A framework for regulating healthcare AI at the federal level has begun taking shape
America’s two major political parties agree on very little of late, but they have a mutual interest in working together toward overseeing AI.
Healthcare presents an especially unitive rallying point. This is evident in a legal analysis posted May 14 in the National Law Review. Authored by attorneys at the Nashville-based Polsinelli law firm, the piece drills into three early-stage AI initiatives gaining momentum in Washington.
Taken together, these efforts trace the contours of a “dedicated AI regulatory framework” in the making:
1. The Executive Branch’s Blueprint for an AI Bill of Rights. This document, posted by the White House’s Office of Science and Technology Policy, has limited legal standing, the attorney-authors point out. However, it tips the White House’s hand on preferences and priorities where regulations concern AI in healthcare:
“Many of the Blueprint’s problematic examples involve situations in which AI technology is used to deny coverage, limit care, or deliver care in a sub-optimal (and often discriminatory) manner. It is likely that the Blueprint will be consulted in developing regulations in the health space.”
2. The Department of Commerce’s AI Accountability Request for Comment. Commerce’s National Telecommunications and Information Administration (NTIA) will use submitted comments to make formal recommendations on AI accountability policy as informed by the White House’s blueprint, the Polsinelli attorneys remind.
“While the RFC still represents an early stage of policy development, it is important because it reflects the ongoing influence of the Blueprint. The RFC presents an important opportunity for developers or users of AI to ensure their perspective is heard at this early stage of AI policy development.”
3. Office of the National Coordinator’s HTI-1 Proposed Rule. As it stands, this proposed HHS rule references and integrates the Blueprint along with the 21st Century Cures Act, related Biden Administration executive orders and other policy communications, the authors note.
“Because the Proposed Rule modifies Certified Electronic Health Record Technology (CEHRT) requirements, it would affect not only developers of health IT modules that seek to obtain or retain certification but also the healthcare providers who use and rely on such technology to deliver healthcare services and receive reimbursement for such services.”
It is important for organizations contemplating the use of AI technology, or who may be affected by AI technology, to understand this developing regulatory framework, the authors advise. “Agencies are actively seeking comment on these policies,” the Polsinelli attorneys add, “so entities that may be affected—including healthcare providers, innovators, payors and advisors—have an important opportunity to shape the future of AI policy in healthcare.”
Expect immediate interparty contention over AI policy in Washington, but watch for eventual attempts at cooperation there and beyond.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.