Cybersurgery: the cutting edge.I. INTRODUCTION The year is 2050. A woman in Cuenca, Ecuador Cuenca is the third largest city in Ecuador, capital of the Azuay province. It is located in the Sierra, the highlands of Ecuador at about 2500m (8200 ft) above sea level. Its full name is Santa Ana de los cuatro ríos de Cuenca. unexpectedly gives birth to conjoined twins conjoined twins or Siamese twins Identical twins (see multiple birth) whose embryos did not separate completely. Conjoined twins are physically joined (typically along the trunk or at the front, side, or back of the head) and often share some organs. who require immediate surgery in order to survive. Although the mother has been receiving excellent prenatal care prenatal care, n the health care provided the mother and fetus before childbirth. in a well-equipped hospital with a neonatal neonatal /neo·na·tal/ (ne?o-nat´'l) pertaining to the first four weeks after birth. ne·o·na·tal adj. Of or relating to the first 28 days of an infant's life. unit capable of sustaining the twins through recovery, the doctors and surgeons at the local hospital are not experienced in performing the procedure. It is impossible to transport the twins, as one has respiratory difficulties such that changes in air pressure from air travel would be extremely hazardous. Further, the need for surgery is immediate, and there is not enough time for a specialist to travel to Ecuador. However, the doctors contact a surgeon at a prominent hospital in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , and using "cybersurgery" the twins have the life-saving procedure without ever leaving Ecuador or requiring a surgeon to travel to them. The surgeon remains in the United States and uses a computer and a real-time audio and video connection to control a robotic surgery Using robots in the operating room to assist the surgeon in performing surgery. The surgeon views the patient via a terminal and manipulates robotic surgical instruments via a control panel. Views of the organs being worked on are transmitted from tiny cameras inserted into the body. system located in the Cuenca hospital. While a creation of the author's imagination, these events are by no means science fiction. They present a view, albeit somewhat idealized i·de·al·ize v. i·de·al·ized, i·de·al·iz·ing, i·de·al·iz·es v.tr. 1. To regard as ideal. 2. To make or envision as ideal. v.intr. 1. , of the role cybersurgery could play in reducing some of the disparities in global, as well as national medical care while advancing medical technology to a point previously unimaginable. This Note explores some of the legal and regulatory pitfalls that, without attention, will hinder the full realization of cybersurgery's potential. (1) Part II discusses the technology itself as well as potential applications. Part III discusses cybersurgery within the broader context of e-health, telemedicine ("long distance" medicine) Using a videoconferencing link to a large medical center in order that rural health care facilities can perform diagnosis and treatment. A specialist can monitor the patient remotely taking cues from the general practitioner or nurse who is actually examining , and cybermedicine. Part IV considers a hypothetical case involving telemedicine and cybersurgery which outlines problems of jurisdiction, licensing, choice of law, and standard of care. Part V discusses the current laws surrounding telemedicine, the legal issues with respect to the telecommunications industry, and the inadequate law on jurisdictional and standard of care questions. Part VI concludes by summarizing legal and policy recommendations. II. CYBERSURGERY: TECHNOLOGY, USES, AND POTENTIAL To demonstrate the feasibility of cybersurgery, one need only look to the world's first successful performance of cybersurgery on humans: on September 7, 2001, Dr. Jacques Marescaux Jacques Marescaux (born August 8, 1948 in Clermont) is a french doctor of international renown. He is Chairman of the digestive and endocrine surgery at University Hospital, Strasbourg. (2) used a computer in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. to control a robot located in Strasbourg, France to remove a patient's gallbladder. (3) The doctor was in a building in Manhattan, not a hospital, and the robot and patient were in a hospital in Strasbourg. (4) The doctor utilized Computer Motion's ZEUS[R], a voice-activated robotic system robotic system An integrated system of devices that automate production and manufacturing of goods and services Surgery An AI-based surgical assistant system, which processes sensory input from haptic interfaces and/or allows surgeons to act with more accuracy than . (5) France Telecom, one of Europe's top three Internet service providers Internet service provider (ISP) Company that provides Internet connections and services to individuals and organizations. For a monthly fee, ISPs provide computer users with a connection to their site (see data transmission), as well as a log-in name and password. and one of its largest wireless operators, provided high-speed fiberoptic service that linked the surgeon and the robotic system. (6) The surgery, aptly named "Operation Lindbergh" after the first solo transatlantic flight | Transatlantic flight is any flight of an aircraft, whether fixed-wing aircraft, balloon or other device, which involves crossing the Atlantic Ocean — with a starting point in North America or South America and ending in Europe or Africa, or vice versa. , took forty-five minutes and involved forty people, including the medical team, telecommunication engineers, and robotic system specialists. (7) "Transatlantic high-bandwidth fiberoptic service" linked all of the equipment. (8) The ZEUS[R] system is composed of three robotic arms A robotic arm is a robot manipulator, usually programmable, with similar functions to a human arm. The links of such a manipulator are connected by joints allowing either rotational motion (such as in an articulated robot) or translational (linear) displacement. operated by the surgeon from a remote console A terminal or workstation in a remote location that is used to monitor and control a local computer. (located a few feet from the operating table or across the ocean). (9) Two of the arms hold instruments and are controlled by the surgeon's manipulation of joysticks at the console; the third arm is voice-controlled and operates a camera. (10) The "system is equipped with a dual security system" and "[s]ignals are checked more than 1,000 times per second." (11) The setup of Operation Lindbergh was as follows: the doctor in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of worked at the robot control Robot control is the theory of how to model and control robots. A simplistic model of a robot is to view it as a collection of links connected by joints. station, with a computer transmitting his commands. (12) Using a headset Headphones combined with a microphone. Used in call centers and by people in telephone-intensive jobs, headsets provide the equivalent functionality of a telephone handset with hands-free operation. Many people use headsets at the computer so they can converse and type comfortably. , he talked to the team in France while viewing the patient on a video screen in New York. (13) All the equipment (including computers, videoconferencing A real time video session between two or more users or between two or more locations. Although the first videoconferencing was done with traditional analog TV and satellites, inhouse room systems became popular in the early 1980s after Compression Labs pioneered digitized video systems equipment, and audio equipment in both New York and France, as well as the robot, the camera, and the robot command station) was connected so that the robot responded to the surgeon's commands in real time with no significant delay in the transmission of sounds or images. (14) The use of cameras and computer equipment in surgery has been steadily evolving. The advent of minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. , also known as laparoscopic surgery laparoscopic surgery: see endoscope. , was introduced in 1988. (15) Laparoscopic surgery involves the use of a tiny camera so that the surgeon can make smaller incisions and does not need to fully open up a patient's abdominal or chest cavity. (16) The first computer assisted surgery took place in 1996. (17) Computer assisted surgery "involves inserting a computer interface between the surgeon and the patient, enabling an analysis of the surgeon's actions in order to repeat them, ensure their safety and then transmit them to a remote manipulation device that performs the actual surgical manipulation." (18) The 2001 cybersurgical operation was the first time technology could reduce the time delay of long distance transmissions enough to make truly remote surgery possible. (19) The camera "transmits a video image to a transmitter that transmits the image over a telecommunications link Uplink For other uses, see Uplink (computer game) and . An uplink (UL or U/L) is the portion of a communications link used for the transmission of signals from an Earth terminal to a satellite or to an airborne platform. An uplink is the inverse of a downlink. to a remote receiver. The receiver relays the image to another computer that generates an image of the internal body tissues of the patient on a monitor." (20) A constant time delay of less than 200 milliseconds must exist between the surgeon's movements and the video image received. (21) Currently, a satellite link would create "a time delay of 600 milliseconds, making a reliable surgical manipulation impossible." (22) However, the use of satellite transmissions has proved useful in bringing medical care to developing countries. For example, the inspiration for the Cuenca operation at the beginning of this Note comes from a medical journal's discussion of a bilateral open inguinal inguinal /in·gui·nal/ (in´gwi-n'l) pertaining to the groin. in·gui·nal adj. 1. Of or located in the groin. 