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Registries for Evaluating Patient Outcomes User's Guide

Slide presentation from the AHRQ 2011 conference.

On September 19, 2001, Jane Thorpe made this presentation at the 2011 Annual Conference. Select to access the PowerPoint® presentation (380 KB). Plugin Software Help.

Slide 1

Registries For Evaluating Patient Outcomes User's Guide

Beyond the Patient—Protection of Registry Data from Litigation and other Confidentiality Concerns For Providers, Manufacturers, and health Plans

Jane Hyatt Thorpe, JD

Slide 2

Protection of Registry Data

  • Growing use of registries:
    • Support health information collection, access, research, quality measurement and improvement initiatives, safety initiatives, etc.
    • Public (federal and state) and private payors, professional associations, public health.
  • Content may include private/confidential and/or proprietary information.
  • Considerable attention to protecting privacy and confidentiality of individually identifiable health information about patients (e.g., HIPAA).
  • Less attention to privacy/confidentiality concerns of sources or other subjects of registries—providers, manufacturers, and health plans.

Slide 3

Sources of Protection

  • Federal Laws and Regulations:
    • AHRQ Confidentiality Statute.
    • Patient Safety and Quality Improvement Act of 2005.
    • Quality Improvement Organization Statute and Regulations.
    • HHS Certificate of Confidentiality.
    • HIPAA Privacy Rule.
    • Privacy Act of 1974.
    • Freedom of Information Act.
    • Federal Trade Secrets Act.
    • Federal Rules of Evidence and Civil Procedure.
    • Patient Protection and Affordable Care Act.

Slide 4

Sources of Protection, cont'd

  • State Laws and Regulations:
    • Safe Harbor Laws.
    • Peer Review Laws.

Slide 5

Lots of Sources, But Very Narrow

  • No consistent or comprehensive protection.
  • Available protections apply to very narrow set of activities.
  • "Chilling effect" on registry development.
  • Federal legislation? A delicate balance:
    • What type of data should be protected?
    • What types of registry activities should be protected?
    • What types of legal actions may require release of registry data?
Page last reviewed October 2014
Internet Citation: Registries for Evaluating Patient Outcomes User's Guide. October 2014. Agency for Healthcare Research and Quality, Rockville, MD.


The information on this page is archived and provided for reference purposes only.


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