INTRODUCTION
I.   DEFINING TELEMEDICINE
II.  CURRENT LAWS, POLICIES, AND POSITIONS RELATING TO THE PRACTICE OF TELEMEDICINE
      A. Current Federal Law and Applications
      B. State Telemedicine Laws
III. REGULATING THE QUALITY OF CARE: LICENSURE, MEDICAL MALPRACTICE AND THE DOCTRINE OF INFORMED CONSENT
      A. Regulation by Licensure
          1. Current Licensure Laws
          2. National Initiatives: Professional Organizations, Institutions, and Commissions
          3. Current Legislative Activity
      B. Regulating Quality: Serving the Best Interests of the Patient
      C. Informed Consent
IV. REGULATING ACCESS AND STAMDARDS
      A. Regulating Access: The FCC and "Universal" Access
      B. Regulating "Teledevices"
      C. Regulating Access Excess: Protecting The Patient's Privacy, Confidentiality and Security Interests
          1. Privacy, Confidentiality and Telemedicine
          2. Federal Protections
          3. State laws
          4. Professional Codes of Ethics and Private Positions
          5. Proposals
V. REGULATING COSTS: WHAT SERVICE AT WHAT PRICE?
      A. Federal Funding
      B. State Approaches To Reimbursement
      C. Private Funding of Telemedicine
VI. TELEMEDICAL POLITICAL PROPOSALS
VII. A CALL TO ACTION
CONCLUSION

In 1996, eleven people died while trying to climb Mount Everest.[1] Shortly thereafter, physicians worldwide began turning to technology to provide remote medical treatment. In May 1998, physicians, scientists and technologists determined it was time to safeguard the health of another team attempting to scale the world's highest mountain.[2] They turned to telemedicine, equipping the climbers with "Bio-Packs" that measured the climbers' surface and core temperatures, pulse rates and oxygen saturation levels,[3] "Geo-Packs" that constantly updated the climbers' location using a geonavigation system, and EKG and EEG telemetry devices.[4] Just one week before the Mount Everest expedition, a physician in New Jersey practiced a far simpler and more modest form of telemedicine: he answered medical queries using his web site. Three months later, physicians at the University of Colorado Health Science Center developed and implemented plans to make "house calls" to the three Texas RE/MAX pilots during their attempt to fly around the world in a balloon.[5]
Telemedicine is not just for those seeking lofty goals or technologically adept physicians. A mobile telemedicine platform was employed by the U.S. military in Bosnia. Because there were radiologists, orthopedists and other specialists in the United States to immediately address soldiers' illnesses or injuries, soldiers did not need to evacuate to Germany.[6] Patients can effectively now 'dial a treatment'. Telemedicine promises to save lives, improve the quality of medical services, increase access to treatment and even control the skyrocketing costs of health care delivery. In fact, telemedicine is a mechanism to address health care delivery issues that plague the United States. If the goals are quality, access and curtailing costs, telemedicine is one part of a complex answer. And yet, with health care costs escalating, society struggles to realize telemedicine's promise.
Quite simply, telemedicine symbolizes and catalyzes the clash between the reality of our legal and political approach to health care and the American dream of bringing health care to all patients. Telemedicine, like our health care delivery systems, is regulated by many layers of government. Unlike other issues, telemedicine cuts through and challenges the traditional controls of access and cost. As such, telemedicine is a microcosm of our health care delivery system and a lens through which one may analyze the obstacles to access in the current system. This article examines these issues, proposes that telemedicine's goal should be to improve quality, access, and, costs for the American patient, and offers suggestions for obtaining these goals.
In the past five years, professional, governmental, and private organizations' interest in telemedicine has grown exponentially. Although telemedicine is still in its infancy, the technology driving telemedicine continues to advance more rapidly than the laws that apply to its use. Three main issues remain unresolved: (1) who controls quality; (2) how patients gain access; and, (3) who pays for that access? The combination of innovative application of technology and the regulated world of medicine, governed by our unique political landscape, compels us to examine and resolve issues relating to quality, access and costs.
Over the next five years, we are poised to spend over $100 billion on telemedicine and other emerging information technologies.[7] For this investment to pay off, the current framework for regulating telemedicine must be replaced with one that facilitates the delivery of these services.[8] Those seeking to deliver telemedicine must contemplate cost, access and quality, and must pay particular attention to the best interests of the patient.[9]
Although telemedicine has been heralded, it has also been criticized,[10] both for advancing too quickly and for moving too slowly[11], for taking on too much, for not taking on enough and for adding costs to health care. The telemedicine subject has raised a plethora of questions. This article will examine those questions in the context of our legal, regulatory and political/ethical framework. Part I defines "telemedicine" and "telehealth," and explores current and future applications. Part II addresses regulation of quality and focuses on licensure, credentialing, and malpractice actions. Part III considers access and the regulatory monitors of telemedicine: the Federal Communications Commission ("FCC"), the Food Drug and Cosmetic Administration ("FD&CA") and Health Care Financing Administration ("HCFA"). Part IV focuses on the cost of telemedicine, including funding and payment systems for telemedicine delivery services, and suggests guidelines that should provide fiscal support for telemedicine projects. Part V discusses current federal, state and private telemedicine proposals and suggests model approaches for achieving access, quality and cost objectives. Part VI suggests that telemedicine is a means to improving medical treatment. To that end, this article proposes solutions that will drive telemedicine toward improved quality and access for our entire health care delivery system.

