Document is current
Any future updates will be listed below
-
Authors
Pan, Yiheng https://orcid.org/0000-0003-1967-872X
Gorenflo, Maria P.
Davis, Pamela B.
Kaelber, David C.
De Luca, Susan
-
Funding
Funding for this research was provided by:
U.S. Department of Health & Human Services | NIH | National Institute on Alcohol Abuse and Alcoholism (AA029831)
U.S. Department of Health & Human Services | NIH | National Institute on Aging (AG057557, AG061388, AG062272, AG07664)
- License Information
-
More Information
Article History
Received: 22 February 2024
Revised: 14 July 2024
Accepted: 19 July 2024
First Online: 9 August 2024
Competing interests
: The authors declare no competing interests.
: TriNetX is compliant with the Health Insurance Portability and Accountability Act (HIPAA) and is certified to the ISO 27001:2013 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 of de-identifying data is attested to through a formal determination by a qualified expert as defined in Section §164.514(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’s in Cleveland, OH, has waived the need of ethical approval for this study.
: 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.
