Overview
Title
To ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes.
ELI5 AI
The bill wants to make sure that using computer smart helpers (AI) in hospitals and for health is done safely and fairly for everyone. It says the hospital people can get a lot of money to help, but they must be careful and smart about how they use it.
Summary AI
S. 4862 aims to ensure the ethical use of artificial intelligence (AI) in healthcare to benefit all individuals. It requires the National Institutes of Health (NIH) to develop resources for AI-driven health research, provide education, and improve clinical research capabilities. The bill mandates standards for data exchange and requires hospitals to ask patients for permission to use their health data for research. Additionally, it provides funding for these initiatives and emphasizes the importance of including NIH officers in national AI research discussions.
Published
Keywords AI
Sources
Bill Statistics
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Language
Complexity
AnalysisAI
Summary of the Bill
The legislation, titled S. 4862, is focused on the ethical adoption of artificial intelligence (AI) to enhance health outcomes for all individuals. The bill proposes various amendments aimed at promoting the integration and use of AI in healthcare settings. Key elements include the development of computational and data capabilities by the National Institutes of Health (NIH), ensuring patient consent for the use of health data, establishing standards for data interoperability, and strengthening the role of the National Library of Medicine. The bill authorizes significant funding, such as $400 million for the NIH and additional funds dedicated to health IT projects and data sharing initiatives.
Significant Issues
Several concerns accompany the proposed legislation. Firstly, while substantial funding is authorized, there is a noticeable lack of specific accountability or oversight measures, potentially leading to wasteful spending. The bill refers to technical terms such as "federated resources" and "federated data sharing," which may confuse stakeholders unfamiliar with these concepts, complicating implementation and management.
Another issue is the ambiguity surrounding terms like "health-related research purposes" and "consent," particularly in the context of Medicare requirements. These may lead to misunderstandings or misinterpretations in how patient data is used and shared. Furthermore, the lack of defined criteria for "scientifically sound, ethical, and inclusive research" leaves room for subjective interpretations, increasing the risk of funds not being utilized effectively or ethically.
Impact on the Public
Broadly, the bill aims to advance healthcare by leveraging AI technology, potentially leading to innovative medical research and more personalized healthcare services. For the general public, this could mean more effective treatments and enhanced health outcomes. However, the vague language and lack of specific guidelines could result in the misuse of health data and inefficient allocation of resources, undermining the potential benefits of such a significant investment in AI in healthcare.
Impact on Specific Stakeholders
Healthcare providers, researchers, and AI developers might see positive impacts from this bill due to increased funding and resources for AI projects. This could lead to advancements in medical research and technology development. However, the ambiguity around data sharing and privacy could present challenges, especially regarding patient trust and consent. Hospitals, specifically, will have to navigate new requirements for obtaining patient consent for data use, which could add administrative challenges.
For patients, while there is potential for improved healthcare, concerns around data privacy and consent could lead to hesitancy in sharing personal health information. This underscores the need for clear communication and assurance regarding data security and ethical use.
In summary, the bill presents an opportunity for significant advancements in healthcare through the use of AI but falls short in addressing key areas of clarity, oversight, and accountability, which are crucial for ensuring both the ethical implementation and the maintenance of public trust.
Financial Assessment
The bill S. 4862 includes significant financial allocations meant to ensure the ethical use of artificial intelligence (AI) in healthcare. These appropriations are detailed across various sections of the bill, each outlining specific funding for different purposes within the National Institutes of Health (NIH) and related entities.
National Institutes of Health (NIH) Appropriations
The bill authorizes $400,000,000 for the NIH to develop computational resources and datasets for AI-driven health research, provide education, and enhance clinical research capabilities. However, a key issue associated with this allocation is the lack of a detailed breakdown or oversight mechanisms, which could potentially lead to inefficiencies or wasteful expenditure. The appropriation is significant yet lacks explicit accountability measures to monitor how the funds are utilized effectively.
Office of the National Coordinator for Health Information Technology
The National Coordinator is allocated $10,000,000 to engage in health research using electronic health records and $50,000,000 to establish data and interoperability standards. The latter amount, in particular, raises issues as there are no specific details on the process of developing these standards, nor on any oversight to prevent fragmented efforts or undue proprietary influence. The concerns are compounded by the potential ambiguity in terms, which could lead to inconsistencies in how funds are managed and applied.
National Library of Medicine
The bill allocates $100,000,000 each for two functions related to federated data sharing and establishing core data science programs. These funds are intended to establish facilities for data sharing and enable a comprehensive community of research data users. However, the lack of clear objectives or justifications for these appropriations raises concerns about their potential to be allocated wastefully.
Medicare and Hospital Requirements
The bill mandates that hospitals obtain patient consent for using electronic health record data for research purposes, yet fails to address how these processes will be funded or managed. The undefined nature of terms like "consent" and "health-related research purposes" serves as a potential issue that could affect how funds are allocated and utilized, leaving room for confusion and misinterpretation.
Overall Financial Oversight and Accountability
A prevailing issue throughout the bill is the absence of explicit criteria or detailed guidelines for evaluating the effectiveness of the allocated funds. There is also concern regarding potential conflicts of interest, particularly with NIH officers having a role in national AI research discussions without clear boundaries. Furthermore, patient data security and handling measures are not adequately detailed, posing potential privacy and security risks.
In summary, while the bill S. 4862 outlines significant financial allocations to support AI development in healthcare, it presents various challenges relating to oversight, accountability, and the specific application of funds. Addressing these issues would be crucial to ensuring that the financial resources are used effectively and ethically.
Issues
Section 1.: The bill authorizes significant spending, including $400,000,000 to the NIH, without specifying clear accountability or oversight measures, raising concerns about potential waste or misallocation of funds.
