According to a 2001 market report, titled “The Cure Is in Hand,” handheld computers, or personal digital assistants (PDAs), will “dramatically change the way that physicians practice medicine.”Footnote 1 Such enthusiasm has resulted in an extraordinarily rapid diffusion of PDAs into a wide range of clinical settings. One report states that 47% of internists use PDAs once a day with rates of daily usage reaching 70% for resident physicians.Footnote 2 Another study found clinical usage as high as 85% in teaching hospitals.Footnote 3 The rapidly expanding employment of PDAs, however, has been uneven. Some clinicians have explored the devices’ benefits more thoroughly than their colleagues. Similarly, a number of potentially valuable uses of the handheld computer have been ignored or remain insufficiently developed by the medical community and the health delivery system at large. The use of PDAs is likely to bring much benefit to patients, society, and the medical profession. On one hand, delay in the use of a clearly beneficial technology is ethically, and potentially legally, problematic. On the other hand, precipitous adoption of such a powerful modality may preclude sufficient consideration of a broad range of clinical, professional, ethical, and legal issues that may not have yet fully surfaced. The identification and weighing of benefits, risks, harms, and implications of widespread proliferation of handheld computers into clinical practice is still a speculative endeavor. But it is the exploration that the medical profession and society should pursue in the lengthening shadow of a technology as consequential as handheld computers.
Ethical Aspects of Technology Diffusion
When considering the adoption and use of a new medical technology, there are two potential classes of error: (1) clinicians and institutions may adopt an innovation too soon or wrongly or (2) they may delay or fail to adopt a beneficial technology. As a general matter of professional and ethical propriety, a new medical technology should be employed if its use “improves the quality of care at an acceptable cost in time and money or if it maintains the existing standard of care at a reduced cost in time or money.”Footnote 4 Benefits both to the patient and to society must be weighed. Patient and clinician preferences are relevant but not necessarily controlling when other factors such as quality of care, economics, or overall social good indicate that the new technology offers, on balance, clear advances over previous ways of practicing medicine and providing healthcare services. In some cases, the new technology may offer only a minor benefit over previous and conventional practice patterns, or the benefits or risks of the technology may be uncertain or indefinite. In such instances, clinicians may choose to adopt or to ignore the innovation. In other cases, however, the overall benefits of a new technology impose a positive moral and professional obligation on the physician to weigh carefully and honestly the value of the technology and perhaps to integrate the innovation into his or her practice. Conversely, new medical technologies should not be used if the overall benefits to patient and society are not clearly demonstrated or if the risk, time, expense, and resources expended on the new technology are not justified by patient gain.Footnote 5
These general observations regarding the ethical proliferation and use of new medical technologies are as true for medical PDAs as they are for any other emerging therapeutic or diagnostic modality. And, like other therapeutic and diagnostic options, the PDA has rapidly diffused into the day-to-day professional life of clinicians without rigorous testing, evaluation, and analysis. The FDA has adopted a “low intervention” policy on “stand-alone” medically based computer software, as long as physician decisionmaking is still involved and the software is not physically connected to or integrally related to running a device that provides patient care (e.g., a CT scanner).Footnote 6 As a result, there are no formal limitations on their use. Even if PDAs were regulated by the FDA like other devices, the bulk of scrutiny would be focused on the the clinical trial phase of the device's development. However, many significant issues related to a new technology will not be visible until hundreds or thousands of rank-and-file physicians have treated tens-of-thousands of rank-and-file patients. Only then will the limitations, error traps, and therapeutic seams surface, be recognized, and demand remediation. This seems the unavoidable reality of technology diffusion in the United States.Footnote 7 Although there is no likelihood of changing this reality in the short run, it is still important to recognize that it creates a dynamic that demands a response. Medical technology will inevitably proliferate widely before the most appropriate uses and hidden dangers are uncovered. Given these observations, it is even more vital that professional observers and clinicians prepare themselves to recognize the limitations as they arise and prepare to meet them.
Undoubtedly, there will be at least some professional resistance to the broad-based use of PDAs. Resistance may be heightened by the recognition that this technology, like all others, is likely to have at least some unforeseen and unintended consequences. But some of the opposition will be based on little more than clinician preference or the very common and very human hostility to change and affinity for the familiar. Concerns about unforeseen consequences should be taken seriously, but the mere desire to continue to do things as they have been done in the past cannot. If a particular use of PDA technology offers notable patient benefit with only limited financial burden and patient risk, then it will be difficult to oppose legitimately widespread dissemination and use.
