Research During Public Health Emergencies Sample Clauses

Research During Public Health Emergencies a. During a national epidemic that has been declared a “Public Health Emergency” by the Secretary of the Department of Health and Human Services in accordance with Section 319 of the Public Health Service (PHS) Act, the Governing Council and Epic may vote to permit requests for a patient’s information using Care Everywhere to support research directly related to that Public Health Emergency. For the purposes of these Rules, “research” will have the meaning assigned to it under HIPAA (see 45 CFR 164.501). Upon such approval, if You are based in in the United States and are licensed for Epic’s Research module, You can request a patient’s information using Care Everywhere from other organizations in the United States for Public Health Emergency-related research purposes if Your request meets all of the following requirements: i. It is made to enable research that: 1. is directly related to treatment, testing, or vaccine development for that Public Health Emergency; and 2. has been approved by Your Institutional Review Board. ii. You have obtained informed consent and an authorization to use and disclose each research participant’s Protected Health Information for research purposes that each satisfy the requirements of 45 CFR Part 46, 45 CFR Section 164.508, and 21 CFR Parts 50 and 56 as applicable, and such consent and authorization clearly indicate to the participant that You intend to request their information from other healthcare organizations for research purposes that meet the requirements of Section 14(a)(i). b. You cannot make a request using Care Everywhere to initially identify or recruit research participants. c. You may opt out of responding to all requests for a patient’s information using Care Everywhere for research purposes during Public Health Emergencies. If You opt out of this use case, You agree that: i. You will not respond to any requests for a patient’s information using Care Everywhere for research purposes, regardless of which organization initiates a request. ii. You will not make any requests for a patient’s information using Care Everywhere for research purposes. d. Requests for research purposes are only permitted under this Section 14 throughout the duration of the applicable Public Health Emergency. Prior to the expiration or other termination of the Public Health Emergency, the Governing Council or Epic may decide to no longer permit requests for a patient’s information using Care Everywhere for research purposes related to tha...
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Related to Research During Public Health Emergencies

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