HIPAA Limited Data Set (45 CFR 164.514(e))
A limited data set excludes most direct identifiers but retains dates and geographic data; disclosure requires a written data use agreement.
Primary source
45 CFR 164.514(e) — eCFR →https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.514#p-164.514(e)
Verified May 23, 2026 · This is the authoritative regulator URL. The summary below is a research aid; the linked source controls.
45 CFR 164.514(e)) defines a limited data set: PHI that excludes name, address (other than town/city/state/ZIP), telephone, fax, email, SSN, MRN, beneficiary number, account number, certificate/license number, vehicle identifiers, device identifiers, URLs, IP addresses, biometric identifiers, and full-face images — but retains dates of service, town/city/state/ZIP, and other less direct identifiers.
Limited data sets may be disclosed only for research, public health, or health care operations purposes, and only pursuant to a written data use agreement with the recipient. The agreement must obligate the recipient to use the data only for the purposes stated, restrict further use or disclosure, require appropriate safeguards, require reporting of unauthorized use, and prohibit re-identification.
The limited data set is the middle ground between de-identified data (no HIPAA at all) and full PHI (full Privacy Rule). It is commonly used for retrospective chart studies, claims analytics, and public health surveillance.
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Related across the archive
- RegulationHIPAA De-Identification Standard (45 CFR 164.514(a)-(b))Two methods for de-identifying PHI so that it is no longer subject to the Privacy Rule: the Safe Harbor method removing 18 identifier categories, and the Expert Determination method.
- 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.
- RegulationHIPAA Business Associate Agreements (45 CFR 164.504(e))Required contract elements for any business associate that creates, receives, maintains, or transmits PHI on behalf of a covered entity.
- RegulationHIPAA Fundraising Restrictions (45 CFR 164.514(f))Covered entities may use limited PHI categories for their own fundraising but must include a clear opt-out mechanism in each communication and honor opt-outs going forward.
- ComplianceAnnual HIPAA Training Curriculum (What to Cover + How to Document)A 2026 annual HIPAA training curriculum for small healthcare practices — eight required modules under 45 CFR 164.530(b) and 45 CFR 164.308(a)(5), with documentation templates.
- GlossaryLimited Data SetPHI 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.
- 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.
- 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.
Last reviewed May 23, 2026 · Citation verified May 23, 2026
Research aid, not legal advice. This summary is an administrative research aid prepared by D3rx. It does not certify compliance, provide legal advice, replace counsel, or guarantee an audit outcome. For authoritative regulatory text follow the primary source link at the top of this page. The practice remains responsible for reviewing, adopting, and maintaining its compliance program.