HIPAA
HIPAA de-identification: Safe Harbor and Expert Determination
The HIPAA Privacy Rule, at 45 CFR 164.514(b), gives two ways to treat health information as de-identified.
Expert Determination. 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 the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual, and documents the methods and results of the analysis.
Safe Harbor. The identifiers of the individual, and of relatives, employers and household members, listed below are removed, and the organisation does not have actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual.
The 18 identifier types in the Safe Harbor method are:
- Names
- Geographic subdivisions smaller than a State, including street address, city, county, precinct and ZIP code (with a limited exception for the first three digits of a ZIP code)
- All elements of dates, except year, directly related to an individual, and ages over 89
- Telephone numbers
- Fax numbers
- Email addresses
- Social Security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate and license numbers
- Vehicle identifiers and serial numbers, including license plates
- Device identifiers and serial numbers
- Web URLs
- IP addresses
- Biometric identifiers, including finger and voice prints
- Full-face photographs and comparable images
- Any other unique identifying number, characteristic or code
Removing these types is not the whole test. The “actual knowledge” condition means free-text details outside the list can still matter, and the other route, Expert Determination, exists for cases where Safe Harbor is too blunt or not enough. Choosing the method, and signing off the result, belongs to your privacy officer or a qualified expert.