BIG - The Ethics of Electronic Health Records (unpublished)
Various faculty at the IU Center for Bioethics have had a long-standing interest in the ethical issues associated with electronic health records (EHRs). These issues include who has access to these records; how patients understand their health information, in order to be more effective partners in their health care; and the potential for patients to be offered some level of “granular control” over their records allowing them to restrict access to some portion of their record to at least some personnel involved in their clinical care.
On the last point, the IUCB has participated in a project (2011-2013) exploring that very issue. In August 2012, we finalized a “Points to Consider” document – an ethics framework – to guide informaticists and medical personnel involved in designing and implementing EHR systems as they encounter the inevitable ethical quandaries that will arise. More on that project here.
These web pages highlight some of the ethical issues that arise in the context of EHRs and provide various resources and source materials for further reading. The issues we have addressed have most of their philosophical and public policy basis in notions of patient privacy and medical confidentiality.
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
The authors discuss several of the difficulties in current EHR systems related to sharing of electronic health records: 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.
Fairweather, N.B., Rogerson S. (July, 2001) A moral approach to electronic patient records. Medical Informatics & 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.
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.
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.
Gostin, Lawrence O. (September, 2009) Privacy: Rethinking Health Information Technology and Informed Consent. Connecting American Values with Health Reform, 15-17. PMID: 20446984
Gostin proposes a new definition of privacy tailored to protect patient dignity while not limiting equally valuable public health activities. Gostin proposes a new system of health information technology that safeguards patient privacy through policy, technology, and legal sanctions without significantly hindering the manner in which patient data could be used to improve public health and health care in general.
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.
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.
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
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.
Malin, BA, El Emam, K, O'Keefe, CM. (2013). Biomedical data privacy: problems, perspectives, and recent advances. Journal of the American Medical Informatics Association. 20:2-6. PMID: 23221359
The article provides an overview of issues raised with respect to personal privacy, generally, and medical information, specifically. Since it is the introductory article to a special issue on informatics, privacy, and data sharing, the article lays out the rationale for how the subsequent articles in the special issue are organized. For instance, some articles are characterized by being predominantly about collection, primary use, or secondary use. Other articles are either socio-legal in nature or technical. This article provides the context for each of the articles in the issue, and as such, presents a summary of the entire issue.
McGraw, D, Dempsey, JX, Harris, L, Goldman, J. (2009). Privacy as an enabler, not an impediment: building trust into health information exchange. Health Affairs. 28(2): 416-427. PMID: 19275998
The authors’ main thesis is that by building privacy and security protections into health information technology systems, trust in those systems will be enhanced, and their adoption will be bolstered.
Navarro, Robert. (October, 2008) An ethical framework for sharing patient data without consent. Informatics in Primary Care, 16, 257-262. PMID: 19192326
Navarro argues that when patient consent cannot be obtained, the ethical sharing of patient data should be guided by how great a risk to patient privacy each act of sharing entails, what Navarro calls privacy breach risk.
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.
Spriggs M, Arnold MV, Pearce CM, Fry C. (2012). Ethical questions must be considered for electronic health records. Journal of Medical Ethics. 38:535-539. PMID: 22573881
The authors argue that ethical issues (including privacy and consent) are often sublimated to technical issues in the design and implementation of electronic health record (EHR) initiatives, and they cite this fact as contributing to the failure of the UK EHR system. The article then focuses on ethical and conceptual issues that will impact the success/failure of EHRs, both in Australia (where the authors are based) and internationally. Among the issues/questions they raise are: issues of equity that arise in the context of personal control; who benefits and who pays; what are the legitimate uses of Australia’s Personally Controlled Electronic Health Record system (a patient opt-in EHR system); and how privacy should be implemented. (IUCB note: It should be pointed out that Australia’s EHR system is shifting “its status from a professionally controlled infrastructure to a personally control option.”)
Woodward, Beverly. (October, 2001). Confidentiality, Consent and Autonomy in the Physician-Patient Relationship. Health Care Analysis, 9 (3), 337-351. PMID: 11794836
Woodward argues that the uncertainty of disclosure rules for electronic medical systems hinders a patient’s ability to make an informed decision about sharing their medical information. (Note this article precedes HIPAA.)
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.
Ancker JS, Silver M, Miller MC, Kaushal R. (2013) Consumer experience with and attitudes toward health information technology: a nationwide survey. Journal of the American Medical Informatics Association, 20:152-156. PMID: 22847306
The authors conducted a survey of 1000 randomly selected individuals to ascertain their attitudes toward electronic health records (EHRs) and electronic health information exchange (HIE), both from a general perspective and with respect to privacy protections. The survey found that the 66% of respondents felt EHRs would improve healthcare quality, with respondents under the age of 40 most likely to feel this way. Fully 50% of respondents felt that EHRs would worsen privacy and security (18% felt privacy/security would improve). The survey also found that a 79% of respondents thought HIEs would improve healthcare quality, while 48% believed they would worsen privacy/security and 19% thought HIEs would improve privacy/security.
