The designated record set for clinical genetic and genomic testing: A points to consider statement of the American College of Medical Genetics and Genomics (ACMG)

Author:

Tayeh Marwan K.,Chen Margaret,Fullerton Stephanie M.,Gonzales Patrick R.,Huang Samuel J.,Massingham Lauren J.,O’Daniel Julianne M.,Stewart Douglas R.,Stiles Ashlee R.,Evans Barbara J.

Publisher

Elsevier BV

Subject

Genetics (clinical)

Reference56 articles.

1. 45 CFR pts. 160, 164 (Privacy Rule), id. at § 164.501 (Definitions).

2. United States Department of Health & Human Services. Individuals’ right under HIPAA to access their health information 45 CFR § 164.524. Update January 31, 2020. Accessed June 3, 2022. https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html

3. 45 CFR § 160.103. Definitions.

4. Regulatory changes raise troubling questions for genomic testing;Evans;Genet Med,2014

5. 45 CFR § 164.512(i). Uses and disclosures for which an authorization or opportunity to agree or object is not required.

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