United StatesHIPAA Privacy Rule, de-identification of protected health information
HIPAA Privacy Rule, 45 CFR 164.514(a)-(c)
In force since .
A de-identification rule binding public and private bodies.
- Enforcement body
- The Secretary of Health and Human Services.
- Obligation class
- Governance, Prohibition
- Audit expectation
- none
What it requires
- Treat health information as not individually identifiable by expert determination only if a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods determines that the risk is very small that an anticipated recipient could use the information, alone or in combination with other reasonably available information, to identify an individual, and documents the methods and results of the analysis that justify the determination (45 CFR 164.514(b)(1)).
- Treat health information as not individually identifiable by the safe harbor only if you remove the identifiers 45 CFR 164.514(b)(2)(i) lists for the individual and for relatives, employers and household members, and you have no actual knowledge that the information could be used alone or in combination with other information to identify an individual (45 CFR 164.514(b)(2)).
- If you assign a code or other means of record identification so that you can re-identify de-identified information, derive it from no information about the individual, make sure it cannot otherwise be translated to identify the individual, use or disclose it for no other purpose, and never disclose the mechanism for re-identification (45 CFR 164.514(c)).
These lines are LexLint's reading of the law's text.
If you get it wrong
Penalty structure
45 CFR 160.404 sets four culpability tiers per violation, adjusted for inflation annually and published at 45 CFR 102.3 (2025 figures shown): (i) no knowledge and no reasonable diligence would have revealed the violation, $145 to $73,011 per violation; (ii) reasonable cause, not willful neglect, $1,461 to $73,011; (iii) willful neglect, corrected within 30 days, $14,602 to $73,011; (iv) willful neglect, not corrected within 30 days, $73,011 up to the annual cap. Every tier is subject to a $2,190,294 annual cap for identical violations of the same administrative simplification provision in a calendar year.
- Rule
- Per violation only
- As of
- Minimum
- 145
- Currency
- USD
- Fixed cap
- 2,190,294
- Per violation unit
- Violation
- Per violation amount
- 2,190,294
What it makes you log
Logging duty
A covered entity that relies on an expert determination must have the expert document the methods and results of the analysis that justify the determination. The section states no retention period and no audit of the record by any party.
- Kind
- Implicit
- As of
- Provision
- 45 CFR 164.514(b)(1)(ii) (document the methods and results of the analysis that justify an expert determination)
- Trigger
- personal_data_processing
What this law does
Health information that does not identify an individual, and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual, is not individually identifiable health information (45 CFR 164.514(a)). A covered entity may determine that health information is not individually identifiable health information only by expert determination or by the safe harbor (45 CFR 164.514(b)).
Under expert determination, a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information, and documents the methods and results of the analysis that justify the determination.
Under the safe harbor, the identifiers listed in paragraph (b)(2)(i) of the section are removed for the individual and for relatives, employers, or household members of the individual, and the covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.
The listed identifiers include names, geographic subdivisions smaller than a State with a limited exception for the initial three digits of a zip code, all elements of dates except year directly related to an individual, Social Security numbers, Internet Protocol address numbers, biometric identifiers including finger and voice prints, and full face photographic images and any comparable images.
A covered entity may assign a code or other means of record identification to allow information de-identified under the section to be re-identified by the covered entity, provided that the code is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual, and the covered entity does not use or disclose the code for any other purpose and does not disclose the mechanism for re-identification (45 CFR 164.514(c)).
Under 45 CFR 160.402(a), the Secretary of Health and Human Services imposes a civil money penalty on a covered entity or business associate that the Secretary determines has violated an administrative simplification provision. The definition of health plan in 45 CFR 160.103 includes Part A and Part B of the Medicare program and the Medicaid program.
When LexLint raises it
When your app profile says your app handles health records or processes de-identified data.
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