New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable the use of Medical Body Area Networks (MBANs). MBANs are low-power wideband networks consisting of multiple body-worn sensors that transmit various patient data to a control device that collects data from the sensors. Wireless devices operating on the MBAN spectrum can be used to continuously monitor a patient’s health by measuring indicators such as blood glucose levels, blood pressure and electrocardiogram results. Additionally, wireless health devices can include mobile devices and associated applications of increasing relevance to consumer health and personalized medicine, such as mobile-device enabled sensors that monitor vital signs for any number of traits or conditions like blood pressure, glucose levels or even the early signs of an asthma attack.
Among the benefits of MBAN use are improved patient outcomes and comfort due to increased mobility as patients are untethered from the cables that restrict them to a hospital bed. Additionally, there is decreased risk of hospital-acquired infection for patients. Furthermore, wireless devices using MBANs lower costs by giving physicians real-time and accurate data and allowing them to intervene prior to more drastic deterioration. This creates more opportunities for preventative care and continuous monitoring of chronic conditions. It has been estimated that wireless monitoring technology could save as much as $197 billion over the next 25 years in the United States.
While it is likely that the majority of the early utilization of MBANs will be on an inpatient basis, in-home use of MBANs for monitoring patients with chronic illness will likely increase as the technology develops. At the FCC’s June 6, 2012 mHealth Summit, FCC Chairman Julius Genachowski announced that the FCC intends to amend its rules to create more flexibility for experimental uses of the spectrum for wireless health care technologies.
In addition to the FCC’s oversight of MBAN broadband networks, MBAN equipment will also generally be required to gain approval or clearance from the U.S. Food and Drug Administration (FDA) if such equipment qualifies as a medical device. The FDA and FCC have jointly committed to working together to clarify and streamline the regulatory processes for evaluating the safety and efficacy of wireless-enabled medical devices, including MBANs and other mobile devices, while encouraging innovation and affording the public the potential benefit of these devices. In 2007 draft guidance entitled “Radio Frequency Wireless Technology in Medical Devices,” the FDA commented that wireless medical device manufacturers should maintain wireless quality of service, wireless coexistence and the integrity and security of data transmitted wirelessly.
Among the concerns facing the FDA as they develop guidelines for MBAN manufacturers is the vulnerability of wireless medical devices to hacking. The Information Security and Privacy Advisory Board (ISPAB), which advises the Office of Management and Budget, recently proposed that the FDA or another federal agency assess the security of medical devices before they are sold. Additionally, the Government Accountability Office is currently preparing a report on the security vulnerability of wireless medical devices. These developments, and continued industry, user and provider education efforts, are likely to significantly influence the FDA’s guidance and enforcement decisions regarding the development and distribution of MBANs and other mobile devices and applications as they continue to proliferate in coming years.
Early MBAN proponents have continued to develop the technology, despite the fact that there is no federal reimbursement for MBAN utilization and some concerns exist regarding their implementation. Among the concerns is the risk that harmful disturbance or interference from other frequency bands will prevent the accurate transmission of the medical data through MBANs. In order to mitigate this risk, the FCC will require registration for MBAN use at health care facilities. Furthermore, the FCC does not find the risk of interference threatening because MBAN devices may operate over relatively short distances and at a low power, which decreases the risk of interference disrupting the transmission of medical data. In any event, it is likely that the FDA will address this risk as it develops standards for the approval of MBAN equipment.
In addition to the FCC and the FDA overlay, MBANs also present significant HIPAA compliance concerns, as well as other data privacy concerns, particularly with respect to the security of the sensitive personal health data being transmitted by such devices. Health care providers and others utilizing or contemplating the use of MBANs at their facilities, and companies developing MBANs or other innovative wireless medical devices and applications, should consult with counsel to ensure that they are in compliance with the FCC and FDA rules, HIPAA and other federal and state regulations.
Research assistance provided by Amit Bhagwandass, a second-year law student at the University of North Carolina School of Law.