EXECUTIVE SUMMARY

Introduction

Despite the unique promise of Telemedicine to expand the productive capacity and extend the distributive efficiency of health care resources, and to thereby address the ever-present challenge of delivering affordable, high quality healthcare to the greatest number of people, there are concerns about its potentially damaging effects on the healthcare system, quality of care, patients’ rights, the position of rural and other "isolated" healthcare practitioners and on medico-legal exposure. Indeed, a review of the relevant literature reveals a notable diversity, and quite often a marked polarity, of opinions on all of these issues.

Definitions

The polarity of opinion results in part from the fact that many commentators are at terminological cross-purposes when analysing the "vices" and "virtues" of telemedicine. This is not surprising given that telemedicine is a nascent and evolving industry, where the lines of demarcation and relationships with other technological applications of the "healthcare information infrastructure" are often blurred and shifting.

For the purposes of consistency, this Report will adopt the definition of "telemedicine" used in the report prepared for the Department of Industry, Science and Tourism entitled The Telemedicine Industry in Australia: From Fragmentation to Integration (February 1998). There, "telemedicine" was defined as consisting of the following components:

• The delivery of health services (including clinical, educational and administrative services)
• at a distance
• through the transfer of information, including audio, video and graphic data
• using telecommunications
• and involving a range of health professionals, patients and other recipients

However, as that Report and others have observed, the expression "telemedicine" may soon be replaced by a more all-encompassing expression such as "telehealth", "health telematics", or "e-health".

Scope of this Report

As the US Telemedicine Report to Congress observed:

"The challenge for telemedicine policy makers lies in identifying emerging concerns that are unique to telemedicine".

This Report will therefore not address in detail those policy and regulatory issues and challenges which telemedicine confronts in common with emerging applications of the "health information infrastructure" (and indeed the national and global "information economies"), but will instead attempt to adopt a "telemedicine-centric" focus.

This Report will primarily focus on clinical applications relevant to intra and interstate telemedicine practices of medical practitioners registered to practise in the State of Victoria.

What this Report will seek to achieve

This Report seeks to contribute to the identification of the nature and scope of the obstacles confronting the optimum implementation of telemedicine strategies, clarify the extent to which and means through which some of those obstacles can be overcome through legislation or regulation, and where that is not possible or is inadvisable, through risk minimisation and risk management strategies. The Report will seek to assist administrators and practitioners who are responsible for delivering care via telemedicine to better understand the issues, and to recognise where the potential pitfalls exist (and equally importantly — where they do not exist) so that they can take the necessary preventative measures and make informed strategic decisions.

However, the Report will not seek to address all of the myriad of technical organisational, financial and attitudinal barriers which must also be overcome to optimise telemedicine. Accordingly, it will not substantively address such critical "success factors" as technical infrastructure issues; human infrastructure issues or the creation of an evaluation framework for assessing cost-effectiveness and medical usefulness.

The U.S. Telemedicine Policy and Regulatory Environment: Why should we compare and collaborate?

While the healthcare systems of Australia and the USA have a very different policy ethos, practice patterns and policy structures, there is nonetheless a great deal to be gained from a cautious and considered analysis of the telemedicine policy and regulatory environment in the USA. Both nations (and indeed, other developed nations such as Canada) face common problems: large land masses with widely distributed populations, many of whom reside in rural or other remote locations; uneven geographic distribution of healthcare resources throughout the country; inadequate access to healthcare by certain segments of the population and unabating rise in the cost of care. Each nation is seeking to deliver a high standard of healthcare at a reasonable cost in an environment where the population is growing and aging, where there is an increase in the ratio of chronic to acute disease resulting in longer, more extensive treatments, where technological breakthroughs have expanded treatment options and where there has been a shift in focus from inpatient to outpatient care. Like the USA, Australia’s healthcare system is in a phase of rapid transition and restructuring. Traditional health service models are being replaced by business-driven models that focus on the delivery of services that are efficient, cost and outcome-effective and customer-focussed. Each country, and each jurisdiction within each country, is in effect seeking to do more with less, and telemedicine has been identified as one means of achieving this end.

