art_68__para_1

1. For the purposes of granting access to electronic health data, the health data access bodies shall assess whether all the following criteria are fulfilled: the purposes described in the health data access application correspond to one or more of the purposes listed in Article 53(1); the requested data are necessary, adequate and proportionate for the purposes described in the health data access application, taking into account data minimisation and purpose limitation requirements provided for in Article 66; the processing complies with Article 6(1) of Regulation (EU) 2016/679 and, in the case of pseudonymised data, there is sufficient justification that the purpose cannot be achieved with anonymised data; the health data applicant is qualified in relation to the intended purposes of data use and has appropriate expertise, including professional qualifications in the areas of healthcare, care, public health or research, consistent with ethical practice and applicable laws and regulations; the health data applicant demonstrates sufficient technical and organisational measures to prevent the misuse of the electronic health data and to protect the rights and interests of the health data holder and of the natural persons concerned; the information on the assessment of ethical aspects of the processing, referred to in Article 67(2), point (j), where applicable, complies with national law; where the health data applicant intends to make use of an exception under Article 71(4), the justification required by national law adopted pursuant to that Article has been provided; all other requirements in this Chapter are fulfilled by the health data applicant.

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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.