvajanja odstavka 1 sprejme:
For facilitating the implementation of paragraph 1, the Commission shall adopt :
Komisija za olajševanje izvajanja odstavka 1 predlaga :
For facilitating the implementation of paragraph 1, the Commission shall suggest :
Navedeni ukrepi bodo brez dvoma vplivali na dejavnosti zdravstvenih delavcev in varstvo javnega zdravja.
The listed measures are bound to have an effect on the activities of healthcare professionals and the protection of public health.
Države članice bi morale obdržati pristojnost na tem področju.
Member States should be allowed to retain their competence in these fields.
Kot je priporočeno v mnenju evropskega nadzornika za varstvo podatkov, je to pomembno za visoko stopnjo zaščite podatkov.
As recommended in the EDPS opinion, this is important in order to have a high level of data protection
Člen 14 – odstavek 2 – točka (b a) (novo)
Article 14 – paragraph 2 – point b a (new)
(ba) ukrepe, s katerimi olajša stik med osebo, ki predpisuje, in osebo, ki izdaja, z željo po odpravi negotovosti v zvezi z receptom;
(ba) measures to facilitate contact between the prescribing party and the dispensing party with a view to resolving uncertainties about prescription;
Sistem priznavanja evropskih receptov bi moral dovoljevati neposreden stik med zdravniki in farmacevti.
A system of European prescriptions recognition should permit direct contact between doctors and pharmacists.
Neposreden stik je eden osnovnih predpogojev za odpravo negotovosti pri zdravljenju z zdravili in je v državah članicah že uveljavljena praksa.
Such direct contact is an essential precondition for the resolution of uncertainties concerning treatment with medicines, and is already current practice in the Member States.
Člen 14 velja tudi za recepte za zagotavljanje medicinskih pripomočkov, ki so dovoljeni v skladu z zakoni zadevne države članice.
Article 14 shall also apply to prescriptions for the supply of medical devices authorised in accordance with the laws of the Member State concerned .
Člen 15 – odstavek 3 – uvodni del in točka (a)
Article 15 – paragraph 3 – introductory part and point a
(a) seznam posebnih meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže, vključno s seznamom področij redkejših bolezni, ki jih je treba upoštevati, ter 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 a list of rarer disease areas needing to be taken into account 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:
Kakor je navedeno v obrazložitvenem memorandumu k predlogu Komisije (točka 8.3), je glavni cilj evropske referenčne mreže „zagotoviti zdravstveno varstvo pacientom, za zdravstveno stanje katerih je potrebna posebna koncentracija virov ali strokovnega znanja, da se zagotovi dosegljiva, visoko kakovostna in stroškovno učinkovita oskrba“.
As stated in the Explanatory Memorandum to the Commission proposal (point 8.3), the main objective of the European reference network is to ‘provide healthcare to patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care.’
Ta cilj se mora odražati tudi v ustreznem členu te direktive.
The relevant article of the directive should reflect this.
Člen 15 – odstavek 3 – točka (ba) (novo)
Article 15 – paragraph 3 – point b a (new)
(ba) ukrepe za zagotovitev finančne in geografske dostopnosti evropskih referenčnih mrež.
(ba) measures to ensure the financial affordability and geographical accessibility of European reference networks.
Če bo izvajanje določene specializirane oskrbe organizirano na evropski ravni, je treba zagotoviti jamstvo, da ostane dostopna.
If the provision of certain specialised care is to be organised at European level, guarantees must be provided that it remains accessible.
Zdravniki telemedicine, ki zagotavljajo zdravstveno varstvo pacientom v EU, so registrirani pri zdravstvenem zakonodajalcu države članice, iz katere se ponuja telemedicinsko zdravljenje.
Telemedicine practitioners who provide healthcare for patients in the EU shall be registered with the medical regulator of the Member State from where the telemedicine treatment is provided.
Zdravstveni zakonodajalci v državah članicah EU morajo urejati vse zdravnike, ki ponujajo zdravstveno varstvo za paciente v njihovih državah članicah, ne glede na kraj, iz katerega zdravnik ponuja takšno zdravljenje.
Medical regulators in EU Member States must regulate all doctors who provide healthcare for patients in their Member States, irrespective of where the practitioner is providing such treatment.
Sodelovanje pri upravljanju zdravstvene tehnologije
Cooperation on management of health technologies
Predlagana mreža se mora voditi po načelu dobrega upravljanja, kot je določeno v beli knjigi Komisije o evropskem upravljanju iz leta 2001, zlasti glede odprtosti, zanesljivosti, učinkovitosti in skladnosti.
The proposed network must be operated according to good governance principles, as established in the Commission’s White Paper on European Governance (2001), particularly with regard to openness, accountability, effectiveness and coherence.
V sodelovanju pri ocenjevanju zdravstvene tehnologije je treba poudarjati pregledne, objektivne ter vključujoče in pravočasne postopke.
Cooperation on health technology assessments should be to foster transparent, objective, inclusive and timely procedures.
Komisija lahko torej dovoli ocenjevanje zdravstvene tehnologije samo organom, ki ustrezajo tem standardom.
The Commission should therefore only admit health technology assessment authorities which meet these standards.
Predlog spremembe je povezan s predlogom spremembe uvodne izjave 43.
This amendment goes with an amendment to Recital 43.
Člen 17 – odstavek 1 a (novo)
Article 17 – paragraph 1 a (new)
Evropska komisija v sodelovanju z Evropskim parlamentom vzpostavi delovni okvir za mrežo, ki temelji na načelih dobrega upravljanja, vključno s preglednostjo, objektivnostjo, poštenimi postopki in polnim sodelovanjem vseh zainteresiranih družbenih skupin, tudi zdravstvenih delavcev, pacientov, raziskovalcev in industrije.
