In Hays, Kansas, an infant is born with a heart murmur. Because there is a slight chance of severe cardiac problems when this happens, Robert Cox, M.D., a pediatrician and medical director of rural development and telemedicine at Hays Medical Center, seeks the advice of a cardiologist in Kansas City, which is 270 miles away. Yet the infant and Cox never leave the small town of Hays.
Instead, using interactive videoconferencing, the cardiologist in Kansas City examines the infant and listens to the heartbeat as a technician in Hays holds an instrument similar to a stethoscope against the baby's body. The cardiologist also can view the baby's chest x-ray and electrocardiogram. Because of this technology, Cox says, "Today, we refer only 1 percent of infants with heart murmurs to an out-of-town hospital, instead of 100 percent."
An elderly man who has trouble walking is referred to a small hospital in rural West Virginia. "Even after doing a complete physical exam, no one was sure what the problem was," recalls James Brick, M.D., a rheumatologist and medical director of the telemedicine program at the West Virginia University School of Medicine in Morgantown.
So a medical student at the rural hospital used videoconferencing to present the patient's case to the chairman of the university's neurology department. The neurologist examined the patient, put him through various tests, and made a diagnosis of amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease.
These doctors are practicing telemedicine, which involves the use of computers and telecommunications equipment to provide health care over long distances. It is actually an extension of one of the oldest, simplest, and most popular forms of electronic medical consultation: a telephone conversation between doctor and patient or a medical generalist and a specialist. But, unlike the telephone, some aspects of telemedicine are regulated by the Food and Drug Administration.
Telemedicine Technology
Teleradiology is the oldest form of telemedicine referenced in the medical literature and one FDA has been involved in since 1977, according to Melvyn Greberman, M.D., of FDA's Center for Devices and Radiological Health. As now practiced, this technology involves creating and transmitting medical images, such as x-rays or computed tomography scans, electronically in the form of a digital signal from one location to another. An expert at a distant site receives the images, evaluates them, helps make a diagnosis, and suggests additional care as needed. The process is much like sending an x-ray by mail or courier--but with telemedicine, the transmission is almost instantaneous.
FDA and the medical community share responsibility for ensuring the safety and effectiveness of the medical devices used in the telemedicine process. For example, photographs of a suspicious skin lesion can be sent electronically as digital images. The images are then reconstructed for display on a monitor and read by the doctor who receives them.
"The question that the doctor should ask is, 'Is the resulting image adequate for the purposes intended?'" FDA's Greberman says. "If an image will be used for diagnosis, then the clinician must be certain that it has sufficient detail to permit accurate interpretation."
For example, he says, the digitized image, which may be compressed to reduce transmission time and storage requirements, should not have degraded significantly in quality when it is viewed as a reconstructed image. "FDA requires a manufacturer to indicate on-screen when compression that results in the loss of some data is used, but the doctor must determine the impact of this compression on the clinical adequacy of the image," he adds.
Another form of telemedicine is interactive videoconferencing, also known as interactive television and interactive teleconferencing. This technique permits two doctors and a patient to confer simultaneously, even though they are at different sites. For example, a camera in an examining room would enable one doctor to present the patient to the other. The other doctor, usually a consultant, also in front of a video camera, would offer an opinion.
Nurses and other health professionals also can use interactive television to monitor patients at home. For example, in Hays, an older woman receives regular visits from a home health nurse via cable television.
The woman's television emits a beep two minutes before the nurse is scheduled to check on her. The patient switches on the television, which also is equipped with a small videocamera. She can see the nurse, and the nurse can see her. The nurse assesses the patient's overall appearance; reviews her temperature, blood pressure, and other vital signs; and reminds her to take her medication.
"With this technology, we found that one home health nurse could visit nine patients in one morning during a blizzard, simply by working from her base station," Kansas doctor Cox says.
The same technology also is used for educational purposes. For example, the Georgia Telemedicine Network, which is based at the Medical College of Georgia in Augusta, links the medical college with 44 sites throughout the state, including the Eisenhower Army Medical Center and Emory University Medical Center, according to Max Stachura, M.D., the network's executive director. Medical students in remote locations take classes at the university, doctors earn continuing medical education credits, and health information is communicated to the public.
FDA's Role
FDA's primary role with respect to telemedicine is to review the devices, or hardware, before clearing them for marketing and to conduct postmarketing surveillance--that is, to be aware of significant problems that occur after the devices are marketed.
In July 1996, the Center for Devices and Radiological Health issued the report "Telemedicine Related Activities." It reviews current and potential areas of telemedicine of interest to FDA and is available on the World Wide Web at http://www.fda.gov/cdrh/telemed.html.
Certain medical software products that may be used for diagnostic purposes also fall under FDA's jurisdiction. However, other government agencies--such as the Federal Communications Commission, which regulates some aspects of the communications technologies--are involved in telemedicine, as well. The Federal Joint Working Group on Telemedicine, of which FDA is a participant, includes representatives from various government agencies working together to clarify regulatory issues related to telemedicine.
Benefits
Telemedicine advocates believe the technology can make a critical difference in health-care delivery in rural communities, where access to specialized care is often sporadic and people may hesitate to travel long distances to see a doctor. With telemedicine, experts say, patients can benefit from the expertise of distant specialists and still receive treatment in the community.
