CHAPTER 2: DEFINITIONS AND SCOPE OF THIS REPORT

Definitional challenges

Definitional precision is elusive where the lines of demarcation between one application and another are either indistinct or non-existent. This is particularly relevant to telemedicine, which is a nascent industry lacking definitive guidelines and guidance from peak bodies and where major technological change occurs at a great, and sometimes alarmingly rapid, pace. (1)

Definitions have been approached from several, significantly different perspectives: the identification of the "end user";(2) the technology used; (3) the activity conducted; (4) the process of care involved (5) or the medical discipline or clinical application involved. (6)

DIFFERING CLINICAL APPLICATIONS GENERATE DIFFERING POLICY, REGULATORY AND MEDICAL-LEGAL ISSUES

Some clinical applications are better suited to a smooth transition into the electronic age than others. As the IOM observed in its Telemedicine report:

"Clinical applications of telemedicine are marked by diversity. They differ in the medical problems addressed, the evidence base for decision making, the personnel and setting of care involved, the diagnostic and therapeutic strategies employed, and the organizational and cost implications of these strategies (and involve) a large number of possible quality, access, cost and acceptability measures for different clinical applications of telemedicine". (7)

For example, radiology is ideally suited to the conversion to "teleradiology"; (8) because the radiological community:

• Has a well-established infrastructure based on mail and courier services in order to facilitate the provision of consultations, second opinions and primary interpretation.
• Has extensive experience in the use of digital imaging technologies.
• Is not reliant on interaction with the patient. In this respect, the patient has always been "remote" from the radiologist.
• Is paid for services by the funding authorities

GUIDING PRINCIPLES/WORKING DEFINITIONS FOR THE PURPOSES OF THIS REPORT.

A definition of telemedicine that is accurate, comprehensive, intelligible and acceptable and meaningful to all stakeholders is largely unattainable, particularly given the relatively embryonic stage in the current development of the "telemedicine industry".

For the purposes of policy, regulatory and medico-legal analysis, it is critical to either seek to achieve definitional clarity and consistency or, if this cannot be achieved, then to appreciate the many "shades" of telemedicine/telehealth. (9) Appreciation of definitional and conceptual variations is needed to:

• collect accurate and reliable information upon which to base policy and business investment analyses.
• provide an organizational and conceptual framework for the discussion of policy and practice issues.
• avoid the confusion that arises from the use of a multitude of idiosyncratic definitions, and
• undertake regulatory and medical-legal analysis.

For the purposes of this Report, the following "guiding principles" will be adopted:

1. Telemedicine and the technologies associated with it are fast-changing and still in their early stages. Telemedicine is a rapidly evolving field requiring flexibility and creativity to respond to its challenges. For the sake of achieving consistency in policy analysis and because it represents a comprehensive description of telemedicine, this report will adopt the definition used in the DIST Report. There, (10) "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

2. Telemedicine is a tool or a series of tools - a family of enabling technologies. It is simply a way of providing health care and is not an end it itself. From a policy and regulatory perspective, it is appropriate to adopt the approach of Bashshur, who regarded telemedicine as:

"An innovation bundle; involving various mixes of technology, organization, manpower, and clinical services. This bundle, which is not uniform in structure or form is being introduced into, and is expected to bring changes to, a complex clinical, physical, cultural, social and psychological landscape of medical care. Whereas the promise and the potential of telemedicine to alter the complex web of accessibility are considerable, determining the specific nature, direction, and extent of the alteration is another matter. The impact is not simple, uniform, or unidimensional" (11)

SCOPE OF THIS REPORT

THE POLICY/REGULATORY CONTEXT OF TELEMEDICINE

Telemedicine, however defined, does not exist in a policy vacuum. As befits an area sitting at the intersection of the law, medicine, information technology and communications technology, the identification and analysis of policy, regulatory and medico-legal problems relevant to it fall within several, larger contexts:

• Telemedicine/telehealth is but one part of what has been called the "health information infrastructure" or "health infostructure". Other components of the health information infrastructure include, but are not limited to: integrated networked health/hospital information systems; personal health information and management; health informatics; the "electronic medical record" or computer-based patient record; the World Wide Web and computer-based decision support tools. The issues which telemedicine/telehealth confronts are similar but not always identical to those confronted by other applications in that infrastructure. (12)
• The health sector is a market segment of the "national information infrastructure" which itself is part of the "global information infrastructure" and is influenced and shaped by the same, national and global forces. Many of the policy, regulatory and medical legal issues confronting "health IT" in general and telemedicine/telehealth in particular are also faced by other or all sectors of the "information economy". Numerous Federal and State bodies have issued policy papers or are undertaking projects that address issues of relevance, both directly and indirectly, to telemedicine/telehealth, including electronic commerce, privacy (and specifically health information privacy), electronic signatures and the evidentiary status of electronic data.

WHAT THIS REPORT WILL NOT ADDRESS

Policy Issues Transcending Telemedicine/Telehealth

It is not appropriate for this Report to seek to in effect "reinvent the wheel" by covering ground which has already been or is already being covered by other, more highly qualified persons or bodies.

As the focus of this Report is on telemedicine, it will seek to avoid dealing in any substantive way with those policy, regulatory and legal issues which are common to the information economy in general or the health information infrastructure in particular.

Multiple, Critical Success Factors Affecting The Success Of Telemedicine Which Are Beyond The Scope Of This Report

While the issues that will be discussed in this Report are important ones for the future of telemedicine, they are not the only important ones. Major technical, organizational, financial and attitudinal barriers must also be overcome, including:

• Technical infrastructure issues

The high cost of telecommunications infrastructure, the absence or paucity of that infrastructure in certain remote and rural locations and the difficulties of "integrating many pieces and types of information in many formats, on many platforms, from many stakeholder environments, for use in many geographic locations", (13) remain major issues and have been identified as such by both the HOL and DIST reports (14)

• Human infrastructure issues

Despite its many attractive attributes, and despite the substantial labours of policy-makers, regulators and telemedicine "champions", telemedicine is still not widely practiced in the USA, or indeed anywhere else. Many reasons have been offered to explain the profession’s resistance to telemedicine, including

• "technophobia"
• the unwieldiness and inconvenience of the current technology.
• concerns about the quality, reliability, cost-effectiveness and safety of the equipment - and resultant concerns about legal exposure.
• economic factors — fear that telemedicine threatens "business-as-usual" and will generate "turf wars".
• "behavioral inertia", (15) the reluctance to "change habits that are ingrained as a result of years of practice." (16)

• Evaluation framework for assessing cost effectiveness and medical usefulness

The Council on Competitiveness felt that:

"Many barriers to implementation will fall if hypotheses on effectiveness and usefulness are proven" (17)

Similarly, the Telemedicine Report to Congress opined that:

"The absence of evaluative information continues to be a hurdle to the wider use of telemedicine. Policy makers at both the federal and state levels may find it hard to answer critical questions regarding cost, infrastructure, quality, and effectiveness without more sound and thorough information about the use of telemedicine to improve healthcare delivery".(18)

WHAT THIS REPORT WILL ADDRESS

This Report will examine those policy, regulatory and medico-legal issues that are:

• Telemedicine-specific". As the Telemedicine Report to Congress observed:

"The challenge for telemedicine policy makers lies in identifying emerging concerns that are unique to telemedicine" (19)

• Relevant to clinical applications of Telemedicine, often referred to as "classical telemedicine" (20)

Although this Report has adopted a definition of "telemedicine" that extends beyond the clinical aspects associated with the provision of "remote care", it is submitted that it is these clinical aspects which are likely to generate many of the most difficult policy, regulatory and medico legal issues.

WHAT THIS REPORT WILL SEEK TO ACHIEVE

Telemedicine is a moving target - and a fast-moving one at that - in respect of which there are no "easy answers".

It is tempting and at least superficially logical to look to the national and international banking industries for guidance as they appear to have moved service provision into the information age quickly and with relative ease. Why, some ask, cannot the health sector follow suit? The answer was in part provided by the OTA:

"The healthcare delivery system has several unique characteristics that discourage the spread of information technologies. Health professionals perform a wide variety of tasks including rapidly changing combinations of "hands-on" care, effective and diagnostic thinking, detailed record-keeping, patient education, and communication with colleagues. Most of the hardware and software approaches that address one of these aspects of medical practice intrude unacceptably on some other aspects… in addition, medical practice is extraordinarily complex and it changes rapidly. Systematizing even the process of performing medical procedures, much less rationalizing the language and scientific knowledge underlying those procedures, is an almost intractable problem".(21)

In such circumstances, it would be imprudent at best and arrogant at worst for this Report to aim to provide "all the answers".

Instead, this Report will attempt to assist policy-makers, regulators and would be "telepractitioners" by seeking to meaningfully categorize the policy, regulatory and medico-legal issues and obstacles. In this way, the Report will seek to:

• Contribute to the identification of the nature and scope of the obstacles confronting the optimal 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 relevant risk management and risk reduction strategies, and
• Assist administrators and practitioners who are responsible for delivering care via telemedicine to identify and understand the relevant issues and pitfalls so they can be apprised of relevant issues and, where appropriate, take the necessary preventive measures.

