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

Health Care Analysis 11 (3):207-218 (2003)
Abstract
The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has been widely criticized because—it is claimed—it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1023/B:HCAN.0000005493.21521.42
Options
 Save to my reading list
Follow the author(s)
Edit this record
My bibliography
Export citation
Find it on Scholar
Mark as duplicate
Request removal from index
Revision history
Download options
Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 30,749
Through your library
References found in this work BETA

No references found.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles
Autonomy, Consent and the Law.Sheila McLean - 2010 - Routledge-Cavendish.
The HIPAA Paradox: The Privacy Rule That's Not.Richard Sobel - 2007 - Hastings Center Report 37 (4):40-50.
Can Broad Consent Be Informed Consent?M. Sheehan - 2011 - Public Health Ethics 4 (3):226-235.
Research on Medical Records Without Informed Consent.Franklin G. Miller - 2008 - Journal of Law, Medicine & Ethics 36 (3):560-566.
Rethinking Informed Consent in Bioethics.Neil C. Manson - 2007 - Cambridge University Press.
Added to PP index
2010-08-24

Total downloads
2 ( #797,760 of 2,197,346 )

Recent downloads (6 months)
1 ( #298,877 of 2,197,346 )

How can I increase my downloads?

Monthly downloads

Sorry, there are not enough data points to plot this chart.
My notes
Sign in to use this feature