A legislative discussion draft has been introduced in the Senate that seeks input from industry stakeholders, clinicians, and policy experts on expanding the use of AI tools in healthcare, while ensuring transparency, patient safety, and compliance with data privacy and security laws. The bill seeks to develop a more predictable and consistent framework for review of AI technologies and establish a reimbursement pathway for adoption of AI-based tools in healthcare.
The bill, the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care (PATIENT AI) Act, was introduced by Senate HELP Committee chair, Senator Dr. Bill Cassidy (R-LA). The bill calls for the U.
S. Department of Health and Human Services to engage a nonprofit organization to examine and develop recommendations concerning liability related to AI-based applications in healthcare settings and identify any potential issues. The Comptroller General should produce a report examining public proposals for establishing transparency and explainability measures for the development, validation, use, and deployment of healthcare AI applications The bill requires the HHS to expand the use of AI within the department to improve the efficiency of internal operations as well as healthcare outcomes, and should work with the Director of the National Institute of Standards and Technology (NIST) and healthcare and public health sector stakeholders to develop materials for training healthcare and public health sector entities on the best uses of AI-based applications in healthcare.
The HHS Chief Information Officer (CIO) is instructed to build datasets to be used to support health care research using artificial intelligence-based applications. Responsibilities have been proposed for the Food and Drug Administration concerning reviews of integrated devices, software-based devices, third-party reviews and certification, postmarket surveillance, applying medical device product liability laws to integrated and software-based devices, and it is required to develop a rolling process for AI software reviews.
Get The FREE HIPAA Compliance Checklist Immediate Delivery of Checklist Link To Your Email Address Please enable JavaScript in your browser to complete this form. Business Email * Name * First Last Number * Company Name * Get Free Checklist Please Enter Correct Email Address Your Privacy Respected HIPAA Journal Privacy Policy The Office of the National Coordinator for Health Information Technology (ONC) should work with agencies within the HHS to provide technical assistance with implementing AI tools within each agency, and expand Certified Health Information Technology to include clinical research technology, and AI-based applications not considered to be FDA-regulated devices.
The HHS Secretary is instructed to create a coverage evaluation framework for artificial intelligence-based services, develop payment methodologies to reimburse for AI-based services, and AI-based applications that deliver care autonomously. “We’re living in a new digital age as artificial intelligence transforms how we deliver care,” said Sen. Cassidy.
“Implementing AI in health care must be done responsibly and to the benefit of patients, innovators, and consumers. This discussion draft proposes solutions to expand access to AI-based technologies by creating regulatory predictability while prioritizing patient safety.” The post Senate Bill Seeks to Expand Use of AI Technologies in Healthcare and Reimburse for Adoption appeared first on The HIPAA Journal .
Originally published at hipaajournal.com
