natgillin/translations-raw huggingface dataset:
guarantee the confidentiality of electronic health record systems as well as provide for appropriate technical and organisational measures, including rules on incident detection and management processes, in case of a breach of security or identity mechanisms leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of or access to personal data transmitted, stored or otherwise processed in electronic health record systems.
zagotavljati zaupnost sistemov za vodenje elektronskih zdravstvenih zapisov in določiti ustrezne tehnične in organizacijske ukrepe, npr. pravila o naključnem odkritju in postopkih upravljanja za primere kršenja varnosti ali mehanizmov identitete, ki vodijo do naključnega ali nezakonitega uničenja, izgube, spremembe, nepooblaščenega razkritja ali dostopa do osebnih podatkov, ki so bili preneseni, shranjeni ali kako drugače obdelani v sistemih za vodenje elektronskih zdravstvenih zapisov.
Incidents or violations should be identified promptly and effectively and measures or solutions should be put in place to manage such incidents, including informing and involving the individuals concerned, the national data protection supervisory authorities, and other appropriate stakeholders.
Incidente ali kršitve je treba pravilno in učinkovito identificirati ter izvesti ukrepe ali rešitve za obvladovanje tovrstnih incidentov, vključno z obveščanjem in vključevanjem zadevnih posameznikov, nacionalnih organov za nadzor varstva podatkov ter drugih zadevnih interesnih skupin.
Member States should furthermore:
Države članice morajo:
stimulate the deployment of security-enhancing products, processes and services to prevent and fight identity theft and other privacy-intrusive attacks;
spodbujati razvoj izdelkov, procesov in storitev za povečanje varnosti ter se bojevati proti kraji identitete in drugim vsiljivim napadom na zasebnost;
ensure that data protection safeguards are embedded in electronic health record systems, including through the widest possible use of Privacy Enhancing Technologies (PETs) in their design and implementation.
zagotoviti, da so nadzorni ukrepi za zaščito podatkov vključeni v sisteme za vodenje elektronskih zdravstvenih zapisov, vključno s pomočjo najširše uporabe tehnologij za varovanje zasebnosti (PET) pri njihovem oblikovanju in uporabi.
In order to ensure monitoring and evaluation of cross-border interoperability of electronic health record systems, Member States should:
Da bi države članice zagotovile spremljanje in vrednotenje čezmejne medobratovalnosti sistemov za vodenje elektronskih zdravstvenih zapisov, morajo:
consider the possibilities for setting up a monitoring observatory for interoperability of electronic health record systems in the Community to monitor, benchmark and assess progress on technical and semantic interoperability for successful implementation of electronic health record systems;
preučiti možnosti vzpostavitve nadzorne opazovalne skupine za medobratovalnost sistemov za vodenje elektronskih zdravstvenih zapisov v Skupnosti za spremljanje, primerjalno analizo in oceno napredka tehnične in semantične medobratovalnosti za uspešno uporabo sistemov za vodenje elektronskih zdravstvenih zapisov;
undertake a number of assessment activities.
izvesti določeno število ocenjevanj.
These could include defining the quantitative and qualitative criteria for measuring the eventual benefits and risks (including economic benefits and cost-effectiveness) of interoperable electronic health record systems and assessing the benefits and risks achieved by the systems and services developed by such practical demonstrators as the Large Scale Pilot projects (Pilot Actions A) that are incorporated within the Competitiveness and Innovation Programme ICT Policy Support Programme.
Ta lahko vključujejo določanje kvantitativnih in kvalitativnih kriterijev za merjenje potencialnih koristi in tveganj (vključno z ekonomskimi koristmi in stroškovno učinkovitostjo) pri medobratovalnih sistemih za vodenje elektronskih zdravstvenih zapisov ter oceno koristi in tveganj sistemov in storitev, ki so bili razviti v okviru praktičnih predstavitvenih projektov, kot so širši pilotni projekti („pilotni ukrepi A“), ki so vključeni v program za konkurenco in inovacije programa v podporo politikam IKT.
Education and awareness raising
Izobraževanje in ozaveščanje
In terms of education, training and awareness raising, Member States should:
Glede izobraževanja, usposabljanja in ozaveščanja morajo države članice:
increase awareness about the benefits of and need for standards in electronic health record systems and their interoperability among producers and vendors of information and communication technologies, healthcare providers, public health institutions, insurers and other stakeholders;
proizvajalce in prodajalce informacijskih in komunikacijskih tehnologij, ponudnike zdravstvenega varstva, javne zdravstvene ustanove, zavarovalnice in druge interesne skupine ozaveščati o koristih in potrebah ter standardih v sistemih za vodenje elektronskih zdravstvenih zapisov in njihovi medobratovalnosti;
consider requirements for education and training with regard to health policy-makers and health professionals;
preučiti zahteve za izobraževanje in usposabljanje oblikovalcev politike e-zdravja in zdravstvene delavce na visoki ravni;
pay particular attention to education, training and dissemination of good practices in electronically recording, storing and processing clinical information as well as in gaining informed consent of the patient and lawfully sharing patient’s personal data;
posebno pozornost nameniti izobraževanju, usposabljanju in širjenju dobrih praks o elektronskem zapisovanju, shranjevanju in obdelovanju kliničnih podatkov ter o ozaveščanju pacienta ter zakonitem širjenju podatkov ter razumevanja zahtev glede upravljanja podatkov;
provide parallel information and training, including awareness raising, for all individuals, in particular patients.
zagotoviti vzporedne informacije in usposabljanje, vključno z ozaveščanjem vseh posameznikov, zlasti pacientov.
Such an approach would make for more effective use of health information as patients move between a variety of healthcare providers, along the continuum of care, and receive whenever possible treatment, care and data in their own homes.
Tak pristop bi pripeljal do bolj učinkovite rabe zdravstvenih podatkov, saj pacienti prejemajo zdravstveno varstvo od različnih ponudnikov, ter dobijo zdravljenje, nego in podatke na dom.
Member States are invited to report, on a yearly basis, to the Commission on the measures they have taken in relation to the implementation of cross-border interoperability of electronic health record systems.
Države članice morajo vsako leto poročati Komisiji o ukrepih, ki so jih sprejele v zvezi z izvajanjem čezmejne medobratovalnosti sistemov za vodenje elektronskih zdravstvenih zapisov.
The first report should be presented by Member States one year following the day of publication of this Recommendation.
Prvo poročilo morajo države članice predstaviti eno leto po objavi tega priporočila.
The Recommendation is addressed to Member States.
To priporočilo je naslovljeno na države članice.
COM(2004) 356 final.
COM(2004) 356 konč.
COM(2007) 860 final.
COM(2007) 860 konč.
Directive modified by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
Direktiva, kakor je bila spremenjena z Uredbo (ES) št. 1882/2003 (UL L 284, 31.10.2003, str. 1).
Directive modified by Directive 2006/24/EC (OJ L 105, 13.4.2006, p. 54)
Direktiva, kakor je bila spremenjena z Direktivo 2006/24/ES (UL L 105, 13.4.2006, str. 54).
COM(2007) 228 final.
COM(2007) 228 konč.
Directive as last amended by Directive 2008/29/EC (OJ L 81, 20.3.2008, p. 51).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2008/29/ES (UL L 81, 20.3.2008, str. 51).
See at present Working Document 131 of 15 February 2007 on the processing of personal data relating to health in electronic health records.
Glej trenutni delovni dokument 131 z dne 15. februarja 2007 o obdelavi osebnih zdravstvenih podatkov v elektronskih zdravstvenih zapisih.
The European Parliament, on 23 May 2007, passed a Resolution on the impact and consequences of the exclusion of health services from the Directive on services in the internal market [3].
Evropski parlament je 23. maja 2007 sprejel resolucijo o vplivu in posledicah izključitve zdravstvenih storitev iz Direktive o storitvah na notranjem trgu [3].
The Resolution invites the Commission to encourage Member States to actively support the introduction of eHealth and telemedicine, particularly by developing interoperable systems allowing the exchange of patient information between healthcare providers in different Member States.
V resoluciji Komisijo poziva, da spodbuja države članice, naj aktivno podpirajo vzpostavitev e-zdravja in telemedicine, zlasti z razvojem medobratovalnih sistemov, ki omogočajo izmenjavo pacientovih podatkov med ponudniki zdravstvenih storitev v različnih državah članicah.
Member States should follow the guidance on electronic health record systems provided for by the Working Party set up under Article 29 of Directive 95/46/EC [9].14.
Države članice morajo slediti smernicam za sisteme za vodenje elektronskih zdravstvenih zapisov, ki jih je zagotovila delovna skupina, ustanovljena na podlagi člena 29 direktive 95/46/ES [9].14.
Member States should lay down a comprehensive legal framework for interoperable electronic health record systems.
