№ files_lp_4_process_1_35198
Compliance guidance outlining conditions under which healthcare practices may use or disclose patient Protected Health Information for research, including authorization requirements, IRB or Privacy Board waivers, ongoing research protocol permissions, and limited data set data-sharing arrangements.
Subject: Use and disclosure of Protected Health Information (PHI) for research
Document Type: Compliance guidance
Sector: Healthcare
Regulatory Context: Health information privacy
Responsible Authority: Institutional Review Board (IRB); Privacy Board; U.S. Department of Health and Human Services (HHS)
Key Topics: Research authorization; waiver of authorization; limited data set; data use agreements; patient consent; privacy protection
Applicable Entities: Medical practices; healthcare providers conducting research
Related Agreements: Data Use Agreement; Business Associate Agreement
Record Retention Requirement: Minimum six years for signed authorizations
Authorization Elements: Patient authorization, revocation procedure, expiration statement
Research Oversight: Institutional Review Board (IRB) or Privacy Board review and waiver determinations
Price: 8 / 10 USD
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