Evaluation and Analysis of Clinical Use of PDAs
At this point, the choice of hardware and operating systems is not a normative issue and remains largely a matter of personal preference and economic considerations. Instead, the ethical and legal questions surrounding these devices cluster around the type of functions for which these devices are used.
Scheduling and Billing Programs
Medical scheduling software, like products such as PatientTracker, WardWatch®, Mobile MedData, and OmniMD, for the most part, merely substitutes for a physician's hard-copy paper calendar. These programs, though a boon for busy clinicians, raise few significant ethical and legal issues. There is little to suggest that the benefits or risks of scheduling software installed on PDAs either mandate or preclude the use of this technology. These programs, and others like them, allow physicians to keep notes in the traditional history and physical (H & P) or SOAP note format, as well as providing an electronic platform for recording and organizing, with date and time entries, current medications, labs, vital signs, and the results of other diagnostic procedures. It is increasingly clear that such software can record more information in a more legible and organized form than virtually any form of handwritten notes. Handwritten patient notes sometimes can leave other members of the health team with gaps of information, which cannot be filled without time-consuming and difficult follow-up searches.
Electronic patient management programs installed on PDAs can make the transmission of patient information both easier and more accurate. Clinicians can provide through electronic transmission fuller information and instructions to staff members on other shifts. That information will be more accessible and, according to some observers, more accurate by decreasing the possibility of error that is associated with handwritten, incomplete, and disorganized notations.Footnote 8
Billing and charge-capture programs for PDAs such as PocketCode, CodeMeister, Bluefish RX ICD, and Pocket ICD/CPT help physicians navigate the increasingly complicated duty of billing and coding medical procedures. Some software contains diagnosis codes (ICD9-CM) and procedure codes (CPT 2000 and HCPCS) as well as fee schedules for the relevant third-party payer plans. Available programs now allow clinicians to dictate the procedures performed, advise physicians when they have miscoded a procedure, and transmit records submitted via wireless connection to in-house coders or across the Internet to a practice management service that codes the procedures and forwards them to the appropriate third-party payer.Footnote 9 Charge capture programs can increase reimbursement and decrease institutional overhead, coding and billing errors, overcharges to patients and third party payers, fraud and abuse charges, and the administrative costs that are said to cripple the U.S. healthcare system.Footnote 10
Reference Software
In contrast, medical reference software allows clinicians to carry complete versions of classic medical literature with them at all times. For example, The Physicians’ Desk Reference, Harrison's Principles of Internal Medicine, Merck Manual, practice guidelines, and a score of other standard medical texts are now available for PDA use. Some reference programs provide more guidance than traditional hardcopy resources. EPocrates, eDR, ePharmacopoeia, and LexiDrugs are clinical drug databases that can be used to research or verify indicated usages, recommended dosages, drug interactions, and known adverse reactions.Footnote 11 Medical reference software, like patient data and management programs, has the potential to directly improve patient care on a case-by-case basis. The human mind can only hold and recall a limited percentage of the scientific, diagnostic, prognostic, and treatment information now available. Although journals, medical reference texts, and even desktop computer programs make this information theoretically accessible, the practical difficulty in consulting these sources on a patient-by-patient basis has limited their widespread use. The same information rendered mobile in PDA format can be used more frequently and to greater advantage than ever before.Footnote 12
As long as traditional medical reference tools are reproduced in total electronically, they pose few risks. The ability to consult comprehensive reference materials during the clinical encounter is far more likely to enhance patient care, rather than harm it. There is still room for some caution. Clinicians and institutions should be wary if the electronic medical reference tool contains less information than the hard-copy version or is organized in a substantially different manner that may subvert easy or familiar access to information. Some observers may worry that ubiquitous electronic availability of medical reference sources may lead to a degradation of physician standards and skillsFootnote 13 and that clinicians will grow to rely too heavily on the PDA reference programs. But how great a danger do these fears represent if such technology becomes ubiquitous and clinicians always have access to their handheld computers? Medical reference texts in electronic format do not directly threaten to supplant physician judgment and analysis. They merely provide information that is already available in a more convenient form. If clinicians give electronic versions of standard research tools no more or less respect than they have given their previously available hard-copy versions, there is little reason for concern. What little danger does exist is almost certainly mitigated by the benefit of having immediate access to hundreds of pages of standard literature that should help both strong and weak physicians practice better medicine.