The commonality of factors affecting both countries is not surprising in an era of increasing globalisation. The globalisation extends not just to healthcare trends and the increasing reliance of information and communication technologies both within and outside of the health sector, but also to medico-legal trends. Consequently, many of the factors influencing the US policy environment operate with equal effect in Australia.

The USA plays a leading role in the commitment of resources aimed at overcoming barriers to the optimal use of telemedicine. That commitment is demonstrated in many ways, including extensive Federal and Congressional activity, regional and State government telemedicine initiatives, reports and taskforces, and the creation of numerous industry groups, trade associations and other peak bodies, the publication of numerous, specialist journals and the holding of conferences. The variety of telemedicine initiatives in the U.S.A. makes it an ideal test-bed for experimentation and innovation.

Telemedicine and Medical Liability

Telemedicine is not a single technology, a medical specialty or a discrete set of related technologies but is rather a large and very heterogeneous collection of clinical practices, technologies and organisational arrangements. By enabling the delivery of healthcare in a manner that transcends the conventional boundaries of distance, hierarchies, institutional structures and -on occasion-time, telemedicine acts as both enabler and destabiliser. This Report will consider how these forces may affect the identification, analysis and resolution of legal issues pertaining to telemedicine.

From a policy and medico-legal perspective, a central question is whether telemedicine’s capacity to generate major and sometimes revolutionary change to the healthcare delivery system necessarily requires change of a similar magnitude to be made to the legal principles and mechanisms that govern such system. This Report will explore that contention and will seek to determine how common law and statute law might address the challenges to conventional legal analysis posed by telemedicine, by considering both the relevant "black letter" legal principles and the practical realities of medical liability litigation.

While on one view, telemedicine simply constitutes the overlay of a new form of technology on an established system of care delivery, there are certain features of telemedicine which render more complex the conventional analysis of legal roles, relationships and duties. Telemedicine may generate novel or complex liability questions because it generates new ways of interacting with the patient; it potentially redefines existing roles and relationships between practitioners; it can involve new models of therapeutic, diagnostic and consultative interaction not only between the patient and the medical practitioner but between medical practitioners; it ignores and transcends borders and is disrespectful of conventional boundaries; it involves a greater number and different types of "players". It may increase the number of non-medical staff involved in the patient interaction, including allied health, technical support and those persons responsible for manufacturing, supplying and maintaining the necessary information and communication technologies.

As a result, telemedicine raises difficult "duty of care" and "standard of care" issues concerning:

• The allocation of roles and responsibilities as between a local and a distant practitioner, or as between a "hub" and a "spoke" practitioner
• The reliability of data conveyed or clinical and professional interactions conducted electronically and, in particular, whether they constitute a reliable substitute for a face-to-face interaction
• The steps that must be taken (and by whom) to ensure that telemedicine is as safe or as clinically acceptable as conventional medicine
• The formulation and implementation of practice guidelines and protocols to ensure the delivery of quality telemedicine in a consistent manner
• The drafting of contracts and agreements between various persons and institutions whose services are required to facilitate or conduct the telemedicine encounter
• The risk that telemedicine, like many other technological advances, will increase patients’ expectations and thereby increase the risk of litigation when those expectations are not met.

Precisely what new legal issues are provoked by the telemedicine interaction will very much depend on the precise type of service being delivered and, it is submitted, on the extent to which such service deviates from conventional patterns of healthcare service delivery. This Report will address in detail the "duty of care" and "standard of care" challenges posed by telemedicine.

Standards and Standards-setting issues

This Report will also address the difficulties arising from the measurement and assessment of telemedicine quality, reliability and safety, which requires a consideration and analysis of numerous issues, including

• What is the impact of the technology of the doctors’ relationship with the patient?
• Is the technology safe, accurate and reliable?
• How can practitioners assess dangers to patients in telemedicine encounters?
• What information is lost or gained using telemedicine as compared to other forms of service? And how does this affect patient outcomes?
• How do practitioners manage risks when using telemedicine?
• What are the competencies needed for patients and for practitioners to enable the delivery of quality care using various telemedicine technologies?
• How can patient and practitioner competencies be assessed?
• What, if any, steps should and must institution or practitioners engaged in telemedicine take to modify or adapt a telemedicine practice so as to overcome or minimize those aspects which result or may result in a qualitatively reduced service?

