Health Information Technology and the Idea of Informed Consent

King J. S. Moulton B. W. , “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law and Medicine 32, no. 4 (2006): 429–501, at 435.

Faden R. R. Beauchamp T. L. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986): at 276.

Id., at 277.

Id., at 280.

Id., at 277 (emphasis in original).

See King Moulton , supra note 1, at 437.

See Faden and Beauchamp , supra note 2, at 278.

Ahronheim J. Moreno J. , and Zuckerman C. , Ethics in Clinical Practice, 2nd ed. (Sudbury, MA: Jones and Bartlett Publishers, 2004): at 28; see Faden Beauchamp , supra note 2, at 280.

See Faden and Beauchamp , supra note 2, at 281–282.

Katz J. , “Disclosure and Consent,” in Milunsky A. Annas G. , eds., Genetics and the Law II (New York: Plenum Press, 1980): At 122 and 128.

See King Moulton , supra note 1, at 491.

Id., at 430

Id., at 431.

See Faden Beauchamp , supra note 2, at 284.

Smith V. K. Gifford K. , and Kramer S. , State E-Health Activities in 2007: Findings from a State Survey, The Commonwealth Fund, February 2008, available at <http://www.nga.org/Files/pdf/07EHEALTHSURVEYREPORT.PDF> (last visited December 1, 2009); see also State-level Health Information Exchange Consensus Project, “Profiles of State-level HIE Efforts,” available at <http://www.slhie.org/efforts.asp> (last visited December 2, 2009).

California Assembly Bill 1298 (October 14, 2007)); Cal. Civ. Code Ann. §§ 56.06; 1798.80 et. seq.; 1798.29(e)(4)-(5); 1785.11.2(n). (2009).

MidSouth Health Alliance, available at <http://www.mid-southeha.org> (last visited December 2, 2009).

WI Stat. §§ 146.82, 146.83.

See Smith , supra note 15.

Dimitropoulos L. L. , Privacy and Security Solutions for Interoperable Health Information Exchange: Assessment of Variation and Analysis of Solutions, Executive Summary, AHRQ Contract No. 290-05-0015, RTI International, 2007, available at <http://www.rti.org/pubs/avas_execsumm.pdf> (last visited December 2, 2009).

Health Information Security and Privacy Collaboration (HISPC), Executive Summary, RTI International, 2008, available at <http://privacysecurity.rti.org/Portals/0/HISPC_Exec_Summary_2008.pdf (last visited December 2, 2009).

Dimick C. , “Complicated Game: HISPC Privacy and Security Collaborative Hands Off Three Years of Work,” Journal of the American Health Information Management Association 80, no. 5 (2009): 20–25, at 24–25.

Health Information Security and Privacy Collaboration (HISPC), Intrastate and Interstate Consent Policy Options Collaborative: Final Report, RTI International, March 31, 2009, at 3–1, available at <http://healthit.hhs.gov> (last visited December 2, 2009).

Berner E. S. , “Ethical and Legal Issues in the Use of Health Information Technology to Improve Patient Safety,” Health-Care Ethics Committee Forum 20, no. 3, (2008): 243–258, at 244.

The Center for Democracy and Technology (CDT), “Rethinking the Role of Consent in Protecting Health Information Privacy,” January 2009, at 8, available at <http://www.cdt.org/healthprivacy/20090126Consent.pdf (last visited December 2, 2009).

CDT and the Markle Foundation, “Beyond Consumer Consent: Why We Need a Comprehensive Approach to Privacy in a Networked World,” February 2008, available at <http://www.cdt.org/healthprivacy/20080221consentbrief.pdf (last visited December 2, 2009).

Bloche M. G. , “Managed Care, Medical Privacy, and the Paradigm of Consent,” Kennedy Institute of Ethics Journal 7, no. 4 (1997): 381–86.

See CDT, supra note 25; see also Terry N. Francis L. , “Ensuring the Privacy and Confidentiality of Electronic Health Records,” University of Illinois Law Review 781 (2007): 681–735, at 725 (“patient “consent” to information sharing is often a nonnegotiable precondition to treatment – there is no genuine choice.”); Gostin L. O. , “Privacy: Rethinking Health Information Technology and Informed Consent,” in Connecting American Values with Health Reform, The Hastings Center, 2009, at 15–17, available at <http://www.thehastingscenter.org/uploadedFiles/Publications/Primers/privacy_gostin.pdf> (last visited December 2, 2009).

Beauchamp T. Childress J. F. , Principles of Biomedical Ethics, 6th ed. (New York: Oxford University Press, 2008): at 107.

McGuire A. Gibbs R. , “No Longer De-Identified,” Science 312, no. 5772 (2006): 370–371; Kluge E.-H. W. , “Informed Consent and the Security of the Electronic Health Record (EHR): Some Policy Considerations,” International Journal of Medical Informatics 73 (2004): 229–234.

