Wireless Medical Devices: Navigating Government Regulation in the New Digital Age

BNA’s Medical Devices Law & Industry Report, February 24, 2010

We have come a long way since the health care industry's only reliance on wireless technology was the ability of doctors to wear beepers on the golf course.

The ongoing revolution in wireless communications today has the potential to dramatically change the nature of many medical devices and the delivery of health care services, while improving care and lowering costs. Patients who rely on such devices no longer need to be tethered to a tangle of cables, enabling physicians to obtain vital information on a real time basis without the need for office visits or hospitalization.

Some wireless devices are implanted and used, for example, to control bodily functions such as heart rhythms or nerve stimulation or to monitor cranial pressure. Other wireless devices are worn on the body and used, for example, to measure and report on an array of physiological conditions such as body temperature and other vital signs or assist the movement of artificial limbs. Wireless devices can even be incorporated into pills themselves to monitor patients' compliance with their dosage regimen. Whether implanted, worn, or ingested, wireless medical devices offer the prospect of greatly improving preventative, therapeutic, and managed care.