Bae, Jay P
Kallenbach, Lee
Nelson, David R
Lavelle, Kevin
Winer-Jones, Jessamine P
Bonafede, Machaon
Murakami, Masahiro
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 24 October 2023
Accepted: 24 April 2024
First Online: 1 May 2024
Declarations
:
: The Veradigm Cardiology Registry only contains de-identified data as per the de-identification standard defined in Section § 164.514(a) of the Health Insurance Portability and Accountability Act of 1996 (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. U.S. law 45 Code of Federal Regulations Part 46, human participant protection regulations, and Protection of Human Subjects (45 CFR 46) requires institutional review board (IRB) approval for all research involving identifiable private information or identifiable biospecimens from human subjects as defined in 45 CFR 46.102(e)(5) and in 45 CFR 46.102(e)(6). However, protected health information that has been de-identified under the standard set for in 45 CFR 164.514(b)(1) is no longer considered to be identifiable health information and therefore is no longer subject to the IRB requirements set forth in 45 CFR 46. Because this study used only de-identified records, it is therefore no longer subject to the HIPAA Privacy Rule, the requirements for informed consent, or the IRB requirements set forth in 45 CFR 46. This study was conducted in compliance with the Declaration of Helsinki and used only de-identified data.
: Not Applicable.
: LK, KL, JPW, and MB are employees of Veradigm, which received fees from Eli Lilly and Company related to this work. JPB, DRN, MM are employees of Eli Lilly and Company.