2. herniorraphy (hernia hernia, protrusion of an internal organ or part of an organ through the wall of a body cavity. The hernia is enclosed by a sac formed by the lining of the cavity. It results from a weakness or rupture in the wall, usually where there is already a natural weakness. surgery), performed in Cuenca, Ecuador. (23) Through the Cinterandes Foundation's mobile surgical facility, surgeons, doctors, and students in Richmond, Virginia Richmond IPA: [ɹɯʒmɐnɖ] is the capital of the Commonwealth of Virginia, in the United States. were able to view the procedure in real time and speak to the surgeons in Ecuador performing this standard, minimally invasive, camera-assisted surgery. (24) A mobile satellite telephone transmitted audio and video from a computer to an Integrated Services Digital Network Integrated services digital network (ISDN) A generic term referring to the integration of communications services transported over digital facilities such as wire pairs, coaxial cables, optical fibers, microwave radio, and satellites. (ISDN ISDN in full Integrated Services Digital Network Digital telecommunications network that operates over standard copper telephone wires or other media. ) videoconferencing system in Richmond. (25) In addition to ZEUS[R], the other major remote controlled robotic surgery system in use today is the da Vinci da Vinci Surgery A surgical robot for performing certain surgeries–eg, mitral valve repair and laparoscopic procedures–eg, cholecystectomy and gastric ulcer repair. See Laparoscopic surgery, Robotics, Surgical robot. [R] system from Intuitive Surgical Intuitive Surgical Inc. (NASDAQ: ISRG) is a corporation that manufactures robotic surgical systems, most notably the da Vinci Surgical System. Intuitive Surgical has a market capitalization of 9.77 billion USD and is part of the Nasdaq-100 and S&P 400 MidCap Indices. . (26) Using the da Vinci[R] system, the surgeon also sits at a remote console and, in real time, controls robotic arms that operate like a surgeon's hands. (27) "[T]he robotic 'hands' [are] actually capable of some movement and maneuvers that would be difficult, if not impossible, for a human wrist and hand to accomplish." (28) Da Vinci[R] uses InSite[R] Vision, a system of fiberoptic cables providing stereoscopic vision stereoscopic vision n. The single perception of a slightly different image from each eye, resulting in depth perception. . (29) This differs from ZEUS[R], which only gives the surgeon two-dimensional video images. (30) While da Vinci[R] only responds to manual controls, ZEUS[R] responds to audio controls as well. (31) Despite the differences, it is sufficient to say that these robots represent, quite literally, the cutting edge of medical technology. (32) Even though cybersurgery is not yet part of current medical practice, further extensions of the technology have been contemplated, such as the "automatic surgeon." (33) The automatic surgeon is much like an automatic pilot. (34) In addition, with an automatic surgeon, much of the surgery could be performed offline. (35) The surgeon would start the procedure, discover any irregularities in the patient's anatomy and input the information and operative plan into the automatic surgeon. (36) There are several reasons why both cybersurgery and automatic surgery might not be as nerve-wracking as they sound. (37) First, surgeries on astronauts in space notwithstanding, (38) one must consider some of the uses for cybersurgery. Cybersurgery can greatly increase the survival chances of victims of severe trauma, who might otherwise have no such chance. (39) Studies indicate that survival after major trauma is inversely related to the delay in getting the victim to a surgeon. (40) Put another way, if a person were going to die before being able to reach a surgeon, he or she might be more inclined to have the surgeon reach him or her in whatever way possible, such as through the use of a mobile surgical facility. The military also has an interest in cybersurgery; for example, treating soldiers in a biologically contaminated contaminated, v 1. made radioactive by the addition of small quantities of radioactive material. 2. made contaminated by adding infective or radiographic materials. 3. an infective surface or object. zone. (41) Cybersurgery will also be of great value to rural areas, which have already benefited greatly from the use of telemedicine. (42) Cybersurgery can also bring surgeons to very remote areas where it is not cost-effective for them to relocate. (43) In further considering the application of this new technology to more routine or less exigent circumstances An exigent circumstance, in the American law of criminal procedure, allows law enforcement to enter a structure without a warrant, or if they have a "knock and announce" warrant, without knocking and waiting for refusal under certain circumstances. , one must realize that surgery today is performed more like "automatic surgery" than one might think. Most of the work during a surgical procedure is not actually done by the famous doctor a patient might have chosen, but is performed by his or her residents; often, the surgeon is not even in the operating room operating room n. Abbr. OR A room equipped for performing surgical operations. . (44) In the 1970s, Dr. Michael DeBakey, the world famous heart surgeon, "simultaneously supervised as many as ten residents-in-training performing CABGs [coronary artery bypass Coronary artery bypass Surgical procedure to reroute blood around a blocked coronary artery. Mentioned in: Heart Failure coronary artery bypass, n ]." (45) It is comforting, of course, to know that the supervising surgeons are liable for the outcome and mistakes of a resident-in-training. (46) Technology is available for cybersurgery and automatic surgery and is compatible with the current methods by which surgeons are trained as residents, gradually performing more and more complex tasks under the supervision of a supervising surgeon who has the ability to take over at any moment. (47) For example, Computer Motion also manufactures "SOCRATES Socrates (sŏk`rətēz), 469–399 B.C., Greek philosopher of Athens. Famous for his view of philosophy as a pursuit proper and necessary to all intelligent men, he is one of the great examples of a man who lived by his principles even (TM)," a "second control panel [for] the cybersurgery system [ZEUS[R]]." (48) Essentially, SOCRATES[TM] supervises ZEUS[R]: "[a] key feature of the SOCRATES[TM] control panel is that the surgeon using it has robotic arm priority over the surgeon at the ZEUS[R] control panel ... the surgeon at the SOCRATES[TM] control panel can override An arrangement whereby commissions are made by sales managers based upon the sales made by their subordinate sales representatives. A term found in an agreement between a real estate agent and a property owner whereby the agent keeps the right to receive a commission for the sale of direction given by the surgeon at the ZEUS[R] control panel." (49) The price tag attached to a machine such as da Vinci[R] or ZEUS[R] is approximately one million dollars, (50) so without even considering the cost needed to set up a technology infrastructure suitable for cybersurgical procedures, the cost of cybersurgery is currently prohibitive pro·hib·i·tive also pro·hib·i·to·ry adj. 1. Prohibiting; forbidding: took prohibitive measures. 2. . However, the cost of robots is declining and usage by the world's population is increasing. (51) According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the U.N.'s 2004 World Robotics robotics, science and technology of general purpose, programmable machine systems. Contrary to the popular fiction image of robots as ambulatory machines of human appearance capable of performing almost any task, most robotic systems are anchored to fixed positions Survey, the domestic use of robots will surge by 2007, a boom "which [will coincide] with record orders for industrial robots An industrial robot is officially defined by ISO[1] as an automatically controlled, reprogrammable, multipurpose manipulator programmable in three or more axes. ." (52) According to one robotics corporation executive, "we are just at a point where robots are becoming affordable." (53) The U.N. study noted "a robot sold in 2003 cost a quarter of what a robot with the same performance cost in 1990." (54) The study predicted that by 2010, robots will "not only clean our floors, mow our lawns and guard our homes but also assist old and handicapped people with sophisticated interactive equipment, carry out surgery, inspect pipes and sites that are hazardous to people, fight fire and bombs." (55) The increase is already evident in Asia, Europe, and North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , but notably, "the machines are also taking off in richer developing countries, including Brazil, China and Mexico." (56) III. RELEVANT DEFINITIONS AND CONTEXT As technology expands, confusion over terminology does as well. Inconsistent uses of terminology will hinder the development of an appropriate regulatory framework. Understanding the terminology in any discussion of developing technology is critical. The starting point Noun 1. starting point - earliest limiting point terminus a quo commencement, get-go, offset, outset, showtime, starting time, beginning, start, kickoff, first - the time at which something is supposed to begin; "they got an early start"; "she knew from the in this discussion is the broad concept of e-health. E-health encompasses both cybermedicine and telemedicine, which have differing policy and legal implications. (57) Cybermedicine covers a broad range: "[c]ybermedicine includes marketing, relationship creation, advice, prescribing and selling drugs and devices, and as with all things in cyberspace Coined by William Gibson in his 1984 novel "Neuromancer," it is a futuristic computer network that people use by plugging their minds into it! The term now refers to the Internet or to the online or digital world in general. See Internet and virtual reality. Contrast with meatspace. , levels of interactivity as yet unknown." (58) Examples include doctor-patient e-mail communication, interactions with doctors or nurses through an Internet call center, the creation of websites, as well as Internet pharmaceutical sales. (59) The World Health Organization defines telemedicine as [t]he delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities. (60) The definition the American Medical Association American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science. uses for telemedicine is "medical practice across distance via telecommunications and interactive video technology." (61) Finally, the American Telemedicine Association American Telemedicine Association (ATA), established in 1993 as a non-profit organization, ATA goal is to promote access to medical care for consumers and health professionals via telecommunications technology (alternatively referred to as telemedicine, telehealth or eHealth). defines telemedicine as "the use of medical information exchanged from one site to another via electronic communications to improve patients' health status." (62) While definitions may vary, one knows what cybermedicine and telemedicine are when one sees them. A few examples are helpful. CyberDocs is a website which provides medical care on-line. (63) Patients receive consultations, second opinions, referrals, and prescription refills. (64) Board-certified American Emergency Medicine Specialists staff the website twenty-four hours a day. (65) Since the inception of CyberDocs in 1996, over 20,000 healthcare sites have emerged on the Internet. (66) Over one hundred million adult Americans have used the Interact at least once to look at health or medical information. (67) Even indigenous groups in Cambodia (which, according to the World Health Organization, has "the direst health situation in the Western Pacific region" (68)) benefit from a telemedicine clinic. (69) A satellite link allows doctors in a hospital to e-mail diagnoses, images of x-rays, ECGs, and ultrasound results. (70) In surgery, telemedicine plays a role in the mentoring of inexperienced in·ex·pe·ri·ence n. 1. Lack of experience. 