What is Protected Health Information (PHI)?

Regulatory basis: PHI is defined at 45 CFR 160.103. De-identification standards are specified at 45 CFR 164.514(a)-(c). The Privacy Rule governing use and disclosure of PHI is codified at 45 CFR Part 164, Subpart E.

Definition

Protected Health Information (PHI) is individually identifiable health information that is created, received, maintained, or transmitted by a covered entity or business associate. Under 45 CFR 160.103, individually identifiable health information is a subset of health information, including demographic information, that:

  • Is created or received by a health care provider, health plan, employer, or health care clearinghouse
  • Relates to the past, present, or future physical or mental health condition of an individual, the provision of health care to an individual, or the past, present, or future payment for health care
  • Identifies the individual, or for which there is a reasonable basis to believe it can be used to identify the individual

The 18 HIPAA Identifiers

The Safe Harbor method of de-identification (45 CFR 164.514(b)(2)) specifies 18 categories of identifiers that must be removed for information to be considered de-identified:

#IdentifierScope
1NamesFull name or any part (first, last, maiden, alias)
2Geographic dataAll geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code (first 3 digits may be retained if the geographic unit contains more than 20,000 people)
3DatesAll elements of dates (except year) directly related to an individual, including birth date, admission date, discharge date, date of death; ages over 89 and all elements of dates for such ages
4Telephone numbersAll telephone numbers
5Fax numbersAll fax numbers
6Email addressesAll email addresses
7Social Security numbersAll SSNs
8Medical record numbersNumbers assigned by the covered entity
9Health plan beneficiary numbersNumbers assigned by health plans
10Account numbersAny account number
11Certificate/license numbersAny certificate or license number
12Vehicle identifiers and serial numbersIncluding license plate numbers
13Device identifiers and serial numbersIncluding medical device UDIs
14Web URLsAny web universal resource locator
15IP addressesAny internet protocol address number
16Biometric identifiersFingerprints, voiceprints, retinal scans
17Full-face photographsAny comparable images
18Any other unique identifying number, characteristic, or codeExcept as permitted for re-identification under 164.514(c)

PHI vs. ePHI

PHI

Protected Health Information in any form -- paper records, oral communications, electronic data. Governed by the Privacy Rule (45 CFR Part 164, Subpart E).

ePHI

Electronic Protected Health Information -- PHI that is created, received, maintained, or transmitted in electronic form. Governed by both the Privacy Rule and the Security Rule (45 CFR Part 164, Subpart C).

De-identification Methods

Expert Determination

45 CFR 164.514(b)(1)

A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable applies such principles and methods and determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, to identify an individual. The methods and results of the analysis must be documented.

Safe Harbor

45 CFR 164.514(b)(2)

Remove all 18 categories of identifiers listed above, and the covered entity has no actual knowledge that the remaining information could be used alone or in combination with other information to identify an individual.

What is NOT PHI

The following are commonly mistaken for PHI but do not meet the regulatory definition:

  • De-identified data -- information that has been de-identified per 45 CFR 164.514(a)-(c) is no longer PHI and is not subject to HIPAA.
  • Employment records -- health information held by a covered entity in its role as employer (not as health care provider) is not PHI under HIPAA, though it may be protected by other laws.
  • Education records -- covered by FERPA, not HIPAA, for educational institutions.
  • Data held by non-covered entities -- fitness trackers, health apps, and consumer health devices not operated by or on behalf of a covered entity are generally not subject to HIPAA (though may be subject to FTC or state laws).

Practical Guidance

When in doubt about whether information constitutes PHI, apply the conservative interpretation: if the data relates to health and could reasonably identify an individual, treat it as PHI. The penalties for unauthorized disclosure of PHI range from $100 to $50,000 per violation under 45 CFR 160.404, with an annual maximum of $1.5 million per violation category. Criminal penalties under 42 USC 1320d-6 can include fines up to $250,000 and imprisonment up to 10 years.