+PRILOG III. Tehnička dokumentacija
---+1. A detailed description of the EHR system including: (a) its intended purpose, and the date and …
---+2. A detailed description of the system in place to evaluate the EHR system performance, where …
---+3. The references to any common specification used in accordance with Article 36 and in relation to …
---+4. The results and critical analyses of all verifications and validation tests undertaken to …
---+5. A copy of the information sheet referred to in Article 38.
---+6. A copy of the EU declaration of conformity.
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PRILOG III. Tehnička dokumentacija
PRILOG III.
Tehnička dokumentacija
Tehnička dokumentacija iz članka 37. mora sadržavati barem sljedeće informacije, ovisno o tome što je primjenjivo na usklađene softverske komponente sustava elektroničkih zdravstvenih zapisa u relevantnim sustavima elektroničkih zdravstvenih zapisa:
1.
Detaljan opis sustava elektroničkih zdravstvenih zapisa, uključujući:
(a)
namjenu te datum i verziju sustava elektroničkih zdravstvenih zapisa;
(b)
kategorije osobnih elektroničkih zdravstvenih podataka za čiju je obradu sustav elektroničkih zdravstvenih zapisa osmišljen;
(c)
način na koji je sustav elektroničkih zdravstvenih zapisa u interakciji ili se može upotrijebiti za interakciju s hardverom ili softverom koji nije dio samog sustava elektroničkih zdravstvenih zapisa;
(d)
verzije relevantnog softvera ili integriranog softvera i sve zahtjeve povezane s ažuriranjem verzija;
(e)
opis svih oblika u kojima se sustav elektroničkih zdravstvenih zapisa stavlja na tržište ili u uporabu;
(f)
opis hardvera koji se planira koristiti za rad sustava elektroničkih zdravstvenih zapisa;
(g)
opis arhitekture sustava u kojem je objašnjeno kako se softverske komponente međusobno nadopunjuju ili potpomažu te kako su uključene u cjelokupnu obradu, uključujući prema potrebi označene slikovne prikaze (npr. dijagrami i crteži), koji jasno označuju ključne dijelove ili softverske komponente i sadržavaju objašnjenje koje je dovoljno za razumijevanje crteža i dijagrama;
(h)
tehničke specifikacije, kao što su značajke, dimenzije i odlike učinkovitosti, sustava elektroničkih zdravstvenih zapisa te svih inačica ili konfiguracija i pribora koji bi se obično naveli u specifikaciji proizvoda stavljenoj na raspolaganje korisniku, npr. u brošurama, katalozima i sličnim publikacijama, uključujući detaljan opis struktura podataka, pohrane i ulaza/izlaza podataka;
(i)
opis svih promjena sustava tijekom njegova životnog ciklusa;
(j)
korisničke upute za uporabu i prema potrebi upute za instalaciju.
2.
Prema potrebi, detaljan opis sustava za ocjenu učinkovitosti sustava elektroničkih zdravstvenih zapisa.
3.
Upućivanja na sve zajedničke specifikacije primijenjene u skladu s člankom 36. u odnosu na koje se navodi sukladnost.
4.
Rezultate i kritičku analizu svih testiranja u svrhu provjere i potvrđivanja provedenih radi dokazivanja sukladnosti sustava elektroničkih zdravstvenih zapisa sa zahtjevima iz poglavlja III., a posebno s primjenjivim bitnim zahtjevima.
5.
Primjerak informacijskog lista iz članka 38.
6.
Primjerak EU izjave o sukladnosti.
1. Pregled
| Naslov |
Regulativa |
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1. A detailed description of the EHR system including: (a) its intended purpose, and the date and …
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1.
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A detailed description of the EHR system including:
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(a)
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its intended purpose, and the date and version of the EHR system;
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(b)
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the categories of personal electronic health data that the EHR system has been designed to process;
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(c)
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how the EHR system interacts or can be used to interact with hardware or software that is not part of the EHR system itself;
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(d)
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the versions of relevant software or firmware and any requirement related to version update;
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(e)
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the description of all forms in which the EHR system is placed on the market or put into service;
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(f)
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the description of hardware on which the EHR system is intended to run;
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(g)
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a description of the system architecture explaining how software components build on or feed into each other and integrate into the overall processing, including, where appropriate, labelled pictorial representations (e.g. diagrams and drawings), clearly indicating key parts or software components and including sufficient explanation to understand the drawings and diagrams;
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(h)
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the technical specifications, such as features, dimensions and performance attributes, of the EHR system and any variants or configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications, including a detailed description of the data structures, storage and input/output of data;
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(i)
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a description of any change made to the system throughout its lifecycle;
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(j)
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the instructions for use for the user and, where applicable, installation instructions.
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2. A detailed description of the system in place to evaluate the EHR system performance, where …
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2.
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A detailed description of the system in place to evaluate the EHR system performance, where applicable.
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3. The references to any common specification used in accordance with Article 36 and in relation to …
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3.
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The references to any common specification used in accordance with Article 36 and in relation to which conformity is declared.
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4. The results and critical analyses of all verifications and validation tests undertaken to …
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4.
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The results and critical analyses of all verifications and validation tests undertaken to demonstrate conformity of the EHR system with the requirements laid down in Chapter III, in particular the applicable essential requirements.
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5. A copy of the information sheet referred to in Article 38.
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5.
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A copy of the information sheet referred to in Article 38.
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6. A copy of the EU declaration of conformity.
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6.
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A copy of the EU declaration of conformity.
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,
1.1 Reference
1.2 Utvrđeni zahtjevi
1.3 Povezani standardi
2. Utvrđeni zahtjevi
3. Povezani standardi
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