The Medical Librarian

Monday, March 20, 2006

e-Pathfinder: The Ethics of Electronic Medical Records

This e-pathfinder acts as an overview of the resources pertaining to ethics in relation to electronic patient records (EMRs). The development of EMRs (also known as electronic patient records and electronic health records) has created a new ethical discourse about what patient privacy and professional responsibility means. This dialogue (at times, heated) will continue as long as EMRs are adopted by more hospitals and legal battle lines are drawn.

Included here are print materials, electronic resources, academic, government, and non-profit institutions, and relevant citations/abstracts. There will be some overlap of information into bioethics. Most descriptions are excerpts from various sites where URLs were found, as noted.

PATHFINDER MAP:

MONOGRAPHS
JOURNALS
ETHICS CENTERS & PROFESSIONAL ASSOCIATIONS
ACADEMIC ETHICS CENTERS
OTHER WEB RESOURCES OF INTEREST: NON-PROFIT & FEDERAL
RELEVANT LINKS
CITATIONS & ABSTRACTS
EXPERTS



Library of Congress Subject Headings:

Medical informatics -- Moral and ethical aspects.
Medicine -- Information services -- Moral and ethical aspects.
Computer networks -- Social aspects.
Medical Informatics -- Case Reports.
Ethics, Medical -- Case Reports.

National Library of Medicine Subject Headings
:

Medical Informatics-- ethics.
Medical Records Systems, Computerized.
Ethics, Medical.
Disclosure.
Forms and Records Control.

MONOGRAPHS

Ethics and information technology : a case-based approach to a health care system in transition / Anderson, James G. & Goodman, Kenneth W.; New York: Springer, 2002

Table of Contents: Ch. 1. Introduction: case studies in ethics and health informatics -- Ch. 2. The business of cyber health care -- Ch. 3. Contents consumer health information: let the viewer beware (caveat viewor) -- Ch. 4. Privacy and confidentiality -- Ch. 5. The challenge of bioinformatics -- Ch. 6. Evaluation: an imperative to do no harm -- Ch. 7. Online challenges for human subjects research.

ISBN: 0387953086


Concise Encyclopedia of the Ethics of New Technologies /Chadwick, Ruth, Academic Press, 2001.

Publisher Description: The ethical assessment of new technologies raises two principal concerns: the need to develop effective policies and legislation, and the reconsideration of the ethical frameworks in which these policies and laws are developed. The importance of rapid, accurate examinations of tensions between Philosophy and Law and the relationship between philosophical principles and empirical data has never been greater. The Concise Encyclopedia of Ethics of New Technologies includes 23 articles previously published in the highly-acclaimed Encyclopedia of Applied Ethics, nine updated articles, and five new articles, commissioned especially for this volume. Over half of the previously published articles include updated facts and bibliographic citations. Authors of genetics articles have updated their works to include the most recent developments and publications. New articles include: "Cloning," "Geneticization," "Health Technology Assessment," "Intrinsic and Instrumental Value," and "Novel Foods."

ISBN: 0121663558


Health data in the information age: use, disclosure, and privacy / Donaldson, Molla S. & Lohr, Kathleen N.; Institute of Medicine (U.S.) (Committee on Regional Health Data Networks.); Washington, DC: National Academy Press, 1994.

Table of Contents: Health databases and health database organizations: uses, benefits and concerns -- Public disclosure of data on health care providers and practitioners -- Confidentiality and privacy of personal data -- Fact-finding for the committee on regional health data networks -- Committee on regional health data networks biographical sketches

ISBN: 0309049954


Ethics, computing, and medicine : informatics and the transformation of health care / Goodman, Kenneth W., Cambridge; New York: Cambridge University Press, 1998.

Table of Contents: Bioethics and health informatics : an introduction / Kenneth W. Goodman -- Medical informatics and human values / Terrell Ward Bynum and John L. Fodor -- Responsibility for computer-based decisions in health care / John W. Snapper -- Evaluating medical information systems : social contexts and ethical challenges / James G. Anderson and Carolyn E. Aydin -- Health care information : access, confidentiality, and good practice / Sheri A. Alpert -- Ethical challenges in the use of decision-support software in clinical practice / Randolph A. Miller and Kenneth W. Goodman -- Outcomes, futility, and health policy research / Kenneth W. Goodman -- Meta-analysis : conceptual, ethical, and policy issues / Kenneth W. Goodman

Publisher Description: New technology always raises compelling ethical questions. As those in medicine increasingly depend on computers and other intelligent machines, the intersection of ethics, computing and the health professions grows much more complex and significant. This book attempts systematically to identify and address the full range of ethical issues that arise when intelligent machines are used in medicine, nursing, psychology, and allied health professions. It maps and explores a variety of important issues and controversies, including ethics and evaluation in computational medicine, patient and provider confidentiality, responsibility for use of computers in medicine, appropriate use of decision support sThe Ontological Status of Electronic Patient Recordsystems, outcomes of research and computational prognosis (including mortality predictions), and computer-based biomedical research - especially meta-analysis. This book is accessible to participants in the fields of bioethics and medical informatics. It is appropriate for physicians, nurses, administrators, ethicists, health attorneys, advanced undergraduates and graduate students.

ISBN: 0521464862 (hardbound); 0521469058 (pbk.)


