Overview:

Faculty members at the Indiana University Center for Bioethics at IU School of Medicine have a long-standing interest in the ethical issues associated with electronic health records (EHRs). These issues include access to records; patients’ understanding of their health information; and the potential for patients to have some level of granular control over their health and medical records. This control allows people to restrict access to some portion of their record to at least some personnel involved in their clinical care.

The IU Center for Bioethics participated in a project (2011-13) exploring the issue of granular control. In August 2012, the center finalized a “Points to Consider” document—an ethics framework—to guide informaticists and medical personnel involved in designing and implementing electronic health records systems as they encounter the inevitable ethical quandaries that arise.

Some of the ethical issues that arise in the context of electronic health records are detailed here through source materials for further reading. These issues focus primarily on patient privacy and medical confidentiality.

Ethical Analysis:

Principles of Medical Ethics

Fairweather, N.B., Rogerson S. (July, 2001) A moral approach to electronic patient records. Medical Informatics and The Internet in Medicine, 26 (3), 219-234. PMID: 11706931. The authors attempt to identify a moral approach to electronic patient records (EPRs) that generally promotes, and does not conflict with, fundamental principles of medical ethics.

Informed Consent

Frisse, ME. (2010). Health Information Technology and the Idea of Informed Consent. The Journal of Law, Medicine and Ethics, 38 (1), 27-35.  PMID: 20446981.

Goldstein argues that the current model of clinical informed consent, what she calls rule-based consent, is insufficient for satisfying the requirements of informed consent with regards to an EMR system, and must incorporate autonomous authorization.

Health Technology Training 

Goodman, Kenneth W. (Spring, 2010) Ethics, Information Technology, and Public Health: New Challenges for the Clinician-Patient Relationship. The Journal of Law, Medicine and Ethics, 38 (1), 58-63.

Goodman begins by identifying professional education as a major barrier to the use of health information technology (HIT). Clinical staff must be trained in its use for HIT to be fully utilized, and we actually have a duty to fully utilize it if it can provide health benefits to populations.

Treatment of Health Information 

Kluge, E-HW. (1994). Health information, the fair information principles and ethics. Methods of Information in Medicine. 33: 336-45.  PMID: 7799808. Kluge makes the point that because electronic patient records are “epistemic patient analogues in information space” that a traditional view of the records under a property model is insufficient to address how that information should be ethically handled. In other words, patient information should be treated as ethically and respectfully as one would treat the patient about whom the information pertains.

Legal Control of Health Data 

Kluge, E-HW. (1996). Professional ethics as basis for legal control of health care information. International Journal of Bio-Medical Computing. 43: 33-37.  PMID: 8960919.

Kluge develops a model code of ethics for handling computerized electronic patient records. He then lays out a set of principles for a model code of ethics.

Technological Capabilities 

Layman, E. (2003). Health informatics; ethical issues. Health Care Manager, 22(1), 2-15.  PMID: 12688606.

This article discusses some of the technological capabilities accompanying health informatics as well as ethical principles that can be applied to the challenges these capabilities raise. Layman suggests a variety of ways in which at least some of the ethical principles can be applied to address the technologies’ expansion

Patient Access 

Beard, L, Schein, R, Morra, D, Wilson, K, Keelan, J. (2012). The challenges in making electronic health records accessible to patients. Journal of the American Medical Informatics Association. 19:116-120.  PMID: 22120207.

Difficulties in current electronic health records systems related to sharing of electronic health records include cost and security concerns; issues in assigning responsibilities and rights among the various players; liability issues; and tensions between flexible access to data and flexible access to physicians.

Guiding Principles

Layman, E. J. (April, 2008) Ethical issues and the electronic health record. The Health Care Manager, 27 (2), 165-176.  PMID: 18475119.

Layman addresses key ethical principles related to electronic health records (EHRs) (beneficence, autonomy, fidelity, and justice) and examines how well current EHR implementations have succeeded in promoting these principles. Layman concludes by presenting four guiding principles that should be followed in order to create an EHR system that maximizes support to the ethical principles examined.

General Readings:

New Policy Development

Petersen C, DeMuro P, Goodman KW, Kaplan B. (2013). Sorrell v. IMS Health: issues and opportunities for informaticians. Journal of the American Medical Informatics Association. 20:35-37.  PMID: 23104048.

The authors discuss how “informaticians” can contribute to new policies that will be implemented as a result of the 2011 Supreme Court ruling that provider consent was not required before provider-identified pharmacy records of prescription information were sold for marketing purposes.

Impact of Health Data on Patients

Wynia M., Dunn K. (Spring, 2010) Dreams and Nightmares: Practical and Ethical Issues for Patients and Physicians Using Personal Health Records. Journal of Law, Medicine and Ethics, 38 (1), 64-73  PMID: 20446985.

The authors argue that much of the optimism surrounding electronic and personal health records is based on somewhat unrealistic thinking. The average patient might get overloaded by the information in their PHR and, instead of being engaged, they might get mental fatigue or suffer from decision paralysis. The authors suggest a number of ‘carrots’ to encourage patients to make ‘healthy’ choices regarding their PHRs.

Use of Health Data

Bloomrosen, M, Detmer, D. (2008). Advancing the framework: use of health data–a report of a working conference of the American Medical Informatics Association. Journal of the American Medical Informatics Association. 15(6): 715-722.  PMID: 18755988. This article presents the results of a group of experts convened in 2006 and 2007 to discuss ways to devise a national framework for health data use.

Fair Information Practice

Gellman R. Fair information practices: a basic history. Version 1.89; 2012 Apr 25.

This paper presents a comprehensive discussion of the development of Fair Information Practice (FIP) principles, starting with the 1973 report, “Records, Computers, and the Rights of Citizens,” and continues his history detailing many of the U.S. federal government documents that incorporate FIPs. The document concludes with a section of commentary and criticism of FIPs.

Structural Framework

Markle Foundation. (2008-12). The Connecting for Health Common Framework for networked personal health information.

The Framework consists of two major components: the Common Framework for Private and Secure Information Exchange and the Common Framework for Networked Personal Health Information. These multifaceted documents (several hundred pages, if printed out) present a fairly detailed analysis of the policy and technical aspects of networked electronic personal health information as well as guides for implementing these systems.

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