While still in the research stage, the possibility of implantable sensors is very real. Benefits are expected to include accuracy and convenience, though perhaps at the expense of security and privacy.
It sounds like something out of a science fiction novel: Sensors implanted inside the body of people with rheumatoid arthritis offer around-the-clock monitoring of symptoms and the effectiveness of treatment. In reality, though, such research is already being done in the laboratory and may very well become part of patient care in the not-so-distant future.
“Implantable medical monitoring and therapy is the future of health care,” says Sam Bierstock, MD, BSEE, president and founder of Champions in Healthcare, a health care information technology company in Delray Beach, Fla. “In many ways, the patient will become the interface with the electronic health record in many instances, allowing for augmented clinical decision support — computerized assessment and decision-making that assists doctors and caregivers in their diagnosis and treatment approaches.
But what do biomedical sensors really mean for RA treatment?
Researchers are exploring the possibilities of using implantable biomedical sensors for a variety of ailments. Depending on the health issue and data desired, Dr. Bierstock says, a device can be implanted either on or under the skin or superficial tissues or implanted deeper within the body, as in the case of cardiac stent flow sensors. The device then monitors the condition and transmits signals that contain the desired information. This could include anything from the flow rate of blood through the blood vessels to pressure in the eye. The measurements are transmitted to a machine that receives them and either directs the information to caregivers or stores it for future review and analysis. This happens 24/7, so all data is available.
Biomedical sensors could prove useful for people with rheumatoid arthritis in a number of ways. “The current focus is on sensors that are integrated in new joints, such as artificial hips and knees,” says Jeroen Bergmann, PhD, a fellow at the Brain Sciences Foundation in the United Kingdom and author of research that looked at patient preferences about sensors, published in the December 2012 issue of the journal Sensors. “They monitor when the artificial joint has suffered so much wear that it might fail," he says. "In that case, the joint can be replaced before damage is done as the result of any dysfunction.
Specifically, the sensors can measure forces, torques, pressure, and accelerations, which all contribute information about the functioning of the particular joint. Though the possibilities may be intriguing, Bergmann cautions that it's all still very much in the realm of research.
In terms of health and practical considerations, implantable biomedical sensors could have real benefits. Data is very accurate, and problems can be spotted and handled in a timely manner. Convenience is another plus: Information can be transmitted and monitored without the patient having to take the time and trouble to visit the doctor.
Finally, the information is readily available. It can be incorporated into your electronic health record as well as being accessible to all caregivers, regardless of their location.
As with many high-tech advances, there are some cons to implantable biomedical sensors, too. For instance, more research needs to be done to learn of any possible effects that the materials and technologies might have on the body they're implanted in. It will also be crucial to make sure the sensors are fully functioning and not prone to failure quickly or easily.
Whether full 24/7 monitoring will be expected, and realistically available, still needs to be considered, as does how to handle what may ultimately be too much data generated to be practical. Devices also will need to go through the U.S. Food and Drug Administration approval process, which Bierstock noted could take awhile.
Privacy and security issues related to implantable biomedical sensors are still evolving.
“Concerns about privacy focus on the ability to detect implantable medical devices and intercept their communications,” says Aaron Messing, an information privacy lawyer at OlenderFeldman LLP in Union, N.J. “Privacy concerns tend to revolve around ensuring that implantable medical devices only communicate with intended recipients of data.”
In other words, Messing says, unauthorized individuals or companies should not be able to determine whether a person has an implantable medical device installed nor be able to access information stored on or transmitted by the device or other private information such as name, diagnosis, or medical history. This is important to avoid any chance of discrimination by employers or any social stigma that could result.
Security is another concern. “Researchers have demonstrated the ability to hack certain medical devices, and the ability of a device to receive firmware upgrades might also make it susceptible to attack,” he says. “For example, one researcher demonstrated the ability to hack a wireless insulin pump to deliver a fatal overdose, and other researchers have posited the use of denial-of-service attacks against an implantable medical device that would cause the device’s battery to drain, overflow, modify the device’s internal data storage, or prevent it from communicating with appropriate medical authorities.”
Finally, the issue of who owns the data is both complicated and important to keep in mind. As of now, raw data from implanted devices is not considered to be medical record information under federal privacy regulations, commonly referred to as HIPAA. That means that patients do not have the same rights to access the information that they have for data held by their health care provider, Messing says. Once the information is sent to the patient’s physician, however, it's covered by HIPPA.
Some or all of this may be changing, however. The HIPAA Omnibus Rule went into effect at the end of March 2013, with companies required to comply with it by Sept. 23, 2013. It states that companies that service and have access to medical devices and information may be considered business associates who must comply with the HIPAA Security Rule. Security and patient access may increase, but it's too early to draw any conclusions before seeing how the new rules are interpreted, Messing says.
As with any new technology, there's still much to research and figure out about biomedical sensors, and that includes the role of the patient, aka the user — an area of study particularly interesting to Bergmann.
“There is still a gap to fill between really unobtrusive sensing in the clinic and what comes out of the research labs,” he says. “The patient needs to become more central in these debates in order to ensure the devices produced will be user-friendly and yield greater levels of acceptability. In the end, the patients should be able to decide if they want to take added benefit of these devices.
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