Have a surgical robot, why not provide cybersurgery?

The Canadians have taken cybersurgery, that is, remote robotic surgery, from a prototype demonstration to a limited, but operational, model. Compared with traditionally provided surgical care, cybersurgery has a number of advantages including operation with greater economies-of-scale and the avoidance of transportation costs. So, why have more countries not followed the Canadians’ lead? The answer seems to be a combination of three factors: an uncertain legal environment, money and communication skills. This article discusses these factors and concludes that, while these factors may retard current market growth because change is often non-linear, small changes in one or two of these factors could stimulate substantial growth in cybersurgery.

Cybersurgery is not a new concept. In late 2001, a French surgeon located in New York (NY, USA) performed a cholecystectomy on a patient located in rural France using a da Vinci^® surgical robot (Intuitive Surgical, Mountainview, CA, USA) and a virtual private network (VPN) telecommunication link [1]. Compared with traditional surgical care, cybersurgery holds out the promise of operating with greater economies-of-scale and allowing countries to avoid substantial transportation costs [2]. Thus, it is not surprising that the Canadians, who operate a universal access healthcare system for a widely dispersed population, have moved cybersurgery from the prototype stage to an operation model [3].

Of course, cybersurgery has its disadvantages; especially the substantial amount of capital needed to enter the market [4]. However, the recovery of this capital investment in cybersurgery is not impossible as newer markets may open in response to robotic surgical technology. For example, under certain economic conditions it may be possible for developed nations to export cybersurgery to developing countries [5]. So, why is it that so few countries have shown any interest in developing their cybersurgery markets?

In order of importance, three reasons that appear to be hindering the market growth of cybersurgery are: an uncertain legal environment, money and communication skills. Acting individually and in concert these factors suppress the commercial development of cybersurgery. Herein, this article (which is not intended to be comprehensive) examines how these three economic factors tend toward stifling the growth of cybersurgery. This article concludes that, just as economic barriers to other markets are ultimately removed, so will these to the cybersurgery market; thereby rewarding providers and investors who have researched the market.

Uncertain legal enviroment

The legal uncertainty associated with providing cybersurgery arises from a number of sources, including medical malpractice, conduit provider liability, audit trails, jurisdiction and intellectual property. Much of this uncertainty is novel. However, the novelty of the uncertainty associated with cybersurgery only compounds the situation because even when the perils of a risk are well recognized, risk management is more of an art form than a science [6]. Accordingly, cybersurgery legal uncertainty is likely to retard market growth (especially in the international sector) for some time, while the rules for apportioning risk are elucidated [7].

Malpractice

Perhaps the most difficult cybersurgical risk arising from legal uncertainty concerns the risk of a medical malpractice suit. While no cybersurgical medical malpractice litigation has been reported, the first case of medical malpractice involving a surgical robot was recently reported. In this case, Mr Greenway, who underwent a prostatectomy, died after sustaining an injury to his aorta and inferior vena cava [8]. The publicly available facts in this case suggest that the litigation degenerated into a ‘finger-pointing’ case; where two or more defendants asserted that the other party was at fault. From the plaintiff’s point of view, finger-pointing cases are desirable because they almost always settle. In the Greenway case, true to form, the conclusion was a settlement with the surgeon settling at his policy limit, and the hospital settling for an undisclosed sum.

However, there is more to this story. It is generally under-appreciated that medical malpractice cases involving medical devices, such as surgical robots, virtually all degenerate into finger-pointing cases. When an adverse surgical outcome is associated with a medical device, the plaintiff is likely to file a product liability lawsuit against the medical device manufacturer in addition to suing the surgeon and hospital for medical malpractice [9]. While the products liability and medical malpractice actions may procedure in separate court rooms, the addition of the device manufacturer means that another defendant will attempt to shift blame. In particular, if the medical device manufacturer can convince a jury that the adverse clinical outcome was due to the surgeon’s or hospital’s error, the medical device manufacturer can avoid having to pay any damages to the plaintiff.

Moreover, the medical device manufacturer is highly motivated to shift blame through expert testimony to the medical providers. Unlike medical malpractice litigation against a physician, where damages are frequently limited by a number of legal mechanisms, in a product liability action a manufacturer faces unlimited liability. The losses in a product liability action are perhaps more frightening to manufacturers because they are frequently held to a higher standard of care (i.e., strict liability) than medical providers. Such motivation to shift blame to healthcare providers after adverse events helps explain why the surgical robotics manufacturer involved in the Greenway litigation conducted a timely inspection of its surgical instrument and concluded that its machine was in perfect working order.

