New FCC Rules for Medical Body Area Networks

by Cooley LLP
Contact

On August 21, 2014, the Federal Communications Commission (“FCC”) released an Order with new and clarified rules to foster the development and deployment of Medical Body Area Networks (MBANs). The Order provides more flexibility in the design and use of MBAN facilities and specifies procedures and qualifications for the FCC’s selection of an MBAN coordinator to administer an MBAN registration program.

Background: MBAN technology connects multiple body-worn sensors that measure and record physiological parameters or perform diagnostic or therapeutic functions primarily in health care facilities. An MBAN consists of a patient’s programmer/control transmitter, together with body-worn devices that communicate information about the patient to the programmer/control transmitter. MBANs will operate under the FCC’s Medical Device Radiocommunication Service on the 2360-2390 MHz and 2390-2400 MHz bands. MBANs in the 2360-2390 MHz band may operate only at indoor locations within a health care facility and require prior registration and coordination with an FCC-appointed MBAN coordinator to avoid interference with primary use of the band by Aeronautical Mobile Telemetry (AMT) Service stations. MBAN devices in the 2390-2400 MHz band may operate indoors or outdoors and do not have to be registered or coordinated if the equipment used cannot operate in the 2360-2390 MHz band.

Reconsideration of MBAN Rules: On reconsideration of its initial order authorizing MBANs, the FCC more narrowly defined the institutions that may use MBANs operating in the 2360-2390 band, with the idea to make the 2390-2400 MHz band the preferred band for MBANs. The FCC also addressed the application of the new rules to interconnection of bedside devices and antenna installations on outdoor roof terraces and similar locations. In addition, the FCC clarified information requirements for registering new MBAN installations and affirmed that the MBAN coordinator must consult with the AMT coordinator before a registered MBAN changes its location or operation. The FCC also clarified that MBAN transmitters must be capable of ceasing transmissions when necessary to avoid interference in the 2360-2390 MHz band and that health care facilities using equipment capable of transmission in the 2360-2390 MHz band must register with the MBAN coordinator even if they have no plans to use the capability.

The FCC also provided additional flexibility for MBANS. Under the revised rules,

  • Programming/control transmitters from separate MBAN systems may communicate with other MBANS for the limited purpose of choosing channels to avoid interference;
  • Two medical body-worn devices in the same MBAN may communicate directly with each other to coordinate in situations such as the loss of communications from one device from a patient’s change in position;
  • A body-worn medical device rather than the programmer/controller device may perform coordinator node functions; and
  • The antenna on an MBAN device need not be permanently affixed to its associated transmitter (but must be provided with the device and considered part of the transmitter subject to FCC equipment authorization).

Role and Selection of MBAN Frequency Coordinator: The new MBAN frequency coordinator for the 2360-2390 MHz band must maintain an MBAN registration database, determine when MBAN sites are within line-of-sight of AMT facilities, coordinate MBAN operations with an AMT coordinator, notify MBAN users when they must change frequencies or cease operations to comply with an AMT coordination agreement, and develop procedures to ensure that MBAN users comply with coordination requirements.

The MBAN coordinator will provide service to all eligible health care institutions on a non-discriminatory basis, charge fees that reflect only its actual costs, and serve for a ten-year term, subject to removal by the FCC on six months’ notice

The new rules will become effective thirty days after publication in the Federal Register, with rules involving data collection subject to additional approval by the Office of Management and Budget.

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.

© Cooley LLP | Attorney Advertising

Written by:

Cooley LLP
Contact
more
less

Cooley LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.