8725078749_00627cd860_oThe new rules for the operation of small unmanned aircraft systems (sUAS) currently under consideration by the Federal Aviation Administration (FAA) create an important opportunity to explore and experiment with the possible medical uses of drones within the United States. The Mayo Clinic suggested in a recent article that it intends to explore the role drones can play in managing care for critically ill patients before they can reach a hospital.

Drones ability to provide for a fast, direct, delivery method that poses no risk to an on board crew make them uniquely suited to transporting blood and other supplies to disaster relief zones, mass casualty scenes, and even small remote hospitals who may have difficulty keeping expensive, perishable supplies like blood plasma and platelets on hand.  At least one logistics company overseas has already begun piloting a program to use drones to transport medicines to remote hospitals.  Last year, a university student in the Netherlands identified another potential application to emergency medicine when he created a prototype drone that could carry a defibrillator to a victim in cardiac arrest along with a live audio and video feed for medical professionals to deliver instructions to people at the scene. His premise was that a drone, unhampered by traffic and roads could arrive at the victim faster than an ambulance, thus reducing response time and increasing chances for survival.

Testing and use of drones for medical and other purposes is an area where the U.S. has lagged behind other countries due largely to a prohibition on the operation of drones for commercial or non-hobby uses without special authorization of the FAA. However, the FAA’s recent issuance of proposed rules designed to incorporate small unmanned aircraft systems (sUAS) into the US national airspace system lays the ground work for the evolution of drone use for emergency and medical purposes in the US.  These proposed rules are currently open for public comment until April 24, 2015.

The proposed rules

The rules the FAA proposed would allow sUAS, defined as unmanned aircraft systems (UAS) weighing less than 55 pounds, to operate in US airspace for commercial and non-hobby purposes provided they meet certain operational requirements. This rulemaking addresses only the lowest risk operations that can be undertaken by sUAS and is the first in what the FAA has described as an incremental approach to introducing sUAS into US airspace. Thus, while the rules as proposed would allow for certain tests in a controlled environment, a looser set of restrictions would be required to allow for uses like those discussed above.

Some of the operational requirements included in the proposed rules are:

  • Either the “operator” or one or more “visual observers” must maintain visual line of sight contact with the sUAS at all times while it is in operation. Their view of the sUAS may not be aided by anything other than corrective lenses. The “operator” of the sUAS must be able to exercise line of sight contact with the sUAS in this way at all times, but he is not required to watch the sUAS in this manner at all times, provided a visual observer is fulfilling this role.
  • The sUAS may not operate over anyone not directly involved in its operation.
  • The sUAS must stay within a maximum airspeed of 100 miles per hour, stay within an altitude of 500 feet above the ground, and operate with a minimum weather visibility of 3 miles from the control station.
  • The sUAS may operate only in daylight.
  • No operator or visual observer may perform that role for more than one sUAS at a time.
  • The sUAS must yield to the right-of-way of manned aircraft.
  • The sUAS may not operate in Class A airspace, defined as 18,000 feet and above, and may operate in Class B, C, D, and E airspace only with the permission of air traffic control. These latter classes note airspace restricted due to airports, air traffic control towers, and other reasons. The sUAS may operate without permission in class G airspace, which is unrestricted airspace generally very near the ground.

The rules also propose allowing a class of sUAS weighing less than 4.4 lbs, known as “microUAS” to operate in unrestricted airspace directly over people not involved in their operation provided they meet a separate set of requirements. Should this measure be approved, it could provide a faster route to certain medical uses for drones.

The proposed rules provide certification requirements for both the operators and the aircraft. The sUAS would not require an FAA airworthiness certification, but the operator would need to perform a preflight inspection of the sUAS. Additionally, all sUAS would be subject to the same registration and marking requirements as all other aircraft. Operators would not need to obtain a pilot’s license, but would be required to pass an initial aeronautical knowledge test, be vetted by the Transportation Security Administration, obtain an unmanned aircraft operator certificate with a sUAS rating, and pass a recurrent aeronautical knowledge test every 24 months.

Looking forward

While the current proposed rules do not allow for the transport of property for compensation or the carrying of an external payload, the exemption process that the FAA has been using thus far to allow for the selective commercial use of drones would continue to be available for uses like these that fall outside the rules. Such exemptions are granted under Section 333 of the FAA Modernization and Reform Act of 2012. This provision requires the Secretary of Transportation to determine whether the UAS can operate safely in US airspace. In making this determination, Secretary is required to evaluate whether a UAS would pose a hazard to other aircraft or the public or pose a threat to national security and 2) whether an airworthiness certification, certificate of waiver, or certificate of authorization is required. If he determines that the UAS can be operated safely, the law requires he establish requirements for these safe operations. Additionally, the FAA has requested comment on whether and under what requirements these types of activities should allowed under the rule itself.

In light of the quickly evolving technologies associated with UAS, the FAA has also invited comment on whether the final rule should relax operating requirements through some type of waiver on sUAS equipped with new technologies that would address the concerns underlying the restrictions in the rule. The FAA has identified two primary concerns unique to UAS that are the reasons behind many of the operational restrictions contained in the proposed rules. These include the lack of an individual on board a UAS to “see and avoid” other aircraft in time to avoid a collision and the possibility of loss of control of the UAS by the remote operator.

Read the Notice of Proposed Rulemaking “Operation and Certification of Small Unmanned Aircraft Systems.” (RIN 2120-AJ60). Comments on the proposed rules, published in the February 23, 2015 edition of the Federal Register, will be due on April 24, 2015.