Endnotes to Chapter 2

(1) See HOL Report, p.29

(2) The settings could include a hospital, clinic, home, prison, workplace, battlefield or public space

(3) The technology involving one or a combination of data, audio, graphics and video. Whether the use of the telephone constitutes a form of telemedicine will be discussed in Chapter 4 in this Report

(4) In its report Telemedicine, the IOM provided the following categories and examples of telemedical applications: patient care (radiology consultations; post surgical monitoring; triage of emergency patients); professional education (continuing medical education [CME] programs; on-line information and education resources; individual mentoring and instruction); patient education (on-line help services for patients with chronic health problems); research (aggregation of data from multiple sites; conducting and coordinating research at multiple sites); public health (access to care for disadvantaged groups; poison control centres; disease reporting); and health care administration (vide conferences for managers of integrated health systems; utilization and quality monitoring). Some commentators have questioned whether CME, rather than being an example of telemedicine, is more properly an example of the broader concept of "telehealth". This was the view adopted by the HOL report

(5) The IOM, for example, looked at two separate but related categories:

1. The urgency, complexity, pathophysiology and the persistence of the clinical problems, the precise type of telemedicine application relevant to this category depended on whether the presenting, clinical problems were:

• Emergency or urgent problems for which prompt evaluation and management is important.
• Acute problems that may be evaluated and treated on a scheduled basis and that have generally predictable periods of resolution following treatment, or
• Chronic problems that require monitoring and management over a long time period.

2. The type of care, source of care and source of clinical information. The type of telemedicine application relevant to this category depended on whether the process of care involved:

• Prevention, diagnosis, treatment, rehabilitation, or monitoring
• Generalist care or specialty care
• Remote-site clinician, patients, or technical personnel

Interactive examination or questioning of a patient (or patient data) or deferred use of recorded information.

Institute of Medicine (IOM), Committee on Evaluating Clinical Applications of Telemedicine, Telemedicine: A Guide to Assessing Telecommunications in Health Care. (M.J. Fields, Editor). National Academy Press, Washington, D.C. 1996, p.31

(6) Telemedicine already plays a role in the following medical disciplines: anesthetics, cardiology, dentistry, dermatology, dialysis, endocrinology, ENT, Emergency Medicine/Triage, Medicine. Geriatrics, Immunology, Nephrology, Mental Health, Oncology, Ophthalmology, Pathology, Primary Care, Public Health, Radiology, Rheumatology and Surgery

(7) 10M Telemedicine p7

(8) The International Communications Union described teleradiology in the following terms:

International Telecommunication Union: Telecommunication Development Bureau. ITU-D Study Group 2 Impact of Telecommunications in Health-Care and other Social Services: Telemedicine and Developing Countries, October 1996, p. 17.

(9) With these considerations in mind, reports such as the DIST report and the HOL Report observe that the concept "telemedicine" will inevitably be replaced with the broader concept of "telehealth". Other argue that as telemedicine merges with health informatics, "telematics" will become the preferred nomenclature.

(10) At page 2

(11) Bashshur et al Telemedicine Theory and Practice p.20

(12) The multifaceted, interrelated and occasionally overlapping nature of the health information infrastructure was recognized in several policy papers published by the Department of Human Services (DHS). That interrelatedness makes policy analysis more complex. Based in part on the lack of definitional clarity and consistency regarding the meaning of telemedicine/telehealth, the lines of demarcation between what is "telemedicine/telehealth" and what constitutes another component of the "health information infrastructure", or what the World Health Organization (WHO) called "health telematics", is both blurred and shifting. As one North American expert on telemedicine legal issues observed, telemedicine is closely linked to two other fields: advanced computer decision support and computerized patient records. That commentator predicted that over time these fields will become "deeply interlinked" R J Waters: "Telemedicine-Establishing Health Care Links Around the World" Proceedings of the New York State Bar Association Heath Law Section Fall Meeting, November 1998, New York City, p.9

(13) pp v, vi

(14) See, for example, the HOL Report at Chapter 2 and the DIST Report at page 74

(15) Grigsby "Current States of Domestic Telemedicine" Journal of Medical Systems, Vol. 19, No. 1, 1995, p. 19 and p. 25

(16) ibid

(17) Highway to Health, p.24

(18) p 11 In Australia, these issues have been recently examined in a report prepared for the Department of Human Services (DHS) by the "Centre for the Study of Clinical Practice" Centre for the Study of Clinical Practice, St. Vincent’s Hospital (Melbourne). Evaluating Telehealth Services in Victoria: A General Framework. A Report for the Victorian Department of Human Services, by I. McDonald, S. Mill, J.Dali and B.Crowe

(19) p. 79

(20) This Report will, therefore, not consider in any substantive way the related issues associated with that part of telehealth which involves the provision of continuing medical education (CME) or consumer education. However, the issues are interrelated. For example, the increase in consumer access to health information via, for example, the World Wide Web may create a more, and hopefully better, informed health care consumer. This can significantly affect the power imbalance that has historically been encountered in the therapeutic relationship between healthcare practitioner and healthcare consumer, by empowering the consumer and requiring the practitioner to in effect "keep up" with developments.

(21) U.S. Congress, Office of Technology Assessment (OTA), Bringing Health Care Online: The Role of Information Technologies, September 1995, p. 3. Similar observations were made in the Report by the Centre for the Study of Clinical Practice Evaluating Services in Victoria, p 9

Index