Patient Information
Policy
De-identification of Protected Health Information
SCOPE:
All Louisiana State University (LSU) System health care
facilities and providers including, but not limited to,
hospitals, physician practices, clinics, schools, etc.
on the LSU Health Sciences Center New Orleans Academic
Campus.
Nota Bene: All LSU System Health care facilities and
providers including, but not limited to hospitals,
physician clinics, schools, etc. on the LSU Health
Sciences Center New Orleans Academic Campus, are
referred to in this policy as LSUHSC-NO.
PURPOSE:
To provide guidance to the health care facilities and
providers affiliated with the LSUHSC-NO on the
requirements of the Health Insurance Portability and
Accountability Act, Standards for Privacy of
Individually Identifiable Health Information (HIPAA
Privacy Regulations), to de-identify an individual’s
Protected Health Information.
POLICY:
All LSUHSC-NO affiliated health care facilities and
providers should comply with the applicable requirements
of the HIPAA Privacy Regulations when de-identifying an
individual’s Protected Health Information.
DEFINITIONS:
Protected Health Information (sometimes referred to as
“PHI”) – for purposes of this policy means individually
identifiable health information, that relates to the
past, present or future health care services provided to
an individual. Examples of Protected Health Information
include medical and billing records of the patient.
Authorization – A written document completed and signed
by the individual that allows use and disclosure of PHI
for purposes other than treatment, payment or health
care operations.
For the purposes of the definition "Designated Record
Set":
-
The term
"record" means any item, collection, or
grouping of information that includes PHI and is
maintained, collected, used or disseminated by or
for LSUHSC-NO.
-
The term
"record" also includes patient information
originated by another health care provider and used
by LSUHSC-NO to make decisions about a patient.
-
The term
"record" includes tracings, photographs,
videotapes, digital and other images that may be
recorded to document care of the patient.
Designated Record Set – a group of records maintained by
or for LSUHSC-NO that is:
-
The medical records and billing records about
individuals maintained by or for LSUHSC-NO; or
-
Any records used, in whole or part, by or for
LSUHSC-NO to make decisions about individuals.
-
Any record that meets this definition of Designated
Record Set and which are held by a HIPAA
-
Business Associate of LSUHSC-NO are part of
LSUHSC-NO Designated Record Set.
Psychotherapy Notes – means notes recorded by a health
care provider who is a mental health professional
documenting or analyzing the contents of conversation
during a private counseling session or a group, joint or
family counseling session and that are separated from
the rest of the individual’s record. Psychotherapy notes
does not include: medication prescription and
monitoring, counseling session start and stop times, the
modalities and frequencies of treatment furnished,
results of clinical tests, and any summary of the
following items: diagnosis, functional status, the
treatment plan, symptoms, prognosis, and progress to
date.
Privacy Officer – Person designated by the facilities
and clinics as the Privacy Officer.
PROCEDURE:
| 1.0 |
Definition of De-identification of PHI: health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual is not individually identifiable health information. |
| 2.0 |
Uses and Disclosures of
De-identified Information |
| 2.1 |
When possible or practical, the
facility will use and disclose de-identified
information when conducting health care
operations. The facility is not required to
de-identify PHI for health care operations. |
| 3.0 |
Creating De-identified
Information and Re-identifying Information: |
| 3.1 |
The facility may use PHI to create de-identified
information or disclose PHI only to a business
associate to create de-identified information
for use by:
-
The facility;
-
A business associate; or
-
Another valid requestor.
|
| 3.2 |
If PHI Cannot Be De-Identified. The facility may
not be able to remove identifiers from protected
health information. If the facility cannot use
or disclose PHI for a particular purpose, but
believes that removing identifiers is
excessively burdensome, it can choose:
-
Not to release the PHI;
-
Consider use of a Limited Data Set; or
-
Seek an authorization from the individual
for the use and disclosure of PHI including
some or all of the identifiers.
|
| 3.3 |
The facility may contract with
a business associate to perform
de-identification. |
| 3.4 |
De-identification Methods.
PHI may be de-identified only by using methods
for de-identification approved by the U.S.
Department of Health and Human Services. By
using these methods, the facility may reasonably
believe that health information is not
individually identifiable health information. |
| |
| 3.4.1 |
Statistical Method – A person with
appropriate knowledge and experience
applying generally accepted statistical
and scientific principles and methods
for rendering information not
individually identifiable:
-
Makes a determination that the risk
is very small that the information
could be used, either by itself or
in combination with other reasonably
available information, by
anticipated recipients to identify a
subject of the information; and
-
Documents the analysis and results
that justify this determination.
|
| 3.4.2 |
Removal of All Identifiers Method –
‘Safe Harbor Method’– All of the
following identifiers of the patient,
relatives, employers, or household
members of the patient, are removed:
-
Names;
-
All geographic subdivisions smaller
than a state: street address, city,
county, precinct, ZIP code, and
their equivalent geocodes. Exception
for ZIP codes: The initial three
digits of the ZIP Code may be used,
if according to 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; and
- The initial three digits of a ZIP
code for all such geographic units
containing 20,000 or fewer people is
changed to ‘000’.