2. Lack of the knowledge gained from experience. in surgeons. (71) At Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. , a central site and an operative site are separated by a distance of about three and a half miles. (72) The mentor at the central site can monitor the activity in the operating room while viewing the procedure in real time and override certain procedures if necessary. (73) In 1998, prior to the realization of truly remote surgery in 2001, one doctor defined cybersurgery as: an attempt to embrace and describe a new conception for general surgery and a new set of terms by which surgeons can both comprehend and reimagine their craft in the Information Age. It encompasses both an emerging complementarity between clinicians and machines (particularly computers) and the integration of diverse digital technologies into the full spectrum of surgical care. (74) In 2001, Operation Lindbergh was considered an example of telesurgery (from "tele ("long distance") Operations performed remotely or by telephone. The "tele" prefix is used to designate many technologies such as telecommunications and teleconferencing. ," the Greek word for "far off") (75) but:
[t]here is often a certain amount of confusion associated with
the term "telesurgery." It has been applied to computer-assisted
surgery, since there is indeed a distance of one or two meters
between the surgeon and the patient. It has also been used as a
surgical equivalent of "telemedicine," meaning guiding the
surgeon performing the procedure ("telementoring" or
"teleprotectoring"). For "telementoring" applications, the
remote contribution to the surgical actions consists only in
providing recommendations. On the other hand, Project
Lindbergh involves what the Americans refer to as "remote
surgery," which consists in performing the entire procedure
remotely. (76)
In this Note, the author uses the term "cybersurgery" to describe "a surgical technique that allows a surgeon, using a telecommunication conduit connected to a robotic instrument, to operate on a remote patient." (77) The author believes this, along with the term telesurgery, is how the term is currently used with respect to remote surgery where the patient and surgeon are really in different places and not just separated by a few feet in the operating room. As laws develop surrounding e-health, consistent definitions will become increasingly important, as characterization of a term can often determine the outcome of a case or application of a law. IV. A HYPOTHETICAL OUTLINING SEVERAL LEGAL AND REGULATORY ISSUES PRESENT IN TELEMEDICINE AND CYBERSURGERY Some of the legal issues in cybersurgery are apparent in the following hypothetical. This hypothetical, summarized in the paragraph below, was posited by the Defense Counsel Journal, (78) and presents some of the legal problems associated with a telemedicine malpractice malpractice, failure to provide professional services with the skill usually exhibited by responsible and careful members of the profession, resulting in injury, loss, or damage to the party contracting those services. case in the United States. Notably, a host of issues arise without even considering the use of cybersurgery or similar events in an international context. Consider the following: a car accident in rural New Mexico New Mexico, state in the SW United States. At its northwestern corner are the so-called Four Corners, where Colorado, New Mexico, Arizona, and Utah meet at right angles; New Mexico is also bordered by Oklahoma (NE), Texas (E, S), and Mexico (S). leaves a person with closed head injuries. (79) A CAT scan CAT scan (kăt) [computerized axial tomography], X-ray technique that allows relatively safe, painless, and rapid diagnosis in previously inaccessible areas of the body; also called CT scan. is transmitted over the Internet to an academic hospital in Baltimore, where neuroradiologists interpret that the films are within normal limits. (80) Using the Baltimore neuroradiologists' report, the New Mexico physicians decide surgery is not needed. (81) Several days pass and the patient shows no signs of recovery. New images are sent to the Baltimore neuroradiologists who see a change indicating surgery is now necessary. (82) A plan for surgery is formulated by neurosurgeons in New Mexico and Maryland. (83) The operation occurs in New Mexico, and via a digital Internet link, the Baltimore neurosurgeons "monitor and provide technical assistance." (84) While the patient survives the operation, he suffers significant damage. (85) He files a complaint in New Mexico state court against the various doctors, including the neuroradiologists and neurosurgeons in New Mexico and Maryland. (86) One might consider the following questions: Are the Baltimore physicians subject to suit in New Mexico state court? Have they had sufficient contacts in that state to invoke traditional person jurisdiction concepts? By consulting with the New Mexico physicians, have the Baltimore physicians (not licensed as physicians in New Mexico) engaged in the practice of medicine in New Mexico, even though they never left Maryland? Would the Baltimore physicians be agents, servants or employees (either actual or apparent) of either the New Mexico physicians or the hospital where the surgery took place? If the case ultimately ends up in federal court (which one?) which state's substantive law would be applied? Would the Baltimore physicians' malpractice insurance cover this 'out of state' activity? (87) Presently, these questions do not have answers. There is very little applicable law currently available. One can only imagine expanding this hypothetical to include the performance of a cybersurgical procedure, much less across international borders. What if the parties included surgeons in different states or countries controlling ZEUS[R] and SOCRATES[TM]? What if a fire, accidentally started by an intoxicated in·tox·i·cate v. in·tox·i·cat·ed, in·tox·i·cat·ing, in·tox·i·cates v.tr. 1. To stupefy or excite by the action of a chemical substance such as alcohol. 2. employee of the telecommunication provider, caused a failure in transmission during a critical moment of the surgery? (88) Perhaps one might conclude that no body of law could ever consistently solve the liability, choice of law, and jurisdictional problems presented. However, if one knows that cybersurgery could have played a life saving role in the many permutations of this hypothetical, one has no choice but to tackle these questions, not only with respect to choice of law and jurisdiction, but with respect to questions of licensing and the application of traditional tort principles. (89) Another consideration is the role of telecommunications and telecommunications service providers A Telecommunications Service Provider or TSP is a type of Communications Service Provider that has traditionally provided telephone and similar services. This category includes ILECs, CLECs, and mobile wireless companies. in defining a standard of care. (90) The following section discusses some of these issues in greater detail. V. LEGAL AND REGULATORY ISSUES AFFECTING TELEMEDICINE Cybersurgery is really only "the ultimate application of technology to medicine," (91) and all the technology involved is currently in use on some level today. Yet there are no "international treaties or global agreements that deal with telemedicine...." (92) Insisting that issues be identified and resolved will pave PAVE Cardiology A clinical trial–Post AV Node Ablation Evaluation the way for the continued application of technology to global health. In addition, "concern over the diffusion of e-health is a part of the broader issue of access to new health technologies, a theme of growing global importance." (93) At the global level, the law impacting the practice of telemedicine is: an odd amalgamation of laws affecting trade, telecommunications and, to a more limited extent, health care. At points there are linkages among the respective areas of law bearing on e-health, but these linkages are largely because telecommunications and trade policies are so interrelated, and not due to any concerted attempt to devise unifying legal principles for e-health technologies. (94) In 1997, Malaysia (the only country to date) enacted a "generic telemedicine law, covering licensure licensure (lī´s tr. & intr.v. com·pli·cat·ed, com·pli·cat·ing, com·pli·cates 1. To make or become complex or perplexing. 2. To twist or become twisted together. adj. 1. the formation of private contracts, (96) and pose "challenges for the harmonization har·mo·nize v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es v.tr. 1. To bring or come into agreement or harmony. See Synonyms at agree. 