This piece was originally published in the May/June 2019 issue of electroindustry.

Katy Milner Ross, Partner, Wiley Rein LLP

Katy Milner Ross is a telecommunications attorney who also advises clients on U.S. unmanned aircraft systems’ legal, regulatory, and public policy issues, including analysis of FAA and FCC regulations and state and local considerations.

One day soon, unmanned aircraft systems (UAS, commonly called drones) may be able to deliver pizzas and packages to our doorsteps. But some in the UAS industry are using UAS to deliver even more essential cargo—lifesaving medical devices. The Federal Aviation Administration (FAA) recently approved Flirtey, a drone delivery company, to conduct beyond visual line of sight (BVLOS) UAS flights to deliver automated external defibrillators (AEDs). The FAA granted Flirtey this authority in connection with Flirtey’s participation in the UAS Integration Pilot Program (IPP), an FAA-led program launched in 2017 that brings together local governments with private sector entities to study safe drone integration into the national airspace.

Cardiac emergencies can happen anywhere, and prompt defibrillation after a cardiac event can mean the difference between life and death. Drones present a unique way to get AEDs to victims, particularly those in rural or otherwise challenging areas to reach. A drone can carry an AED to the location of a victim and permit a bystander to detach and use the device quickly. Swedish researchers testing AED-carrying drones found that the drones arrived more quickly than emergency medical services in all eighteen test flights they conducted, saving a median time of 16:39 minutes.¹

Flirtey’s flights under the IPP are a good first step but will not immediately lead to widespread medical device delivery. The FAA’s current rules for commercial drone operators forbid BVLOS flights, thus precluding the use of delivery drones to reach remote victims.² Eventually, as the FAA authorizes more expanded operations, the agency should permit routine BVLOS operations, but those rules are likely years away.

In the interim, operators can petition the FAA for a waiver of this rule. FAA Part 107 waiver applicants must describe their proposed drone operation and satisfy the FAA that the operator understands the operational risks associated with the activity and has undertaken methods to lessen or mitigate such risks. For example, the FAA will want to understand how  the pilot will be able to continuously determine the position, altitude, and movement of the drone and how the pilot will avoid other aircraft, people, and obstacles. If the FAA grants the waiver, the applicant will receive a Certificate of Waiver detailing the effective waiver dates, which may be up to four years, and the waiver provisions. Common waiver provisions for BVLOS flights include mandatory use of at least one visual observer or safety pilot to aid in drone operations and ensuring that all personnel are properly trained to operate UAS BVLOS.

For now, authority to conduct BVLOS drone delivery of medical devices is rare. As the regulatory landscape for commercial use of drones continues to develop, innovators may discover more ways that drones can improve our lives—and perhaps our health. ei

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¹ Andreas Claesson et al., Time to Delivery of an Automated External Defibrillator Using a Drone for Simulated Out-of-Hospital Cardiac Arrests vs Emergency Medical Services, Research Letter, 317 Jama 2332 (2017)

² 14 C.F.R. § 107.31