Telemedicine and integrated health care delivery: compounding malpractice liability.
I. INTRODUCTION
Telemedicine became a significant part of the health care equation long before we realized what it was or how important it will be in the furore. Telephone discussions and consultations between health care providers have been a part of medical practice since Alexander Graham Bell gifted society with telephones.(1) Furthermore, who among us has not been transfixed watching and learning about open heart surgery on cable television?(2) Propelled by the information superhighway and the breadth of emerging computer and communication technologies, telemedicine will change the face of medicine and methods of interaction between providers and patients.(3) Access, quality and cost of health care may all improve, but not without the sacrifice of some time-honored norms in medical practice.(4)
The changes telemedicine will bring to medical practice exacerbate the changes deriving from the proliferation of managed care integrated delivery systems (IDSs) and the contraction of the health care industry.(5) The solo practitioner revered by Norman Rockwell is rapidly becoming extinct, superseded by groups of providers employed by or engaged in contractual partnerships with one or more integrated managed care plans.(6) The community hospital of the mid-twentieth century has merged, remerged and now emerged as part of an organized network of hospital services, often affiliated with one or more health plans.(7) The traditional Blue Cross and Blue Shield plans spun off for-profit managed care plans that, along with provider partners, are vibrant and successful, while the gutted parent companies languish, relics of the past.(8)
This Article considers how theories of medical negligence might be applied in the context of telemedicine and integrated delivery health plans. Part Two summarizes the history of telemedicine, its increasing breadth of application and opportunity and promise for the future. Part Three reviews traditional negligence principles and precedents and demonstrates how they might be applied when a telemedicine interaction results in negligence and harm to the patient. Part Four discusses evolving theories of shared liability applicable to health plans and managed care entities. Finally, Part Five demonstrates how shared liability theories will be applied to situations involving telemedicine technologies.
II. TELEMEDICINE: HISTORY, PRESENT APPLICATIONS AND FUTURE PROMISE
Telemedicine's "simple, but serviceable" definition is the use of telecommunication to diagnose and treat a patient.(9) Telemedicine encompasses a panoply of technologies and communication modalities that allow health care providers to connect with, examine, counsel and advise patients about treatment options,(10) These include teleradiology and other teleimaging diagnostics,(11) telesurgery and robotics,(12) video and Internet/e-mail conferencing,(13) transmission of electrocardiographic and other physiological data by telephone, telecommunications, or Internet lines(14) and "telehealth" education via the Internet and cable television.(15) Although many of these examples rely on relatively recent communications technologies, telemedicine escaped the bounds of the simple telephone call at least thirty years ago and has already acquired an impressive history.
A. FOUND IN SPACE: THE HISTORY OF MODERN TELEMEDICINE
Although isolated telemedicine experiments date back to the early 1960s,(16) telemedicine began with the space program. One of the National Aeronautics and Space Administration's (NASA) pivotal concerns was the medical monitoring of astronauts.(17) This concern began with the earliest Mercury and Gemini flights, developed through the Apollo Moon Program and continues today with space shuttle and MIR missions.(18) NASA's scientists created telemetric technologies that allowed the long-distance measurement and transmission of physiological data through space.(19)
While refining the use of telemetry in space, NASA facilitated the terrestrial use of this and other telemedicine technologies domestically and internationally? In the mid1970s, NASA entered into a collaborative venture with the Indian Health Service and the Papago Indian Tribe.(21) This project borrowed technology from the space program that enabled mobile health unit practitioners to telecommunicate with, and transfer data to, specialists at a distant public health hospital.(22) The program's evaluation concluded that mobile health workers delivered a comparable quality of care as would have been supplied through an on-site consultation.(23) In Alaska, a similar program used NASA satellites to supply a consistent method of voice communication and linkage by which local health aides and nonphysician providers could access information and consult with physicians.(24)