- (Note: The 17 currently
restricted 3-digit ZIP codes to be
replaced with ‘000’ include: 036,
059, 063, 102, 203, 556, 692, 790,
821, 823, 830, 831, 878, 879, 884,
890, and 893.)
- 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. 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; (including
prescription numbers and clinical trial
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 code used
for re-identification purposes; and
- The facility does not have actual
knowledge that the information could be used
alone or in combination with other
information to identify an individual who is
the subject of the information.
|
|
| 3.5 |
Re-identification. The facility
may wish to re-identify information previously
de-identified, but is not required to do so.
This re-identification may be accomplished
through the use of a unique code, key or other
means of record identification, provided that
the following specifications are met:
- Code Origin. The code, key or other
means of record identification is not
derived from or related to the PHI about the
individual, and is not otherwise capable of
being translated so as to identify the
individual. In other words, the unique code,
key or record identifier must not be such
that someone other than the facility could
use it to identify the individual (such as a
derivative of the individual’s name or
social security number.)
- Code Security. The facility does not use
or disclose the code, key or other record
identifier for any other purpose, and does
not disclose the mechanism for
re-identification. The code, key or other
record identifier must be kept confidential
and secure.
|
| 3.6 |
If the facility uses
specialized software to de-identify PHI or
re-identify information, access by workforce
members to the software will be governed by the
appropriate facility policies and procedures on
information security and privacy, including, but
not limited to:
- Access controls
- Password management
- Media controls
- Physical safeguards
- Confidentiality and privacy of PHI
|
| 4.0 |
Processing Requests for
De-identified Information |
| 4.1 |
Requests for de-identified
information from the facility must be in writing
and submitted to the facility Privacy Officer.
|
| 4.2 |
Written requests must include
the following information:
- Requestor information – Name, address,
telephone numbers, title, organization or
department.
- Date of request.
- Purpose of the request.
- Record parameters or selection criteria
– Time period included, minimum number of
patient records, type of patient records
(such as by inpatient, outpatient,
diagnosis, procedure, drug use, or other
criteria.)
- Date the recipient requires the
de-identified information.
- A statement assuring the recipient will
not give, sell, loan, show or disseminate
the de-identified information to any other
parties without the express written
permission of the facility.
- A statement assuring the recipient will
not link the facility de-identified data to
any other data the recipient may have access
to, where the linked data identifies
individual patients. For example, linking
de-identified data from the facility with
publicly available census data and the
linking reveals the identity of individual
patients.
- A statement assuring the recipient will
not contact any patient, or their relatives,
employers, or other household members that
may accidentally be identified by the
recipient.
(See
Attachment A – Request for De-identified
Information for a form the facility may use
for implementing this policy.) |
| 4.3 |
The
request for de-identified information must be
reviewed, approved or denied by the appropriate
facility personnel designated by the facility. |
| 4.4 |
Requests for de-identified
information may be denied if:
-
The facility cannot
de-identify the PHI,
-
The requestor refuses to
agree to required statements on the request
form,
-
The recipient refuses to
compensate the facility for generating the
de-identified information, or
-
It is an imposition to
the operations of the facility.
|
| 4.5 |
The
LSUHSC-NO Privacy Officer shall approve requests
for creating the de-identified information. |
| 4.6 |
The designated facility
personnel must use one of the approved methods
for de-identifying PHI. The de-identified
information must be accompanied by a statement
certifying that either:
-
The risk is very small
that the information could be used, either
by itself or in combination with other
reasonably available information, by
anticipated recipients to identify a subject
of the information; or
-
All identifiers of the
patient, or relatives, employers, or
household members of the patient, are
removed, and
-
The facility does not
have actual knowledge that the de-identified
information could be used alone or in
combination with other reasonably available
information to identify an individual who is
subject of the information.
|
| 4.7 |
The de-identified information
will be delivered to the approved recipient upon
approval of the Privacy Officer. |
|
4.8 |
Fee Schedule |
| |
|
4.8.1 |
The requestor of
de-identified information may be asked
to compensate the facility for resource
expenditures related to the request. |
|
4.8.2 |
The facility may
establish a fee schedule to compensate
for the use of facilities, personnel
time, supplies, software, hardware or
other equipment for:
-
Reviewing
requests for de-identified
information (Application Fee).
-
Generating the
de-identified information.
-
Re-identifying
de-identified information.
-
Other specified
activities related to the request
for de-identified information.
|
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REFERENCES:
45 C.F.R.
§ 164.514(a)(b) and (c)
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