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According to this legislation, neither obtaining informed consent from patients nor approval by a medical ethics committee is obligatory for these types of observational studies that contain no directly identifiable patient data (art. 24 GDPR Implementation Act jo art. 9.2 sub j GDPR). For Nivel-PCD, the project has been approved by the relevant governance bodies of Nivel-PCD under number NZR-00320.087. As mentioned, the EHR data used in this study were pseudonymized before analysis.
J Med Internet Res 2025;27:e64628
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