HIPAA for Psychologists Privacy Rule Course FAQ

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.

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Requiring Consent vs. Waiving Consent for Medical Records Research: A Minnesota Law vs. the U.S. (HIPAA) Privacy Rule

Health Care Analysis ◽

10.1023/b:hcan.0000005493.21521.42 ◽

2003 ◽

Vol 11 (3) ◽

pp. 207-218

Author(s):

Beverly Woodward ◽

Dale Hammerschmidt

Keyword(s):

Medical Records ◽

Privacy Rule ◽

Hipaa Privacy Rule ◽

Medical Records Research ◽

The U.S

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The Impact of the Privacy Rule on Cancer Research: Variations in Attitudes and Application of Regulatory Standards

Journal of Clinical Oncology ◽

10.1200/jco.2009.22.3289 ◽

2009 ◽

Vol 27 (24) ◽

pp. 4014-4020 ◽

Cited By ~ 6

Author(s):

Elizabeth Goss ◽

Michael P. Link ◽

Suanna S. Bruinooge ◽

Theodore S. Lawrence ◽

Joel E. Tepper ◽

...

Keyword(s):

Cancer Research ◽

Future Research ◽

Research Committee ◽

Data Repositories ◽

Privacy Rule ◽

Regulatory Standards ◽

American Society ◽

Definition Of ◽

High Level ◽

The Impact

Purpose The American Society of Clinical Oncology (ASCO) Cancer Research Committee designed a qualitative research project to assess the attitudes of cancer researchers and compliance officials regarding compliance with the US Privacy Rule and to identify potential strategies for eliminating perceived or real barriers to achieving compliance. Methods A team of three interviewers asked 27 individuals (13 investigators and 14 compliance officials) from 13 institutions to describe the anticipated approach of their institutions to Privacy Rule compliance in three hypothetical research studies. Results The interviews revealed that although researchers and compliance officials share the view that patients' cancer diagnoses should enjoy a high level of privacy protection, there are significant tensions between the two groups related to the proper standards for compliance necessary to protect patients. The disagreements are seen most clearly with regard to the appropriate definition of a “future research use” of protected health information in biospecimen and data repositories and the standards for a waiver of authorization for disclosure and use of such data. Conclusion ASCO believes that disagreements related to compliance and the resulting delays in certain projects and abandonment of others might be eased by additional institutional training programs and consultation on Privacy Rule issues during study design. ASCO also proposes the development of best practices documents to guide 1) creation of data repositories, 2) disclosure and use of data from such repositories, and 3) the design of survivorship and genetics studies.

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