the ethical and legal implications of handheld medical computers
TRANSCRIPT
This article was downloaded by: [Newcastle University]On: 20 December 2014, At: 12:47Publisher: Taylor & FrancisInforma Ltd Registered in England and Wales Registered Number:1072954 Registered office: Mortimer House, 37-41 Mortimer Street,London W1T 3JH, UK
Journal of Legal MedicinePublication details, including instructionsfor authors and subscription information:http://www.tandfonline.com/loi/ulgm20
THE ETHICAL ANDLEGAL IMPLICATIONSOF HANDHELD MEDICALCOMPUTERSKenneth A. De Ville aa Professor, Department of MedicalHumanities, Brody School of Medicine, EastCarolina UniversityPublished online: 10 Nov 2010.
To cite this article: Kenneth A. De Ville (2001) THE ETHICAL AND LEGALIMPLICATIONS OF HANDHELD MEDICAL COMPUTERS, Journal of LegalMedicine, 22:4, 447-466, DOI: 10.1080/01947640152750928
To link to this article: http://dx.doi.org/10.1080/01947640152750928
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The Journal of Legal Medicine, 22:447–466Copyright C° 2001 Taylor & Francis0194-7648/01 $12.00 + .00
THE ETHICAL AND LEGAL IMPLICATIONS
OF HANDHELD MEDICAL COMPUTERS
Kenneth A. De Ville, J.D., Ph.D.*
INTRODUCTION
The stroke patient was given Dilantin to control seizures as a critical care nurseprepared to administer a dose of dopamine to control the patient’s dangerouslylowered blood pressure. At the bedside, the attending physician quickly con-sulted his handheld computer and discovered that combining dopamine withhigh doses of Dilantin could have potentially lethal results. The physician sub-stituted a different drug. If the medical team had done “the usual thing,” thephysician reported, then “the patient would have been dead within minutes.”1
Such testimonials to the capabilities, utility, and promise of handheldcomputers in medicine are increasingly common in print, in clinics, in hospi-tals, and in medical schools. Handheldcomputers, or personaldigital assistants(PDAs), are designed to perform a wide range of clinical and administrativetasks for physicians and are taking the medical world by storm. In Januaryof 2001, industry data indicated that 20% of United States physicians car-ried and used PDAs. That number is undoubtedly higher now. At least 50companies manufacture medical software for handheld computers in an in-creasingly competitive and growing market.2 Many medical schools, healthcenters, and group practices are either requiring or providing PDAs for theirmedical staffs and students. Over 200,000 health professionals, including100,000 physicians, have downloaded one clinical drug reference guide.3
In a market report, auspiciously titled The Cure Is in Hand, investmentconsulting group WR Hambrecht C Co. con� dently predicted that handheld
* Professor, Department of Medical Humanities, Brody School of Medicine, East Carolina University. OfCounsel, Hollowell, Peacock & Meyer, P.A., Raleigh, N.C. Address correspondence to Professor DeVille at Department of Medical Humanities, Brody School of Medicine, East Carolina University, 2S-17Brody, Greenville, North Carolina 27858-4354,or via e-mail at [email protected].
1 Milt Freudenheim, Digital Doctoring, N.Y. TIMES, Jan. 8, 2001, at A1.2 Id.3 Duke Health SaddlesPhysicians with New Technology, BUS. J., available at http://triangle.bcentral.com/
triangle/stories/2001/02/26/daily12.html (last visited June 5, 2001).
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devices will “dramatically change the way that physicians practice medicine.”According to its authors, PDAs soon will be used for everything from schedul-ing to prescribing, from billing and reimbursement responsibilities to medicaldecision support.4
The excitement surrounding the medical use of handheld computers iswell founded. PDAs and developing medical software have the potential toimprove patient care as well as saving both money and time. This enthusiasm,combined with aggressive marketing campaigns by both hardware and soft-ware developers, as well as a number of pharmaceutical sponsors, has resultedin an extraordinarily rapid diffusion of PDAs into the clinical workplace, at apace virtually unparalleled in the history of medical technology.5 For over twodecades, observers have been forecasting a dramatically more expansive rolefor computers in the bedside practice of medicine.6 The handheld computermay have � nally brought these predictions to reality. While it is clear that theuse of handheld computers is likely to bring much bene� t to patients, society,and the medical profession, the precipitous adoption and use of such a pow-erful technology undoubtedly masks a broad range of clinical, professional,ethical, and legal issues that may not have yet fully surfaced. This articleidenti� es and examines some of the issues that the extensive use of handheldcomputers in the clinical setting likely will raise.7
I. PROFESSIONAL AND ETHICAL CONSIDERATIONS
When considering the adoption and use of a new medical technology,there are two potential classes of error: (1) clinicians and institutions mayadopt an innovation too soon or wrongly; or (2) they may delay or fail toadopt a bene� cial technology. As a general matter of professional and ethicalpropriety, a new medical technology should be employed if its use “improvesthe quality of care at an acceptable cost in time and money or if it maintains theexisting standard of care at a reduced cost in time or money.”8 Bene� ts both tothe patient and to society must be weighed. Patient and clinician preferences
4 Josh Fisher & Rosemary Wang, The Cure Is in Hand, Oct. 2000, at 4, available at http://www.wrham-brecht.com/research/coverage/ehealth/ir/ir20001019.pdf(last visited June 5, 2001) (market report fromWR Hambrecht C Co.).
5 H. David Banta, Embracing or Rejecting Innovations:Clinical Diffusion of Health Care Technology, inTHE MACHINE AT THE BEDSIDE: STRATEGIES FOR USING TECHNOLOGY IN PATIENT CARE 65 (Stanley Reiser &Michael Anbar eds. 1984).
6 See, e.g., id.7 The current market for medical handheld computers and their software is extraordinarily competitive.
Nothing in this article shouldbe construed as an implicit or explicit endorsement of a particular operatingsystem, handheld computer, or software. The industry is in such a profound state of � ux that any suchconclusion would be premature.
8 Robert A. Miller et al., Ethical and Legal Issues Related to the Use of Computer Programs in ClinicalMedicine, 102 ANNALS INT. MED. 529, 529 (1985).