The ethics of electronic patient records / Kluge, Eike-Henner W. New York : P. Lang, 2001. (Series: International healthcare ethics, v. 6)

Table of Contents: Introduction: Computer-based Information Technology - Relevance of Ethical Considerations - The Appropriateness of an Ethical Basis/The Ethical Status of Electronic Patient Records: A Patient-Centred Perspective /Ethical Implications for the Physician /The Health Service Institution and Other Stakeholders/Ethical Implications for the Informatics Professional/Research, Marketing and Other Issues

ISBN: 0820452599 (alk. paper)


A handbook of ethics for health informatics professionals / Kluge, Eike-Henner. (British Computer Society. Health Informatics Committee.
International Medical Informatics Association.), Swindon, UK : Health Informatics Committee, British Computer Society, 2003.

Notes: "Endorsed by the International Medical Informatics Association."

ISBN: 1902505522


JOURNALS

The Internet Journal of Law, Healthcare and Ethics TM (ISSN: 1528-8250)

American Journal of Bioethics (ISSN:1526-5161)


ETHICS CENTERS & PROFESSIONAL ASSOCIATIONS

Center for Medical Ethics and Health Policy

Description from site: The Center for Medical Ethics and Health Policy is a joint project of Baylor College of Medicine and Rice University. Baylor is primarily responsible for administering the program. The joint sponsorship of the program enables the center to draw on the rich intellectual resources of both institutions.

The impetus for founding the center was in recognition that the ever-increasing abilities of medicine raise fundamental value questions of how society should use these abilities and how much of them society can afford to use. The very success of medicine has made its practice morally complex. The mandate of the center is to develop teaching and research programs that address the moral, legal and public policy questions raised by health care and the biomedical sciences.


International Medical Informatics Association (IMIA)
Description from site: The IMIA plays a major global role in the application of information science and technology in the fields of healthcare and research in medical, health and bio informatics. The basic goals and objectives of the association are to:

* promote informatics in health care and research in health, bio and medical informatics.
* advance and nurture international cooperation.
* to stimulate research, development and routine application.
* move informatics from theory into practice in a full range of health delivery settings, from physician's office to acute and long term care.
* further the dissemination and exchange of knowledge, information and technology.
* promote education and responsible behaviour.
* represent the medical and health informatics field with the World Health Organization and other international professional and governmental organizations.


IMIA Code of Ethics for Health Information Professionals: http://www.imia.org/English_code_of_ethics.html

Description from site: The reason for constructing a code of ethics for HIPs instead of merely adopting one of the codes that have been promulgated by the various general associations of informatics professionals is that HIPs play a unique role in the planning and delivery of health care: a role that is distinct from the role of other informatics professionals who work in different settings. Part of this uniqueness is centred in the special relationship between the electronic health record (EHR) and the subject of that record. The EHR not only reveals much about the patient that is private and should be kept confidential but, more importantly, it functions as the basis of decisions that have a profound impact on the welfare of the patient. The patient is in a vulnerable position, and any decision regarding the patient and the EHR must acknowledge the fundamental necessity of striking an appropriate balance between ethically justified ends and otherwise appropriate means. Further, the data that are contained in the EHR also provide the raw materials for decision-making by health care institutions, governments and other agencies without which a system of health care delivery simply could not function. The HIP, therefore, by facilitating the construction, maintenance, storage, access, use and manipulation of EHRs, plays a role that is distinct from that of other informatics specialists.


American Medical Informatics Association (AMIA)
Description from site: The AMIA plays a pivotal role in the transformation of the US health system and makes measurable contributions to the improvement of health of the nation through continued development and implementation of health information technology. AMIA is an integrating force that strengthens the nation’s ability to create and manage the science and knowledge base of health care. AMIA is active in the development of global health information policy and technology with particular emphasis on using health information technology to meet the health needs of underserved populations.
AMIA Launches 'GotEHR?' National Initiative Web Site to Promote the Use of Electronic Health Records for Patient Safety: http://www.amia.org/gotehr/about.html


American Health Information Management Association
Description from site: AHIMA is the former the American Medical Records Association. Site contains on-line Journal of AHIMA and IN Confidence (devoted to privacy, security and confidentiality issues). Also "consumer advice" on health information issues.


Medical Records Institute
Description from site: The Medical Records Institute's (MRI) Mission is to promote and enhance the journey towards electronic health records, e-health, mobile health, and related applications of information technologies (IT).

MRI does this by:

* Serving as an international forum for sharing knowledge, experience, and solutions with the healthcare community at large, but especially with healthcare practitioners, as well as professionals in information system (IS) and health information management (HIM), with vendors and vendor executives in regard to market strategies and technologies, and with patients, patient advocates and agents, and the general public, regarding the management of personal health information.
* Conducting international conferences, seminars, and other events, including Towards the Electronic Patient Record (TEPR), the annual conference on e-health and clinical IT issues.
* Publishing the Institute’s publication (Health IT Advisory Report) and Web sites.
* Supporting, coordinating, and leading the process of creating healthcare information standards.
* Acting as a voice of conscience on aspects of confidentiality, security, and social impact.


