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United States · Bill · HR

H.R. 663 (108th)

Patient Safety and Quality Improvement Act of 2004

openUnited States· United States Congress· EN

Introduced

11 February 2003

Last action

Status

Message on Senate action sent to the House.

Sponsors

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Discovery layer

Source updated

21 April 2025

Summary

Patient Safety and Quality Improvement Act - Amends the Public Health Service Act to make "patient safety work product" privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. Imposes a civil penalty on providers who violate the privileged status of patient safety work product. Directs the Secretary of Health and Human Services to establish and maintain a database to receive relevant nonidentifiable patient safety work product, consistent, if practicable, with the administrative simplification provisions of the Social Security Act. Permits the Secretary to provide to patient safety organizations and to States technical assistance with reporting systems for health care errors. Directs the Secretary to establish a process for the Secretary or another approved Federal or State governmental organization to certify patient safety organizations. Requires the Secretary to develop or adopt voluntary national standards promoting the interoperability of information technology systems involved with health care delivery. Requires the Secretary to issue and periodically revise regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the Food and Drug Administration, or the packager or labeler of such a product, to include a unique product identifier on the packaging.

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Documents

14 official files

Engrossed Amendment Senate (text)

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