There may be even a clearer ethical mandate to employ some of the several available pharmaceutical reference programs, as they sometimes provide information in a form unattainable by traditional hard-copy alternatives.Footnote 14 These pharmaceutical reference guides have the potential to improve efficiency and protect the safety of patients by preventing prescription error. The Institute of Medicine study “To Err Is Human” echoed previous commentators in hailing the use of computer programs as one of the key ways to decrease the acknowledged and widespread medication error in the country.Footnote 15 One early study involving handheld computers projected that the nationwide use of a popular clinical drug reference guide could help avoid two million adverse drug events every year.Footnote 16 Although this study was based on extrapolation from a small data set, such potential patient benefit, if genuine, cannot justifiably be ignored. Specialized software promises other benefits. One PDA application helps clinicians choose the most appropriate antibiotic therapy, decreasing their reliance on problematic and less effective broad spectrum antibiotics and the looming threat of widespread antimicrobial resistance.Footnote 17 PDA programs that collect physician orders may reduce errors originating in poor handwriting.Footnote 18 Many of the pharmaceutical software programs provide for regular updates on available medications, as well as indications and adverse events, a feature unavailable with hard-copy reference tools.
The availability of electronic pharmaceutical reference tools and their ability to improve care and limit errors may make their integration into everyday clinical practice an ethical and professional obligation. Again though, caution is in order. Although there may be a mandate to investigate and take seriously the potential benefits of adopting this technology, there is a corresponding obligation to understand the limitations of the various options and choose the most appropriate software. No such program provides an inclusive listing of all medication and all relevant information. All do not provide updates on late-breaking information at the same rate or easy access. If used, clinicians will have an ongoing responsibility to update information where it is available and to supplement the software in the areas in which its guidance is limited.
Electronic Prescriptions and Orders
Medical prescribing and electronic order programs for PDAs allow physicians to automate virtually the entire process of prescribing medications and ordering patient care. Available programs include such applications as iScribe, Bluefish Rx Writer, Doc-u-Script, TouchScript, Palmscription, Allscripts, PocketScript, ePhysician, and Parkstone. Programs vary, but most allow physicians to enter patient data, dosage, instructions, and other information. The program then generates a prescription that is printed, faxed, or sent by wireless transmission or the Internet to the pharmacist. Various programs are combined with pharmaceutical reference software and also will cross-check the prescription for correct dosage, potential interactions with other medications, and known adverse reactions.Footnote 19 Some programs interface with existing electronic medical records systems, such as IDX. Other programs allow clinicians to enter orders for labs and other diagnostic tests on their PDAs.
A critical evaluation of currently available electronic prescribing software uncovers multiple and substantial benefits and few problems. Disadvantages included staff reluctance, incompatibility with existing institutional technologies, and the still limited number of participating pharmacy contacts.Footnote 20 But the elimination of paper prescriptions and lab orders promises to significantly decrease the administrative costs associated with patient care and increase physician productivity, generating savings that might be used in other healthcare arenas. Moreover, PDA prescribing may reduce substantially the errors associated with handwritten prescriptions. The Institute for Safe Medication Practices has recently called for elimination of handwritten prescriptions within three years.Footnote 21 Adverse drug events invariably represent a significant proportion of preventable medical error in any currently available study. Some studies suggest that the use of handheld scanners and bar-coders can eliminate 85% of the medication errors.Footnote 22 Incorrect dosages play a central role in medical error, as do flawed methods of delivery, poor penmanship, and known and documented, but overlooked, patient-specific counterindications, allergies, and drug interactions. PDA software, combining electronic prescribing with pharmaceutical reference databases, promises to diminish each of these well-known sources of error by informing treating physicians and alerting them when they have gone astray.Footnote 23 Echoing the Institute for Safe Medication assertions,Footnote 24 another study found that electronic prescribing led to a 55% reduction in medication errors.Footnote 25 In another study, allergic drug reactions and excessive dosages dropped 75%.Footnote 26 Similarly, a 2005 study found that use of a PDA program decreased the inappropriate use of antimicrobials by 32%.Footnote 27
It is true that the infrastructure is not entirely in place to allow an immediate wholesale move to electronic prescribing. Approximately 66% of U.S. hospitals do not have computerized physician orders available and only 5% of the institutions in which it is available require its use.Footnote 28 But, according to some observers, the financial costs of implementing such a system are relatively modest and the technology already exists to institute the practice on a much larger scale than is currently being attempted. Given the ability of these programs to reduce costs and protect against incorrect dosages and potential drug and allergic reactions, it appears as if there should be significantly greater pressure to expand the usage of these potentially valuable tools.Footnote 29 The technology is not flawless, and there are undoubtedly a number of hidden complications. As with other PDA software, serious and vexing privacy and confidentiality concerns remain. Despite these complications, the prospect of certain, direct, and tangible improvement in patient care at a reasonable cost cannot with good conscience be ignored or delayed. As G. Stephen Nance, of MD Net Guide, has predicted:
Handheld computing is going to revolutionize the way that medicine is practiced. Computerized physician order entry is ultimately going to be a key factor in reducing errors in medicine, and I think these devices will serve as a major hardware interface. . . . I think in most hospitals, it will eventually become the norm for physicians to enter orders using a PDA or Tablet PC; I think it will have to be the norm, . . . I think it has to be, because of the perceived problems with errors in the system.Footnote 30
Decision Support and Diagnostic Software
Physicians appear increasingly interested in the now widely available decision-support softwareFootnote 31 such as InfoRetriever, 5 Minute Clinical Consultant, MedNotes, and TheraDoc. One of the most elaborate programs includes brief synopses of over 1000 medical journal articles, 850 abstracts from the Cochrane Database of Systematic Reviews, prescribing information for over 1200 drugs, scores of clinical prediction rules, summary of evidence-based guidelines, tables, and algorithms. This program also allows clinicians to enter patient-specific data and test results and provides information on the reliability of the particular diagnostic test and on the overall probability that the patient is suffering from a particular malady. Inforetriever provides guideline summaries, including specific prescribing dosage recommendations, for the treatment of the illness, disease, or injury.Footnote 32 Software is also frequently available for a wide range of specific treatment challenges. One software application is designed to aid emergency room personnel (who may be unfamiliar with burn protocols) to calculate vital fluid resuscitation before the patient is transferred to a burn unit.Footnote 33 Another allows a patient's clinical signs to be charted against current medical literature and the acknowledged indicators for MIs.Footnote 34 Programs such as DiseaseDex, FirstConsult, InfoRetriever, and UpToDate purportedly search and synthesize the primary literature related to the patient's problem to aid clinicians who do not have those skills or the time to implement them. The software provides “predigested forms of information.”Footnote 35
The capabilities of decision-assist programs are exciting and appear to be a tangible step toward the cybermedicine of science fiction lore. Touting Inforetriever, Newsweek magazine proclaimed that the “program doesn't just enhance their [physicians’] efficiency . . . it can improve their decisions.”Footnote 36 Despite this excitement, the proliferation and use of decision-support software is the most complex and disturbing potential use of the PDA platform. Commentators have long argued that the development of a computerized system that can even approach the diagnostic ability of the human physician is highly unlikely.Footnote 37 Although these programs are sometimes stunning in their apparent capabilities, they are also encumbered by a broad range of uncertainties and potential hazards. There is a rich literature on the potential limitations of medical decision-support programs. Diagnosis, after all, is more than a mechanical, algorithmic function. Instead, as Randolph Miller has explained, medical diagnosis
represents a sequence of interdependent, often highly individualized processes: elicitation of initial patient data; integration of the data into plausible scenarios regarding known disease processes; evaluating of additional patient information; initiation of therapy at appropriate points in time (including before a diagnosis is established); and evaluation of the effect of both the illness and the therapy over time.Footnote 38
Computer programs are unlikely to fully replicate this sophisticated and in some ways still mysterious diagnostic exercise. Programmers, even medical-savvy programmers, will be handicapped by the existence of imprecise medical terminology, the fact that clinical parameters used in arriving at a diagnosis are alternatively statistically independent and dependent variables, and because most decision-assist programs require a static, and thus skewed, representation of the patient's medical history. Critics also note that even talented diagnosticians cannot “accurately break down the diagnostic through processes into explicit, understandable steps.”Footnote 39 Thus, it seems unlikely that a computer programmer could trace and capture the physician-expert's thought processes in a diagnostic algorithm.Footnote 40
Given that programmers are unlikely to duplicate physicians’ ability to diagnose patients in all cases, the medical profession is faced with decision-support software with inherent limitations. For a clinician to know when it is advisable to use and in some cases rely on diagnostic software, he or she would have to be sensitive to the limitations of the technology so that its guidance can be ignored. Most rank-and-file physicians will not be capable of this insight. For them, the decision-assist program on their PDA will remain very much a “black box,” the inner workings of which are largely inscrutable. In addition, the clinician would have to have a grasp of the various databases on which the digital consultation bases its conclusions.Footnote 41 If the program contains information that is dated, incomplete, or drawn from a different patient population than that which the clinician is treating, the advice generated may be inapplicable to the case at hand, but the physician would not know it.Footnote 42 But at a deeper level, a physician using a decision-assist product installed on a PDA has a duty to understand the nature of the algorithm used in developing the program and “the ways in which it might fail, both due to inherent theoretical limitations and due to the flaws that might occur during the process of implementation.”Footnote 43 The programs, too, might have insufficiently analyzed and weighed the data and peer reviewed literature that is available on the diagnostic problem. Many rank-and-file physicians will not be able to tell from routine use of the program where such mistakes have been made and may therefore fail to guard against the program's limitations.