ACADEMIC ETHICS CENTERS

Center for Bioethics (University of Pennsylvania)
Center for Bioethics and Health Law (University of Pittsburgh)
Center for Biomedical Ethics (Case Western Reserve University)
Center for Clinical Bioethics (Georgetown University)
Center for Clinical Ethics and Humanities in Health Care (University of Buffalo)
Center for Health Care Ethics (Saint Louis University)
Center for Health Policy and Ethics (Creighton University)
Center for Medical Ethics and Health Policy (Baylor College of Medicine)
Center for the Study of Bioethics (Medical College of Wisconsin)
Centre for Applied Ethics (University of British Columbia)
Department of Health Management & Informatics (University of Missouri)
Free-Net Bioethics Information Center (University of Buffalo)
Healthlawblog
Institute for Bioethics (New York Medical College)
Kennedy Institute of Ethics (Georgetown University)
National Reference Center for Bioethics Literature (Georgetown University)
MacLean Center for Clinical Medical Ethics (University of Chicago)
Practical Ethics Center (University of Montana)


OTHER WEB RESOURCES OF INTEREST – NON-PROFIT & FEDERAL (compiled from: http://www.med.harvard.edu/publications/Milbank/art/www.html, Descriptions from site)

Center for Democracy and Technology
CDT is a non-profit public-interest advocacy organization, focusing on computer and communications policy issues, including privacy. Site has summaries of current policy issues, collection of background papers, links to other sites. Section on health information privacy issues.

CHAS Health-Related Links
List of health-related links, maintained by the Center for Health Administration Studies (CHAS), University of Chicago. A good starting point to find federal and state government, educational, journal and news source, professional association, and private corporation links.

Dept. of Health and Human Services, Data Council
The Data Council coordinates all health and non-health data collection activities of the DHHS. It is also responsible for implementation of the administrative simplification provisions of the Kassebaum-Kennedy Act (PL104-191). Site has links to other entities engaged in information policy activities.

Electronic Frontier Foundation
Another non-profit advocacy organization, devoted to privacy, free expression and other information issues. Site has comprehensive policy archive and "current events" listings. Links to other sites.

Electronic Privacy Information Center
Another non-profit advocacy organization, but focused on privacy issues. News about privacy and other computer/communications issues, policy and document archive, guide to current privacy-related legislation, and links to other privacy-focused sites. One of the best privacy-advocacy sites.

General Accounting Office
GAO's site has its reports and testimony (from FY 1995 to date), Comptroller General decisions and opinions, reports on federal agency major rules, and GAO policy and guidance materials.

HCIA: Health Care Information Associates
HCIA is a commercial "information content" provider, marketing bench-marking data and decision-support systems. It claims to maintain "industry's largest private health care database," and to serve the largest US insurance companies, managed care organizations, pharmaceutical manufacturers as well as over 1,500 hospitals.

National Association of Health Data Organizations
National health information organization dedicated to "improving health care through collection, analysis, dissemination and use of health care data." Reports, links to other sites, including the new National Health Information Resource Center project

National Committee on Vital and Health Statistics
NCVHS is the statutorily-mandated public advisory body to the Secretary of Health and Human Services in the area of health data and statistics. The NCVHS web site provides access to transcripts, minutes, testimony and written statements from its public meetings, including the on-going hearings under PL104-191.

Office of Technology Assessment
OTA ceased to exist in 199x, but the National Academy Press maintains an archive of all reports for downloading and printing.

Privacy Rights Clearinghouse
Like CDT, EFF and EPIC, a non-profit advocacy organization, focused on personal privacy issues.

Other relevant links:

American College of Physicians Center for Ethics and Professionalism
American College of Surgeons Ethics Page
American Medical Association
American Medical Association Institute for Ethics
American Philosophical Association
Center for Studying Health System Change
Department of Clinical Bioethics (NIH)
Department of Health and Human Services
National Medical Association
U.S. Department of Health and Human Services
U.S. Food and Drug Administration
Veterans Health Administration National Center for Ethics in Health Care

This extensive selection of links is from a great resource, Bioethics: A Pathfinder: Western New England College School of Law Library, (descriptions from site):

MAJOR WEB RESOURCES

It is a mistake to believe that any listing of websites can provide the researcher with a complete and current compilation of relevant links. However, there are many websites useful as starting points for bioethics research, and these major sites are noted below. Due to the nature of the Internet, there is no guarantee that the site will be as described or the address will be as listed. With this caveat, below are some of the major sites for bioethics research. Keep in mind that there are many different paths that can be used to locate a particular document; for example, to find a particular bioethics-related report, you might visit a government website, a major university research center website, or your favorite web search engine and enter the name of the report.

American Society for Bioethics and Humanities
Under “Resources,” this website provides a nice list of links to bioethics organizations and online resources.

American Society of Law, Medicine & Ethics
The American Society of Law, Medicine & Ethics provides scholarship, debate, and critical thought to the community of professionals at the nexus of law, medicine, and ethics. The website includes a good collection of links to bioethics resources.

Applied Ethics Links
The Applied Ethics site is from the Notre Dame Center for Ethics & Culture. Select the “Bioethics” category to view an extensive list of bioethics sites which is further subdivided into subjects such as academic centers, health law, government sites, and journals, etc.

Bioethics.net ¦ American Journal of Bioethics
Bioethics.net is produced by the Center for Bioethics at the University of Pennsylvania, and the American Journal of Bioethics, and is the most visited bioethics site on the Internet. The Features Menu offers resource pages including Bioethics for Beginners, Genetics, and Cloning. “Bioethics on MSNBC” offers summaries of recent news articles on bioethical issues, which link to full-text articles. Free Weekly News Updates are available via email. Abstracts and selected full-text articles from the American Journal of Bioethics are also available; the full-text of other articles may be available for purchase through the site.

Bioethics Resources on the Web – National Institutes of Health
Compiled by the National Institutes of Health, this site provides information about bioethics-related programs, news, publications, reports, guidelines, and laws and regulations. It offers comprehensive links to annotated resources providing background information and various positions on issues in bioethics. The brief annotations are divided into the following five categories: Bioethics and the NIH; Other Federal Resources; General Resources; Specific Topics (Genetics, Research Ethics, and Medicine and Health Care); and Organizations of Interest.

