Next step for drones: Blood delivery? Opportunity, but regulatory hurdles
One North Carolina program is set to begin blood delivery via drone.
A new use for drones is taking off. WakeMed Health and Hospitals in Raleigh, North Carolina, is using the unmanned aircraft to transport blood from one campus building to another.
And, at least for the hospital, the regulatory obstacles associated with the program aren’t that much different from those that currently are required, said Susan James, chief legal officer at WakeMed.
“When we first sat down, we kept trying to make it hard, kept asking, ‘Why is it different with the drone?’” she said in an interview. “But the same regulations that apply to us taking things in a car will be the same that apply to us taking it in a drone. If there’s a car crash, and we lose samples, those are the same issues as if the drone crashes, and we lose samples.”
Risk threshold
But don’t expect to see drones whizzing overhead through cities and states en route from one health care facility to another with blood or other hazardous materials in tow — at least not for a while.
That’s because Federal Aviation Administration (FAA) regulations allow for the use of drone technology “at a very minimum risk threshold,” said Mark Aitken, senior policy adviser at Akin Gump Strauss Hauer & Feld.
For example, for so-called “revenue flights” like the ones being conducted at the North Carolina hospital, the aircraft, including its attached package, must weigh less than 55 pounds, remain within the visual line of sight, and is prohibited from crossing state lines, unless additional FAA waivers were granted. There also is a U.S. Department of Transportation economic authority compliance component.
‘A great milestone’
Still, the short flights across the North Carolina hospital campus are “a great milestone,” Aitken said, adding the program “shows how you can actually facilitate this through the current regulatory mechanism.”
Waivers can be given for those provisions, but to date the FAA has granted a limited number of waivers to the “visual line of sight” requirement, Aitken said.
A waiver of “visual line of sight is going to be the key to unlock the potential,” of the use of drones in a commercial capacity, said Laura Ponto, counsel at Hogan Lovells and former head of public policy and regulatory affairs for Google X’s Project Wing. “It’s going to take a coordination between the private sector and the regulators to make sure that [the technology] can be integrated safely, and that can take some time.”
North Carolina is one of less than a dozen sites nationwide to participate in the FAA’s Integration Pilot Program, which is designed to provide the regulatory tools needed to explore expanded operations, Aitken said.
Compliance with FAA lies with drone operator, not hospital
WakeMed’s CLO James said the hospital plans to expand the program to include miles-long routes between different Raleigh-area WakeMed buildings, adding that compliance with the FAA lies with the drone operator, not the hospital. The current flights are one-third of a mile.
“On the health care side, the [regulatory process] is not as involved as we initially thought it would be,” she said.
Other health care facilities looking to introduce a medical-specimen drone delivery program — either in a manner similar to WakeMed’s current format or in an expanded capacity if and when updated regulations are implemented — must consider many factors, legal experts said.
Risks with not managing materials carefully, securely
As with traditional medical air transport, there are many risks, arguably more with drones, associated with not managing materials carefully and securely, said Linda Pissott Reig, shareholder at Buchanan Ingersoll & Rooney.
“Can you imagine if there were an instance where drones were crashing and materials were spilling and not able to be controlled?” she said. “You have to ask, ‘Are they truly protected and secure? Is our system robust enough to ensure that if there is some mishap they are.’”
Robert Van de Vuurst, a partner at Baker, Donelson, Bearman, Caldwell & Berkowitz, advises that “the best thing that hospitals can do from a liability perspective is exactly what they’re doing now” with traditional air medical transport.
‘Make sure the drone is insured’
“Contract out to a vendor, make sure that vendor knows what they’re doing and can operate the drone safely,” he said. “Make sure the drone is insured, and then require the vendor to indemnify for anything.”
Kristen Rasmussen (krasmussen@alm.com) is an Atlanta-based reporter who covers corporate legal departments and in-house attorneys, Georgia government and health care.
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