Telemedicine can be described as the use of electronic communication and information technologies to provide or support clinical care at a distance.[12] This simple definition is used throughout this paper. Today in the United States, telemedicine is being used in academic medical centers,[13] community hospitals, managed-care companies, and in rural hospitals.[14] Telemedicine is also being used internationally to link providers in developing countries to hospitals in the United States and Europe.[15] Advances in digital communication, telecommunication, and the Internet[16] introduce an unprecedented opportunity to remote access to medical care.
Telemedicine is currently employed in patient care, professional and patient education, research and public-health applications.[17] It has been applied and studied in rural and city environments, by the public and private sector. It is being used in space,[18] on the prairies, on mountaintops[19] and under the sea, domestically and internationally,[20] on the battlefield[21] and in peacetime.[22] It is used in triage[23] and post-surgically,[24] by generalist and specialist alike, for home and clinical care. Telemedicine providers are expanding and cover the entire spectrum of health care practices, from cardiology to trauma medicine, from dentistry to toxicology, and from gynecology to ophthalmology.[25] Telemedicine now and in the future will include the full panoply of health related fields, from administrative services to utilization review,[26] from child-abuse assessment to home health care.[27] Other applications include back-up coverage for physicians, continuing medical education, disability evaluations, home health care, nursing care,[28] pre-operative meetings with patients, quality assurance, remote proctoring, utilization review and consumer education.[29] Care through telemedicine is being provided at home,[30] in prisons,[31] at VA hospitals, in urban settings and in rural areas, in acute and long-term facilities, and by medical specialties and nurses.[32] As technology revolutionizes the communications industry, clinicians' lives will be transformed as well. Specific examples of current applications include: physicians who answer patients' questions through on-line information services; consultation via electronic mail between patients' primary care physicians and tertiary care specialists; linking data systems for evaluations of CT scans or radiology studies; and real-time examination, treatment and diagnosis through interactive television and emergency centers where physicians and/or nurses remotely evaluate patients' symptoms and recommend an appropriate course of action.[33]
By far, the greatest financial supporter of telemedicine has been the government, either directly, or through financial support to hospitals or medical centers. At least thirteen federal agencies and many states provide funding, grants and reimbursements for telemedicine program development.[34] There are reportedly over 150 telemedicine projects being conducted in over four-fifths of our states, involving well over 5000 patients.[35] Telemedicine is widely used by the military-to improve quality and access, and to reduce costs. The Department of Defense has developed battlefield and peacetime telemedicine applications. One of the uses is a "reality helmet" that allows combat medics to communicate with physicians during the critical minutes after a soldier is wounded and before the soldier can be brought from the battlefield. A handheld device monitors the vital signs of the wounded.[36]
Recently, home telemedicine has been growing. A company in the midwest is using telemedicine to provide home health care. A two-way video interaction system, using the existing telephone system, is installed in the patient's home and run through regular telephone lines. The patient and the health care provider can communicate, and the system provides blood pressure, pulse checks and like medical information.[37] Further, telecare often supports video telepharmacy. Pharmacists are able to dispense medication at physician's offices, rural clinics, nursing homes and assisted-living facilities "with just the touch of a button."[38] Telemedicine is a tool that provides enhanced care to rural patients-improving access and the quality of care.[39]
Telemedicine brings promises of reduced health care expenditures,[40] improved cost-monitoring, encouraging better record keeping, and augmented access to quality care.[41] It provides access to health care services by bringing care to the patients, increasing patient understanding of their own health issues, and permitting patients to examine their own health data. In addition, there are promised improvements to the health professional's role by increasing local medical self-reliance, diminishing the sense of professional isolation, expanding educational opportunities for health care providers and offering the potential to reduce malpractice insurance. There are benefits to the community in, for example, permitting nurses to provide greater assistance in the delivery of health care, reducing hospital stays, and in the potential for greatly improved epidemiological studies provided by telemedicine.
As the need for home health and long-term care grows, telemedicine will provide the opportunity to deliver care to those in need who otherwise might not receive care. For example, telemedicine is being used in correctional facilities, and its use shows great potential for further expansion. Other areas, such as hospices and schools, provide testing sites for telemedicine to bring care to patients, reducing the costs of travel without compromising the quality of care.[42] A hallmark of "distance medicine" is that it gives access to care for areas that are medically underserved, or for people that have been traditionally underserved. Medical hospitals such as Texas Tech and the Medical College of Georgia have employed telemedicine to link physicians with patients and other physicians located in remote areas.[43] In many states, physicians are evaluating state prisoners through the use of video-conferencing. In the prison context telemedicine has the additional benefits of reducing traveling time for physicians and minimizing security risks.
Regardless of telemedicine's potential, significant regulatory and policy barriers threaten to disrupt the development of distance medicine. These barriers include reimbursement limitations and uncertain funding, cumbersome credentialing requirements, legal liability uncertainties and malpractice exposure, unclear data on cost-effectiveness,[44] and a lack of uniform national practice standards and telemedicine standards. Additionally, telemedicine has neither practice guidelines nor measurement criteria, and scant information exists regarding clinical efficacy. There is even debate in the medical community regarding telemedicine's direction and infrastructure.[45] As a result, telemedicine is being legislated, regulated, studied,[46] reported, journalized,[47] conferenced, advanced, propounded, debated, bibliographed,[48] and webbed.[49] Telemedicine is being researched and piloted, both on small scale and large commercial endeavors. Telemedicine is the subject of multi-government laws and laws in waiting. However great telemedicine's promise, its full potential to address issues of quality, access and costs are imperiled by the lack of a strategic plan.[50]
With all the promise that telemedicine brings to the treatment of the remote patient, or that the remote physician brings to the patient, telemedicine, is, in itself, an oxymoron. Potentially, it is one more tool in "distancing" the patient from the caretaker and a series of events culminating in taking the physician yet another "real" distance from his ward.
Not long ago, the patient's relationship with his doctor was not merely clinical, but personal as well. This relationship was built at the bedside, not on the "public" operating table. There weren't any intermediaries, or providers, or insurance forms. Since that time, health care has changed and many more parties are involved in the delivery of services: the federal and state governments, insurance companies, Medicare, Medicaid, managed care, and the litany of HMOs, IPOs, PPOs, MSOs-providers of care in every size, shape and form. The patient, once the sole focus of the doctors' attention, now must navigate a new regulatory course to obtain the very treatment sought. With the need to reduce health care costs, and improve access, the patient is, de jure and de facto, further distanced from the physician. In fact, many physicians are torn between their regulators and the person they have sworn to treat. Telemedicine, used initially and primarily in rural areas, holds the promise of reuniting the doctor to the patient.[51] If indeed this is telemedicine's promise, the telemedical community should not lose sight of its axiomatic principle: to bring health care to the patient by bringing the physician to his patient.
The physician, however, is only "virtually" present with the patient. Telemedicine, for all of its potential glory, could, in its application, have a dark side. Although telemedicine is viewed as a panacea for the ills of the underserved, there is the potential that telemedicine will not be used to augment the quality of care to the underserved, but to provide a minimum care from a distance in lieu of care that should optimally be provided in person; e.g. that telemedicine could be employed as a cheaper method to provide the least-necessary care, and in the name of improved access, deny the quality of care to a population that both needs improved quality the most and would ordinarily not be able to get the best care by the best physicians. This underserved population, e.g. the homebound, the prisoner, the elderly, the inner-city populous, need to be protected from potential abuse in using telemedicine solely for the purpose of saving costs.
What, then, are the key legal, regulatory issues posed by the telemedical care? First, to address issues of quality, each state should allow its medical licensing authority to require that any physician practicing "distance" medicine on patients in the state obtain registration from their licensing board. The board should require distance providers to meet minimum practice standards.[52] Enforcement of this requirement would be a matter of comity among the states. For example, California deems it "unprofessional conduct" for a California physician to practice telemedicine into another state without satisfying legal requirements set forth for practice by that state.[53] The states should coordinate credentialing requirements with other states. In addition, each state should coordinate a plan with JCAHO[54] and NCQA[55] to set telemedical credentialing standards in an effort to reduce the burden of obtaining credentials in each location where a remote physician practices. Second, physicians should always obtain informed consent of the patient. With respect to the telemedical practice, this should include the benefits, the risks, and the option of not participating in the telemedical consultation.[56] Third, to protect the confidentiality and privacy of the patient's telemedical treatment, the federal government should set minimum standards requiring: (1) the telepractitioner to obtain the patient's consent before transmitting any information electronically; (2) regulatory protections to deter any violations of confidentiality or invasions of privacy; and, (3) patient access to his or her records-especially records of studies regarding treatment and the disclosure of the risks associated with particular telepractice. Guideposts for regulatory measurement should be thorough and should comprehensively protect the patient's rights. For the most part, current laws, although prolific in this area, do not address the panoply of issues facing the telemedicine practitioner and patient.

Telemedicine today is the confluence of a number of areas, with most of the laws, regulators and professionals sharing the principle that telemedicine's end should be to improve the public good. First, it is widely-held that universal health care is a worthwhile goal, and professionals in the health care field are striving to see that all citizens, regardless of their socioeconomic class, or geographic location, have access to quality health care. Second, federal and state governments are attempting, through a variety of laws, to promote more efficient health care and to remove unnecessary barriers to delivery of services. The Telecommunications Reform Act of 1996 reflects the government's aim to provide this access.[57] Many of these ends can be furthered by telemedicine, but telemedicine has barriers preventing universal acceptance.[58] Three regulatory questions dominate this area: (1) licensure, credentialing, and liability; (2) access concerns, including standards for use, confidentiality, privacy; and, (3) economic issues, reimbursement for services, funding and cost effectiveness. Although telemedicine is just one of many health care systems designed to improve access, it provides a model for examining the necessary means for universal access.[59] As is the case in any circumstance involving the use of innovative applications of technology in the regulated world of medicine, the advancement of telemedicine applications will require resolution of many issues, including resolution of many parochial barriers that have been raised.[60] These barriers are often raised to protect the entrenched medical professionals, and fail to put the best interest of the patient first.[61]
In order to understand what action plans may be most successful for the optimum regulation of telemedicine, it is important to track the current laws and plans. The federal government has contributed millions of dollars to telemedicine projects. In fact, many existing state projects depend on federal dollars. But the licensing of telemedicine is controlled at the state level. Although there are some federal laws that facilitate delivery of telemedicine, those laws primarily allocate and release funds to support telemedicine delivery systems and provide reimbursement for services. Each state has either created a telemedicine-friendly environment to facilitate the use of telemedicine or an environment that barricades telemedicine from its borders. After looking at the pieces that make this montage, it is easier to identify the real leverage points to ensure that the best interests of the patient are addressed by those who both have the authority and power to take action.[62] In this section, I will first examine the current applicable laws relating to telemedicine, both federal and state. Next, I will set forth the barriers and checkpoints for telemedical applications-licensure, credentialing laws, as well as the checks on quality delivery-and the potential liabilities.

