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II
116TH CONGRESS
1ST SESSION
S. 1012
To amend the Public Health Service Act to protect the confidentiality of
substance use disorder patient records.
IN THE SENATE OF THE UNITED STATES
APRIL 3, 2019
Mr. MANCHIN (for himself, Mrs. CAPITO, Mr. WHITEHOUSE, Ms. HARRIS, Ms.
KLOBUCHAR, Mrs. FEINSTEIN, Mr. KING, Mr. TILLIS, Ms. COLLINS, Mr.
CASSIDY, and Mr. CRAMER) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
A BILL
To amend the Public Health Service Act to protect the
confidentiality of substance use disorder patient records.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Protecting Jessica
4
Grubb’s Legacy Act’’.
5
SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS
6
RELATING TO SUBSTANCE USE DISORDER.
7
(a) CONFORMING CHANGES RELATING
TO SUB-
8
STANCE USE DISORDER.—Subsections (a) and (h) of sec-
9
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•S 1012 IS
tion 543 of the Public Health Service Act (42 U.S.C.
1
290dd–2) are each amended by striking ‘‘substance
2
abuse’’ and inserting ‘‘substance use disorder’’.
3
(b) DISCLOSURES
TO COVERED ENTITIES CON-
4
SISTENT WITH HIPAA.—Paragraph (2) of section 543(b)
5
of the Public Health Service Act (42 U.S.C. 290dd–2(b))
6
is amended by adding at the end the following:
7
‘‘(D) To a covered entity or to a program
8
or activity described in subsection (a), for the
9
purposes of treatment, payment, and health
10
care operations, so long as such disclosure is
11
made in accordance with HIPAA privacy regu-
12
lation. Any redisclosure of information so dis-
13
closed may only be made in accordance with
14
this section.’’.
15
(c) DISCLOSURES OF DE-IDENTIFIED HEALTH IN-
16
FORMATION TO PUBLIC HEALTH AUTHORITIES.—Para-
17
graph (2) of section 543(b) of the Public Health Service
18
Act (42 U.S.C. 290dd–2(b)), as amended by subsection
19
(b), is further amended by adding at the end the following:
20
‘‘(E) To a public health authority, so long
21
as such content meets the standards established
22
in section 164.514(b) of title 45, Code of Fed-
23
eral Regulations (or successor regulations) for
24
creating de-identified information.’’.
25
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•S 1012 IS
(d) DEFINITIONS.—Subsection (b) of section 543 of
1
the Public Health Service Act (42 U.S.C. 290dd–2) is
2
amended by adding at the end the following:
3
‘‘(3) DEFINITIONS.—For purposes of this sub-
4
section:
5
‘‘(A) COVERED ENTITY.—The term ‘cov-
6
ered entity’ has the meaning given such term
7
for purposes of HIPAA privacy regulation.
8
‘‘(B) HEALTH
CARE
OPERATIONS.—The
9
term ‘health care operations’ has the meaning
10
given such term for purposes of HIPAA privacy
11
regulation.
12
‘‘(C) HIPAA PRIVACY REGULATION.—The
13
term ‘HIPAA privacy regulation’ has the mean-
14
ing given such term under section 1180(b)(3) of
15
the Social Security Act.
16
‘‘(D)
INDIVIDUALLY
IDENTIFIABLE
17
HEALTH INFORMATION.—The term ‘individually
18
identifiable health information’ has the meaning
19
given such term for purposes of HIPAA privacy
20
regulation.
21
‘‘(E) PAYMENT.—The term ‘payment’ has
22
the meaning given such term for purposes of
23
HIPAA privacy regulation.
24
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•S 1012 IS
‘‘(F) PUBLIC
HEALTH
AUTHORITY.—The
1
term ‘public health authority’ has the meaning
2
given such term for purposes of HIPAA privacy
3
regulation.
4
‘‘(G) TREATMENT.—The term ‘treatment’
5
has the meaning given such term for purposes
6
of HIPAA privacy regulation.’’.
7
(e) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD-
8
MINISTRATIVE
INVESTIGATIONS, ACTIONS,
OR
PRO-
9
CEEDINGS.—Subsection (c) of section 543 of the Public
10
Health Service Act (42 U.S.C. 290dd–2) is amended to
11
read as follows:
12
‘‘(c) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD-
13
MINISTRATIVE CONTEXTS.—Except as otherwise author-
14
ized by a court order under subsection (b)(2)(C) or by the
15
consent of the patient, a record referred to in subsection
16
(a) may not—
17
‘‘(1) be entered into evidence in any criminal
18
prosecution or civil action before a Federal or State
19
court;
20
‘‘(2) form part of the record for decision or oth-
21
erwise be taken into account in any proceeding be-
22
fore a Federal agency;
23
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•S 1012 IS
‘‘(3) be used by any Federal, State, or local
1
agency for a law enforcement purpose or to conduct
2
any law enforcement investigation of a patient; or
3
‘‘(4) be used in any application for a warrant.’’.
