De-Identification

De-Identification

Health information which has been de-identified (in accordance with 45 CFR 164.502(d) and 164.514(a)(b)(c) of the Privacy Rule) may be disclosed and used for research purposes. To qualify as being de-identified under HIPAA, the following data elements about the individual and the individual’s relatives, employers, or household members must be removed:

  • Names;
  • All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geographic codes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census; (a) the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (b) the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed 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, including license plate numbers;
  • Device identifiers and serial numbers;
  • Web Universal Resource Locators (URLs);
  • Internet Protocol (IP) address numbers;
  • Biometric identifiers, including finger and voice prints;
  • Full face photographic images and any comparable images; and
  • Any other unique identifying number, characteristic, or code, except a covered entity may assign a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, provided that: (a) the code or other means of record identification 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 (b) the covered entity does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification.

A de-identified data set might include age, gender, ethnicity, marital status, and relevant medical information, provided there are no identifying links to the source data. De-identified data is not subject to HIPAA’s Privacy Rule. Thus, if a researcher receives only de-identified data or samples from an entity covered by HIPAA, the Privacy Rule’s additional requirements do not apply. If a researcher him/herself views records containing identifiable health information and from those records extracts a de-identified data set, one of the other exceptions to the individual authorization requirement must be met. Alternatively, in some cases, the covered entity may be able to enter into a business associate agreement with the researcher to create a de-identified data set. HIPAA’s requirements for business associate agreements must be met.