Commercial tissue repositories: HIPAA raises sponsors' fears

IRB Ethics and Human Research

Volumn 26, Issue 5, 2004, Pages 9-11

  Allen, Michael D ^a  

^a Pelino and Lentz PC ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONFLICT OF INTEREST; DONOR; ECONOMICS; HEALTH CARE FACILITY; HEALTH INSURANCE; HUMAN; INDUSTRY; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LEGAL APPROACH; LEGAL ASPECT; MEDICAL RESEARCH; MOORE V. REGENTS OF THE UNIVERSITY OF CALIFORNIA; ORGANIZATION AND MANAGEMENT; PHYSICIAN; PRIVACY; RESEARCH SUBJECT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH; MOORE V. REGENTS OF THE UNIVERSITY OF CALIFORNIA;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; CONFLICT OF INTEREST; CONSENT FORMS; DISCLOSURE; HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT; HUMANS; INDUSTRY; INFORMED CONSENT; OWNERSHIP; PHYSICIANS; PRIVACY; PRIVATE SECTOR; RESEARCH SUBJECTS; TISSUE DONORS; UNITED STATES;

EID: 13844280305     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563947     Document Type: Short Survey

References (6)

1. Health Insurance Portability and Accountability Act of 1996. http://www.hhs.gov/ocr/hipaa/
2. A specimen of human tissue or fluid itself, without any other information, is not likely to be deemed "protected health information" under HIPAA. However, since such specimens are usually accompanied with data that could be used to identify the individual donor, for practical purposes it is assumed that the protections of HIPAA apply.
3. 51 Cal-3d 120, 793 P.2d 479, 271 Cal. Rptr. 146 (1990), cert, den., 499 U.S. 936 (1991).
4. In Moore, the court was ruling on the demurrer of the defendants. In such a situation, the court determines whether a cause of action exists even if all of the facts asserted by the plaintiff are true. Since the parties eventually settled, it is important to note that Mr. Moore's factual allegations were never proved or disproved at trial.
5. Unlike repositories maintained by commercial sponsors, repositories maintained by covered entities, such as hospitals and physicians, are governed by HIPAA indefinitely. Therefore, not only must the addition of the specimen be conducted in accordance with HIPAA, but each future use of the specimen must also comply with HIPAA.
6. 45 C.F.R. § 46.116 and 21 C.F.R. § 50.20.