Senate Introduces PATIENT AI Act Discussion Draft to Regulate and Reimburse Healthcare AI
Senator Bill Cassidy (R-LA), chair of the Senate HELP Committee, introduced a legislative discussion draft called the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care (PATIENT AI) Act. The bill seeks stakeholder input on expanding AI technologies in healthcare while ensuring transparency, patient safety, and compliance with data privacy and security laws. It proposes a predictable regulatory framework for reviewing healthcare AI and a reimbursement pathway for AI-based tool adoption. The draft assigns roles to HHS, the FDA, NIST, and the Office of the National Coordinator for Health Information Technology (ONC) covering liability studies, transparency/explainability reporting, device review processes, training materials, and payment methodologies for AI-delivered care.
Detalhes técnicos
The bill directs HHS to engage a nonprofit to study AI liability issues in healthcare settings and requires the Comptroller General to report on transparency and explainability measures for AI application development and deployment. HHS must expand internal AI use and collaborate with NIST and sector stakeholders on training materials; the HHS CIO is tasked with building datasets to support AI-based healthcare research. The FDA would gain responsibilities for reviewing integrated and software-based devices, third-party certification, postmarket surveillance, applying medical device product liability laws, and establishing a rolling AI software review process. The ONC would provide technical assistance for AI implementation across HHS agencies and expand Certified Health IT criteria to include clinical research technology and non-FDA-regulated AI applications. The HHS Secretary must create a coverage evaluation framework and payment methodologies for AI-based and autonomous AI-delivered care services.
Linha do tempo
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Senate Introduces PATIENT AI Act Discussion Draft to Regulate and Reimburse Healthcare AI
ler a análise desta fonte ocultar
Senator Bill Cassidy (R-LA), chair of the Senate HELP Committee, introduced a legislative discussion draft called the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care (PATIENT AI) Act. The bill seeks stakeholder input on expanding AI technologies in healthcare while ensuring transparency, patient safety, and compliance with data privacy and security laws. It proposes a predictable regulatory framework for reviewing healthcare AI and a reimbursement pathway for AI-based tool adoption. The draft assigns roles to HHS, the FDA, NIST, and the Office of the National Coordinator for Health Information Technology (ONC) covering liability studies, transparency/explainability reporting, device review processes, training materials, and payment methodologies for AI-delivered care.
Technical Details
The bill directs HHS to engage a nonprofit to study AI liability issues in healthcare settings and requires the Comptroller General to report on transparency and explainability measures for AI application development and deployment. HHS must expand internal AI use and collaborate with NIST and sector stakeholders on training materials; the HHS CIO is tasked with building datasets to support AI-based healthcare research. The FDA would gain responsibilities for reviewing integrated and software-based devices, third-party certification, postmarket surveillance, applying medical device product liability laws, and establishing a rolling AI software review process. The ONC would provide technical assistance for AI implementation across HHS agencies and expand Certified Health IT criteria to include clinical research technology and non-FDA-regulated AI applications. The HHS Secretary must create a coverage evaluation framework and payment methodologies for AI-based and autonomous AI-delivered care services.