Biotechnology and Health Care Ethics
The Markkula Center for Applied Ethics at Santa Clara University provides this website offering articles, cases, and briefings in all fields of applied ethics. Select “Biotechnology and Health Care Ethics” and you will view relevant online sources, Center programs, and other internet links.

Center for Bioethics – University of Minnesota
A program of the University of Minnesota, the Center for Bioethics hosts research programs in various areas of bioethics. Each of these programs provides materials such as bibliographies, web resources, conference presentations, and news articles in its area of study. The Center also makes available its newsletter, “Bioethics Examiner,” and “Reading Packets” containing issue overviews, articles, and other sources of information.

Center for Bioethics and Health Law - Bioethics Links
The University of Pittsburgh provides an excellent collection of links to organizations and research institutions concerned with bioethics issues.

Center for Bioethics and Human Dignity
The Center is a national and international leader in producing a wide range of resources examining bioethical issues. It is a great site for news and current events, and provides a good collection of links and research bibliographies.

Center for the Study of Bioethics
Provided by the Medical College of Wisconsin, the website offers a comprehensive collection of web resources.

Hastings Center
The Hastings Center is an independent, nonprofit bioethics research institute that explores emerging questions in health care and biotechnology. The Center’s research projects range from ethical decision-making for newborn genetic screening to surgically shaping children. The Center offers a catalog of the Center’s library holdings and a selection of websites that may be useful for bioethics research.

Johns Hopkins Bioethics Institute
The Bioethics Institute website features a list of recent news stories in bioethics.

National Library of Medicine
The National Library of Medicine home page provides web access to the world’s largest medical library, including access to the MEDLINE database. Under “Health Information” click on the link to “Bioethics” to access the published literature on the ethical, legal, and public policy issues surrounding health care and biomedical research.

National Reference Center for Bioethics Literature
The National Reference Center for Bioethics Literature (NRCBL) is maintained by the Kennedy Institute of Ethics at Georgetown University. It is a specialized collection of books, journals, newspaper articles, legal materials, regulations, codes, government publications, and other pertinent documents concerned with issues in biomedical and professional ethics. This site includes the searchable databases: ETHX on the web (Journal articles, analytics, bills, laws, court decisions, reports, and news articles relating to bioethics and professional ethics) and Genetics and Ethics (books, journal articles, analytics, bills, laws, court decisions, reports, news articles and audiovisuals).

The President’s Council on Bioethics
The Presidential Council was created to study and advise the President on specific areas of concern, including cloning, stem cell research, drugs, sex selection and research ethics. This page hosts background information on the Council’s areas of investigation, council documents, and its executive authorization. Information provided includes articles, working and background papers, transcripts of council sessions, and agendas of past meetings. Other information includes suggested reading material and links to other bioethical commissions.

UNESCO’s International Bioethics Committee
UNESCO’s Bioethics Programme maintains two advisory bodies, the International Bioethics Committee (IBC) and the Intergovernmental Bioethics Committee (IGBC), which offer advice and make recommendations to UNESCO on subjects of bioethical concern. This page includes access to bioethics declarations, reports, committee proceedings, and other publications of both Committees.


RELEVANT CITATIONS & ABSTRACTS (COMPILED FROM PUBMED)

Public Health. 2005 Nov;119(11):1003-10. Epub 2005 Sep 26.
Comment in: Public Health. 2005 Nov;119(11):949-51.

Attaining adequate consent for the use of electronic patient records: an opt-out strategy to reconcile individuals' rights and public benefit.

Clark AM, Findlay IN.

Faculty of Nursing, University of Alberta, Edmonton, Canada, and Department of Cardiology, Royal Alexandria Hospital, Paisley, UK.

Electronic patient records (EPRs) hold great promise for improving patient care and public health. However, governments in Europe and North America have recently adopted legislation for the processing of personal data. In the United Kingdom there is a consensus that the Data Protection Act (1998) and the Human Rights Act (1998) have significant implications for the consent required for health data to be processed or passed. However, interpretations of these implications have been wide-with considerable differences apparent between regulatory bodies, government, researchers and practitioners. These arguments centre on the form of consent generally required to pass electronic personal data to health care personnel for use in decisions about the health care of populations or the individual, the circumstances in which different methods of consent are appropriate and the sufficiency of the public interest needed to counter the need for direct informed consent. To assist those developing EPRs or similar systems, we present the 'opt-out' consent strategy used for the implementation of the Coronary Heart Disease (CHD) Register developed as part of the Scottish Executive National CHD Demonstration Project. This strategy balanced the individual's right to consent with the public interest by taking all reasonable steps to inform residents about the potential direct and indirect purposes of the register, storage arrangements and types of individuals likely to access personal and anonymised data on the register. Simultaneously, the population was provided with easy and equally available opportunities to opt-out of inclusion.

PMID: 16185734 [PubMed - indexed for MEDLINE]


Medinfo. 2004;11(Pt 1):635-8.

Informed consent to the secondary use of EHRs: informatic rights and their limitations.

Kluge EH.

Department of Philosophy, University of Victoria and WG4 (Security and Confidentiality) IMIA, Victoria, British Columbia, Canada V9W 3P4. ekluge@uvic.ca

It is frequently asserted that the secondary use of data contained in electronic health records (EHRs) requires the informed consent of the subjects of these records. This paper argues that while correct in principle, this has four important ethically based limitations: when it seriously threatens the equal and competing right of others, when it undermines the ability of health care providers to carry out their mandates, when it imperils the possibility of establishing and maintaining a health care system in the first place, and when it makes bona fide research impossible. Nevertheless, as a general rule, when consent can be had, it should be had. This paper provides a theoretical basis for these claims by looking at the nature and role of EHRs and provides some possible approaches for incorporating them into the health care delivery process.