Section 1.: The language used in describing 'federated resources' and 'federated data sharing' is unclear, potentially leading to confusion among stakeholders who may be unfamiliar with these technical terms.
Section 403E.: The allocation of $400,000,000 lacks detailed breakdowns or oversight mechanisms, which might result in inefficient or wasteful spending.
Section 1.: Ambiguous terms like 'health-related research purposes' and 'consent' in the context of Medicare requirements could create confusion or misinterpretation, affecting patient data-sharing practices.
Section 3023.: The $50,000,000 authorized for establishing data and interoperability standards lacks specific details on development and oversight, raising concerns over potential proprietary influence or fragmented efforts.
Section 403E.: The bill does not define specific criteria for 'scientifically sound, ethical, and inclusive research,' leading to possible misuse of funds.
Section 1.: There is a lack of specific measures or criteria for evaluating the effectiveness of AI initiatives, potentially resulting in inefficient use of funds without achieving intended outcomes.
Section 1.: Conflicts of interest may arise from including an NIH officer or employee in the National Artificial Intelligence Research Resource's steering subcommittee without clear boundaries or oversight.
Section 1.: There is a lack of detail on how patient data will be securely handled and protected against misuse in research, posing a privacy and security risk.
Section 468.: The purposes for the $100,000,000 appropriations for sections 465(b)(8) and 465(b)(9) are not clearly described, lacking detailed justification or objectives which could lead to wasteful allocation.
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Governing ethical AI use and innovation for health care development Read Opens in new tab
Summary AI
The text outlines amendments to promote ethical and inclusive use of artificial intelligence in health care. It includes provisions for developing AI resources, requiring hospitals to seek patient consent for data use in research, establishing data standards, appropriations for NIH and health IT projects, and enhancing the role of the National Library of Medicine in data sharing.
Money References
- “(b) Authorization of appropriations.—There is authorized to be appropriated to the Director of NIH to carry out this section $400,000,000 for fiscal year 2025.”
- (b) Authorization of appropriations.—There are authorized to be appropriated to the National Coordinator for fiscal year 2025— “(1) $10,000,000 to carry out subsection (a)(1); and “(2) $50,000,000 to carry out subsection (a)(2).”.
- — (1) IN GENERAL.—Section 465(b) of the Public Health Service Act (42 U.S.C. 286(b)) is amended— (A) in paragraph (7), by striking “and” after the semicolon; (B) by redesignating paragraph (8) as paragraph (10); and (C) by inserting after paragraph (7) the following: “(8) establish facilities so that the Library serves as the central exchange center of federated data sharing; “(9) establish a core data science program to guide and enable a diverse and comprehensive community of health-related research data users; and”. (2) AUTHORIZATION OF APPROPRIATIONS.—Subpart 1 of part D of title IV of the Public Health Service Act (42 U.S.C. 286 et seq.) is amended by adding at the end the following: “SEC. 468. Authorization of appropriations. “There are authorized to be appropriated to the Secretary for fiscal year 2025— “(1) $100,000,000 to carry out section 465(b)(8); and “(2) $100,000,000 to carry out section 465(b)(9).”. ---
403E. Artificial intelligence Read Opens in new tab
Summary AI
The legislation mandates the NIH Director to create resources for using artificial intelligence in health research, offer expertise, maintain data resources, support a research community, and enhance clinical research. It also proposes a budget of $400 million for these activities in 2025.
Money References
- (a) In general.—The Director of NIH shall— (1) develop computational resources and datasets necessary to use artificial intelligence approaches for health and health care research; (2) provide expertise in biomedical research and the use of artificial intelligence; (3) develop and maintain federated resources that provide unified access to data from fundamental biomedical research and the clinical care environment; (4) provide education and ongoing support to a nationwide user community to foster scientifically sound, ethical, and inclusive research using artificial intelligence that addresses the health needs of all individuals; and (5) extend the clinical research capabilities of the National Institutes of Health to address significant gaps in evidence to guide clinical care and to serve the needs of every community. (b) Authorization of appropriations.—There is authorized to be appropriated to the Director of NIH to carry out this section $400,000,000 for fiscal year 2025. ---
3023. Artificial intelligence Read Opens in new tab
Summary AI
The section outlines the responsibilities of the National Coordinator to enhance health research through electronic health records, establish data standards for clinical data exchange using a National Artificial Intelligence Research Resource, and allocates funding with $10 million for data collection and $50 million for setting interoperability standards for the fiscal year 2025.
Money References
- (a) In general.—The National Coordinator shall— (1) carry out activities to engage in health research by— (A) utilizing the electronic health record as a data collection tool; and (B) requiring that individuals are offered an opportunity to direct the use of their health data for health care research; and (2) establish data and interoperability standards for access, exchange, and use of clinical and administrative data from the clinical care environment through a National Artificial Intelligence Research Resource, in alignment with— (A) the United States Core Data for Interoperability; (B) the Fast Health Interoperability Resources; and (C) the Trusted Exchange Framework and Common Agreement. (b) Authorization of appropriations.—There are authorized to be appropriated to the National Coordinator for fiscal year 2025— (1) $10,000,000 to carry out subsection (a)(1); and (2) $50,000,000 to carry out subsection (a)(2). ---
468. Authorization of appropriations Read Opens in new tab
Summary AI
The section authorizes the allocation of $100 million for each of two activities, as specified in sections 465(b)(8) and 465(b)(9), to the Secretary for the fiscal year 2025.
Money References
- There are authorized to be appropriated to the Secretary for fiscal year 2025— (1) $100,000,000 to carry out section 465(b)(8); and (2) $100,000,000 to carry out section 465(b)(9). ---