In recent years, the space program fortified and enhanced satellite technology and capacity.(25) Government and disaster management organizations have used the satellite-based communication system to provide medical aid and coordinate relief efforts in cases of natural disaster(26) and war.(27) In the 1990s NASA inaugurated the "spacebridge" to Moscow, an international telemedicine project that included specialist consultation in a variety of disciplines, medical education opportunities for physicians from Russia and the United States, and emergency medical services coordination and consultation.(28) The newest iteration of the spacebridge project has incorporated implements in computer technologies and networks to diversify and enhance the exchange of medical information and consultation.(29) The new spacebridge to Russia provides for the encoding of medical information and patient tests in digital files that are then transmitted over the Internet and discussed in videoconferencing sessions.(30) The spacebridge allows physicians in Moscow to teleconference with faculty from several tertiary care centers in the United States.(31)
With the ping-ponging of signals around the globe commonplace, satellite communication technology is becoming available and financially accessible to the private sector.(32) In addition, the explosion of advances in computer technology, including the transformation of the Internet, has exponentially increased telemedicine applications in terms of variety, speed and capacity.(33) Audio, video, images and data beam instantaneously from site to site; furthermore, transmissions can be stored and forwarded without degradation.(34) As familiarity with the technology grows, a broader cross-section of both providers and patients is interested and willing to use it to facilitate health care interactions.(35) Finally, the technology dovetails nicely with the increasing regionalization and integration of health care systems.(36)
B. TELEMEDICINE TODAY
Telemedicine is no longer limited to transmission of hazy images and telemetry data from the remote, isolated Alaskan village or orbiting spacecraft. Highly sophisticated communication and computer systems provide high-resolution images,(37) "crunch" complex data,(38) have analytic, even artificial intelligence, capacity,(39) and allow access to real-time, delayed and stored information.(40)
Telemedicine is becoming an integral part of health care delivery in diverse settings.(41) It is breaking down boundaries between different types of health care providers, revolutionizing rural health care delivery, improving and facilitating care for underserved and difficult to manage populations and enhancing discourse between patients and providers. There is also a growing telehealth movement.
A large health care system, Allina Health System, based in Minneapolis, uses physician extenders to triage patients presenting with emergency conditions.(42) Using telemedicine, these first-line providers consult with specialty physicians, treat patients more quickly and coordinate care more efficiently.(43) It uses telemedicine technology to facilitate specialty consultations, medical education, medical information storage and transmittal and administrative efficiency.(44)
The University of North Carolina (UNC) uses telemedicine technology to provide pediatric cardiology consultations to neonates in hospitals in its area, thereby avoiding delays in patient care that occured when echocardiograms were sent to UNC for review.(45) Previously, such subspecialty care was often unavailable to patients without easy access to an urban, usually university-based, medical center.(46) Now, with telemedicine, one subspecialist can serve several hospitals and locales, providing teleconsultations to patients without ever leaving the university medical center.(47) Recently, UNC broadened the scope of its program by entering into an agreement with the University of Chile to provide neonatal cardiac evaluations by telemedicine for Chilean newborns.(48)
A number of telemedicine programs have been designed to focus on the needs of patients in rural America.(49) This population is sparsely distributed over large geographic areas, with little or no public transit.(50) Moreover, large populations of elderly, who are more likely to have health problems and transportation difficulties, live in rural areas.(51) The need for telemedicine in the rural setting is compounded by the scarcity of rural health care facilities and providers.(52) Telemedicine is a way providers can serve this traditionally underserved population.(53) Implementation of telemedicine technologies in rural settings is just beginning,(54) but recent incentives, notably the availability of reimbursement under Medicare, are expected to spur the use of telemedicine in rural areas.(55) Additionally, investment in rural telemedicine is boosted by managed care IDSs that seek to increase their service areas and market share.(56)
Prison inmates are another underserved population receiving the benefits of telemedicine programs. Numerous prisons have adopted telemedicine to deliver care to this difficult to manage population.(57) Using interactive video and consultation, doctors deliver care more rapidly.(58) Moreover, prisoners appear satisfied with the care received, and early studies indicate that the programs are cost efficient.(59)
Home health agencies and providers also use interactive video links to enhance care for home-bound patients.(60) This growing segment of the health care industry, and contributor to increasing costs, previously depended on nurses and other providers to visit physically and care for the patients in their homes.(61) However, with the advent of telecommunications, medical technology and computer devices, many providers now offer services without a visit.(62) Using telemedicine technology, video visits and monitoring of vital signs can be accomplished electronically, medication compliance can be verified and patient education can be enhanced.(63) Telemedicine is also cost effective because it eliminates providers' costly travel time.(64) In addition, patients are empowered through their interaction with the physician rather than merely receiving treatment.(65)
