Safer DATA Act
The source supplies the latest action, but no lifecycle stage.
Latest action (29 Mar 2007): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
What this bill does
This bill, the Safer Drug Assessment Technology Advancement Act, would require the Secretary of Health and Human Services to establish new systems for collecting and analyzing data about prescription drug safety after they have been approved and are on the market. This includes creating minimum standards for how electronic health records collect and share information, and developing an integrated system to analyze safety data from various sources. The goal is to better identify and understand potential drug risks.
The bill would also direct the Secretary to set up an active surveillance system to gather and report pharmaceutical postmarket data. This system would collect information from government health programs, private insurance claims, and electronic health records. Additionally, the Secretary would be required to improve transparency by creating an Internet site with comprehensive drug safety information for prescription drugs, making it more accessible to patients and healthcare providers.
This legislation was introduced in the Senate in March 2007 and was referred to the Committee on Health, Education, Labor, and Pensions. As of its introduction, no further action has been taken on the bill.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.
Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.
Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.
Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.
Timeline
29 Mar 2007
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Common questions
- What does S. 1024 do?
- This bill, the Safer Drug Assessment Technology Advancement Act, would require the Secretary of Health and Human Services to establish new systems for collecting and analyzing data about prescription drug safety after they have been approved and are on the market. This includes creating minimum standards for how electronic health records collect and share information, and developing an integrated system to analyze safety data from various sources. The goal is to better identify and understand potential drug risks. The bill would also direct the Secretary to set up an active surveillance system to gather and report pharmaceutical postmarket data. This system would collect information from government health programs, private insurance claims, and electronic health records. Additionally, the Secretary would be required to improve transparency by creating an Internet site with comprehensive drug safety information for prescription drugs, making it more accessible to patients and healthcare providers. This legislation was introduced in the Senate in March 2007 and was referred to the Committee on Health, Education, Labor, and Pensions. As of its introduction, no further action has been taken on the bill.
- Has S. 1024 become law?
- The source does not supply a confirmed lifecycle stage for S. 1024. Check the latest action and official source below.
- Who sponsored S. 1024?
- S. 1024 was sponsored by Sen. Gregg, Judd [R-NH] (R-NH), with 2 cosponsors.
- What's the latest action on S. 1024?
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (29 Mar 2007).
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