American Journal of Law & Medicine

Informed consent in the electronic age.

I. INTRODUCTION

A. INFORMING THE PATIENT ... MILLENNIUM STYLE

Dr. X, a urologist, has just told his patient, Mr. Y, a fifty-eight-year-old businessman, that he has prostate cancer. The revelation was difficult for both parties, but it did not come as a complete surprise because it had been preceded by a multistep diagnostic process. Although hoping for better, Mr. Y and his wife were expecting this bad news when they went into the doctor's office.

After offering some words of hope and encouragement, Dr. X tells the patient and his wife that, before they discuss any further the important choices that lie ahead in the treatment of Mr. Y's condition, he would like them to take time to review carefully the information contained in the CD-ROM program he has just handed them. The program, entitled "Living with a Diagnosis of Prostate Cancer," is one of a library of such programs developed and marketed by a company specializing in computer-based patient education products.

Dr. X explains to Mr. and Mrs. Y that the computer program can convey the complex facts that bear on this decision process more fully and effectively than he has the ability or time to do, and it uses sophisticated multimedia effects to aid viewers' understanding. Moreover, Dr. X continues, the couple can consider each aspect of the explanation fully, spending as long on each part as they feel is necessary. They can do this in the comfort and privacy of their own home, where they can discuss the information and the choices more freely than they may feel comfortable doing in the doctor's presence. Dr. X has already ascertained that his patient has a computer to play the CD-ROM, and Mr. Y is confident that he can use the program properly. It is, after all, no more difficult than working through Myst or Riven, two computer games that Y and his wife enjoy playing together.

The doctor explains that while Mr. Y works through the program, it will ask him, at various points, to answer questions about what he has seen and read. If his comprehension is lacking on any point, he will be instructed to go back and review the relevant material, after which he will be queried again. An electronic record will later reveal to the doctor the points on which the patient may be uncertain, helping to focus further conversation between them. Ultimately, the program will document the patient's successful completion of the instructional exercise and provide proof that the patient understands the material essential to his informed consent for whatever treatment the parties jointly choose.

Dr. X and his patient agree to meet again in a week, with Mrs. Y present if her husband wishes, after the two of them have navigated through the educational program and digested its contents. Dr. X assures them that, in this follow-up meeting, they can take as much time as they need to discuss questions, options and other aspects of the choices Mr. Y has to make. The CD-ROM, the doctor explains, is not meant as a substitute for his professional input or for their personal interaction, but only as a basis for their further discussions. Their entire meeting, including the presentation of the lab results confirming the existence of the cancer, has taken less than fifteen minutes.

The above scenario is one of many that might be used to illustrate how doctor-patient relations are changing as we enter the twenty-first century. The medical world of the future, here now in many respects, or at least right around the corner, is a wondrous place, with much that is attractive and hopeful; but it has its dark aspects too.

On the plus side, the prepackaged patient education program described above allows an effective, low-transaction-cost transmission of information from a physician to a patient desiring, and presumably about to receive, his services. For the doctor's part, he is able to convey to the patient all of the relevant and necessary information with significantly less time and effort than was formally required. Moreover, the computer program generates lasting evidence of that communication, in both paper and electronic form, while also documenting the patient's comprehension. These last two functions historically have been very difficult for doctors to perform. In terms of the efficient and thorough instruction of patients on matters of great importance to them, the process described here is a major step forward.

For the patient's part, Mr. Y and his wife received a thorough explanation of the alternative approaches available to treat his condition, with full details on risks and consequences of the available options. They accessed the material at their own speed, not pressured by any consciousness of the doctor's "ticking clock" and in a format that not only allowed them to explore aspects of interest as fully as they liked, but also with an opportunity to test their comprehension and, where it was found lacking, to go back and fill in the blanks. Sophisticated diagrams, computer animations and other cutting-edge instructional devices were available to aid their understanding. All things considered, computer-aided patient education will make it more likely than ever that patients truly understand, and thus are able to participate in, the crucial, life-determining choices they are called on to make.

On the negative side, this technology smacks of George Orwell's Nineteen Eighty-Four, with a silicon-chip artificiality intruding on, and perhaps driving out, human interaction while an electronic Big Brother tracks the patient's every move.(l) Some may feel that, even if the doctor and patient spend "quality time" together in a follow-up meeting, and despite the potential efficiencies of this approach to patient care and its heightened ability to transmit factual information, the dilution of the compassionate, human exchange that forms the core of the doctor-patient relationship is just too great to countenance.