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 449
are relevant but not necessarily controlling when other factors (quality of care,economics, or overall social good) indicate that the new technology offers,on balance, clear advances over previous ways of practicing medicine andproviding health care services. In some cases, the new technology may offeronly a minor bene� t over previous and conventional practice patterns. Or,the bene� ts or risks of the technology may be uncertain or inde� nite. In suchinstances, clinicians may choose to adopt, or to ignore, the innovation. In othercases, however, the overall bene� ts of a new technology impose a positivemoral and professional obligation on the physician to weigh carefully andhonestly the value of the technology and perhaps to integrate the innovationinto his or her practice. Conversely, new medical technologies should not beused if the overall bene� ts to patient and society are not clearly demonstratedor if the risk, time, expense, and resources expended on the new technologyare not justi� ed by patient gain. Finally, the use of some technologies may bejusti� ed only if they are used in a responsible and appropriate manner.
These general observations are relevant to the use of handheld medicalcomputers in that some applications and functions may offer only marginalbene� ts to patient care and economy, some offer clear and signi� cant bene-� t, and some represent patient and societal bene� t only if they are employedin an appropriate fashion or are introduced with accompanying safeguardsto mitigate the predicted negative impact of the innovation. The identi� ca-tion and weighing of bene� ts, risks, harms, and implications of widespreadproliferation of handheld computers into clinical practice is, of course, a spec-ulative and potentially contentious endeavor. But it is the exploration that themedical profession and society should pursue in the lengthening shadow of atechnology as consequential as handheld computers.
II. THE STATE OF THE ART: EVALUATION AND ANALYSIS
The use of PDAs may raise a number of important questions relatedto clinical and ethical propriety as well as legal responsibility. Obviously,the answer to these questions depends substantially on the type of functionsfor which these devices are used. A number of companies offer handheldcomputers that can be used in conjunction with medical software.9 Thesecomputers range from a few ounces to a little over a pound,are only marginallylarger than a deck of cards, and can easily be carried all day in the clinic andon rounds in the hospital.10
9 There are three main competing operating systems: Palm OS;°R Windows CE°R or Windows CE forPocket PC°R; and Symbian°R (EPOC). Although loyalties run deep among devoted users, the choice ofhardware and operating systems is, at this point, largely a matter of personal preference and economicconsiderations.
10 Neil Chesanow, Put a Computer in Your Pocket and Change Your Life, 77 MED. ECON. 76 (2000).
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Available medical software can be roughly classi� ed into six main cat-egories: (1) scheduling programs; (2) data management programs; (3) billingand charge-capture programs; (4) medical reference software; (5) medicalprescribing; and (6) decision-support programs.
The � rst category of medical software, scheduling programs, transposesa physician’s paper calendar to electronic form using a handheld version ofsoftware, such as Microsoft Outlook, scheduling.com, or one of the othermany good available programs. Medical scheduling software, for the mostpart, merely substitutes for a physician’s hard-copy paper calendar. Theseprograms, though a boon for busy clinicians and their of� ce staff raise fewethical and legal issues. Con� dentiality concerns aside, there is little to suggestthat the bene� ts and risks of scheduling software installed on handheld com-puters either mandate or preclude the use of this technology. Most practicestypically employ some manner of electronic scheduling system and coordi-nation with the clinician’s handheld computer represents only a minor changefrom current practice and likely has only scant ethical or legal signi� cance.Scheduling software may lead to some increase in both the clinician’s and, byextension, the health delivery system’s ef� ciency. If these economic bene� tsof such programs are signi� cant, then it may be possible to argue that theirimplementation is ethically required in order to conserve resources for usesin other areas of the health care sector.
The second category of PDA software, data management programs,includes products such as PatientTracker and PatientKeeper. These programs,and others like them, allow physicians to keep notes in the traditional historyand physical (H & P) or SOAP note format. In addition, such programs allowdate and time entries for current medications, labs, vital signs, and the results ofa wide range of other diagnostic procedures. Some programs allow cliniciansto consult a series of lab results or vital signs over time in order to discern trendsin the patient’s illness or recovery. The notes usually can be shared with otherclinicians by infrared transfer from onePDA to another, to a desktop computer,or to a printer. Some programs will allow the electronic notes to be transferredto the patient’s electronic medical record through infrared transmission orthrough a so-called “hot sync,” in which the handheld computer is placed ina cradle connected by a cable to a desktop computer.
At � rst glance, too, the second category of PDA software, patient man-agement programs, appears to merely replicate the hard copy notations onpatients that physicians traditionally have dictated, or taken on paper, indexcards, or cafeteria napkins. However, it is increasingly clear that such soft-ware can record more information in a more legible and organized form thanvirtually any form of handwritten notes. This attribute has major implicationsfor the improvement of patient care and the ef� ciency of the health care insti-tution and of the health delivery system at large. Handwritten patient notes,in the short term, sometimes can leave other members of the health care team
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 451
with gaps of information, which cannot be � lled without time-consuming anddif� cult follow-up searches.
Electronic patient management programs installed on PDAs can makethe transmission of patient information both easier and more accurate. For ex-ample, in-house clinicians can provide through electronic transmission fullerinformation and instructions to staff members on other shifts. That informa-tion will be more accessible and, according to some observers, more accurateby decreasing the possibility of error that is associated with handwritten, in-complete, and disorganized notations. More accurate and more ef� cient trans-mission of important patient information has the potential to improve patientcare in signi� cant ways.11 In addition, improved ef� ciency within health careinstitutions can generate � nancial bene� ts that lessen the overall economicburden, on the health system in general and the health care institution inparticular, potentially preserving resources for the care of underserved popu-lations. The extent of these bene� ts, of course, remains speculative. But thepromise of electronic patient management systems brought to the bedside onPDA platforms is striking and suf� ciently compelling to suggest that medicalprofessionals and health care institutions havean ethical and professional obli-gation to explore actively the prospects and impact of widespread adoptionby clinicians.
