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How Can Covered Entities Use and Disclose Protected Health
Information for Research and Comply with the Privacy Rule?
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Key Points:

De-identified health information, as described in the Privacy
 Rule, is not PHI, and thus is not protected by the Privacy
 Rule.

PHI may be used and disclosed for research with an
individual's written permission in the form of an
Authorization.

PHI may be used and disclosed for research without an
Authorization in limited circumstances: Under a waiver of the
Authorization requirement, as a limited data set with a data
use agreement, preparatory to research, and for research on
decedents' information.

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The Privacy Rule describes the ways in which covered entities can
use or disclose PHI, including for research purposes. In general,
the Rule allows covered entities to use and disclose PHI for
research if authorized to do so by the subject in accordance with
the Privacy Rule. In addition, in certain circumstances, the Rule
permits covered entities to use and disclose PHI without
Authorization for certain types of research activities. For
example, PHI can be used or disclosed for research if a covered
entity obtains documentation that an Institutional Review Board
(IRB) or Privacy Board has waived the requirement for
Authorization or allowed an alteration. The Rule also allows a
covered entity to enter into a data use agreement for sharing a
limited data set. There are also separate provisions for how PHI
can be used or disclosed for activities preparatory to research
and for research on decedents' information.

It is important to note that there are circumstances in which
health information maintained by a covered entity is not protected
by the Privacy Rule. PHI excludes health information that is
de-identified according to specific standards. Health information
that is de-identified can be used and disclosed by a covered
entity, including a researcher who is a covered entity, without
Authorization or any other permission specified in the Privacy
Rule. Under the Privacy Rule, covered entities may determine that
health information is not individually identifiable in either of
two ways. These are described below.

De-identifying Protected Health Information Under the Privacy Rule

Covered entities may use or disclose health information that is
de-identified without restriction under the Privacy Rule. Covered
entities seeking to release this health information must determine
that the information has been de-identified using either
statistical verification of de-identification or by removing
certain pieces of information from each record as specified in the
Rule.

The Privacy Rule allows a covered entity to de-identify data by
removing all 18 elements that could be used to identify the
individual or the individual's relatives, employers, or household
members; these elements are enumerated in the Privacy Rule. The
covered entity also must have no actual knowledge that the
remaining information could be used alone or in combination with
other information to identify the individual who is the subject of
the information. Under this method, the identifiers that must be
removed are the following:

1. Names.

2. 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:

a. The geographic unit formed by combining all ZIP Codes with
  the same three initial digits contains more than 20,000
  people.

b. The initial three digits of a ZIP Code for all such
  geographic units containing 20,000 or fewer people are
  changed to 000.

3. 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.

4. Telephone numbers.

5. Facsimile numbers.

6. Electronic mail addresses.

7. Social security numbers.

8. Medical record numbers.

9. Health plan beneficiary numbers.

10. Account numbers.

11. Certificate/license numbers.

12. Vehicle identifiers and serial numbers, including license
  plate numbers.

13. Device identifiers and serial numbers.

14. Web universal resource locators (URLs).

15. Internet protocol (IP) address numbers.

16. Biometric identifiers, including fingerprints and
  voiceprints.

17. Full-face photographic images and any comparable images.

18. Any other unique identifying number, characteristic, or
  code, unless otherwise permitted by the Privacy Rule for
  re-identification.

Covered entities may also use statistical methods to establish
de-identification instead of removing all 18 identifiers. The
covered entity may obtain certification by "a person with
appropriate knowledge of and experience with generally accepted
statistical and scientific principles and methods for rendering
information not individually identifiable" that there is a "very
small" risk that the information could be used by the recipient to
identify the individual who is the subject of the information,
alone or in combination with other reasonably available
information. The person certifying statistical de-identification
must document the methods used as well as the result of the
analysis that justifies the determination. A covered entity is
required to keep such certification, in written or electronic
format, for at least 6 years from the date of its creation or the
date when it was last in effect, whichever is later.

Other Issues Relating to De-identification

Under the first method, unique identifying numbers,
characteristics, or codes must be removed if the health
information is to be considered de-identified. However, the
Privacy Rule permits a covered entity to assign to, and retain
with, the health information a code or other means of record
identification if that code is not derived from or related to the
information about the individual and could not be translated to
identify the individual. The covered entity may not use or
disclose the code or other means of record identification for any
other purpose and may not disclose its method of re-identifying
the information. For example, a randomly assigned code that
permits re-identification through a secured key to that code would
not make the information to which it is assigned PHI, because a
random code would not be derived from or related to information
about the individual and because the key to that code is secure.

A covered entity is permitted to de-identify PHI or engage a
business associate to de-identify PHI. For example, a researcher
may be a covered entity him/herself performing, or may be hired as
a business associate to perform, the de-identification. In most
cases, the covered entity must have a written contract with the
business associate containing the provisions required by the
Privacy Rule before it provides PHI to the business associate. In
addition, a covered entity, if a hybrid entity, could designate in
its health care component(s) portions of the entity that conduct
business associate-like functions, such as de-identification.

