Introduction

During the 1990s, Americans became increasingly reliant on the Internet, personal computers, and even hand held computers to manage information needs. Health websites proliferated, ranging from those offering a wide array of health information to sites dedicated to specific disease entities. Health-related information emerged as among the most frequently sought material on the Internet.

...adoption of innovative new approaches to care has occurred at a much more rapid pace than legal and regulatory questions have been answered.

Concurrently, more sophisticated electronic monitoring and assessment tools were developed, facilitating innovative approaches to remote monitoring of health status. This remote monitoring capability resulted in creative approaches to disease management. Technology that gathers and electronically transmits patient data to the physician for evaluation holds promise for saving both patient and providers substantial dollars. Escalation in deployment of remote technology to enhance health care, accompanied by expanded public and private reimbursement for distance care, indicates that the U.S. is accepting the concept of health care delivery via telemedicine as standard medical practice. This article will discuss the foundations of telehealth nursing and addresses legal and regulatory issues emerging from this new practice modality. As is often the case, adoption of innovative new approaches to care has occurred at a much more rapid pace than legal and regulatory questions have been answered.

The Foundations of Telehealth Nursing

Regulatory Perspective

Based on the Tenth Amendment to the U.S. Constitution, each state is empowered to establish laws to protect the citizens of the respective state.

Thus the century old, state-based licensure structure is now being challenged by an exploding world of technology and entrepreneurial care delivery services which are completely impervious to the confines of invisible state borders.

A component of this "public protection" mandate is the state responsibility for establishing standards for health care professionals who provide services for citizens of that state. For almost a hundred years, America has had a firmly established system for issuing state-based licenses to health care providers, including authorization to practice within the boundaries of the state that issued the license. However, no state is empowered to grant authority for professional practice in another state. Until recent years, licensure was not seen as an impediment to providing health care because the health facility, the health care provider, and the patient were almost always in the same location; and providers were licensed where the care was given. With the advent of multistate delivery systems and nursing call centers, however, the nurse and the patient are often in different geographical locations. Thus the century old, state-based licensure structure is now being challenged by an exploding world of technology and entrepreneurial care delivery services which are completely impervious to the confines of invisible state borders.

Federal Involvement

The Balanced Budget Act (BBA) of 1997 provided an impetus to the development of telehealth when it authorized Medicare telemedicine reimbursement under certain circumstances. Additionally, substantial federal dollars were earmarked for telemedicine grants to determine the viability of telemedicine to increase access to quality health care services for the underserved through use of advanced telecommunications and information technologies by rural health providers. Medicare currently pays for teleconsultation using two-way interactive video encounters as a substitute for "face to face" visits, but only if the patient is a part of the interactive video session.

To assist with evaluation of the overall telemedicine environment, Congress mandated preparation of a comprehensive report analyzing the obstacles to the advancement of telemedicine. This 1997 Department of Health and Human Services (DHHS) Telemedicine Report to Congress identified five major barriers to adoption of telemedicine, including: legal and regulatory issues; payment issues; safety and standards; telecommunications infrastructure, as well as privacy, security and confidentiality issues. The section of this report on legal and regulatory issue primarily addressed licensure with some discussion of liability. The revised 2001 DHHS Telemedicine Report to Congress indicates that the legal and regulatory dilemmas are as yet unresolved.

This article will address major barriers related to legal and regulatory issues of telehealth. Other articles in the Online Journal of Issues in Nursing Topic of Teleheath address issues relating to payment, privacy, security and confidentiality issues.

Telehealth Practice

The term telemedicine was originated by early international relief endeavors and fueled by technological advances of the space program. The incorporation of distance care into health care practice produces terms, such as: teledentistry, telehealth, telenursing, telepathology, telepharmacy, and telepsychiatry. The multiplicity of telemedicine applications ranges from POTS (plain old telephone system) to such high technology practices as remote surgery. The role of nursing is an integral component of telehealth practice. Some telehealth programs are based almost entirely on provision of nursing care while others focus on enhancing the ability of physicians to provide diagnostic services. The three areas of greatest interest to nurses are:

• telephone practice/ telephone triage/ call center nursing

• care using two-way interactive video (especially home care)

• care using high tech equipment (primarily in military settings)

The debate continues as to whether the umbrella term should be telehealth or telemedicine.

..."telemedicine" referred to "the use of electronic communication and information technologies to provide or support clinical care at a distance." Telehealth is a broader concept.

In discussing legal and regulatory issues, the terms telemedicine and telehealth may be used interchangeably, depending on the context - yet always referring to the practice of using electronic technology to provide patient care over distance. In the Department of Health and Human Service 1997 Report to Congress, "telemedicine" referred to "the use of electronic communication and information technologies to provide or support clinical care at a distance." Telehealth is a broader concept. In the 2001 Report to Congress, telehealth is defined as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.

Although a myriad of legal and regulatory questions surround telehealth practice, at this point, lawsuits specifically indicating practice across state lines as a critical factor in the lawsuit have not been reported. It is important to note, that most telehealth programs are acutely attuned to quality issues and patient care follow-up, and aggressively monitor the outcome of recommended interventions. Patient satisfactions reports are consistently high.

Telehealth Nursing Practice

A major objective of the "restructuring" of the American health care system was to increase quality and access of care and to minimize cost. An outgrowth of these changes in the delivery system is the proliferation of nursing call centers that provide telephone triage, health information and referral services. Some call center systems maintain large centralized operations serving multiple states, while others provide "off hours" support for clinics, small hospitals and medical facilities. This 24 hour access to health care resources has proven so popular that many insurance providers now provide all members with access to a nurse via an "800" telephone number. One national call center reported as many as 25,000 telephone encounters per month (Walcott,1998). A 1997 Wall Street Journal article, "Telephone Triage," speculated that by the turn of he century, over 100 million Americans would have access to a nurse via an 800 number.

Use of call centers is not limited to the United States. The American Telemedicine Association (www.americantelemed.org) notes reported that Canada recently announced establishment of a nationwide health care call center service, to be provided free for all Canadians. The article also noted international competition for outsourcing call centers, with India and the Philippines now vying to be worldwide leaders in call centers and actively seeking contracts from institutions around the world (Call Centers, Outsourcing Grows, 2001). Currently, call centers use voice data but in the future remote patient monitoring will likely be included.

A number of home care providers have begun supplementing home care services with two-way interactive video encounters with patients. Early home care services were provided via specially installed home monitoring and communication equipment, but newer programs via the Internet are even more promising. Currently, Medicare does not allow televisits to substitute for a single in-person visit, but will allow supplementing the approved number of visits. A recent Kaiser Permanente study of telehealth nursing showed cost savings, positive health outcomes, and unexpectedly high patient satisfaction, especially in the elderly community, resulting from the use of telehealth care (Johnson, 2000).

Much of the "high tech" care, such as distance surgery and virtual diagnostics, is being developed by the military. However, nurses are maintaining an integral involvement in this development. These nurses remain enthusiastic about future possibilities in this "high tech" area. At the other end of the spectrum, nursing has an incredible opportunity to use technology to augment ongoing nurse-patient relationships, especially for management of chronic conditions, home care, rehabilitation, and long term care. Nursing has often voiced interest in enhanced mechanisms to provide nursing care for clients in non-acute care settings. The increased availability of systems to support telecare provide a vital resource for expanding avenues for nursing practice.

Since the advent of nursing care over distance, Boards of Nursing (BONs) have been receiving calls about licensure, liability and other legal issues emerging from this new arena of practice, especially when the nurse and patient are in different states. Employers have expressed uncertainty about how to manage nursing licensure questions, particularly the need for licensure in multiple states. Nurses are justifiably concerned about providing care in states in which they do not hold a license. This dramatic conundrum demonstrates the impact of rapid integration of technology into health care, and the much slower establishment of appropriate policy regulations.

Legal Issues Emerging in Telehealth

While each of the respective areas of telehealth practice presents unique legal questions, three overarching "telehealth" questions are raised most frequently.

The first major regulatory question, at the very heart of nursing practice and the nursing profession, is whether nursing care provided electronically over distance is actually the practice of nursing.

The first major regulatory question, at the very heart of nursing practice and the nursing profession, is whether nursing care provided electronically over distance is actually the practice of nursing. The most widespread misperception about telenursing is that, while "tele" care may be highly interactive, it is not "hands on" and therefore not nursing practice. Additionally, nurses in call centers have been challenged about whether they are practicing nursing, since one element of their practice utilizes physician-approved protocols. Some speculate that telephone triage is actually delegated medical practice, not nursing practice, so licensure is not an issue.

The essence of the question is whether telephone and electronic nursing care are within the scope of nursing practice as authorized by the state nurse practice acts. To respond to this question, BONs have closely evaluated the definitions of nursing and scope of nursing practice. They have determined that nursing practice occurs at the point that a nurse utilizes the knowledge, skill, judgment and critical thinking that is inherent in nursing education and that is authorized through the nursing license. The state's legal definitions of nursing almost always include a) use of nursing education, b) critical thinking, and c) judgment. For example, any nurse could provide general information about preschool children with elevated temperatures. By contrast, when a parent contacts a telephone call center about a child with an elevated temperature, and a nurse initiates a series of assessment questions, e.g., other symptoms, duration of the fever, rash, fluid intake, and response to medication, and then the nurse synthesizes data as a basis for providing direction about the care, that nurse is utilizing the knowledge, judgment and expertise achieved through education and authorized by law to make decisions and recommendation about care. In these cases the nurse is indeed engaged in the practice of nursing.

A second regulatory dilemma is whether jurisdiction over telemedicine/telehealth will remain in the domain of traditional State‘s Rights provisions (as is most traditional health care) with the issues being resolved by the states, or whether the practice will be deemed as interstate commerce. As described in the U.S. Constitution, interstate commerce is seen as provision of goods and services across state lines and is within the jurisdiction of the federal government. The benefit of matching the patient with the right provider, regardless of state boundaries, is without question. In recent years, the federal government has become involved with standards for health care, but only when it was determined that the wide variation and disparity among state standards was not in the best interest of the patient. One example of the federal government exerting its influence in health standards was adoption of the Clinical Laboratories Improvement Act (CLIA), which authorizes HCFA to set standards for and regulate all clinical labs across the country. Another example is the Mammography Quality Standards Act (MQSA) passed by Congress in 1992 to ensure that mammography is safe and reliable and that breast cancer is detected in its most treatable stages. The Food and Drug Administration has the responsibility for implementing and enforcing MQSA, which requires that all mammography facilities in the United States meet certain stringent quality standards, be accredited by an FDA-approved accreditation body, and be inspected annually.

As of this writing (September, 2001) recent draft language from potential federal legislation has been disseminated for review. This language would allow consultation in Community Health Centers by physicians duly licensed in states other than the state where the Community Health Center is located. Although, already supported by several health care organizations, reaction to this language is yet to be seen.

A third intriguing legal question impacts not only health care, but also other electronic services and business. With the emergence of telemedicine, there is no clear law or body of knowledge to resolve the question of "where does care occur" when the patient and the provider are in different geographical locations. Is the care legally provided at the location of the patient or at the location of the provider? If care occurs at the location of the patient, is the nurse practicing telenursing expected to obtain a nursing license in every state where there might be electronic contact with a patient? If care is determined to occur at the location of the provider, how does the patient/consumer know where and how to seek recourse in the event of substandard care or malpractice?

Among the first to address this question, the Federation of State Medical Boards (www.fsmb.org) (1996) devised a physician licensure model for a special purpose license for those desiring to practice across state lines. Their model is based on the belief that care occurs at the location of the patient. However, others in the physician community believe that by accessing electronic systems, patients are implicitly traveling to the physician. In nursing, the Mutual Recognition Model of licensure, as proposed by the National Council of State Boards of Nursing (1998), calls for each state to adopt an interstate compact that establishes legal authority for nurses to practice at both locations - the location of the patient as well as the location of the provider (www.ncsbn.org). To date, fifteen states have enacted the interstate compact, with legislation being considered in additional states.

Regulatory Issues: Credentialing and Certification

One of the consistent questions about telehealth nursing is whether there is a need for certification or additional credentialing for telehealth practice. This question is being raised even though the last century has been replete with the introduction of new tools and technology in health care, resulting in a system that is quite adept at incorporating new technologies into patient care and that understands the expectation that users are trained, proficient and safe in using any new technology. Many of the calls for certification are from those who take a very narrow definition of telemedicine, and believe that the technology is so complex that some sort of credentialing mechanism is needed. The health care community seems to have reached consensus that current licensure authorizes the entirety of professional practice and therefore additional licensure is not necessary. However, the Office for the Advancement of Telehealth (OAT) established a task force to consider certification and delineated a number of issues to be addressed prior to establishing any certification process. The final report (OAT, 1999) cites a number of questions which must be addressed if additional telehealth certifications are created.

As with other specialty practice, nurses practicing in this new environment must met the challenge of developing standards for safe and effective practice.

As with other specialty practice, nurses practicing in this new environment must met the challenge of developing standards for safe and effective practice. Nursing has already risen to meet this need. In 2001, the American Academy of Ambulatory Care Nursing (AAACN) published Telehealth Nursing Practice and Administration Standards and followed in 2001, with debut of the Telephone Nursing Practice Core Course Manual. The American Nurses Association has published Core Principles on Telehealth (1998), Competencies for Telehealth Technologies in Nursing (1999), and Developing Telehealth Protocols: A Blueprint for Success (2001). These standards will be particularly useful for nurses entering telehealth practice since they reflect extensive analysis of the role of nurses in this emerging area of practice. Nurses with expertise in this area of practice have identified the appropriate competencies for utilizing telepractice to augment patient care and enhance patient outcomes.

Conclusion

In spite of the complexity of these legal and regulatory challenges, it is important to remember that quality patient care must be the focus of these discussions. Telehealth holds tremendous possibilities as a adjunct to care, especially for those in geographically remote areas. Patient responses to date have been extremely positive regarding telehealth nursing. For many years, nursing has sought a mechanism to effectively utilize the unique nursing abilities to assist all people in maximizing their health potential - whether in illness or health, and wherever they live. Telehealth can provide the illusive tool that will enable us to meet this goal, once the legal and regulatory issues related to telehealth have been resolved.

Author

Carolyn M. Hutcherson, MS, RN
E-mail hutcherc@arentfox.com

Carolyn Hutcherson , RN, MS, specializes in health care regulatory issues with special emphasis on licensure and credentialing, telehealth and e-health. Currently, Ms. Hutcherson serves as Executive Director for the Center for Telemedicine Law, a non-profit organization which provides leadership in gathering and analysis of legal and regulatory information about all aspects of telehealth and telemedicine services.

Prior to joining Center for Telemedicine Law, Ms. Hutcherson served as Senior Policy Advisor for the National Council of State Boards of Nursing, the organization which coordinates regulatory and licensure issues for all nurses in the United States. In that role, Ms. Hutcherson established the first organizational governmental affairs program and established a mechanism to monitor and evaluate the regulatory impact of state and federal legislation as well as trends in health care delivery. She was instrumental in development of a proposed new model for nursing licensure to accommodate multistate practice. Ms. Hutcherson was also Executive Director for the Georgia Board of Nursing for over ten years. While in this role, she was elected to the Board of Directors for the National Council of State Boards of Nursing, serving a two-year term as President. Ms. Hutcherson has also taught nursing and management and has clinical experience in home care, critical care, and a variety of other clinical settings.

Federation of State Medical Boards (1996, April). Telemedicine report: A model to regulate the practice of medicine across state lines. Euless, TX: Author. Retrieved September 22, 2001 from the World Wide Web:
www.fsmb.org/Policy%20Documents%20
and%20White%20Papers/telemed.htm

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