使用大型语言模型扩展医疗器械监管科学规模.
Hanyang Li1, Xiao He1, Adarsh Subbaswamy2
1Unaffiliated, San Francisco, California, CA, USA.
NPJ digital medicine
|February 5, 2026
概括
大型语言模型 (LLM) 可以准确分析复杂的医疗器械监管文件,达到80%以上的准确性. 这种AI进步有助于监控设备验证,编码报告和识别不良事件风险.
科学领域:
- 监管科学 监管科学
- 人工智能的人工智能
- 医疗器械开发 医疗器械开发
背景情况:
- 人工智能 (AI) 和机器学习 (ML) 的快速发展导致了支持AI/ML的医疗设备的增加.
- 这些设备的开发,测试和监测的新兴最佳实践带来了监管挑战.
- 手动注释复杂的,充满术语的监管文件是耗时的,限制了数据分析.
研究的目的:
- 验证大型语言模型 (LLM) 在分析医疗器械监管文件中的有效性.
- 评估LLM在监管科学中扩展数据分析的潜力.
- 通过对监管环境的最新数据分析,为政策制定提供信息.
主要方法:
- 进行了对LLMs进行广泛的验证研究,以分析监管文件.
- 使用专家手册注释评估的LLM输出.
- 在绩效评估中采用"LLM-as-a-judge"的方法.
主要成果:
- 在从监管文件中提取属性方面,LLM表现出高准确度,通常超过80%.
- 在市场前和市场后环境中,LLM成功地提取了与市场前和市场后环境相关的信息.
- 该研究证实了LLMs能够扩展数据分析以适用于监管科学应用的能力.
结论:
- 法律法规提供了一种强大而准确的解决方案,可以克服分析非结构化监管数据的挑战.
- 基于LLM的分析可以显著提高监测设备验证,医疗设备报告和识别不良事件风险的监控.
- 这项研究强调了LLMs在推动医疗器械监管科学和政策方面的变革潜力.
相关概念视频
Cis-regulatory Sequences
11.9K
Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...
11.9K
Cis-regulatory Sequences
4.2K
4.2K
Language
918
Language is a unique communication system that uses words and systematic rules to organize and transmit information. Unlike other forms of communication, which may involve postures, movements, odors, or vocalizations, language relies on symbols and grammar. This makes human communication distinct from that of other species, who also communicate but do not use language in the same way humans do.
Corballis and Suddendorf (2007) and Tomasello and Rakoczy (2003) highlight the role of language in...
Corballis and Suddendorf (2007) and Tomasello and Rakoczy (2003) highlight the role of language in...
918
Psychology as a Science
3.9K
Psychology, as a scientific discipline, aims to understand the mind and behavior through rigorous and systematic methods. The foundation of psychological research is evidence-based, relying heavily on the scientific method to derive and validate knowledge. This structured approach ensures that findings are reliable, valid, and applicable to broader contexts.
The scientific method in psychology involves six critical steps: making observations, formulating hypotheses, conducting tests, analyzing...
The scientific method in psychology involves six critical steps: making observations, formulating hypotheses, conducting tests, analyzing...
3.9K
pH Scale
80.0K
Hydronium and hydroxide ions are present both in pure water and in all aqueous solutions, and their concentrations are inversely proportional as determined by the ion product of water (Kw). The concentrations of these ions in a solution are often critical determinants of the solution’s properties and the chemical behaviors of its other solutes. Two different solutions can differ in their hydronium or hydroxide ion concentrations by a million, billion, or even trillion times. A common means of...
80.0K
Components of Language
821
Language, whether spoken, signed, or written, consists of specific components: lexicon and grammar. The lexicon is the vocabulary of a language, comprising its words. Grammar is the set of rules used to convey meaning through the lexicon. For example, English grammar adds “-ed” to most verbs to indicate past tense. Words are formed by combining phonemes, which are the basic sound units of a language. Different languages have different sets of phonemes (e.g., “ah” vs.
821


