- Background and Overview
- mHealth Task Force
- Healthcare Connect Fund
- Office of Engineering and Technology
- Frequency Bands for Medical Devices
- Interagency Health IT Strategy
- National Broadband Plan
- How to Engage with the FCC
- Other Federal Agency Resources
Background and Overview
The FCC is committed to accelerating the adoption of health care technologies to improve health outcomes and lower health care costs. There are various bureaus and offices within the FCC that work on proceedings and initiatives related to health care technology.
The Office of Engineering and Technology manages spectrum and works to create new opportunities for competitive technologies, including wireless medical devices.
The Wireline Competition Bureau oversees the Healthcare Connect Fund, to expand health care provider (HCP) access to broadband, especially in rural areas, and encourage the creation of state and regional broadband health care networks.
In 2010, the FCC released the National Broadband Plan, which includes a chapter on health care that details a strategy for combining networks, applications, devices, and individual actions to create increased opportunity for broadband-enabled health IT solutions.
mHealth Task Force
In June 2012, Chairman Genachowski hosted the FCC's first mHealth Summit at the Commission's headquarters with private, academic, and government leaders in wireless health technology to discuss the promise of mobile devices to improve health care and lower costs, including practical steps the assembled leaders could take to foster innovation in the sector. The Chairman was joined by senior executives and leaders from companies at the forefront of the mHealth revolution, including Philips, Qualcomm, Verizon, and Medtronic, startups such as MedApps, Telcare, TheCarrot, and WellDoc, non-profits including the West Wireless Health Institute and the Alfred Mann Foundation, hospital leaders, and government experts from the FCC, FDA, HHS, VA, CMS, and NIH.
Following the event, participants came together to create an independent mHealth Task Force, which collaborated on several policy recommendations to the FCC, other federal agencies, and to industry, with the goal of making mHealth a routine medical best practice by 2017. These recommendations were announced at an event hosted by the Information Technology and Innovation Foundation (ITIF) in September 2012, and can be accessed here. Recommendations include actions to increase interagency collaboration and information sharing, expand on existing programs to encourage mHealth adoption, and build on government and industry efforts to increase capacity, reliability, interoperability, and safety of mHealth technologies. To learn more, see the FCC's Fact Sheet. To access the mHealth Task Force’s full recommendations, please download the report (PDF).
Healthcare Connect Fund
The FCC's Wireline Competition Bureau (WCB) oversees the Healthcare Connect Fund, the Rural Health Care Telecommunications and Internet Access Programs, and the Rural Health Care Pilot Program. The Universal Service Administrative Company (USAC), under WCB oversight, administers the day-to-day operations of these programs. The FCC's Healthcare Connect Fund order is available via download here: http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-12-150A1.doc
In 2012, the FCC established the Healthcare Connect Fund to expand health care provider (HCP) access to broadband, especially in rural areas, and encourage the creation of state and regional broadband health care networks. Building on the success of the Rural Health Care Pilot Program (see below), the Healthcare Connect Fund provides support to eligible public and not-for-profit HCPs for the cost of broadband services or facilities that they use for health care purposes. The Healthcare Connect Fund also permits HCPs to receive support for constructing and owning broadband infrastructure. The Healthcare Connect Fund encourages HCPs to organize into consortia to reap the benefits of network participation, including higher bandwidth and better quality connections at lower rates than those generally available to individual HCPs, though it also allows individual rural HCPs to participate. The existing Internet Access and Rural Health Care Pilot programs (see below) ultimately will be transitioned into the Healthcare Connect Fund.
In the 1996 Telecommunications Act, Congress directed the FCC to provide rural HCPs with “an affordable rate for the services necessary for the provision of telemedicine and instruction relating to such services.” In 1997, the FCC established the Rural Health Care Telecommunications program to ensure that rural HCPs paid no more than their urban counterparts for their telecommunications needs. In 2003, the FCC added the Rural Health Care Internet Access program to provide a 25% discount off the cost of monthly Internet access. These two programs together are called the Rural Health Care Primary Program.
In 2006, the FCC established the Rural Health Care Pilot Program to support state and regional broadband networks designed to bring the benefits of telemedicine and telehealth services to areas of the country where they were most needed. The Pilot program was specifically intended to provide the FCC with more information on how to best support a nationwide broadband health network, so that it could reform the overall Rural Health Care Primary Program. In 2012, WCB issued a Staff Report finding that the Pilot Program has, among other things, fostered the creation and extension of broadband networks of HCPs throughout the country; demonstrated the cost savings, relative administrative simplicity, and network-facilitating value of a consortium approach; and shown that supporting non-rural HCPs yields many benefits, including project leadership, administrative and technical resources, and access to medical specialists through telemedicine. The Pilot Program is closed to new applicants. HCPs and consortia will be able to participate in the new Healthcare Connect Fund, when it becomes effective, or in the existing Telecommunications and Internet Access Programs.
Office of Engineering and Technology
The FCC's Office of Engineering and Technology (OET) conducts many activities relating to wireless medical devices, including equipment authorization (for products such as smartphones, car door remote controls, Wi-Fi devices, baby monitors, and personal computers); testing for radio frequency safety; and regulation of radio spectrum.
