Regulation on the European Health Data Space (EHDS)
Secondary use: health data access bodies and procedures – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 57: Run the access body tasks: decide, prepare data, supervise, and publish permits and refusals

Articles 57 and 58: access bodies decide on applications and requests, issue permits, provide access in secure environments, supervise users and holders, request, combine, pseudonymise or anonymise data, protect IP and trade secrets, oversee quality labels, keep a management system of applications and permits, publish the national dataset catalogue, each application on receipt, all permits, approvals and refusals with reasons within 30 working days, enforcement measures and results, and inform the public on legal bases, safeguards, rights, recipients and outcomes; they facilitate opt-out where assigned, pass significant findings to holders for the person or their clinician (who may decline them), and cooperate with supervisory authorities and the EHDS Board.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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