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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 \u00a7164.514(a) of the HIPAA Privacy Rule. The process of de-identifying data is attested to through a formal determination by a qualified expert as defined in Section \u00a7164.514(b)(1) of the HIPAA Privacy Rule. The data shared through the TriNetX Platform are attenuated to ensure that they do not include sufficient information to facilitate the determination of which HCO contributed which specific information about a patient. The platform includes embedded statistical functions that conduct analyses on patient-level data. It presents the results and data on a population level, ensuring that no protected health information (PHI) identifiers are included (and therefore no risk of protected health information disclosure), Institutional Review Boards (IRBs) do not have jurisdiction over studies that utilize HIPAA de-identified data. Since the study concerns non-human subject research, consent from participants was waived and the Institutional Review Board (IRB) of MetroHealth System\u2019s in Cleveland, OH, has waived the need of ethical approval for this study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"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.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}],"article-number":"327"}}