23 results found (page 1 of 2)
https://www.federalregister.gov/articles/2011/01/07/2010-33174/establishment-of-the-perman…

…s, which would suggest that surveillance involves the reporting of only adverse events. Therefore, the commenter suggested using the term “monitoring” to describe the surveillance process because the commenter asserted that “monitoring” better conveys the process of assessing the…

https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-…

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…

https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-int…

…Additional Supply of Medication (Resupply) xii. Communicate Drug Administration Events (DrugAdministration) xiii. Request and Respond to Transfer One or More Prescriptions Between Pharmacies (RxTransferRequest, RxTransferResponse, RxTransferConfirm) xiv. Recertify the Continued A…

https://www.federalregister.gov/documents/2012/09/04/2012-20982/health-information-technol…

…ld be certified to this criterion without also being certified to the auditable events and tamper resistance certification criterion we proposed to adopt at § 170.314(d)(2) (due to the proposed policy change we specified in section IV.C.1 of the proposed rule related to EHR Modul…

https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and…

…nition B. Exceptions 1. Infeasibility a. Infeasibility Exception—Uncontrollable Events Condition b. Third Party Seeking Modification Use c. Manner Exception Exhausted 2. Manner Exception—TEFCA Reasonable and Necessary Activities a. Background b. TEFCA Condition for the “Manner” E…