|
An Abridged Version
of a Report for the Telemedicine |
| Index CHAPTER 5: DUTY OF CARE, STANDARD OF CARE AND STANDARDS GENERAL PRINCIPLES Duty of care Whether a duty of care is owed by an individual healthcare practitioner or a corporate healthcare institution is determined, as a matter of law, by applying the concepts of "foreseeability" and "proximity". The duty can exist regardless of the absence of a contract and even when a medical service is rendered gratuitously. (1) Indeed, less direct relationships than a traditional doctor-patient relationship may be sufficiently "proximate" to give rise to a duty of care. Recent court decisions have reinforced that the category of persons to whom a duty is owed are not closed, and may expand in line with increased medical knowledge and changing social and legal attitudes.(2) Individual practitioners are not only responsible for their own acts and omissions (once a duty of care is established) but also for the negligence of their employees, under the principle of vicarious liability. At institutional level, liability attaches not only vicariously but also often on the basis of a direct, non-delegable duty of care. TELEMEDICINE AND DUTY OF CARE ISSUES (BIPARTITE OR TRIPARTITE) Telemedicine/telehealth can complicate the duty of care analysis by not only increasing the number of persons or institutions who might be seen to owe a duty, but also by generating uncertainty as to when such duty is and is not owed as a matter of law. Duty of care analysis in telemedicine is not susceptible to a generic approach given the variability of telemedical applications, problems addressed, specific outcomes sought, diagnostic and therapeutic strategies and the information infrastructure required. (3) How can and does a telemedical encounter deviate from a "traditional", face-to-face clinical interaction between patient and medical practitioner? Telemedicines capacity to transcend the conventional limitations of time and place blurs the distinctions that are, by geographical and temporal necessity, generally clear in a conventional, clinical interaction. Precisely how telemedicine achieves this depends on the specific treatment scenario, which can include:
Each of these interactions can be undertaken in a variety of settings (clinic, hospital, doctors rooms, patients home) and via a range of technological mediators (interactive video conferencing and "store and forward" technologies being the main ones). These novel models of interaction can generate difficult legal questions. For example:
American commentators have long grappled with these issues, which one US analyst summarised as follows: "There are arguments both for and against the existence of a physician patient relationship in the telemedicine context. Arguing against the establishment of such a relationship is the element of control or more accurately, the lack thereof- the consulting telemedicine practitioner has over the patients course of treatment. If the consulting physician is found to be acting only in an advisory capacity, with the local physician as the final decision maker, an argument can be made that the telemedicine consultant cannot be held responsible for a course of treatment another physician finalized and the implementation of which the consultant cannot oversee. However, if the consultant physician attempts to intervene, supervise or control a procedure, treatment of surgery then the physician could no longer be considered simply an advisor, and a physician-patient relationship would be established. Weighing against the existence of the relationship are the "consultant exception" statutes in many States. The exceptions allow out-of-state physicians to enter the state in consultative capacities, and they relieve these consultants from licensure requirements by excluding them from the States licensure Act. It might be possible by removing these consultants from a States licensure requirements, they will not be considered to be practicing medicine in that State. A public policy argument in favor of protecting consultants can be made and applied to telemedicine by analogy as one court stated, "to expose physicians to to liability for simply conferring with a colleague would be detrimental in the long run to those seeking competent medical attention and is contrary to public policy " (4) In analyzing the legal significance of the teleconsultants role, some American commentators have sought to identify analogous situations that have already been the subject of judicial comment. They have therefore looked to cases involving telephone consultations with a distant consultant, (5) or telephone communications with a distant consultant where the consultant has either no or limited physical contact with the patient. In these latter cases, the central factors determining whether a duty of care exists include: whether the consulting doctor and the patient ever actual saw each other; whether the doctor ever examined the patient; whether the patients records were ever viewed by the doctor; whether the doctor knew the patients name and whether the doctor charged a fee.(6) As one American commentator has noted: "Telemedicine entails several of the factors favored by the courts in establishing a doctor - patient relationship. Using telemedicine technology, the consulting physician meets and examines the patient by audio-visual link, accesses and reviews the patients medical records and offers a diagnosis and potential course of treatment for the patient. Knowing the patients name, speaking with the patient, offering advice in front of the patient, examining the patient, reviewing the patients record, and charging a fee all factors in to establishing a relationship and malpractice liability. All of these items point toward the establishment of a physician-patient relationship in a telemedicine context".