FCC Begins Major Rulemaking Proceeding Concerning Medical Devices and the Health Care Industry

The FCC has initiated a major rulemaking proceeding to determine whether certain regulations should be imposed, modified, or eliminated with respect to health care equipment and technologies. In this proceeding, the FCC will determine, among other things, whether to create a new service for advanced medical radio communication (“MedRadio”) devices that would operate in the 401-406 MHz band.

To accommodate a wider variety of devices than the current MICS service, which is in the 402-405 MHz band and is limited to the use of implant devices, the FCC is considering permitting the use of body-worn transmitting devices in the MedRadio service. The FCC has also proposed allowing the use of low power, low duty cycle MedRadio devices at 401-402 MHz and 405-406 MHz, without requiring the frequency agility capability required by the current MICS rules.

In addition, the FCC is proposing to continue to require only frequency agility devices in the 402-405 MHz band. Supporters of this proposal will almost certainly contend that without its adoption, life critical devices, such as cardiac pacemakers, are likely to incur interference from other medical devices that are less time sensitive, such as blood glucose monitoring systems. Opponents of this proposal will likely argue that there is no need for such a requirement, and that if such a proposal is adopted, many devices that otherwise would be beneficial to health care providers will be unavailable because they will violate FCC regulations.

Resolution of the issues in this proceeding will impact the following:

  • How medical implant and body-worn devices will be manufactured and designed in the future, and the restrictions and limitations on such manufacture and design.
  • The costs of designing and manufacturing such devices (which also impacts the price that will be charged to health care providers for such devices).
  • The extent to which such devices may be subject to harmful interference from other sources that prevents them from operating properly.

This rulemaking will greatly impact:

  • Manufacturers of implanted devices and other external sensors that communicate non-time-sensitive data such as oxygen levels, glucose levels and blood pressure.
  • Manufacturers of devices, such as cardiac pacemakers, that communicate time sensitive data.
  • Manufacturers of body-worn transmitting devices.
  • Hospitals, assisted living facilities and physicians.

In addition, the FCC is also initiating a Notice of Inquiry, in which it is seeking comment on information concerning developments that are anticipated in the medical device field and their likely spectrum requirements. Among other matters, the inquiry seeks comment on:

  • New implant and body-worn medical radio communication technologies and how the Commission can address the RF spectrum issues involved.
  • The advantages and disadvantages of licensed and unlicensed approaches with respect to authorizing the operation of these devices.
  • Coordination between the FCC and the FDA regarding educating industry leaders about medical radio device electromagnetic immunity issues in an RF environment.

If you wish to receive additional information or updates about this matter (or if you may wish to participate in this matter), please contact:

Alan Fishel
202.857.6450
[email protected]

Jeffrey Rummel
202.715.8479
[email protected]

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