Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination
Fast Facts
Agencies face challenges regulating drones, medical devices with artificial intelligence, and other emerging technologies in a timely manner.
We asked agencies that regulate some of these complex, rapidly evolving technologies about their strategies. They told us that they:
Use varied approaches—including strategic foresight tools like "scenario planning"—to anticipate regulatory issues
Coordinate with other federal agencies and foreign governments to share information and achieve shared goals
Engage with industry and others to learn more about emerging technologies
We made 3 recommendations to agencies to improve their ongoing efforts.
Highlights
What GAO Found
Selected federal agencies—the Department of Transportation (DOT), the Federal Communications Commission (FCC), and the Food and Drug Administration (FDA)—reported using a variety of practices and approaches to prepare for and address regulatory challenges and opportunities posed by emerging technologies. However, FDA officials said updated authorities would help it regulate medical devices enabled with artificial intelligence (AI), in particular. Members of Congress are currently considering enhancing oversight of AI, including in medical devices, and congressional members have discussed barriers with FDA. However, FDA has not clearly identified, documented, and communicated to Congress the specific legislative changes that would help it address these challenges. Without this information, Congress may not be able to appropriately update FDA's authorities, and FDA may miss opportunities to fully realize the public health benefits of this technology.
Examples of Emerging Technologies: 3D Printing of Biological Materials, Next Generation Wireless, and Drones
Selected federal agencies have reported coordinating with other domestic and foreign agencies to support their efforts to regulate some emerging technologies. Agencies' interagency collaboration activities include efforts to share information and pursue goals for these technologies. However, DOT has not communicated progress made on a department-wide council to resolve jurisdictional and regulatory gaps associated with emerging transportation technologies. By assessing and publicly communicating the council's plans and progress, DOT could provide important information to stakeholders and help ensure the council is accountable for achieving its goals.
Knowledge-building and outreach efforts used by some selected foreign regulators were more extensive than those used by selected domestic regulators, particularly with industry and academia. For example, foreign regulators have clear channels for communicating with industry, the public, and regulated entities. The Federal Aviation Administration (FAA) recently established a group to engage with industry on drone regulation. But FAA could improve its outreach and communication with industry by publicizing this initiative, called the Emerging Technologies Coordination section. FAA currently does not include information online about how to contact this group. Industry can only participate in it by FAA's invitation, which may prevent some entities from getting the full benefit from its assistance.
Why GAO Did This Study
Emerging technologies have the potential to unlock immense societal benefits. Developing effective regulations to tackle complex emerging problems takes time. As a result, these technologies present a pacing problem for regulators. Ensuring regulations keep pace with the rapid development of emerging technologies is critical to protecting public interests and facilitating innovation.
GAO was asked to review how federal agencies regulate emerging technologies. This report examines, for selected agencies, (1) challenges and opportunities they report facing in regulating emerging technologies; (2) their collaboration and cooperation activities; and (3) lessons they can learn from other governments' experiences.
GAO reviewed documentation and interviewed officials from DOT, FCC, FDA, and other knowledgeable agencies and compared agencies' coordination efforts to selected leading practices. GAO also interviewed government officials in the European Union, the United Kingdom, and Japan, as well as 10 stakeholders spanning industry groups, academia, and other experts about practices in regulating emerging technologies.
Recommendations
GAO is making three recommendations, that FDA document potential legislative changes, DOT provide the public with information on collaborative efforts, and FAA publicize an industry-facing initiative. The agencies concurred with the recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | The Commissioner of FDA should identify and document the specific changes to its statutory authorities that would enable FDA to take the actions it determines best to oversee AI/ML-enabled medical devices, and then communicate these potential legislative changes to Congress. (Recommendation 1) |
FDA agreed with our recommendation. In a July 2024 letter, FDA said that it is engaged in the procedures outlined in the Office of Management and Budget's (OMB) Circular No. A-19 for the coordination and clearance by OMB of agency recommendations on proposed, pending, and enrolled legislation. FDA said that it is unable to estimate when this process will be completed. FDA has also identified and communicated to Congress about several authorities that it believes will be necessary to maintain safety and effectiveness standards while not stifling the pace of innovation. For example, FDA described its strategic vision for more effective regulation of AI/ML-enabled devices to Congress and other stakeholders, highlighting the need for additional statutory authority in its May 22, 2024 testimony before the House Energy and Commerce Subcommittee on Health. We will continue to track FDA's progress and provide updated information when available.
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| Department of Transportation | The Secretary of Transportation should provide the public with information on the NETT Council's completed and planned efforts to evaluate relevant emerging technologies. (Recommendation 2) |
DOT agreed with this January 2024 recommendation and told us that the agency plans to issue a series of annual reports that will outline the Nontraditional and Emerging Transportation Technology (NETT) Council's completed activities. DOT issued the first of these reports in December 2023. However, this report does not include information on the council's planned efforts, such as technologies that the council has prioritized for future evaluation or member agencies' plans to implement NETT Council recommendations. Until DOT regularly provides the public with information on the status of both the council's completed and planned activities, the NETT Council may continue to miss an opportunity to help ensure that it is accountable for achieving its goals of identifying and resolving regulatory gaps related to emerging transportation technologies.
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| Federal Aviation Administration | The Administrator of the FAA should publicize the ETC and establish a mechanism for regulated entities to communicate with the ETC to obtain assistance with applicable drone requirements. (Recommendation 3) |
The Department of Transportation concurred with the recommendation. In a May 2024 letter, Department of Transportation said that FAA recognizes the need to establish a mechanism for regulated entities to communicate with the FAA on all emerging entrant requirements, including drones. An enterprise-wide team evaluated existing agency processes and recommended a solution that begins with the development of an external facing emerging entrant FAA website to serve as the initial entry point to the FAA for all emerging entrants. FAA anticipates that solution will be implemented by June 30, 2025 and will include access to the ETC. We will provide updated information once we confirm FAA has completed this project.
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