Although this may be true, diagnostic programs need not be infallible to provide some benefit to patient and society. They may serve as a guide to a clinician's thinking through a problem or a memory spur to a physician who has momentarily forgotten the details of a particular diagnosis or set of symptoms. Instead of diagnostic infallibility, the more appropriate test is whether a particular decision-assist technology provides patient and societal benefit that exceeds the risks and burdens that it carries with it. If the programs represent a significant benefit for patients, despite their limitations, the profession and society should investigate and support expanded but controlled use of the devices. But the evidence is not yet clear whether and under what conditions decision-support programs should be used. All the while, the PDA platform is bringing decision-support technology to the bedside at an increasingly rapid rate.
An insightful and experienced clinician would presumably be able to identify those times when a decision-assist program provided incorrect or suspect recommendations and thus reject them. But responsible use would still require that the clinician understand the working of the program and the data and algorithms upon which its diagnosis and treatment recommendations are based. Notably, when discussing a medical-reference/decision-assist program for a PDA, a physician-reviewer warned “don't use 5MCC [a clinical assist program] to treat disorders that you aren't familiar with, but it is a very handy reference tool for on-the-fly lookups to round out your brain's memory of disorders.”Footnote 44 In addition, he disputed the program's drug of choice for myocardial infarction and noted that the use of thrombolytics was not mentioned.Footnote 45 Not all clinicians, however, are insightful and experienced. Ironically, the seasoned clinicians most prepared to critique the methodology and relevance of decision-assist programs may be the least likely to use them. Instead, relative newcomers to the profession may be the greatest supporters of decision-support programs, younger and student physicians who have yet to develop fully their analytical, problem solving, and clinical skills and thus who may be less able to recognize blind spots in the various available software. One medical educator, in a jocular tone, has already labeled a resident's quick reflexive reach for a PDA in response to a question from an attending physician as the “intern's palmomental reflex.”Footnote 46 Given both the potential data and analytical shortcomings of these programs, a comprehensive training program seems a reasonable protection against the potential overreliance—or reflexive reliance—on an inherently and unavoidably limited technology that is proliferating without oversight. Ongoing assessments and clinical trials of the safety and efficacy of decision-assist programs when used by physicians of differing skills, experience, and specialties would also be essential.Footnote 47
Law and the PDA
There will likely be only a very brief period before the medical profession will need to face directly legal questions related to handheld computers in court. In order for a patient to collect medical malpractice damages from a physician, he or she must prove that a physician–patient relationship existed, that there was a breach of standard of care, and that the damages suffered by the patient were caused by the breach. Juries must typically rely on medical experts to explain the standard of care in the case under consideration. The standard of care required of physicians holds that they are expected to possess and exercise the same degree of learning, skill, and care that “a reasonably prudent physician” would possess and exercise in the same or similar circumstances.Footnote 48
Negligent Use of PDAs
Physicians who rely on handheld medical applications may be held liable for their negligent misuse. Flaws in the software itself that lead to patient harm will likely be litigated as product liability suits filed against the software developer or manufacturer. But physicians who use those flawed or limited programs might be held legally responsible as well. Technically, physician negligence is not based on the use of a flawed program, but rather the failure to be aware of the limitations of the program and for relying uncritically on a computer application when they knew or should have known its limitations. Plaintiffs will have to prove that a reasonably prudent physician would not have relied on the data, information, or advice generated by the PDA program and that “but for” the reliance on the flawed program the patient would not have been injured. The discussion of standard of care in any particular case will focus on the degree to which a physician may justifiably rely on the specific PDA software, whether it is a data management, reference, or decision-assist program. This is a question that experts will answer on a case-by-case basis and will depend on considerations such as the degree of risk to which the patient is exposed if the software is defective, the amount of knowledge that a reasonably prudent physician would possess of the workings and limitations of the software, and the extent to which a reasonably prudent physician would have sought out independent confirmation for the information generated by the program.Footnote 49 Consider the following illustrative hypothetic based on a case created by Arnold Rosoff:
Dr. B uses PDA-based decision-assist software linked to a patient's electronic medical record (EMR) to help decide what drug to prescribe for a patient's condition. Knowing that the patient's EMR is supposed to contain information about all medications the patient is currently taking and that the decision-assist software is designed to flag potential drug interactions, she relies upon the decision-assist program's recommendation without taking the time to ask the patient if he is taking any other medications. Unfortunately, the patient is on a drug, prescribed a week before by another physician, Dr. A, that should not be taken concurrently with the one Dr. B is now prescribing. The patient assumes Dr. B knows about the medication previously prescribed by Dr. A and makes no mention of it; and the patient suffers a serious adverse reaction from the drug interactions. Upon investigation, it is found that either Dr. A failed to enter the prescription properly, or the EMR software "mis-posted" the information and it never made its way into this patient's permanent record, or the information was correctly posted but the decision-assist program failed for some reason to flag the drug interaction potential.Footnote 50
In determining Dr. B's potential negligence, an expert would be asked to express an opinion on a number of issues. Would a reasonably prudent physician rely solely upon the EMR and the decision-assist software in recommending the patient's remedy? If there were flaws in the EMR protocol or in decision-assist program or in the interface between the two, would a reasonably prudent physician have been aware of these flaws or limitations? Is the risk to the patient of drug interaction in this case so high that a reasonably prudent physician would have taken the additional safeguard of asking the patient for a list of current medications? Dr. B's negligence would almost certainly not be based on the fact that she used a flawed program. Instead, it would be based on whether the reliance and care she took when using it was commensurate with that of a reasonably prudent physician. In addition to the obvious problems posed in this case, medical reference material and decision-assist programs are frequently based on data that are time sensitive. Physicians who use such software undoubtedly incur a duty to be aware of outdated software and are very likely required to take advantage of program updates when available.
Therefore, if a negligently designed software program provides an incorrect diagnosis, recommendation, or dosage or insufficient or incorrect information, a physician is not automatically exonerated. As with flesh and blood consultants, medical software exists only to assist the judgment of the attending physician. Thus, if a physician declines to follow the guidance of computer software and the patient is injured as a result, then the physician may be protected if he or she had viable reasons for doing so and acted as a reasonably prudent physician would have acted in the same circumstances.
Failure to Use Available Handheld Technology and the Role of “Customary” Practice
At some point, a future medical malpractice jury will be asked to determine whether a physician is required to use available computerized databases via a PDA or desktop. The test of whether a particular technology, like a PDA, must be used is no different than that of other medical negligence cases. If physicians fail to do so and patients are injured as a result, then they might be called to account for patient injuries.
One of the advantages of computer programs is that they assist physicians in routine but information dense medical situations. Routinization, however, is not always desirable when the computer application in question contains inherent flaws or limitations.Footnote 51 The test of whether a clinician has breached the standard of care in reliance on an imperfect program will turn on whether a reasonably prudent physician have known of those flaws, been sensitive to how those defects could impact patient care, and taken steps to protect patients from those shortcomings. Therefore, if a negligently designed software program provides an incorrect diagnosis, recommendation, or dosage or insufficient or incorrect information, a physician is not automatically exonerated. Neither is the physician automatically in legal peril in declining to follow the recommendation of the handheld computer programs. As with flesh and blood consultants, medical software exists only to assist the judgment of the attending physician. Thus, if a physician declines to follow the guidance of computer software and the patient is injured as a result, then the physician may be exonerated if he or she had viable reasons for doing so and acted as a reasonably prudent physician would have acted in the same circumstances. These questions, like those regarding the negligent “use” of PDAs, can only be answered by expert witnesses on a case-by-case basis.
