Limited Data Set
PHI that excludes direct identifiers but may include city, state, ZIP, dates, and other quasi-identifiers; may be disclosed for research, public health, or healthcare operations under a Data Use Agreement.
1 min read · Last reviewed May 23, 2026
At a glance
- Category
- HIPAA & Privacy
- Primary sources
- 2
- Workspace handoff
- templates →
Where this comes up
Privacy officers and practice managers handle this — patient rights requests, accounting of disclosures, BAA reviews with new vendors, breach risk assessments after an incident, and OCR responses when a complaint lands. The 60-day breach-notification clock starts at discovery, not at investigation close.
Full definition
What it is in practice
45 CFR 164.514(e) defines the LDS. The required DUA limits use, prohibits re-identification, and requires safeguards.
How it shows up in your practice
LDS-with-DUA is the right structure for many public-health and quality-improvement data flows that do not need full identifiers.
Sources
- 45 CFR 164.502 — Uses and disclosures of PHIhttps://www.ecfr.gov/current/title-45/section-164.502
- HHS — Research Provisions of the Privacy Rulehttps://privacyruleandresearch.nih.gov/
Use the LDS / DUA templates
Open templates →Related terms
- HIPAA & PrivacyDe-identificationThe process of removing identifiers from PHI such that the resulting information is not individually identifiable health information.
- Compliance ProgramResearch and HIPAAHIPAA-authorized pathways for using or disclosing PHI for research, including authorization, IRB waiver, limited data sets with data use agreement, and decedent research.
- HIPAA & PrivacyData Use Agreement (DUA)A written agreement required for disclosing a Limited Data Set, restricting the recipient's use and requiring safeguards.
D3rx is a healthcare-billing and compliance research aid maintained by D3rx Inc. Articles are drafted by an LLM (Anthropic Claude) against primary HHS, OCR, CMS, eCFR, NIST, and state-regulator publications, and reviewed for restraint and source fidelity by the D3rx team.
Reviewer status: a named credentialed reviewer (CHC, CHPC, or healthcare attorney) is being engaged. Until that engagement is finalized, this page does not claim credentialed review.
Related across the archive
- GlossaryData Use Agreement (DUA)A written agreement required for disclosing a Limited Data Set, restricting the recipient's use and requiring safeguards.
- GlossaryDe-identificationThe process of removing identifiers from PHI such that the resulting information is not individually identifiable health information.
- GlossaryResearch and HIPAAHIPAA-authorized pathways for using or disclosing PHI for research, including authorization, IRB waiver, limited data sets with data use agreement, and decedent research.
- RegulationHIPAA Research Uses and Disclosures (45 CFR 164.512(i))Research uses of PHI without individual authorization require either IRB or Privacy Board waiver, a limited data set with data use agreement, or reviews preparatory to research and decedent research with specific safeguards.
- GlossaryAuthorization for DisclosureA written authorization signed by the individual permitting a covered entity to use or disclose PHI for a purpose not otherwise permitted by the Privacy Rule.
- GlossaryHIPAA Privacy RuleThe federal regulation at 45 CFR Part 164 Subpart E that governs the use and disclosure of PHI.
- BillingBusiness Associate Agreement Checklist for Small PracticesA working checklist for small practices to identify which vendors need a Business Associate Agreement, what clauses the BAA must contain, and how to track them.
- SRAHIPAA Patient Right of Access: A Small-Practice WalkthroughHow 45 CFR 164.524 governs patient access to their records, the 30-day rule and 30-day extension, the limited fees a practice may charge, and the OCR Right of Access Initiative.
This glossary entry is a research aid for billing and compliance staff. It does not provide legal, medical, or financial advice and does not replace counsel. References cited link to primary sources at HHS, OCR, CMS, eCFR, NIST, and the relevant payer or industry body.