Undoubtedly, there will be at least some professional resistance to thebroad-based use of patient management tools on handheld computers. Someof the institutional and professional skepticism may be based on the under-standable and sometimes laudatory hesitance to change practices that haveprovided good patient care in the past. This resistance may be heightened bythe recognition that this technology, like all others, is likely to have at leastsome unforeseen and unintended consequences. But some of the oppositionwill be based on little more than clinician preference or the very commonand very human hostility to change and af� nity for the familiar. Concernsabout unforeseen consequences should be taken seriously, but the mere desireto continue to do things as they have been done in the past cannot. If futureevaluation and assessments con� rm notable patient bene� t with only limitedadditional � nancial burden and patient risk, then it will be dif� cult to opposewidespread dissemination and use throughout the health care community. Theimplementation of speci� c safeguards regarding use of PDAs in this context,including con� dentiality concerns, will have to be addressed as the impact ofthe technology is more fully considered.
Billing and charge-capture programs (for example, PocketCode,°R
Mdeverywhere,°R and VirtMed°R ), the third category, help physicians andhealth care facilities navigate the increasingly complicated duty of billing
11 Feature: Naval Medical Center Portsmouth, available at http:www.pdaMD.com/features/cs/nmpeprise.xml (last visited June 5, 2001).
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and coding medical procedures. Some software contains diagnosis codes(ICD9-CM), procedure codes (CPT 2000 & HCPCS), as well as fee sched-ules for the relevant third-party payer plans. Some programs advise the physi-cian when he or she has miscoded a procedure or diagnosis for billing pur-poses. Other software allows the clinician to dictate the proceduresperformed.That transcript is sometimes transmitted via wireless connection to in-housecoders or across the Internet to a practice management service that appropri-ately codes the procedures and forwards them to the appropriate third-partypayer.12
Charge-captureprogramscan increase reimbursement by easing the doc-umentation and coding process for individual physicians. In addition, they candecrease institutional overhead by streamlining and centralizing the billingprocess. Finally, they can decrease coding and billing errors that sometimeslead to fraud and abuse charges. While these services may � rst appear to bematters solely of administrative convenience and risk management, their usemay be ethically obligatory in a number of respects. If charge capture softwareresults in more accurate billing, then overcharges to patients and third-partypayers can be avoided. While most such overcharges are inadvertent and maybe the result of a mindnumbingly complex reimbursement system, the fail-ure to avoid or decrease such errors, when a reasonable solution is available,could be considered morally culpable. Therefore, if billing software installedon handheld computers can reduce mistakes that lead to overcharges by clini-cians and institutions at a modest cost, then those options should be exploredand, if viable, pursued.
Second, as mentioned, many observers believe that computer-assistedbilling and coding will increase, not decrease, the overall revenue generatedby health care providers; because their ease of use will increase the recordingof bedside charges and because the systems will decrease the administra-tive costs associated with the process. The United States health care systemis burdened with the highest health care administrative costs in the world.13
In part, as a result, a country that spends more than any other on healthcare is at the same time plagued with endemic health care in� ation and anever-growing number of uninsured and underinsured patients. Any innova-tion that lightens that administrative burden promises to leave more healthdollars available for medical care increasing the overall well-being of society.Public health care institutions that depend on Medicare and Medicaid fund-ing who employ streamlined and more accurate billing procedures will beable to care for more patients and better satisfy their missions. The ability ofPDA-based charge-capture software to increase both gross and net receiptsmay make it one of the most popular programs among health care admin-
12 Fisher & Wang, supra note 4, at 32-33, 43-45.13 Stef� e Woolhandler et al., Administrative Costs in U.S. Hospitals, 329 NEW ENG. J. MED. 400 (1993).
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 453
istrators. But the potential of the programs to allow the provision of morecare for less money at both the societal and the institutional level is an at-tribute that makes its serious consideration an ethical as well as a � nancialresponsibility.
The fourth category, medical reference software, allows clinicians tocarry complete versions of classic medical literature with them at all times.For example, The Physicians’ Desk Reference, Harrison’s Principles of In-ternal Medicine, Merck Manual, practice guidelines, and a score of otherstandard medical texts are now available for handheld computer use. Somemedical reference programs provide more guidance than traditional hard copyresources. EPocrates,°R eDR,°R ePad,°R ePharmacopoeia,°R and LexiDrugs,°R forexample, are clinical drug databases that can be used to research or verify in-dicated usages, recommended dosages, drug interactions, and known adversereactions.14
Medical reference software, like patient data and management programs,has the potential to directly improve patient care on a case-by-case basis. Datamanagement programs help the clinician recall and organize the enormousamount of patient information generated by modern diagnostic technologies.Reference software now available on handheld computers allows bedside orexamining room access to vast amounts of general medical knowledge gener-ated in the second half of the twentieth century. Thehuman mind can only holdand recall a limited percentage of the scienti� c, diagnostic, prognostic, andtreatment information now available. While journals, medical reference texts,and even desktop computer programs make this information theoreticallyaccessible, the practical dif� culty in consulting these sources on a patient-by-patient basis has limited their widespread use. The same information, inPDA format, can be used more frequently and to greater advantage than everbefore.15
As long as traditional medical reference tools are reproduced in totalelectronically, it is dif� cult to oppose their widespread use. For the most part,medical reference software is merely a more accessible version of conven-tional research tools. The ability to consult comprehensive reference materialsduring the clinical encounter is far more likely to enhance patient care, ratherthan harm it. However, there is still room for some caution. Clinicians and in-stitutions should be wary if the electronic medical reference tool contains lessinformation than the previous hard copy version or is organized in a substan-tially different manner that may subvert easy or familiar access to information.In these instances, it is incumbent on the user to be aware of the gaps in theelectronic version and be certain that he or she has a working knowledge ofthe software before employing it in practice.