The capacity of standards-setting authorities and peak bodies to develop "industry standards" will for some time be hampered by the paucity of scientific data. In some circumstances, formal standards may not be required at all, either because up front standards could stifle the evolution of the technology, or because a proper course can be steered through a number of established principle and common sense. Several US bodies have, in considering these issues, developed guidelines and principles which, it is submitted, could provide a useful framework for Australian policy-makers and standards-setting authorities. These include:

• The ITSWG, which formulated a set of "core principles".
• The Physicians Insurers Association of America (PIAA), which published a Telemedicine Medical Liability White Paper including a set of "Risk Management Recommendations".
• The Institute of Medicine which, in its report Telemedicine, devised checklists on such issues as "evaluating care", "evaluating quality of care and health outcome", and "evaluating patient perceptions"

Although the challenges of telemedicine are manifold, it is submitted that as a general rule they will not require the creation of novel legal principles. Instead, the law will apply established legal principles to the novel telemedical facts. Precisely how the law will ultimately address these issues is far from certain but it is clear that a careful and considered analysis of the issues and the implementation of appropriate risk-reduction strategies will both facilitate the delivery of care while minimising the prospect of legal or disciplinary repercussions. As in other areas of professional practice, good judgment, good skills and good documentation will serve to enhance quality while reducing the risk of liability.

Telemedicine and Evidentiary Issues

Telemedicine and related technologies permit and indeed require the capture, transmission, storage and retention of data (including aural, visual and textual data) in ways that differ dramatically from the practices associated with the conventional paper-based medical record (PBMR). The creation, transmission and retention of electronic data either as a supplement to or a substitute (be it partial or complete) for the PBMR can have major repercussions for quality assurance, risk management and litigation by affecting the ability to locate evidence and to ensure its accuracy and reliability. Whether this technology and its repercussions will ultimately be regarded as harmful or helpful both in terms of quality assurance and medico-legal exposure will depend on the steps taken to identify and address the evidentiary challenges posed by and the new opportunities presented by telemedicine. Closer liaison and better coordination of activities will be required between stakeholders and with their advisers, to ensure that each stakeholder understands in broad terms how data is created, transmitted and stored in the new electronic environment. Armed with such knowledge, stakeholders can take steps to minimize risks and maximise opportunities.

Cross-border/Interstate Issues

Because healthcare is regulated along State lines and because telemedicine is a technology that is innately disrespectful of conventional borders, it is inevitable that if and when a telemedicine service crosses a State or Territorial border or involves a "multi-jurisdictional" component, difficult policy, regulatory and legal questions will arise. The American experience has demonstrated that the resolution of cross-border telemedicine policy issues can be extremely complex, involving longstanding constitutional, political and "turf" battles as well as more conventional legal ones. In many respects, the issues raised by cross-border telemedicine serve to amplify and highlight legal problems which have long existed but which never needed to be tested in the conventional setting.

While cross-border telemedicine might create novel models for the delivery of care, the law is accustomed to dealing with disputes arising out of transactions with multi-jurisdictional elements and there are legal principles already available to adjudicate upon them. However, the interpretation and application of these principles to any given factual circumstances is complex, unwieldy and unpredictable. It is therefore inevitable that litigation arising from cross-border telemedicine will generate proceedings that last longer and are more costly than intrastate telemedicine disputes, as a combined result of the procedural complexity and uncertainty of the law regarding jurisdiction and choice of law and the strategic manoeuvres consequently deployed by the litigants.

