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)
  Copy   BIBTEX

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

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 90,616

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Autonomy, consent and the law.Sheila McLean - 2010 - New York, N.Y.: Routledge-Cavendish.
Informed consent: a primer for clinical practice.Deborah Bowman - 2012 - New York: Cambridge University Press. Edited by John Spicer & Rehana Iqbal.
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 and Ethics 36 (3):560-566.
Rethinking informed consent in bioethics.Neil C. Manson - 2007 - New York: Cambridge University Press. Edited by Onora O'Neill.

Analytics

Added to PP
2010-08-24

Downloads
14 (#846,545)

6 months
1 (#1,040,386)

Historical graph of downloads
How can I increase my downloads?

Citations of this work

No citations found.

Add more citations

References found in this work

No references found.

Add more references