14 Chesanow, supra note 10.15 STANLEY JOEL REISER, MEDICINE AND THE REIGN OF TECHNOLOGY 204-05 (1978).
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Two thousand years ago, Socrates worried that written documents would“create forgetfulness in the learners’ souls, because they will not use theirmemories; they will trust to the external written characters and not remem-ber of themselves.”16 Similarly, some observers may worry that ubiquitouselectronic availability of medical reference sources may lead to a degradationof physician standards and skills17 and that clinicians will grow to rely tooheavily on the PDA reference programs. Perhaps. But how great a danger dothese fears represent if such technology becomes ubiquitous and cliniciansalways have access to their handheld computers? Medical reference texts inelectronic format do not directly threaten to supplant physician judgment andanalysis. They merely provide information that is already available in a moreconvenient form. If physicians begin to treat electronic texts as the � nal and� xed word on clinical matters, then these programs may pose a risk of danger;but if clinicians give electronic versions of standard research tools no moreor less respect than they have given their previously available hard copy ver-sions, there is little reason for concern. What little danger does exist is almostcertainly mitigated by the bene� t of having immediate access to hundreds ofpages of standard literature that should help both strong and weak physicianspractice better medicine.
There may be even a clearer ethical mandate to employ some of theseveral available pharmaceutical reference programs. This software fre-quently provides information in a form unattainable by traditional hardcopyalternatives.18 Some of these programs begin to blur the line between purereference sources and decision-assist programs. These pharmaceutical refer-ence guides have the potential to improve ef� ciency and protect the safetyof patients by preventing prescription error. The Institute of Medicine studyTo Err Is Human echoed previous commentators in hailing the use of com-puter programs as one of the key ways to decrease the acknowledged andwidespread occurrence of medication error in the country.19 One early studyinvolving handheld computers projected that the nationwide use of a popularclinical drug reference guide could help avoid two million adverse drug eventsevery year.20 Although this study was based on extrapolation from a small dataset, such potential patient bene� t, if genuine, cannot justi� ably be ignored.More specialized software promises other bene� ts. One handheld applicationhelps clinicians choose the most appropriate antibiotic therapy, an increasingly
16 Robert C. Snider, The Machine in the Classroom, 74 PHI DELTA KAPPAN 316, 317 (1992) (quotingSocrates).
17 Kenneth Goodman, Bioethics and Health Informatics, in ETHICS, COMPUTING, AND MEDICINE: INFORMATICS
AND THE TRANSFORMATION OF HEALTH CARE 2 (Kenneth Goodman ed. 1998).18 Greg Jeansonne, Feature—In My Opinion: ePocrates qRx 4.0, available at http://www.pdamd.com/
features/epocratesopinion.xml (last visited June 5, 2001).19 INSTITUTE OF MEDICINE, TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM 9, 40 (2000).20 ePocrates, Duke University to Provide ePocretes Handheld Medical Software to Af� liated Physicians,
available at http://www.ePocrates.com/headlines/story.cfm?storyC10063 (last visited June 5, 2001).
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 455
dif� cult task given the range of potential available remedies. Advocates con-tend that such programs may allow clinicians to decrease their reliance onbroad spectrum antibiotics and the looming threat of widespread antimicro-bial resistance.21 Many of the pharmaceutical software programs provide forregular, even daily, updates on available medications, as well as indicationsand adverse events, a feature unavailable with hard copy reference tools.
The availability of electronic pharmaceutical reference tools and theirability to improve care and limit errors may make their careful integrationinto everyday clinical practice an ethical and professional obligation. Againthough, caution is in order. No such program provides an inclusive listingof all medication and all relevant information. All do not provide updateson late-breaking information at the same rate or easy access. Moreover, allpharmaceutical programs are not created equally. Thus, while there may be amandate to investigate and take seriously the potential bene� ts of adopting thistechnology, there is a corresponding obligation to understand the limitationsof the various options and choose the most appropriate software. Finally, ifsuch programs are employed in clinical practice, then clinicians will havean ongoing responsibility to update information where it is available and tosupplement the software in the areas in which its guidance is limited.
The � fth category of medically related software designed for hand-held computers, medical prescribing programs, allows physicians to auto-mate virtually the entire process of prescribing medications. Available pro-grams include such applications as iScribe°R and Allscripts,°R PocketScript,°R
ePhysician,°R and Parkstone.°R Programs vary, but most allow physicians todownload patient names and information onto the handheld computer, typi-cally the patients scheduled for the day. The clinician can then use a stylusand touch-screen, keyboard, or, in some cases, voice instructions to enterpatient data, dosage, instructions, and other information. The program thengenerates a prescription that is either printed out on a printer, or faxed or sentby wireless transmission or the Internet to the pharmacist. Various programsare combined with pharmaceutical reference software and also will cross-check the prescription for correct dosage, potential interactions with othermedications taken by the patient, and known adverse reactions.22 Some of theprograms interface with existing electronic medical records systems, such asIDX. Other programs allow clinicians to enter orders for labs and other diag-nostic tests on their PDAs and then transmit those through wireless, infrared,or so-called hot-sync transmission.
Electronic prescribing appears to offer substantial bene� ts econom-ically and medically for the health care system. A critical evaluation of
21 EPocrates, ePocrates Handheld Guide Aids in AppropriateAntibioticTreatment Selection, Feb. 7, 2001,available at http://www.ePocrates.com/headlines/story.cfm?storyC10063.
22 Chesanow, supra note 10.
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currently available electronic prescribing software uncovered few problems.Disadvantages included staff reluctance, incompatibility with existing insti-tutional technologies, and the still limited number of participating pharmacycontacts.23 The elimination of paper prescriptions and lab orders promises tosigni� cantly decrease the administrative costs associated with patient care,generating savings that might be used in other health care arenas. Moreover,electronic medical orders are anticipated to reduce substantially the errorsand administrative costs associated with handwritten prescriptions. Poor pen-manship plays an acknowledged role in incorrect dosages, methods of de-livery, frequency, and even in the intended drug itself. One study found thatelectronic prescribing led to a 55% reduction in medication errors.24 In an-other study, allergic drug reactions and excessive dosages dropped 75%.25
In part as a result of such � ndings, the Institute for Safe Medication Prac-tices recently called for elimination of handwritten prescriptions within threeyears.26
It is true that the infrastructure is not entirely in place to allow an im-mediate wholesale move to electronic prescribing. But, according to someobservers, the � nancial costs of implementing such a system are relativelymodest and the technology already exists to institute the practice on a muchlarger scale than is currently being attempted. Currently, approximately 5%of United States physicians employ some manner of electronic prescribing.Given the ability of this program to reduce costs, eliminate the dif� culty anddangers associated with handwritten orders, protect against incorrect dosagesand potential drug and allergic reactions, it appears as if there should be a sig-ni� cantly greater institutional and professional initiative to expand the usageof these potentially valuable tools.27
Clearly, the technology is not � awless and there are undoubtedly a num-ber of hidden complications. There are, as with other handheld software, seri-ous and vexing privacy and con� dentiality concerns.These issues arguably aremore disconcerting given that personally identi� able patient information willbe transmitted outside the institution, either through the Internet or throughwireless transfer. In addition, physicians and institutions will have to besensitive and wary to the number of ways in which drug detailers will use
23 Orin M. Goldblum, Electronic Prescribing: Criteria for Evaluating Handheld Prescribing Systems andan Evaluation of a New, Handheld, Wireless Wide Area Network (WWAN) Prescribing System, 7 DER-MATOLOGY ONLINE J. 1 (2000), at http://dermatology.cdlib.org/DOJvol7num1/media review/ephysician/goldblum.html.
