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Article History

Received: 27 April 2025

Accepted: 8 July 2025

First Online: 26 August 2025

Declarations

:

: The study used de-identified data from the TriNetX Global Health Research Network. According to the local regulations (German Research Guidelines and § 15 of the Berlin State Hospital Act), the use of fully anonymized retrospective data does not require approval by an institutional ethics committee. Therefore, ethical approval was waived by the Ethics Committee of Charité– Universitätsmedizin Berlin. The requirement for informed consent was waived as all data were anonymized at the source. All methods were carried out in accordance with relevant guidelines and regulations. All HCOs reporting data to TriNetX obtained informed consent in writing from all patients and their legal guardians. TriNetX complies with the Health Insurance Portability and Accountability Act (HIPAA), the US federal law that protects healthcare data’s privacy and security. TriNetX is certified to the ISO 27001:2022 standard and maintains an Information Security Management System (ISMS) to ensure the protection of the healthcare data it has access to and to meet the requirements of the HIPAA Security Rule. Any data displayed on the TriNetX Platform in aggregate form, or any patient-level data provided in a data set generated by the TriNetX Platform, only contains de-identified data as per the de-identification standard defined in Section § 164.514(a) of the HIPAA Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert, as defined in Section § 164.514(b)(1) of the HIPAA Privacy Rule. This legal determination by a qualified expert, refreshed in 2022, supersedes the need for TriNetX’s previous waiver from the Western Institutional Review Board (IRB). The TriNetX network contains data provided by participating Healthcare Organizations (HCOs), each of which represents and warrants that it has all necessary rights, consents, approvals, and authority to provide the data to TriNetX under a Business Associate Agreement (BAA), so long as their name remains anonymous as a data source and their data are utilized for research purposes. The data shared through the TriNetX Platform are attenuated to ensure that they do not include sufficient information to determine which HCO contributed specific details on a patient [Available from: ].

: Not applicable.

: The authors declare no competing interests.