H.R. 663: Patient Safety and Quality Improvement Act of 2004

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H.R. 663: Patient Safety and Quality Improvement Act of 2004

108th Congress · introduced 2003-02-11 · Health · Latest: Message on Senate action sent to the House.

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Official title

Patient Safety and Quality Improvement Act of 2004

Plain summary

Patient Safety and Quality Improvement Act - Title I: Patient Safety and Quality Improvement - (Sec. 101) 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. Prohibits patient safety work product: (1) from being subject to a civil or administrative subpoena or order; (2) from being required to be admitted as evidence in any State or Federal civil or administrative proceeding; or (3) if the patient safety work product is identifiable information and is received by a national accreditation organization in its capacity as a patient safety organization, from being used by such organization in an accreditation action against the provider that reported the information. Requires disclosure to the Food and Drug Administration for safety purposes. Protects individuals who report information to a patient safety organization from adverse employment actions. Permits the voluntary disclosure of identifiable information by a provider or patient safety organization under specified conditions, including that it be for improving quality and safety. Imposes a civil penalty for violating this section. Declares that patient safety work product remains confidential, even if a patient safety organization has its certification revoked or otherwise ceases to exist. Directs the Secretary of Health and Human Services to establish and maintain a database to receive relevant nonidentifiable patient safety work product, consistent with the administrative simplification provisions of the Social Security Act. Permits the Secretary to provide to patient safety organizations and to States: (1) technical assistance with reporting systems for health care errors; and (2) guidance on the type of data to be voluntarily submitted to any National Patient Safety Database. Directs the Secretary to establish a process for the Secretary or another approved Federal or State governmental organization to certify patient safety organizations. Sets forth criteria a patient safety organization must meet to be certified. (Sec. 102) 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 take into account the costs to the health care system from the standards and any efficiencies resulting from the adoption of the standards. (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to require 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. Considers as misbranded any drug or biological product without such a unique product identifier. Permits the Secretary to waive these regulatory requirements or add provisions in order to safeguard the public health. (Sec. 104) Allows the Secretary of Health and Human Services to make grants to physicians and certain other health care professionals for the purpose of establishing electronic prescription programs. Requires grantees to fund 50 percent of the cost of such programs. Directs the Agency for Healthcare Research and Quality to conduct a study of the cost-effectiveness of electronic prescription programs. Establishes reporting requirements. (Sec. 105) Directs the Secretary of Health and Human Services to make grants to hospitals and other health care providers for new or improved computer hardware and software for the purposes of improving patient safety and health care quality and reducing adverse events and complications from medication errors. Requires grantees to fund 50 percent of the cost of such information technologies. Permits the Secretary to provide technical assistance to applicants and grantees. Establishes reporting requirements. (Sec. 106) Authorizes appropriations through FY 2005. Title II: Medical Information Technology Advisory Board - (Sec. 201) Amends the title XI (General Provisions) of the Social Security Act to direct the Secretary to appoint a Medical Information Advisory Board (the MITAB). Declares that the MITAB shall make recommendations to the Secretary regarding medical information technology, including on: (1) the best current practices in medical information technology; and (2) methods of implementing records security. Establishes reporting requirements. Allows Federal agencies to detail employees to the MITAB, and permits the MITAB to secure such information from Federal agencies as is allowed under specified Federal law pertaining to Government organization and employees. Applies the provisions of the Federal Advisory Committee Act to the MITAB. Terminates the MITAB 30 days after the submission of its final report. Authorizes appropriations.

Congressional Research Service summary (Passed House amended), quoted unchanged (nonpartisan). Read the source.

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Bilirakis, Michael [R-FL-9] · 29 cosponsors

Cost estimate: CBO cost estimate: H.R. 663, Patient Safety and Quality Improvement Act (2003-03-03); CBO cost estimate: H.R. 663, Patient Safety and Quality Improvement Act (2003-03-03)

Cosponsors on this site

Edward J. Markey (D-MA), Frank Pallone, Jr. (D-NJ), Darrell Issa (R-CA)

Recorded votes

• House roll call 60 (2003): On Motion to Suspend the Rules and Pass, as Amended, HR663 (2003-03-12): Passed

Sources

• Congressional Research Service summary (Passed House amended)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-108hr663.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/108/hr>

Record fed-us-cong108-hr663 · catalog fed-us-congress-bills-cong108 · updated 2026-11-15 by psicol fed-bills-cong108