4
(f) PENALTIES.—Subsection (f) of section 543 of the
5
Public Health Service Act (42 U.S.C. 290dd–2) is amend-
6
ed to read as follows:
7
‘‘(f) PENALTIES.—The provisions of sections 1176
8
and 1177 of the Social Security Act shall apply to a viola-
9
tion of this section to the extent and in the same manner
10
as such provisions apply to a violation of part C of title
11
XI of such Act. In applying the previous sentence—
12
‘‘(1) the reference to ‘this subsection’ in sub-
13
section (a)(2) of such section 1176 shall be treated
14
as a reference to ‘this subsection (including as ap-
15
plied pursuant to section 543(f) of the Public Health
16
Service Act)’; and
17
‘‘(2) in subsection (b) of such section 1176—
18
‘‘(A) each reference to ‘a penalty imposed
19
under subsection (a)’ shall be treated as a ref-
20
erence to ‘a penalty imposed under subsection
21
(a) (including as applied pursuant to section
22
543(f) of the Public Health Service Act)’; and
23
‘‘(B) each reference to ‘no damages ob-
24
tained under subsection (d)’ shall be treated as
25
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a reference to ‘no damages obtained under sub-
1
section (d) (including as applied pursuant to
2
section 543(f) of the Public Health Service
3
Act)’.’’.
4
(g) ANTIDISCRIMINATION.—Section 543 of the Public
5
Health Service Act (42 U.S.C. 290dd–2) is amended by
6
adding at the end the following:
7
‘‘(i) ANTIDISCRIMINATION.—
8
‘‘(1) IN GENERAL.—No entity shall discrimi-
9
nate against an individual on the basis of informa-
10
tion received by such entity pursuant to a disclosure
11
made under subsection (b) in—
12
‘‘(A) admission or treatment for health
13
care;
14
‘‘(B) hiring or terms of employment;
15
‘‘(C) the sale or rental of housing; or
16
‘‘(D) access to Federal, State, or local
17
courts.
18
‘‘(2) RECIPIENTS OF FEDERAL FUNDS.—No re-
19
cipient of Federal funds shall discriminate against
20
an individual on the basis of information received by
21
such recipient pursuant to a disclosure made under
22
subsection (b) in affording access to the services
23
provided with such funds.’’.
24
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•S 1012 IS
(h) NOTIFICATION IN CASE OF BREACH.—Section
1
543 of the Public Health Service Act (42 U.S.C. 290dd–
2
2), as amended by subsection (g), is further amended by
3
adding at the end the following:
4
‘‘(j) NOTIFICATION IN CASE OF BREACH.—
5
‘‘(1) APPLICATION
OF
HITECH
NOTIFICATION
6
OF BREACH PROVISIONS.—The provisions of section
7
13402 of the HITECH Act (42 U.S.C. 17932) shall
8
apply to a program or activity described in sub-
9
section (a), in case of a breach of records described
10
in subsection (a), to the same extent and in the
11
same manner as such provisions apply to a covered
12
entity in the case of a breach of unsecured protected
13
health information.
14
‘‘(2) DEFINITIONS.—In this subsection, the
15
terms ‘covered entity’ and ‘unsecured protected
16
health information’ have the meanings given to such
17
terms for purposes of such section 13402.’’.
18
(i) SENSE OF CONGRESS.—It is the sense of the Con-
19
gress that any person treating a patient through a pro-
20
gram or activity with respect to which the confidentiality
21
requirements of section 543 of the Public Health Service
22
Act (42 U.S.C. 290dd–2) apply should access the applica-
23
ble State-based prescription drug monitoring program as
24
a precaution against substance use disorder.
25
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(j) REGULATIONS.—
1
(1) IN GENERAL.—The Secretary of Health and
2
Human Services, in consultation with appropriate
3
Federal agencies, shall make such revisions to regu-
4
lations as may be necessary for implementing and
5
enforcing the amendments made by this section,
6
such that such amendments shall apply with respect
7
to uses and disclosures of information occurring on
8
or after the date that is 12 months after the date
9
of enactment of this Act.