2. Music To provide harmony for (a melody). of e-health with trade law" (97) at the public level. A. Telecommunications The International Telecommunications Union See ITU. (body, standard) International Telecommunications Union - (ITU) ITU-T, the telecommunication standardisation sector of ITU, is responsible for making technical recommendations about telephone and data (including fax) communications systems for PTTs and suppliers. (ITU (International Telecommunication Union, Geneva, Switzerland, www.itu.ch) A telecommunications standards body that is under the auspices of the United Nations. Comprising more than 185 member countries, the ITU sets standards for global telecom networks. ) is the oldest international legislative body, originally created by twenty European countries to set telegraph standards. (98) Today, the ITU is responsible for almost all international regulation covering all forms of telecommunications and is a prominent body dealing with the global regulation of cyberspace. (99) The ITU partners with the private sector to encourage telecommunications growth in developing countries, in addition to its standard-setting role. (100) "As the organization which sets the baseline for global telecommunications, the ITU standards impacting telemedicine will need to be carefully considered in any international arrangement involving cross-border electronic medicine." (101) But what will happen when things go wrong? Liability of information conduit providers Service interruption in the transmission of computer data is commonplace. However, it is unlikely conduit providers will face significant liability for service interruption, which could have disastrous consequences in the performance of cybersurgery. (102) In the United States, telephone companies provide the best point of comparison. Under tariffs, plaintiffs are afforded incidental Contingent upon or pertaining to something that is more important; that which is necessary, appertaining to, or depending upon another known as the principal. Under Workers' Compensation statutes, a risk is deemed incidental to employment when it is related to whatever a damages. (103) Recently enacted Emergency Service E-911 protects telephone companies from liability for injuries sustained by people using E-911 services for medical treatment or safety. (104) Further, "limited liability under tariff law for hard-wired telephone service is being extended to the media of broadband--the expected media for cybersurgery data transfer." (105) The public policy behind these laws is that companies must be able to charge reasonable rates and to hold information conduit services providers liable would pass on costs to the public through rate increases. (106) To hold an ISP (1) See in-system programmable. (2) (Internet Service Provider) An organization that provides access to the Internet. Connection to the user is provided via dial-up, ISDN, cable, DSL and T1/T3 lines. [internet service provider] liable for intermittent failures in transmission "could result in such extraordinarily high levels of liability that no one would provide Internet services at a reasonable cost." (107) One scholar has made an interesting comparison between dialing 911 and telemedicine, noting that "[d]ialing 911 is the use of telecommunications technology to enhance the delivery of medical care, and could fall under a rough definition of telemedicine." (l08) Emergency 911 failures require too "many conclusions to form a causal connection" to find liability. (109) However, in telemedicine, the doctor uses communication lines more like an instrument, and one could examine the liability for "less than adequate instruments," (110) suggesting that conduit service providers may not, or should not, escape liability. Since surgeons are not required to have any formal training in computer engineering or telecommunications, yet will rely heavily on the technology, it seems that some regulation of conduit service providers will be essential in certain telemedicinal applications such as cybersurgery. B. Jurisdiction When one considers the number of parties involved in a "cybersurgical misadventure misadventure n. a death due to unintentional accident without any violation of law or criminal negligence. Thus, there is no crime. (See: homicide) MISADVENTURE, crim. law, torts. An accident by which an injury occurs to another. " (111) (the telecommunications provider, the robot manufacturer, the doctor and technical team plus the other equipment manufacturers), the idea that the Internet should be treated as its own jurisdiction with its own applicable legal rules is not so far-fetched. (112) Cybersurgery simply defies the traditional principles of jurisdiction as applied to medical malpractice Improper, unskilled, or negligent treatment of a patient by a physician, dentist, nurse, pharmacist, or other health care professional. . Generally, courts view medical treatment as a personal service and the patient's location is considered the point of service in resolving jurisdictional problems. (113) Yet courts have held that if the patient travels to a physician voluntarily without solicitation solicitation In criminal law, the act of asking, inducing, or directing someone to commit a crime. The person soliciting another becomes an accomplice to the crime. The term also refers to the act of obtaining bribes, as well as to the crime of a prostitute who offers sexual , then the patient ought to expect to travel again to that jurisdiction should he or she wish to sue the doctor. (114) There is very little case law with respect to telemedicine and jurisdiction. The one case that barely qualifies as such, Bradley v. Mayo Foundation, (115) does so because a Minnesota doctor changed a Kentucky resident patient's prescription via telephone and subsequently mailed the prescription to the patient in Kentucky, where the patient filled it. (116) In Bradley, the patient alleged the Mayo Clinic Mayo Clinic: see Mayo, Charles Horace. Mayo Clinic voluntary association of more than 500 physicians in Rochester, Minnesota. [Am. Hist.: EB, 11: 723] See : Medicine , which is in Minnesota, failed to diagnose and treat a cancerous bone tumor bone tumor Oncology A generic term encompassing both malignant and benign tumors in bone; most cancer in bone tissue is 2º to metastasis from a distant 1ºs–eg, from breast or prostate; 1º bone CA–eg, osteogenic sarcoma is rare. properly. (117) The lawsuit was filed in Kentucky. (118) The doctor had seen and examined the plaintiff on several occasions at the Clinic in Minnesota and corresponded with the plaintiff by mail and over the phone. (119) After a lengthy minimum contacts analysis, the court concluded that no medical treatment was conducted by the Mayo Clinic in Kentucky. (120) The court noted that written and telephone communications are routine events regardless of a patient's location and were incidental to the in-person examinations which the plaintiff sought out and for which he traveled out of state. (121) The court distinguished this case from McGee v. Riekhof, (122) where a Montana plaintiff traveled to Utah for an eye operation. (123) After the surgery in Utah, the doctor told the patient (who was back in Montana) over the telephone to return to work, where he suffered a severe complication. (124 The doctor was subject to suit in Montana because the sole claim of negligence rested on the telephone recommendation, which was rendered to plaintiff while plaintiff was in Montana. (125) The Bradley court also distinguished the plaintiff's situation from the one in Kennedy v. Freeman. (126) In Kennedy, the plaintiff's doctor in Oklahoma removed a mole from the plaintiff's body and sent the specimen to another doctor in Texas who measured it incorrectly and failed to diagnose melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. . (127) Four years later, cancer had spread over the patient's entire body. (128) The court reasoned that while the Texas doctor did not seek out the plaintiff, he did direct his activities towards her in Oklahoma. (129) The court also noted that the plaintiff did not travel to the doctor's state. (130) Certainly, this is the appropriate outcome, but interestingly, the court did not contemplate the situation where a plaintiff might have traveled to have a suspicious mole measured. (131) Under reasoning similar to Bradley, it seems that the doctor would not be subject to suit outside of his own state. This very small glimpse into jurisdictional problems in medical malpractice indicates there is the potential for inconsistent analysis and that somewhat arbitrary factors are plugged into jurisdictional formulas. Cybersurgery, which defies traditional notions of space and location, will highlight the arbitrary focus on whether a patient physically travels somewhere or not. In cybersurgery, the patient does not travel for services, but essentially is physically present on the doctor's computer screen, and, assuming the patient has consented to the procedure, has sought to make use of the doctor in the patient's own state or country. Further, should a doctor who directs his activities at a patient who otherwise might not be able to receive the proper care necessarily be subject to suit just because technically the patient remained where he or she was? Some of the seemingly logical ideas for determining jurisdiction in a telemedicine (and ultimately cybersurgical) case prove unsatisfactory. "Electronically transporting" the patient to the jurisdiction (the country or state) where the doctor is located (assuming one could even determine before discovery that the doctor was the party primarily at fault) would fail because states will not give up protecting their own citizens and because it would further complicate matters to "transport" patients to foreign jurisdictions. (132) Transporting the physician to another jurisdiction is equally problematic. (133) One reasonable suggestion, focusing on the United States, would be to implement a national telemedicine system with national licensing, allowing for federal court jurisdiction and applying the same law and same procedure for the fifty states when disputes between citizens from different states arise. (134) According to one author, "in the context of an international telemedicine system, federal court jurisdiction simplifies matters for foreign defendants or plaintiffs." (135) However, while this approach is a start, it may oversimplify o·ver·sim·pli·fy v. o·ver·sim·pli·fied, o·ver·sim·pli·fy·ing, o·ver·sim·pli·fies v.tr. To simplify to