Susan E. Volkert[*]
November 1, 2000 6 Mich. Telecomm. Tech. L. Rev. 147 (2000)
Cite as: Susan E. Volkert, Telemedicine: Rx for the Future of Health Care,
6 Mich. Telecomm. Tech. L. Rev. 147 (2000),
available
at <http://www.mttlr.org/volsix/Volkert.html>.
Comments about this article should be sent to mttlr@umich.edu
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]