(7) While it can generally be argued that there is no doctor-patient relationship when a consultation is solely between physicians and no specific patient is identified, this could change dramatically in a telemedical context.(8) Another analogy is with the role of the doctor-proctor. According the "Proctor Argument", the distant consultant is acting in a manner analogous to a proctor and the referring physician alone is therefore liable for any negligence. The consulting physician bears no more responsibility than that of a proctor whose duty is to supervise surgery or treatment.(9) This argument does not withstand sustained scrutiny, at least in relation to those cases where the teleconsultant has "contact" with the distant patient. In the proctor situation, proctor and patient never meet, the physician who is being supervised never asked for assistance and the proctor did not receive a fee. In telemedicine, the consulting physician generally meets, questions and examines the patient through an audio-visual link and hopes to be paid for his efforts. The consultant is actively involved and is not simply present to supervise.(10) INDIVIDUAL DUTY OF CARE ISSUES Based on the American anaylsis, there is a real risk that a telepractitioner, in whatever context, will be found to owe a duty of care and that a distant practitioner cannot seek to use the involvement of a local practitioner as a medico-legal "buffer" or "liability shield". Having said that, there is an important element missing from some telemedicine encounters that is found routinely in the "traditional" doctor-patient interaction-control: does the telepractitioner control the diagnosis or treatment or is he or she simply offering suggestions to the referring doctor? Arguably, the absence of control will not negate the duty when all the other surrounding, circumstances suggest that such duty is owed. It is suggested that Australian courts are likely to adopt a similar position. Indeed, if anything the approach Australian courts have in recent years taken to the identification of the duty of care will increase the likelihood that telepractitioners will be found to owe a duty of care in all instances. Unlike American courts, Australian courts will not just consider to whether the facts give rise to a doctor-patient relationship, but will also consider the broader issue of whether the facts disclose a relationship of "proximity" sufficient to establish a duty of care. While these matters are yet to be tested by the courts and while each case will ultimately turn on its on facts, it is submitted that Australian courts are likely to impose a duty of care upon telepractitioners in most instances. Certainly, it would be imprudent for medical practitioners, their professional indemnity insurer, or their medical defense organization, to assume that the doctors involvement in telemedicine does not impose upon them a legal duty to exercise care for the wellbeing of the patient. INSTITUTIONAL DUTIES From an institutional perspective, the duty of care challenge arises because: "Telemedicine programs operate in an unusual organizational environment. They are composed of distributed systems, usually cooperative ventures linking independent hospitals and clinics. There is often no clear hierarchy of administration, leadership, or authority this can magnify communication and organizational problems."(11) When technology facilitates or inadvertently generates linkages between previously unaffiliated organizations, very complex duty of care issues can arise. As one American commentator observed: "One can conceive a court placing upon a network a duty to adequately supervise the usage of the telemedicine system by all network parties, especially as the host exercises increasingly greater control over network activities".(12) The potential for miscommunication or non-communication between responsible entities requires a careful consideration of the roles which each entity plays. DUTY OF CARE AND PERSONS OTHER THAN MEDICAL PRACTITIONERS Because it involves a plethora of additional personnel upon whose services the quality of the telemedical encounter may depend, telemedicine imposes a duty of care on a wider range of people, both within and outside of the clinical setting. For example, where a distant consultant requests a nurse to act as his or her "proxy" to obtain the history, record observations, conduct basic physical examinations and convey results, difficult questions may arise as to the precise delineation of the nurses role, responsibility and legal exposure. Similarly, "in-house" technical personnel, such as health information managers, clinical data specialists, document managers and data security officers, have an increased responsibility and correspondingly an increased "exposure" in a telemedical context . The involvement of external parties in the creation of the technical infrastructure which facilitates the clinical interaction can complicate duty of care analysis in numerous ways: increasing the number of potential defendants; generating new forms of claims, such as "transmission malpractice"; and leading to increased reliance upon and scrutiny of the relevant contractual arrangements between external suppliers/consultants and the healthcare institution. CONCLUSIONS/REFORM AND RISK MANAGEMENT OPTIONS In summary, telemedicine potentially involves more parties in more ways than conventional medicine. The identification of the nature and scope of the duty owed by those persons and institutions involved in telemedicine does not necessarily raise novel questions of law. It does, however, require existing legal principles to be applied to a variety of novel factual situations, applications and new "players". The position that is ultimately adopted by the courts will as ever turn, to a great extent, on the individual circumstances of any given case. The fact the relevant legal analysis may vary according to individual circumstances underscores and reinforces the desirability of a proactive stance on the part of persons and institutions involved in telemedicine. The parties engaged in telemedicine must recognize how that process differs from established patterns of professional interaction so that they can take steps to become "masters of their own fate" by identifying, negotiating and demarcating the lines of responsibility in relation to such matters as:
