Law on the Rights of Patients (Pacientu tiesību likums), research use of patient data
Pacientu tiesību likums, s. 10(7) and s. 11(7)
In force since .
A de-identification rule binding public and private bodies.
- Instrument type
- an act of a legislature
- Obligation class
- Consent
What it requires
- Use patient data recorded in medical documents in research only if the information to be analysed cannot directly or indirectly identify the patient, or the patient has agreed in writing to the use of the information in that specific study (Patients' Rights Law s. 10(7)).
- Use information gained about a patient in a clinical study only with the consent of the patient, or of the person who consented to the patient's involvement, and only while the patient's anonymity is guaranteed (s. 11(7)).
These lines are LexLint's reading of the law's text.
What this law does
Section 10(7) of the Patients' Rights Law allows patient data recorded in medical documents to be used in research if the information to be analysed cannot directly or indirectly identify the patient, or if the patient has agreed in writing to the use of the information in that specific study.
Section 11(7) allows information gained in clinical studies about a patient to be used if the patient, or the person who consented on the patient's behalf, has given consent and the patient's anonymity is guaranteed. The Law has been in force since .
When LexLint raises it
When your app profile says your app handles health records, processes personal data or processes de-identified data.
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