Registries for Evaluating Patient Outcomes User's Guide

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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

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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.

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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.

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Sources of Protection, cont'd

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

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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?