Telecommunication conduit

As complex as the blame-shifting game can become with robotic surgery; it will be even more complex after an adverse cybersurgery event. This is because there will be a fourth defendant to point an accusatory finger: the telecommunication company that provides the VPN. Traditionally, telecommunication providers have not been held responsible for service interruption [10]. This policy consideration was extended to telecommunication providers because, first, before the mid-1980s it was hard to imagine that the transmission of a voice signal could harm another person; and, second, allowing some individuals the privilege of recovering damages from a telecommunication provider for service interruption would only result in everyone having to pay a higher rate.

For anyone contemplating entering the cybersurgical market, it is not hard to imagine a patient being harmed during a cybersurgical procedure by the interruption of a VPN transmission. And, if VPN service interruption did result in patient injury, it should be expected that the telecommunication provider would assert that it was not responsible for the adverse cybersurgical outcome, thereby leaving the robotics manufacturer, surgeon and hospital to pay for an injury caused by the telecommunication provider. Such an outcome would hardly be equitable.

There are three approaches to handling the legal liability of telecommunication interruption during a cybersurgical operation. First, the surgeon, hospital and robotics manufacturer could contract away any liability for telecommunication interruption. That is, the contract for VPN service would stipulate that the telecommunication provider was responsible for service interruption; and, in the event of a patient being harmed by VPN service interruption, the telecommunication provider would indemnify other defendants. The problem with this approach is that the telecommunication provider may not agree to sign such a contract.

The second method for handling the uncertainty of VPN interruption during cybersurgery would be to obtain an insurance policy that covered any injury during a cybersurgical procedure, regardless of cause. The limitation of this approach is that an insurer may not know how to accurately assess the risk of VPN interruption. This means that until the risks of cybersurgery are more clearly defined, any insurer willing to cover all cybersurgical injuries is likely to demand a significant premium.

The final method for handling the risk of VPN interruption during cybersurgery can be used when the surgeon, hospital and/or robotics manufacturer fail to prospectively allocate risk prior to a patient’s injury. In the absence of a pre-existing agreement, the traditional defendants of a medical malpractice and/or products liability action could file a lawsuit seeking contribution from the telecommunication provider for an injury caused by VPN interruption. The key argument here would be that the telecommunication provider is not entitled to immunity for service interruption during a cybersurgical operation because of a material change in circumstances. That is, because telecommunications now provides more than voice transmission, telecomunication providers are no longer entitled to protection developed for a bygone era. This argument is supported by policy considerations in the Telecommunications Act of 1996 [11]. Under the Act, telecommunication companies that provide only basic (voice) telephone services continue to be free from liability for service interruption. By contrast, telecommunication providers who offer enhanced services, like data transmission and VPN cybersurgery hook-ups, are liable for service interruption.

Of course, making the telecommunication provider a potential defendant following an adverse cybersurgical outcome only makes the finger-pointing case more complex. Regardless of whether a telecommunication provider is held potentially responsible for adverse events by indemnification, insurance contract or litigation the telecommunication provider will have an incentive to shift blame to one of the other defendants. With so many defendants willing to point a finger after an adverse cybersurgical outcome, without some form of tort reform, settlement is likely to be the rule after cybersurgical misadventures, a fact that is likely to attract more of the plaintiffs’ bar.

Audit trails

In any litigation involving an uncertain legal terrain, the outcome turns on the evidence; and this will be true of litigation cybersurgery. Yet, as we move into the world of high-tech robotic medicine, few providers are aware of liability associated with metadata evidence. Commonly defined as ‘data about data’, metadata are automatically generated by virtually all computer programs [12]. The importance of metadata is that it creates an audit trail of the computer’s use. Metadata audit trails may contain information such as when the computer was used, who used it, how the computer was used and when the computer underwent routine maintenance.

Robotic surgery is only possible because computers facilitate the translation of the surgeon’s hand movements into position changes of the robotic instrument. This means that the computer in the robotic instrument will contain a wealth of metadata information. When the robotic manufacturer in the Greenway litigation investigated the competence of its machine, the manufacturer undoubtedly reviewed the robots metadata. From a legal perspective, what is important about metadata is that the recent changes to the Federal Rules of Civil Procedure allow virtually all metadata to be discovered. To the extent that any cybersurgery provider is unaware of the wealth of metadata held within a surgical robot, the provider creates an uncertain legal risk of harboring damning information. (Conversely, in other situations metadata may be exculpatory.) Accordingly, the robotic or cybersurgery provider’s best interest is served when the provider takes the time to familiarize themselves with the metadata stored within the robotic instrument.

Jurisdiction

When jurisdiction is discussed in the context of telemedicine, the focus of the discussion is usually on the licensure status of the remote physician. While proper licensure is important, it is not controversial. As a general rule, any person who provides medical care without a license commits a felony. Owing to the criminal nature of providing medicine without a license, the person providing such care may be extradited to a remote jurisdiction under the principle of extraterritorial jurisdiction [13]. What is controversial about jurisdiction, however, is whether an unlicensed physician will actually be extradited and whether a victorious plaintiff in a medical malpractice action can collect a judgment against a cybersurgery provider.

