Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.512

Document information
Reference	USA 45 CFR Part 160 09-Apr-2025
Validity area	USA
Scope(s)	G
Document name	45 CFR Part 160
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter C—Administrative Data Standards and Related Requirements Part 164 Security and Privacy https://www.ecfr.gov/current/title-45
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.1.3
Scope	G
Document part	§ 164.512
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Data protection, Requirements, FDA

Content

§ 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required. Except as provided by § 164.502(a)(5)(iii), a covered entity may use or disclose protected health information without the written authorization of the individual, as described in § 164.508, or the opportunity for the individual to agree or object as described in § 164.510, in the situations covered by this section, subject to the applicable requirements of this section and § 164.509. When the covered entity is required by this section to inform the individual of, or when the individual may agree to, a use or disclosure permitted by this section, the covered entity's information and the individual's agreement may be given verbally. [...] (b) Standard: Uses and disclosures for public health activities —

  (1) Permitted uses and disclosures. A covered entity may use or disclose protected health information for the public health activities and purposes described in this paragraph to:

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     (iii) A person subject to the jurisdiction of the Food and Drug Administration (FDA) with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity. Such purposes include:
        (A) To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations;
        (B) To track FDA-regulated products;
        (C) To enable product recalls, repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback); or
        (D) To conduct post marketing surveillance;

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