De-identifying PHI according to Privacy Rule standards may enable
many research activities; however, the Privacy Rule recognizes
that researchers may need access to and generate identifiable
health information during the course of research. Where PHI is
needed for research activities, the Privacy Rule permits its use
and disclosure if certain standards are met. These standards are
discussed in the following sections.

Authorization for Research Uses and Disclosures

One way the Privacy Rule protects the privacy of PHI is by
generally giving individuals the opportunity to agree to the uses
and disclosures of their PHI by signing an Authorization form for
uses and disclosures not otherwise permitted by the Rule. The
Privacy Rule establishes the right of an individual, such as a
research subject, to authorize a covered entity to use and
disclose his/her PHI for research purposes. This requirement is in
addition to the informed consent to participate in research
required under the HHS Protection of Human Subjects Regulations
and other applicable Federal and State law.

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

Permissions for Research

Authorization

Informed Consent

Informed Consent

IRB/Privacy Board Responsibilities

Requires the covered entity to obtain Authorization for research
use or disclosure of PHI unless a regulatory permission applies.
Because of this, the IRB or Privacy Board would only see requests
to waive or alter the Authorization requirement. In exercising
Privacy Rule authority, the IRB or Privacy Board does not review
the Authorization form.

The IRB must ensure that informed consent will be sought from, and
documented for, each prospective subject or the subject's legally
authorized representative, in accordance with, and to the extent
required by, HHS regulations. If specified criteria are met, the
IRB may waive the requirements for either obtaining informed
consent or documenting informed consent. The IRB must review and
approve the Authorization form if it is combined with the informed
consent document. Privacy Boards have no authority under the HHS
Protection of Human Subjects Regulations.

The IRB must ensure that informed consent will be sought from, and
documented for, each prospective subject or the subject's legally
authorized representative, in accordance with, and to the extent
required by, FDA regulations. If specified criteria are met, the
requirements for either obtaining informed consent or documenting
informed consent may be waived. The IRB must review and approve
the Authorization form if it is combined with the informed consent
document. Privacy Boards have no authority under the FDA
Protection of Human Subjects Regulations.

Elements of an Authorization

A valid Privacy Rule Authorization is an individual's signed
permission that allows a covered entity to use or disclose the
individual's PHI for the purposes, and to the recipient or
recipients, as stated in the Authorization. When an Authorization
is obtained for research purposes, the Privacy Rule requires that
it pertain only to a specific research study, not to nonspecific
research or to future, unspecified projects. The Privacy Rule
considers the creation and maintenance of a research repository or
database as a specific research activity, but the subsequent use
or disclosure by a covered entity of information from the database
for a specific research study will require separate Authorization
unless the PHI use or disclosure is permitted without
Authorization (discussed later in this section). If an
Authorization for research is obtained, the actual uses and
disclosures made must be consistent with what is stated in the
Authorization. The signed Authorization must be retained by the
covered entity for 6 years from the date of creation or the date
it was last in effect, whichever is later.

An Authorization differs from an informed consent in that an
Authorization focuses on privacy risks and states how, why, and to
whom the PHI will be used and/or disclosed for research. An
informed consent, on the other hand, provides research subjects
with a description of the study and of its anticipated risks
and/or benefits, and a description of how the confidentiality of
records will be protected, among other things. An Authorization
can be combined with an informed consent document or other
permission to participate in research. Whether combined with an
informed consent or separate, an Authorization must contain the
following specific core elements and required statements
stipulated in the Rule:

Authorization Core Elements:

A description of the PHI to be used or disclosed, identifying
 the information in a specific and meaningful manner.

The names or other specific identification of the person or
 persons (or class of persons) authorized to make the requested
 use or disclosure.

The names or other specific identification of the person or
 persons (or class of persons) to whom the covered entity may
 make the requested use or disclosure.

A description of each purpose of the requested use or
 disclosure.

Authorization expiration date or expiration event that relates
 to the individual or to the purpose of the use or disclosure
 ("end of the research study" or "none" are permissible for
 research, including for the creation and maintenance of a
 research database or repository).

Signature of the individual and date. If the individual's
 legally authorized representative signs the Authorization, a
 description of the representative's authority to act for the
 individual must also be provided.

Authorization Required Statements:

A statement of the individual's right to revoke his/her
 Authorization and how to do so, and, if applicable, the
 exceptions to the right to revoke his/her Authorization or
 reference to the corresponding section of the covered entity's
 notice of privacy practices.

Whether treatment, payment, enrollment, or eligibility of
 benefits can be conditioned on Authorization, including
 research-related treatment and consequences of refusing to
 sign the Authorization, if applicable.

A statement of the potential risk that PHI will be
 re-disclosed by the recipient. This may be a general statement
 that the Privacy Rule may no longer protect health information
 disclosed to the recipient.

The Privacy Rule does not specify who may draft the Authorization,
so a researcher could draft it regardless of whether the
researcher is a covered entity. However, in order to have a
Privacy Rule-compliant Authorization, it must be written in plain
language and contain the core elements and required statements,
and a signed copy must be provided to the individual signing it if
the covered entity itself is seeking the Authorization. The
companion piece Sample Authorization Language contains language
that illustrates the inclusion of core elements and required
statements.

NOTE: If an Authorization permits disclosure of the individual's
PHI to a person or organization that is not a covered entity or a
business associate acting on behalf of a covered entity (such as a
sponsor or funding source of the research), the Privacy Rule does
not continue to protect the PHI disclosed to such entity. However,
other applicable Federal and State laws between the disclosing
covered entity and the PHI recipient may establish continuing
protections for the disclosed information. Under the HHS
Protection of Human Subjects Regulations or the FDA Protection of
Human Subjects Regulations, an IRB may impose further restrictions
on the use or disclosure of research information to protect
subjects.

An Authorization for research uses and disclosures need not have a
fixed expiration date or state a specific expiration event; the
form can list "none" or "the end of the research project."
However, although an Authorization for research uses and
disclosure need not expire, a research subject has the right to
revoke, in writing, his/her Authorization at any time. The
individual's revocation is effective, except to the extent that
the covered entity has taken action in reliance upon the
Authorization prior to revocation. For example, a covered entity
is not required to retrieve information that it disclosed under a
valid Authorization before learning of the revocation. And the
preamble to the Privacy Rule states that, for research uses and
disclosures, the reliance exception would permit the continued use
and disclosure of PHI already obtained with an Authorization to
the extent necessary to protect the integrity of the research—for
example, to account for a subject's withdrawal from the research
study, to conduct investigations of scientific misconduct, or to
report adverse events.

Waiver or Alteration of the Authorization Requirement

Many health research projects and protocols cannot be undertaken
using health information that has been de-identified. Also, it may
not be feasible for a researcher to obtain a signed Authorization
for all PHI the researcher needs to obtain for the research study.
In other cases, a researcher may determine that consents obtained
prior to April 14, 2003, that permit the use and disclosure of
information obtained from research subjects are inadequate,
insufficient, or restrict the research protocol or procedure such
that an Authorization may be necessary to permit the PHI use or
disclosure for the research.

To address these and other situations that may arise in the course
of a research project or protocol, the Privacy Rule contains
criteria for waiver or alterations of Authorizations by an IRB or
another review body called a Privacy Board. Many of the provisions
were modeled on the HHS Protection of Human Subjects Regulations.
The Privacy Rule does not change current requirements that specify
when researchers must submit protocols to the IRB for review and
approval, and obtain informed consent documents. The Privacy Rule
adds to such requirements only when a researcher requests a waiver
or an alteration of Authorization. If a covered entity has used or
disclosed PHI for research with an IRB or Privacy Board approval
of waiver or alteration of Authorization, documentation of that
approval must be retained by the covered entity for 6 years from
the date of its creation or the date it was last in effect,
whichever is later.

For research uses and disclosures of PHI, an IRB or Privacy Board
may approve a waiver or an alteration of the Authorization
requirement in whole or in part. A complete waiver occurs when the
IRB or Privacy Board determines that no Authorization will be
required for a covered entity to use and disclose PHI for a
particular research project. A partial waiver of Authorization
occurs when an IRB or Privacy Board determines that a covered
entity does not need Authorization for all PHI uses and
disclosures for research purposes, such as disclosing PHI for
research recruitment purposes. An IRB or Privacy Board may also
approve a request that removes some PHI, but not all, or alters
the requirements for an Authorization (an alteration).

The Privacy Rule does not alter IRB membership requirements,
jurisdiction on matters concerning the protection of human
subjects, or other procedural IRB matters. The Privacy Rule states
that the required documentation must indicate that the IRB
followed normal or expedited procedures in reviewing and approving
the waiver or alteration. Thus, an IRB's authority to act on
waiver or alteration requests under the Privacy Rule is in
addition to the other authorities derived from the HHS Protection
of Human Subjects Regulations and other applicable statutes and
regulations. The process and criteria for obtaining a waiver of
Authorization under the Privacy Rule is similar to the process and
criteria for waiving informed consent in the HHS Protection of
Human Subjects Regulations. Additional information on the Privacy
Rule and IRBs can be found in the companion piece entitled
Institutional Review Boards and the HIPAA Privacy Rule.

Privacy Boards are new, alternative review boards authorized by
the Privacy Rule to review requests for alteration or waiver of a
research Authorization. If a covered entity is to use or disclose
PHI on the basis of a waiver or an alteration of Authorization
from a Privacy Board, the Board must be established in accordance
with Section 164.512(i) of the Privacy Rule. These provisions
state that:

Members must have varying backgrounds and appropriate
 professional competencies as necessary to review the effect of
 the research protocol on individuals' privacy rights and
 related interests.

Each Board must have at least one member who is not affiliated
 with the covered entity or with any entity conducting or
 sponsoring the research and who is not related to any person
 who is affiliated with such entities.

Members may not have conflicts of interest regarding the
 projects they review.

Additional information on the Privacy Rule and Privacy Boards can
be found in the companion piece entitled Privacy Boards and the
HIPAA Privacy Rule.

Documentation of the waiver or alteration of Authorization must
include a statement identifying the IRB or Privacy Board that made
the approval and the date of approval. Among other things, the
documentation must also include statements that the IRB or Privacy
Board has determined that the waiver or alteration of
Authorization, in whole or in part, satisfies the following
criteria:

1. The use or disclosure of the PHI involves no more than
  minimal risk to the privacy of individuals based on, at least,
  the presence of the following elements:

a. An adequate plan to protect health information identifiers
  from improper use and disclosure.

b. An adequate plan to destroy identifiers at the earliest
  opportunity consistent with conduct of the research (absent
  a health or research justification for retaining them or a
  legal requirement to do so).

c. Adequate written assurances that the PHI will not be reused
  or disclosed to (shared with) any other person or entity,
  except as required by law, for authorized oversight of the
  research study, or for other research for which the use or
  disclosure of the PHI would be permitted under the Privacy
  Rule.

2. The research could not practicably be conducted without the
  waiver or alteration.

3. The research could not practicably be conducted without
  access to and use of the PHI.

The Privacy Rule does not require an IRB or Privacy Board to
review the form or content of the Authorization a researcher or
covered entity intends to use, or the proposed uses and
disclosures of PHI made according to an Authorization. Under the
Privacy Rule, an IRB or Privacy Board need only review requests to
waive or alter the Authorization requirement.

Many research projects take place at multiple sites and/or require
the use and disclosure of PHI created or maintained by more than
one covered entity (collectively, multisite projects). Often,
different IRBs are involved in multisite project reviews. The same
situation is expected to occur with Privacy Boards. In some
circumstances, Privacy Boards and IRBs will coexist. Where these
boards coexist, the Privacy Rule does not require approval of a
waiver or an alteration of Authorization by both bodies because a
covered entity may rely on a waiver or an alteration of
Authorization approved by any IRB or Privacy Board, without regard
to the location of the approver.

HHS has stated (65 Federal Register 82692, December 28, 2000) that
a covered entity's responsibility is to "obtain the documentation
that one emphasis added IRB or privacy board has approved the
alteration or waiver of Authorization." Consequently, the Privacy
Rule allows a waiver or an alteration of Authorization obtained
from a single IRB or Privacy Board to be used to obtain PHI in
connection with a multisite project. However, HHS also recognizes
that "covered entities may elect to require duplicate IRB or
Privacy Board reviews before disclosing PHI to requesting
researchers" (67 Federal Register 53232, August 14, 2002). While
the Privacy Rule does not address potential splits between IRBs
and Privacy Boards, HHS "strongly encourages researchers to notify
IRBs and privacy boards of any prior IRB or privacy board review
of a research protocol" (65 Federal Register 82692, December 28,
2000).

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

Review of Cooperative Research

Requests to waive or alter the Authorization requirement are
reviewed and approved by an IRB or Privacy Board. The Privacy Rule
permits a covered entity to reasonably rely on the determination
of an IRB or Privacy Board, if the covered entity obtains
appropriate documentation of such determination.

Each institution is responsible for safeguarding the rights and
welfare of human subjects and for complying with the HHS
Protection of Human Subjects Regulations. With the approval of
HHS, an institution participating in a cooperative project may
enter into a joint review arrangement, rely upon the review of
another qualified IRB, or make similar arrangements for avoiding
duplication of effort.

Cooperative research/multi-institutional studies may use joint
review, reliance upon the review of another qualified IRB, or
similar arrangements aimed at avoiding duplication of effort.

Waivers of Authorization or Informed Consent Requirements

Allows waiver or alteration of Authorization when IRB or Privacy
Board deems the following criteria are met: (1) Use or disclosure
involves no more than minimal risk to the privacy of individuals
because of the presence of at least the following elements: (a) An
adequate plan to protect health information identifiers from
improper use or disclosure, (b) an adequate plan to destroy
identifiers at the earliest opportunity absent a health or
research justification or legal requirement to retain them, and
(c) adequate written assurances that the PHI will not be used or
disclosed to a third party except as required by law, for
authorized oversight of the research study, or for other research
uses and disclosures permitted by the Privacy Rule; (2) research
could not practicably be conducted without the waiver or
alteration; and (3) research could not practicably be conducted
without access to and use of PHI.

Permits an IRB to waive some or all of the elements of informed
consent, or to waive the requirement to obtain informed consent,
provided the IRB finds and documents that (1) the research
involves no more than minimal risk to the subjects; (2) the waiver
or alteration will not adversely affect the rights and welfare of
the subjects; (3) the research could not practicably be carried
out without the waiver or alteration; and (4) whenever
appropriate, the subjects will be provided with additional
pertinent information after participation.

Permits an IRB to waive the requirement for the investigator to
obtain a signed consent for some or all of the subjects if it
finds either (1) that the only record linking the subject and the
research would be the consent document and the principal risk
would be potential harm resulting from a breach of
confidentiality; or (2) that the research presents no more than
minimal risk of harm to subjects and involves no procedures for
which written consent is normally required outside of the research
context.

Permits FDA to waive the IRB review requirement.

Permits an IRB to approve a clinical investigation without
subjects' informed consent in certain circumstances specified in
21 CFR 50.23 and 21 CFR 50.24. These include (1) circumstances in
which immediate use of the test article is, in the investigator's
opinion, required to preserve the life of the subject, and time is
not sufficient to obtain informed consent; (2) circumstances when
the U.S. President may waive informed consent for military
personnel for administration of an investigational product to
members of the armed forces; and (3) circumstances involving
emergency research.

Limited Data Set and Data Use Agreement

The Privacy Rule permits a covered entity, without obtaining an
Authorization or documentation of a waiver or an alteration of
Authorization, to use and disclose PHI included in a limited data
set. A covered entity may use and disclose a limited data set for
research activities conducted by itself, another covered entity,
or a researcher who is not a covered entity if the disclosing
covered entity and the limited data set recipient enter into a
data use agreement. Limited data sets may be used or disclosed
only for purposes of research, public health, or health care
operations. Because limited data sets may contain identifiable
information, they are still PHI.

Limited Data Set - Refers to PHI that excludes 16 categories of
direct identifiers and may be used or disclosed, for purposes of
research, public health, or health care operations, without
obtaining either an individual's Authorization or a waiver or an
alteration of Authorization for its use and disclosure, with a
data use agreement.

Data Use Agreement - An agreement into which the covered entity
enters with the intended recipient of a limited data set that
establishes the ways in which the information in the limited data
set may be used and how it will be protected.

A limited data set is described as health information that
excludes certain, listed direct identifiers (see below) but that
may include city; state; ZIP Code; elements of date; and other
numbers, characteristics, or codes not listed as direct
identifiers. The direct identifiers listed in the Privacy Rule's
limited data set provisions apply both to information about the
individual and to information about the individual's relatives,
employers, or household members. The following identifiers must be
removed from health information if the data are to qualify as a
limited data set:

1. Names.

2. Postal address information, other than town or city, state,
  and ZIP Code.

3. Telephone numbers.

4. Fax numbers.

5. Electronic mail addresses.

6. Social security numbers.

7. Medical record numbers.

8. Health plan beneficiary numbers.

9. Account numbers.

10. Certificate/license numbers.

11. Vehicle identifiers and serial numbers, including license
  plate numbers.

12. Device identifiers and serial numbers.

13. Web universal resource locators (URLs).

14. Internet protocol (IP) address numbers.

15. Biometric identifiers, including fingerprints and
  voiceprints.

16. Full-face photographic images and any comparable images.

A data use agreement is the means by which covered entities obtain
satisfactory assurances that the recipient of the limited data set
will use or disclose the PHI in the data set only for specified
purposes. Even if the person requesting a limited data set from a
covered entity is an employee or otherwise a member of the covered
entity's workforce, a written data use agreement meeting the
Privacy Rule's requirements must be in place between the covered
entity and the limited data set recipient.

The Privacy Rule requires a data use agreement to contain the
following provisions:

Specific permitted uses and disclosures of the limited data
 set by the recipient consistent with the purpose for which it
 was disclosed (a data use agreement cannot authorize the
 recipient to use or further disclose the information in a way
 that, if done by the covered entity, would violate the Privacy
 Rule).

Identify who is permitted to use or receive the limited data
 set.

Stipulations that the recipient will

Not use or disclose the information other than permitted by
 the agreement or otherwise required by law.

Use appropriate safeguards to prevent the use or disclosure
 of the information, except as provided for in the agreement,
 and require the recipient to report to the covered entity
 any uses or disclosures in violation of the agreement of
 which the recipient becomes aware.

Hold any agent of the recipient (including subcontractors)
 to the standards, restrictions, and conditions stated in the
 data use agreement with respect to the information.

Not identify the information or contact the individuals.

If a covered entity is the recipient of a limited data set and
violates the data use agreement, it is deemed to have violated the
Privacy Rule. If the covered entity providing the limited data set
knows of a pattern of activity or practice by the recipient that
constitutes a material breach or violation of the data use
agreement, the covered entity must take reasonable steps to
correct the inappropriate activity or practice. If the steps are
not successful, the covered entity must discontinue disclosure of
PHI to the recipient and notify HHS.

Section 164.512 of the Privacy Rule also establishes specific PHI
uses and disclosures that a covered entity is permitted to make
for research without an Authorization, a waiver or an alteration
of Authorization, or a data use agreement. These limited
activities are the use or disclosure of PHI preparatory to
research and the use or disclosure of PHI pertaining to decedents
for research.

Activities Preparatory to Research

For activities involved in preparing for research, covered
entities may use or disclose PHI to a researcher without an
individual's Authorization, a waiver or an alteration of
Authorization, or a data use agreement. However, the covered
entity must obtain from a researcher representations that (1) the
use or disclosure is requested solely to review PHI as necessary
to prepare a research protocol or for similar purposes preparatory
to research, (2) the PHI will not be removed from the covered
entity in the course of review, and (3) the PHI for which use or
access is requested is necessary for the research. The covered
entity may permit the researcher to make these representations in
written or oral form.

According to HHS guidance on the Privacy Rule,

The preparatory to research provision permits covered entities
to use or disclose protected health information for purposes
preparatory to research, such as to aid study recruitment.
However, the provision at 45 CFR 164.512(i)(1)(ii) does not
permit the researcher to remove protected health information
from the covered entity's site. As such, a researcher who is
an employee or a member of the covered entity's workforce
could use protected health information to contact prospective
research subjects emphasis added. The preparatory research
provision would allow such a researcher to identify
prospective research participants for purposes of seeking
their Authorization to use or disclose protected health
information for a research study.

Under the preparatory to research provision, a covered entity may
permit a researcher who works for that covered entity to use PHI
for purposes preparatory to research. A covered entity may also
permit, as a disclosure of PHI, a researcher who is not a
workforce member of that covered entity to review PHI (within that
covered entity) for purposes preparatory to research. Within a
hybrid entity, the situation is similar. A covered entity that is
a hybrid entity may permit a researcher within its health care
component to use, without an individual's Authorization, PHI for
activities preparatory to research. A covered entity may also
permit a researcher who is outside the hybrid entity's health care
component to review PHI within that health care component without
an individual's Authorization for purposes preparatory to
research.

Researchers should note that any preparatory research activities
involving human subjects research as defined by the HHS Protection
of Human Subjects Regulations, which are not otherwise exempt,
must be reviewed and approved by an IRB and must satisfy the
informed consent requirements of HHS regulations.

Research on Decedents' Protected Health Information

To use or disclose PHI of the deceased for research, covered
entities are not required to obtain Authorizations from the
personal representative or next of kin, a waiver or an alteration
of the Authorization, or a data use agreement. However, the
covered entity must obtain from the researcher who is seeking
access to decedents' PHI (1) oral or written representations that
the use and disclosure is sought solely for research on the PHI of
decedents, (2) oral or written representations that the PHI for
which use or disclosure is sought is necessary for the research
purposes, and (3) documentation, at the request of the covered
entity, of the death of the individuals whose PHI is sought by the
researchers.

Other Uses and Disclosures of Protected Health Information

Some of the PHI uses and disclosures that are permitted under the
Privacy Rule at Section 164.512 without Authorization, waiver or
alteration of Authorization, or data use agreement are summarized
below. Covered entities seeking to use and disclose PHI for these
or other purposes permitted under Section 164.512 should consult
the Privacy Rule for information on the relevant implementation
requirements.

Among other limited purposes, a covered entity may use or disclose
PHI without an Authorization, as follows:

To the extent the use or disclosure is required by law and
 complies with, and is limited to, the relevant requirements of
 such law. For example, a covered entity may disclose, without
 Authorization, PHI to cancer registries if the disclosure (or
 reporting) is required by law. In addition, a covered entity
 may disclose to the Federal Government, without Authorization,
 PHI associated with data first produced under a Federal award
 in accordance with 45 CFR 74.363 .

For disclosure to a public health authority that is authorized
 by law to collect or receive the information for purposes of
 preventing or controlling disease, injury, or disability.
 Activities included here are reporting disease, injury, and
 vital events, such as birth or death, as well as conducting
 public health surveillance, investigations, and interventions.
 For example, a covered entity may disclose PHI, without
 Authorization, related to an adverse event to NIH or FDA as
 public health authorities. Additional guidance on the use and
 disclosure of PHI for public health purposes is available at:
 Centers for Disease Control and Prevention (2003). HIPAA
 Privacy Rule and Public Health Guidance from CDC and the U.S.
 Department of Health and Human Services. Morbidity and
 Mortality Weekly Report, 52.

To a person subject to the jurisdiction of the FDA with
 respect to an FDA-regulated product or activity for which that
 person has responsibility, for purposes related to the
 quality, safety, or effectiveness of the FDA-regulated product
 or activity (including, but not limited to, adverse event
 reporting; FDA-regulated product tracking; post-marketing
 surveillance; and enabling product recalls, repairs,
 replacements, or lookback). For example, a covered entity may
 disclose adverse event/safety reports to sponsors of
 investigational new products.

To health oversight agencies for oversight activities
 authorized by law that are necessary, for example, for the
 appropriate oversight of government-regulated programs. For
 example, because Office for Human Research Protections (OHRP)
 is a health oversight agency under the Privacy Rule, a covered
 entity may disclose PHI, without Authorization, to OHRP for
 purposes of determining compliance with the HHS Protection of
 Human Subjects Regulations.

Minimum Necessary Restriction

With some exceptions, the Privacy Rule imposes a minimum necessary
requirement on all permitted uses and disclosures of PHI by a
covered entity. This means that a covered entity must apply
policies and procedures, or criteria it has developed, to limit
certain uses or disclosures of PHI, including those for research
purposes, to "the information reasonably necessary to accomplish
the purpose of the sought or requested use or disclosure." For
uses and routine and recurring disclosures of and requests for
PHI, the covered entity must develop policies and procedures
(which may be standard protocols) to reasonably limit such uses,
disclosures, and requests to the minimum necessary to achieve the
purpose of the use or disclosure. For nonroutine disclosures and
requests, a covered entity must review each disclosure or request
individually against criteria it has developed.

There are several exceptions to the minimum necessary requirements
that may affect researchers (Sections 164.502(b) and 164.514(d) of
the Privacy Rule). The minimum necessary standard does not apply
to the following:

Uses and disclosures made with an individual's Authorization.

Disclosures to, or requests by, a health care provider for
 treatment.

Disclosures to the individual.

Uses or disclosures required by law.

Disclosures to HHS for purposes of determining compliance with
 the Privacy Rule.

When required for compliance with other HIPAA rules (e.g., to
 fill out required or situationally required data fields in
 standard transactions).

Unless otherwise excepted, covered entities are required to
implement policies and procedures or establish criteria that limit
the PHI used, disclosed, or requested to the minimum amount
reasonably necessary to achieve the purposes (e.g., necessary for
the specific research) for which disclosure is sought. These
covered entity policies and procedures will apply to researchers
who are members of the covered entity's workforce and may apply to
business associates.

The Privacy Rule does not require a covered entity to
independently determine, in all instances, whether a request for
PHI meets the minimum necessary requirement. As relevant here, the
Privacy Rule permits the covered entity to rely, when reasonable,
on a request for disclosure of PHI as the minimum necessary when
making permitted disclosures to public officials, disclosing
information requested by another covered entity, or when
disclosing PHI to researchers who have documentation of an IRB or
Privacy Board waiver or alteration of Authorization or certain
other representations permitted by the Privacy Rule, which are
discussed in detail in related publications, Institutional Review
Boards and the HIPAA Privacy Rule and Privacy Boards and the HIPAA
Privacy Rule.

How Are Research Subjects' Rights Affected by the Privacy Rule?

-----------------------------------------------------------------

Key Points:

The Privacy Rule provides individuals with certain rights
 about how their health information is used and disclosed as
 well as how they can gain access to health records and
 information about when their PHI was released without their
 permission.

The Privacy Rule describes how covered entities can implement
 these rights while maintaining the integrity of the research
 project.

-----------------------------------------------------------------

In addition to establishing conditions for the use and disclosure
of PHI, the Privacy Rule establishes certain rights of individuals
with respect to their health information. Covered entities must
provide individuals with written notice of the entity's privacy
practices and the individual's privacy rights. In addition, the
Rule permits individuals to gain access to, request amendment of,
request restrictions on, and request confidential communication of
certain records related to their health care. Individuals are also
given the right to request and receive a written account from a
covered entity of when and why their PHI has been disclosed
without their Authorization, except under limited circumstances.
Individuals also have the right to complain to the covered entity
and to the Secretary of Health and Human Services if they believe
a violation of the Privacy Rule has occurred. This document
discusses an individual's rights to access PHI and receive an
accounting of PHI disclosures.

Access to Protected Health Information

With few exceptions, the Privacy Rule guarantees individuals
access to their medical records and other types of health
information to the extent the information is maintained by the
covered entity or its business associate within a designated
record set. Research records maintained by a covered entity may be
part of a designated record set if, for example, the records are
medically related or are used to make decisions about research
participants.

In most cases, patients or research subjects can have access to
their health information in a designated record set at a
convenient time and place. One exception, among others, is during
a clinical trial, when the individual's right of access can be
suspended while the research is in progress if, in consenting to
participate in research including treatment, the individual agreed
to the temporary denial of access. The covered entity, however,
must inform the individual that the right to access his/her health
records in the designated record set will be restored upon
conclusion of the clinical trial.

Designated Record Set - A group of records maintained by or for a
covered entity that includes (1) medical and billing records about
individuals maintained by or for a covered health care provider;
(2) enrollment, payment, claims adjudication, and case or medical
management record systems maintained by or for a health plan; or
(3) used, in whole or in part, by or for the covered entity to
make decisions about individuals. A record is any item,
collection, or grouping of information that includes PHI and is
maintained, collected, used, or disseminated by or for a covered
entity.

Accounting of Disclosures of Protected Health Information

The Privacy Rule permits individuals to obtain a record of certain
disclosures of their PHI by covered entities or their business
associates, including certain disclosures made by researchers who
must comply with the Rule. This is known as an accounting of
disclosures. It is important to emphasize the difference between a
use and a disclosure of PHI. In general, the use of PHI means
communicating that information within the covered entity. A
disclosure of PHI means communicating that information to a person
or entity outside the covered entity, or the communication of PHI
from a health care component to a non-health care component of a
hybrid entity. The Privacy Rule restricts both uses and
disclosures of PHI, but it requires an accounting only for certain
PHI disclosures.

Upon receiving an individual's request, a covered entity must
account for disclosures of that individual's PHI made on or after
the covered entity's compliance date (for most entities, April 14,
2003), unless a particular disclosure or type of disclosure is
excluded from this accounting requirement in Section 164.528(a) of
the Privacy Rule. For example, an accounting is not needed when
the PHI disclosure is made:

Accounting of Disclosures - Information that describes a covered
entity's disclosures of PHI other than for treatment, payment, and
health care operations; disclosures made with Authorization; and
certain other limited disclosures. For those categories of
disclosures that need to be in the accounting, the accounting must
include disclosures that have occurred during the 6 years (or a
shorter time period at the request of the individual) prior to the
date of the request for an accounting. However, PHI disclosures
made before the compliance date for a covered entity are not part
of the accounting requirement.

Use - With respect to individually identifiable health
information, the sharing, employment, application, utilization,
examination, or analysis of such information within the entity or
health care component (for hybrid entities) that maintains such
information.

Disclosure - The release, transfer, access to, or divulging of
information in any other manner outside the entity holding the
information.

For treatment, payment, or health care operations.

Under an Authorization for the disclosure.

To an individual about himself or herself.

As part of a limited data set under a data use agreement.

Prior to the compliance date.

An individual's right to receive an accounting of disclosures
(unless an exception applies) starts with the covered entity's
compliance date and goes back 6 years from the date of the
request, not including periods prior to the compliance date. A
covered entity must therefore keep records of such PHI disclosures
for 6 years.

The Privacy Rule allows three methods for accounting for
research-related disclosures that are made without the
individual's Authorization or other than a limited data set: (1) A
standard approach, (2) a multiple-disclosures approach, and (3) an
alternative for disclosures involving 50 or more individuals.
Whatever approach is selected, the accounting is made in writing
and provided to the requesting individual. Accounting reports to
individuals may include results from more than one accounting
method.

Standard Accounting

Standard accounting includes, for each disclosure, the
following information:

The date the disclosure was made.

The name and, if known, address of the person or entity
 receiving the PHI.

A brief description of the PHI disclosed.

A brief statement of the reason for the disclosure.

Multiple Disclosures Accounting

Multiple disclosures accounting is permissible if the covered
entity has made multiple disclosures of PHI to the same person
or entity for a single purpose under Sections
164.502(a)(2)(ii) or 164.512 of the Privacy Rule. For each
disclosure, the following must be included:

The date the initial disclosure was made during the accounting
 period.

The name and, if known, address of the person or entity
 receiving the PHI.

A brief description of the PHI disclosed.

A brief statement of the reason for the disclosure.

The frequency, periodicity, or number of the disclosures made
 during the accounting period.

The date of the last such disclosure during the accounting
 period.

Alternative Accounting

If a covered entity has made disclosures regarding 50 or more
individuals for a particular research project under Section
164.512(i) of the Privacy Rule, the accounting may be limited
to the following information:

The name of the protocol or research activity.

A plain-language description of the research protocol or
 activity, purpose of the research, and criteria for selecting
 particular records.

A description of the type of PHI disclosed.

The date or period of time during which the disclosure(s)
 occurred or may have occurred, including the date of the last
 disclosure during the accounting period.

The name, address, and telephone number of the entity that
 sponsored the research and of the researcher who received the
 PHI.

A statement that the individual's PHI may or may not have been
 disclosed for a particular protocol or research activity.

If the covered entity uses the alternative accounting method, it
must, if requested to by the individual, assist the individual in
contacting the research sponsor and the researcher. Such
assistance, however, is limited to those situations in which there
is a reasonable likelihood that the individual's PHI was actually
disclosed for the research protocol or activity.

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