FCC Draws mHealth Road Map, Part 1

Smartphones can perform all kinds of neat tasks, such as instantly directing owners to the nearest sushi bar, or providing inning-by-inning updates of the World Series. Beyond these eye-catching consumer conveniences, the potential for more substantive uses for mobile telecom is enormous.

One such area is healthcare, including a wide range of services from processing electronic health records to actually diagnosing and treating health problems. Smartphones and tablets will have an ever-growing role in healthcare — but an array of other electronic devices will also become critical in the evolving area of mobile health — variously referred to as mHealth, telemedicine, or e-care.

A central factor affecting vendors and service providers in the healthcare device and IT market is the role the Federal Communications Commission (FCC) plays through its mission of managing the radio frequency impacts of electronic devices as well as broadband and spectrum access. While the agency has taken a few steps to support healthcare, it has now endorsed a comprehensive road map to ramp up its mHealth program to meet the needs of patients, healthcare providers and vendors.

The future direction of the agency’s efforts was outlined in the findings and recommendations of a task force report on mHealth released in late September. The report was initiated by the FCC at a healthcare “summit” it convened last June, and was directed by three outside experts in healthcare and e-commerce.

Task Force Sets Goals

“Access to medical services, availability of state-of-the-art medical products, and the capacity of wireless telecommunications networks are critical to the success of a 21st-Century healthcare system,” said Robert Jarrin, senior director of government affairs for Qualcomm, and one of task force leaders.

“Although the mHealth industry has grown significantly over the past couple of years, there are still many advances that need to be made. The FCC’s primary responsibility should be to support the industry through regulations that promote innovation, not stifle it,” Jennifer Covich Bordenick, CEO of the eHealth Initiaitve, told the E-Commerce Times.

In its report, the task force listed five broad goals:

1. The FCC should continue to play a leadership role in advancing mobile health adoption.
2. Federal agencies should increase collaboration to promote innovation, protect patient safety and avoid regulatory duplication.
3. The FCC should build on existing programs and link programs when possible in order to expand broadband access for healthcare.
4. The FCC should continue efforts to increase capacity, reliability, interoperability and radio-frequency safety of mHealth technologies.
5. Industry should support continued investment, innovation, and job creation in the growing mobile health sector.

Among existing issues that impede mobile health technology adoption, the task force listed the lack of access to fixed and mobile broadband coverage for providers and patients in ‘underserved’ situations, especially rural areas. The report also noted that outdated reimbursement regulations and policies continue to inhibit the proliferation of mobile health technologies. In addition, inter-agency collaboration among federal agency partners can significantly enhance current programs and help to create data for improving healthcare, the task force said.

Actions to Enhance Vendors

For vendors in the healthcare device and IT space, the task force outlined several major requirements that would facilitate market development. These include:

• Product testing: Testing and evaluating innovative wireless healthcare devices is complex and expensive, “in part due to the scarcity of complete wireless test environments and expertise,” the task force said. A more effective approach to using spectrum for test‐bed environments is needed. The FCC should finalize its proposal to streamline its experimental licensing program, including licensing for medical device experimentation, which will enable commercial entities to form their own wireless test beds and publicly share their results. “There are a lot of mHealth developments that need the ability to test in a high density ‘live’ environment versus a limited in-house test and it requires some spectrum to do that,” Douglas Trauner, CEO of Health Anayltic Services and a co-director of the task force, told the E-Commerce Times.
• Spectrum allocation: Additional licensed mobile spectrum will help meet future demands and ensure reliable mobile broadband connectivity for spectrum-intensive healthcare services such as live video, remote monitoring, radiological imaging, and other medical applications, the task force said.
• Image utilization: Transmission of medical images such as CT scans, MRIs, ultrasound, and digital angiography using disks is a barrier to efficient and effective care, the task force said. Patients are burdened with requesting image disks from referring providers and mailing the files to consultants. Healthcare facilities import data from hundreds of thousands of patient provided image disks annually. National IT infrastructure should accommodate current and future medical image transmission to enable more timely and reliable healthcare delivery. The task force urged the FCC to solicit comment from the medical community to better understand the bandwidth and clinical use requirements for transmission of medical images.

FCC Takes Steps

While the FCC’s June health summit resulted in the task force report, the agency has been monitored closely by Congress in pursuing an mHealth agenda. In 2010 the FCC and the Food and Drug Administration agreed to a joint effort to encourage the use of mHealth products and services. However, last April six members of Congress, including Rep. Joseph Pitts, R-Pa., who chairs the Commerce subcommittee on health, asked the agencies to report on their plans.

“We are concerned that applying a complex regulatory framework could inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care and allow the health system as a whole reduce costs and improve quality,” Pitts said.

Coinciding with the release of the task force report, the FCC listed several of its recent mHealth support accomplishments. For example, last May the FCC adopted procedures to enhance the use of wireless medical body area networks (MBANs). The use of MBANs allow medical professionals to place multiple inexpensive wireless sensors at different locations on or around a patient’s body and to aggregate data from the sensors for transmission to a monitoring station. Benefits include reducing the risk of infection by eliminating the need to insert wires into a patient’s body and providing greater mobility for patients at hospitals and even at home.

Last year the FCC adopted rules to enable a new generation of wireless medical devices called medical micropower networks (MMNs) 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. The agency also initiated a pilot program to facilitate the use of broadband in rural areas for medical purposes.

FCC Draws mHealth Road Map, Part 2