24 David W. Bates et al., Effect of Computerized Physician Order Entry and a Team Intervention onPrevention of Serious Medication Errors, 280 J.A.M.A. 1311 (1998).
25 R. ScottEvanset al., A Computer-Assisted ManagementProgramforAntibioticsandOther Anti-InfectiveAgents, 338 NEW ENG. J. MED. 232 (1998).
26 Institute for Safe Medication, A Call to Action: Eliminate Handwritten Prescriptions Within ThreeYears!, available at http://www.ismp.org/msaarticles/whitepaper1.html (last visited June 5, 2001).
27 Id.
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 457
the new technology to gain coveted access to physician prescribers. Pharma-ceutical companies already have played a signi� cant role in subsidizing thehardware, software, or wireless services associated with electronic prescrib-ing. Despite these complications, the prospect of certain, direct, and tangibleimprovement in patient care in the short term at a modest cost cannot withgood conscience be ignored or delayed.
The sixth category of software currently available in PDA formats aredecision-support programs. They might include programs like InfoRetriever,°R
5 Minute Clinical Consultant,°R MedMath,°R MedCalc,°R and Archimedes.°R
These programs provide both more and less guidance than is available froma mere digitalized reference book: more in that they frequently include di-agnosis, treatment and medication algorithms, decision trees, outcomes data,evidence-based guidelines, and predictive calculations; less in that they donot include all the information contained in standard medical reference texts.Some software is tailored for particular treatment challenges. For example,there is a software application that is speci� cally designed to aid emergencyroom personnel (who may be unfamiliar with burn protocols) calculate vital� uid resuscitation before the patient is transferred to a burn unit.28 Anotherprogram allows the wireless transmission of computerized tomography im-ages to neurologists’ PDAs for analysis.29
Oneof the most elaborate programs includesbrief synopses ofover1,000medical journal articles, 850 abstracts from the systematic compilation of datain the Cochrane Database of Systematic Reviews, prescribing information forover 1,200 drugs, scores of clinical prediction rules, summary of evidence-based guidelines, tables, and algorithms. This program also allows cliniciansto enter patient-speci� c data and test results and generates both the reliabilityof the particular diagnostic test and the overall probability that the patient issuffering from a particular malady. Inforetriever also provides guideline sum-maries, including speci� c prescribing dosages, for the treatment of the illness,disease, or injury.30 Newsweek magazine proclaims that the “program doesn’tjust enhance their [physicians’] ef� ciency . . . it can improve their decisions.”31
There is at least some evidence that at least some physicians agree and areincreasingly interested in using these types of decision-support software.32
28 Amy C. Roth et al., A Personal Digital Assistant for Determination of Fluid Needs for Burn Patients,34 BIOMED. SCI. INSTRUMENTATION 186 (1997).
29 Jarmo Reponen et al., InitialExperience with a Wireless Personal DigitalAssistant as a TeleradiologicalTerminal for Reporting Emergency Computerized Tomography Scans, 6 J. TELEMED. & TELECARE 45(2000).
30 Neil Chesanow, Colleagues Rate the Leading Software, 77 MED. ECON. 105, 122 (2000); MedicalIn-foRetriever.com, at http://www.medicalinforetriever.com/ (last visited June 5, 2001).
31 Geoffrey Cowley & Anne Underwood, Finding the Right RX, 134 NEWSWEEK 66, 66 (1999).32 Mark H. Ebell et al., Family Physicians’ Preferences for Computerized Decision-SupportHardware and
Software, 45 J. FAM. PRAC. 137 (1997).
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It is this area of decision-support computer software, and its greater pro-liferation through the use of PDAs, that is most complex and disturbing. Manycommentators have argued that we are unlikely to develop a computerizedsystem that can even approach the diagnostic ability of the human physician.33
While this may be true, diagnostic programs need not be infallible to providesome bene� t to patient and society. They may serve as a guide to a clinician’sthinking through a problem or a memory spur to a physician who has mo-mentarily forgotten the details of a particular diagnosis or set of symptoms.Instead of diagnostic infallibility, the more appropriate test of whether a par-ticular decision-assist technology should be employed is whether it providespatient and societal bene� t that exceeds the risks and burdens that it carrieswith it. Although these programs are sometimes stunning in their apparentcapabilities, they are also encumbered by the greatest number of uncertaintiesand potential hazards.
There is a rich literature on the potential limitations of medical decision-support programs. Diagnosis is more than a mechanical, algorithmic function.Instead, as Randolph Miller has explained, medical diagnosis
representsa sequenceof interdependent,oftenhighly individualizedprocesses:elici-tation of initial patient data; integrationof the data into plausible scenarios regardingknown disease processes; evaluating and re� ning of diagnostic hypotheses throughselective elicitation of additional patient information; initiation of therapy at appro-priate points in time (including before a diagnosis is established); and evaluation ofthe effect of both the illness and the therapy on the patient over time.34
For a number of reasons, computer programs are unlikely to fully repli-cate this sophisticated and in some ways still mysterious diagnostic exercise.Programmers, even medical-savvy programmers, will be handicapped by theexistence of imprecise medical terminology, the fact that clinical parametersused in arriving at a diagnosis are alternatively statistically independent anddependent variables, and because most decision-assist programs require astatic, and thus skewed, representation of the patient’s medical history. Criticsalso note that even talented diagnosticians cannot “accurately break down thediagnostic thought process into explicit, understandable steps.” Thus, it seemsunlikely that a computer programmer could trace and capture the physician-expert’s thought processes in a diagnostic algorithm.35
Given that programmers are unlikely to duplicate physicians’ ability todiagnose patients in all cases, the medical profession is faced with decision-support software with inherent limitations. If the programs represent a
33 Victor L. Yu, Conceptual Obstacles in Computerized Medical Diagnosis, 8 J. MED. & PHIL. 67 (1983).34 Randolph A. Miller, Why the Standard View Is Standard: People, Not Machines, Understand Patients’
Problems, 15 J. MED. & PHIL. 581, 584 (1990).35 Yu, supra note 33, at 73.