Kansas doctor Cox notes, for instance, that his clinic has established a relationship with a hematologist/oncologist (a specialist in blood diseases and cancer) at the University of Kansas Medical Center. The specialist visits Hays twice a month, and also is available twice a week via telemedicine. "Thus, we have a specialist available in our town twice a week either in person or electronically," he says. "The result is that we're able to deliver more health-care services to the community. In addition, the level of quality at our local hospital is bolstered, so our staff feels better working here. Everyone benefits."
The community benefits financially, as well, Cox says, because medical tests and prescriptions generated by the specialist are handled locally.
The Georgia Telemedicine Network has brought similar benefits by "empowering local practitioners," network director Stachura says. An initial concern about telemedicine was that it would take patients away from local primary-care doctors by moving them to larger facilities. "But we've been able to demonstrate that 88 percent of patients seen by specialists via telemedicine never leave their hometown," he says.
Telemedicine also can be cost-effective. In Georgia, for example, telemedicine is used to provide services to prisoners who otherwise would have to be transferred to health-care facilities, a move that can be costly because of the need for guards to accompany prisoners and for transportation. Now, according to Stachura, a mobile telemedicine van comes to the prison on a regular basis, plugs in, and allows the health-care professionals to give medical check-ups to inmates on site.
A cable television health-care program that is being instituted in Georgia also can help cut health-care costs by serving as a type of "electronic house call," both in rural communities and underserved urban neighborhoods, Stachura notes. For example, in some instances, at-home monitoring can delay an older person's entry into a nursing home, resulting in improved quality of life, as well as significant cost savings.
As the technology becomes more accepted, telemedicine could be used for home-based follow-up care for the chronically ill, Stachura adds. Doctors could monitor patients with diabetes or asthma at home, thus avoiding hospitalization unless it is truly necessary. Similarly, high-risk patients with heart problems could have their electrocardiograms and blood pressure readings monitored at home, forestalling the onset of more serious problems and allowing for more cost-effective, early care.
A computerized service that could facilitate this type of care was developed to monitor various health signs, according to a December 1996 New York Times report. The service helps patients check their blood pressure and undergo an electrocardiogram at home, and then sends the results via modem to a health-care provider. According to the newspaper, the service is now in clinical trials to see whether its use can cut down on hospital stays and emergency visits by patients with congestive heart disease who are recovering at home.
Obstacles
Although telemedicine offers benefits, there still are obstacles to overcome before it becomes part of mainstream medicine, experts say.
One obstacle involves reimbursement. While Medicare and insurance companies pay for diagnostic services such as teleradiology, most do not yet pay for other consultative telemedicine services.
Cox joined the pediatric committee of a Kansas insurance company to help convince company officials to provide reimbursement for telemedicine. He argued that the technology allows doctors to take medical histories, review scans and x-rays, diagnose problems, schedule follow-ups, and prepare reports. "The company ultimately agreed that those components make the consultation a reimbursable event," Cox says, adding that he hopes other insurers will follow this precedent.
Medical licensing is another potential problem. Because telemedicine can cross state lines, some states could require an out-of-state doctor whose use of telemedicine crosses into their jurisdiction to get a license in their state, even if the doctor's practice is physically located elsewhere.
Stachura notes for instance that he sees patients from both Georgia and South Carolina because his Georgia clinic is near the South Carolina border. "If the patient comes to me, everything is fine," Stachura says. "But if I use telemedicine technology to see a patient in South Carolina--that is, if I were going to the patient, so to speak--then I would need a license to practice medicine in South Carolina."
The licensing issue is further complicated by laws some states have passed that prohibit out-of-state physicians from performing telemedicine in their states, he notes.
Medical liability is an issue, as well. For example, a remote specialist who does not perform a hands-on examination could be regarded as delivering less-than-adequate care. Or if compressed digital images are not reconstructed well, causing loss of valuable diagnostic information, a doctor could possibly face a malpractice suit.
And, as in other areas, telemedicine advocates admit, the use of technology often means that things may not run smoothly every time. Brick recalls a time when the West Virginia telemedicine program switched to another phone carrier. "We had people from the state licensing board there to view the equipment, and nothing worked. We discovered we had to reboot all the computers to make the new phone connection."
Another time, he recalls, lightning hit a small hospital nearby and shorted out all the computers. "It took several weeks to fix." Also, he says, "a couple of times in the four years that we've been running the program, the system went down while a patient was waiting on the other end."
These technical problems notwithstanding, experts advise patients to give telemedicine a try. "Go into it with an open mind," Brick says. "Expect to be able to see and hear the doctor on the other end. Expect the doctor to connect with you and personalize the experience for you. Talk to him, ask whatever questions you have, just as you would in an in-person consultation."
According to Stachura, it's only a matter of time before the obstacles are overcome, and doctors and the public become more accepting of telemedicine. "If 20 years ago, someone said you could walk up to a machine on the street, press a few buttons and get cash or have your financial portfolio displayed, you would have said, 'It's incredible.' " But, like automated teller machines, he says, telemedicine eventually will be accepted, too.
FDA / FDA Consumer
