The FCC is expected to initiate a major rulemaking proceeding early this year to determine what regulations should be imposed, modified, or eliminated with respect to health care equipment and technologies. The Chief of the Office of Engineering and Technology at the FCC recently stated that "now may be a good time to take a complete look at the medical area to see what could be done there in terms of rulemaking."

This represents a tremendous opportunity for companies in the health care field – both manufacturers and health care providers – to (i) meet with the FCC prior to the initiation of the rulemaking to discuss matters of interest and issues that should be included in the rulemaking; and/or (2) participate in the rulemaking once it is formally initiated.

The rulemaking will greatly impact medical device manufactures and health care providers, including hospitals, assisted living facilities and physicians. Some of the issues that may be addressed in the rulemaking include the following:

• Which regulations should be modified or eliminated with respect to medical telemetry equipment (i.e., equipment used in hospitals and health care facilities to transmit patient measurement data, such as pulse and respiration rates, to a nearby receiver). Issues involving medical telemetry equipment that may be addressed in a rulemaking include, among others, the following:
  • Whether the Commission should eliminate or modify prohibitions against in-home use of such equipment or use of such equipment in ambulances.
  • Whether the Commission should eliminate or modify prohibitions against voice and/or video communications using such equipment.
  • Whether the Commission should modify its rules with respect to interference, channel usage or maximum field strength requirements with regard to such equipment.
  • Whether the Commission should modify its authorization process for such equipment.

• Which regulations should be modified or eliminated with respect to equipment operating under the Medical Implant Communications Service (i.e., equipment used with respect to transmitting data in support of diagnostic or therapeutic functions associated with medical implant devices). Issues involving medical implant devices that may be addressed in a rulemaking include, for example, the following:
  • Whether the Commission should eliminate or modify the requirement that such equipment listen before transmit (two companies have received waivers of limited duration with regard to this issue).
  • Whether the Commission should eliminate or modify prohibitions against voice communications or communications that can be used to relay information to a receiver that is not included within a medical implant device.
  • Whether the Commission should modify regulations relating to maximum transmitter power, channel use, or permitted length of communication requirements.
  • Whether the Commission should modify its authorization process for such equipment.

• Whether to establish a new medical data service (“MEDS”) in which devices would either have to be low power and have a low duty cycle, or use smart radio technology (i.e., have frequency agility and listen before transmit capability).
  • Supporters of MEDS claim it would provide lower cost, higher quality treatment and data collection in hospitals, assisted living facilities, physicians’ offices and patients’ homes; and support the manufacture and use in health care facilities and patients’ homes of body-worn and implanted medical devices used to, among other things, “(i) monitor vital signs; (ii) administer insulin and other pharmaceuticals; (iii) regulate heart activity; (iv) control incontinence; and (v) provide spinal cord and nerve stimulation for the control of chronic pain and management of epilepsy and Parkinson’s disease.” These supporters further claim that unless MEDS is established, there will not be sufficient spectrum for medical implant and body-worn devices to use without being subject to unacceptable levels of interference.
  • Opponents of a MEDS service claim that if the FCC does create such a service many devices that otherwise would be beneficial to health care providers will be unavailable because they will violate FCC regulations.

• Resolution of the above issues relating to medical implant devices and MEDS will impact, among other things, 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.

If you any questions, wish to receive additional information, or may wish to participate in this matter, please contact:

Alan Fishel
202.857.6450
fishel.alan@arentfox.com

Jeffrey Rummel
202.715.8479
rummel.jeffrey@arentfox.com