Murphy, Thomas R.
Busse, William
Holweg, Cecile T. J.
Rajput, Yamina
Raimundo, Karina
Meyer, Craig S.
Seetasith, Arpamas
Gupta, Sachin
Iqbal, Ahmar
Kaner, Robert J.
Article History
Received: 5 May 2022
Accepted: 17 October 2022
First Online: 14 November 2022
Declarations
:
: To protect patient anonymity and confidentiality in compliance with the Health Insurance Portability and Accountability Act of 1996, all data used in this analysis were deidentified. The study was conducted according to the International Conference on Harmonisation E6 Guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki 2013. Administrative permissions were not required to access the data. The study did not require institutional review board approval as this research falls under the HIPPA Privacy Rule for Research, Limited Data Sets with a Data Use Agreement. A data use agreement was entered into by both the covered entity (Optum Inc COVID-19 database) and the researcher (Genentech Inc), pursuant to which the covered entity may disclose a limited data set to the researcher for research, public health, or health care operations. See 45 CFR 164.514(e).Information on Optum.® de-identified COVID-19 Electronic Health Record dataset (2007–2021), August 2021Given the urgent need to clinically understand the novel virus of COVID 19, Optum developed a low latency data pipeline that enables minimal data lag, while preserving as much clinical data as possible. The data is sourced from Optum’s longitudinal EHR repository, which is derived from dozens of healthcare provider organizations in the United States, including more than 700 Hospitals and 7000 Clinics. The data is certified as de-identified by an independent statistical expert following HIPAA statistical de-identification rules (Guidance Regarding Methods for De‐identification of Protected Health Information in Accordance with the Health Information Insurance Portability and Accountability Act (HIPAA) Privacy Rule (Dated as September 4, 2012, as first released on November 26, 2012) and managed according to Optum® customer data use agreements.
: The study did not require consent for publication approval because only deidentified data were included. See information on the Optum Inc. database above.
: TRM has been part of speaker bureaus for ALK, AstraZeneca, Boehringer Ingelheim, Genentech, Inc., and Optinose, and an advisory board member for Stallergenes Greer. WB has received grant support from the National Institutes of Health (NIH)-National Institute of Allergy and Infectious Diseases, and consultant fees from AstraZeneca, Genentech, Inc., GlaxoSmithKline, Novartis, and Sanofi/Regeneron. CTJH, YR, and CSM are former employees of Genentech, Inc. AS holds stock in F. Hoffmann-La Roche Ltd. KR, AS, SG, and AI are employees of Genentech, Inc. RJK has consulted for Boehringer Ingelheim, Genentech, Inc., and United Therapeutics; has received research support from Boehringer Ingelheim and the NIH; was a clinical investigator for Bellerophon, the NIH, Respivant, and Toray; and was on the data and safety monitoring board for Pliant and PureTech.