The Federal Communications Commission (“FCC”) is seeking input from medical device manufacturers, hospitals, assisted living facilities and other interested parties in a regulatory matter that will have significant implications with regard to (i) implanted, body-worn and associated external medical devices, and (ii) their uses in hospitals, assisted living facilities, physicians’ offices and patients’ homes.

Medtronic, Inc. (“Medtronic”) is requesting that the FCC institute a proceeding to establish a medical data service (“MEDS”) that Medtronic and its supporters claim would

• provide lower cost, higher quality treatment and data collection in hospitals, assisted living facilities, physicians’ offices and patients’ homes;
• 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”; and
• require that device manufacturers whose products will operate in the MEDS service spectrum either manufacture their devices to be low power and have a low duty cycle, or use smart radio technology (i.e., listen before transmitting and frequency agility).

Medtronics and its supporters further claim that unless MEDS is established in the manner described above, (i) there will not be sufficient spectrum for medical implant and body-worn devices to use without being subject to unacceptable levels of interference; and (ii) life critical devices, such as cardiac pacemakers, currently operating in the existing Medical Implant Communications Service (MICS) spectrum, are likely to incur interference from other medical devices that are less time sensitive, such as blood glucose monitoring systems.

Opponents of Medtronic’s proposal, including Dexcom Inc. and Biotronik Inc., claim that there is no need to create a MEDS service in the manner requested by Medtronics, and 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.

This regulatory matter 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 and operate in the MICS spectrum.
• Hospitals, assisted living facilities and physicians.

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
fishel.alan@arentfox.com

Jeffrey Rummel
202-715-8479
rummel.jeffrey@arentfox.com