Within the last two years, three major federal laws were enacted which directly influenced telemedicine.[63] The first, the Telecommunications Reform Act of 1996, requires the FCC to assure that health care providers in rural areas have access to telecommunications services at rates comparable to those found in urban areas.[64] The Telecommunications Reform Act speaks to the availability of communication services as a vehicle to provide health-delivery services impacting telemedical services.
In the Telecommunications Reform Act, Congress updated and clarified the notion of "universal service" first articulated in the Communications Act of 1943.[65] In enacting this legislation, Congress required the FCC to ensure that rural healthcare providers have access to telecommunications systems necessary to deliver services at rates comparable to those offered in urban areas.[66] Health care providers, schools and libraries are to have early access to the benefit of advanced telecommunications. As such, Congress gave special consideration to health care providers in rural areas, maintaining that rural health care providers were to receive subsidies to the extent their rural rates were higher than urban rates. The Act defined advanced telecommunications, mandated the FCC institute a Federal State Joint Board, and the FCC was charged to enhance access to "health care providers."[67] Under the law, states are authorized to develop their own definition of services which improve health care delivery. Moreover, states are to encourage the deployment on a reasonably and timely basis of advanced telecommunications capability to all Americans. What this means for telemedicine is yet to be seen but the Telecommunications Reform Act certainly lined the potential wires with gold. The door is open for health care advocates to suggest, develop and deploy advanced telecommunications networks. Most importantly, the FCC authorized the use of up to $400 million each year to help subsidize improvements to rural providers and telecommunications networks and charges for telecommunications services. These funds will provide toll-free access to the Internet, cover long-distance charges of rural healthcare providers using telemedicine applications, and subsidize other telemedicine projects.
The second major reform was the Balanced Budget Act of 1997.[68] On January 1, 1999, the Secretary of Health and Human Services began making Medicare Part B payments for certain telemedical consultations provided to Medicare beneficiaries residing in underserved rural areas. The Secretary is required to establish a methodology[69] for determining the amount to be paid for these kinds of consultations. The subsidy will be shared between the referring physician or practitioner and the consulting physician or practitioner.[70] The Secretary is to report to Congress with an analysis of the manner in which telemedicine and telehealth systems are expanding access to health care services, the clinical efficacy and cost-effectiveness of telemedicine and telehealth services, the quality of the services, and the reasonable costs of the charges relating to telecommunications in these specific rural, frontier and under-served areas. In addition, the Secretary is required to provide a report to Congress, discussing the possibility of expanding reimbursement to areas other than the rural and underserved. The Secretary is to look specifically at providing Part B Medicare coverage for telemedicine services for beneficiaries not located in the designated areas but who are nonetheless homebound and for whom transfer to a care facility would impose a hardship. The Secretary's report must include information regarding the potential costs and savings to Medicare.[71] The Secretary is also to fund a single, four-year demonstration project to use "eligible" health care provider telemedicine networks to improve primary care, and to prevent health care complications to Medicare beneficiaries with Diabetes Mellitus who are residents of these medically under-served rural or inner-city areas.[72]
The third major reform occurred with the Food, Drug and Cosmetic Act. The FDA already regulates medical devices, but the FDA has provided notice that telemedical devices-both hardware and software-are under the jurisdictional arm and regulatory authority of the Food and Drug Administration.[73] FDA, although not regulating the delivery of health care services, regulates technologies associated with health care delivery. The provisions of the law that are most likely to impact telemedical delivery services are the risk-based regulation of medical devices and the standards for medical products, which include DRGs and related devices.[74]

The federal regulatory scheme provides the framework to view the national boundaries of telemedicine application. The actual building of telemedicine programs and applications is both being legislated and built at the state level. On the state front, telemedicine activity has taken place in some form in every state with the possible exception of Rhode Island.[75] Many states have recently established and coordinated efforts. For example, in California and Kansas professional self-regulation and the governmental regulation of licensure and professional requirements are intertwined. For many reasons, licensure requirements have been designed by the states and are, in fact, delegated to the states as part and parcel of the states' police power. Part of this is historical in nature, part of this is because of the recent trend to decentralize government power to the states, and much of it relates to the growth of the medical profession and the manner in which it has developed. The licensure requirements and credentialing processes are based upon standards that have been developed by the medical professionals. Although under the auspices of the state government police power, the "policing" of the practice of medicine is in the physician's control. Medical boards, the licensing bodies, and even disciplinary panels are usually made up of medical professionals.

Licensure is a state-based patient protection system.[76] Since telemedicine poses, by its very nature, the probability that medicine will be practiced across state lines, state cooperation or federal regulation must be considered.

Throughout this country's history, states have been the gatekeepers of medical licensure.[77] Today, every state in the United States has laws and/or regulations that set forth strict requirements to be met before any physician, nurse, dentist or other "health professional" may hold themselves out, and legally practice, that profession within the borders of that particular state.[78] State licensing statutes require a physician to be licensed in the state in which the physician is practicing medicine. When a physician in a state renders telemedical services to a patient in the same state, there is usually no additional requirement for a license. But once the practice of telemedicine extends beyond the state line, licensing issues become more complex. There are several permutations to this "regulatory locus" problem: the patient may be located in a state different from the state in which the physician is located, the physician may be in the same state as the patient but consult with a physician located out of state, or the patient, physician and consulting physician may all be in different states.[79]
Within the last five years, states have begun to enact laws that specifically address telemedicine licensure. States adopt a variety of approaches. First, telemedicine laws sanction liberal interstate practice of medicine. Second, telemedicine practice might employ existing statutory frameworks that provide limited exceptions, including consultation with out-of-state practitioners. Finally, other states prohibit the practice of medicine by a telepractitioner outside the states borders.
Only four states do not provide for out-of-state consultation exceptions.[80] The prerequisite for the "consulting exemption" is that the physician located within the state is the treating physician. In many instances, the limitation imposed on the exemption assures that the outside consultant will not have the authority over the care of the patient being treated within the state.[81] To assist physicians in seeking medical expertise from other physicians out of state, most states have created exceptions to the general rule and permit some form of consulting exception. Until recently, most state statutes did not offer "protection for an out-of-state clinician unless a consultation is requested by or otherwise involves an in-state clinician."[82] In Massachusetts, for example, the licensing requirements do not apply to "a physician or surgeon resident in another state who is a legal practitioner therein, when in actual consultation with a legal practitioner of the [C]commonwealth."[83] This exception to the rule has limitations, as interpreted and thus, the "consultation" exception only applies if the out-of-state physician provides a Massachusetts' patient with a teleconsultation, and, if the out-of-state physician "is consulting with a Massachusetts physician of the same specialty."[84]
Instead of providing more "license" to encourage telemedicine practice, many states' physician licensing boards have placed even more restrictions on consultations, making routine telemedical consultations impractical if not impossible.[85] By limiting the number of consultations an out of state physician may provide without first obtaining a license from the state, by limiting the number of days or type of consultation that may occur, or limiting the state or the locality of the state in which the consultation may occur, states have closed the door on the practical application of "telemedicine."[86]
Strategies to address telemedicine vary from state to state, but most states that have addressed the issue of telemedicine have also addressed the issue of what telemedicine means to their definition of the "practice of medicine." At the end of 1997, at least 15 states [87] had addressed the need to amend or enact new legislation, one state had written an administrative rule addressing out-of-state licensure and another had the Attorney General issue an opinion on the subject.[88] To alleviate the burdens on physicians created by the licensure process, most states have carved out exceptions to the rule requiring a "license" to practice medicine.[89]
Some states, recognizing they may be losing some of their physicians to other states on a regular or consultative basis, have taken the position that they would, in effect, burden access to other state's practitioners.[90] Other states, such as North Dakota, have mandated the study of the use of telemedicine and what is needed for licensing changes.[91] Still other states, such as Illinois, have directed its state health department to study the feasibility of using telemedicine for both rural areas and patients that are homebound.[92] There are a few states that have not fully determined a stance on the licensure issue but have had conferences and/or bills proposed regarding their policy.[93]
In a minority of states, legislatures have restricted consultations, making routine telemedical consultations impossible.[94] These states limit the number of consultations that can occur without obtaining a local medical license, or limit the number of days that consultations occur, or limit the consultations to physicians practicing in bordering states. In a few states, the consultation exemption has been eliminated and the laws now require than any consultation occur only with a physician licensed by that state.[95] A number of states have reduced the existing burdens of individual state licensure by expediting the licensure process. South Dakota and Tennessee have allowed for reciprocity for the practice of telemedicine providing the other state's requirements are not less stringent than theirs. New Mexico has allowed telemedicine licensure by endorsement if a physician otherwise meets the requirements of New Mexico's laws.[96] Finally, Alabama and Tennessee have adopted restricted or special licenses.
State licensure has worked well for many years to regulate physicians. This system delegates to the states the power to adapt their regulations to the needs of their constituents, and gives wide latitude to make changes that will best serve their local needs. On the other hand, to the patient who is in need of a specialist located in another state, to the telepractitioner that cannot obtain a consultation because state laws prohibit the practice of medicine within its boundaries by those not licensed in the state, or to the hospital located on the border of a state with specialized needs located in its sister state, state laws can impede the telepractitioner's practice-in terms of time, expense and licensure requirements.[97]

Notwithstanding the government's interest in promoting telemedicine, many state licensing laws for physicians inhibit telemedicine's full realization.[98] Commissions and professional associations, recognizing that licensure is a key area that needs to be addressed, have proposed a variety of suggestions to remove licensure as a barrier to the practice of telemedicine.[99] Private organizations reflect the tensions between established regulatory systems and emerging reforms, disagreeing over which body-federal or state- deserves primary regulatory power in this area. A Telemedicine Report to Congress suggested that although there is a strong presumption against state preemption, states would have to give way to paramount Federal legislation.[100] As a California Commission suggested, the state adopted a license that permits consultants to practice within the State of California, but the ultimate decision making power rests with the patient's California doctor.[101] The Western Governors' Association has recommended a task force to draft a Uniform State Code for Telemedicine Licensure that would be similar in principle to the Uniform Commercial Code.[102]
The medical societies that have addressed telemedicine issues hold fast to the concept of self-regulation, and although professional organizations have come to a variety of proposed solutions, none espouses a national licensure scheme as proposed by the Telemedicine Task Force.[103] The American Medical Association has examined the interstate[104] licensure issue, and recommends that all physicians be fully licensed in every state where their patients are located and/or where they practice medicine.[105] Likewise, the American College of Radiologists recommends that telemedicine physicians maintain residential licenses in addition to remote state licenses.[106] However, the Federation of State Medical Boards, which in the past had opposed national type legislation, has drafted model legislation that if adopted by states would move a step in between and create a special license for physicians. This approach would eliminate the necessity for a license in every state where the physician might practice telemedicine. In 1996, in response to telemedicine issues, the Federation of State Medical Boards developed this Model Act to regulate medicine across states lines. The Act, as proposed, requires physicians practicing medicine across state lines to obtain a special license issued by a state medical board. The license would be limited to those practicing medicine across state lines, and would be required for regular or frequent telemedicine practitioners. It would exempt a physician who engaged in practice across state lines in an emergency.

