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Article History

Received: 17 February 2023

Accepted: 12 September 2023

First Online: 18 September 2023

Declarations

:

: The authors declare no competing interests.

: This work was reviewed by the Institutional Review Board (IRB) for Health Sciences Research of the University of Virginia (IRB tracking ID #23100), which determined that this project did not meet the criteria for Human Subject Research; the IRB deemed no further submission/review necessary to proceed with this project.All methods were carried out in accordance with relevant guidelines and regulations.The need for informed consent was waived by the Institutional Review Board (IRB) for Health Sciences Research of the University of Virginia (IRB tracking ID #23100) because of the retrospective nature of the study.TriNetX is compliant with the Health Insurance Portability and Accountability Act (HIPAA), the US federal law which protects the privacy and security of healthcare data. TriNetX is certified to the ISO 27001:2013 standard and maintains an Information Security Management System (ISMS) to ensure 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, is de-identified according to the de-identification standard defined in Section § 164.514(a) of the HIPAA Privacy Rule. The process by which the data are de-identified is attested to through a formal determination by a qualified expert, as defined in Section § 164.514(b) [] of the HIPAA Privacy Rule. This formal determination by a qualified expert, refreshed in December 2020, supersedes the need for TriNetX’s previous waiver from the Western Institutional Review Board (IRB). The TriNetX network contains data provided by participating 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 utilised for research purposes. The data shared through the TriNetX Platform are minimised to ensure that they do not include sufficient information to facilitate the determination of which HCO contributed specific information about a patient [].

: Not applicable.