See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at sections 3–2 to 3–3.

See, e.g., National Committee on Vital and Health Statistics (NCVHS) Reports and Recommendations, Report to the Secretary of the U.S. Department of Health and Human Services: Individual Control of Sensitive Health Information Accessible Via the NHIN for Purposes of Treatment, February 20, 2008, available at <http://ncvhs.hhs.gov/080220lt.pdf> (last visited December 2, 2009).

See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at 3–1.

Pritts J. Conner K. , “The Implementation of E-consent Mechanisms in Three Countries: Canada, England, and the Netherlands (The Ability to Mask or Limit Access to Health Data),” Georgetown Health Policy Institute and The Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, February 16, 2007, available at <http://ihcrp.georgetown.edu/papers.html> (last visited December 2, 2009).

Rothstein M. A. Talbott M. K. , “Compelled Disclosure of Health Information: Protecting Against the Greatest Potential Threat to Privacy,” JAMA 295, no. 24 (2006): 2882–2885.

See CDT, supra note 25, at 3.

Id., at 11 (“[C]onsent should ideally be part of a process of patient education, not just a form to sign or a box to check. Dialogue between provider and patient can enhance understanding of what is at stake in giving or withholding consent.”)

Markle Foundation, “Consumer Consent to Collections, Uses, and Disclosures of Information,” Connecting for Health Common Framework for Networked Personal Health Information, June 2008, at 2, available at <http://www.connectingfor-health.org> (last visited December 2, 2009).

See Kluge , supra note 30, at 230.

Id., at 232.

Id., at 229.

See Berner , supra note 24, at 248–249.

Id., at 251.

Kluge E.-H. W. , “Security and Privacy of EHR Systems – Ethical, Social and Legal Requirements,” Studies in Health Technology and Informatics 96 (2003): 121–127, at 126.

See Terry Francis , supra note 28, at 726; Markle Foundation, “Electronic Health Data Exchanges: Patient and Consumer Principles for System Design,” Connecting for Health, Personal Health Technology Council, October 2005, available at <http://www.connectingforhealth.org> (last visited December 2, 2009).

NCVHS Reports and Recommendations, Letter to the Secretary of the U.S. Department of Health and Human Services: Privacy and Confidentiality in the Nationwide Health Information Network (NHIN), June 22, 2006, available at <http://ncvhs.hhs.gov/060622lt.htm> [“NCVHS Privacy and Confidentiality”] (last visited December 1, 2009); see also NCVHS, supra note 32; CDT, supra note 25, at 16–17; D. McGraw, “Privacy and Health Information Technology,” in Legal Solutions in Health Reform, O'Neil Institute for National and Global Health Law, Washington, D.C., 2009, at 23.

See Pritts Conner , supra note 34.

Markle Foundation, “Connecting for Health: Networked Health Information,” Connecting for Health Common Framework for Networked Personal Health Information, 2006, available at <http://www.connectingforhealth.org/commonframework/#guide> (last visited December 4, 2009).

See CDT, supra note 25, at 15.

See discussion supra pp. 6, 10–11. (Will need to change these page numbers in proofs.)

See McGraw , supra note 46, at 25.

Goldstein M. M. Blumenthal D. , “Building an Information Technology Infrastructure,” Journal of Law, Medicine & Ethics 36, no. 4 (2008): 709–715, at 710.

See CDT, supra note 25, at 19.

See Goldstein , supra note 52.

See CDT, supra note 25, at 19.

See Markle Foundation, supra note 38.

See NCVHS Privacy and Confidentiality, supra note 46.

See discussion on page 30 of this article.

See CDT, supra note 25, at 21; Markle Foundation, supra note 38, at 2; see also Gostin , supra note 28, at 16 (“Although consent is a dominant theme in law and ethics, in practice it fails to adequately protect personal privacy[.]”)

See Beauchamp Childress , supra note 29, at 120.

Markle Foundation, “Connecting for Health, Notification and Consent When Using a Record Locator Service,” The Connecting for Health Common Framework: Resourcesfor Implementing Private and Secure Health Information Exchange, 2006, available at <http://www.connectingforhealth.org/common-framework/docs/P3_Notification_Consent.pdf> (last visited December 4, 2009).

See Faden Beauchamp , supra note 2, at 285.

Rothstein M. , “Improve Privacy by Eliminating Informed Consent? IOM Report Misses the Mark,” Journal of Law, Medicine & Ethics 37, no. 3 (2009): 507–512; Institute of Medicine, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health through Research (National Academies Press: Washington, D.C.: 2009): At 33.

See Gostin , supra note 28, at 16.

See CDT, supra note 25, at 17.

See WI Stat., supra note 18.

See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at 3–1.