The advent and global availability of the Internet produced an explosion of the telehealth movement. The Internet is replete with medical information at every level of sophistication.(66) Digital models and virtual humans allow students to study and research anatomy, physiology and pathology.(67) Patients and providers can access scientific peer journal articles,(68) government documents relating to health care issues(69) and extensive disease-related information provided by advocacy groups.(70) A vibrant network of chat groups for patients, their family and friends exists as well.(71) These groups empower patients to learn about and manage their afflictions, facilitate the exchange of information among patients similarly afflicted and even enable them to discuss cases with physicians and obtain referrals online.(72)
C. REDEFINING TELEMEDICINE TO ENSURE ITS FUTURE
As telemedicine applications broaden and diversify, the "simple, but serviceable"(73) definition of the past requires some retooling.(74) This redefinition process clarifies both the characteristics and the functional attributes of modern telemedicine. The baseline characteristics of telemedicine include: the geographic separation between the provider and patient during the clinical encounter or between two providers collaborating on the patient's behalf; the use of telecommunication or computer technology to enable, facilitate or enhance the interactions between the parties; the development of protocols and normative standards to replace those of the traditional face-to-face contact; and sufficient staffing and infrastructure to support the telemedicine technology.(75) One leading proponent of telemedicine has identified three functional areas in this growing field: (1) decision-making aids, (2) remote sensing and (3) collaborative arrangements for the management of patients at a distance.(76)
Decision-making aids encompass many of the information resources available electronically(77) as well as computer systems and programs that apply the information to a specific patient's symptom complex and history.(78) This artificial intelligence type of searching and analysis is further linked to expert physicians around the world who can then consult about the patient after receiving images of the patient's physically visible abnormalities, test results and diagnostic studies by high-speed Internet connections.(79)
Remote sensing builds on the early telemedicine transmission of electrocardiogram and pacemaker signals over the telephone lines.(80) However, the sophistication of the diagnostic-testing modalities is compounded by the sophistication of the communications and computer capabilities,(81) Complex images are transmitted in computerized digital format,(82) compared with a library of similar images and then subjected to expert review if necessary and desired,(83)
The advances made in remote-sensing capabilities promote collaborative patient management, the third functional attribute of telemedicine.(84) Interactive video workstations allow doctors to collaborate and diagnose from a distance.(85) One study allowed physicians to view patients with Parkinson's disease, a degenerative neurologic disease that impairs mobility, thereby allowing physicians to provide proper assessment and care to patients outside of a metropolitan area without requiring them to travel to the physicians' offices.(86) Collaboration among physicians is enhanced by efforts to link diverse sources of information and expertise in an integrated fashion to provide greater collaborative possibilities.(87)
Armed with a broader and more encompassing definition, promoters of telemedicine have redesigned its window of opportunity, and telemedicine is now poised to become an integral part of the health care industry rather than merely an interesting but limited curiosity.(88) The opportunity for telemedicine's expansion comes at a perilous time. The health care industry is beseiged by relentless, often well reasoned complaints that it is too costly, provides inadequate access and fails to deliver a consistent and satisfying quality of care.(89) For telemedicine to flourish and achieve a place in a competitive market, its promoters will have to demonstrate that it can improve access, cost and quality.(90)
Perhaps the greatest strength of telemedicine lies in its ability to conquer distance in both geographical and temporal terms. Capitalizing on this strength, Congress has supplied incentives to enhance telemedicine access for two largely underserved populations: rural communities and the elderly.(91) There is a risk that by removing geographic barriers, telemedicine will succeed in unleashing an unrealized demand for health care services from those previously unable to obtain access.(92) Although this would satisfy the policy aim of improved access, it may also result in an increased volume of health care services and a net increase in cost.(93) Such cost increases could slow the continued growth and stature of telemedicine.