the point of causing misrepresentation, misconception, or error. v.intr. choice of law issues, especially in the international context, considering some countries do not even recognize medical malpractice. C. Standard of Care Problems In addition to jurisdictional problems, establishing a standard of care is equally difficult. (136) Standard of care problems are inherent in the use of new medical technology on many levels. (137) The lack of sufficient knowledge of technology leads doctors and companies to offer surgical instrument technology to interested patients with alarming consequences. (138) "This form of surgical negligence--injury through ignorance of technology--was most recently demonstrated with the introduction of laparoscopic surgery." (139) Many patients sustained injuries because the surgeons were unable to assess the complexity of the new laproscopic instrument that was required for proper hand-eye coordination hand-eye coordination Eye-hand coordination Surgery Oculomanual synchronization, required by surgeons, especially for laparoscopic surgery. See Laparoscopic surgery, Paradoxical movement. . (140) Surgeons had a difficult time learning how to use laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies equipment, and "[t]hus, the lesson of laparoscopic surgery for the future application of cybersurgery is that, despite all the years of training, a surgeon is no better intellectually equipped to handle sophisticated instruments without specific detailed training than anyone else." (141) In December 2003, the family of a Florida man sued a hospital alleging the surgeon was not adequately trained. (142) The man died after an "aborted a·bort v. a·bort·ed, a·bort·ing, a·borts v.intr. 1. To give birth prematurely or before term; miscarry. 2. To cease growth before full development or maturation. 3. robotic kidney removal." (143) The family alleged that "the hospital was negligent negligent adj., adv. careless in not fulfilling responsibility. (See: negligence) in allowing two doctors lacking experience and training to use [da Vinci[R]]." (144) In the United States, the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. is involved in regulating the use of surgical robots surgical robot Surgery A device used to perform some surgical procedures Pros Smaller incisions, ↓ pain, correction of surgeon error and tremors, ↓ infections and other post-surgical complications, faster recovery, better outcomes Cons . (145) "Recognizing that there is a significant learning curve in the use of the surgical robotic systems, the FDA requires manufacturers to implement training programs for surgeons before surgeons are authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: to use robotic surgical systems on patients." (146) Concerning ZEUS[R], the robot presently available to perform cybersurgery, "Computer Motion [has] to provide an in-depth plan for surgeon training as well as a commitment to conduct this training. Typically, training for the ZEUS[R] surgical system involves approximately 40 hours...." (147) D. Enterprise Liability One method that has emerged in the healthcare industry to ensure rational and consistent recovery in malpractice cases that takes into account the potential pitfalls of new technology is enterprise liability. (148) Enterprise liability shifts liability from individual physicians to business organizations providing medical services. (149) Enterprise liability "envisions that a single provider will be responsible for all negligence that is associated with providing the service of cybersurgery." (150) Under this scheme, a "medical service provider would have a financial incentive to select the best cybersurgical instruments and conduit service provider." (151) The theory is premised on the idea that the "most valuable insights about medical accidents [are] generated by [a health care provider] piecing together a series of apparently idiosyncratic id·i·o·syn·cra·sy n. pl. id·i·o·syn·cra·sies 1. A structural or behavioral characteristic peculiar to an individual or group. 2. A physiological or temperamental peculiarity. 3. incidents to find common patterns in the way that errors, by people or equipment occurred." (152) Cybersurgery, with its multiple parties, increases the risk for "handoff Switching a cellular phone transmission from one cell to another as a mobile user moves into a new cellular area. The switch takes place in about a quarter of a second so that the caller is generally unaware of it. errors," therefore those involved must be provided with the proper financial incentives to reduce errors. (153) A further benefit of enterprise liability, which could counter the potential for errors associated with the use of sophisticated technology, is that a more "nonpunitive culture" would increase error reporting. (154) Enterprise liability decreases the transaction costs Transaction Costs Costs incurred when buying or selling securities. These include brokers' commissions and spreads (the difference between the price the dealer paid for a security and the price they can sell it). of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and "aligns the financial incentives of the cybersurgical provider with the safety interests of the patients." (155) Enterprise liability seems to resolve some of the problems in a country such as the United States where the threat of malpractice looms more than in other nations. Yet "[m]ost industrialized in·dus·tri·al·ize v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es v.tr. 1. To develop industry in (a country or society, for example). 2. countries are not hindered by excessive threats of malpractice actions." (156) Interestingly, the threat of malpractice actually inhibits the growth and use of telemedicine in the United States. (157) Further, enterprise liability will not necessarily help set the proper standard of care. (158) E. An International Standard of Care and Licensing Thinking about the proper training for using robotic equipment (a likely component in showing a breach of the standard of care) forces one to consider that showing breach gets harder and harder as more and more necessary and indispensable parties An individual who has an interest in the substantive issue of a legal action of such a nature that a final decree cannot be handed down without that interest being affected or without leaving the controversy in a condition whereby its final determination would be totally are involved. In addition to doctors, instrument manufacturers and conduit providers, there will be software companies involved, since computer software will control much of the robotic movement. (159) Yet "due to the absence of laws regulating telemedicine on both domestic and international planes, physicians' accountability [will be] reduced since it is more difficult to impose liability [and] the patients' ability to evaluate the quality of care they are receiving is diminished." (160) To realize the potential of telemedicine and cybersurgery, international cooperation is imperative. This is so difficult to achieve because countries have differing licensure requirements, differing laws on license reciprocity reciprocity In international trade, the granting of mutual concessions on tariffs, quotas, or other commercial restrictions. Reciprocity implies that these concessions are neither intended nor expected to be generalized to other countries with which the contracting parties , differing laws on how foreign doctors may practice in a given country, differing technological standards, differing cultural beliefs and differing views on technology in general. (161) "In some respects, the lack of international licensure guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. for the practice of telemedicine is a chicken and egg question. There are few crossnation telemedicine projects. Are there no standards because there are few projects? Or, are there few projects because there is no regulatory framework?" (162) Unexpected factors can influence whether patients will reap the benefits of technology and to what degree different countries are able to collaborate. "Most countries collaborate their telemedicine practices by sharing advanced computers that make telemedicine link-ups feasible. However, the United States limits the sharing of certain technologies to countries because of the potential threats to national security." (163) For example, certain supercomputers are deemed threats because they can launch nuclear weapons. (164) Another major hindrance hin·drance n. 1. a. The act of hindering. b. The condition of being hindered. 2. One that hinders; an impediment. See Synonyms at obstacle. to international agreements with respect to telemedicine may be that countries approve equipment at different rates as well as for different procedures. (165) While complete international harmony with respect to the uses of technology is an unrealistic goal, one must remember that while "[t]he human body is the same throughout the world, laws are different." (166) The establishment of an international standard of care for telemedicine, intertwined with international licensing is most sensible, yet also most ambitious. (167) An international standard of care should be modeled on America's trend towards a national standard of care. In medical malpractice, there are two ways to evaluate the proper standard of care. In the United States, the locality 1. locality - In sequential architectures programs tend to access data that has been accessed recently (temporal locality) or that is at an address near recently referenced data (spatial locality). This is the basis for the speed-up obtained with a cache memory. 