Just because a legal theory allows for extradition that does not mean that all such defendants will be extradited. Extradition is a complex process that requires the cooperation of the forum jurisdiction requesting extradition and the remote jurisdiction rendering extradition. Within the USA, cooperation between the states to prosecute unlicensed providers is the rule. However, the same is not necessarily true if the provider is located in a foreign jurisdiction. As general rule, countries rarely extradite their citizens, unless of course the citizen is charged with a capital criminal offense. Unfortunately, practicing medicine without a license is not a capital criminal offense. This means that rendering jurisdictions are unlikely to extradite their telemedicine providers.

Second, extradition of cybersurgeons, and more generally any telemedicine providers, may be against a foreign jurisdiction’s best interest. In such situations, it is even more unlikely that the rendering jurisdiction will extradite its citizen-entrepreneurs. For example, consider India with its trade policy goal of gaining a larger share of the American healthcare market. Accordingly, any Indian telemedicine provider who successfully exports millions of dollars of telemedicine service to the USA will be considered a patriot; and countries rarely extradite their patriots. True, the USA may be able to obtain some redress from telemedicine trade imbalances through the negotiations of its trade representative, but the USA is unlikely to extradite a successful Indian cybersurgeon from India.

Extradition of a cybersurgical provider to stand trial for medical malpractice, a civil action, is also unlikely. The burden of proof to extradite an individual from a foreign jurisdiction to stand trial for a civil offense is determined by a minimal contact analysis. While a detailed discussion of minimal contacts is beyond the scope of this paper, an injured plaintiff is more likely to recover damages by filing a lawsuit against the local facility that provided the cybersurgery service for the negligent hiring and supervision of the cybersurgery provider. Furthermore, while the legal details of such a lawsuit are beyond the discussion of this paper, all that needs to be recognized here is that jurisdiction in international medical malpractice actions will be another factor that places cybersurgery in a legal state of ambiguity.

Intellectual property

The final hard-to-quantify legal risk of providing cybersurgery concerns patent law. During the 1990s the USA (and other countries) liberally granted patents for medical processes. One of these patents was the Wilk-Brookhill (WB) patent for the performance of remote robotic surgery [14]. After Intuitive Surgical placed the da Vinci^® surgical robot on the market, the holder of the WB patent filed a lawsuit alleging that Intuitive Surgical had infringed on its patent. After several years of litigation, Intuitive Surgical ultimately settled the case; and received, in essence, a functional title to the WB patent.

In general, a valid patent provides the title holder with a market monopoly. For cybersurgery, this means that anyone interested in entering the market needs to be aware of the potential to pay Intuitive Surgical tribute, in the form of royalties or licensure. If Intuitive Surgical were to adopt such a business strategy the transaction costs for cybersurgery could increase, thereby slowing market growth because traditional, less expensive surgery would be more attractive.

A recent Supreme Court decision, however, has placed the validity of WB patent in jeopardy. For a patent to be valid it must describe technology that is novel, nonobvious (meaning not previously described) and useful. In the case of KSR International versus Teleflex the requirements of the nonobvious element of a patent were challenged [15]. The Court concluded that requirements for an invention to be nonobvious were more onerous than had previously been understood. Accordingly, the patent in KSR International and the many medical process patents granted in the 1990s are likely to be invalid. How much protection the WB patent now provides Intuitive Surgical is an open question. If the WB patent was found to be invalid, the economic barriers to entering the cybersurgical market would be lowered. Unfortunately, testing the validity of the WB patent will require litigation that could cost the challenger several millions of dollars in attorneys’ fees. In short, anyone contemplating entering the cybersurgery market should consider:

•	Secure a patent waiver/release from Intuitive Surgical
•	License the right to use the patent from Intuitive Surgical
•	Be prepared for expensive litigation.

Money

In any market, money matters; and money certainly matters in cybersurgery [16]. Presently, reimbursement and the capital needed to enter the market are significant barriers to the development of a cybersurgery. However, small changes in the market could rapidly eliminate these barriers.

Reimbursement

As with other forms of telemedicine, concerns over reimbursement are likely to negatively impact the expansion of cybersurgery. Traditionally the government and private insurers have only provided compensation for face-to-face doctor–patient interactions. Such a policy makes it difficult for telemedicine providers to recover their initial investments in technology and other network infrastructure expenses. Indeed, a recent not-for-profit organization’s review of provider reimbursement for telemedicine concluded that the reimbursement prejudice against telemedicine was the biggest obstacle to market expansion [101]. Overcoming institutional resistance to providing reimbursement for telemedicine and/or cybersurgery will not be easily.