In addition to cost concerns, telemedicine raises quality-of-care questions.(94) There is a potential that patients will be inadvertently harmed by providers and telemedicine systems.(95) Such harm may result from negligence by telemedicine providers who, like in-person interaction, may fail to deliver care that meets recognized and accepted standards.(96) Many more providers will be involved in the patient's care.(97) This trend could potentially lead to confusion as to who is accountable for individual medical decisions as well as the overall care of the patient. Alternatively, the harm could result from malfunctions or a poorly designed technology or communication network.(98) Any of these scenarios would result in potential liability under the well-established tenets of medical malpractice law.
III. APPLICATION OF TRADITIONAL MEDICAL MALPRACTICE PRINCIPLES TO TELEMEDICINE
The traditional medical negligence doctrine requires that the plaintiff-patient prove that the defendant-provider had a duty toward and implicit contract with the plaintiff as a result of an established physician-patient relationship.(99) The plaintiff must then prove, generally by a preponderance of evidence, that the defendant breached this duty by failing to conform to the accepted standard of care and that, as a direct result of the breach, the plaintiff sustained harm with ascertainable damages.(100) Telemedicine challenges this doctrine by reconfiguring the physician-patient relationship and the duty that flows from that relationship. In addition, telemedicine may qualitatively change the standard of care.
A. TELEMEDICINE: RECONFIGURING THE PHYSICIAN-PATIENT RELATIONSHIP
In the traditional medical negligence case, the plaintiff must establish the existence of a physician-patient relationship.(101) Typically, the alleged negligence occurred within the temporal boundaries of an episode of care delivered by an identified physician.(102) Furthermore, any additional consultations with specialists occurred in a sequential pattern, each occupying a distinct quantum of patient and provider time.(103) However, in the case of a telemedicine interaction, the temporal boundaries are more fluid.(104) Moreover, the intervention may involve multiple physicians and consultants simultaneously,(105) or involve stored and forwarded images and data that the primary or secondary providers review at a later, undefined time.(106) Thus, telemedicine presents the opportunity for the courts to recast the physician/provider-patient relationship and the duties that flow from it more flexibly.
It is likely that two lines of case law that involve nuances in the physician/provider-patient relationship will guide the courts accommodating the challenges raised by telemedicine. The first line of cases involves telephone calls between the physician and the patient that allegedly resulted in negligent diagnosis or treatment advice to the patient. The second line of cases involves a consultant or secondary health care provider whose advice resulted in or contributed to the allegedly negligent care.
1. Use of Telecommunications to Initiate the Physician-Patient Relationship
The telephone enables patients to access physicians directly and provides an instrument by which an implicit contract can be initiated.(107) However, to form a contract, the physician must agree to undertake the care of the patient.(108) Absent this agreement, the physician has assumed no duty toward the patient.(109) Thus, the content of the interaction during the initiation of the contract must show that the physician has undertaken the responsibility to care for the patient for this episode of illness and that the patient has relied on that representation.(110)
In the context of telephone communications, a patient's call to a physician to request or schedule an appointment does not necessarily result in the formation of a contract and the creation of a physician-patient relationship.(111) The physician may decline to accept the patient(112) or, alternatively, the patient may fail to fulfill his role in forming the alleged contract.(113)
However, if in the course of making the appointment over the telephone, the physician indicates to the patient that the physician has indeed agreed to provide care for the instant episode of illness and the patient reasonably assumes that care is forthcoming and relies on that assumption by ceasing further efforts to obtain care for the condition, then a relationship giving rise to a duty will have been formed. In Lyons v. Grether,(114) for example, a patient requested an appointment with a specialist physician for care of a specific complaint related to the physician's particular practice area.(115) Relying on the assurance that the physician would see her, the patient arrived at his office with her child and guide dog at the appointed time.(116) The physician refused to see her unless she left her guide dog outside.(117) Concerned for the safety and security of the dog, she insisted the dog remain with her.(118) Thereon, the physician reneged on his agreement to see her and evicted her from the office.(119) In overruling the trial court's grant of demurrer in favor of the defendant, the Virginia Supreme Court held that, because the plaintiff's appointment was made concerning a specific ailment within the physician's specialty, the scheduling of the appointment possibly amounted to a consensual transaction that resulted in the formation of a physician-patient relationship and gave rise to a duty on the part of the physician to provide the necessary medical services.(120)
