+Članak 69.
---+Article 69 1
---+Article 69 2
---+Article 69 3
---+Article 69 4
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Članak 69.
1. Pregled
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Regulativa |
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Article 69 1
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1. The health data applicant may submit a health data request for the purposes referred to in Article 53 with the aim of obtaining a response only in an anonymised statistical format. A health data access body shall not provide a response to a health data request in any other format and the health data user shall have no access to the electronic health data used to provide that response.
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Article 69 2
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2. A health data request as referred to in paragraph 1 shall include the following information:
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(a)
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the identity of the health data applicant and a description of that health data applicant’s professional functions and activities;
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(b)
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a detailed explanation of the intended use of the electronic health data, including the purposes referred to in Article 53(1) for which the health data request is submitted;
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(c)
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a description of the requested electronic health data, their format and the sources of those data, where possible;
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(d)
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a description of the statistical content;
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(e)
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a description of the safeguards planned to prevent any misuse of the requested electronic health data;
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(f)
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a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679 or Article 5(1) and Article 10(2) of Regulation (EU) 2018/1725;
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(g)
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where the health data applicant intends to make use of an exception under Article 71(4), the justification required in that regard by national law pursuant to that Article.
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Article 69 3
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3. The health data access body shall assess if the health data request is complete and take into account the risks referred to in Article 68(2).
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Article 69 4
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4. The health data access body shall assess the health data request within three months of receipt of the request and, where possible, subsequently provide the response to the health data user within a further three months.
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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
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