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H.R.5478 / 107th Congress

To amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety, and for other purposes.

Referred to the Subcommittee on Health.

Official summary

Version 00 · Introduced in House · Sep 26, 2002

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.Authorizes the Secretary to make grants to practitioners for electronic prescription programs, with a matching requirement of not less than 50 percent of the costs.Directs the Secretary to make grants to hospitals and other health care providers for information technologies, and to provide technical assistance to applicants and grantees. Sets forth a matching requirement for the grants of not less than 50 percent of the costs.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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Who introduced it

Rep. Bilirakis, Michael [R-FL-9] · R–FL

Committees

  • Energy and Commerce Committee
26 cosponsorship records, including any withdrawals

Actions

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  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

  3. Introduced in House

  4. Introduced in House

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.

Source last updated: Feb 10, 2026. Consult Congress.gov for the current record.

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Objective

Analyze H.R.5478 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Fairness and public impact

Progressive lens

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Institutions and government scope

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Individual rights and government power

Liberty lens

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