PMID: 15360890 [PubMed - indexed for MEDLINE]


J Healthc Inf Manag. 2003 Summer;17(3):41-8.

EMR confidentiality and information security.

Kurtz G.

Geisinger Health System, Danville, PA, USA.

Healthcare is no longer one patient and one physician. Many people and services are involved, and they all need access to the same accurate, complete data to provide excellent care. The onus is on healthcare providers to come up with information security solutions that don't hinder patient care while still providing the confidentiality of patient information.


Stud Health Technol Inform. 2003;96:121-7.

Security and privacy of EHR systems--ethical, social and legal requirements.

Kluge EH.

University of Victoria, BC, Canada. ekluge@uvic.ca

This paper addresses social, ethical and legal concerns about security and privacy that arise in the development of international interoperable health information systems. The paper deals with these concerns under four rubrics: the ethical status of electronic health records, the social and legal embedding of interoperable health information systems, the overall information-requirements healthcare as such, and the role of health information professionals as facilitators. It argues that the concerns that arise can be met if the development of interoperability protocols is guided by the seven basic principles of information ethics that have been enunciated in the IMIA Code of Ethics for Health Information Professionals and that are central to the ethical treatment of electronic health records.


Medinfo. 2001;10(Pt 2):1262-5.

Expert systems, security and quality assurance: implications of patient records as data-space.

Kluge EH.

University of Victoria and HEALNet, Victoria; Canada. ekluge@uvic.ca

The concept of data-space is fruitful in trying to understand the ethical rights and duties that surround the treatment of patient records. However, it also provides a solution to three apparently unconnected problems: the construction of expert diagnostic systems, the development of an internal security element within the sphere of permitted data-access for health care professionals, and the development of a professional quality assurance mechanism. This paper presents a model of how these diverse aims may be achieved. It does so by developing the notion of the logical form of data within a data-space and by showing how the path taken by a health care professional through a profession-relative data-space can provide checks for the security, quality and appropriateness of the path itself. The result is important in that it provides an integrated method for information specialists to meet their fiduciary obligations towards the patients whose records are in their care, and towards the institutions that employ them.

PMID: 11604931 [PubMed - indexed for MEDLINE]


Med Inform Internet Med. 2001 Jul-Sep;26(3):219-34.

A moral approach to electronic patient records.

Fairweather NB, Rogerson S.

Centre for Computing and Social Responsibility, Faculty of Computing Sciences and Engineering, De Montfort University, Leicester, UK.

This paper seeks to establish a morally appropriate balance between the various moral standards that are in tension in the field of Electronic Patient Records (EPRs). EPRs can facilitate doctorpatient relationships, however at the same time they can undermine trust and so harm the doctorpatient relationship. Patients are becoming increasingly reluctant to tell their own doctor everything that is relevant. A number of moral principles and the question of consent to release of records are considered here. There is also explicit mention of the principles for the treatment of the EPRs of the dead. A number of tensions between principles are explored, including that between privacy and promotion of welfare, both in an emergency and in more routine situations. The discussion also includes the tension between access and the right to not know about a condition that may undermine, for example, self-esteem; and the tensions between principles that arise when epidemiology, public health surveillance and healthcare evaluation are conducted. Suggestions are made about an appropriate balance between the principles. It is suggested that the patient's right to informed consent should be dominant.

PMID: 11706931 [PubMed - indexed for MEDLINE]


Int J Med Inform. 2000 Nov;60(2):85-96.

Professional codes for electronic HC record protection: ethical, legal, economic and structural issues.

Kluge EH.

Department of Philosophy, University of Victoria, Canada. ekluge@uvic.ca

Guidelines for the protection of electronic health care data frequently stipulate that national laws should be followed. This stipulation is subjected to analysis and critique. It is argued that it commits the fallacy of nationality, and suggests that appropriately constructed ethical guidelines for the protection of electronic health care data must focus solely on fundamental ethical principles as these are applied to the types of situations in which such electronic data are generated, used and ultimately disposed of. The relevance of economic considerations is also be addressed. An attempt is made to sketch a general ethical framework within which data protection guidelines could be situated.

PMID: 11156741 [PubMed - indexed for MEDLINE]


Methods Inf Med. 1999 Dec;38(4-5):345-9.

Finding ethical principles and practical guidelines for the controlled flow of patient data.

Rigby M, Draper R, Hamilton I.

Centre for Health Planning and Management, Keele University, Staffordshire, U.K. m.j.rigby@keele.ac.uk

The application of computing to health care, and particularly to electronic patient records, offers major benefits but raises issues of confidentiality and of potential misuse. Sound access control mechanisms are therefore important, but most models focus upon informed consent by the data subject. This raises challenges in mental health care, and for other vulnerable patients including those comatose, and the severely ill and temporarily distressed. Published algorithms which are used to control record access within a controlled environment therefore have value, as a means of ensuring an open and informed, yet ethically sound, solution. The paper describes the background and issues, and gives an example of such an algorithm.

PMID: 10805026 [PubMed - indexed for MEDLINE]


Methods Inf Med. 1999 Dec;38(4-5):253-9.

Medical narratives and patient analogs: the ethical implications of electronic patient records.

