I. INTRODUCTION
The year is 2050. A woman in Cuenca, Ecuador unexpectedly gives
birth to conjoined twins who require immediate surgery in order to
survive. Although the mother has been receiving excellent prenatal care
in a well-equipped hospital with a neonatal 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, 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 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, 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, 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 (2) used a computer
in New York City 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. (5) France Telecom, one of Europe's
top three Internet service providers 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, 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 operated by
the surgeon from a remote console (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 worked at the robot control station, with a computer transmitting
his commands. (12) Using a headset, 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 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, also known
as laparoscopic surgery, 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 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
herniorraphy (hernia surgery), performed in Cuenca, Ecuador. (23)
Through the Cinterandes Foundation's mobile surgical facility,
surgeons, doctors, and students in Richmond, Virginia 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 (ISDN)
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[R] system from Intuitive
Surgical. (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. (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 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, 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. (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]."
(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(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 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. However, the cost of robots is declining and usage by the
world's population is increasing. (51) According to the U.N.'s
2004 World Robotics Survey, the domestic use of robots will surge by
2007, a boom "which [will coincide] with record orders for
industrial robots." (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, 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 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, 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 uses for
telemedicine is "medical practice across distance via
telecommunications and interactive video technology." (61) Finally,
the American Telemedicine Association 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 surgeons. (71) At Johns Hopkins University, 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," 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
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 leaves a
person with closed head injuries. (79) A CAT 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 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 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 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, informed consent,
and telemedicine standard for development." (95) However, as more
countries develop laws and regulations, it will further complicate the
formation of private contracts, (96) and pose "challenges for the
harmonization of e-health with trade law" (97) at the public level.
A. Telecommunications
The International Telecommunications Union (ITU) 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 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 [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" (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.
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,
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, which is in
Minnesota, failed to diagnose and treat a cancerous bone tumor 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. (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 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. (140) Surgeons had a difficult time learning how to use
laparoscopic 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 robotic kidney removal." (143) The family
alleged that "the hospital was negligent in allowing two doctors
lacking experience and training to use [da Vinci[R]]." (144) In the
United States, the FDA is involved in regulating the use of surgical
robots. (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 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 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 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 of 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 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 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, 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 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 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 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." (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 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 jur