The U.S. Federal Communications Commission (FCC) recently voted to initiate several proceedings to re-examine the spectrum needs and associated regulatory requirements for advanced medical communication devices.

If any interested parties, such as medical device vendors or hospitals, have an interest in these issues, they should consider apprising the FCC of their views and participate in the proceedings. Parties may either submit written comments or schedule a meeting with FCC staff.

As FCC Commissioner Kevin J. Martin stated when he announced a notice of proposed rulemaking (NPRM), recent advances in medical and wireless technology offer hospitals and their physicians the ability to use new implantable and body-worn devices to dramatically improve the level of patients’ care and operate with greater efficiency. Among other things, wireless devices already monitor vital signs, help control the delivery of insulin, and mitigate the tremors of neurological patients.

The FCC’s action supports continued development and deployment of advanced devices by proposing the allocation of a new spectrum and greater flexibility for medical radio devices. As technology improves, the scope of potential uses under this new service ranges from devices that restore muscle control though microchips, improve sight among the visually impaired, and treat conditions such as Parkinson’s disease.

In particular, the FCC issued an NPRM to establish a new service for advanced medical radio communication (MedRadio) implant and body-worn devices using wireless technologies. The FCC has requested interested parties to weigh in on this matter by submitting comments to the agency either in support of, or in opposition to, its proposals. The FCC has not yet set the relevant deadlines for submitting comments in this proceeding.

As part of the NPRM, the FCC proposes to allocate additional exclusive radio spectrum at 401-402 MHz and 405-406 MHz. Combined with the existing Medical Implant Communications Service (MICS) band at 402-405 MHz, additional spectrum for implant and body-worn transmitting devices could be used for a broad array of health care purposes.

The FCC is also proposing to increase the flexibility of its rules for the newly designated 401-402 MHz and 405-406 MHz bands. The FCC seeks to allow manufacturers to develop medical radio devices that operate with a low duty cycle and low transmitting power levels and without the capability to automatically switch between frequencies (i.e., frequency agility). Devices that operate in the MICS band will be required to include this capability to accommodate devices that might be used for more critical purposes.

The FCC also voted to issue a notice of inquiry (NOI) requesting general information on how it can proactively address the wireless communications needs of the medical community and accommodate anticipated developments in the medical devices field. An NOI proceeding is one in which the FCC seeks out information from industry members, experts in a particular field, and other interested parties to develop a more thorough record on a particular issue.

The FCC will review all comments submitted in the NOI proceeding to make its policy decision, and will likely use the record as the basis for issuing future NPRMs relating to medical communication devices. The FCC’s NOI requests comment on the following issues:

  • New implant and body-worn medical wireless technologies and their likely spectrum requirements
  • The relative benefits and tradeoffs that should be considered with respect to both licensed and unlicensed approaches to authorizing the operation of these devices
  • Collaborative efforts between the FCC and the U.S. Food and Drug Administration (FDA) regarding ways to educate medical device manufacturers about medical radio device electromagnetic immunity issues in a radio frequency (RF) environment

The full text of the FCC’s NPRM and NOI have not yet been released and, thus, specific details of these proposals are not yet available.

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