HIPAA Safe Harbor vs. Limited Data Set

When a data set is received from an honest broker, it must be determined if it is “safe harbor” de-identified, or if it is a “limited data set”.  The differences are described below. 

  • A safe harbor data set should be used whenever possible.  It may be possible for the honest broker to code dates into timepoints, or broaden geographic information in order to make the dataset a safe harbor data set.
  • When necessary, a limited data set can be used, and it allows for collection of dates and some geographic information.  In this case, you should clarify in your protocol why a safe harbor data set would not suffice.  You will also need to upload a completed Data Use Agreement for Limited Data Sets form prior to submitting your protocol.  In the DUA, ensure consistency with the protocol regarding data points, etc.   

Safe Harbor

HIPAA “Safe Harbor” De-Identification of Medical Record Information: HIPAA requires that each of the following identifiers of the individual or of relatives, employers, or household members of the individual must be removed from medical record information in order for the records to be considered de- identified (HIPAA “Safe Harbor”)

  1. Names
  2. All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial 3 digits of a zip code if, according to the currently publicly available data from the Bureau of Census:
    1. The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than 20,000 people; and
    2. The initial 3 digits of a zip code for all such geographic units containing 20,000 or fewer people is changes to 000.
  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.
  4. Telephone numbers
  5. FAX numbers
  6. Electronic mail addresses
  7. Social security numbers
  8. Medical record numbers
  9. Health plan beneficiary numbers
  10. Account numbers
  11. Certificate/license numbers
  12. Vehicle identifiers and serial numbers; license plate numbers
  13. Device identifiers and serial numbers
  14. Web Universal Resource Locators (URLs)
  15. Internet Protocol (IP) address numbers
  16. Biometric identifiers
  17. Full face photographic images and any comparable images
  18. Any other unique identifying number, characteristic, or code, except a code to permit re-identification of the de-identified data by the Honest Broker.

Limited Data Sets

For Limited Data Sets, HIPAA requires that each of the following identifiers of the individual or of relatives, employers, or household members of the individual must be removed from medical record information.

  1. Names
  2. Postal address information, other than town or city, State, and zip code
  3. Telephone numbers
  4. FAX numbers
  5. Electronic mail addresses
  6. Social security numbers
  7. Medical record numbers
  8. Health plan beneficiary numbers
  9. Account numbers
  10. Certificate/license numbers
  11. Vehicle identifiers and serial numbers; license plate numbers
  12. Device identifiers and serial numbers
  13. Web Universal Resource Locators (URLs)
  14. Internet Protocol (IP) address numbers
  15. Biometric identifiers
  16. Full face photographic images and any comparable images

 

2/1/2022