Most states that have not enacted statutes directed at telemedicine do have telemedicine bills pending under the following rubrics: individual state, interstate, model act and national licensure proposals. This nomenclature, although somewhat forced, provides a spectrum to look not only at the variety of approaches to regulating the quality of care, but the policy issues driving those approaches.

Most states, recognizing that special licensing issues are required to further telemedicine, bring telemedicine within their existing "practice of medicine" definitions. California and Mississippi, for example, have expanded their definitions while maintaining exclusive control of medical regulation. [108]California's approach, granting its Medical Board the authority to develop a registration program that would allow out-of-state physicians to provide telemedicine services to California residents, provides a broadened acceptance of the telemedical practice, and simultaneously, addresses quality control over its patients. Most of the laws and legislative proposals require a special license providing for telemedical services, but make exceptions for consultations, educational demonstrations, lectures and emergencies. The California approach, however, is atypical as most states continue to regulate only those physicians practicing within their borders. In fact, the individual state license is the approach endorsed by the American Medical Association (AMA). The AMA's House of Delegates has urged that physicians be licensed in every state where their patients are located.[109]

The interstate licensure model has been proposed by one state compendium, the Western Governors' Association. It takes a number of forms: a multistate licensure system, mutual recognition, a uniform interstate licensure system, or interstate compact. State licensing bodies would provide consistent licensure requirements and allow physicians to qualify for practice in other states without duplicative examinations and repetitive application costs. As proposed by the Center for Telemedicine Law White Paper, this system would define which law will govern the conduct of a physician, who practices across state lines, and who holds a license in both states. The physician would not be subject to the requirements of separate and inconsistent state laws. Or, as proposed by the National Council of State Boards of Nursing, registered nurses licensed in one state will be able to practice in any state that adopts the compact, provided they follow the laws and regulations of the state in which they are practicing. Under this system, the licenses are recognized in multiple states, facilitating telepractice, but each individual state has the authority to set its own educational, behavioral and competency requirements. This approach has the advantage of placing the responsibility on the physician to comply with the state laws, and vests each state with the authority to enforce its laws. However, for the telepractitioner specialist needed in many states, or for the telepractitioner practicing in numerous jurisdictions, interstate licensure could be burdensome.[110]

In April of 1996, the House of Delegates of the Federation of State Medical Boards ("FSMB") proposed model legislation known as the "Model Act."[111] The Model Act suggests a "special purpose license to practice medicine across state lines upon application for the same from a person holding a full and unrestricted license to practice medicine in any and all states . . . in which such individual is licensed, provided there has not been previous disciplinary or other action against the applicant by the state or jurisdiction." Although no state has endorsed the Model Act in total, several state medical boards have endorsed provisions of the Model Act,[112] and some states have, unsuccessfully, proposed implementation of the Model Act.[113] The Model Act has been criticized by the Western Governors Association, the Mayo Foundation, and the American Medical Association because its provisions are too broad.[114]

A national licensure system would eliminate state licensures and replace them with a national-level licensure.[115] Arguably, Congress has the authority to regulate this type of activity since it has a substantial effect on interstate commerce.[116] Although there has been much discussion regarding a national license, and many scholars, especially telemedicine proponents, favor such national licensure, there is no evidence that sufficient support exists for such a scheme. In fact, the Western Governors are "loath to cede this authority to Washington, D.C., when state leadership and cooperation among other interested parties could help to alleviate the licensure burden placed on physicians and patients in a telemedicine context."[117] There are a number of arguments that compel moving to a national licensure system, and equally, a number of arguments that disfavor moving to such a system. Each of these will be examined from a quality of care perspective, with the focus on what ultimately will serve the best interests of the patient.
First, a national licensing system would remove the current barrier that states use to keep out-of-state physicians from entering their state.[118] Second, state licensure limits networking because such requirements limit interstate networking capability.[119] Third, educational and professional competency requirements for an initial state medical license are now more standardized.[120] Every state requires that licensed practitioners graduate from an accredited medical school and pass a national test, the United States Medical Licensing Exam.[121] Fourth, there is now the National Practitioner Data Bank that collects, on a nationwide basis, information about physicians, including licensure matters.[122] Fifth, there is a track record of proving a national system will work, as the federal government funds a great part of the telemedical practice and has been using national licensure for many years.[123] Sixth, national licensure should not pose problems because the federal government clearly has the authority to regulate the medical professions, and has exercised this authority by setting standards in many other areas of health care.[124] Seventh, there now exist coordination efforts of telemedicine programs by the Joint Working Group on Telemedicine (JWGT),[125] including the JWGT's urge to consider a national licensure system.[126] Last, such a system would require uniform standards, as well as a centralized system coordinating physicians data, and would permit physicians to practice in any state without the necessity of obtaining a license in every separate state.[127]
A national system, however appealing in theory, may not be the best practical solution or even the best solution for assuring patients obtain the best quality of care possible. First, a national license does not have the support of all professional groups-this alone is a difficult obstacle to overcome.[128] Second, telemedicine is young. Consensus does not exist on what exactly should be licensed, and by whom.[129] Third, regulation could cause more harm than good.[130] Fourth, licensure exists to protect the patient by keeping the gates closed to anyone who failed to meet the minimum qualifications necessary for entry. States have historically done an excellent job at policing, and there is no data to suggest a national system would work as well as the existing state systems.[131] Last, as our political climate warms to a national licensure system, progress is better ensured through voluntary state entry than by federal preemption and regulation. In fact, as states adopt telemedicine statutes and amend their licensing laws to reflect telemedicine practices, states incrementally move toward a model uniform approach. The energy put into flexible state approaches will protect patients, continuously adapt to fit the needs of the constituents, and simultaneously move toward the best "model" approaches.

