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) 68: Decide on permits within three months against the Article 68 criteria and set permit conditions

Article 68: the body grants a permit only if purposes match Article 53(1), data are necessary and proportionate, the GDPR lawful basis and pseudonymisation justification are met, the applicant is qualified, safeguards are sufficient, ethics and opt-out justifications comply, and national security and regulatory confidentiality risks are mitigated; it decides within three months of a complete application (extendable by three; two plus one for public health bodies under the accelerated procedure), may offer an anonymised statistical answer instead, requests data immediately and provides them within two months of receipt, states reasons for refusal, and sets permit content (data, purpose, authorised persons including the principal investigator, duration up to 10 years, once renewable, tools, fees, conditions); data are deleted within six months after expiry.

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

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