2. approach compares a doctor's actions with those of others doctors in similar localities. (168) The national approach holds doctors in the same field responsible for the same knowledge and skill regardless of where he or she is located. (169) There is a trend in some jurisdictions in the United States, given modern education, transportation and communication, to hold doctors to a national standard. (170) With respect to licensing, one may argue that "a national license, even if only for telemedical use would further the establishment of a dependable and logical standard." (171) Further, "a national system would be able to establish a bright line rule as to liability for equipment failure." (172) As strict liability applies to sellers of traditional medical equipment that is deemed defective and unreasonably dangerous, the same could hold true for telemedical equipment. (173) Extending this logic further, a universal standard of care for doctors, equipment manufacturers and conduit service providers involved in cybersurgery could be established. An international licensure scheme would provide local courts and legislatures with what the governing standards should be. (174) "The technology does not obey geographic borders, and neither should standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given ." (175) VI. CONCLUSION Whether cybersurgery will become commonplace remains to be seen. The medical community may well discover that the risks outweigh the benefits. However, the potential for unsolvable or unsatisfactorily resolved legal problems should not be an impediment A disability or obstruction that prevents an individual from entering into a contract. Infancy, for example, is an impediment in making certain contracts. Impediments to marriage include such factors as consanguinity between the parties or an earlier marriage that is still valid. for the full realization of telemedicine's potential. Clear policy recommendations emerge when considering cybersurgery: international cooperation and global standards, a rethinking of the framework for the liability of information conduit service providers, providing for consistent jurisdictional and choice of law outcomes, and creating an international standard of care. These recommendations would not just pave the way for the successful use of cybersurgery, should the medical community choose to embrace the technology, but would also further the less futuristic fu·tur·is·tic adj. 1. Of or relating to the future. 2. a. Of, characterized by, or expressing a vision of the future: futuristic decor. b. practice of telemedicine today. (1.) Fiction does come in, perhaps, in the hope that the state of global health is such that cybersurgery realistically can be on the agenda of many developing countries in the future. But to keep the scope of this Note in perspective, one must consider that: [a]ccording to the WHO [World Health Organization], approximately sixty percent of the world cannot be x-rayed for anything, fifty percent of the world cannot have an ultrasound, and outside the Western world, roughly fifty percent of all imaging is sub-standard and is done with outdated equipment. Furthermore, in many non-Western countries, about fifty percent of the equipment is nonfunctional. Leah B. Mendelsohn, Comment, A Piece of the Puzzle. Telemedicine as an Instrument to Facilitate the Improvement of Healthcare in Developing Countries? 18 EMORY INT'L L. REV. 151, 198-99 (2004). (2.) In 1994, Dr. Marescaux founded IRCAD-EITS, the Institute for Research into Cancer of the Digestive System The Institute for Research into Cancer of the Digestive System (known in French as Institut de Recherche contre les Cancers de l'Appareil Digestif) is a medical research institute dedicated to cancer research and located in Strasbourg, France. , and the European Institute of Telesurgery. Press Conference, IRCAD IRCAD Institut de Recherche contre les Cancers de l'Appareil Digestif (French: Institute for Research into Cancer of the Digestive System, France) , France Telecom, Computer Motion, "Operation Lindbergh" A World First in TeleSurgery: The Surgical Act Crosses the Atlantic! (Sept. 19, 2001) [hereinafter here·in·af·ter adv. In a following part of this document, statement, or book. hereinafter Adverb Formal or law from this point on in this document, matter, or case Adv. 1. Press Conference] (on file with the Rutgers Computer and Technology Law Journal). (3.) Id. at 3. The patient in "Operation Lindbergh" was a sixty-eight year old woman with chronic gall bladder gall bladder, small pear-shaped sac that stores and concentrates bile. It is connected to the liver (which produces the bile) by the hepatic duct. When food containing fat reaches the small intestine, the hormone cholecystokinin is produced by cells in the intestinal problems. She was specially briefed before the operation, toured the Strasbourg facility, saw the robot work, was informed of the risks in compliance with French law, and received a favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. opinion from a patient's rights board in France. Id. (4.) Id. Surgeons in Strasbourg were standing by to intervene if necessary. Id (5.) Press Conference, supra A relational DBMS from Cincom Systems, Inc., Cincinnati, OH (www.cincom.com) that runs on IBM mainframes and VAXs. It includes a query language and a program that automates the database design process. note 2, at 5. Computer Motion "is a high tech medical device company evolving surgical practices to enhance patient lives. The company develops, manufactures and markets proprietary computer-enhanced and robotic surgical systems, which enhance surgeons' capabilities, improve outcomes and reduce costs." Press Release, IRCAD, France Telecom, Computer Motion, Surgeons Achieve World First with Successful Tele-Surgery from New York on Patient in France (Sept. 19, 2001) [hereinafter Press Release] (on file with the Rutgers Computer and Technology Law Journal). The company noted that it had over 150 partners in both the Middle East and Europe and that 65,000 patients have been treated successfully through the use of their products. Id. ZEUS[R] was developed in 1995. Press Conference, supra note 2, at 5. Computer Motion has since merged with Intuitive Surgical. See infra [Latin, Below, under, beneath, underneath.] A term employed in legal writing to indicate that the matter designated will appear beneath or in the pages following the reference. infra prep. note 26. (6.) Press Release, supra note 5. (7.) Press Conference, supra note 2, at 3. (8.) Press Release, supra note 5. "While the present telecommunication technology is limited by a need to physically connect two points with fixed cable, broadband technology broadband technology Telecommunications devices, lines, or technologies that allow communication over a wide band of frequencies, and especially over a range of frequencies divided into multiple independent channels for the simultaneous transmission of different signals. rapidly is supplanting sup·plant tr.v. sup·plant·ed, sup·plant·ing, sup·plants 1. To usurp the place of, especially through intrigue or underhanded tactics. 2. the need to achieve a physical nexus through cable. Broadband technology allows telecommunication without the need for a continuous hardwire connection between the two parties." Thomas R. McLean, Cybersurgery--An Argument for Enterprise Liability, 23 J. LEGAL MED. 167, 169 n. 15 (2002) [hereinafter McLean I]. (9.) Press Conference, supra note 2, at 5. (10.) Id. (11.) Id. (12.) Id. at 3, 5. (13.) See generally Press Release, supra note 5. (14.) Id. (15.) Press Conference, supra note 2, at 9. (16.) Interview with Dr. Janet Norton, MD, FACS FACS Fellow of the American College of Surgeons. FACS abbr. Fellow of the American College of Surgeons FACS fluorescence-activated cell sorter. , Attending Surgeon, St. Vincent's Catholic Medical Center, Staten Island Staten Island (1990 pop. 378,977), 59 sq mi (160 sq km), SE N.Y., in New York Bay, SW of Manhattan, forming Richmond co. of New York state and the borough of Staten Island of New York City. , N.Y. in Newark, N.J. (Nov. 2, 2004). (17.) Press Release, supra note 5. (18.) Press Conference, supra note 2, at 9. An interesting benefit to computer-assisted surgery and similar technologies is that an objective trail of events may be preserved for scrutiny in a lawsuit. See McLean I, supra note 8, at 172 n.27. (19.) Press Release, supra note 5. Of course, surgery using robots is technically remote surgery since the surgeon is removed at least some distance in the operating room from the patient, with the robot as the intermediary. (20.) Brookhill-Wilk 1, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control v. Intuitive Surgical, Inc., 334 F.3d 1294, 1300 (Fed. Cir. 2003). (21.) Press Release, supra note 5. It should be noted that:
Because the speed of light is a constant everywhere in the universe,
there is a limit to how far the surgeon and patient can be
separated ... humans are not capable of coordinating movement when
the time between a signal initiation in the brain and the
corresponding movement is delayed by more than 100 msec ... In a
cybersurgical circuit between a surgeon and patient, the two most
significant sources of delay are great distances (it takes light
eight minutes to travel from the sun to the earth) and the need for
the signal to travel through router switches. A typical internet
connection must past through more than 10 routers. Thus, it will
not be possible for an earth-bound surgeon to operate
cybersurgically on an astronaut in the Alpha-Centurion solar system
(located 4.4 light years away). Whether the coming age of the
"Fibrosphere" (a fiberoptic replacement for the electronic
Internet) will allow for sufficient elimination of router switches
so that a cybersurgeon in Chicago can operate on an Antarctic
researcher with appendicitis remains to be seen.