Several of these issues will in due course need to be addressed by learned Colleges and professional associations. Until then, practitioners and institutions "at the coal face" will need to address those issues, for example through:
STANDARD OF CARE Institutional and individual practitioners of telemedicine which owe a duty of care are legally required to discharge that duty through the exercise of "reasonable" care and skill. This broad proposition entails a number of subsidiary points, many of which are of particular relevance to telemedicine:
THE CHALLENGES OF TELEMEDICINE The ability of the courts to delineate "reasonable" standards of telemedicine, either in general terms of with reference to specific factual circumstances is to an extent impaired by the relative novelty of telemedicine and the absence of formal guidelines or input from peak bodies. Broadly, telemedicines reliance on technological mediators not associated with conventional care delivery gives rise to new, complex standard of care questions, both within and between institutions. Unless and until there is definitive guidance from peak bodies (and even perhaps afterwards), practitioners and institutions engaged in telemedicine need to consider the following issues:
These ostensibly simple questions in fact are likely to require a reasonable "telepractitioner" to assess and analyse the following:
THE FUTURE: STANDARD OF CARE ISSUES AND THE FAILURE TO USE TELEMEDICINE If and when telemedical care becomes the norm, such that the prefix "tele" is tautologous, several fresh liability questions will arise where a practitioner or an institution either chooses not to introduce or adopt telemedicine or, alternatively, chooses not to offer or recommend it to patients in a given instance:
As in any medical negligence litigation, courts are likely to ask themselves what is the reasonable standard of care in all the circumstances. In the absence of guidance from peak bodies, it would not be surprising to encounter a divergence of judicial opinion concerning the necessary standard of care, based as much on the idiosyncratic views of the judges and the factual peculiarities of given cases as on any "hard" legal principles. Having said that, telepractitioners should assume that if anything, the courts are likely to impose a more rigorous standard rather than a lesser standard. STANDARDS - SETTING ISSUES A separate but related issue concerns the creation of telemedicine/telehealth "standards". A critical, threshold question is whether standards are desirable and achievable in the short term, or at all. Some argue that the creation of "standards" at this time is premature, given the relative immaturity of the telehealth industry and the myriad care delivery scenarios enabled by the various technologies, and that existing standards of professional practice, combined with common sense, may suffice either with or without slight modification to accommodate the challenges generated by telemedicine/telehealth. Indeed, some argue that the call for telemedicine-specific standards or guidelines constitutes "overkill" and is an inappropriate and disproportionate reaction to what is simply the introduction of a new tool for the delivery of care. Further, there is legitimate concern that the creation of standards at this early stage could stifle the evolution of relevant technologies. While these concerns are legitimate, it is submitted that peak bodies must nevertheless seek to address the challenges posed by telemedicine. As the American College of Radiology argued: "it is important that professional medical societies use their expertise to develop appropriate standards to guide physicians through this mine field of uncertainty"(16) Such approach is particularly appropriate once it is recognised that standardisation is "the foundation of interoperability, comparability of outcomes, and, ultimately, clinical success"(17) In the USA, bodies such as the American College of Radiology (ACR) and the Interdisciplinary Telehealth Standards Working Group (ITSWG) have led the standards debate. The position adopted by the ITSWG is, it is submitted, one that could be valuably adopted in Australia: "As telehealth technology rapidly evolves and commercial interests advocate for its application, it appears to be important for health care professions to agree on some basic principles regarding professional practice and telehealth that will be applicable across very different patterns of practice. The most basic purpose of these principles is to protect clients who may be recipients of telehealth services. This has always been the central aspect of health care professionals responsibilities. These principles can then be used as a basis for the development of more profession-specific or setting-specific policies by various groups, rather than each group having to create an entire policy structure independently unless a significant professional voice can be heard, policies related to telehealth are likely to be driven primarily by commercial market interests. This raises serious concerns about the potential for telehealth technologies to contribute to the fragmentation of the client-practitioner relationship, the potential for telehealth technologies to be used in the service of cost containment rather than quality enhancement, the potential that telehealth creates for the exploitation of practitioners and clients, and the potential for telehealth to contribute to the increasing dominance of huge managed care organizations in the health care marketplace. The direct collaboration of health care professions in developing telehealth technologies can ameliorate these concerns and contribute to the development of responsible, safe, ethical, and clinically useful systems." (18) The ITSWG recognised that the concept of "standards" or the more specific concept of "clinical standards" in fact covered a broad range of separate but related issues including:
Like others, the ITSWG recognised that there is currently neither the empirical nor the experiential basis that would be necessary to develop clinical guidelines and that, in any event, standards of professional practice are unlikely to change simply as a result of developing telemedicine technology. It will be some time before the professions can ascertain the changes in core competencies required by telehealth, the ITSWG observed. REFORM/RISK MANAGEMENT OPTIONS In the absence of judicial precedent or guidance from medical leadership, telepractitioners will need to exercise caution in determining what is likely to constitute acceptable and, in the language of tort law, "reasonable" standards of care. It is submitted that the standard of care imposed by law will certainly be no less demanding than in conventional care and, if anything, is likely to be more demanding. While the law will apply established legal principles to novel telemedical facts, precisely how it will do so is far from certain. It is, however, clear that a careful and considered analysis of the issues, and the implementation of appropriate risk-reduction strategies will not only facilitate care delivery but will also minimise the prospect of legal or disciplinary repercussions. In one critical respect, the principles governing the delivery of care via telemedicine are identical to those relevant to all other aspects of healthcare delivery: "As in other areas of medical practice, the usual protections against liability-good judgment, good skills, good documentation and good faith-apply, although they do not guarantee immunity from litigation" (32) Several, notable examples of "common sense" risk management initiatives have been undertaken in the USA.
"1. The basic standards of professional conduct governing each health care profession are not altered by the use of telehealth technologies to deliver health care, conduct research, or provide education. Developed by each profession, these standards focus in part on the practitioners responsibility to provide ethical and high quality care. 2. A health care system or health care practitioner cannot use telehealth as a vehicle for providing services that are not otherwise legally or professionally authorized. 3. Services provided via telehealth must adhere to basic assurances of quality and professional health care in accordance with each health care disciplines clinical standards. Each health care discipline must examine how telehealth impacts and/or changes its patterns of care delivery and how this may require modifications of existing clinical standards. 4. The use of telehealth technologies does not require additional licenses. 5. Each health care profession is responsible for developing its own processes for assuring competencies in the delivery of health care through the use of telehealth technologies. 6. Practice guidelines and clinical guidelines in the area of telehealth should be developed based on empirical evidence, when available, and professional consensus among all involved health care disciplines. The development of these guidelines may include collaboration with government agencies. 7. The integrity and therapeutic value of the client-health care practitioner relationship should be maintained and not diminished by the use of telehealth technology. 8. Confidentiality of client visits, client health records and the integrity of information in a health care information system is essential. 9. Documentation requirements for telehealth services must be developed that assure documentation of each client encounter with recommendations and treatments, communication with other health care providers as appropriate, and adequate protections for client confidentiality. 10. All clients directly involved in a telehealth encounter must be informed about the process, attendant risks and benefits, and their rights and responsibilities, and must provide adequate informed consent. 11. The safety of clients and practitioners must be ensured. Safe hardware and software, combined with demonstrated user competency, are essential components of safe telehealth practice. 12. A systematic and comprehensive research agenda must be developed and supported by government agencies and health care professions for the ongoing assessment of telehealth services." The "research agenda" referred to in point 12 included but was not limited to a call for research into the following areas: effectiveness and evaluation methodologies in connection with such areas as treatment effectiveness, treatment efficacy, generalisability, clinical utility, quality, patient outcomes, safety, risks, benefits, costs and cost-effectiveness; competence; confidentiality; "informed consent" and documentation and communication. It is submitted that these "Core Principles" and the proposed research agenda identified by the Working Group form a useful model for government agencies and professional groups in Australia.