Države članice morajo določiti obsežen pravni okvir za medobratovalne sisteme za vodenje elektronskih zdravstvenih zapisov.
on safe and efficient in-vehicle information and communication systems: update of the European Statement of Principles on human-machine interface
o varnih in učinkovitih avtomobilskih informacijskih in komunikacijskih sistemih: Posodobitev Evropske izjave o načelih glede vmesnika človek–stroj
(notified under document number C(2008) 1742)
(notificirano pod dokumentarno številko C(2008) 1742)
Whereas the Commission adopted Recommendation 2000/53/EC [1] on safe and efficient in-vehicle information and communication systems on 21 December 1999, notified under document number C(1999) 4786, and whereas it is essential to update this Recommendation in order to ensure safe use of in-vehicle information systems, taking due account of technological progress;
Komisija je 21. decembra 1999 sprejela Priporočilo 2000/53/ES [1], notificirano pod dokumentarno številko C(1999) 4786, o varnih in učinkovitih avtomobilskih informacijskih in komunikacijskih sistemih. To priporočilo je treba posodobiti, da se ob primernem upoštevanju tehnološkega napredka zagotovi varna uporaba avtomobilskih informacijskih in komunikacijskih sistemov.
Whereas further work was subsequently carried out by an expert group appointed by the Commission, on the expansion of the original principles, explaining each principle in more detail, describing the rationale and giving examples of good practices, as well as on the verification procedures, and the resultant report was published in July 2001;
Strokovna skupina, ki jo je imenovala Komisija, je naknadno razširila prvotna načela, pri čemer je vsako načelo podrobneje obrazložila in utemeljila ter navedla primere dobrih praks, pa tudi postopkov preverjanja. Poročilo o tem je bilo objavljeno v juliju 2001.
Whereas the Commission adopted a Communication on information and communication technologies for safe and intelligent vehicles on 15 September 2003, COM(2003) 542 final, including recommendations for human-machine interface as one of the priority actions;
Komisija je 15. septembra 2003 sprejela Sporočilo o informacijskih in komunikacijskih tehnologijah za varna in inteligentna vozila (COM(2003) 542 konč.), ki vsebuje tudi priporočila glede vmesnika človek–stroj kot enega izmed prednostnih področij.
Whereas the joint industry/public sector eSafety Forum established a Working Group on human-machine interface, which produced its final report in February 2005, confirming the necessity of updating the 1999 Recommendation;
Forum eSafety, v katerem sodelujeta industrija in javni sektor, je ustanovil delovno skupino za vmesnik človek–stroj. Skupina je februarja 2005 izdala končno poročilo, v katerem je potrdila potrebo po posodobitvi Priporočila iz leta 1999.
Whereas the Commission adopted a Communication (COM(2006) 59 final) on the i2010 Intelligent Car Initiative of 15 February 2006, and announced this Recommendation as one of the priority actions,
Komisija je 15. februarja 2006 v okviru pobude i2010 sprejela Sporočilo (COM(2006) 59 konč.) o pobudi Inteligentni avtomobil in to priporočilo označila za enega izmed prednostnih ukrepov –
PRESENTS THE UPDATE OF THE 1999 RECOMMENDATION ON HUMAN-MACHINE INTERFACE
PREDSTAVLJA POSODOBITEV PRIPOROČILA IZ LETA 1999 O VMESNIKU ČLOVEK–STROJ
This Recommendation asks all interested parties, such as the industry and professional transport-related organisations, to adhere to the updated European Statement of Principles, and the Member States to monitor their application and use.
To priporočilo vse zainteresirane strani, npr. industrijo in poklicne organizacije na področju prometa, poziva, da ravnajo v skladu s posodobljeno Evropsko izjavo o načelih, države članice pa, da spremljajo izvajanje in uporabo načel.
The updated European Statement of Principles (2006 version) summarises the essential safe design and use aspects to be considered for the human-machine interface (HMI) for in-vehicle information and communication systems.
Posodobljena Evropska izjava o načelih (različica iz leta 2006) povzema glavne vidike v zvezi z varno zasnovo in uporabo, ki jih je treba upoštevati pri razvoju vmesnika človek–stroj (HMI) za avtomobilske informacijske in komunikacijske sisteme.
This 2006 Recommendation and its Annex replace the previous 1999 Recommendation and Annex,
Priporočilo iz leta 2006 in njegova priloga nadomeščata Priporočilo iz leta 1999 in njegovo prilogo.