10
(2) EASILY UNDERSTANDABLE NOTICE OF PRI-
11
VACY PRACTICES.—Not later than 1 year after the
12
date of enactment of this Act, the Secretary of
13
Health and Human Services, in consultation with
14
appropriate experts, shall update section 164.520 of
15
title 45, Code of Federal Regulations, so that cov-
16
ered entities provide notice, written in plain lan-
17
guage, of privacy practices regarding patient records
18
referred to in section 543(a) of the Public Health
19
Service Act (42 U.S.C. 290dd–2(a)), including—
20
(A) a statement of the patient’s rights, in-
21
cluding self-pay patients, with respect to pro-
22
tected health information and a brief descrip-
23
tion of how the individual may exercise these
24
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•S 1012 IS
rights (as required by paragraph (b)(1)(iv) of
1
such section 164.520); and
2
(B) a description of each purpose for
3
which the covered entity is permitted or re-
4
quired to use or disclose protected health infor-
5
mation without the patient’s written authoriza-
6
tion (as required by paragraph (b)(2) of such
7
section 164.520).
8
(k) DEVELOPMENT AND DISSEMINATION OF MODEL
9
TRAINING PROGRAMS FOR SUBSTANCE USE DISORDER
10
PATIENT RECORDS.—
11
(1) INITIAL PROGRAMS AND MATERIALS.—Not
12
later than 1 year after the date of the enactment of
13
this Act, the Secretary of Health and Human Serv-
14
ices (referred to in this subsection as the ‘‘Sec-
15
retary’’), in consultation with appropriate experts,
16
shall identify the following model programs and ma-
17
terials (or if no such programs or materials exist,
18
recognize private or public entities to develop and
19
disseminate such programs and materials):
20
(A) Model programs and materials for
21
training health care providers (including physi-
22
cians, emergency medical personnel, psychia-
23
trists,
psychologists,
counselors,
therapists,
24
nurse practitioners, physician assistants, behav-
25
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•S 1012 IS
ioral health facilities and clinics, care managers,
1
and hospitals, including individuals such as gen-
2
eral counsels or regulatory compliance staff who
3
are responsible for establishing provider privacy
4
policies) concerning the permitted uses and dis-
5
closures, consistent with the standards and reg-
6
ulations governing the privacy and security of
7
substance use disorder patient records promul-
8
gated by the Secretary under section 543 of the
9
Public Health Service Act (42 U.S.C. 290dd–
10
2), as amended by this section, for the con-
11
fidentiality of patient records.
12
(B) Model programs and materials for
13
training patients and their families regarding
14
their rights to protect and obtain information
15
under the standards and regulations described
16
in subparagraph (A).
17
(2) REQUIREMENTS.—The model programs and
18
materials described in subparagraphs (A) and (B) of
19
paragraph (1) shall address circumstances under
20
which disclosure of substance use disorder patient
21
records is needed to—
22
(A) facilitate communication between sub-
23
stance use disorder treatment providers and
24
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other health care providers to promote and pro-
1
vide the best possible integrated care;
2
(B) avoid inappropriate prescribing that
3
can lead to dangerous drug interactions, over-
4
dose, or relapse; and
5
(C) notify and involve families and care-
6
givers when individuals experience an overdose.
7
(3)
PERIODIC
UPDATES.—The
Secretary
8
shall—
9
(A) periodically review and update the
10
model programs and materials identified or de-
11
veloped under paragraph (1); and
12
(B) disseminate such updated programs
13
and materials to the individuals described in
14
paragraph (1)(A).
15
(4) INPUT OF CERTAIN ENTITIES.—In identi-
16
fying, reviewing, or updating the model programs
17
and materials under this subsection, the Secretary
18
shall solicit the input of relevant stakeholders.
19
(l) RULES OF CONSTRUCTION.—Nothing in this Act
20
or the amendments made by this Act shall be construed
21
to limit—
22
(1) a patient’s right, as described in section
23
164.522 of title 45, Code of Federal Regulations, or
24
any successor regulation, to request a restriction on
25
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•S 1012 IS
the use or disclosure of a record referred to in sec-
1
tion 543(a) of the Public Health Service Act (42
2
U.S.C. 290dd–2(a)) for purposes of treatment, pay-
3
ment, or health care operations; or
4
(2) a covered entity’s choice, as described in
5
section 164.506 of title 45, Code of Federal Regula-
6
tions, or any successor regulation, to obtain the con-
7
sent of the individual to use or disclose a record re-
8
ferred to in such section 543(a) to carry out treat-
9
ment, payment, or health care operation.
10
(m) SENSE OF CONGRESS.—It is the sense of the
11
Congress that—
12
(1) patients have the right to request a restric-
13
tion on the use or
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