The threat of a malpractice action is another related legal issue which impacts telemedicine's future use and the quality of health services provided to the patient.[132] Telemedicine offers tremendous opportunities to improve both the quality and quantity of healthcare, but may also exacerbate the potential for liability that would arise in more traditional settings.[133] Telemedicine practice challenges the already complicated issues and risks in traditional face-to-face medical settings. To protect the quality of this relationship, whether face to face or through high resolution video, fiber-optic cables, or other advanced imaging technology, we should look to the law of malpractice certainly as a deterrent but also as an indication of what protections should be put in place in the first instance to avoid potential questions of malpractice.[134]
The health care delivery system is in such turmoil that "default" regulation, i.e. liability actions, are also unresolved.[135] Outside of the federal government, telemedicine is in a nascent stage and, as such, no answers exist as to what "liability" may coincide with its use. More than 40 percent of telemedicine programs surveyed[136] have been providing teleconsultations for one year or less.[137] It usually takes at least 21 months following an alleged incident of an adverse outcome for a medical malpractice claim to be brought.[138] One of the reasons we may have so few reported medical malpractice cases relating to telemedical practice is that not enough time has elapsed for claims to have been filed.[139]
Malpractice liability is a potential concern in this relatively "new" health delivery model[140] and for that reason it is perceived as a major barrier to telemedicine's growth.[141] But in the absence of any liability theory's emergence, why are medical malpractice suits perceived as a significant barrier to telemedicine's growth? Quite simply, telemedicine may affect the quality of care and, especially since it is new, the use itself may lead to malpractice liability suits. The uncertainty of its practice, coupled with the fact that care will take place over a distance, may increase the likelihood of malpractice suits.[142] Telemedicine might also augment the potential for missing a signal or symptom that would otherwise be observed in a face-to-face encounter. Skeptics of telemedicine suggest that advanced technology might even mask symptoms that would be noticed if the physician and patient were in the same room, and, thus lead to the increased possibility of misdiagnosis. Other concerns relate to the potential for a mistake in the transfer of information, for dissemination to a third party or loss of the information in the technological transfer. There is, however, no empirical evidence of malpractice claims increasing as a result of telemedical practice.[143] It may be that telemedicine practice will reduce the likelihood of malpractice by bringing care to the patient who might not otherwise have healthcare.[144] Moreover, pragmatic barriers develop: since telemedicine is new, the risks are unclear, and unclear risks cost more to insure.[145]
Another concern to be addressed is whether the practitioner has formed a physician-patient relationship via telemedicine. Medical malpractice cases generally recognize that a physician's duty to a patient is predicated on the existence of a physician-patient relationship. The telemedicine encounter would not change this underlying question, but may complicate the parameters of establishing whether a duty of care has clearly been established. Generally, courts have considered whether the physician has met the patient, examined the patient, reviewed the patient's records, knows the patient by name and was paid for services rendered.[146] A number of courts, wrestling with this issue in the non-telemedical context, indicate that the physician-patient relationship will exist and evolve whether the meeting is in person, telephone or optic image.[147] Generally, courts will find a physician-patient relationship even if the physician has had only brief telephone contact with the patient. In Bienz v. Central Suffolk Hospital, a New York court held that it was a question of fact whether a physician-patient relationship existed, and refused deem a telephone call to a physician's office to initiate treatment insufficient to form a physician-patient relationship.[148] In a Texas case, the court found a physician patient relationship existed between a pathologist and a patient where the pathologist had examined a biopsy slide of the patient, but had never actually met the patient.[149] The latter situation is indicative of what courts could find in a telemedical context where the physician has established a relationship with the patient even though the two have not met face to face.
After establishing the existence of a physician-patient relationship, another question is whether the physician has met the applicable standard of care during the course of treating the patient. Assuming a virtual relationship exists, there will be no liability if the physician or consulting physician has met the applicable standard of care.[150] In the telemedical context, the standard of care owed to the patient must begin with an analysis akin to medical malpractice questions in the non-telemedical context. Medical practice standards of care are "not normally established by either judge or jury."[151] The medical profession establishes the standards of practice; and the courts enforce the standards in a medical malpractice setting.[152] The recognized standards for determining a physician's negligence have been the "national standard" and the local, regional or "community standard." This latter standard or custom of practice by those in the physician's specialty is usually established through expert testimony. The standard of care, by which the conduct of the physician is measured, requires the trier of fact to find that the injury to the patient was caused by a failure to exercise the "required degree of care, skill and diligence" under the circumstances.[153] More and more, courts employ a "national" standard, so the impact of the exact locality of the physician and patient should not impact the outcome. The question, more likely than not, will focus on the physician's knowledge, skill and treatment regime regardless of location. Thus, telemedicine's advent compels jurisdictions toward a national standard of care. For some time, information and consultation have been available via a telephone line, and information regarding where the specialists might be found is always available on the Internet.[154] Any reason to revert to the "local" rule is further diminished since specialists are usually board certified by national tests, rather than local. In Robbins v. Footer, the court found that a nationally certified specialist would be held to a "national" standard of care grounded upon the omnipresent nature of telecommunications.[155] As information becomes more available through medical databases and the Internet, the average physician likely will be held to a higher standard of knowledge. Although no court has held that a physician has a duty to check a national database, use telemedical contacts, or engage in a telemedical consultation, the ability to have "expert" advice instantly available will raise the bar of existing "duty" standards. Predictably, access to such databases will diminish the role of the "locality" rule, augment the use of the "national" standard, and, most likely, establish a higher standard of care bar so that physicians will be required or expected to find readily-available information through existing databases and the use of accessible experts and data. Although not decided in the telemedical context, this standard will allow evidence demonstrating the resources under which the particular physician operates. In Hall v. Hillbun, [156] the court stated:
The duty of care . . . takes two forms: (a) a duty to render a quality of care consonant with the level of medical and practical knowledge the physician may reasonably be expected to possess and the medical judgment he may be expected to exercise, and (b) a duty based upon the adept use of such medical facilities, services, equipment and options as are reasonably available.[157]
Courts following Hall will allow the trier of fact to consider the resources available to the physician, including the facilities, staff and other equipment available in the environment in which the physician practices. For instance, the rural or country physician traditionally was not expected to have the same access to facilities, knowledge or equipment as the city physician.[158] With instant access to information through technology and the availability of distance medicine, the country physician may be able to have access to a host of resources otherwise unavailable.
As telemedicine develops further, the appropriate standard of care is an area that could be better defined by the development of practice guidelines.[159] Defining guidelines will assist physician, patient and regulator alike. A national spokesperson on telemedicine has suggested that of the various legal barriers to the furtherance of telemedical delivery systems, there are "several vexing legal issues that may impede wide adoption of telemedicine by the medical profession" and suggests, with respect to the litigation process, that the set of issues may be "more amenable to amelioration, if not prevention."[160] Sanders suggests that "the most effective approach is the development of practice guidelines for telemedicine, including standard clinical protocols and professional norms of conduct governing clinical encounters."[161]
Whether the risk for potential lawsuits would increase or decease, standards or professional codes of telepractice would assist both physician and patient alike. Actions that telepractitioners could agree to take before practicing "telemedicine at a distance" would inure to the best interest of the patient and, prophylactically, reduce the likelihood of any later lawsuits. Toward this end, there should be full disclosure of the telemedical transaction to the patient. From the patient's standpoint, guidelines addressing what constitutes a "telepractice" would both address concerns the patient may have and, at the same time, provide a solid basis to avoid, as much as possible, any misunderstandings and resulting potential liability.
These guidelines or telemedical codes of professional conduct specifically should address communication between physicians, clarify the roles of the consulting and treating doctors, and provide for disclosures of any conflicts of interest. Additionally, such codes of professional conduct should provide for agreements regarding reimbursement and payment, as well as detailed conditions addressing confidentiality of physician-patient relationship, security, informed-consent requirements and the substantive proposed teletreatment process and options. Since application of the standard of care will depend upon not only the physician's duty to his patient, but many attendant issues relating to the coordination of consulting physicians, ancillary equipment and the proper communication among the treating practitioners, guidelines or codes of professional practice will provide a checklist for physicians to follow. Hopefully, these guidelines will not only help the physicians provide certain basic, minimum information to the patient, but also will reduce practice variation in the telemedical context. Such practice guidelines would provide a base upon which physicians would be able to share "best practices," thus continually improving the process of the practice of distance medicine and concomitantly reducing the margin of error in the practice.[162]
Yet another concern involves the location where an action may be brought. In the traditional face-to-face physician-patient relationship, the forum in which malpractice actions arise was the court of the state in which the diagnosis and treatment occurred. In a situation where the treating physician, the consulting physician and the patient are located in different states, there will multiple forums in which a malpractice action may be brought. As telemedicine becomes more and more commonplace, this area could develop through litigation in the various potential forums-allowing the relevant courts to answer this choice of law question. In this traditional approach, the courts develop the law on a fact-sensitive basis. Today, physicians who practice telemedicine could be subject to the jurisdiction of a patient's state. Physicians usually will have had the "minimum contacts" with the state in which their patient is located unless the court finds that the physician's presence was only "casual" or "isolated."[163] Conflict-of-law principles generally have provided that jurisdiction will be in the state in which the injury occurred and the state that has the greatest connection to the injury.[164] Plaintiffs usually have sought their own local court systems for the simple reason that their courts are convenient and familiar to them. In the telemedical context, it can be foreseen that a plaintiff, having a choice of forums in which to file an action, could shop around and bring a suit in which the awards are most likely to be the highest.[165] In discussing the issues of "multiple forums," the best interests of the patient have received little attention, such as when physicians should be subject to the jurisdiction of their patients' home states. The focus in the future must center on the patient. A number of reasons compel this position. First, physicians who practice telemedicine should be deemed to have the requisite "minimum contacts" with the state in which the telemedical consultation has taken place.[166] Second, jurisdiction over such a case usually will be found in the state in which the injury occurred and the state that has the greatest connection to the injury.[167] Third, the growing sentiment by many states is that their police powers may need to be stronger to protect the health and safety of their residents. States have approached this new arena in a variety of ways, and some states have defined statutorily what will be the jurisdictional reach if such telepractice takes place.[168] To the extent that these choice-of-law issues are anticipated, states could choose to legislate what will be deemed "minimum contacts" in the telemedical context. Such legislation would put both physician, providers, insurers and patients on notice.