Telemedicine is one of many challenges to the current, State-based system of medical registration (or as it is called in the USA, "licensure"). The major challenge confronting registration authorities is how to permit the benefits of telemedicine to be brought to the public in a manner that is not unduly burdensome to the profession but which ensures at the same time that the public is adequately protected. In the USA, this central question has generated a remarkable diversity of responses. While Australia may be better positioned to address the issues, particularly in light of the existence of the mutual recognition system established under the Mutual Recognition Act 1992 and its mirror legislation throughout the States and Territories, there are many, remaining questions that must be addressed:

• The jurisdictional question - where a patient is in one State and a doctor is delivering a telemedical service from another State, in what State is the doctor practicing medicine?
• Related to the first question is the definition of the "practice of medicine".
• How will telemedicine function when different jurisdictions have different rules and different procedures?
• How can and should regulators distinguish (assuming a distinction is required) between the various service delivery options available through telemedicine and other forms of "remote medicine" that have traditionally been delivered by out-of-State medical practitioners without the need for registration?

State and Territory registration boards and their umbrella body, the Australian Medical Council, will need to develop clear policies governing the circumstances in which cross-border professional interactions of any kind, but particularly those in which telemedicine in all of its diverse forms and for all of its myriad of clinical purposes, requires registration.

Privacy, Confidentiality and Security Issues

The concepts of privacy, security and confidentiality are related but distinct, although such distinctions have often being ignored or misunderstood. Protection of privacy and confidentiality, and the maintenance of security are not absolutes but must be balanced against questions of cost, access and any overriding public policy concerns.

This Report will focus on the identification and analysis of those privacy, confidentiality and security issues which are either unique to telemedicine or which have the greatest relevance to telemedicine, and on those US initiatives that most usefully address such issues. It is submitted that telemedicine does not raise any new "philosophical" or conceptual problems but does present problems concerning the practical implementation of steps to accommodate the new communications environment.

Telemedicine not only raises several new challenges to privacy, confidentiality and security but also requires resolution of longstanding challenges. However, while it is true that conventional health care practices and paper-based medical records offer numerous opportunities for unintentional, careless or deliberate infringement of medical privacy, the electronic recording, storage, transmission and retrieval of patient information complicates the situation and increases the opportunities for privacy and confidentiality of medical information to be infringed. Not only do computers create new and more clearly defined problems but they also bring longstanding issues into sharper focus and raise their profile. Technology has changed the accepted methods for defining legitimate access and maintaining security.

While a legislative approach to national privacy issues is desirable, it might not be achievable. Regardless of whether such legislation is ultimately enacted, other steps will need to be taken at institutional and at industry level to protect the privacy, confidentiality and security of electronic health data. While some of those steps will need to be directed towards the specific and unique challenges posed by the health information infrastructure, other will require no more than a thoughtful application of established principles, common practices and common sense. A combination of physical measures, organisational practices, a revised technological framework and staff training will be required.

LIST OF ABBREVIATIONS

ACR American College of Radiology

AHIMA American Heath Information Management Organisation

AMA American Medical Association/Australian Medical Association

AMC Australian Medical Council

ATA American Telemedicine Association

ATSP Association of Telemedicine Services Providers

CANARIE Canadian Network for the Advancement of Research, Industry and Education

CAP College of American Pathologists

CME Continuing Medical Education

CTL Centre for Telemedicine Law

DHS Department of Human Services (Victoria)

DIST Department of Industry, Science and Tourism

DPAC Data Protection Advisory Council

ECEG Electronic Commerce Expert Group

FSMB Federation of State Medical Boards

HHS Department of Health and Human Services (USA)

ICT Information and Communications Technology/Technologies

IOM Institute of Medicine

IT Information Technology/Technologies

ITSWG Interdisciplinary Telehealth Standards Working Group

JCAHO Joint Commission on the Accreditation of Health Organisations

JWGT Joint Working Group on Telemedicine/Telehealth

NCVHS National Committee on Vital and Health Services

NIIAC National Information Infrastructure Advisory Council

NLM National Library of Medicine

NOIE National Office of the Information Economy

NTC National Telehealth Committee

OTA Office of Technology Assessment

PIAA Physicians Insurers Association of America

TGA Therapeutic Goods Administration

WGA Western Governors’ Association

Index