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 459
signi� cant bene� t for patients, despite their limitations, the profession andsociety should investigate and support expanded but controlled use of the de-vices. But the evidence is not yet clear, whether and under what conditionsdecision-support programs should be used. All the while, the handheld com-puter platform is bringing decision-support technology to the bedside at anincreasingly rapid rate. Potential problems abound.
For a clinician to know when it is advisable to use and in some cases relyon diagnostic software, he or she would have to be sensitive to the limitationsof the technology so that its guidance can be ignored. At this stage of devel-opment, most rank-and-� le physicians will not be capable of this insight and,for them, the decision-assist program loaded on their PDA will remain verymuch a “black-box,” the inner workings of which are largely inscrutable. Inaddition, the clinician-user would have to have a grasp of the various databaseson which the digital consultation bases its conclusions.36 If the program con-tains information that is dated, incomplete, or limited in some other respect(for example, drawn from a different patient population than that which theclinician is treating), the advice generated may be inapplicable to the case athand but the physician would not know it.37 The physician would have to beaware of and employ available updates to the program. But at a deeper level,a physician using a decision-assist product installed on a PDA (or elsewhere)has a duty to understand the nature of the algorithm used in developing theprogram and “the ways in which it might fail, both due to inherent theoret-ical limitations and due to the � aws that might occur during the process ofimplementation.”38
An insightful and experienced clinician presumably would be able toidentify those times when a decision-assist program provided incorrect orsuspect recommendations and thus reject them. Notably, when discussing amedical-reference/decision-assist program for a PDA, a physician reviewerwarned “don’t use 5MCC [a clinical assist program] to treat disorders that youaren’t familiar with, but it is a very handy reference tool for on-the-� y lookupsto round out your brain’s memory of disorders.” In addition, he disputed theprogram’s drug of choice for myocardial infarction and noted that the use ofthrombolytics was not mentioned.39
Not all clinicians, however, are insightful and experienced. In fact, it ispossible that the physicians most likely to take advantage of the new waveof computer technology will be younger and student physicians who have
36 Randolph A. Miller & Kenneth W. Goodman, Ethical Challenges in the Use of Decision-Support Soft-ware in Clinical Practice, in ETHICS, COMPUTING, AND MEDICINE, supra note 17, at 102.
37 Caroline Whitbeck & Reven Brooks, Criteria for Evaluating a Computer Aid to Clinical Reasoning,8 J. MED. & PHIL. 51 (1983).
38 Miller, supra note 34, at 582.39 Jim Thompson, 5 Minute Clinical Consultant, available at http://www.pdamd.com/reviews/review-
6.xml (last visited June 5, 2001).
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yet to develop fully their analytical, problem-solving, and clinical skills andthus may be less able to recognize blind spots in the various available soft-ware. In light of this problem, one observer has suggested that novice users ofdecision-support software be required to take training courses to ensure ap-propriate adoption and use of this powerful technology. Given the dif� culty offully understanding the implications of both the data and analytical shortcom-ings of these programs, a comprehensive training program seems a reasonableprotection against the potential over-reliance on an inherently limited tech-nology that is proliferating without oversight. Other measures might includeongoing assessments and clinical trials of the safety and ef� cacy of decision-assist programs when used by physicians of differing skills, experience, andspecialties.40
Decision-assist programs pose a special problem in the context of medi-cal education. Medical students, and to a lesser degree residents, do not as yethave fully developed skills for clinical analysis and diagnosis. In fact, one ofthe central goals of medical education in the clinical years is to train studentsto “think like doctors,” much as law students are taught and exhorted to “thinklike lawyers.” One of the abiding fears accompanying the introduction of newtechnologies of all sorts has been the concern that the innovation will result in“de-skilling” of the relevant profession or trade.41 This uneasiness is based onthe intuition that essential, foundational skills and habits of mind will be lostif there is an arti� cial means of reaching conclusions that previously requiredthe expenditure of intellectual effort.
As one commentator notes, our culture too frequently views the powerof the computer as an excuse to put our brains in neutral.42 These con-cerns echo those heard following the widespread introduction of the cal-culator into K-12 education.43 Critics then worried that theoretical knowl-edge and analytical skills would atrophy or never develop as calculatorstook over much of the heavy lifting of mathematical computation. For ex-ample, some studies have suggested that many undergraduates had becomeuncertain of their own analytical abilities and were unwilling to question theauthority of an answer produced by a calculator even when it had been pro-grammed to provide incorrect computations.44 Such an eventuality in medicinefollowing widespread access to medical decision-assist programs would beunthinkably tragic, and dangerous. Physicians in training might fail to
40 Miller & Goodman, supra note 36, at 110.41 Maris G. Martinsons& Patrick K.C. Chong,The In� uence of Human Factors and Specialist Involvement
on Information Systems Success, 52 HUMAN RELATIONS 123 (1999); Jeffrey K. Liker et al., Perspectiveson Technology and Work Organization, 25 ANN. REV. SOCIOLOGY 575 (1999).
42 Rebecca Ganzel, How We Get Computers Wrong, 34 TRAINING 52 (1997).43 Snider, supra note 16, at 317.44 Bob Glasgow & Barbara J. Reys, The Authority of the Calculator in the Minds of College Students, 98
SOC. SCI. & MATH. 383 (1998).
