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Message 11036 of 11043
From: Joe Gillaspie <[EMAIL PROTECTED]>
Date: Sat Dec 23, 2000 1:34am
Subject: [Fwd: executive order on health]
THE WHITE HOUSE
Ofice of the Press Secretary
For Immediate Release
ecember 20, 2000
XECUTIVE ORDER
- - - - - - -
TO PROTECT THE PRIVACY OF PROTECTED HEALTH
INFORMATION IN OVERSIGHT INVESTIGATIONS
By the authority vested in me as President of the United States by
the Constitution and the laws of the United States of America, it is
ordered as follows:
Section 1. Policy.
It shall be the policy of the Government of the United States that
law enforcement may not use protected health information
concerning an individual that is discovered during the course of
health oversight activities for unrelated civil, administrative, or
criminal investigations of a non-health oversight matter, except
when the balance of relevant factors weighs clearly in favor of its
use. That is, protected health information may not be so used
unless the public interest and the need for disclosure clearly
outweigh the potential for injury to the patient, to the physician-
patient relationship, and to the treatment services. Protecting the
privacy of patients' protected health information promotes trust in
the health care system. It improves the quality of health care by
fostering an environment in which patients can feel more
comfortable in providing health care professionals with accurate
and detailed information about their personal health. In order to
provide greater protections to patients' privacy, the Department of
Health and Human Services is issuing final regulations concerning
the confidentiality of individually identifiable health information under
the Health Insurance Portability and Accountability Act of 1996
(HIPAA). HIPAA applies only to "covered entities," such as health
care plans, providers, and clearinghouses.
HIPAA regulations therefore do not apply to other organizations and
individuals that gain access to protected health information,
including Federal officials who gain access to health records during
health oversight activities.
Under the new HIPAA regulations, health oversight investigators
will appropriately have ready access to medical records for
oversight purposes. Health oversight investigators generally do not
seek access to the medical records of a particular patient, but
instead review large numbers of records to determine whether a
health care provider or organization is violating the law, such as
through fraud against the Medicare system. Access to many
health records is often necessary in order to gain enough evidence
to detect and bring enforcement actions against fraud in the health
care system. Stricter rules apply under the HIPAA regulations,
however, when law enforcement officials seek protected health
information in order to investigate criminal activity outside of the
health oversight realm. In the course of their efforts to protect
the health care system, health oversight investigators may also
uncover evidence of wrongdoing unrelated to the health care
system, such as evidence of criminal conduct by an individual who
has sought health care. For records containing that evidence, the
issue thus arises whether the information should be available for
law enforcement purposes under the less restrictive oversight rules
or the more restrictive rules that apply to non-oversight criminal
investigations. A similar issue has arisen in other
circumstances. Under 18 U.S.C. 3486, an individual's health
records obtained for health oversight purposes pursuant to an
administrative subpoena may not be used against that individual
patient in an unrelated investigation by law enforcement unless a
judicial officer finds good cause. Under that statute, a judicial
officer determines whether there is good cause by weighing the
public interest and the need for disclosure against the potential for
injury to the patient, to the physician-patient relationship, and to
the treatment services. It is appropriate to extend limitations on
the use of health information to all situations in which the
government obtains medical records for a health oversight purpose.
In recognition of the increasing importance of protecting health
information as shown in the medical privacy rule, a higher standard
than exists in 18 U.S.C. 3486 is necessary. It is, therefore, the
policy of the Government of the United States that law enforcement
may not use protected health information concerning an individual,
discovered during the course of health oversight activities for
unrelated civil, administrative, or criminal investigations, against
that individual except when the balance of relevant factors weighs
clearly in favor of its use. That is, protected health information may
not be so used unless the public interest and the need for
disclosure clearly outweigh the potential for injury to the
patient, to the physician-patient relationship, and to the treatment
services.
Sec. 2. Definitions.
(a) "Health oversight activities" shall include the oversight
activities enumerated in the regulations concerning the
confidentiality of individually identifiable health information
promulgated by the Secretary of Health and Human Services
pursuant to the "Health Insurance Portability and Accountability
Act of 1996," as amended.
(b) "Protected health information" shall have the meaning ascribed
to it in the regulations concerning the confidentiality of
individually identifiable health information promulgated by the
Secretary of Health and Human Services pursuant to the "Health
Insurance Portability and Accountability Act of 1996," as
amended.
(c) "Injury to the patient" includes injury to the privacy interests of
the patient.
Sec. 3. Implementation.
(a) Protected health information concerning an individual patient
discovered during the course of health oversight activities shall
not be used against that individual patient in an unrelated civil,
administrative, or criminal investigation of a non-health oversight
matter unless the Deputy Attorney General of the U.S
Department of Justice, or insofar as the protected health
information involves members of the Armed Forces, the General
Counsel of the U.S. Department of Defense, has authorized such
use. (b) In assessing whether protected health information should
be used under subparagraph (a) of this section, the Deputy
Attorney General shall permit such use upon concluding that the
balance of relevant factors weighs clearly in favor of its use. That
is, the Deputy Attorney General shall permit disclosure if the public
interest and the need for dis-closure clearly outweigh the potential
for injury to the patient, to the physician-patient relationship, and to
the treatment services.
(c) Upon the decision to use protected health information under
subparagraph (a) of this section, the Deputy Attorney General,
in
determining the extent to which this information should be used,
shall impose appropriate safeguards against unauthorized use.
(d) On an annual basis, the Department of Justice, in consultation
with the Department of Health and Human Services, shall
provide to
the President of the United States a report that includes the
following information:
i) the number of requests made to the Deputy Attorney
General for authorization to use protected health information
discovered during health oversight activities in a non-health
oversight, unrelated investigation;
(ii) the number of requests that were granted as applied for,
granted as modified, or denied;
(iii) the agencies that made the applications, and the
number
of requests made by each agency; and
(iv) the uses for which the protected health information was
authorized. (e) The General Counsel of the U.S.
Department of Defense will comply
with the requirements of subparagraphs (b), (c), and (d), above.
The General Counsel also will prepare a report, consistent with
the requirements of subparagraphs (d)(i) through (d)(iv), above,
and
will forward it to the Department of Justice where it will be
incorporated into the Department's annual report to the
President.
Sec. 4. Exceptions.
(a) Nothing in this Executive Order shall place a restriction on the
derivative use of protected health information that was obtained
by a law enforcement agency in a non-health oversight
investigation.
(b) Nothing in this Executive Order shall be interpreted to place a
restriction on a duty imposed by statute.
(c) Nothing in this Executive Order shall place any additional
limitation on the derivative use of health information obtained by
the Attorney General pursuant to the provisions of 18 U.S.C.
3486.
(d) This order does not create any right or benefit, substantive or
procedural, enforceable at law by a party against the United
States, the officers and employees, or any other person.
WILLIAM J. CLINTON
THE WHITE HOUSE,
December 20, 2000.
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