Cybersurgery: why the United States should embrace this emerging technology.

• Author: Hamilton-Piercy, Meghan

Introduction

John Jones and his wife Maggie are in the mountains of Montana on their 50th wedding anniversary. (1) John has always dreamed of seeing the towering mountains and lush valleys where his parents grew up before moving to the East Coast with their young family, and the couple thought the occasion was a perfect time to get away before advancing age and declining health restricted their mobility. Unfortunately, on the last night of their stay, John started feeling intense pain radiating from his chest down his left arm. The couple rushes to their vehicle and drive fifty miles to the nearest emergency room, with John gasping and getting grayer by every mile marker sign. Upon reaching the tiny local hospital, nurses confirm the couple's worst nightmare--John is in cardiac arrest. The only possible way to save John is through emergency open-heart surgery, and the closest surgeon capable of such a surgery is 300 miles away at the next hospital.

However, the Jones' are fortunate because this local hospital recently opened a new cybersurgery wing which would allow John access to a surgeon in New York via remotely operated surgical device. As soon as John is anesthetized and the physician assistant has prepared the device, the surgeon in New York connects via broadband technology and performs the critically needed surgery. With the accuracy of both the skilled surgeon and the robotic machine, only a small sized incision is made. Within days, John is healing and back on the East Coast surrounded by his grandchildren. Without the remote surgery, John would have died within the hour. Although this sounds like science fiction, the scenario described above has already played out in reality several times. (2) The particular circumstances may have been different - perhaps someone suffered a gallbladder attack, or a mother gave birth to an infant with a heart malformation--but remote surgeries are no longer a technology of the future. (3) Cybersurgery is the term that describes a surgical procedure where a surgeon with access to a control panel in one location utilizes a telecommunication connection to control a medical device in another location. (4) The technology was first used when the Food and Drug Administration (FDA) approved the first medical device intended for robotic surgery in July 2000. (5)

The practical implications of this technology are far-reaching. Medically under-served areas could offer their patients access to the most qualified specialists; third world countries could offer their citizens United States quality healthcare; dying members of the armed forces could be moments away from salvation via a mobile cybersurgery vehicle. The list goes on. However, despite the potential for overwhelming benefits, substantial legal obstacles hinder this technology's future. 6 This Note will focus on the possible implications of cybersurgery for Americans, and the need for the United States government to facilitate the entrance of this technology into our healthcare industry.

Part I will discuss the origins and current state of cybersurgery. Part II will discuss the obstacles facing the cybersurgery field and the current state of healthcare and the healthcare industry in the United States. Part III will discuss the possibilities this technology could hold for the United States, including savings for the healthcare industry, strides in the global economy, and improvements of the quality of healthcare. The current steps the United States has taken toward embracing this technology and how the United States can further support the cybersurgery field will also be discussed in Part III.

Part I - History

Cybersurgery is part of the broader field of medicine called telemedicine. (7) The definition of telemedicine, or telehealth, varies across jurisdictions within the United States. (8) The federal definition of "telehealth services" for Medicare reimbursement purposes changes frequently and is defined based on coverage of specific services rather than a broad idea of what telehealth means. (9) Generally, the main themes in all of the formal definitions of telehealth are the movement of health information via electronic or telecommunicative means and the provision of medical services via electronic or telecommunicative means without direct face-to-face interaction between the healthcare professional and the patient. (10)

While experiencing growth in the medical field, telehealth poses many challenges for the legal field. Regulators must strike a balance between making treatment safe and keeping medical information secure and confidential, while not stymieing the progress of the medical field in this new direction. (11) While cybersurgery shares some of these challenges, it poses its own separate obstacles and rewards as well. (12) For example, from a legal standpoint, one can just imagine the multitude of issues that arise from the surgery performed on John Jones in the previous hypothetical situation. If something went wrong who would be liable: the surgeon, the device manufacturer, the local hospital, or the telecommunication connection provider? Does the New York surgeon need to be licensed in Montana? Will the Montana hospital be reimbursed by John Jones' insurance? If so, how does the New York surgeon get paid? The answers to many of these questions are unclear, or worse, the answers merely create more questions. (13)