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IMPLICATIONS OF HANDHELD MEDICAL COMPUTERS 461
acquire and develop the very knowledge and skills that are essential to judg-ing when to rely upon or reject the guidance provided by medical computerprograms.
The answer to this threat is not the absolute prohibition of PDAs in med-ical education any more than it would have been wise to ban calculators fromelementary school education. Instead, medical educators should promote thelimited, guided, programmed use of handheld computer software employed ina judicious and discriminating fashion. Medical software that serves merelyas a more convenient electronic version of a traditional reference source doesnot endanger the educational process. However, decision-assist software willhave to be integrated into the curriculum in such a way as to enhance, ratherthan to subvert, the development of traditional and essential problem-solvingknowledge and skills. Ful� lling this mandate will be no mean feat, but it isone that must be borne if future physicians are to have the insight to care forpatients and skeptically use the computing tools that they undoubtedly willhave at their disposal.
In sum, though intellectually exciting, decision-assist programs are themost problematic of the software available for handheld computers. To usethem responsibly, clinicians will require intimate understanding of the work-ing of the program and of the data upon which its diagnosis and treatmentrecommendations are based. Ironically, the seasoned clinicians most preparedto critique and question the methodology and relevance of decision-assistprograms may be the least likely to use them. Instead, relative newcomers tothe profession may be the greatest supporters of decision-support programs.While more limited versions of these programs have been in existence forsome time, it has only been since the introduction of the handheld platformthat they stand poised to enter routine clinical practice in large numbers.Physicians and institutions need to take seriously the limitations and potentialimplications of this innovation in the relatively brief time remaining beforethey become ubiquitous features of the medical environment.
III. LAW AND THE PDA
While it seems likely that clinicians and institutions may have a moraland professional duty to consider, and in some cases to implement, some ofthe available and prospective medical applications for handheld computers,the potential legal aspects of these new technologies are less certain and notas pressing. There will likely be at least a brief period before the medicaland legal professions need to face directly the questions related to the use ofhandheld computer programs at the beside.
There is arguably an ethical and professional duty to employ such tech-nology if its use “improves the quality of care at an acceptable cost in time andmoney or if it maintains the existing standard of care at a reduced cost in time
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or money.”45 But this is not the legal standard used to determine whether aparticular technology must be used. The basic rule of liability holds that physi-cians are required to possess and exercise the same degree of learning, skill,and care that “a reasonably prudent physician” would possess and exercise inthe same or similar circumstances.46 Expert witnesses typically are requiredto demonstrate that a defendant-physician failed to act as a reasonably pru-dent physician would have acted in a comparable situation. Although it is notalways de� nitive, “customary practice” plays a central role in the vast ma-jority of cases in determining what is reasonable medical practice and whatconstitutes the standard of care. Medical experts ordinarily rely heavily oncustomary practice when evaluating a defendant-physician’s performance.47
Therefore, at this stage of development, it is highly unlikely that the use ofa handheld computer in the clinical setting could be deemed the standard ofcare.
Despite their extraordinarily rapid proliferation and clear value in somecontexts, the use of PDAs in clinical settings cannot now be considered eithercustomary or the standard of care. It is theoretically possible that an expertmight now testify that a reasonably prudent physician would use handheldcomputers in the clinical setting, but it is highly unlikely, even when it canbe shown clearly that the use of a particular diagnostic or treatment softwarewould have prevented the injury suffered by the patient-plaintiff. And, it willnot always be possible to demonstrate that the non-use of a PDA caused thepatient’s injury.
Thus, in the short term, it is unlikely that a physician could or would beheld liable for the failure to use a handheld computer. Physicians, however,are required to keep abreast of changing standards of care48 and the extentto which the use of PDAs is customary or the standard of care is a rapidlymoving target. After all, over 100,000 physicians had downloaded ePocratesby late 2000.That � gure is growing and combined with other similar programswill likely lead some experts to argue that the use of some handheld clinicalprograms, in some contexts, is the standard of care. There is no bright linerule 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 occurwithin a relatively short period of time.
In contrast, physicians who choose to employ handheld medical appli-cations before they become the standard of care may be held liable for theirnegligent misuse. Physicians probably will not be vulnerable to legal claims
45 Miller et al., supra note 8, at 529.46 GRAHAM DOUTHWAITE, JURY INSTRUCTIONS ON MEDICAL ISSUES 121 (4th ed. 1992).47 Id. at 131.48 Id. at 143.
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that they selected a program with limitations or � aws to help them in theirwork. Flaws in the programs themselves that lead to patient harm likely willbe litigated primarily as a species of product liability. But physician usersmight be held legally responsible for being reasonably aware of the � aws ina program and for relying on an application when they knew or should haveknown its limitations. Similarly, medical reference material and programs thatare based on such data are time sensitive. Physicians also will incur a duty tobe aware of outdated software and likely will be required to take advantage ofprogram updates when available. If they fail to do so and patients are injuredas a result, then they might be called to account for patient injuries.
Oneof the advantagesof computer programsis that they assist physiciansin routine, but information-rich, medical situations. Routinization, however,is not always desirable when the computer application in question containsinherent � aws or limitations.49 The test of whether a clinician has breachedthe standard of care in reliance on an imperfect program will turn on whethera reasonably prudent physician should have known of those � aws, been sensi-tive to how those defects could impact patient care, and taken steps to protectpatients from those shortcomings. Therefore, if a negligently designed soft-ware program provides an incorrect diagnosis, recommendation or dosage,or insuf� cient or incorrect information, then a physician is not automaticallyexonerated. Neither is the physician automatically in legal peril in decliningto follow the recommendation of the handheld computer programs. As with� esh-and-blood consultants, medical software exists only to assist the judg-ment of the attending physician. Thus, if a physician declines to follow theguidance of computer software and the patient is injured as a result, then thephysician may be exonerated if he or she had viable reasons for doing soand acted as a reasonably prudent physician would have acted in the sameor similar circumstances. These are questions that can only be answered byexpert witnesses on case-by-case bases.