McLean I, supra note 8, at 170 n.17. (22.) Press Conference, supra note 2, at 9. (23.) Edgar B. Rodas et al., Telesurgical Presence and Consultation for Open Surgery. 137 ARCHIVES OF SURGERY The Archives of Surgery is a monthly professional medical journal published by the American Medical Association. Archives of Surgery publishes original, peer-reviewed clinical and basic research articles addressing new operative techniques, important clinical findings, and 1360 (2002). (24.) See id. (25.) Id. at 1361. (26.) McLean I, supra note 8, at 169. Intuitive Surgical unsuccessfully defended a patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. lawsuit. See Brookhill-Wilk 1, LLC v. Intuitive Surgical Inc., 334 F.3d 1294, 1304 (Fed. Cir. 2003). At the heart of the issue was the definition of the term remote surgery, Id. The court held that while da Vinci[R] was developed anticipating procedures where the surgeon was outside the operating room, the concept of remote surgery still applied when the surgeon was in the operating room since he or she still would not be touching the patient or surgical instruments A surgical instrument is a specially designed tool or device for performing specific actions of carrying out desired effects during a surgery or operation, such as modifying biological tissue, or to provide access or viewing it. and camera. Id.; see also McLean I, supra note 8, at 169. In 2003, Intuitive Surgical merged with Computer Motion, its competitor in the field of high-tech medical robots. See Press Release, supra note 5; see also Press Release, Intuitive Surgical and Computer Motion Close Merger Intuitive Surgical Completes" Reverse Stock Split (June 30, 2003), http://investor.intuitivesurgical.com/ phoenix.zhtml?c=122359&p=irol-newsArtiele&ID=427228&highlight=(on file with the Rutgers Computer and Technology Law Journal). The merger sought to end ongoing patent disputes between the two companies. Press Release, Intuitive Surgical and Computer Motion Announce Merger Agreement (March 7, 2003), http://investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irolnews/ article&ID=389193&highlight=(on file with the Rutgers Computer and Technology Law Journal). Further, the chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Computer Motion stated: [s]eparately, our companies wouldn't be able to accomplish for patients and our shareholders what we will be able to accomplish together. By sharing our complementary technologies in networking, articulation, control and visualization, we believe we will significantly strengthen the surgical capabilities of both the da Vinci[R] and ZEUS[R] product platforms. We look forward to working as one team to enhance the care received by patients through less-invasive surgery. Id. (27.) McLean I, supra note 8, at 169. (28.) Id. at 169n.13. (29.) Id. at 169 n.12. (30.) Thomas R. McLean, Cybersurgery: Innovation or a Means to Close Community Hospitals and Displace dis·place tr.v. dis·placed, dis·plac·ing, dis·plac·es 1. To move or shift from the usual place or position, especially to force to leave a homeland: Physicians?, 20 J. MARSHALL J. COMPUTER St; INFO. L. 495, 498 (2002) [hereinafter McLean II]. (31.) Id. (32.) Since the merger, it is not clear whether cybersurgery is the present focus of the company. At least with respect to da Vinci [R], Intuitive Surgical's website states: "[t]he da Vinci[R] Surgical System can theoretically be used to operate over long distances. This capability, however, is not the primary focus of the company and thus is not available with the current da Vinci[R] Surgical System." Intuitive Surgical, Frequently Asked Questions, http://www.intuitivesurgical.com/products/ faq/index.apsx (last visited Apr. 18, 2006) (on file with the Rutgers Computer and Technology Law Journal). However, the literature suggests that cybersurgery will move forward. See, e.g., Dr. Sunil Shroff n. 1. A banker, or changer of money. , Telemedicine: Possibilities and Realities, MEDINDIA, http://www.medindia.net/ articles/article2.asp (last visited Apr. 2, 2006) (on file with the Rutgers Computer and Technology Law Journal); Melina McDaris-Dass, Telesurgery: The Medical Wave of the Future, U. OF S. CAL. TECH. COMMERCIALZATION ALLIANCE 161, 173-74 (2003). (33.) See McLean II, supra note 30, at 502. (34.) Id. (35.) Id. (36.) Id. at 507. Those that have contemplated this procedure have done so with the understanding that from a legal perspective a malpractice suit for cybersurgery will involve the surgeons and doctors, the robot and other equipment manufacturers, and the information conduit service provider (like a telephone or cable company). See McLean I, supra note 8, at 168. In the United States, applying current statutory and case law to a medical malpractice suit involving cybersurgery, even if the cause of the harm was due to an interruption in transmission that was the fault of the information conduit provider (telephone, cable or broadband), the provider would likely escape liability. See McLean I, supra note 8, at 200; see infra Part V.A. (37.) It is the author's opinion that cybersurgery, even perhaps automatic surgery, will indeed one day be commonplace. Fifty years ago, telemedicine began in its most primitive form with hospitals in four states connected by a telephone link. P. Greg Gulick, E-Health and the Future of Medicine. The Economic, Legal Regulatory, Cultural, and Organizational Obstacles; Facing Telemedicine and Cybermedicine Programs, 12 ALB. L.J. SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec. (hardware) SCI - 1. Scalable Coherent Interface. 2. UART. . & TECH. 351, 364 65 (2002)[hereinafter Gulick I]. At that time the world probably did not conceive of Verb 1. conceive of - form a mental image of something that is not present or that is not the case; "Can you conceive of him as the president?" envisage, ideate, imagine e-mail or laser eye surgery. In the words of a legal scholar and surgeon: [perhaps] the concept of an automatic surgeon ever working, let alone working safely is an impossibility. But, I am sure that was the same response that IBM's management gave to queries about Apple's new personal computer in the early 1980's. Moreover, computerized surgery has already gone well beyond the flirtation or brainstorming stage. Rather the biggest impediment to automatic surgery is whether society is ready to embrace the technology. Hence, the question is not whether the technology exists, but rather whether the market place is ready to embrace the technology. McLean II, supra note 30, at 508-509. (38.) See McLean I, supranote 8, at 170 & n.17. (39.) See id. at 171 & n.21. (40.) Id. at 171 n.121 (explaining that field resuscitation resuscitation /re·sus·ci·ta·tion/ (-sus?i-ta´shun) restoration to life of one apparently dead. cardiopulmonary resuscitation should not delay transporting a trauma victim and noting a study that found unexpected survivors of severe trauma had very short transport times). (41.) Id. at 170. The U.S. military is actually "[o]ne of the most extensive users of telemedicine." P. Greg Gulick, Note, The Development of a Global Hospital is Closer Than We Think. An Evaluation of the International Implications of Telemedicine and the Developments, Uses and Problems Facing International Telemedicine Programs, 11 IND. INT'L & COMP. L. REV. 183, 190 (2000) [hereinafter Gulick II]. One interesting example is the "digital dog-tag," which contains personal information and a soldier's complete medical record, Id (42.) See definition and description of telemedicine infra Section III. (43.) How rural areas of the U.S. have benefited from telemedicine is beyond the scope of this note. However, it is a most interesting topic, and rural healthcare should be of great concern. In the late 1990s, there were 2,682 counties or parts of counties in the U.S. that had "less than one primary care physician for every 3500 persons in those areas." Gulick II, supra note 41, at 192. (44.) Norton, supra note 16. (45.) McLean II, supra note 30, at 506. (46.) Id at 505-506. (47.) Norton, supra note 16; McLean II, supra note 30, at 504 n.38. (48.) McLean II, supra note 30, at 503. The company "developed SOCRATES[TM] precisely to ensure that a learned intermediary exist[s] to accept liability in the event of a products liability suit." Id. at 504. Whether this will survive legal scrutiny remains to be seen. (49.) Id. at 503. (50.) Id. at 500. (51.) Associated Press Associated Press: see news agency. Associated Press (AP) Cooperative news agency, the oldest and largest in the U.S. and long the largest in the world. , UN." Robot Use to Surge Sevenfold sevenfold Adjective 1. having seven times as many or as much 2. composed of seven parts Adverb by seven times as many or as much Adj. 1. by 2007, http://www.livescience.com/technology/robot_increase_041020.html (last visited Apr. 2, 2006) (on file with the Rutgers Computer and Technology Law Journal). (52.) Id. (53.) Id. (54.) Id. (55.) Id. (emphasis added). Robot means "any machine that operates automatically to perform tasks in a human-like way, often replacing the human workers who did the job previously. In most cases, robots move under their own propulsion Propulsion The process of causing a body to move by exerting a force against it. Propulsion is based on the reaction principle, stated qualitatively in Newton's third law, that for every action there is an equal and opposite reaction. and do not need to be controlled by a human operator after they have been programmed." Id. (56.) Id. A sound recommendation for promoting the success of telemedicine in poorer developing counties is government investment. See generally Mendelsohn, supra note 1. (57.) Gulick I, supra note 37, at 364. (58.) Id. at 369. (59.) Id. (60.) Gulick 11, supra note 41, at 184. (61.) Gulick I, supra note 37, at 364. (62.) ATA (1) (AT Attachment) The specification for IDE drives. See IDE. (2) See analog telephone adapter. ATA - Advanced Technology Attachment News and Resources, http://www.atmeda.org/news/definition.html (last visited Apr. 19, 2006) (on file with the Rutgers Computer and Technology Journal). (63.) More information is available on CyberDocs' website, http://www.cyber (1) From "cybernetics," it is a prefix attached to everyday words to add a computer, electronic or online connotation. The term is similar to "virtual," but the latter is used more frequently. See virtual. docs.com. (64.) Shira D. Weiner, Comment, Mouse-to-Mouse Resuscitation: Cybermedicine and the Need for Federal Regulation, 23 CARDOZO L. REV. 1107, 1107 (2002). (65.) Id. (66.) Id. at 1108. (67.) Gulick I, supra note 37, at 355. (68.) Alecks P. Pabico, Health-Cambodia: Telemedicine Brings Care to Indigenous Peoples The term indigenous peoples has no universal, standard or fixed definition, but can be used about any ethnic group who inhabit the geographic region with which they have the earliest historical connection. , http://www.ipsnews.net/interna.asp?idnews=25485 (Sept. 16, 2004) (on file with the Rutgers Computer and Technology Law Journal). (69.) See id. (70.) Id. (71.) Derek F. Meek meek adj. meek·er, meek·est 1. Showing patience and humility; gentle. 