As argued above, physicians may be deemed to have an ethical duty to employ a technology if its use “improves the quality of care at an acceptable cost in time and money or if it maintains the existing standard of care at a reduced cost in time or money.”Footnote 52 But this is not the legal standard used to determine whether a particular technology must be used. As noted, plaintiffs, through their expert witnesses, are typically required to prove that a defendant-physician failed to act as a reasonably prudent physician would have acted in a comparable situation. If a reasonably prudent physician would have used a particular technology in the same or similar circumstances and the defendant physician did not, then the treating physician breached the standard of care and could be held liable if the breach caused injury to the patient.
The medical expert may rely on an analysis of the clinical facts, her training, the scientific and medical literature, and guidance from evidence-based medicine (EBM) to outline what should be expected of a reasonable physician in the factual scenario before the court.
But medical experts also ordinarily rely very heavily on “customary” practice when evaluating a defendant-physician's performance. In the majority of jurisdictions, “customary practice” plays a critical role in determining what constitutes “reasonable medical practice.” Judicial deference to custom allows the physician-community's practice to establish conclusively, in many cases, the medical standard of care—even if reasonable and progressive medical and scientific thinking suggested a different conclusion. If the jury finds that the defendant-physician's actions were consistent with the “custom” of the profession, they are required to find that the physician acted within the appropriate standard of care. The law's heavy reliance on “custom” means that the newest or best techniques or procedures and the most reliable information do not typically become part of the standard of care until the knowledge, procedure, or technique has gained general acceptance and usage in the medical community.Footnote 53 Indeed, physicians have been protected in many contexts by the claim that although a “reasonable physician” may have acted differently, the defendant-physician acted within the standard of care because medical “custom” did not require the use of the particular diagnostic or treatment technology.
Despite its rapid proliferation and clear value in a number of contexts, the use of PDAs in clinical settings cannot now be considered “customary,” even though many of the foregoing arguments suggest that a limited number of PDA usages could be considered part of a reasonably prudent physician's practice. Consider a hypothetical drug interaction lawsuit. A plaintiff's expert might conceivably testify that a reasonably prudent physician should have consulted a computerized pharmacological database (perhaps on a PDA) in order to determine the existence of a drug interaction. But as long as the defendant's expert testified that the use of pharmacological software was not usual and “customary” practice within the profession, the defendant might escape liability, even though it could be shown that the software would have identified the pharmacological danger in advance, thereby preventing the patient's injury. Because of the protection provided by “custom” in a broad range of jurisdictions, it may be difficult to successfully sue physicians for the failure to use a PDA-based clinical program.
The protection that “custom” provides physicians in regards to handheld computers may be short-lived. Physicians are required to keep abreast of changing standards of care, and the extent to which the use of PDAs is customary or the standard of care is a rapidly moving target. After all, over 100,000 physicians had downloaded ePocrates by late 2000. That figure is growing and, combined with other similar programs, will likely lead some experts eventually to say that use of some handheld clinical programs, in some contexts, is the standard of care. There is no bright line rule and no way to predict precisely when that threshold point will be reached, but physicians must stay cognizant of the profession-wide use of the PDAs. Clinicians should be aware that, historically speaking, the transition may occur within a relatively short period of time and that it is becoming increasingly likely that a physician could be held liable for the failure to use a handheld computer or refer to an available computer data base.
The Declining Legal Relevance of “Medical Custom”
Clinicians should be aware as well that there is a clear and growing movement among some courts and legal scholars that challenges the conventional reliance on customary practice as a gauge of whether defendant-physicians have performed up to the standard of care. This position, if it becomes ascendant, would severely undercut the defensive importance of “custom” as the definitive indicator of the acceptable standard of care.
