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Regulatory oversight, causal inference, and safe and effective health care machine learning.
Biostatistics ( IF 1.8 ) Pub Date : 2019-11-19 , DOI: 10.1093/biostatistics/kxz044
Ariel Dora Stern 1 , W Nicholson Price 2, 3
Affiliation  

In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging actively in thinking about how best to facilitate safe and effective use. Although the scope of its oversight for software-driven products is limited, if FDA takes the lead in promoting and facilitating appropriate applications of causal inference as a part of ML development, that leadership is likely to have implications well beyond regulated products.

中文翻译:

监管监督,因果推断以及安全有效的医疗保健机器学习。

近年来,机器学习(ML)在医疗保健提供环境中的应用已变得越来越丰富和引人注目。监管机构已经注意到这些事态发展,美国食品药品监督管理局(FDA)一直在积极考虑如何最好地促进安全有效地使用。尽管其对软件驱动产品的监督范围是有限的,但如果FDA率先促进和促进因果推理的适当应用作为ML开发的一部分,则领导地位可能会产生超出监管产品的影响。
更新日期:2020-04-17
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