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Health Information Technology and the Idea of Informed Consent

Published online by Cambridge University Press:  01 January 2021

Melissa M. Goldstein
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Extract

As policy makers place great hope in health information technology (HIT) as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange (HIE) networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary (and possibly rightful) importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 1 , Spring 2010 , pp. 27 - 35
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

King, J. S. and 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.CrossRefGoogle Scholar
Faden, R. R. and Beauchamp, T. L., A History and Theory of Informed Consent (New York: Oxford University Press, 1986): at 276.Google Scholar
Id., at 277.Google Scholar
Id., at 280.Google Scholar
Id., at 277 (emphasis in original).Google Scholar
See King, and Moulton, , supra note 1, at 437.Google Scholar
See Faden, and Beauchamp, , supra note 2, at 278.Google Scholar
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.Google Scholar
See Faden, and Beauchamp, , supra note 2, at 281–282.Google Scholar
Katz, J., “Disclosure and Consent,” in Milunsky, A. and Annas, G., eds., Genetics and the Law II (New York: Plenum Press, 1980): At 122 and 128.Google Scholar
See King, and Moulton, , supra note 1, at 491.Google Scholar
Id., at 430Google Scholar
Id., at 431.Google Scholar
See Faden, and Beauchamp, , supra note 2, at 284.Google Scholar
Smith, V. K., Gifford, K., and Kramer, S. et al., 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).Google Scholar
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).Google Scholar
MidSouth Health Alliance, available at <http://www.mid-southeha.org> (last visited December 2, 2009).+(last+visited+December+2,+2009).>Google Scholar
WI Stat. §§ 146.82, 146.83.Google Scholar
See Smith, et al., supra note 15.Google Scholar
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).Google Scholar
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).Google Scholar
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.Google Scholar
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).+(last+visited+December+2,+2009).>Google Scholar
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.Google Scholar
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).Google Scholar
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).Google Scholar
Bloche, M. G., “Managed Care, Medical Privacy, and the Paradigm of Consent,” Kennedy Institute of Ethics Journal 7, no. 4 (1997): 381–86.CrossRefGoogle Scholar
See CDT, supra note 25; see also Terry, N. and 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).Google Scholar
Beauchamp, T. and Childress, J. F., Principles of Biomedical Ethics, 6th ed. (New York: Oxford University Press, 2008): at 107.Google Scholar
McGuire, A. and 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.CrossRefGoogle Scholar
See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at sections 3–2 to 3–3.Google Scholar
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).+(last+visited+December+2,+2009).>Google Scholar
See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at 3–1.Google Scholar
Pritts, J. and 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).+(last+visited+December+2,+2009).>Google Scholar
Rothstein, M. A. and Talbott, M. K., “Compelled Disclosure of Health Information: Protecting Against the Greatest Potential Threat to Privacy,” JAMA 295, no. 24 (2006): 2882–2885.CrossRefGoogle Scholar
See CDT, supra note 25, at 3.Google Scholar
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.”)Google Scholar
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).+(last+visited+December+2,+2009).>Google Scholar
See Kluge, , supra note 30, at 230.Google Scholar
Id., at 232.Google Scholar
Id., at 229.Google Scholar
See Berner, , supra note 24, at 248–249.Google Scholar
Id., at 251.Google Scholar
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.Google Scholar
See Terry, and 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).Google Scholar
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; McGraw, D., “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.Google Scholar
See Pritts, and Conner, , supra note 34.Google Scholar
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).+(last+visited+December+4,+2009).>Google Scholar
See CDT, supra note 25, at 15.Google Scholar
See discussion supra pp. 6, 10–11. (Will need to change these page numbers in proofs.)Google Scholar
See McGraw, , supra note 46, at 25.Google Scholar
Goldstein, M. M. and Blumenthal, D., “Building an Information Technology Infrastructure,” Journal of Law, Medicine & Ethics 36, no. 4 (2008): 709–715, at 710.CrossRefGoogle Scholar
See CDT, supra note 25, at 19.Google Scholar
See Goldstein, , supra note 52.Google Scholar
See CDT, supra note 25, at 19.Google Scholar
See Markle Foundation, supra note 38.Google Scholar
See NCVHS Privacy and Confidentiality, supra note 46.Google Scholar
See discussion on page 30 of this article.Google Scholar
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[.]”)Google Scholar
See Beauchamp, and Childress, , supra note 29, at 120.Google Scholar
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).+(last+visited+December+4,+2009).>Google Scholar
See Faden, and Beauchamp, , supra note 2, at 285.Google Scholar
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.Google Scholar
See Gostin, , supra note 28, at 16.Google Scholar
See CDT, supra note 25, at 17.Google Scholar
See WI Stat., supra note 18.Google Scholar
See HISPC, Intrastate and Interstate Consent Policy Options Collaborative, supra note 23, at 3–1.Google Scholar