Confidentiality in AHRQ-Supported Research

Notice Number: NOT-HS-18-012

Key Dates
Release Date: July 26, 2018  

Related Announcements
None

Issued by
Agency for Healthcare Research and Quality (AHRQ)

Purpose

This Notice reminds the research community of AHRQ's policy regarding Confidentiality in AHRQ-supported research. The AHRQ confidentiality statute provides that “no information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under this subchapter may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Director) to its use for such other purpose. Such information may not be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person has consented (as determined under regulations of the Director) to its publication or release in other form.”  42 U.S.C. § 299c—3(c).

Background

The confidentiality of identifiable persons and establishments in research supported by the Agency for Healthcare Research and Quality (AHRQ) is protected from disclosure by federal statute.  For more than 20 years, the consent requirements of statutory confidentiality have established the necessary legal guarantees for AHRQ to build a research enterprise founded on the good stewardship of sensitive information.  The AHRQ Confidentiality Statute, 42 U.S.C. § 299c—3(c), restricts the use, publication and release of identifiable information about individuals and establishments obtained in the course of activities undertaken or supported under Title IX of the Public Health Service Act.  The Medical Expenditure Panel Survey (MEPS) and the Healthcare Cost and Utilization Project (HCUP) rely on the assurances provided in this statute for the acquisition and protection of data.

Scope and Applicability

The statute applies to both primary and secondary sources of identifiable information about individuals and establishments acquired by AHRQ, its grantees and contractors, and any other individual, organization or entity engaged in AHRQ-supported activities.  AHRQ support is not limited to financial consideration. 

A distinguishing feature of the statute, which it shares with a similar law protecting National Center for Health Statistics data, is that it applies to both individual research subjects and establishments, such as hospitals and hospital systems.  Information determined by AHRQ to be non-identifiable, however, is not subject to the statute.  The use and dissemination of non-identifiable information may nevertheless be governed by the terms of a data use agreement between AHRQ, the agency’s recipients, and the research participant or data supplier.

Consistent with AHRQ’s authorizing legislation, identifiable information collected with AHRQ support may be used only for purposes of research and statistical aggregation.  Absent consent, no exceptions to the statute exist for other governmental purposes such as law enforcement, claims adjudication, or civil investigations.  Information covered by the statute is subject to Exemption 3 under the Freedom of Information Act for records specifically exempted by statute.  Violations of the AHRQ Confidentiality Statute are subject to the assessment of civil monetary penalties in an amount not to exceed $14,371 per violation.

Given the scope of the statute’s protections, it is unnecessary for AHRQ recipients to hold a certificate of confidentiality for research projects.  Some secondary sources used in AHRQ research projects are subject to independent statutory protections, such as the Confidential Information Protection and Security Act (CIPSEA), 1 in addition to the protections afforded by the AHRQ Confidentiality Statute.

Inquiries

Please direct all inquiries to:

Hope Hongzhu He, JD, MPA, MA
Human Protections Administrator (HPA)
Agency for Healthcare Research and Quality (AHRQ)/ HHS
Office of Extramural Research, Education, and Priority Populations (OEREP)
Email: HopeHongzhu.He@ahrq.hhs.gov

 


1. Title V of the E-Government Act of 2002, P.L 107-347; 44 U.S.C. § 101.