art_67__para_2

2. The health data access application shall include: the health data applicant’s identity, a description of that health data applicant’s professional functions and activities, including the identity of the natural persons who would have access to the electronic health data if a data permit were issued; the health data applicant shall notify the health data access body of any update of the list of natural persons; the purposes referred to in Article 53(1) for which access to data is applied for; a detailed explanation of the intended use of the electronic health data and expected benefit related to that use and how that benefit would contribute to the purposes referred to in Article 53(1); a description of the requested electronic health data, including their scope, time range, format, sources and, where possible, the geographical coverage where such data are requested from health data holders in several Member States or from authorised participants in HealthData@EU referred to in Article 75; a description explaining whether the electronic health data need to be made available in a pseudonymised or anonymised format; in the case of a pseudonymised format, a justification as to why the processing cannot be carried out using anonymised data; where the health data applicant intends to bring datasets already held by that health data applicant into the secure processing environment, a description of those datasets; a description of the safeguards, which are to be proportionate to the risks, planned to prevent any misuse of the electronic health data, as well as to protect the rights and interests of the health data holder and of the natural persons concerned, including to prevent any re-identification of natural persons in the dataset; a justified indication of the period during which the electronic health data are needed for processing in a secure processing environment; a description of the tools and computing resources needed for a secure processing environment; where applicable, information on any assessment of ethical aspects of the processing, required under national law, which may serve to replace the health data applicant’s own ethics assessment; where the health data applicant intends to make use of an exception under Article 71(4), the justification required by national law pursuant to that Article.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.