The Electronic Health Record: Ethical Considerations

By Eike-Henner W. Kluge

The Electronic Health Record: Ethical Considerations analyses the ethical issues that surround the construction, maintenance, storage, use, linkage, manipulation and communication of electronic health records. Its purpose is to provide ethical guidance to formulate and implement policies at the local, national and global level, and to provide the basis for global certification in health information ethics.

Electronic health records (EHRs) are increasingly replacing the use of paper-based records in the delivery of health care. They are integral to providing eHealth, telehealth, mHealth and pHealth - all of which are increasingly replacing direct and personal physician-patient interaction - as well as in the developing field of artificial intelligence and expert systems in health care. The book supplements considerations that are raised by national and international regulations dealing with electronic records in general, for instance the General Data Protection Regulation of the European Union.

This book is a valuable resource for physicians, health care administrators and workers, IT service providers and several members of biomedical field who are interested in learning more about how to ethically manage health data.

• Provides examples to explain the various points made in each chapter to increase the readability of the book and provide, in more familiar terms, illustrations of the reasoning that is advanced
• Encompasses several diagrams to illustrate the logical structure of the ethical relationships that are discussed in the various chapters and to show how they are related to the decision making process
• Presents a glossary to provide short definitions for some of the more technical terms used in the book

• Language: English
• Publisher: Academic Press
• Release date: Feb 26, 2020
• ISBN: 9780128220467

Eike-Henner W. Kluge

Eike Henner W. Kluge PhD, FRSC, taught at various universities in the US and Canada before joining University of Victoria. In 1989, Dr. Kluge was asked by the Canadian Medical Association to establish the Department of Ethics and Legal Affairs, for which he was the first Director. Dr. Kluge was the first expert witness in medical ethics recognized by Canadian courts. He is a member of working group SiHIS (Security in Health Information Systems) of the International Medical Informatics Association, and he was the lead author of the IMIA Code of Ethics (2003) and he wrote the revised Code (2016). In 2007, Dr. Kluge was awarded the Abbyann Lynch Medal in Bioethics by the Royal Society of Canada and was made a Fellow of the Royal Society of Canada in 2018. His other awards and honors include Woodrow Wilson Fellowship, senior Fellow of Phi Kappa Phi as well as General Motors, NSERC, and Canada Council Fellowships.

Book preview

The Electronic Health Record

Ethical Considerations

Eike-Henner W. Kluge

Contents

Cover

Title page

Copyright

Preface

Acknowledgments

Chapter 1: The nature of electronic health records

Abstract

Introduction

Health records themselves

Chapter 2: From ethical principles to information ethics

Abstract

Introduction

Ethical principles in general

Chapter 3: Ownership, privacy, and related issues

Abstract

Introduction

Chapter 4: Physicians, health information professionals, and health care institutions

Abstract

Introduction

Chapter 5: Framework considerations

Abstract

Introduction

Chapter 6: Ethics, the reality of use and global considerations

Abstract

Introduction

A confluence of factors

Ethics in practice

Pragmatic Considerations

Final considerations

Glossary

Index

Copyright

Academic Press is an imprint of Elsevier

125 London Wall, London EC2Y 5AS, United Kingdom

525 B Street, Suite 1650, San Diego, CA 92101, United States

50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States

The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom

Copyright © 2020 Elsevier Inc. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

Library of Congress Cataloging-in-Publication Data

A catalog record for this book is available from the Library of Congress

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library

ISBN: 978-0-12-822045-0

For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals

Publisher: Stacy Masucci

Acquisitions Editor: Rafael Teixeira

Editorial Project Manager: Mona Zahir

Production Project Manager: Kiruthika Govindaraju

Designer: Matthew Limbert

Typeset by Thomson Digital

Preface

The history of medical record keeping is generally presented in longitudinal terms that focus on changes in the material medium of the records themselves. The discussion therefore usually begins by identifying stone,a clay,b and string (quipus)c as some of the first recording media and may even mentions waxd as another early recording medium. The accounts then usually go on to say that these media were ultimately superseded by paper and then—while this is still an ongoing process—in the second half of the 20th century began to be replaced by electronice methods of recoding and storage.

This way of presenting the evolution of medical record keeping, however, is somewhat limited in scope. It ignores or underplays the fact that the introduction of electronic medical record keeping marked the beginning of a fundamental change in more than merely the material nature of the records themselves. It also had profound implications for the delivery of health care and the relationship between the records and the subjects of the records, as well as for the ethical frameworks in which the records are embedded.

Not to put too fine a point on it, with the advent of electronic patient record keeping the patient record changed from a material entity that contains data to a patient analogue in information- and decision-space.f As yet, this evolution is still in its beginning because the structure of these records, inclusive of their relationship to artificial intelligence, is still evolving, and has not as yet been fully integrated into all aspects of health care delivery and planning. Nevertheless, the process is well under way, and to truly appreciate the significance of this requires that one abandon the old perspective that was appropriate for paper-based records and adopt a wholly new way of thinking. The aim of this study is to indicate the way. It begins with an outline of the precise nature of electronic health records from an ethical perspective and then attempts to situate them in the ethics of contemporary health care decision-making at the clinical as well as the administrative and business level. Particular attention will be paid to the ethical implications for the various parties concerned, as well for such issues as record ownership, privacy, and related matters.

By way of procedure, it may be appropriate to preface what follows with a terminological note. There are different ways of referring to electronic records about patients. The best known and most common are electronic health records (EHRs), electronic medical records (EMRs), electronic patient records (EPRs), respectively.g While all of them refer to electronic records that contain data about patients, there are slight differences in how the terms are used. For instance, EMR tends to be used to refer to a clinic- or institution-based electronic patient record, and therefore tends not to contain patient data that are not generated within or at the request of the institutional or clinical setting; PHR tends to be used to refer to health-related documentation that is maintained by the individual to whom it pertains. As such, a PHR is usually much more limited in scope than an EMR and generally does not contain all medically relevant data about the patient. By contrast, the term EHR is generally used to refer to an electronic patient record that includes all available data about the subject of that record. Therefore, on this understanding, an EHR, when properly constructed, is an electronic version of a patient’s medical history and includes diagnoses, prognoses, medications, treatment plans, immunizations, allergies, laboratory and radiology reports, etc. as well as all administrative clinical data relevant to that person’s care inclusive of demographic data, progress notes, problems, etc.h

While these terms overlap in their actual usage, the preferred term for this study is electronic health record (EHR). The reason for this is not merely because that this has the widest scope of all terms but also because it includes the term health, which is a notion that expands beyond the purely clinical and is in line with the World Health Organization’s definition of health: Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.i An EHR, therefore, may also contain data that are provided by psychologists and counselors, physiotherapists, and acupuncturists, etc. insofar as these provide or have provided some of the health-related treatments that a patient has undergone or is undergoing as well as the sorts of administrative data that were mentioned above.

Moreover, by way of introduction, it may be important to point out that one of the fundamental presuppositions of dealing with the ethical issues that are raised by EHRs is that there be clarity on the notion of health itself. Unless the concept is clearly defined, the domain of health care practices will be amorphous and what constitutes appropriate qualifications for those who provide health care will be unclear. Likewise, unless clarity exists on the notion of health, the domain of health records in general and of EHRs in particular remains unclear, and what constitutes ethically appropriate treatment of such records—as well as the rights and obligations that are associated with their development and deployment—cannot be clearly adumbrated.

Unfortunately, the word health is not a univocal term. It can be understood in a variety of ways because there is a whole series of distinct ways of conceptualizing it: ways that range from dealing with the health of individuals to focusing on population health and even more generally to dealing with the health of entire species. Each of these delimits a distinct domain and entails a distinct set of measures. Likewise, mental health is usually understood as being different from physical or social health; and biostatistical as opposed to functional or holistic approaches again have a conceptually different grounding and engage a distinct set of measures and legitimate distinct types of interventions. Likewise, not to overstate the issue, health considerations relative to specific life-stages such as infancy vs. maturity vs. old age are distinct from considerations that have the whole life span as their focus. Nor is it possible to identify a single meaning for health by contrasting it with the notions of illness or disease, because these notions suffer from the same systematic ambiguity. And finally—as has been pointed out by a variety of authors—the term health has value associations, which is why different societies with distinct value perspectives may vary in their understanding of the term and hence in what should be included under the rubric of health services.j

However, this variation notwithstanding, in one way another all such conceptualizations involve the identification of characteristics, patterns, or states of affairs that are considered acceptable or that are evaluated positively and are to be encouraged, as opposed to those that are evaluated negatively and call for some corrective or ameliorative action. This, in turn, means that no matter how the notion of health is understood, it is a notion that inherently has a comparative aspect in the sense that what is identified as a healthy state, characteristic or pattern is identified as such only in comparison with a state, characteristic or pattern that does not meet this standard. This is the case whether the state, characteristic or pattern is physical, psychological, or social in nature. In what follows, and in keeping with what was said a moment ago, the notion will be understood in this wide sense as promulgated by the World Health Organization. Therefore, matters that are captured by this understanding of health are appropriately continued in EHRs and expand their breadth.

Finally, the point of the study is not simply to outline theoretical matters. Part of its purpose is to lay the foundation for providing a framework for implementing the relevant ethical considerations in the real world. It therefore addresses the question of how to ensure this for those who handle EHRs. Part of this task—its groundwork, so to speak—was already achieved by developing the IMIA Code of Ethics for Health Informatics Professionalk and its accompanying handbook.l However, the focus of these was restricted to the ethical implications of EHRs for health information professionals. Consequently they provided only a partial picture for the domain of health care in general. The current study also addresses the ethical issues that concern clinical health care professionals, administrators, health care institutions, researchers, and informatics service providers in their use of EHRs. To this end, in Chapter 6, it deals with what may be called the issue of ethics certification.

---

a Brosius M. (ed.) Ancient Archives and Archival Traditions: Concepts of Record-Keeping in the Ancient World. Oxford U P, 2003.

b Nesbit, William Marsiglia. Sumerian records from Drehem. New York: AMS Press, 1914.

c Ascher M and Ascher R. Code of the Quipu: A Study in Media, Mathematics, and Culture, M. Ascher and R. Ascher, University of Michigan Press, Ann Arbor, 1981.

d Brosius, op. cit. chapter 1.

e The term electronic is intended to cover both electronic and photonic methods of recording and storing.

f Kluge EH. Advanced patient records: some ethical and legal considerations touching medical information space. Methods Inf Med. 1993. 32(2):95–103. For a contrary opinion, see Grémy F, Leplège A, Heve D. The computerized medical record is not the patient analog: A four partners scenario in clinical encounters. Methods Inf Med. 1993 Aug;32(4):339–40.

g Ambinder EP. Electronic Health Records. Journal of Oncology Practice 2005; 1(2): 57–63.

h Centers for Medicare & Medicaid Services, Definition; Available from: https://www.cms.gov/medicare/e-health/ehealthrecords/index.html

i World Health Organization: WHO definition of Health, Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19–22 June 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948. http://www.who.int/about/mission/en/

j Boorse C, Concepts of Health and Disease, in F. Gifford, ed. Philosophy of Medicine (North Holland, 2011) 13-64; Coser R, Concepts of Health and Disease: Interdisciplinary Perspectives, JAMA. 1982;248(19):2528; Engelhardt HTJr. The Concepts of Health and Disease (125-141) and Kopelman, L On Disease: Theories of Disease and the Ascription of Disease: Comments on The Concepts of Health and Disease" (143-150) in Evaluation and Explanation in the Biological Sciences ed. Engelhardt and Spicker. Dordrecht: Reidel, 1975) Millstein, S. G., & Irwin, C. E. (1987). Concepts of health and illness: Different constructs or variations on a theme? Health Psychology, 6(6), 515-524; Naomar de Almeida Filho (2001), For a General Theory of Health: preliminary epistemological and anthropological notes. Cadernos de Saúde Pública 17:4; Nordenfelt L. The concepts of health and illness revisited. Med Health Care Philos. 2007 Mar10 (1):5-10; Tengland P-A, A Two-Dimensional Theory of Health, Theoretical Medicine and Bioethics, 28(4): 257-284; Whitbeck, C, A Theory of Heath, in Arthur L. Caplan, H. Tristram Engelhardt & James J. McCartney (eds.), Concepts of Health and Disease: Interdisciplinary Perspectives. Addison-Wesley, Advanced Book Program/World Science Division. pp. 611--626 (1981).

k IMIA Code of Ethics – Updated Version 2016, available at http://imia-medinfo.org/wp/imia-code-of-ethics/. Those interested in seeing a detailed discussion of the relationship between the theory in this book and its implementation in the IMIA’s Code of Ethics are referred to Handbook of Ethics for Health Informatics Professionals, which is available on the IMIA website.

l Ethics for Health Informatics Professionals: The IMIA Code, its Meaning and Implications; available at https://imia-medinfo.org/wp/wp-content/uploads/2015/07/Handbook-for-revised-Code-of-Ethics.pdf.

Acknowledgments

The present work has benefitted immensely from my longtime association with members of the Security in Health Information Systems Working Group of the International Medical Informatics Association, and in particular with Bernd Blobel, Paulette Lacroix, Jochen Moehr, and Pekka Ruotsalainen. Without their encouragement, the idea of pursuing the subject of ethics in health informatics would not have gone beyond the ideas stage.

Chapter 1

The nature of electronic health records

Abstract

Contemporary health care increasingly relies in its planning and delivery on the use of electronic health records. These records differ from traditional paper-based records not only in that they are electronic in nature, but also that they constitute patient analogues. The present chapter examines how and why this is the case. It begins with an analysis of the relationship between health records and their subjects, sketches how this relationship is situated in data- and information-space, outlines the difference between paper-based and electronic records, and indicates the ethical implications this has for originating them and dealing with them in an appropriate fashion.

Keywords

analogue

data

EHR

information

record

sign

Introduction

Health and records in the realm of health care

In ancient times health care providers relied on memory for identifying something as a health-related issue and for what constituted an appropriate way of dealing with it. As time went by, memory was replaced by records. Records not only had the advantage of greater permanence but also extended the limits of how health-related information and data could be shared. They also opened the door to identifying patterns across populations, and of discerning the distribution of health-related factors. Not just that: they also made it possible to determine the effectiveness-or lack thereof-of particular ways of dealing with health-related issues beyond individual patients, and to develop methods for systematically training health care professionals and for setting appropriate standards for health-related practices. For obvious reasons this meant that as time went by, health records became integral to providing health care both at the policy and the hands-on levels-and they have retained that role ever since.

However, this development raised some important ethical questions: questions that centered in issues such as the scope of health records, their ownership and use, as well as matters like privacy and confidentiality. Also implicated were ethical issues that centered in record quality, usability, availability, and security as well as in their linkage-and indeed the creation of the records themselves in the first place. Moreover, why these issues arose and what form they took then as now-or whether they arise at all-was and is functionally determined by the role of those who produce, access, or use these records and not simply by the nature of the records themselves. The rest of this study will address these issues, with its focus being on electronic health records (EHRs). It will deal with this in the context of health care institutions, health information professionals, health policy makers, and health care corporations. However, before undertaking this task, it is important to be clear on the relationship between health records and the subjects of such records, and on the difference between paper-based records and EHRs. This will then set the stage for the rest of this study on the ethics of EHRs.

Health records themselves

Signs, data, information, and logical spaces

To begin with records themselves: Records consist of signs that stand for data, and when properly understood these provide information. To appropriately appreciate how this is the case, it may be useful to begin with a brief analysis of the relationship between signs, data, and information, and of how these relate to the concepts of information- and decision-space.

Signs

Understood causally

In general terms, a sign is any entity that is referentially connected with some other entity. However, the notion of a sign can be understood in two distinct ways-causally and conventionally. When the term is understood causally, what is called a sign stands in a causal relationship with that of which it is a sign, where this relationship is a function of the laws of nature.¹ Thus the combination of increased urination and thirst, fatigue and blurred vision, numbness or tingling in the hands or feet, as well as weight loss, slow-healing cuts and bruises, frequent or recurring infections, and difficulty getting or maintaining an erection or persistent vaginal infections is generally considered a sign of diabetes because, taken together, these are the causal results of an improperly functioning insulin production in the pancreas. Similarly, thunder is a sign that lightning has occurred because it is produced by the abrupt expansion of air as a result of a sudden electrostatic discharge superheating