Hunter, Inga M. et. al. (September, 2009) New Zealander’s attitudes towards access to their electronic health records: Preliminary results from a national study using vignettes. Health Informatics Journal, 15 (3), 212-228 PMID: 19713396
This study aimed to find which attributes of information sharing were correlated with patients consenting to such sharing.
Markle Foundation. (2011). Markle survey on health in a networked life 2010. Available at http://www.markle.org/health/public-opinion-surveys/latest-surveys. January 31, 2011.
Markle commissioned two surveys (one with the public and one with physicians) in 2010, exploring the public’s and physician’s attitudes on federal health care reform and the health IT stimulus. Several findings were presented,
National Partnership for Women and Families. (2012). Making IT meaningful: how consumers value and trust health IT. Available at: http://www.nationalpartnership.org/site/PageServer?pagename=issues_health_IT_survey
This survey, conducted with support from The Commonwealth Fund, Merck & Co., Inc., WellPoint, Inc, and the California HealthCare Foundation, was released in February 2012. It surveyed 1,961 adults, attempting (among other things) to measure existing levels of patient trust in how providers use paper and electronic medical record systems today, and identify the demographic group(s) most and least worried about privacy and health IT.
Westin, AF. (2011). What two decades of surveys tell us about privacy and HIT today. Available at: http://patientprivacyrights.org/wp-content/uploads/2011/06/AFW-SUMMIT-6-13-11.pdf. Presented at the Health Privacy Summit; Washington, D.C. June 13, 2011.
Westin lays out central themes in the public’s attitudes toward health privacy. Between 1990-2011, 95 published surveys contained questions regarding health privacy. Throughout the timeframe, the a majority of the public’s attitude toward privacy and security concerns has been very consistent – i.e., that HIT programs will not earn the public’s trust if privacy and security issues are not successfully addressed and implemented. Moreover, privacy is chief among the concerns that the public identifies with HIT systems.
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.
Gellman R. Fair information practices: a basic history. Version 1.89; 2012 Apr 25. Available from: http://bobgellman.com/rg-docs/rg-FIPShistory.pdf.
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.
Markle Foundation. (2008-2012). The Connecting for Health Common Framework for networked personal health information. Available at http://www.markle.org/health/markle-common-framework.
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 hundreds of 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.
President's Council of Advisors on Science & Technology (PCAST). Report to the President realizing the full potential of health information technology to improve healthcare for Americans: a path forward. PCAST, Executive Office of the President, U.S. Washington, D.C.; 2010. 108 p [cited 2012 February 15]. Available from: http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf.
This report details the PCAST’s vision for how information technology can (and will) transform healthcare in the United States. The report identifies some of the current barriers in the healthcare system that discourage innovation and competition in the market to create health IT systems, such as the existence of proprietary applications; the view by healthcare organizations using EHRs that they are internal resources; the legitimate concerns patients have about privacy and security, which make patients uneasy about participating in health IT systems; and that health IT has been more oriented toward administrative functions than it has on better care.
National Committee on Vital and Health Statistics
National Committee on Vital and Health Statistics (NCVHS). Letter to the Secretary - Recommendations regarding Privacy and Confidentiality in the Nationwide Health Information Network; June 22, 2006. NCVHS. Available from: http://www.ncvhs.hhs.gov/060622lt.htm.
This letter from the NCVHS to the Secretary of HHS contains recommendations resulting from hearings and public meetings conducted by the Subcommittee on Privacy and Confidentiality, and covers topics such as the role of individuals in making decisions about the use of their personal health information, policies for controlling disclosures across the National Health Information Network (NHIN), regulatory issues such as jurisdiction and enforcement, use of information by non-health care entities, and establishing and maintaining public trust to ensure NHIN is a success.
National Committee on Vital and Health Statistics (NCVHS). Report to the Secretary of the U.S. Department of Health and Human Services on enhanced protections for uses of health data: a stewardship framework for “secondary uses” of electronically collected and transmitted health data; December 19, 2007. NCVHS. Available from: http://www.ncvhs.hhs.gov/071221lt.pdf.
This report addresses not only uses of health data for treatment, payment, and health care operations, but also for quality measurement, reporting and improvement; research; public health; and in exchange for money or other financial benefit. The report discusses the importance of data stewardship, and lays out observations and recommendations on enhanced protections for uses of health data.
National Committee on Vital and Health Statistics (NCVHS). Letter to the Secretary, Individual control of sensitive health information accessible via the Nationwide Health Information Network for purposes of treatment; February 20, 2008. NCVHS. Available from: http://ncvhs.hhs.gov/080220lt.pdf.