Similarly, in Bienz v. Central Suffolk Hospital,(121) the court held that a telephone conversation, in which a physician provided advice on which the patient relied, could constitute a physician-patient relationship and give rise to a duty on the part of the health care provider.(122) Other courts, however, have indicated that if a patient fails to rely on medical advice provided over the telephone, the mere fact that a physician conversed with the patient on the telephone and listened to a recital of symptoms is not sufficient to establish a physician-patient relationship.(123)
In summary, a number of factors must be present to form a physician-patient relationship based on telephone contact. The physician must agree, directly or indirectly, Eto see or counsel the patient.(124) The content of the interaction must include some evaluation, even if only rudimentary, by the physician as to the patient's complaint.(125) Finally, the patient must rely on the physician's determination, however preliminary that evaluation might have been.(126)
Applying these principles to modern telemedicine, it seems likely that when a physician enters into a dialogue with a patient using telecommunication technologies, complies with a patient's request for evaluation and proffers medical advice that the patient then relies on, a provider-patient relationship, replete with duties and responsibilities, is formed. Such principles would apply to an e-mail consultation in which a physician responded with advice on which the patient relied. A recent study published in the Journal of the American Medical Association reported that when a fictitious "patient" solicited e-mail advice from 58 physicians about a skin complaint, 50% responded and 59% of these explicitly suggested a diagnosis to the patient.(127) Had the patient relied on any one of the diagnoses, the formation of a relationship would be complete.(128) Moreover, if the online diagnosis was in error or falsely reassuring and as a result the patient sustained harm, the patient would likely have a viable negligence action against the e-mail physician.(129)
Telemedicine transactions are, by design, not limited to the traditional primary care attending physician-single patient model of care. Instead, many providers may engage in communication with the patient that is variable at best, and indiscernible at worst. The virtual world has an unlimited supply of consultants.
2. Consultant Liability: Which Virtual Consultants Have a Duty to the Patient?
Although telemedicine has not yet generated any reported case law, existing case law provides substantial clues as to the potential liability of telemedicine consultants. Any single telemedicine encounter may involve several consultants who may communicate among themselves, with the primary physician or with the patient.(130) Some of these communications will be in real-time, some will be delayed, stored and forwarded for a later collaborative consultation, but most will be a combination of the two.(131) The question then is, What will determine which consultations relate sufficiently to the patient and confer a duty on the consulted provider? Once again, parallels to existing case law may help predict the likelihood of future telemedicine liability.
Specialty consultation falls into two general categories: (1) formal consultation when the primary attending physician refers the patient or their records to the consultant for review and advice as to management of the instant illness resulting in a relationship between the consultant and the patient; and (2) informal consultation when the primary attending physician discusses the patient and his history and condition with other physicians or consultants with no resulting relationship between the patient and the consultant. In the former case, the primary attending physician generally seeks specialty guidance to diagnose or manage the patient's care and usually will follow the consultant's advice.(132) In the extreme, the consulting physician will supervise the attending physician and the attending physician will be virtually compelled to follow the suggestions of the supervising consultant.(133) More generally, in formal consultations, the consultant establishes a relationship with the patient and has a duty to that patient, even if the consultant and patient have never met in a face-to-face interaction.(134) In this category of "formal" consultations, the patient is aware of, and consents to, the consultation and usually is billed for the service.(135) For example, in Walters v. Rinker,(136) a patient brought a malpractice action against a pathologist who had examined a mass removed from the patient's leg.(137) The pathologist diagnosed the mass as benign, but the patient later found out that the mass was cancerous.(138) The pathologist argued that because he did not examine, see, treat or prescribe medication for the patient, the requisite physician-patient relationship had not been formed.(139) The court, however, held that a consensual physician-patient relationship existed between the pathologist and the patient because the issue was not who contracted for the service, but whether the service was performed with the express or implied consent of the patient and rendered on behalf of the patient.(140) Courts regularly apply similar analyses in malpractice actions brought against radiologists who frequently also have not met the patients for whom they provide consultation.(141)
