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) 63: Enforce against users and holders, with fines of up to 20 million euro or 4 percent of turnover

Articles 63 and 64: access bodies may request information, notify findings and hear the party within four weeks, inform data protection authorities of possible GDPR breaches, revoke permits and stop processing, exclude users for up to five years, impose periodic penalty payments on holders that withhold data or miss deadlines and exclude repeat offenders from applying for up to five years; administrative fines reach 10 million euro or 2 percent of worldwide turnover for breaches of Articles 60 and 61(1), (5) and (6), and 20 million euro or 4 percent for prohibited uses, extracting personal data from secure environments, re-identification and ignoring enforcement measures.

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

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