The European vehicle manufacturing and supply industries, which design and/or provide and/or fit in-vehicle information and communication systems, whether original equipment providers or after-market system providers, including importers and nomadic device suppliers, should comply with the attached updated European Statement of Principles and should enter into a voluntary agreement on this matter within a period of nine months from the publication of this Recommendation;
1. Evropska podjetja za proizvodnjo in dobavo vozil, ki razvijajo in/ali dobavljajo in/ali vgrajujejo avtomobilske informacijske in komunikacijske sisteme, naj gre za dobavitelje originalne opreme ali opreme, ki se vgradi naknadno, vključno z uvozniki in dobavitelji mobilnih naprav, morajo ravnati v skladu s posodobljeno Evropsko izjavo o načelih in glede tega vprašanja skleniti prostovoljen sporazum v devetih mesecih od objave tega priporočila.
Professional transport-related organisations (e.g. transport companies, vehicle rental companies) should commit to these principles within the same time-frame;
Poklicne organizacije na področju prometa (npr. prevozna podjetja in podjetja za izposojo avtomobilov) se morajo tem načelom zavezati v istem roku.
Member States should monitor activities linked to HMI, disseminate the updated version of the Statement of Principles amongst all relevant stakeholders, and encourage them to adhere to these principles.
Države članice morajo spremljati dejavnosti, povezane s HMI, razširjati posodobljeno različico izjave o načelih med vse ustrezne zainteresirane strani in jih spodbujati, da ravnajo v skladu s temi načeli.
Where appropriate, they should discuss and coordinate their actions through the Commission, the eSafety Forum or other appropriate forums (nomadic devices forum, etc.);
Po potrebi se morajo posvetovati in uskladiti svoje ukrepe s pomočjo Komisije, foruma eSafety ali drugih ustreznih forumov (forum za mobilne naprave itd.).
Member States should perform continuous evaluation and monitoring of the impact of the 2006 European Statement of Principles and report to the Commission about the dissemination activities carried out as well as the results of the application of the 2006 Principles within a period of 18 months from their publication.
Države članice morajo stalno vrednotiti in spremljati učinek Evropske izjave o načelih iz leta 2006 in Komisiji v 18 mesecih po njeni objavi poročati o dejavnostih razširjanja, ki se izvajajo, pa tudi o rezultatih uporabe načel iz leta 2006.
OJ L 19, 25.1.2000, p. 64.
UL L 19, 25.1.2000, str. 64.
Updated version of the European Statement of Principles on human-machine interface (HMI) for in–vehicle information and communication systems
Posodobljena različica evropske izjave o načelih glede vmesnika človek-stroj (HMI) za informacijske in komunikacijske sisteme v vozilih
Definition and objectives
Opredelitev in cilji
This Statement of Principles summarises essential safety aspects to be considered for the human-machine interface (HMI) for in-vehicle information and communication systems.
Ta izjava o načelih povzema bistvene varnostne vidike, ki jih je treba upoštevati pri vmesniku človek-stroj (HMI) za informacijske in komunikacijske sisteme v vozilih.
This updated text version for 2006 replaces the previous one drawn up in 1999.
Ta posodobljena različica za leto 2006 nadomešča prejšnjo iz leta 1999.
These principles promote the introduction of well designed systems into the market, and by taking into account both the potential benefits and associated risks they do not prevent innovation within the industry.
Ta načela spodbujajo uvedbo dobro oblikovanih sistemov na trg ter ob upoštevanju potencialnih koristi in s tem povezanih tveganj ne preprečujejo inovacij v industriji.
These principles presume that those applying them have technical knowledge of the products as well as access to the resources needed to apply the principles in designing these systems.
Ta načela predpostavljajo, da imajo njihovi uporabniki tehnično znanje o proizvodih in dostop do virov, potrebnih za uporabo načel pri oblikovanju teh sistemov.
Considering that the driver’s primary task is to control the vehicle safely in a complex and dynamic traffic environment, the primary goal of the principles is to fulfil this requirement.
Glede na to, da je primarna naloga voznika varno upravljanje vozila v kompleksnem in dinamičnem prometnem okolju, je primarni cilj načel izpolnitev te zahteve.
These principles also take into account the capabilities and constraints of all stakeholders in their efforts to design, install and use in-vehicle information and communication systems.
Ta načela upoštevajo tudi zmogljivosti in omejitve vseh zainteresiranih strani pri njihovem prizadevanju pri oblikovanju, namestitvi in uporabi informacijskih in komunikacijskih sistemov v vozilih.
Since the driver ultimately decides whether to buy and use, for example, an integrated navigation system, a nomadic device or a paper map, the intention is to promote good HMI design rather than prohibit the inclusion of some functionalities by simplistic pass/fail criteria.
Ker je na koncu voznik tisti, ki se odloči, ali bo kupil in uporabil npr. integrirani navigacijski sistem, mobilno napravo ali tiskano karto, je namen spodbujanje dobrega oblikovanja HMI in ne prepoved vključitve nekaterih funkcij s poenostavljenimi merili ustreznosti/neustreznosti.
These principles, which may be reinforced by national legislation or by individual companies, constitute the minimum set of requirements to be applied.
Ta načela, ki se lahko se dopolnijo z nacionalno zakonodajo ali s pravili posameznih podjetij, predstavljajo najmanjši sklop zahtev, ki jih je treba uporabljati.
These principles apply primarily to in-vehicle information and communication systems intended for use by the driver while the vehicle is in motion, for example navigation systems, mobile phones and traffic and travel information (TTI) systems.
Ta načela se uporabljajo predvsem za informacijske in komunikacijske sisteme v vozilih, namenjene voznikovi uporabi, ko je vozilo v gibanju, na primer navigacijske sisteme, mobilne telefone ter sisteme prometnih in potovalnih informacij (TTI).
Due to a lack of comprehensive research results and scientific proof, they are not intended to apply to systems that are voice controlled or to systems providing vehicle braking stabilisation (such as ABS and ESP), or to system functionality providing information, warnings or support requiring immediate driver action (e.g. collision mitigation systems, night vision), sometimes referred to as advanced driver assistance systems (ADAS).
Zaradi pomanjkanja rezultatov celostnih raziskav in znanstvenih dokazov se ne uporabljajo za sisteme, ki so glasovno nadzorovani, sisteme za uravnavanje stabilnosti zavor vozila (kot sta ABS in ESP) ali sistemske funkcije za posredovanje informacij, opozoril ali pomoči, ki zahtevajo takojšnje ukrepanje voznika (npr. sistemi za preprečevanje trčenj, nočno vožnjo), včasih imenovani sodobni sistemi za pomoč voznikom (ADAS).
ADAS are fundamentally different and require additional considerations in terms of human-machine interface.
ADAS se bistveno razlikujejo med seboj in zahtevajo upoštevanje dodatnih vidikov v zvezi z vmesnikom človek-stroj.
They also contain provisions for systems and their functionality that should not be used while driving.
Načela vsebujejo tudi določbe za sisteme in njihove funkcije, ki jih med vožnjo ni dovoljeno uporabljati.
The principles apply specifically to vehicles of categories M and N [1].
Načela se uporabljajo izrecno za vozila kategorij M in N [1].
They apply to both portable and permanently installed systems, and are intended to apply to systems and functionalities in OEM, after-market and nomadic systems.
Uporabljajo se tako za prenosne kot za trajno nameščene sisteme in so namenjena uporabi pri sistemih in funkcijah v sistemih proizvajalca originalne opreme (OEM), sistemih dodatne opreme in mobilnih sistemih.
They apply to HMI functionality independently of the degree of integration between systems.
Uporabljajo se za funkcije HMI, neodvisno od stopnje integracije med sistemi.
vehicle manufacturers offering in-vehicle devices with information and communication functionality,
proizvajalci vozil, ki ponujajo vgrajene naprave z informacijskimi in komunikacijskimi funkcijami,
after-market system and service producers,
ponudniki sistemov dodatne opreme in storitev,
providers of nomadic devices, intended to be used by a driver while driving,
ponudniki mobilnih naprav, namenjenih voznikovi uporabi med vožnjo,
manufacturers of parts enabling the use of nomadic devices by the driver while driving (e.g. cradles, interfaces and connectors),
proizvajalci sestavnih delov, ki omogočajo voznikovo uporabo mobilnih naprav med vožnjo (npr. vilic, vmesnikov in konektorjev),
service providers including software providers or broadcasters of information meant to be used by the driver while driving, e.g. traffic, travel and navigation information, radio programmes with traffic information.
ponudniki storitev, vključno s ponudniki programske opreme, ali oddajniki informacij, namenjeni voznikovi uporabi med vožnjo, npr. prometne, potovalne in navigacijske informacije, radijski programi s prometnimi informacijami.
Existing provisions
Obstoječe določbe
The principles are not a substitute for regulations and standards that should always be heeded and used.
Načela niso nadomestek za predpise in standarde, ki jih treba vedno upoštevati in uporabljati.
All standards are subject to revision, and users of this Statement of Principles should apply the most recent editions of the standards indicated here.
Vsi standardi se nenehno preverjajo, zato morajo uporabniki te izjave o načelih uporabljati najnovejše izdaje tukaj navedenih standardov.
Applicable EU Directives with their subsequent amendments include:
Veljavne direktive EU z njihovimi kasnejšimi spremembami so naslednje: