Institutional Review Board Manual
HIPAA and Research
The second condition under which Protected Health Information (PHI) may be used and disclosed in research is by de-identifying the data. Variations on this de-identification process may be reviewed at http://www.hhs.gov/ocr/hipaa/guidelines/research.pdf
Under this condition, SCDMH's Institutional Review Board (IRB) may approve the use/disclosure of data/information without an individual’s authorization if it determines that health information is not individually identifiable. To meet this condition, all of the following identifiers must be removed before the data is released to the researcher.
- All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical 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:
- The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people, or
- The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.
- All elements of dates (except year) 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.
- Facsimile numbers (Fax).
- Electronic mail addresses (E-mail).
- 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 fingerprints and voiceprints.
- Full-face photographic images and any comparable images.
- Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification.