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HIPAA Privacy Rule - Information for Researchers

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What Health Information Is Protected by the Privacy Rule?
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Key Points:

With certain exceptions, the Privacy Rule protects a subset of
 individually identifiable health information, known as
 protected health information or PHI, that is held or
 maintained by covered entities or their business associates
 acting for the covered entity.

The Privacy Rule does not protect individually identifiable
 health information that is held or maintained by entities
 other than covered entities or business associates that
 create, use, or receive such information on behalf of the
 covered entity.

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To understand the possible impact of the Privacy Rule on their
work, researchers will need to understand what individually
identifiable health information is and is not protected under the
Rule. With certain exceptions, the Privacy Rule protects a certain
type of individually identifiable health information, created or
maintained by covered entities and their business associates
acting for the covered entity. This information is known as
“protected health information” or PHI.

The Privacy Rule defines PHI as individually identifiable health
information, held or maintained by a covered entity or its
business associates acting for the covered entity, that is
transmitted or maintained in any form or medium (including the
individually identifiable health information of non-U.S.
citizens). This includes identifiable demographic and other
information relating to the past, present, or future physical or
mental health or condition of an individual, or the provision or
payment of health care to an individual that is created or
received by a health care provider, health plan, employer, or
health care clearinghouse. For purposes of the Privacy Rule,
genetic information is considered to be health information.

There are, however, instances when individually identifiable
health information held by a covered entity is not protected by
the Privacy Rule. The Rule excludes from the definition of PHI
individually identifiable health information that is maintained in
education records covered by the Family Educational Right and
Privacy Act (as amended, 20 U.S.C. 1232g) and records described at
20 U.S.C. 1232g(a)(4)(B)(iv), and employment records containing
individually identifiable health information that are held by a
covered entity in its role as an employer.

A critical point of the Privacy Rule is that it applies only to
individually identifiable health information held or maintained by
a covered entity or its business associate acting for the covered
entity. Individually identifiable health information that is held
by anyone other than a covered entity, including an independent
researcher who is not a covered entity, is not protected by the
Privacy Rule and may be used or disclosed without regard to the
Privacy Rule. There may, however, be other Federal and State
protections covering the information held by these entities that
limit its use or disclosure.

When health information is individually identifiable and is held
by a covered entity, it is likely to be PHI. In contrast, the HHS
Protection of Human Subjects Regulations describe “private
information” as including information about behavior that occurs
in a context in which an individual can reasonably expect that no
observation or recording is taking place, and information which
has been provided for specific purposes by an individual and which
the individual can reasonably expect will not be made public (for
example, a medical record). Under the HHS Protection of Human
Subjects Regulations, private information must be individually
identifiable (i.e., the identity of the subject is or may readily
be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute
research involving human subjects unless data are obtained through
intervention or interaction with the individual.

Area of Distinction

HIPAA Privacy Rule

HHS Protection of Human Subjects Regulations Title 45 CFR Part 46

FDA Protection of Human Subjects Regulations Title 21 CFR Parts 50
and 56

Identifiable Information

Defines PHI as individually identifiable health information that
is transmitted or maintained in any form or medium (electronic,
oral, or paper) by a covered entity or its business associates,
excluding certain educational and employment records.

Private information must be individually identifiable in order for
obtaining the information to constitute research involving human
subjects. Individually identifiable means the identity of the
subject is or may readily be ascertained by the investigator or
associated with the information.

Title 21 CFR Parts 50 and 56 do not define individually
identifiable health information.

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Site last updated: 02/02/2007

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