mHealth and the FCC: What Does the FCC Have to Do with Medical Devices?

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[author: Ken Keane]

mHealth Newsletter - November 14, 2012

One might not associate the Federal Communications Commission (FCC) with mHealth issues. Yet, the FCC has a vital role to play in this field, and if recent developments are any indication, that role will likely grow.

On September 24, 2012, the FCC mHealth Task Force issued a report containing recommendations for FCC action on mHealth. The stated goal is that the FCC take action so that "by 2017 mHealth, wireless health and e-Care solutions will be routinely available as part of best practices for medical care."1

In a speech to the Information Technology & Innovation Foundation on the same day the Task Force recommendations were issued, FCC Chairman Julius Genachowski announced that the FCC will take the following actions to implement the Task Force's recommendations:

  • First, the FCC will look to streamline its experimental licensing rules to encourage the creation of wireless health "test beds" to permit easier testing of mHealth devices.
  • Second, the FCC will consider an order to reform the Rural Health Care Program. Among other things, this would permit networks of hospitals and healthcare facilities to jointly apply for program funds in order to boost broadband capacity and enable electronic health records.
  • Third, the FCC will encourage regulators in other countries to make spectrum available for a new type of device, Medical Body Area Networks (MBANs), and discuss possible spectrum harmonization for these devices. This would allow for patient travel and better economies of scale for device makers.
  • Fourth, the FCC will develop an outreach plan to promote collaboration between the FCC and the healthcare sector on communications policies.
  • Fifth, Chairman Genachowski said that the FCC would recruit a permanent Healthcare Director who would function as the agency's point of contact on all health-related issues.

FCC action in the healthcare field is by no means new for the agency. The Commission has long sought to provide spectrum resources to support wireless medical technology. For example, the agency has allocated spectrum for the Wireless Medical Telemetry Service (WMTS). By means of WMTS devices, patient information can be transmitted wirelessly within a hospital and to other locations.

Likewise, in 2010, the Commission finalized a memorandum of understanding (MOU) with the U.S. Food and Drug Administration for collaboration between the two agencies. This is noteworthy given the jurisdictional overlap: The FCC has statutory authority over devices that emit radio energy, and the FDA reviews and approves medical devices for patient safety and medical efficacy. The two agencies agreed on the following principles:

  • Developing and integrating wireless and broadband communications technologies with medical devices and applications, which requires agencies to assure that such devices operate in a safe, reliable and secure manner.
  • It is essential for the federal government to provide leadership and encourage innovation and investment in new healthcare technologies that enable patients, doctors and other health professionals to access the highest-quality care.
  • The American public—including industry, providers, patients and other interested stakeholders—should have clear regulatory pathways, processes and standards to bring broadband and wireless-enabled medical devices to market.

Since adoption of the MOU, the FCC has continued to be proactive in the wireless medical device field. In 2011, the FCC adopted rules to enable a new generation of wireless medical devices that can be used to restore functions to paralyzed limbs. Medical Micropower Networks (MMNs) are ultra-low-power wideband networks consisting of transmitters implanted in the body that take the place of damaged nerves, restoring sensation and mobility.

As FCC Chairman Genachowski said, these networks "have the potential—literally—to enable paraplegics to stand and to restore sight to the blind."

In May 2012, the FCC adopted rules for the aforementioned MBANs, which has enabled the United States to become the first country in the world to allocate spectrum for these types of devices. MBANs units will provide a cost-effective way to monitor patients wirelessly, providing more information to physicians and giving patients mobility and greater independence.2

In short, the FCC—while not an agency that one would immediately think of as being involved in mHealth issues—has a vital role to play in this rapidly expanding field. That role will likely grow with the continued development of wireless medical technology.

William K. (Ken) Keane practices in the area of telecommunications law and policy. His practice focuses on the representation of clients in radio spectrum policy and transactional matters. For example, he counsels broadcast and industrial clients on FCC compliance issues; prepares license applications and other filings for submission to the Commission; represents clients in FCC enforcement proceedings; and provides advice and counsel in connection with communications asset transactions.

Notes

  1. mHealth Task Force Findings and Recommendations, Pre-Publication Public Draft, September 24, 2012, at page 1.
  2. Duane Morris played an active role in the formulation of the FCC rules governing MBANs devices, which rules remain subject to reconsideration by the agency.

Topics:  Digital Health, FCC, FDA, Healthcare, Medical Devices, mHealth

Published In: Communications & Media Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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