There have been a few isolated, but highly visible, medical negligencecases that challenge the conventionalreliance on customary practice as a gaugeof whether defendant-physicians have performed up to the standard of care.The infamous Helling v. Carey50 case suggested that, under certain conditions,a defendant might be held liable for failing to use an available technologyeven 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 forglaucoma, held that an entire � eld might be negligent for failing to employ atechnology that was accurate, inexpensive, highly bene� cial, and of low risk
49 Marc Green, On Determining Negligence in Computer Error and Injury: Technical Analysis,ERGO/GERO: HUMAN FACTORS SCIENCE, available at http://www.ergogero.com/pages/computererror.html (last visited June 5, 2001).
50 519 P.2d 981 (Wash. 1974).
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to the patient. Thus, a practitioner could be held to have acted “unreasonably”and be deemed liable even though he or she acted in consonance with theprevailing custom.51
A number of handheld applications, especially those related to refer-ence and pharmaceutical selection and prescription, appear to � t the Hellingtest, if any court were willing to apply it, but this course is unlikely. Onlya few cases have followed the Helling approach and there is no evidencethat future courts will expand physician liability so dramatically.52 There-fore, in the absence of dramatic doctrinal shifts, medical malpractice lawsuitsbased on the failure to use available PDA software likely will depend onthe degree to which the profession at large has adopted the relevant programand the testimony of medical experts at trial. Those clinicians who employhandheld software before it becomes the standard of care may be vulnera-ble if they negligently misuse the technology or are unaware of its � aws andlimitations.
Physicians and health care institutions also will have to address thelegal and ethical information-security issues relating to handheld computers.Physicians will of course have to be cognizant that they are carrying aroundlarge amounts of identi� able patient information in their coat pockets andthat misplacing their PDAs may endanger the private information of theirpatients. In some ways, this risk is no greater than the risk of maintaininginformal patient notes on index cards or in notebooks. In both cases, thephysician owes a duty of care to protect this information. In other respects, thescope, detail, and amount of identi� able information that might be availableon a lost or stolen handheld computer suggests that clinician vigilance in thisregard needs to be proportionately greater as well. Health care providers alsowill have to ensure that the PDAs and clinical software they employ providesuf� cient technological safeguards against prying eyes.
Although clinicians and institutions have an independent duty to protectpatient con� dentiality, the federal regulations promulgated in the wake of the1996 Health Insurance Portability and Accountability Act (HIPAA)53 providespeci� c and detailed technical requirements, administrative procedures, andpolicies to safeguard electronically stored and transmitted information.54 Thespeci� cs of applicable HIPAA regulations are too extensive to outline here, butmany clearly will apply to the use of PDAs in the clinical setting. For example,the password protection on some handheld computers may not be suf� cient to
51 William J. Curran, The Unwanted Suitor: Law and the Use of Health Care Technology, in THE MACHINE
AT THE BEDSIDE, supra note 5, at 119.52 Donald E. Kacmar, The Impact of Computerized Medical Literature Databases on Medical Malpractice
Litigation: Time for Another Helling v. Carey Wake-up Call?, 58 OHIO ST. L.J. 617 (1997).53 Title II, Subtitle F of the Health Insurance Portability and Accountability Act of 1996, Pub. L. No.
104-191, 110 Stat. 1936.54 45 C.F.R. §§ 142.101-142.312(1999).
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meet the standards delineated in the HIPAA regulations. Early reports suggestthat some PDAs and/or operating systems may be accessed with relative easeby unauthorized persons who � nd or steal the devices. As one security analystexplained: “Any attacker with a laptop and a serial (syncing) cable is prettymuch able to access everything on the device.” In some cases, even encryptionsoftware will be insuf� cient to stop unapproved access.55
There may be similar security concerns regarding information that istransmitted via infrared to desktop computers where it is stored without suf� -cient safeguards, or where patient information is sent via wireless or Internettransmission to pharmacy, transcription, billing, insurance, or other services.An innovative and rapidly advancing digital market likely will generate effec-tive technological safeguards for these practices, but it is the ethical and legalduty of clinicians and institutions who employ handheld computers in thisfashion to scrutinize available protections vigilantly and take positive stepsto protect patient information.56 The HIPAA standards will provide crypto-graphic and other guidelines for the storage and transmission of electronicpatient information, but individual physicians will remain responsible for im-plementing these policies and for remaining sensitive to as yet unrecognizedways in which handheld computer usage renders private patient informationvulnerable.57
CONCLUSION
Thisdiscussion regarding the implications of the bedside use of handheldcomputers does not de� nitively outline which PDA software should be usedand when. Neither does it support a formal regulatory or oversight scheme. In-stead it is intended as a guide for physician and institutional self-evaluation—aframework to identify relevant factors to be considered when making adop-tion decisions on a case-by-case basis. Clearly, a tremendous amount of datawill be necessary to demonstrate the accuracy, safety, and ef� cacy of the var-ious handheld computer applications currently available and the many thatundoubtedly are forthcoming.
The proliferation of these clinical tools will not stop as comprehensiveclinical trials are conducted and analyzed. But a commitment to a systematicand multidisciplinary technology assessment in the early stages of the use
55 Robert Lemos, Report: Palm Password No Protection, MSNBC, Mar. 2, 2001, available athttp://www.msnbc.com/news/538361.asp?0nmD N17Q (last visited Mar. 5, 2001).
56 Press Release, Speech Machines, Speech Machines Offer HIPAA-Compliant Medical Transcription So-lution on ASP Platform, available at http://www.speechmachines.com/PressRoom/Articles3 HIPAA%20compliance%20� nal%20html (last visited Feb. 20, 2001).
57 Marvin E. Gozum & Jeff Gilfor, My Humble Opinion—Medical Information Security in the HandheldComputing Environment, available at http://www.pdamd.com/columns/columns/column-28.xml (lastvisited Feb. 21, 2001).
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of PDAs can re� ne the profession’s knowledge of the device’s capabilities,uncover complications, and demonstrate the need for safeguards and special-ized training in some instances. This concurrent, yet prospective, focus on thispowerful medical innovation is indispensable. Hopefully, such insights willtemper in� ated expectations regarding the clinical use of handheld computers,slow or stop problematic applications of the technology, and identify thoseuses for which resistance to change is no longer professionally and ethicallyjusti� ed.
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