A more feasible approach, however, involves providing informed consent because telemedicine is still new, it is often considered optional treatment rather than the first course of treatment. Whether it is optional or primary, it is unclear under what circumstances telemedicine will be used. Clearly, the patient will need to be advised of alternatives. Providing the patient with sufficient information regarding treatment options will enable the patient to make an informed decision. A patient cannot make a decision unless he understands what is involved in the procedure, how the procedure will benefit him, the risks and/or consequences associated with the treatment and the likelihood of these risks and/or consequences occurring.
The doctrine of informed consent is the duty to provide the patient with sufficient information regarding treatment and options that allows the patient to make an "informed decision regarding" the care. This doctrine was first legally recognized in 1914 and has been reaffirmed over the years.[169] Informed consent, grounded in both statutory and case law,[170] encompasses knowing not only what, when, and how the procedure will be accomplished, but the alternatives to the treatment.[171]
Telemedicine does not alter the physician's general duty to inform the patient about the intended care, but it actually may require a more regimented approach in advising the patient. As such, the necessity for informed consent may be of a higher order in a telemedical practice because some telemedical applications are still considered experimental or riskier than an in-person consultation or procedure.[172] On the other hand, the telemedical approach may provide the vehicle to obtain services and medical approaches that otherwise would not be available locally. There is no question[173] that communicating information regarding telemedical application will require, at a minimum, informing the patient of the diagnosis, the nature and purpose of the treatment, the risks and outcomes, and disclosure of the treating physician's skills and the skills available by another physician through the use of telemedicine, especially if the patient may be able to obtain treatment by a physician who has more expertise than available locally.[174] It is critical for the patient to understand any differences between the prognosis if treated locally and teleconsultation. Equally important, the patient should understand the consequences of not pursuing teletreatment. Even if a physician believes that the patient will be best served by a telemedical consultation or treatment, this is not a decision for the physician, hospital or the insurance company. The decision to use telemedicine, like any other treatment, should require the patient's consent. A right of refusal allows patients to control their own health care.
Since telemedicine may be perceived as a new method of providing treatment to patients, it is equally critical that the use of telemedicine be discussed and documented thoroughly.[175] In fact, California's telemedicine law mandates such a course of action.[176] The California approach is a piece of legislation that has been passed or is being considered in many states.[177] The California statute requires both written and verbal communication prior to the delivery of any telemedical care. In informing the patient, the physician should be certain to set forth that the treatment or consultation will be done via telecommunication. If the application is still considered experimental, either because the technology is new or because the procedure has only been performed face-to-face, then the physician should set forth any limitations, including any equipment limitations, risks of the treatment, and potential consequences.[178]
Just as in any face-to-face treatment, the physician should explain any alternate diagnostic options. Above all, the physician should discuss the confidentiality of the procedure. If persons other than the physician will be present, the physician should explain who they are and their roles in the treatment. Finally, the physician should identify the primary physician, the treating physician and the consulting physician.

As reflected by malpractice actions, there are no clearly demarcated lines between quality, access and costs.[179] Like the issue of quality, access must be viewed from a state and national viewpoint because there is no single controlling organization monitoring the progress and regulation of telemedicine. Three federal laws, passed within the last few years, impact telemedicine's future path. Two of these laws, the Telecommunications Reform Act of 1996[180] and the FDA Reform Act of 1996[181] govern entry to the marketplace. The FCC Act of 1996 promises to regulate access to information through telecommunication lines.[182] The FDA Act of 1996 regulates access by regulation of devices into the marketplace. The third, the Balanced Budget Act of 1997, provides the funds to ease telemedicine's path. All three of these federal laws combine to improve the public good and to assist telemedicine's entry to the health care system.[183]

Who is entitled to patient information, who must provide releases for that information, and who should have access to the information? In most respects all of these questions, and the attendant issues of privacy and confidentiality, are not unique to telemedicine. Telemedicine augments privacy concerns, however, because it promises to make common the transmission and storage of personal information. In the traditional patient-physician relationship, privacy and confidentiality were always an issue, but with telemedicine, the patient's records and medical history will be shared with the consulting physician, with two sets of staffs and possible technicians supporting the telemedicine system.[289] Although current mechanisms could be sufficient to hold every physician and medical provider accountable,[290] the traditional concepts of privacy and confidentiality are dramatically changed with telemedicine.
In the health care context, privacy has been protected by an ethical obligation of the health care provider to preserve the confidentiality of medical information, and as a legal right to privacy from the unwarranted use of personal-health information. Confidentiality "refers to a relationship (e.g. between patient and physician) that includes an expectation that personal information obtained as part of that relationship will be protected."[291] Both Reed Hundt, the former chairman of the Federal Communications Commission and Donna Shalala, the agency head of the Department of Health and Human Services, have openly criticized the lack of security and information standards relating to telemedicine, telemedicine systems, telemedicine information and the lack of systems to provide confidentiality and security safeguards in the use of telemedicine or telehealth technology and services.[292] Without appropriate privacy protections, telemedicine cannot be established as a viable treatment alternative.
A number of different confidentiality issues may arise as a result of telemedicine. There may be an improper disclosure, there may be either unauthorized access or an abuse of the information accessed, there may be identification of patients within the data aggregated, or there may be the problem of data integrity and authenticity.[293] Liability could arise in a number of different situations given the nature of the different types of breaches. Concerns exist relating to the ready accessibility to electronic patient information, the conveyance of video images, the presence of additional persons, the possible loss of control over the route of medical information, the integrity of electronic record keeping, and the potential for unauthorized access and disclosure of records. In many instances, leaked information on medical information could cause the loss of a job, the loss of reputation, and, potentially, the loss of health-insurance availability.
Traditionally, and with few exceptions, the issues of privacy and confidentiality, especially relating to the physician-patient relationship, are matters the federal government left to the states. Issues of patient consent, provider confidentiality, and overall security of telemedicine information encompass not only medical histories and records, but image transfers, electronic information stored in the computer, and the security of the data stored.
Unlike many other countries, the U.S. has the barest threads of common law and no encompassing federal statute, nor any visible, or feasible mechanism to address the complicated issues raised by the burgeoning area of telemedicine and telehealth.[294] The issue hasn't been addressed for lack of notice, or lack of debate, but rather more of a paralysis of what should be done and who should be in charge.[295] Debates rage over whether federal regulation of telemedical privacy is appropriate, whether an optional uniform model statute would work, and whether privacy is further threatened by the potential implications of international telemedical practice.[296] Whether in the name of federalism or states' rights, virtually no consensus has been reached on what should be done.[297] Most state laws do not address issues of privacy and confidentiality of medical records within a single statute, but rather states affirm a right to privacy and confidentiality through a web of statutes, regulations and policies. In many states, as in a web, there are gaps and sometimes overlapping laws.[298]
Other substantive areas, in what would on their face appear to be of less concern in life's value chain, have had more success in addressing privacy and confidentiality provisions, e. g. video copying[299] and credit reporting.[300] Congress has passed a number of laws which protect our financial privacy interests.[301] To date, no one has successfully led a charge to garner consensus on a national level to enact one uniform federal law that would comprehensively address privacy issues relating to our health.[302] Interestingly, we have a right to inspect, our financial history,[303] but there is neither a right nor an obligation to a health information, records or history.[304]

Telemedicine is no longer just a playground for dreamers, enthusiasts and pilot programs. It has become a strategic tool for hard-eyed hospital administrators and entrepreneurial practitioners, whose first questions are: Does it make sense economically? Does it improve efficiency enough to justify its cost? Will it help the bottom line?[352]
As of the year 2000, the United States has spent as much as 1.5 trillion dollars on health care costs, with as much as $15 billion dollars on health care "systems."[353] Part of the problem in initiating any new system, practice or technology is money.[354] Telemedicine is no longer for dreamers, but the question remains whether it will reduce health care costs. Will it fulfill its promise of improving the quality of care, augmenting access to care and can it be both economically feasible and cost effective? The issue of paying for telemedicine is a complex and critical issue. Clearly, changes in our health care delivery system and in our demographics signal a strong future for telemedicine. The search for solutions, including managed care, where the focus is on cost containment, continues. With an aging population, there will be more patients, more home health care and nursing-care needs, and as medical science continues to prolong life and cure disease, there will be more chronic medical conditions needing treatment. Toward this end, there are policy questions concerning who should pay and for what and the more difficult questions relating to the cost effectiveness of telemedicine.

In 1997, the federal government, for the first time, approved limited reimbursement of federal funds for on-going medical consultations. The consultations are limited to those who perform telemedical consultations for rural Health Personnel Shortage Areas (HPSAs). Under the provisions, reimbursement will be established for all eligible Part B Medicare services at normal co-payment rates. Combined with the provisions in the Telecommunications Act of 1996 and subsequent actions by the FCC, this Congressional action represents two major public policy decisions that will facilitate better access to health care "for all Americans regardless of their geographic location or socioeconomic status."[355]
On November 2, 1998 HCFA finalized regulations on the new rural health care reimbursement program, providing payment for professional consultation by a physician.[356] HCFA interpreted the legislation, however, as not allowing the reimbursement of fees for store-forward consultations.[357] In effect, the provider or practitioner must actually be present on both ends of the consultation. The regulations will make teleconsultation reimbursement difficult. HCFA has determined that Medicare will not pay for a consultation involving a pre-recorded exam, and that the consultation must include a clinical assessment directed by the physician-consultant and involve feedback from the consultant to the referring physician. This real-time exchange of information also requires the patient's presence.[358] In addition, telemedicine advocates face a number of problems concerning regulation. HCFA limits reimbursable services to live interactive video, ruling out most store-forward services.[359] The final rule states that "review of dermatology photos would not be considered a consultation. We believe that this would be a new service for which payment could not currently be made under Medicare."[360] Moreover, the final rule restricts who will be considered eligible to practice under the program; it also forbids certified nurse anesthetists, and anesthesiologist assistants to provide referrals under the program.[361]
In addition to providing reimbursement for telemedical consultations, the Secretary must also provide for a single, four-year demonstration project to use eligible health care provider telemedicine networks to apply high-capacity computing and advanced networks to improve primary care, and prevent health care complications, to Medicare beneficiaries with diabetes mellitus who are residents of medically underserved rural areas or medically underserved inner-city areas.[362]
To understand telemedicine's cost efficiencies, studies need to produce clearly defined outcome results. These studies should take into account not just issues of getting medicine to patients in rural areas, but health care to the patient population of the future.[363] In January 1999, Medicare began covering teleconsults in professional shortage areas.[364] In contrast to Medicare, HCFA permits Medicaid state agencies to establish state-coverage policies for telemedicine.[365] To date, approximately 10 states permit reimbursement for telemedicine.[366] The states are a fertile area for study, comparison, and outcome data research. HCFA should be looking to the states' experience to learn what telemedicine services should be employed to improve quality and access while reducing costs.[367] For example, telemedicine has gained increasing popularity in the provision of mental-health and substance-abuse services for Medicaid beneficiaries. The Montana Medicaid program has been providing telemedicine services to patients who are more than 100 miles away from the nearest mental health or substance abuse practitioner. [368]There have been a number of outcome studies that clearly demonstrate certain telemedical services do, in fact, provide increased access and assist the patient in need. Until very recently, however, public and private reimbursement for telemedicine services has been a mirror image of the federal government's fragmented and scattered view of telemedicine reimbursement policies.[369]

If telemedicine is going to work, if it is going to be studied and resources provided, it will be far more advantageous to provide those resources in a steady "stream" of reliable funds, than, as in the past, on the drips and drabs of funding or grant moneys.[370] The States recognized that self-reliance is marked by the development of their own reimbursement mechanisms. Although many projects began, a number of projects failed, not for lack of interest or success, but simply as a result of the spigot running dry. States have taken various approaches to telemedicine and to their territorial state health issues. In contrast to HCFA's limited reimbursement of telemedicine services, in which the state has great control over the reimbursement of medical services, such as with Medicare, other types of telemedicine consultations may be reimbursed.[371] A number of states have provided for reimbursement for telemedicine under their Medicaid plans or have legislated telemedical services be treated in the same manner as face-to-face delivery services. California has been an active laboratory, and certainly has been the vanguard in all areas relating to telemedicine-especially on the issue of reimbursement.[372] On September 24, 1996 California passed S.B. 1665, which now requires all payers in California-as a matter of law-to have integrated telemedicine into their reimbursement policies. It also required that by July 1, 1997 Medi-Cal eliminate its requirement for a face-to-face consultation. Until this law was enacted there were no provisions for telemedicine reimbursement in California.[373] To date, at least twelve states[374] have some form of Medicaid coverage for telemedicine services and some states have limited reimbursement for home health and/or mental health services,[375] which will be reimbursed under Medicaid.[376] Four states, including California, have enacted non-discrimination insurance provisions, thus precluding exclusion of coverage because it is tele-based and encouraging private insurers to begin indemnifying telemedicine consultations.[377] In addition, Hawaii and Vermont have similar provisions pending.[378] Other states are following the lead and taking aggressive action.[379]

Although originally few in number, a growing number of private organizations have issued studies on the cost-effectiveness of telemedicine.[380] While conclusions indicate that telemedicine can save costs, no one study is definitive, and a common framework from which to draw comparisons does not exist.[381] The Texas Telemedicine demonstration project was probably the first to deal with the issue of costs. A study of the Texas data conducted by Arthur D. Little documented a savings of approximately 14% over conventional practice, with a payback projected in 2.6 years.[382] The study, privately-funded, linked major public and private providers in Austin, Texas with a 23-bed hospital, a renal dialysis center, a community mental health center, and a prison infirmary in a town of 4,000 people 65 miles away. No providers were reimbursed, no state or federal funds were obtained. Foundation moneys were used, together with contributions from telecommunications industry and health care sources.[383]
In reviewing a number of the projects, both federally and privately funded, a number of observations can be made. Telemedicine is a viable option for systems with limited resources. However, when the health care provider is responsible for the greater part of the total costs of illness . . . the economic benefit of telemedicine becomes immediately apparent. Additionally, telemedicine systems are cost-effective in nonclinical services, such as continuing medical education. Moreover, the use of telemedicine and medical centers "can deliver quick and efficient patient services without the overhead costs of bringing and keeping patients on site."[384] Most importantly, initial studies report that patient satisfaction with telemedicine is "quite high."[385]
HCFA's regulations provide recognition that telemedicine is both a new delivery system and "significant opportunity"[386] for the further enhancement of telemedicine coverage. But the regulations are too restrictive, especially for a "pilot program." The proposed regulations require the teleconsult be "interactive," that the "provider" be actually present on each end of the consultation, that beneficiary eligibility depends upon the place of residence or location of service, that the site of the teleconsult must "effectively transport the patient to the consultation," and that the payment process is cumbersome, providing for only the consulting practitioner to submit the claim and receive the payment, and then remitting the fee to the presenting practitioner.[387]
The issue of telemedicine and regulation of health care costs, in many ways, mirrors the same issues relating to quality and access. There is a role for the federal, state and private sector in which each plays a part in moving telemedicine toward a health-delivery system that can provide improvements to quality and access to care simultaneously saving costs. Such a solution calls for a "balanced federalism" in health reform.[388] In this context, the federal government regulates the broad outline, or national standards, after consultation with the states and the input of the private sector. The states, however, implement these standards, and have the regulatory imprimatur to improve and expand. The entrepreneurial spirit of the states, coupled with unshackling the reins of prohibitive reimbursement schemes, should spur the private marketplace to do what it does best-"follow the money." In following the money, however, states must not trade savings for quality. It is fair to expect that telemedical technologies will assist the health care industry to better deliver health care at costs that approach those of the traditional practices.[389] So far, however, there is scant proof that those in rural areas will get care at less cost than traditional methods.[390] No doubt, as the money flows to support new technologies, this will change.[391] Many of telemedicine's economic benefits may be difficult to assess through the traditional economic measures in use today.[392] For example, if a rural patient cannot get any care at all, is this a fair method to approach telemedicine's cost-effectiveness? Reimbursement mechanisms for telemedicine consults need to be aligned with goals for health care reform.[393]
A number of options exist with respect to reimbursement initiatives. The federal government could facilitate education by disseminating information regarding initiatives, including states' initiatives in telemedicine, centering its study around the issues of cost, quality and access. Such an would be especially appropriate insofar as many states have provided special appropriations for telemedicine studies.[394] Gathering information is a function the federal government performs well since it has the infrastructure and assistance and professional expertise.[395] Since many of our federal health care dollars are spent on presently employed and former federal employees, the federal government should encourage health plans to propose policies on telemedicine and provide coverage, if appropriate. The federal government should also: (1) have the medical communities in the federal government work with the professional medical associations to address the Official Medical Fee Schedule to facilitate reimbursement for telemedical services;[396] (2) immediately address any barriers to the Telecommunications Reform Act of 1996 and facilitate removal of those barriers; (3) employ grants for scientific research; (4) provide financial support, either directly or through incentives, for telemedical public health initiatives;[397] and, (5) bolster the educational use of telemedicine and telehealth by providing incentives/reimbursement for preventive medicine. Study after study indicates there is a forceful role for the federal government to play in the area of preventive medicine.[398] In the area of education, significant expense could be avoided by educating physicians and patients alike.
States have an important role to play too. States have incredible leverage to move forward and accomplish more, tailor the reimbursement schemes to the needs of what is in the best interests of their patient constituency. States should consider California and Oklahoma's approaches to telemedicine.[399] Additionally, states could (1) examine the practices of California,[400] Georgia, Kansas,[401] Texas and Louisiana, (2) provide funding for physicians in underserved areas, whether it be rural or inner city, (3) reimburse and/or provide tax incentives for education, (4) provide funds to train health care professionals and (5) examine the patient's needs in the state and begin to address where there is a telemedical solution to address some of those needs.[402]
Telemedicine needs stable sources of revenue. Congress, and the states should establish what sources are necessary for their respective patients, designate task forces to study what telemedicine services should be reimbursed and specify the types of services, amounts, mechanisms for financing services and a clear basis for reimbursement. Moreover, Congress should demand, as a condition precedent for federal funding, outcome studies detailing telemedicine's successes. Such outcome studies, whether directed by the government, or by the private sector,[403] will provide useful benchmarking data of the benefits telemedicine can bring.[404] The funding from private sources came, in the past, from the telephone companies, from private foundations, and, most recently, from selected providers. The private sector today is very much involved in telemedicine and has determined where it ought to invest, but it is the responsibility of regulators to assure that all laws and regulations are followed to protect the best interests of the patients and to enact laws that will facilitate telemedicine rather than stunt its growth.

