The Food and Drug Administration announced plans to create guidance on regulating medical devices that incorporate generative artificial intelligence capabilities. Rick Abramson, director of the agency’s Digital Health Center of Excellence, indicated that the regulatory approach would include both broad guidance on generative AI applications as well as more specialized guidance addressing particular topics of complexity or concern within the field.
Abramson noted that industry stakeholders have been anticipating regulatory clarity on this issue. The agency’s regulatory framework is expected to help establish expectations and standards for developers and manufacturers of medical devices utilizing generative AI technology.
In related healthcare workforce developments, nurse practitioners are emerging as a potential solution to gaps in the U.S. health care system. These professionals, who must complete a master’s degree and accumulate at least 500 hours of supervised clinical experience, are authorized to perform many of the same medical functions as physicians. However, a significant bottleneck exists in the training pipeline: there is a substantial shortage of preceptors—experienced clinicians willing to supervise student practitioners during their required clinical hours. Accredited schools are obligated to either provide clinical placements directly or assist students in securing them, though many institutions provide minimal support, leaving students to find supervisors independently. While preceptors traditionally work without compensation, it has become increasingly common for students to offer financial compensation, sometimes in cash, to secure the necessary training positions.
The healthcare newsletter also highlighted several other developments, including a public comment period on potential revisions to childhood vaccination schedules and a study examining the effects of soda purchase restrictions among SNAP users in ten states.
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