Technology, Communications & Media

We’ve written previously about the role of the Federal Communications Commission (FCC) in regulating wireless medical devices, chiefly in determining the operating frequency and certain technical rules that ensure co-existence with other devices and wireless users. As part of that process, manufacturers must submit prototypes of new devices for testing and review by independent third party test labs and certification bodies (TCBs). The FCC prohibits responsible parties, such as manufacturers and resellers, from importing, marketing, or selling any device subject to this equipment approval process prior to obtaining approval from a TCB, which comes in the form of a grant of equipment certification.

In preparation for accepting applications for funding under the its COVID-19 Telehealth Program, which will make available $200 million in appropriated funds to support telehealth services during the COVID-19 pandemic, the FCC has released a Public Notice with guidance on how eligible health care providers can ready themselves to participate. The FCC will release a separate Public Notice shortly announcing the date it will begin accepting applications for funding. Applications will be accepted through an online portal, the web address and opening date for which will also be posted on the FCC’s Keep Americans Connected page.

The Federal Communications Commission (FCC) regulates wireless medical devices in conjunction with the Food and Drug Administration (FDA), with the FCC’s role related to certain technical concerns such as the successful sharing of wireless frequency bands. Another area that FCC regulates is radio frequency (RF) safety – the possible harmful effects to human health from RF energy created by wireless devices. The FCC looks to health and safety agencies such as the FDA, EPA, and OSHA, to provide guidance and recommendations on what level of RF emissions are deemed “safe,” and then sets rules for how responsible parties must evaluate compliance with these limits. These rules on safe emission levels apply generally to devices that produce RF signals. The FCC proposed modifications to its RF safety rules in 2013, and finally on December 4, 2019, issued a decision that adopts many of its proposals.

As part of its strategy to make additional mid-band spectrum available for Fifth Generation (“5G”) wireless services, the Federal Communications Commission (“FCC”) recently adopted a Report and Order that revises its rules for the 2.5 GHz band – the largest contiguous band of spectrum below 3 gigahertz – in a manner that will pave the way for the Commission to auction the spectrum for commercial use next year. 

$100 million in Federal funds may soon become available to help healthcare providers cover the costs of broadband and connected care services. Earlier this month, the Federal Communications Commission (FCC) voted on a proposal, on which it will seek public comment, for a new “Connected Care Pilot Program,” and the comment period on that proposal has now begun. The proposed program would direct money to telehealth initiatives, especially for medically underserved populations like low-income families and veterans. The money would come from the Universal Service Fund (USF), which is an existing fund of fees paid by telecommunications service providers currently used for a variety of purposes.

Do you manufacture, import, or market personal hygiene and wellness devices sold in drugstores? If so, you may be focused on U.S. Food and Drug Administration (FDA) compliance, but may not have considered the requirements of another Federal regulatory agency: the Federal Communications Commission (FCC). Manufacturing, importing, and/or marketing non-compliant personal hygiene, wellness and similar devices may violate the FCC’s rules.