October 18, 2021

Volume XI, Number 291

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October 18, 2021

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FCC Announces Rulemaking Enabling Remote Monitoring of Health Care Data

The Federal Communications Commission recently adopted rules that will enable the growth of Medical Body Area Networks, low-power wideband networks that transmit a variety of patient data recorded through patient-worn sensors to a hub device. The rulemaking anticipates a “license by rule” structure by which users will not have to apply for and receive individual licenses, leading to greater and more immediate adoption of new and innovative Medical Body Area Network applications.


On May 24, 2012, the Federal Communications Commission (FCC) adopted rules that will enable the growth of low-power wideband networks, called Medical Body Area Networks (MBANs), that transmit a variety of patient data recorded through patient-worn sensors to a hub device. The rulemaking was the culmination of proceedings that commenced in June 2009, whereby the FCC sought comment on allocating spectrum access and establishing service and rules for the operation of MBANs.

The rulemaking anticipates a “license by rule” structure by which users will not have to apply for and receive individual licenses, leading to greater and more immediate adoption of new and innovative MBAN applications. The FCC order positions the United States as the first in the world to allocate spectrum for wireless MBANs.

The short-term primary benefits of MBANs are as follows:

  • Improved patient satisfaction by allowing greater mobility and untethering from cumbersome cables, whether on an inpatient or outpatient basis
  • Potential reduction in hospital and unplanned emergency admissions by detecting health conditions before an emergency, thereby permitting treatment in a lower cost setting without further intervention
  • Improved patient outcomes through greater opportunities for preventative care and active monitoring of chronic conditions
  • Reduced costs in the system by achieving earlier intervention, treatment in a lower cost setting and more active monitoring of health conditions in advance of more serious deterioration

MBANs are initially conceptualized to be small low-powered sensors located on the body to capture clinical information, such as temperature and respiratory function, which are then channeled to a hub in close proximity to the patient with data further transferred to a server. Although the FCC posits that much of the early activity of MBANs will be on an inpatient basis—monitoring electrocardiogram readings, neonatal monitoring systems, and blood pressure and blood glucose systems—in the near future, MBANs could be leveraged to facilitate remote monitoring and over time migrate to the home. Remote monitoring could be a relatively low-cost way to enhance early detection of medical needs, such as rising blood pressure, and to maintain a real-time, holistic picture of a patient who has co-morbidities. Remote monitoring may also decrease office and hospital visits, which will benefit infirm, aged and chronically ill patients.

The import of the FCC rule is best understood against the backdrop of a number of health care initiatives designed to improve the quality of care while controlling the costs. Institutional providers are under increasing pressure to divine ways to manage patients’ care better and more affordably. For example, the Affordable Care Act penalizes hospitals for certain types of readmissions. Accountable care organizations and other risk-sharing structures can only succeed economically if the cost of the tools to improve quality does not exceed the saved costs from healthier patients. The adoption by providers and health plans of MBANs and additional wireless medical technology plays directly into the government-sponsored—as well as commercially evolving—outcomes and cost-containment strategies of many key stakeholders in the health care ecosystem. Additionally, the larger mobile health industry, consisting of mobile applications, cloud-based data management, wireless medical technology products and many more solutions, is intended to revolutionize diagnosis, treatment and delivery of health care in the United States by making care better and more affordable.

Despite a current lack of federal reimbursement for deployment of MBANs, the enhanced outcomes quality and economic efficiencies of wireless medical devices will inevitably result in greater adoption. Home health agencies, nursing homes, assisted living facilitates and other long-term care providers may also find that providing care through MBANs will open additional lines of business to cope with the burgeoning senior citizen community as baby boomers age. Careful consideration, however, must be given to the legal ramifications of the adoption of this technology, including but not limited to HIPAA and state privacy regimes, the U.S. Food and Drug Administration’s evolving risk-based approach to determining when software and other digital systems constitute “medical devices,” practice of medicine concerns, and data ownership and future use.

© 2021 McDermott Will & EmeryNational Law Review, Volume II, Number 173
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About this Author

Jennifer S. Geetter, McDermott Will & Emery LLP, Attorney
Partner

Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  She focuses her practice on emerging biotechnology and safety issues, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, formulary compliance, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, internal hospital disciplinary proceedings,...

202 756 8205
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