The European Commission shall, in consultation with the European Parliament, set up an operational framework for the network which is based on the principles of good governance including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant societal groups including healthcare professionals, patients, researchers and industry.
Člen 17 – odstavek 2 – točke a (a), (b) in (c) (novo)
Article 17 – paragraph 2 – point a a, b and c (new)
(aa) poiskati trajne načine, kako uravnovesiti cilje dostopa do zdravil, nagrajevanja inovacij in upravljanja proračunov za zdravstveno varstvo;
(aa) to find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets;
(ab) razviti pregledne , objektivne, vključujoče in pravočasne postopke in metodologije, ki bodo vzpostavile ravnovesje med cilji;
(ab) develop transparent, objective, inclusive and timely procedures and methodologies which are balancing all objectives;
(ac) zagotoviti polno sodelovanje vseh pomembnih družbenih skupin, zlasti pacientov, medicinske skupnosti in industrije;
(ac) ensure full participation of all relevant societal groups, in particular patients, medical community, research and industry;
(b) podpreti zagotavljanje objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih informacij o kratkoročni in dolgoročni učinkovitosti zdravstvene tehnologije ter omogočiti 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.
(b) podpiranje zagotavljanja objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih informacij o kratkoročni in dolgoročni učinkovitosti zdravstvene tehnologije in o morebitnih stranskih učinkih ter vplivih na družbo 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 on their possible side-effects and impacts on society, and enable an effective exchange of this information between national authorities or bodies.
Člen predvideva sodelovanje med organi, odgovornimi za oceno tehnološkega učinka v zdravstvenem sektorju.
This article provides for cooperation among the bodies responsible for technology impact assessments in the healthcare sector.
Ti organi razpolagajo z informacijami ne le v zvezi z učinkovitostjo tehnologij, pač pa tudi v zvezi z morebitnimi stranskimi učinki in spremembami, ki jih lahko prinesejo družbi.
These bodies possess information not only on the effectiveness of technologies but also on their possible side-effects and the changes they may bring about in society.
Zaradi tega mora priti tudi do izmenjave informacij o teh vprašanjih.
An exchange of information on these issues should therefore also take place.
Države članice določijo organe ali telesa, ki sodelujejo v mreži, kot je določeno v odstavku 1.
Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1.
Komisija dovoli sodelovanje v mreži le organom, ki izpolnjujejo načela dobrega upravljanja.
The Commission shall only allow authorities to join the network which fulfil the principles of good governance.
Predložena mreža se mora voditi po načelu dobrega upravljanja, kot je določeno v Beli knjigi Komisije o evropskem upravljanju iz leta 2001, zlasti glede odprtosti, zanesljivosti, učinkovitosti in skladnosti.
The proposed network must be operated according to good governance principles, as established in the Commission’s White Paper on European Governance (2001), particularly with regard to openness, accountability, effectiveness and coherence.
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 in upravljanje te mreže v skladu z omenjenimi cilji 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 according to the above objectives and specifying the nature and type of the information to be exchanged.
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 in zlasti 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 navaja 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.
Države članice Komisiji vsaj enkrat na leto predložijo podatke iz odstavka 1, razen podatkov, ki se že zbirajo v skladu z Direktivo 2005/36/ES.
Member States shall transmit the data referred to in paragraph 1 to the Commission at least annually , except for data that are already collected pursuant to Directive 2005/36/EC.
Države članice Komisiji po potrebi predložijo podatke iz odstavka 1, razen podatkov, ki se že zbirajo v skladu z Direktivo 2005/36/ES.
Member States shall, if necessary, transmit the data referred to in paragraph 1 to the Commission, except for data that are already collected pursuant to Directive 2005/36/EC.
Ocena potrebe po teh prenosih v upravičene namene bo vnaprej natančno določena.
An assessment of the necessity of these transfers for legitimate purposes will be duly specified in advance.
Obveznost prenosa podatkov Komisiji mora biti predmet ocenjene potrebe, ne pa letne določitve.
The obligation to transmit data to the Commission should be subject to an assessment of necessity rather than by definition on an annual basis.
Če se izvedbeni ukrepi nanašajo na 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 shall be consulted.
Kot je priporočeno v mnenju evropskega nadzornika za varstvo podatkov, se je pri teh vprašanjih treba posvetovati z njim.
As recommended in the EDPS opinion, it is important the EDPS is consulted on these matters.
Poročilo posveča posebno pozornost posledicam uporabe te direktive na mobilnost pacientov in vseh akterjev zdravstvenih sistemov držav članic.
That report shall pay particular attention to the effects of the application of this Directive on the mobility of patients and of all the actors in the Member States’ health systems.
Komisija, kadar je to potrebno, poročilu priloži predloge zakonodajnih sprememb.
If necessary, the Commission shall include with the report proposals for amending the legislation.
Države članice v ta namen in brez poseganja v člen 22 Komisiji sporočijo vsakršne ukrepe, ki so jih uvedle, spremenile ali ohranile z namenom izvajanje postopkov iz členov 8 in 9.
To that end and without prejudice to Article 22, the Member States shall communicate to the Commission any measure they have introduced, modified or maintained with a view to implement the procedures laid down in Articles 8 and 9.
Države članice v ta namen in brez poseganja v člen 22 Komisiji sporočijo vsakršne ukrepe, ki jih uporabljajo z namenom izvajanja direktive .
To that end and without prejudice to Article 22, the Member States shall communicate to the Commission any measure they are applying to implement the Directive.