Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-26T09:02:16.414Z Has data issue: false hasContentIssue false

A New Age of Patient Transparency: An Organizational Framework for Informed Consent

Published online by Cambridge University Press:  01 January 2021

Abstract

With the many changes occurring in today's healthcare organizations, patients are increasingly equipped with a vast quantity of health care data and being more included in the healthcare decision-making process. The new approach we propose incorporates a new patient-organization framework that examines relevant historical, legal and ethical elements within the doctrine of informed consent in addition to examining the role of new healthcare organizations' obligations to include data to support addressing issues such as population health, health outcomes and health disparities within the informed consent. There is a growing consensus among healthcare professionals that using an evidencebased organizational informed consent framework to improve the informed consent process can lead to better comprehension, health outcomes, transparency and improved patient trust and retention overall.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Schenker, Y. and Meisel, A., “Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Concerns,” JAMA 35, no. 11 (2011): 1130-1131.CrossRefGoogle Scholar
Friedlander, W. J., “The Evolution of Informed Consent in American Medicine,” Perspectives in Biology and Medicine 38, no. 3 (1995): 498-510.CrossRefGoogle Scholar
Holmes, O. W., “The Young Practitioner,” in Medical Essays, 1842-1882 (Boston: Houghton Mifflin, 1911): at 388-389.Google Scholar
Baker, R., Before Bioethics: A History of American Medical Ethics from the Colonial Period to the Bioethics Revolution (Oxford University Press, 2013): at 233.CrossRefGoogle Scholar
Schloendorff v. Society of New York Hospitals, 211 NY 128, 105 NE 93(1914).Google Scholar
Nelson-Marten, P. and Rich, B., “A Historical Perspective of Informed Consent in Clinical Practice and Research,” Seminars in Oncology Nursing 15, no. 2 (1999): 81-88.Google Scholar
Canterbury v. Spence, 464 G2d 772, 776, 784 (DC Cir 1972).Google Scholar
Johnson v. Kokemoor, 545 NW 2d 495 (1996).CrossRefGoogle Scholar
Krause, J. H., “Reconceptualizing Informed Consent in an Era of Health Care Cost Containment,” Iowa Law Review 85, no. 1 (1999): 261-386, at 275.Google Scholar
Alan, M. and Loren, H. R., “Toward an Informed Discussion of Informed Consent: Review and Critique of the Empirical Studies,” Arizona Law Review 25, no. 2 (1983): 265-346, at 265, 283, 306.Google Scholar
Katz, J., “Informed Consent — Must It Remain a Fairy Tale?” Journal of Contemporary Health Law and Policy 10, no. 1 (1994): 69-91.Google Scholar
Wolf, S. M., “Toward a Systemic Theory of Informed Consent in Managed Care,” Houston Law Review 3, no. 5 (1999): 1631-81.Google Scholar
Rothberg, M. B., Sivalingam, S. K., and Ashraf, J. et al., “Patients' and Cardiologists' Perceptions of the Benefits of Percutaneous Coronary Intervention for Stable Coronary Disease,” Annals of Internal Medicine 153, no. 5 (2010): 307-313.Google Scholar
Wood, F., Martin, S. M., and Carson-Stevens, A. et al., “Doctor's Perspectives of Informed Consent for Non-Emergency Surgical Procedures: A Qualitative Interview Study,” Health Expectations 19, no. 3 (2014): 751-761.CrossRefGoogle Scholar
Sudore, R. L., Landefeld, C. S., and Williams, B. A. et al., “Use of a Modified Informed Consent Process among Vulnerable Patients,” Journal of General Internal Medicine 21, no. 8 (2006): 867-873.Google Scholar
See Wolf, supra note 12, at 1638.Google Scholar
Pub. L. 104-191, 110 Stat. 1988 (1996) (codified in scattered sections of 29 U.S.C., 42 U.S.C., and 18 U.S.C.).Google Scholar
Title II, Subtitle F of the HIPAA.Google Scholar
Miller, F., “Health Care Information Technology and Informed Consent: Computers and the Doctor-Patient Relationship,” Indiana Law Review 31, no. 4 (1998): 1019-1042, at 1026.Google Scholar
Jennings, B., Baily, M. A., Bottrell, M., and Lynn, J., eds., Health Care Quality Improvement: Ethical and Regulatory Issues (New York: The Hastings Center, 2007): at 16-27.Google Scholar
Pearson, S. D., Sabin, J., and Emanuel, E. J., No Margin, No Mission: Health-Care Organizations and the Quest for Ethical Excellence (Cary, NC: Oxford University Press, 2003): at 42.Google Scholar
Young, J., “Hospital Prices No Longer Secret as New Data Reveals Bewildering system, Staggering Cost Differences,” The Huffington Post, May 8, 2013, available at <http://www.huffingtonpost.com/2013/05/08/hospital-prices-cost-differences_n_3232678.html> (last visited December 14, 2016).+(last+visited+December+14,+2016).>Google Scholar
Silverman, H. J., “Organizational Ethics in Healthcare Organizations: Proactively Managing the Ethical Climate to Ensure Organizational Integrity,” HEC Forum 12, no. 3 (2000): 202-215.Google Scholar
Morreim, E. H., “To Tell the Truth: Disclosing the Incentives and Limits of Managed Care,” American Journal of Managed Care 3, no. 1 (1997): 35-43.Google Scholar
Floyd, J., Fowler, F. J., Levin, C. A., and Sepucha, K. R., “Informing and Involving Patients to Improve the Quality of Medical Decisions,” Health Affairs 30, no. 4 (2011): at 699-706.Google Scholar
Zikmund-Fisher, B. J., Couper, M. P., and Singer, E. et al., “The Decisions Study: A National Wide Survey of US Adults Regarding Nine Common Medical Decisions,” Medical Decision Making 30, no. 5, Supp. (2010): S20-S34.CrossRefGoogle Scholar
See Katz, supra note 11, at 154.Google Scholar
Tietz, G. F., “Informed Consent in the Prescription Drug Context: The Special Case,” Washington Law Review 61, no. 2 (1986): 367-417.Google Scholar
Morreim, E. H., Balancing Act: The New Medical Ethics of Medicine's New Economics (Georgetown University Press, 1995); E. H. Morreim, “Diverse and Perverse Incentives of Managed Care: Bringing Patients Into Alignment,” Widener Law Symposium Journal 1 (1995): 89-139.Google Scholar
Morreim, E. H., “Economic Disclosure and Economic Advocacy,” Journal of Legal Medicine 12, no. 3 (1991): 275-329.CrossRefGoogle Scholar
Schuck, P. H., “Rethinking Informed Consent,” Yale Law Journal Company 103, no. 4 (1994): 899-959.CrossRefGoogle Scholar
Pellegrino, E. D., “Hospitals as Moral Agents,” in Humanism and the Physician (Knoxville, TN: University of Tennessee Press, 1979).Google Scholar
The Johns Hopkins Hospital, “Patient Bill of Rights and Responsibilities,” 2012, available at <http://www.hopkins-medicine.org/the_johns_hopkins_hospital/_docs/bill_of_rights.pdf> (last visited December 14, 2016).+(last+visited+December+14,+2016).>Google Scholar