Ley 14/2007, Confidentiality, Consent and Secrecy Rules for Personal Health Data in Biomedical Research in Spain
In force since .
A sensitive categories rule binding public and private bodies.
- Obligation class
- Consent, Security
- Audit expectation
- none
What it requires
- If you carry out biomedical research in Spain, keep the personal data and biological samples it produces confidential, disclose personal data to third parties outside the care or research activity only with the person's express written consent, and do not use health data for purposes other than those consented to (Ley 14/2007, Article 5(1) to (3)).
- Bind everyone who accesses personal data in a care or research activity to secrecy, including after the activity ends, and publish results that identify a participant only with that person's prior and express consent (Ley 14/2007, Article 5(4) and (5)).
These lines are LexLint's reading of the law's text.
What it makes you log
Logging duty
Article 5 sets confidentiality, consent and secrecy rules for personal data in biomedical research and names no log of access to or processing of the data.
- Kind
- None
- As of
What this law does
Article 5 of Ley 14/2007, the Biomedical Research Law, requires the protection of personal privacy and the confidential treatment of the personal data that result from biomedical research activity. The same guarantees apply to biological samples that are a source of personal information. Disclosing personal data to third parties outside the medical-care activity or a biomedical research requires the express written consent of the person concerned.
Using data about a person's health for purposes other than those for which consent was given is prohibited. Anyone who accesses personal data in the exercise of their functions in a medical-care activity or a biomedical research is bound by a duty of secrecy that persists after the activity has ended. Where research results cannot be published without identifying a participant or sample donor, they may be published only with that person's prior and express consent.
When LexLint raises it
When your app profile says your app handles health records or processes personal data.
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