The infamous Helling v. Carey (1974)Footnote 54 is the best known challenge to the dominance of custom in the healthcare setting. Helling suggested that, under certain conditions, a defendant might be held liable for failing to use an available technology even if the use of that technology was not customary, or the standard of care, within the profession. Helling, which involved the use of a pressure test for glaucoma, held that an entire professional field might be negligent for failing to employ a technology that was (1) accurate, (2) inexpensive, (3) highly beneficial, and (4) low risk to the patient. Under these conditions, a practitioner could be held to have acted “unreasonably” and deemed liable even though he or she acted in consonance with the prevailing custom.Footnote 55 A number of handheld applications, especially those related to medical reference and pharmaceutical selection and prescription appear to satisfy the Helling tests. PDA software in those contexts is inexpensive, accurate, low risk, and highly beneficial. But until recently, the Helling approach had very few supporters.Footnote 56
But change appears to be underway. Courts are becoming critical of the proposition that “customary” practice invariably trumps reasonably prudent care and is the controlling element of the medical standard of care. Theodore Silver has argued that the “professional custom standard” is the result of jurisprudential accident and sloppy legal reasoning in the late 19th century and has contributed to “one hundred years of harmful error” in medical liability law. Instead, Silver contends that custom should be weighed the same way that it is in every other form of negligence.Footnote 57 The academic and jurisprudential tendency is to share Silver's vision of custom that is closer to the more limited role it plays in negligence claims brought against institutions, industries, and other professions. In those arenas, as Ben Rich explains, “the law has not hesitated to subject the customary practices of those other professions to objective scrutiny, and to find, when the circumstances warranted, that they fell below a minimally acceptable level of prudence and safety.”Footnote 58 And, as Rich outlines, there is as well a gradual and subtle trend in the courts toward the view that, although medical “custom” is a relevant component in the determination of standard of care, it is not controlling. For example, in Toth v. Community Hospital (1968), New York's highest court declared that “customary practice was not the sole test of professional malpractice.”Footnote 59 The court explained its position by declaring: “there is no policy reason why a physician, who knows or believes there are unnecessary dangers in the community practice, should not be required to take whatever precautionary measures he deems appropriate.”Footnote 60 Similarly, in 1992 the Colorado Supreme Court declared, “The standards of medical practice cannot be determined simply by counting how many physicians follow a particular practice. Negligence cannot be excused on the grounds that others practiced the same kind of negligence.”Footnote 61 And, in 1996, the Wisconsin Supreme Court declared that, although in most instances there will be no difference between customary care and reasonable practice, “Should customary medical practice fail to keep pace with developments and advances in medical science, adherence to custom might constitute a failure to exercise ordinary care.”Footnote 62 Indeed, by one count, appellate courts in 17 states have rejected the rule that conformity with professional “custom” is uncontestable evidence that the defendant physician had acted within the standard of care.Footnote 63 The powerful role that “custom” has traditionally been assigned in the law of medical negligence is an embodiment of the social and legal acceptance of the autonomous and sovereign status of the medical profession. Declining respect and influence accorded medical custom in medical liability litigation represents a concomitant deemphasis of the authority of the profession in the law.
Some observers believe that the medical profession's incomplete assimilation of the benefits of PDA-based programs will itself play a role in encouraging the courts to reexamine the role “custom” has played in the articulation of standard of care.Footnote 64 Medical information, digitalized and inexpensively available on handheld platforms, can have a dramatic impact on patient and societal well-being. Quite simply, as patients suffer negative outcomes that could have been avoided by the use of PDA or other accessible computer-based means, courts may be less likely to accept the role of custom uncritically. The drift away from custom has already started; it seems unlikely that courts will continue to allow custom to lag behind inexpensive, practical, and effective technologies and knowledge.Footnote 65 Indeed, Scarpelli and Petras predicted in 1975 that physicians would probably be held liable for failing to use available resources before those resources are adopted by the profession at large.Footnote 66 The handheld platform's usable size, large memory, and reasonable price will undoubtedly accelerate this process. The same information rendered mobile in PDA format can be used more frequently and to greater advantage than ever before. This practicality and benefit of PDAs will be hard for courts to overlook. These transformations, if they materialize as predicted, will bring the legal standard for use of many PDA programs more clearly into consonance with the ethical mandate that appears to already exist to employ at least some of the several software programs now available.
Conclusions
For over two decades, observers have been forecasting a dramatically more expansive role for computers in the bedside practice of medicine. The PDA may have finally brought these predictions to reality. Although caution is advisable with regard to some uses of PDAs, it is equally obligatory—ethically and perhaps legally—to rapidly identify those uses for which resistance to change is no longer professionally and ethically justified. A tremendous amount of data will be necessary to demonstrate the accuracy, safety, and efficacy of the various handheld computer applications currently available and the avalanche of programs that are undoubtedly forthcoming. The proliferation of these clinical tools will not stop as comprehensive clinical trials are conducted and analyzed. But a commitment to a systematic collection of data related to the performance of PDAs in the early stages of its diffusion and use can refine the profession's knowledge of the device's capabilities, uncover complications, and demonstrate the need for safeguards and specialized training in some instances. This concurrent, yet prospective, focus on this and other powerful medical innovations is indispensable. Hopefully, such insights will slow or stop problematic applications of the technology while expanding uses of the devices in the areas of patient care in which delay is no longer defensible.