The PIAAs report entitled Telemedicine: a Medical Liability White Paper, recognised that risk management initiatives need to be implemented at all levels of service delivery and at all stages of the delivery chain. Its major risk management recommendations were as follows: PIAA risk management recommendations "1) Become proficient with the technology.
2) Ensure that the use of telemedicine is appropriate for the situation. 3) Educate patients regarding options and limitations in the use of telemedicine. 4) Become familiar with referring physicians and their credentials. a) Maintain an understanding with referring physicians regarding documentation, case management and follow-up responsibilities. b) Ensure that there is compatibility with that practitioner. 5) Inform your insurance carrier of the nature and scope of your telemedicine practice. 6) If technology does not provide a clear assessment or if results are equivocal, see the patient in person, refer him/her for face-to-face or follow-up consultation. 7) Make sure there are realistic expectations of all parties. This technology is not perfect or appropriate for all types of physician-patient interactions.(33) 8) Clarify roles and responsibilities of all practitioners. Make sure the division of responsibilities is clear and complete. 9) Make sure contractual issues are reviewed and clarified. Contractual issues include those with other providers, vendors and equipment manufacturers. 10) Maintain an archive of each system in use. a) Maintain a system for performing and retaining backups of the systems in use. b) Ensure that all office staff are aware of their responsibilities. 11) Make every attempt to personalize the telemedicine encounter. 12) Document, document, document. Document events appropriately to include equipment used, resolution. It is important to document technology as well as the interaction." It is noteworthy that the PIAA emphasized the importance of accurate and adequate documentation.(34) Where the encounter involves practitioners at two "ends", it is also necessary to clarify which practitioner is responsible for documenting and recording the patients history, physical examination, diagnosis, treatment, consultation and the recommendations. The PIAA also emphasized the need for communication with patients, noting that patients should be told that the consultation will be performed through telemedicine, to explain how that differs from conventional service delivery, to identify the risks and limitations as well as the advantages of telemedicine and to explain which members of staff will participate and why they are participating. In so doing, the patients should be assured that confidentiality will be respected as in any other medical encounter. Australian law, unlike American law, does not recognize a doctrine of "informed consent". It is nevertheless submitted that the PIAAs recommendations concerning "informed consent" are not only consistent with the onerous disclosure obligations mandated by Australian common law but also constitute a sensible risk management and risk minimization strategy. As poor communication is often at the heart of medical liability litigation, it follows that meaningful communication at an early stage should help to reduce legal exposure and patient dissatisfaction. Endnotes to Chapter 5 (1) The Laws of Australia. Medical Practitioners (Chapter 27.2), LBC Information Services, 1998, p. 13 (2) ibid, p. 15 See in particular the case of X v Pal [1991] NSWLR 26, Clarke JA at 36 (3) Telemedicine, p.205 (4) P.F. Grandade and J.H. Sanders, "Implementing telemedicine nationwide: Analyzing the legal Issues". Defense Counsel Journal, 63(1): 67-73, 1996, pp.72 and 73, quoting Lopez v Aziz 852 S.W 2nd 303 (Tex App) 1993 at p 307 (5) As Roberts Waters of the Centre For Telemedicine law (CTL) stated: "A physician who responds to a telephone call by a potential patient by giving treatment advice for a particular illness might create a physician patient relationship even though the physician has never examined the patient. While the telephone, teleconferencing, store and send video taping, e-mail and other electronic communications have tremendous potential to enhance the efficiency and effectiveness of medical care, physicians should be aware of their potential liability for providing such services", R.J Waters "Telemedicine-Establishing Health Care Links Around the World". A paper delivered to the New York State Bar Association Health Law Section Fall Meeting, November 1998, p. 21. (6) Several of the American "telephone" cases have been examined in J. Fitzsimons "Telemedicine: Negligence Revisited" in Topics for Attention Issues Paper Number 7, Autumn 1998 (The Australian Institute of Health Law and Ethics) (7) P. Granade and J. Sanders "Implementing Telemedicine Nationwide: Analyzing the Legal Issues", p. 73 (8) P.F. Granade "Medical Malpractice Issues Related to the Use of Telemedicine An Analysis of the Ways in Which Telecommunications Affect the Principles of Medical Malpractice", North Dakota Law Review Symposium Issues: Telemedicine: The Intersection