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”)
- Names
- 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:
- The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than 20,000 people; and
- The initial 3 digits of a zip code for all such geographic units containing 20,000 or fewer people is changes to 000.
- 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.
- Telephone numbers
- FAX numbers
- Electronic mail addresses
- Social security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers and serial numbers; license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- Biometric identifiers
- Full face photographic images and any comparable images
- 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.
- Names
- Postal address information, other than town or city, State, and zip code
- Telephone numbers
- FAX numbers
- Electronic mail addresses
- Social security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers and serial numbers; license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- Biometric identifiers
- Full face photographic images and any comparable images
2/1/2022