Specialist consultation may result in a physician-patient relationship with tangential or no contact. In one recent case, Bovara v. St. Francis Hospital,(142) a patient with previously diagnosed heart disease consulted a cardiologist to evaluate his heart condition and the potential for corrective coronary angioplasty.(143) The patient already had a coronary angiogram taken elsewhere following a heart attack and presented the film to the cardiologist.(144) The cardiologist readily disclosed to the patient that he was unskilled in interpreting angiograms and recommended that a cardiac interventionist specialist interpret the film.(145) The cardiologist then referred the patient's angiogram to two cardiac interventionists for review.(146) The primary cardiologist received a verbal message from the consultants' office confirming that a review of the film suggested that the patient was a candidate for angioplasty.(147) The doctor transmitted this information to the patient who chose to undergo the angioplasty, but unfortunately died during the procedure.(148)
The consulting cardiac interventionists who evaluated the angiogram argued that their opinion was essentially casual, because they never met the patient nor reviewed the patient's history and medical records.(149) Furthermore, they never billed the patient for his evaluation.(150) Nevertheless, the court held that genuine issue of material fact existed as to whether the consultants provided medical service to the patient, thus making summary judgment inappropriate.(151) The court found that the consultants' opinion had been documented by the primary cardiologist in the patient's chart, that the opinion materially affected the primary physician's advice to the patient and, moreover, that the surgeons who performed the angioplasty had relied on the cardiac consultants' determination in agreeing to perform the fateful procedure.(152)
The Bovara court distinguished the consultation in that case from that in Reynolds v. Decatur Memorial Hospital.(153) In Reynolds, a pediatrician in the midst of examining a child telephoned a more senior physician at home and asked for his advice.(154) The senior physician suggested that the examining physician perform a certain test.(155) The examining physician completed her evaluation of the child, including the test suggested by the second physician.(156) Nevertheless, the examining pediatrician misdiagnosed the child.(157) In this case, because the second physician only gave an informal opinion, had not been asked to see the patient, did not review tests, directly order laboratory or other studies and did not bill the patient,(158) the court held that the consultation amounted to "nothing more that [an] answer [to] inquiry from a colleague."(159)
The Reynolds case exemplifies the second category of cases hinging on the relationship between consultants and patients. This category of specialty consulting generally encompasses a vast number and variety of interactions between physicians discussing management of patient complaints and illnesses in which the consultation is more informal. Such curbside consultations generally involve a presentation of the patient's history, recitation of the diagnostic test results obtained to date and discussion of potential avenues of treatment for this patient and others with similar symptom complexes.(160) In these cases, the patient's identity may be unknown to the specialist, the patient does not know about the consultation and the specialist colleague does not bill for his advice.(161) Such informal consultations fail to result in the establishment of a relationship between the consultant and the patient.(162)
The division between these two types of consultations is not always easy to discern. For example, in McKinney v. Schlatter,(163) a patient arrived at the emergency room with complaints of chest and abdominal pain.(164) The emergency room physician evaluated the patient and consulted the hospital's cardiologist by telephone.(165) The emergency physician apprised the cardiologist of the patient's history, cardiogram and other test results, and the cardiologist recommended additional tests.(166) Based on the results of these tests, the cardiologist determined that the patient's complaints were gastrointestinal and not cardiovascular in etiology.(167) The emergency physician then discharged the patient, who died a few hours later from a dissecting aortic aneurysm.(168) Distinguishing this case from Reynolds, the McKinney court noted that the cardiologist actually participated in the diagnosis of the patient's condition, played a material role in prescribing the course of treatment that the emergency room physician gave to the patient and was on-call for emergency cardiovascular cases.(169) Thus, the cardiologist had a duty to the hospital, staff or patient for whose benefit he was on-call.(170)
Conversely, the court in Oja v. Kin(171) found no duty on the part of an on-call consultant, concluding that on-call status alone was insufficient to create a duty to a patient who was a third-party to the contract between the on-call consultant and the hospital.(172) In Oja, the emergency physician caring for a patient with a gunsho |
