- The head of the Food and Drug Administration has warned the U.S. needs to be “nimble in the use and regulation of large language models” to avoid being “swept up quickly by something that we hardly understand.”
- FDA Commissioner Robert Califf, speaking Monday at the 2023 Science for Patient Engagement Symposium, said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
- Califf identified bias as a specific concern, noting that the models and other algorithms “evolve after they are put into practice” and will likely need continuous adjustment throughout the life cycle to remain accurate.
Large language models (LLMs) such as ChatGPT are a type of artificial intelligence that has advanced quickly in recent years. Califf sees LLMs as having important medtech applications that improve healthcare.
“The great things are really great: imagine a world in which your questions were answered immediately in language appropriate for your literacy and numeracy; also your clinician can actually talk with you rather than spending all their time cutting, pasting and writing clinical notes; I could go on and on,” Califf said.
The commissioner added that he sees “the regulation of large language models as critical to our future.” The speech lacked details of how he envisages the U.S. regulating LLMs, beyond his comment that a “nimble” approach is needed.
Elsewhere in the speech, Califf, the former head of medical strategy at Alphabet, discussed how digital health technologies “provide opportunities to foster more efficient conduct of clinical investigations by making the operating characteristics of specific digital measurements in their context of use.” He cited the use of digital technologies to remotely record and analyze patient data as an example of their value.
The FDA chief added that the technologies “can help improve patient access to, and participation in, clinical investigations by potentially reducing the burden of required visits to a research site.” Califf has advanced that idea as head of the FDA by releasing draft guidance on decentralized clinical trials.