OET has a long history of working to enable health and medical devices. Some of its more recent accomplishments include:
MedRadio (Medical Device Radiocommunications Service): In the course of two rulemaking proceedings, the Commission allocated spectrum and adopted technical rules for innovative new body-worn and implanted medical radio devices that can provide a variety of diagnostic and therapeutic functions from diabetes and heart monitors to pacemakers and cardiofribrilators.
Medical Body Area Networks (MBANs): In 2012, the FCC released an Order to allocate spectrum for Medical Body Area Networks (MBANs), making the U.S. the first country in the world to make spectrum available for this specific usage. MBANs are networks of wireless sensors, often no bigger than a Band-Aid, which can transmit data on a patient's vital health indicators to their doctor or hospital. For more information, see the MBANs Fact Sheet.
Medical Micropower Networks (MMNs): In 2011, the FCC adopted rules to enable a new generation of wireless medical devices that can be used to restore functions to paralyzed limbs. MMNs are ultra-low power wideband networks consisting of transmitters implanted in the body that take the place of damaged nerves, restoring sensation and mobility.
Retinal Implants: In November 2011, OET granted a waiver of the Commission's rules to Second Sight Medical Products, Inc. to allow it to obtain FCC certification for and market its Argus II Retinal Prosthesis System which is a medical implant system designed to treat profoundly blind people suffering from advanced retinal degenerative diseases. For more information, see the waiver (http://hraunfoss.fcc.gov/edocs_public/attachmatch/DA-11-1951A1.pdf)
Experimental Licensing Program: In May 2012, the FCC announced a plan to cut red tape and increase spectrum flexibility for testing new wireless health innovations, to speed new wireless health technologies to market. The new experimental licensing regime will create more flexibility and streamlined processes for testing new wireless medical devices.
FCC-FDA Memorandum of Understanding: In 2010, the FCC entered into an unprecedented partnership with the Food and Drug Administration, working together to ensure that communications-related medical innovations can swiftly and safely be brought to market. In June 2012, the FCC issued a letter in response to an inquiry from Reps. Walden, Bilbray, Blackburn, Burgess, Gingrey, and Pitts regarding wireless medical devices and the FCC's partnership with FDA, providing a comprehensive overview of activities that the two agencies have undertaken since enacting the MOU in 2010.
Frequency Bands for Medical Devices
- Medical Radio Communications Service (MedRadio)
- Authorized under Part 95, subpart I
- Frequency Band – General Usage: medical devices for transmitting data containing operational, diagnostic and therapeutic information associated with a medical implant device or medical body worn devices
- - 401-406 MHz
- Frequency Bands for Specific Applications:
- Medical Micropower Networks (MMNs): wireless medical devices that can be used to restore functions to paralyzed limbs
- - 413-419 MHz
- - 426-432 MHz
- - 438-444 MHz
- - 451-457 MHz
- Medical Body Area Networks (MBANs): networks of body-worn wireless sensors that transmit patient data to a health care provider
- - 2360-2400 MHz
- - 413-419 MHz
- Please refer to the rules to determine specific technical and operational rules for each MedRadio frequency band
- Frequency Band – General Usage: medical devices for transmitting data containing operational, diagnostic and therapeutic information associated with a medical implant device or medical body worn devices
- - 608-614 MHz
- - 1395-1400 MHz
- - 1427-1429.5 MHz(location specific)
- - 1429-1431.5 MHz (location specific)
- - 1395-1400 MHz
Interagency Health IT Strategy
In July 2012, the Food and Drug Administration Safety and Innovation Act was signed into law, reauthorizing the FDA's collection of user fees to increase the speed of regulatory reviews. The statute includes a requirement in Section 618 for the FCC to participate in an effort led by the Department of Health and Human Services, along with the Office of the National Coordinator for Health IT and the Food and Drug Administration, to draft a report outlining a strategy and recommendations for “an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” The report is due in 18 months and must address how to promote innovation, protect patient safety, and avoid regulatory duplication.
For more information on the FDA Safety and Innovation Act, please visit the FDA's website.
National Broadband Plan
The FCC published the National Broadband Plan in 2010, with a specific chapter on broadband for health care.
The Plan sets recommendations to maximize the impact of broadband and health information technology to transform health care delivery, including revamping the Rural Health Care Program, upgrading the Indian Health Services' broadband network, creating economic incentives for broader health IT adoption and innovation, unlocking the power of health care data and advanced analytics, and modernizing rules to increase access to e-care.
How to Engage with the FCC
- FCC Publications Library
- How to File Comment
- How to Comment Electronically
- To Provide Non Docketed Comments or Seek Information via E-mail or On-line:
- General information, comments, & inquiries: fccinfo@fcc.gov
- Complaints: File a Complaint
- Freedom of Information Act requests: FOIA@fcc.gov
- Comments on FCC Internet services: webmaster@fcc.gov
- Elections & political candidate matters: campaignlaw@fcc.gov
- Broadcast Information: Broadcast Information Specialists
Other Federal Agency Resources
- U.S. Department of Health and Human Services: www.hhs.gov
- Food and Drug Administration: www.fda.gov
- Office of the National Coordinator: www.healthit.gov
- National Institutes of Health: www.nih.gov
- Centers for Medicare and Medicaid Studies: www.cms.gov
- Center for Medicare and Medicaid Innovation: www.innovations.cms.gov
- Center for Disease Control: www.cdc.gov
- U.S. Department of Agriculture: www.usda.gov
- Rural Utilities Service: www.usda.gov/rus
