Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
Additional provisions – Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)

Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD) DA 17: Health research: follow the rules on broad consent, compatible reuse, pseudonymisation separation and ethics committee review

Seventeenth additional provision: listed health statutes provide the GDPR 9.2 g to j basis for health and genetic data; for health research, consent may cover general areas of a speciality; public health authorities may study data without consent in exceptional public health situations; reuse for related research areas is compatible if information is published on the centre's website and data subjects notified, with a favourable ethics committee report; pseudonymised data may be used if the research team is technically and functionally separated from those holding re-identification keys, with confidentiality and no re-identification commitments and specific security; research requires a DPIA covering re-identification risk, good clinical practice, and an EU representative for non-EU trial sponsors.

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