The reality of telemedicine's current legal framework and the promises telemedicine brings to address the issues of quality, access and care is bridged by numerous proposals at the federal, state and private levels. The sheer number of proposals-each one addressing a one or more of the barriers to telemedicine implementation-reinforces the difficulty in managing telemedicine as a proposal or a legislative solution. Again, telemedicine exemplifies the issues and barriers that already hinder delivery of health care.
In the last three Congressional sessions, there have been over sixty pieces of federal legislation relating to telemedicine. During the 103rd Congress, at least twenty-two different legislative bills were introduced.[405] During the 104th Congress,[406] another twenty-two pieces of proposed telemedicine legislation were introduced, and the 105th Congress also introduced twenty-two pieces.[407] Of these federal proposals, few became law and many are still bills pending legislative action. At last count there were 15 federal agencies directly addressing telemedicine projects.[408] Countless agencies can affect telemedicine applications, federal projects, and funding.[409] On the state level, at least 20 states have taken legislative action, either through laws directly addressing telemedicine, or laws that impact telemedicine. In addition, there are state commissions, compacts, intergovernmental agencies, various licensing boards, state committees and professional associations addressing issues of "distance" medicine.[410] One federal bill, the Telehealth Act of 1996, has lingered in Congress for over two years, with little sign of movement. In addition to requiring HCFA to reimburse for telemedicine activities,[411] it would have required a status report on the efforts to ease licensing burdens on practitioners, and provided seed money to local communities to support telemedicine programs. This ill-fated bill, however, did not address privacy and confidentiality.[412]
The Institute of Medicine (IOM) has supported the exploration of telemedicine, but has strongly recommended that before Congress or the States adopt this new technology, a business plan should be implemented. The IOM seeks to address the clinical process of caregiving, the patient's status or health outcome, access to care, the costs to the patients, payers, providers and society, and the satisfaction of the clinicians and patients with the technology.[413] The JWGT has submitted a report that raised a number of barriers to the expansion of telemedicine, including reimbursement, lack of an explicit and fair policy for paying for telemedicine services, assessment of barriers to support telemedicine in managed-care systems, national licensing system, removal of barriers relating to liability and patient confidentiality and a telemedical code of ethics. Other potential barriers include hospital-admitting privileges, liability, privacy and system design issues, a clear definition of telemedicine and administration programs.[414] The states have clearly preceded the federal government in reforming telemedicine regulation, but it is clear that there are many remaining barriers to be removed. Federal and the state governments, working together toward this end, could strike a regulatory balance that would avoid the pitfalls of past health care reforms.

Analysis of telemedicine's future resembles a glance into a crystal ball. There is a flurry of activity, but no clear design or direction. Telemedicine portends a long life with lots of promise but also a rocky journey with many snags along the way. With telemedicine's ability to track diabetes patients at home, to monitor physicians' health scaling the highest mountain top in the world, to provide emergency treatment to soldiers wearing smart shirts, to assist early detection and treatment of an isolated patient's rare cancer, and to enable a father to find a physician to treat the spinal cord injury of his paralyzed son, telemedicine is struggling to grow against the weight of legal and governmental restraints.
Although telemedicine is not the solution to the national health care quandary, it promises a series of breakthroughs to problems that beset the delivery of services to our patients. A unified approach might address a number of legal and financial hurdles. However, neither our legal, financial nor political system welcomes a one-shot solution. Rather, the idiosyncratic and diverse systems compete, often producing a far better product. Telemedicine is unique because despite numerous stakeholders and operation on multi-functional levels, it lacks uniform leadership.
With respect to quality, my assumption is that quality is not an end, but a process of improvement. As such, our unique federal-state system has traditionally left to the various states the determination of appropriate criteria to regulate the practice of medicine in the best interests of the patient. Credentialing is governed by state laws that regulate hospital licensure. Likewise, the task of punishing those who breach the state's standards and the duty of care owed to their patient has been addressed by the states. Even as states move toward a national standard of care, it is state law that governs in any civil malpractice action.
There are numerous reasons that militate for the states retaining their police powers, especially with respect to telemedical advances. One overarching reason, however, argues against federal preemption. As we strive to minimize defects in this health-delivery quality process, the more innovation, guarded experimentation, and flexibility will produce a better delivery system, admittedly not all occurring in one miraculous cure, but rather in an incremental fashion over a period of time. States should adopt critical laws that drive politicians, institutions, and care-givers to act in the best interest of patients. To ensure quality of care is not compromised, states, rather than the federal government should enact laws to protect their constituents.[415] In this regard, three proposals are suggested. First, a registration program, directed by the state medical licensing board, should require that physicians practicing telemedicine across state lines be registered by the state's licensing board. California's approach is an appropriate model. Second, the Medical Board should coordinate telemedicine licensure and credentialing with other states. Third, either the appropriate state agency or medical licensing board should review telemedicine programs and technologies, providing policies and guidelines for credentialing off-site telemedicine practitioners. Specifically, policies should set forth when, and under what circumstances, a hospital must credential a remote physician. Moreover, JCAHO and NCQA should develop guidelines for credentialing at health care centers where the remote physician's only practice is via telemedicine. By continuing to use the state-regulating bodies as gatekeepers of registration, licensing and credentialing, the states' medical boards retain the power to issue regulations, to screen physicians, and to ensure standards are equal or better to that within the state. Additionally, the states retain the flexibility to make improvements as technology and other laws in this area change. The foregoing keeps focus on the patient consumer and provides latitude for the state-licensing board to both regulate, enforce and suggest appropriate legislative changes.
The second line of recommendations addresses accelerating and regulating access to telemedical practice. It is ironic that telemedicine is a key proposal to solve access problems, especially for those in medically underserved areas, and yet, access to the underserved is more of a problem than ever before. Both the federal and state regulators have key roles to play. The federal government, through Congress' broad grant of authority in the Telecommunications Act of 1996, should more aggressively propose solutions to the underserved. Instead of focusing on the many difficulties involved with arranging access to rural areas, the FCC should work closely with HHS to design cost-effective incentive programs to enhance service in urban and rural areas. Additionally, the states have an obligation to implement Section 254(h) of the Reform Act. States should be held accountable for the provision of services that deliver remote care at rates that are reasonably comparable to rates charged for similar services in urban areas in that State. Second, although the FDA has been aggressive in addressing telemedicine, it should propose regulations defining a "teledevice." Additionally, the FDA should address what recommendations might be necessary to manage the international implications of telemedical practice.
Last, privacy and confidentiality are critical issues, not unique to telemedicine, but important in the telemedical context. A number of parallel solutions should be pursued. First, initial procedural measures can be put in place immediately. Such measures should include educating physicians and patients, training telemedical staff, identifying sensitive data, providing contractual protection and setting up periodic monitoring of the security policies. Second, there are a number of possible technical safeguards, including firewalls, encryption, authentication, and verification. The most significant changes will take place through imposition of stringent privacy and confidentiality standards for telemedicine practitioners. Each practitioner has not only a legal obligation but also an ethical obligation to assure confidentiality. In this area, a federal law establishing uniform national standards would ensure privacy and confidentiality of medical records. There is, however, no overarching federal law establishing uniform national standards. Nonetheless, a number of bills are currently pending. State laws, as they exist today, are inconsistent. In the absence of federal legislation, a uniform medical-information protection statute should be drafted, and each state should then adopt and improve upon its model language. Although implementation in this area may be difficult, a state-by-state approach may lead to the same end. In addition to protective language, this bill should impose severe penalties for any breaches of privacy. Moreover, aggrieved patients should have, either under federal or state law, a private right of action for improper disclosure of their medical records.
Telemedicine promises ultimately to save costs, thus satisfying a third major problem in our health care delivery process. In the interim, like any start-up or pilot project, it may take money and research to find the best approaches for telemedicine. All parties have a role in this regard, and all have vested interests. The role of federal and state governments should support those projects that bring the care to their patients in the most cost-effective manner. Much could be done to improve the federal government's approach to telemedicine. Organization of the issues has already begun. Sadly, though, no funds have been directed to the programs that most greatly benefit patients. Although the federal government has appointed a task force, no visible federal leadership, no clear federal or fiscal policy, and certainly no strategic outline have developed. Reimbursement policies set by HCFA, however, pave the way for the private marketplace. Although there is now a demonstration project studying telemedicine's virtues, the reimbursement policy proposed seems far too restrictive. Since HCFA already allows state Medicaid agencies to establish their own coverage policies, Medicaid spending in telemedicine should be tracked by the federal government. In this regard, California could be a model example for the federal government to follow. Instead of limiting reimbursement to the narrow area carved out in the pilot program, Congress should not only permit but require private health insurance and managed-care plans to integrate telemedicine into their existing reimbursement policies, treating telemedicine as traditional face-to-face care.

Telemedicine is not the magic pill that will cure our ailing health care system, but it is a potentially miraculous treatment that promises improvements to our delivery systems, bettering quality, access and eventually even costs. Telemedicine will not thrive on a one-shot approach; it requires a regimen of treatments. Its future solution to our health care system's problems of access, quality and costs is best insured by a collaboration of efforts-by the federal, state and private sectors, by bureaucrat, physician and technician. This collaborative effort should have one driving force and end: acting in the best interest of the patient. By moving toward this goal, all players can compete and even without a strategic plan, guarantee improvements and better access and treatments to patients.