+Članak 51.
---+Article 51 1
---+Article 51 2
---+Article 51 3
---+Article 51 4
|
Članak 51.
1. Pregled
| Naslov |
Regulativa |
|
Article 51 1
|
1. Health data holders shall make the following categories of electronic health data available for secondary use in accordance with this Chapter:
|
(a)
|
electronic health data from EHRs;
|
|
(b)
|
data on factors impacting on health, including socioeconomic, environmental and behavioural determinants of health;
|
|
(c)
|
aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing;
|
|
(d)
|
data on pathogens that impact human health;
|
|
(e)
|
healthcare-related administrative data, including on dispensations, reimbursement claims and reimbursements;
|
|
(f)
|
human genetic, epigenomic and genomic data;
|
|
(g)
|
other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data;
|
|
(h)
|
personal electronic health data automatically generated through medical devices;
|
|
(i)
|
data from wellness applications;
|
|
(j)
|
data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person;
|
|
(k)
|
data from population-based health data registries such as public health registries;
|
|
(l)
|
data from medical registries and mortality registries;
|
|
(m)
|
data from clinical trials, clinical studies, clinical investigations and performance studies subject to Regulation (EU) No 536/2014, Regulation (EU) 2024/1938 of the European Parliament and of the Council (35), Regulation (EU) 2017/745 and Regulation (EU) 2017/746;
|
|
(n)
|
other health data from medical devices;
|
|
(o)
|
data from registries for medicinal products and medical devices;
|
|
(p)
|
data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results;
|
|
(q)
|
health data from biobanks and associated databases.
|
|
|
Article 51 2
|
2. Member States may provide in their national law that additional categories of electronic health data are to be made available for secondary use pursuant to this Regulation.
|
|
Article 51 3
|
3. Member States may establish rules for the processing and use of electronic health data containing improvements related to the processing of those data, such as correction, annotation or enrichment, based on a data permit pursuant to Article 68.
|
|
Article 51 4
|
4. Member States may introduce stricter measures and additional safeguards at national level aimed at safeguarding the sensitivity and value of the data that fall under paragraph 1, points (f), (g), (i) and (q). Member States shall notify the Commission of those measures and safeguards and, without delay, of any subsequent amendment affecting them.
|
,
1.1 Reference
1.2 Utvrđeni zahtjevi
1.3 Povezani standardi
2. Utvrđeni zahtjevi
3. Povezani standardi
- Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
- EULAW -
EN: Legal acts of the European Union from EUR-Lex, https://eur-lex.europa.eu/. © European Union. Re-use is authorised by Decision 2011/833/EU, provided the source is acknowledged; the consolidated texts are licensed under CC BY 4.0 (EUR-Lex legal notice). Divided into sections and converted into the GRCA format, the wording unchanged. Only the legislation published in the Official Journal of the European Union is deemed authentic.
DE: Rechtsakte der Europäischen Union aus EUR-Lex, https://eur-lex.europa.eu/. © Europäische Union. Weiterverwendung nach Beschluss 2011/833/EU mit Quellenangabe gestattet; die konsolidierten Fassungen stehen unter CC BY 4.0 (Rechtlicher Hinweis von EUR-Lex). In Abschnitte aufgeteilt und in das GRCA-Format umgewandelt, der Wortlaut unverändert. Verbindlich sind allein die im Amtsblatt der Europäischen Union veröffentlichten Rechtsakte.
|