Thus will the brave new world of medical practice in the electronic information age likely be greeted--with enthusiasm for its advances and a lurking concern about what value might be lost as traditionally personal interactions become increasingly transistorized. This Article explores some of the changes likely to take place in doctor-patient relations as medicine moves into the next century.

B. OVERVIEW: CONTENT AND ORGANIZATION

Although the ways in which the electronic age will affect doctor-patient relations are many and fascinating, this Article is confined to a discussion of how the new technology may affect the doctor's role and responsibility for obtaining the patient's informed consent to diagnostic and therapeutic treatments. Saved for future consideration are: (1) the explosion of health information available on the Internet; (2) the growing use of e-mail and other forms of electronic communication between physicians and patients; (3) the introduction of computer-based clinical decision support systems to supplement physician judgment and encourage or enforce treatment approaches favored by managed care plans; (4) the development of an electronic medical record and the potential effects, both good and bad, of the expanded access providers, and perhaps others, will have to this; (5) consumers' use of the Internet to comparison shop among doctors, health plans, treatments, drugs, and so forth; (6) direct-to-patient marketing by vendors of drugs, supplies and other health care commodities and services; and (7) the wide array of additional topics embraced under the widely used, but still not firmly defined, term telemedicine. All of these topics--and the above list is not exhaustive--raise questions about whether the doctor-patient relationship will survive in anything like its traditional form as the twenty-first century unfolds. Despite its limited scope, this Article explores some of the key themes that intertwine through the broader list of topics.

Part II traces the evolution of devices to aid the physician in obtaining the patient's informed consent. Part III examines the changes posed by the electronic future, raising legal and practical issues in implementing the new technology. Part IV addresses technology's impact on the physician-patient relationship, giving special attention to the philosophical and social dimensions. The Article concludes that, on balance, the relationship will likely be strengthened by the application of the new information technologies, but cautions that sensitivity and vigilance will be required of physicians to ensure that more good than harm is done. As befits a symposium projecting the future course of technologies and practices still in their formative stages, the discussion here is only preliminary. Its goal is to introduce new areas of thought, provoke questions and suggest avenues of inquiry, not to provide definitive answers.

C. PERVASIVE CHANGE IN THE ELECTRONIC AGE

In part, the changes in doctor-patient relations considered herein merely reflect how our world is changing generally. For one thing, the electronic age is changing how we define and acquire knowledge. Increasingly, knowledge is used synonymously with information; and learning is less a matter of studying and memorizing things than it is of knowing how to access information from available sources efficiently and effectively. Physicians, working in a field where scientific knowledge and the state-of-the-art change rapidly, will be especially affected by this redefinition, in terms of how they do their work, how they prepare themselves to do it and how their patients perceive what they do.

Communication between physicians and patients is another key part of what is changing. The ability of physicians to do their jobs requires, as has been recognized at least since the time of Hippocrates,(2) a close, personal relationship with patients, one on which a deep bond of trust and confidence can be established and maintained. Such relationships have been acquired through personal association over long periods of time, with some associations spanning generations on the physician's or patient's side, or both. However, such stable relationships are hard to come by in today's fast-paced, mobile world. Doctors who have known their patients for years are seldom found, and those who knew their patients' parents and grandparents are even more rare.

Managed care has also played its part, at times disrupting established physician-patient relationships(3) and limiting face-to-face interaction. Under managed care, practice controls and financial incentives constrain how long a physician can afford to spend with each patient.(4) Moreover, access times--waiting times for appointments and the length of time it takes to reach one's physician by phone for a quick consult and some reassurance--have grown to an extent that many people must find unsatisfying, or even unacceptable.(5)

The adoption of electronic devices that are meant to supplement, but which may instead supplant, the human exchange between doctor and patient, could make matters worse. How doctors and patients communicate regarding case and treatment information can have broader implications for their relationship. It seems clear that a substantial part of physicians' influence and authority comes, or traditionally has come, from how they manage the flow of information to patients. There are two separate, albeit related, reasons for this. First, because important decisions made or consented to by the patient turn largely on information, the physician and patient who navigate together through this information are engaged in a joint undertaking of great sensitivity and significance.(6) Close collaboration in this endeavor leads to a bond that, although difficult to measure, is critical to the therapeutic enterprise. Second, part of the physician's power in the relationship comes from the patient's belief in the doctor's superior knowledge in medical matters.(7) Such a perception was easier to create and sustain when most, if not all, of the information coming to the patient came through the physician. Almost by definition, the patient knew no more than the physician, and generally knew considerably less. Today, however, the sources of information are more numerous.(8) With the dramatic growth of the Internet, they may become as visible and accessible to the patient as to the physician. …

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