To illustrate, consider what might happen if a hypothetical Bangalore Cybersurgical Associates (BCA) attempted to enter the American healthcare market. The lessons from medical tourism are:

•	Foreign providers (with lower labor costs) can often substantially undercut the price of American healthcare providers
•	American patients are willing to spend out-of-pocket dollars to obtain less expensive healthcare abroad

If it could be shown that BCA provided healthcare quality comparable to that of traditional services provided by American surgeons, it seems likely that some patients would obtain their elective surgical needs from BCA. In particular, Americans would purchase care from lower-priced foreign cybersurgeons to avoid having to travel. As nothing prevents American patients from spending personal savings or health savings account dollars on foreign healthcare, companies like BCA may be able to rapidly gain a significant share of the USA healthcare market.

On the other hand, BCA could be a victim of its own success. As BCA gains market share it will attract the attention of the large healthcare lobbies, such as the American College of Surgeons (ACS). It seems likely that to protect its members, the ACS would lobby for trade barriers to keep BCA out of the American market. How successful lobbying efforts would be is hard to determine; because eliminating foreign competition from the American healthcare market only serves to keep the price of medical services to artificially high levels. Accordingly, ACS’ lobbying for trade barriers would only alienate consumer-patients.

Robotics costs

As mentioned, any cybersurgical operation will have to recover start-up capital and operational expenses. Currently, Intuitive Surgical is the only surgical robotics manufacturer in the world. Having several patents to aid in the protection of its market, Intuitive Surgical’s da Vinci robot sells for US$1.0–1.5 million; a price tag that has not substantially changed since it was introduced to the market. But the expense of the surgical robot only tells part of its financial story. Each robotic operation consumes several expensive disposable instruments during each operation. Given the current state of reimbursement, the added cost of the disposable instruments means that in many areas of the USA, providing robotic surgical services is a money-loser when compared with the same operation provided laparoscopically.

Nevertheless, this situation may change rapidly if a profit could be earned by providing robotic or cybersurgery. In particular, other manufacturers may enter the robotic instrument market and drive down the price of the surgical robot and its disposable instruments. The most likely home for such a manufacturer is China. In today’s manufacturing world, the Chinese have become adept in reverse engineering virtually any manufactured good; and the Chinese often appear to have little respect for the patent laws of other countries [17]. China, moreover, has a vast population in desperate need of Western-style healthcare. These observations suggest that China may someday consider entering the robotic surgical market to produce a copy of the da Vinci robot for their own citizens. While the quality of a Chinese-made surgical robot, its staff support and its price would remain to be determined, if experience in other aspects of manufacturing sector are any indication, Intuitive Surgical could someday face real competition. And while Chinese competition may be bad news for Intuitive Surgical’s shareholders, Chinese manufactured surgical robots could jump start the cybersurgical market.

Communication skills

The final factor impeding the expansion of the cybersurgical market is language skills. Unlike the manufacture of goods, which can often be outsourced to the country with the lowest labor costs, services are different; the production of services is language dependent. Regardless of whether robotic surgery is performed in the same room as the surgeon, or is performed in a room a continent away, the surgeon must be able to communicate with the remote operating room technicians who position the patient and change out the various armatures of the robots. As in any operation, there is no place for miscommunication in the performance of cybersurgery.

Currently, if a cybersurgical procedure is performed domestically, (i.e., with the patient and surgeon located in the same country), the risk of miscommunication should be minimal. But the risk of miscommunication and, hence, adverse outcome, will be much more likely in the international cybersurgery market. The more diverse the languages of the cybersurgeon and the remote technicians, the more likely errors will occur that can lead to a medical malpractice action. True, these languages differences can be minimized by sending technicians from the cybersurgeon’s home country to the foreign market; but the relocation of technicians abroad will only increase the transaction costs of cybersurgery. This suggests that in the international market it may be sometime before unit costs of cybersurgery are on a par with the unit costs of traditional surgery.

Conclusion

To keep this article to a reasonable length, complex issues have only been briefly discussed. Presenting the information in this way may leave some readers with the impression that, in aggregate, law, money and communication skills will forever limit the growth of cybersurgery. This would be wrong. Change often happens nonlinearly and thus can occur rapidly [101]. For example, if the Chinese begin to mass produce surgical robots, the price of the instruments would fall. With more robots in the hands of providers the lobbying for better reimbursement for cybersurgery will become. Once a mechanism for reimbursement is in place, more providers will be willing to purchase surgical robots. In short, a positive feedback cycle could drive the development of cybersurgery. But until that tipping point is reached, uncertainty in the law, a lack of reimbursement and a need for cybersurgeons to communicate with their remote technicians will probably limit the size of the cybersurgery market.

Financial & competing interests disclosure

Nothing in this article should be construed as the Department of Veterans Affairs policy or procedure.

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.