of Law, Medicine and Technology Winter 1997, p. 69 (9) Granade and Sanders "Implementing telemedicine nationwide: analyzing the legal issues", p. 70 (10) ibid, p. 70, and PF Granade "Medical Malpractice Issues Related to the Use of Telemedicine-An Analysis of the Ways in Which Telecommunications Affect the Principles of Medical Malpractice", p. 77-78 (11) Bashshur et al Telemedicine Theory and Practice, p 259 (12) S.R. Klain, W.L. Manning "Telemedicine and the Law", Internet Article (http://www.Netreach.net) (13) According to the High Court in Rogers v. Whitaker "(A) risk is material if, in the circumstances of the particular case, a reasonable person in the patients position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it." [1992] 175 CLR 479 at 490. (14) Indeed, there are
many, to date unresolved, questions about telemedicine/telehealth and
the Australian Law on so-called "informed consent". It is suggested
that Australian courts are likely to hold that the failure to exercise
reasonable care in the provision of information, advice and warnings about
the uses and limitations of telemedicine constitutes negligence. Far more
problematic and challenging is the identification of the measures required
to discharge the duty to exercise reasonable care in disclosure practices. (15) Many of these questions were raised in the "Report of the Interdisciplinary Telehealth Standards Working Groups" (16) Submission annexed to the Telemedicine Report to Congress, p.10 (17) D.A. Vidmar "Plea for Standardization in Teledermatology: A Worms Eye View" Telemedicine Journal Vol. 3 No. 2 1997, p. 173 at page 176. (18) "Report of the Interdisciplinary Telehealth Standards Working Group", pp.2 and 4 (19) "Authorotative statements by healthcare groups that describe the values and responsibilities for which its members are accountable. This focusses on the practitioner and his or her conduct. These standards include, but are not are limited to, statements related to the provision of healthcare services". (20) "Statements regarding the most permanent basic knowledge, skills, and core competencies practitioners." (21) This refers to the legally and professionally authorized range of services that may be offered, or set of clinical activities that may be engaged in, by a member of a particular health profession. (22) The set of activities or range of services that is defined by each healthcare profession as an aspect of the professional practice of that profession. (23) Which is defined by licensing laws and related regulations. (24) Which is defined by a given healthcare system for members of a particular healthcare profession under its employ or contract (25) Which is defined by an individuals training and competence to provide particular services. (26) Pronouncements, statements or declarations that suggest or recommend specific professional behavior or conduct in the delivery of healthcare services aimed at supporting the use of "best practice" in a specific setting or condition. (27) Which consist of recommendations to the professional related to his or her conduct and the issues to be considered in particular areas of clinical practice, rather than focusing on client outcomes or recommendations for specific treatments or specific clinical procedures at the client level. (28) Which provide specific recommendation about the treatments to be offered to clients i.e. client-focused rather then practitioner-focused. The ATAs Technology Taskforce recommended, in April 1997, that standards were needed to guide clinical users in acquiring software, services and equipment (29) The properties of the equipment, hardware, software, or data transmission that are required for a particular service, assessment or test to be conducted reliably. (30) Various types of certification have been offered by professional specialties that require additional training or experience and which are not common to all practitioners in a given profession. (31) The ITSWG noted that: "Presently, some of the concern about the use of telehealth technology by healthcare professionals appears to be focused at a much more basic level: can they use the equipment competently? Given that the familiarity of healthcare professionals with personal computers, for example, ranges from not knowing how to turn one on to regularly using multimedia e-mail transmitted via the Internet this is a reasonable question. However, this appears to reflect the rapid pace of technology more than it represents an appropriate focus on policy development." At p .11 (32) Robert Waters, Centre for Telemedicine Law (33) See Telemedicine p. 177 (34) Elsewhere in the White Paper, the PIAA concluded that the critical elements for documenting a telemedicine consultation involved recording of pertinent clinical data; identification of the patient and the attending family members; identification of the participating doctors and all participating healthcare support and technical personnel; the location of the patient and the providers; the date of the encounter and the timing of the commencement and cessation of the encounter |