As noted above, cybersurgery was born with FDA approval of the first robotic surgery device, Intuitive Surgical's da Vinci [R] Surgical System. (14) Intuitive Surgical's main competitor, Computer Motion received approval for its robotic machine Zeus [R] shortly thereafter. (15) On September 20, 2001, the first cybersurgery was performed via fiber optic cable where a French surgeon named Dr. Marescaux, operating from New York, used da Vinci [R] to successfully remove the gall bladder from a patient in Strasburg, France. (16) Not long thereafter, German and Japanese surgeons conducted their own successful surgeries. (17)

The cybersurgery field is starting to grow, even though many of the approximately 400 da Vinci [R] devices in the marketplace are utilized with the control panel, robot, and patient all in one location. (18) In 2004, the Canadian government opened the Centre for Minimal Access Surgery, where surgeons have performed many surgeries from Hamilton, Ontario while their patients were in North Bay, Ontario. (19) In March 2005, SRI International announced that the company is collaborating with the United States Defense Department's Advanced Research Projects Agency to develop a mobile trauma unit for use in the United States military. (20) SRI is receiving $12 million in grant money in 2006 and 2007 to develop a mobile unit to hold surgical robots which can connect via a wireless connection to a distant surgeon who can stabilize wounded soldiers in preparation for movement to a military hospital. 21 Such advances show progress in the fledgling cybersurgery field.

Although the cybersurgical field seems to be progressing, the legal obstacles surrounding this technology have created resistance to its widespread acceptance. (22) For example, the World Medical Association previously promulgated guidelines which stated that telemedicine should only be used in emergency situations to provide care to patients that have no other access to physicians. (23) Also, Intuitive Surgical does not include a distance-surgery capability on their current da Vinci [R] systems because cybersurgery is not the focus of the company. (24) Such obstacles will be the focus of the next section.

Part II - Facts

As noted above, cybersurgery holds promise for the advancement of modern medicine in the United States, but the current state of the law and general resistance to the new technology are inhibiting the expansion of this area of telemedicine. (25) Some of the obstacles include the following: physician resistance for fear of being displaced by technology; practitioner fear of exposure to liability; the general quagmire of licensure laws within the many jurisdictions of the United States; the lack of international agreements to handle cross- border medical service transactions; and the absence of a reimbursement schedule. Additionally, there are still a few practical problems posed by technological limitations. Privacy concerns must also be solved.

1. Fear of Displacement

   Many of the benefits from cybersurgery come from the ability of surgeons to practice without regard to location. (26) For example, a surgeon sitting at a control panel connected to several locations worldwide could perform many more surgeries than if the surgeon himself had to travel from operating room to operating room, thereby increasing efficiency and decreasing waste. (27) However, increases in efficiency and the practice of medicine regardless of physical location means that every physician is a potential competitor within their specialty regardless of geographic location. Fewer surgeons would be needed to do the same number of surgeries. (28) Surgeons in rural or community hospitals who do not have the same level of experience as those in urban areas may be displaced from their field. (29)

   Consider the hypothetical above. John Jones is in Montana in need of an emergency surgery. Rather than being transported to the nearest surgeon who could perform the needed surgery, Mr. Jones is operated on by a New York surgeon. If this happens on a regular basis, the Montana surgeon may experience a decrease in the number of procedures she performs. If the other hospital is more convenient for many potential patients, the Montana surgeon may lose so many patients that her hospital employer decides to cut the cardiac surgery department. (30) Or, perhaps the hospital sees the success of the cybersurgical program where John Jones received surgical attention and buys its own robotic cybersurgical device and hires remote surgeons. The Montana...