This letter recommends to the Secretary that he adopt a policy for the NHIN to allow individuals to have limited, uniform control over the disclosure of certain sensitive health information for treatment purposes. The letter discusses the importance of individual control, sequestering information in sensitive categories as a reasonable approach, notations of missing data for health care providers, emergency access, re-sequestration of sensitive information, and 8 recommendations regarding sequestration.
National Committee on Vital and Health Statistics (NCVHS). Health data stewardship: what, why, who, how. September 2009. NCVHS. Available from: http://www.ncvhs.hhs.gov/090930lt.pdf.
This Primer lays out the concepts of health data stewardship, “a responsibility, guided by principles and practices, to ensure the knowledgeable and appropriate use of data derived from individuals’ personal health information.” The concept of stewardship is intended to convey accountability in how personal health data are accessed and used. The Primer presents principles that are designed to protect the privacy and rights of patients and insure the quality and integrity of their data and its uses.
National Committee on Vital and Health Statistics (NCVHS). Letter to the Secretary - Recommendations regarding sensitive health information, November 10, 2010. NCVHS. Available from: http://www.ncvhs.hhs.gov/101110lt.pdf.
Based on its deliberations over several years, the letter to the Secretary recommends several steps in managing sensitive health information, which would also enhance patient trust in the system. (This letter is a follow-on to the NCVHS 2008 letter, which identified the different categories for sensitive health information. This letter sets out initial definitions of categories of sensitive information.)
Office of the National Coordinator for Health Information Technology and other HHS offices
Office of the National Coordinator for Health Information Technology (ONC). Nationwide privacy and security framework for electronic exchange of individually identifiable health information. ONC, U.S. Department of Health and Human Services; 2008 Dec 15. Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848088_0_0_18/NationwidePS_Framework-5.pdf.
This framework contains the ONC’s version of Fair Information Practice Principles.
Office of the National Coordinator for Health Information Technology (ONC). Health Information Exchange Challenge Grant Program. ONC, U.S. Department of Health and Human Services; 2011 [cited 2012 February 15]. Available from: http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=3378.
This website contains information about and the announcement for the Challenge grant program created within the American Recovery and Reinvestment Act (ARRA) (the portion of the law known as HITECH, The Health Information Technology for Economic and Clinical Health Act).
Health IT Policy Committee, Privacy and Security Tiger Team. Letter to David Blumenthal, Chairman of the Office of the National Coordinator for Health IT, August 19, 2010 [cited 2012 February 15]. Available from: http://healthit.hhs.gov/portal/server.pt/document/947492/tigerteamrecommendationletter8-17_2_pdf.
This letter details the Tiger Team’s initial draft recommendations on electronic exchange of patient identifiable health information among known entities to meet Stage I of the “meaningful use” requirements, for the HIT Policy Committee’s review and approval.
Goldstein M, Rein A. Consumer consent options for electronic health information exchange: policy considerations and analysis. Privacy and Security Whitepaper Series 2010. ONC, U.S. Department of Health and Human Services; 2010 Mar 23. Available from: http://www.healthit.gov/policy-researchers-implementers/advancing-privacy-and-security-health-information-exchange.
This White Paper discusses the various options for patient consent for records exchanged through electronic health information exchanges. The five options range from “no consent” (i.e., health information is automatically included, with no opt out) to “opt-in with restrictions” (no patient information is made available, although patients may allow select data to be included). The paper also discusses the issues and challenges for both policy and implementation for the range of consent schemes.
Goldstein M, Rein A. Data segmentation in electronic health information exchange: policy considerations and analysis. Privacy and Security Whitepaper Series 2010. ONC, U.S. Department of Health and Human Services; 2010 Sep 29. Available from: http://www.healthit.gov/policy-researchers-implementers/advancing-privacy-and-security-health-information-exchange.
This 66-page White Paper discusses key components of and issues arising from segmenting certain elements of health information. It also covers circumstances for the use of segmentation, associated benefits and challenges, various applied approaches, and the legal environment within which these efforts are occurring.
Standards for privacy of individually identifiable health information. Final Rule, 45 CFR parts 160, 162 and 164. (As amended through February 16, 2006.) Available from: http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/adminsimpregtext.pdf.
These are the final regulations issued by HHS to implement the privacy provisions of the Health Insurance Portability and Accountability Act of 1996.
Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH] and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule. 45 CFR Parts 160 and 164 January 25, 2013. Available from: http://federalregister.gov/a/2013-01073
This is the final rule to: 1) modify the HIPAA Privacy, Security, and Enforcement rules consistent with HITECH; 2) implement an increased, tiered civil money penalty structure; 3) make changes to the breach notification rule’s “harm” threshold; and 4) prohibit most health plans from using or disclosing genetic information for underwriting purposes, as required by the Genetic Information Nondiscrimination Act (GINA).