2. Easily imposed on; submissive. , Telemedicine: How an Apple (Or Another Computer) May Bring Your Doctor Closer, 29 CUMB CUMB Columbia University Marching Band CUMB Chuckling Under My Breath . L. REV. 173, 178 (1998). (72.) Id. (73.) Id. at 179. (74.) Richard M. Satava, Cybersurgery: A New Vision for General Surgery, in CYBERSUGERY: ADVANCED TECHNOLOGY FOR SURGICAL PRACTICE 4 (Richard M. Satava ed., 1998). (75.) Press Conference, supra note 2, at 9. (76.) Id. (77.) McLean II, supra note 30, at 495. (78.) Conning the IADC IADC International Association of Drilling Contractors IADC International Association of Defense Counsel IADC Inter-Agency Space Debris Coordination Committee IADC Inter-American Defense College IADC International Association of Dredging Companies Newsletters, 67 DEF. COUNS. J. 392, 401-402 (2000). (79.) Id. at 401. (80.) Id. (81.) Id. (82.) Id. (83.) Id. (84.) Id. (85.) Id. (86.) Id. at 401-02. (87.) Id at 402. (88.) Inspiration for all the things that could go wrong comes from Thomas R. McLean. See McLean II, supra note 8, at 179-80. (89.) See Gulick II, supra note 41, at 200. (90.) John D. Blum, The Role of Law in Global E-Health: A Tool for Development and Equity in a Digitally Divided World, 46 ST. LOUIS U. L.J. 85, 86 (2002). (91.) McLean I, supra note 8, at 168. (92.) Blum, supra note 90, at 85. (93.) Id. (94.) Id. at 86. The World Medical Association deals with treatment from a "clinical and human rights perspective." Id. at 87. The International Telecommunications Union focuses on the infrastructure of the network used to transmit the information, not on delivery of that information. Id. The International Bar Association has laid out an international licensure scheme. Id. at 89. It is hoped that a 1997 World Trade Organization ("WTO See World Trade Organization. ") pact, among other WTO agreements, will "increase competition in many world telecom markets, reduce prices and spur infrastructure development." Id. at 90. NAFTA NAFTA in full North American Free Trade Agreement Trade pact signed by Canada, the U.S., and Mexico in 1992, which took effect in 1994. Inspired by the success of the European Community in reducing trade barriers among its members, NAFTA created the world's , in theory, if not in actual practice, should "facilitate the movement of goods and services In economics, economic output is divided into physical goods and intangible services. Consumption of goods and services is assumed to produce utility (unless the "good" is a "bad"). It is often used when referring to a Goods and Services Tax. across borders...." Id. at 91 (noting, for example, exemptions in response to Canada's fear of "American healthcare entrepreneurs," and barriers created by licensing restrictions, which the Canadian provinces Noun 1. Canadian province - Canada is divided into 12 provinces for administrative purposes province, state - the territory occupied by one of the constituent administrative districts of a nation; "his state is in the deep south" and American states "jealously guard." Id. at 92). (95.) Blum, supra note 90, at 97. (96.) Id "International agreements in e-health have the added complexity of being formulated and enforced in a multi-jurisdictional context where choice of law issues may be quite challenging, as parties have the ability to have agreements governed by laws of nations not privy One who has a direct, successive relationship to another individual; a coparticipant; one who has an interest in a matter; private. Privy refers to a person in privity with another—that is, someone involved in a particular transaction that results in a union, to a given contract." Id at 95. (97.) Id. at 97. (98.) Id. at 92. For additional information about the history and goals of the International Telecommunications Union see http://www.itu.org. (99.) Blum, supra note 90, at 94. (100.) Id. (101.) Id. (102.) McLean I, supra note 8, at 197-198. (103.) Id. at 199. (104.) Id. at 200. E-911 is Enhanced 911 as distinguished from Basic 911. Id. (105.) Id. (106.) See id. at 202. (107.) Ian R. Landgreen, "Do No Harm": A Comparative Analysis of Legal Barriers to Corporate Clinical Telemedicine Providers' in the United States, Australia, and Canada, 30 GA. J. INT'L & COMP. L. 365, 375 (2002). (108.) Meek, supra note 71, at 189. (109.) Id. at 190. (110.) Id. (111.) This phrase was coined by Thomas R. McLean. See McLean II, supra note 30, at 501. (112.) See David R. Johnson & David Post, Law and Borders--The Rise of Law in Cyberspace, 48 STAN. L. REV. 1367, 1400-01 (1996). (113.) Meek, supra note 71, at 188. (114.) Id. (115.) No. 97-204, 1999 WL 1032806, at * 2 (E.D.Ky. Aug. 10, 1999). (116.) Id. at * 2. The court stated: Through the years the defendant or its agents have contacted Kentucky physicians by mail and/or telephone regarding Kentucky patients like Mr. Bradley referred to and treated at the Mayo clinic. The Mayo clinic or its subsidiaries also offers "telemedicine" apparently involving telephonic, video, or computer aided methods of providing medical support or education to locations throughout the United States. Id. at * 5. (117.) Id. at "9. (118.) Id. at "3. (119.) Id. at "2. (120.) Id. at *9. (121.) Id. (122.) 442 F. Supp. 1276 (D. Mont. 1978). (123.) Bradley, WL 1032806, at * 10. (124.) Id. (125.) McGee, 442 F.Supp. at 1279. (126.) 919 F.2d 126 (10th Cir. 1990). (127.) Id. at 127. (128.) Id. (129.) Id. at 129. (130.) Id. at 127. (131.) See id. (132.) Gulick II, supra note 41, at 206. (133.) Id. (134.) Id. at 206-207. (135.) Id. at 207 (139.) Id. (140.) Id. at 175-76. (141.) Id. (142.) Bernard Wysocki Jr., Robots in the OR, WALL ST. J., Feb. 26, 2004, at B1. (143.) Id. (144.) Id. (145.) McDaris-Dass, supra note 32, at 169. (146.) Id. (147.) Id. (148.) See generally McLean l, supra note 8. Using laparoscopic malpractice cases as a model, McLean argues that under traditional malpractice and products liability law, plaintiffs will recover irrationally and unpredictably, resulting not only in problems for plaintiffs, but for insurance companies as well, who will ultimately pass costs onto patients. Id. at 204-205. (149.) Id. at 205. (150.) Id. at 207. (151.) Id. (152.) Id. (quoting Kenneth S. Abraham & Paul C. Weiler, Enterprise Medical Liability and the Evolution of the American Health American Health Inc. is a company that manufactures health supplements. It is located in Holbrook, New York. One of its products is labeled the "Chewable Original Papaya Enzyme" with the attached registered trademark, "The 'After Meal Supplement'". Care System, 108 HARV HARV High Alpha Research Vehicle (NASA test plane) HARV High Altitude Research Vehicle HARV High Altitude Reconnaissance Vehicle . L. REV. 381, 412 (1994)). (153.) See McLean I, supra note 8, at 207. (154.) Id. at 207 n.203 (citing COMMITTEE ON QUALITY HEALTHCARE IN AMERICA, INSTITUTE OF MEDICINE, TO ERR IS HUMAN "To Err is Human: Building a Safer Health System" is a groundbreaking report issued in 2000 by the U.S. Institute of Medicine which resulted in an increased awareness of U.S. medical errors. The push for patient safety that followed its release currently continues. : BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al. eds. 1999)). (155.) Id. at 210. (156.) Landgreen, supra note 107, at 376 n.49 (citing A.C. Dummay, Medicine in Virtual Environments, 3 TECH. & HEALTH CARE 75, 75-89 (1995)). (157.) See id. at 376. (158.) Additionally, McLean, a proponent One who offers or proposes. A proponent is a person who comes forward with an a item or an idea. A proponent supports an issue or advocates a cause, such as a proponent of a will. PROPONENT, eccl. law. of enterprise liability, does not extend his discussion to cover cases where the plaintiff and the doctor are in different states, which is exactly what cybersurgery contemplates. See, e.g., McLean I, supra note 8, at 171 n.23. (159.) Id. at 167. (160.) Mendelsohn, supra note 1, at 167. (161.) Id. at 168. (162.) Heather L. Daly, Telemedicine: The Invisible Legal Barriers to the Health Care of the Future, 9 ANNALS an·nals pl.n. 1. A chronological record of the events of successive years. 2. A descriptive account or record; a history: "the short and simple annals of the poor" HEALTH L. 73, 89 n.98 (2000). (163.) Gulick II, supra note 41, at 199. (164.) Id. at 199 n.127 (citing R. Dev. Raj raj also Raj n. Dominion or rule, especially the British rule over India (1757-1947). [Hindi r , Science-India: India Beats U.S. Ban on Supercomputer supercomputer, a state-of-the-art, extremely powerful computer capable of manipulating massive amounts of data in a relatively short time. Supercomputers are very expensive and are employed for specialized scientific and engineering applications that must handle very Exports, INTER PRESS SERVICE Inter Press Service (abbreviated: IPS) is a global news agency. Its main focus is the production of independent news and analysis about events and processes affecting economic, social and political development. , Mar. 30, 1998). (165.) See, e.g., FDA Clearance, Intuitive Surgical, http://www.intuitivesurgical. com/products/fdaclearance/index.aspx (last visited Apr. 2, 2006) (on file with the Rutgers Computer and Technology Law Journal) (noting current FDA approved uses for da Vinci[R]). (166.) Daly, supra note 162, at 105. (167.) See id. at 75. (168.) Meek, supra note 71, at 190. (169.) Id. at 191. (170.) See id. (171.) Id. (172.) Id. at 194. (173.) Id. (174.) See Daly, supra note 162, at 105. (175.) Id. at 104 (citing Jay H. Sanders & Rashid L. Bashshur, Challenges to the Implementation of Telemedicine, 1 TELEMEDICINE J. 115, 120 (1995)). Katherine J. Herrmann, J.D. candidate, May 2006, Rutgers School of Law--Newark; B.A. History of Art, Columbia University Columbia University, mainly in New York City; founded 1754 as King's College by grant of King George II; first college in New York City, fifth oldest in the United States; one of the eight Ivy League institutions. , 2000. The author extends her gratitude to the 2L and 3L editors of the Rutgers Computer and Technology Law Journal for all of their hard work on this Note, and especially to Lauren V. Borrone, whose unparalleled patience, help and good humor Noun 1. good humor - a cheerful and agreeable mood amiability, good humour, good temper humour, mood, temper, humor - a characteristic (habitual or relatively temporary) state of feeling; "whether he praised or cursed me depended on his temper at the time"; will not be forgotten. The author wishes to thank her parents, Richard and Lesley Herrmann, for teaching her how to write, and her fiancee, Gerard A. Savaresse, for his unfailing reminders to edit. This note is dedicated to them, without whose love and support law school would not have been possible. |
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