Kluge EH.

University of Victoria, BC, Canada.

An electronic patient record consists of electronically stored data about a specific patient. It therefore constitutes a data-space. The data may be combined into a patient profile which is relative to a particular specialty as well as phenomenologically unique to the specific professional who constructs the profile. Further, a diagnosis may be interpreted as a path taken by a health care professional with a certain specialty through the data-space relative to the patient profile constructed by that professional. This way of looking at electronic patient records entails certain ethical implications about privacy and accessibility. However, it also permits the construction of artificial intelligence and competence algorithms for health care professionals relative to their specialties.

PMID: 10805009 [PubMed - indexed for MEDLINE]


Pediatrics. 1999 Oct;104(4 Pt 1):973-7.
Comment in: Pediatrics. 2001 Jun;107(6):1495.

American Academy of Pediatrics. Pediatric Practice Action Group and Task Force on Medical Informatics. Privacy protection and health information: patient rights and pediatrician responsibilities.

Chilton L, Berger JE, Melinkovich P, Nelson R, Rappo PD, Stoddard J, Swanson J, Vanchiere C, Lustig J, Gotlieb EM, Deutsch L, Gerstle R, Lieberthal A, Shiffman R, Spooner SA, Stern M.

Pediatricians and pediatric medical and surgical subspecialists should know their legal responsibilities to protect the privacy of identifiable patient health information. Although paper and electronic medical records have the same privacy standards, health data that are stored or transmitted electronically are vulnerable to unique security breaches. This statement describes the privacy and confidentiality needs and rights of pediatric patients and suggests appropriate security strategies to deter unauthorized access and inappropriate use of patient data. Limitations to physician liability are discussed for transferred data. Any new standards for patient privacy and confidentiality must balance the health needs of the community and the rights of the patient without compromising the ability of pediatricians to provide quality care.

PMID: 10506245 [PubMed - indexed for MEDLINE]


Crit Care Nurs Q. 1999 Nov;22(3):75-80.

Ethical issues in computerized medical records.


Veronesi JF.

Department of Nursing, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA.

Greater use of computer technology has permitted rapid access to many forms of data. Hospitals have traditionally been slower to accept this technology for patient medical records. With the rapid approach of the new millennium, hospitals are being forced into re-evaluating many processes, including the volumes of data collected on paper. Electronic medical records are one approach to reducing storage and streamlining care across the health care continuum. This article examines the ethical impact of computerized medical records, including access to data, ownership of data, confidentiality, and medical record brokering.

PMID: 10646455 [PubMed - indexed for MEDLINE]


Stud Health Technol Inform. 1996;27:10-22.

Security of the electronic health care record--professional and ethical implications.

Gaunt N, Roger-France F.

Division of Health Care Informatics, Faculty of Medicine, University of Plymouth, Derriford Hospital, UK.

Many challenges face developers of secure computerised clinical systems but the technical problems are overshadowed by procedural, professional and ethical issues. The development and use of computerised systems must be controlled through compliance with standards and procedures for information security, enforced through national legislation and professional codes of conduct, if serious abuse of the data is to be avoided. Health care professionals cannot be expected to acquire working knowledge of how information systems are made secure since this is a technical and highly complex subject. However, it is essential that health care professionals understand why it is important to maintain a secure environment for the records they keep about patients and their care and how this can be organised. This is best achieved through a well structured educational programme involving all trainee and qualified health care staff, a task which should be coordinated by the national professional bodies. A management structure is needed within health care facilities that recognises the responsibility of health care professionals to keep the health care data relating to their patients secure. An arrangement is proposed that gives the most senior clinician in a health care facility the ultimate responsibility for security of health care data held in the organisation. Where appropriate, this would be delegated to a senior clinician with training and experience in information systems and their security. This 'information doctor' would, with the assistance of computer experts and health care managers, implement and monitor the organisation's information security strategy. Contracts should be developed between health care facilities and their patients, defining the limits to the use and disclosure of personal health data. Similar contracts with external agencies should also stipulate the minimum level of security to be applied to health records shared between the organisations.

PMID: 10163725 [PubMed - indexed for MEDLINE]


Medinfo. 1995;8 Pt 2:1596-600.

Patients, patient records, and ethical principles.

Kluge EH.

Department of Philosophy, University of Victoria, British Columbia, Canada.

This paper argues that the "fair information principles" are an insufficient guide to the ethical treatment of patient records, because they lack a proper theoretical basis, are procedurally as well as substantively incomplete, and are ethically dangerous. The paper shows how more appropriate guidelines can be developed by treating patient records as patient analogs in decision-space and applying ethical principles to them. It extends this to a sketch of how a Code of Ethics for Medical Informatics Professionals can be derived in a similar way. The application of ethical principles to patient records is also explained and defended.

PMID: 8591510 [PubMed - indexed for MEDLINE]


Methods Inf Med. 1993 Apr;32(2):95-103.
Comment in: Methods Inf Med. 1993 Apr;32(2):104-7.
Methods Inf Med. 1993 Apr;32(2):108.
Methods Inf Med. 1993 Aug;32(4):339-40.

Advanced patient records: some ethical and legal considerations touching medical information space.

Kluge EH.

Philosophy Department, University of Victoria, Canada.

The application of advanced computer-based information technology to patient records presents an opportunity for expanding the informational resource base that is available to health-care providers at all levels. Consequently, it has the potential for fundamentally restructuring the ethics of the physician/patient relationship and the ethos of contemporary health-care delivery. At the same time, the technology raises several important ethical problems. This paper explores some of these implications. It suggests that the fundamental ethical issue at stake in these developments is the status of the electronic record which functions as the analog of the health-care consumer in health-care decision making. Matters such as control and patient dignity are implicated. Other important ethical issues requiring solution include data ownership, data liability, informed consent to use and retrieval, security and access. The paper suggests that the ethical problems that arise cannot be solved in piecemeal fashion and on a purely national basis. They should be addressed in a coordinated international fashion and receive appropriate legal expression in the relevant countries and be incorporated into appropriate codes of ethics.

PMID: 8321138 [PubMed - indexed for MEDLINE]


Medical Computing Today, December 1997

EMR (In)Security

Marjorie Lazoff, MD

The Web showcases many government agencies and private companies that have money and power invested in EMRs and a technologically sophisticated national network; fortunately, these biases are balanced somewhat by articles and organizations voicing objections or alternatives. The Web, to its credit, also offers many opinions on how to invest in technological safeguards, mass education, and punitive legal sanctions so individual medical privacy remains prioritized in the greater scheme of things. What remains unaddressed, on and off line, is ethical and practical advice on how physicians should proceed if we believe our patients' medical privacy have not been appropriately prioritized by others – or has been, but with insufficient results.


Ethical Issues of Medical Records on the Internet:
http://www.luc.edu/ethics/23260etc2/etc2-7MickConners.html



EXPERTS

Eike-Henner W. Kluge studied ethics and logic at the University of Michigan. He was the founding director of the Department of Ethics and Legal Affairs of the Canadian Medical Association and the first expert witness in medical ethics recognized by Canadian courts. He is a member of WG4 (Security and Confidentiality) of the International Medical Informatics Association and has published widely in the ethics of medical informatics. He teaches at the University of Victoria and is active as an ethics consultant. (from The ethics of electronic patient records / Kluge, Eike-Henner W. New York : P. Lang, 2001.)


KLUGE, EIKE-HENNER:

Email: ekluge@uvic.ca
Languages: English, German
Departments: Philosophy

Friday, February 10, 2006

Scope of my e-Pathfinder

THE ETHICS OF ELECTRONIC MEDICAL RECORDS

This e-pathfinder acts as an overview of the resources pertaining to ethics in relation to electronic patient records (EMRs). The development of EMRs (also known as electronic patient records and electronic health records) has created a new ethical discourse about what patient privacy and professional responsibility means. This legal and philosophical dialogue (at times, heated) will continue as long as EMRs are adopted by more hospitals.

Included here are print materials, electronic resources, academic, government, and non-profit institutions, and relevant citations/abstracts. There will be some overlap of information into bioethics.

"Why should ethical principles apply to patient records at all?"

The initial question, therefore, may be stated as follows: “Why should the treatment of electronic patient records be governed by ethical principles rather than rules of conduct that find their basis in professional agreement and social expectation?”

The short answer is that the nature and role of electronic patient records allows for no other option….the completeness of the package that constitutes the patient record, its functional capabilities, and the increased scale of health care decision-making which has come to rely on data about patients rather than on interaction with the patients themselves, have changed the record from being merely a series of disjointed descriptions that model patients for specific purposes, to being patient-analogues in information- and decision-space.

It is this analogue role which dictates that electronic patient records should be treated according to ethical principles rather than merely heuristic rules of conduct. It is also this role which entails that there ethical principles should be the same principles – or at least relevant analogues of the same principles – that determine ethical behaviour towards the persons who are the subjects of these records
.” (Kluge, 2001)

Sunday, February 05, 2006

"Ethics of Electronic Patient Records"

“On one level, electronic patient records are merely electronically based devices that fulfill the same role as their previous material counterparts, much as is the case with computer-based medical imaging, telemetry, etc.. In that sense, the development of electronic patient records parallels in the latter areas. They are merely more easily accessible than the old-style material records, more easily manipulated, and potentially give much more complete representation of their subjects than could previously be achieved.

However, as in so many instances, what on the surface appears to be merely a change in technology hides a much more profound development in the nature and status of what was thus changed.

In this particular instance, the technological switch from paper-based records to electronically-based records facilitated a functional development that radically altered the relationship between the subject of the record and the records itself, and widely expanded the uses to which the record could be put.

It is this change in relationship, and this expansion of usage that gave rise to a whole series of ethical problems: problems that centre in issues such as record access and security, confidentiality, ownership, integrity, and the like.”

From: The Ethics of Electronic Patient Records, by Eike-Henner W. Kluge, Peter Lang Publishing, 2001.

"Artifacts and Politics; Technologies of the Self"

Information Ethics in History and Philosophy - The Past as Prologue; Philosophy of information and philosophy of technology as applied in contemporary life - family, work, entertainment, sports, national and global security

I really appreciated both Winner's and Capurro's articles. Winner said something that struck me as highly relevant, when he speaks to technologies have political consequences (both intended and unintended):

There are instances in which the very process of technical development is so thoroughly biased in a particular direction that it regularly produces results heralded as wonderful breakthroughs by some social interests and crushing setbacks by others...the technological deck has been stacked in advance to favor certain social interests and some people were bound to receive a better hand than others. (Winner, 1986)

Cybertechnology needs to be analyzed as to how it widens the economic gaps between the haves and have-nots, as we become more and more dependent on information as commodity and computer skills as mandatory skills. There are many aspects about the internet and computers that can herald a new freedom, a new democracy for people of all walks of life to enter into a universal discourse and have access to new channels of knowledge and growth. But first, there must be a leveling of the economic playing field, if that's at all possible.

As Capurro states that to "ensure that the benefits of information technologies are not only distributed equitably, but that they can also be used by people to shape their own lives", we must "work for a more equitable distribution in order to bridge the information gap between the 'information poor' and the 'information rich'". This gap isn't only contingent of wealth, but also is created by age and minority groups. In my INFO 520 course, we talked about the Digital Divide and how we will be unable to solve the digital divide until we solve the power (health/education/wealth) divide. The cost of computer technology is decreasing and it is being made more available by way of community centers, public libraries, and non-profits. As employers and schools begin to take for granted one's IT capabilities, it is a societal responsibility to bolster all citizens' access and education.

It's amazing how so much has changed in the past 20 years, honestly, I didn't begin to truly use computers until college (1992-1996). In high school, I took a "word-processing" class, but I wrote out my papers and as for research, I was limited to print materials and the library's online catalog. I didn't start using e-mail until Sophomore year in college and still most of my research was done via reference materials and then CD-ROMs. Now, my high school gives out iBooks to each student at the beginning of the school and I imagine that even my elementary school has the kids already becoming point-n-click savvy. And, of course, I can't even begin to imagine what my daily work life would look like without computers or how limited my career options would be if I was "computer illiterate".

I believe that getting a college degree was essential to opening up my mind and broadening my perspective and that grad school is just gravy. My family is by no means wealthy, but we have been comfortable and have been able to make education a priority. I'm very lucky in the way that it was just assumed that I would pursue higher education. But when you think about it, the opposite may be true, if a child has lived their life surrounded by poverty, watched one's family struggle to survive, having to forgo expensive academics to work low-paying jobs can become ingrained as well. When there's no money for food, much less healthcare, or paying the utilities, it doesn't matter whether or not you can read or have an interest in pursuing an academic path. Being informed is powerful, but being hungry is more so.

So what it comes down to, I don't believe that the solution is as simple as just offering extra training and more computers in a library to stop the increasing digital divide. I guess that brings me back to ethical basics that all humans are entitled to "life, liberty, and the pursuit of happiness". It's ensuring the well-being of all members of a society and that includes providing consistent, continual educational opportunities for members of the community so that they can become a part of the solution.

"Defining Information Ethics for Today"

Walter Maner defined computer ethics as being a “field of applied professional ethics dealing with ethical problems aggravated, transformed, and created by computer technology” (Spinello & Tavani, 2004). This definition resonated with me as it seems to encompass many of the conundrums of applying long-standing ethical theory to a continually evolving and developing discipline and also addresses the possibility of transformation and evolution of new ethical frameworks.

One thing that I keep pondering is Johnson’s belief that computer technology is truly just a new medium with which we must address age-old ethical issues of “privacy, property, drawing the line between individual freedom and (public and private) authority, treating one another with respect…” (Spinello, 2004). At first glance, this is a reasonable assumption, but it seems to be an oversimplification of the effect that computer technology has changed our way of thinking about communicating with others and the processes of information gathering and distribution. Johnson addresses the key elements, scope, anonymity, and reproducibility that throw a wrench in creating informal and formal guidelines with which to guide human relations in cyberspace. Although, the governing (by self or society) of these characteristics can be traced back to the origins of such core values as doing no harm and being honest and trustworthy, there seems to be another aspect of computer ethics missing.

Moor brings this up by explaining the three factors that cause us to think that computer ethics deserves a more unique perspective. Moor states that computer technology is “logically malleable” (Tavani, 2004), i.e. adaptable for limitless potential uses and purposes. Such flexibility widens the spectrum that ethical frameworks must be applied to. This seemingly endless possibility of what can be accomplished with computers develops “policy vacuums” and “conceptual muddles” due to the fact many of the problems that arise have never been in existence before, therefore never addressed.

Consider the issues of accountability, liability, and patient privacy in the embedding of clinical decision support tools (CDSTs) into electronic medical record systems. By “reading” a patient’s case history, the support tool can make suggestions or display treatment options or relevant citations in direct relation to the patient. This point-of-care system has the great potential of providing customized evidence-based medicine reference for real-time, individual patient cases. The question then becomes, at which stage or level should a clinician depend/not depend on computer-based tools in making diagnostic or treatment decisions? If one makes an error that causes harm to the patient, due to using the CDSTs or NOT using them, is the doctor held liable or the vendor that created the resource? In a worst case scenario, what if the CDST is corrupted by a virus/hacker and clinical information is altered, what stop-gap measures are in place to prevent harm to the patient? Also, the HIPAA laws that protect patient privacy and medical information, how do they apply to these electronic resources and who monitors what happens to the patient’s information as it processed by the CDSTs?

This appears to me to be a situation that has created a policy vacuum, as just in the past decade has CDSTs become more accepted and more advanced within the medical arena as evidence-based medicine has become more prevalent. The conceptual muddle is at what point, is an electronic resource considered simply a reference or when does become a virtual team member in the care of a patient? Johnson’s core concerns can still be pointed out within this ethical dilemma, but for any decision to be made about what is the “right” thing to do, the conceptual vacuum created must be analyzed.

Brey’s disclosive model would prove essential in this process. By considering the issues at hand through his three levels of evaluation: disclosure, theoretical, and application (Tavani, 2004), we can ensure that all facets are identified and investigated for how to rationally apply an ethical framework, whether it be the application of previous ethical standards or the creation of a new school of thought. I hope to develop this idea more as I move toward the creation of my e-pathfinder.