{"title":"大型语言模型未来在健康领域的应用取决于监管机构是否执行安全标准","authors":"","doi":"10.1016/S2589-7500(24)00124-9","DOIUrl":null,"url":null,"abstract":"<div><p>Among the rapid integration of artificial intelligence in clinical settings, large language models (LLMs), such as Generative Pre-trained Transformer-4, have emerged as multifaceted tools that have potential for health-care delivery, diagnosis, and patient care. However, deployment of LLMs raises substantial regulatory and safety concerns. Due to their high output variability, poor inherent explainability, and the risk of so-called AI hallucinations, LLM-based health-care applications that serve a medical purpose face regulatory challenges for approval as medical devices under US and EU laws, including the recently passed EU Artificial Intelligence Act. Despite unaddressed risks for patients, including misdiagnosis and unverified medical advice, such applications are available on the market. The regulatory ambiguity surrounding these tools creates an urgent need for frameworks that accommodate their unique capabilities and limitations. Alongside the development of these frameworks, existing regulations should be enforced. If regulators fear enforcing the regulations in a market dominated by supply or development by large technology companies, the consequences of layperson harm will force belated action, damaging the potentiality of LLM-based applications for layperson medical advice.</p></div>","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":null,"pages":null},"PeriodicalIF":23.8000,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2589750024001249/pdfft?md5=2df13b013a0e89af3fe332b6bcb83ed0&pid=1-s2.0-S2589750024001249-main.pdf","citationCount":"0","resultStr":"{\"title\":\"A future role for health applications of large language models depends on regulators enforcing safety standards\",\"authors\":\"\",\"doi\":\"10.1016/S2589-7500(24)00124-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Among the rapid integration of artificial intelligence in clinical settings, large language models (LLMs), such as Generative Pre-trained Transformer-4, have emerged as multifaceted tools that have potential for health-care delivery, diagnosis, and patient care. However, deployment of LLMs raises substantial regulatory and safety concerns. Due to their high output variability, poor inherent explainability, and the risk of so-called AI hallucinations, LLM-based health-care applications that serve a medical purpose face regulatory challenges for approval as medical devices under US and EU laws, including the recently passed EU Artificial Intelligence Act. Despite unaddressed risks for patients, including misdiagnosis and unverified medical advice, such applications are available on the market. The regulatory ambiguity surrounding these tools creates an urgent need for frameworks that accommodate their unique capabilities and limitations. Alongside the development of these frameworks, existing regulations should be enforced. If regulators fear enforcing the regulations in a market dominated by supply or development by large technology companies, the consequences of layperson harm will force belated action, damaging the potentiality of LLM-based applications for layperson medical advice.</p></div>\",\"PeriodicalId\":48534,\"journal\":{\"name\":\"Lancet Digital Health\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":23.8000,\"publicationDate\":\"2024-08-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2589750024001249/pdfft?md5=2df13b013a0e89af3fe332b6bcb83ed0&pid=1-s2.0-S2589750024001249-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lancet Digital Health\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2589750024001249\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICAL INFORMATICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Digital Health","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589750024001249","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
A future role for health applications of large language models depends on regulators enforcing safety standards
Among the rapid integration of artificial intelligence in clinical settings, large language models (LLMs), such as Generative Pre-trained Transformer-4, have emerged as multifaceted tools that have potential for health-care delivery, diagnosis, and patient care. However, deployment of LLMs raises substantial regulatory and safety concerns. Due to their high output variability, poor inherent explainability, and the risk of so-called AI hallucinations, LLM-based health-care applications that serve a medical purpose face regulatory challenges for approval as medical devices under US and EU laws, including the recently passed EU Artificial Intelligence Act. Despite unaddressed risks for patients, including misdiagnosis and unverified medical advice, such applications are available on the market. The regulatory ambiguity surrounding these tools creates an urgent need for frameworks that accommodate their unique capabilities and limitations. Alongside the development of these frameworks, existing regulations should be enforced. If regulators fear enforcing the regulations in a market dominated by supply or development by large technology companies, the consequences of layperson harm will force belated action, damaging the potentiality of LLM-based applications for layperson medical advice.
期刊介绍:
The Lancet Digital Health publishes important, innovative, and practice-changing research on any topic connected with digital technology in clinical medicine, public health, and global health.
The journal’s open access content crosses subject boundaries, building bridges between health professionals and researchers.By bringing together the most important advances in this multidisciplinary field,The Lancet Digital Health is the most prominent publishing venue in digital health.
We publish a range of content types including Articles,Review, Comment, and Correspondence, contributing to promoting digital technologies in health practice worldwide.