[Ed: We are pleased to present this in-depth report on the recent regulatory changes announced by the FCC related to mHealth research by experienced FCC attorney Robert Primosch.
By: Robert D. Primosch, Esq Partner, Wilkinson Barker Knauer, LLP.
The enormous growth of medical devices that use wireless telecommunications technology – and the corresponding need to accelerate testing of those products – have prompted regulators to take action. The Federal Communications Commission (FCC) has adopted new experimental licensing rules that will create unprecedented opportunities for research and clinical trials of wireless medical devices, replacing the existing approval system with a new, streamlined framework designed to deliver potentially life-saving devices to market in less time.
As observed by FCC Chairman Julius Genachowski, the FCC’s prior experimental licensing regime fostered the development of mHealth innovations such as patient monitoring equipment and Medical Micropower Networks. These types of platforms (and the development of new ones) remain the focus of experimental licensing, as opposed to the Bluetooth devices and cellular telephones that medical personnel have been using for years.
Most importantly, hospitals and other health care institutions will be permitted to use a variety of spectrum bands for experiments “on campus” and in the field for as long as five years, without having to obtain a new experimental license every time they substitute equipment or change their testing parameters. By the same token, the new rules include eligibility, technical, legal and reporting requirements which, while navigable, should be reviewed and considered carefully before the rules go into effect (likely within the next few months). Medical facilities thus may find it prudent to retain or partner with individuals or entities with expertise in FCC matters before pursuing an experimental license.
Two types of experimental licenses will be of particular interest: the “program experimental license” (for product research and development) and a “medical testing license” (for clinical trials). The key aspects of each are discussed below.
The Program Experimental License
Under the FCC’s conventional process for issuing experimental licenses, any entity seeking access to spectrum for research and testing normally is required to obtain a separate license application for each new project and for changes to previously licensed projects. Thus, an entity might be required to obtain multiple licenses (and endure any associated regulatory delays) for experiments conducted under the same research program, even if those experiments are confined to a broad but clearly defined geographic area. Nonetheless, this process will remain available to anyone who wishes to (or, in certain circumstances, must) use it.
The Program Experimental License (PEL), however, is a new paradigm. A holder (or “licensee”) of a PEL will be permitted to conduct any number of experiments under a single license at defined geographic areas under the licensee’s control. A PEL licensee will be able to conduct experiments within a broad range of frequencies, emissions and power levels to support ongoing research, without the need to reapply for new licenses. PELs will have five-year terms and be renewable for another five years.
While those interested in obtaining a PEL should consult the FCC’s decision for all the details, here are some of the more important items to consider:
- The following will be eligible to apply for a PEL: a hospital or health care institution; a college or university with a graduate research program in engineering that is accredited by the Accreditation Board for Engineering and Technology (ABET); a research laboratory; a manufacturer of radio frequency (RF) equipment; or a manufacturer that integrates RF equipment into its end products. Eligible entities must confirm in their applications that their staff (or whomever they are partnering with) possesses the necessary RF expertise for the project at issue.
- PEL applications must specify a geographic area that includes the applicant’s real property where experiment(s) will be conducted, and which is under the applicant’s control. Experiments must be designed to use the minimum power necessary and be restricted to the smallest practicable area required for successful completion of the experiment(s).
- Subject to limited exceptions, PEL licensees will be permitted to operate in any frequency band. But, where an experiment will be conducted on critical service bands (i.e., those used for mobile telephone service, emergency notifications or public safety purposes), a PEL licensee must develop a specific, pre-experiment plan to avoid harmful interference to operations in those bands. That plan must include notice to those operators and, as appropriate, end users of those operators’ services who might be affected by the proposed experiment.
- At least 10 calendar days prior to commencing an experiment, a PEL must electronically register the specifics of its proposed experiment (including steps taken to avoid causing harmful interference to others) on the FCC’s website. The licensee must also identify a “stop buzzer” point of contact who will be available at all times to immediately shut down an experiment that is causing harmful interference. If an entity operating on a protected spectrum believes it will suffer such interference and is unable to reach a solution with the PEL licensee, it may bring its concerns to the FCC for further action.
- In lieu of obtaining a PEL license for itself, a medical facility or other eligible entity may ask the FCC to designate a specific geographic area as an “innovation zone” in which any number of PELs may conduct specific types of experiments.
The Medical Testing License
Because they are required to conduct experiments at geographic locations under their control, PEL licensees only have limited ability to conduct off-site clinical trials that involve, for example, home care. To address this problem, the FCC has created the Medical Testing License (MTL). MTLs will have five-year, renewable terms and generally the same basic application and interference protection requirements as PELs. Unlike PELs, however, MTLs are not restricted to “on campus use” – testing in a patient’s home and other off-campus locations will be permitted.
Eligibility for MTLs is more limited than that for PELs. MTLs will only be available to “healthcare facilities,” which for these purposes are defined as “hospitals and other establishments that offer services, facilities and beds for use beyond a 24 hour period in rendering medical treatment, and institutions and organizations regularly engaged in providing medical services through clinics, public health facilities, and similar establishments, including government entities and agencies such as Veterans Administration hospitals; except the term health care facility does not include an ambulance or other moving vehicle.”
MTLs will permit health care facilities to conduct clinical trials of medical devices that have already cleared the development phase and are ready to be assessed for patient compatibility and use, plus any other issues arising from “real world” operation (in this context, a medical device is something which uses RF wireless technology or communications functions for diagnosis, treatment or patient monitoring). The health care facility that holds the MTL will be the party responsible for testing and proper operation of the equipment, and for curing any interference problems that may arise.
An MTL applicant does not need to have FDA approval of its proposed clinical trial in hand when it files its application with the FCC. At the same time, the FCC cautions that MTL applicants “must be aware of the FDA’s jurisdiction and take all necessary steps to satisfy the requirements of both the FDA and the FCC prior to testing a device.”
In addition, each MTL licensee will be required to file yearly reports regarding its testing activities. The FCC hopes that these reports will provide a vehicle through which medical researchers may share information, and improve patient care as a result.
Finally, a health care institution that would like to offer its facilities as a test bed but lacks the expertise to operate one , may petition the FCC to designate their facility as an innovation zone, so that individual developers and manufacturers may use it under their PELs. The FCC suggests that this approach may be particularly useful for manufacturers who are ineligible for MTLs but want to test medical or other types of equipment that will be used in a health care setting while it is in the product development stage.
The above is only a snapshot of the FCC’s 118-page decision. It is expected that over the next few months the FCC will issue further guidance as to how the new experimental licensing program will work, and will advise interested parties as to when, for example, its new experimental license application and the electronic registration system will be available. iMedicalApps will report on these developments as they occur.
Robert D. Primosch is a partner at the law firm of Wilkinson Barker Knauer, LLP, Washington, D.C.. The firm specializes in providing regulatory and transactional counsel on wireless and wire line matters, including communications services used or offered by health care providers.