IIB 

115TH CONGRESS 

2D SESSION H. R. 6082 

IN THE SENATE OF THE UNITED STATES 

JUNE 21, 2018 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend the Public Health Service Act to protect the 

confidentiality of substance use disorder patient records. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Overdose Prevention 

3 and Patient Safety Act’’. 

4 SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS 

5 RELATING TO SUBSTANCE USE DISORDER. 

6 (a) CONFORMING CHANGES RELATING TO SUB7 STANCE USE DISORDER.—Subsections (a) and (h) of sec8 tion 543 of the Public Health Service Act (42 U.S.C. 

9 290dd–2) are each amended by striking ‘‘substance 

10 abuse’’ and inserting ‘‘substance use disorder’’. 

11 (b) DISCLOSURES TO COVERED ENTITIES CON12 SISTENT WITH HIPAA.—Paragraph (2) of section 543(b) 

13 of the Public Health Service Act (42 U.S.C. 290dd–2(b)) 

14 is amended by adding at the end the following: 

15 ‘‘(D) To a covered entity or to a program 

16 or activity described in subsection (a), for the 

17 purposes of treatment, payment, and health 

18 care operations, so long as such disclosure is 

19 made in accordance with HIPAA privacy regu20 lation. Any redisclosure of information so dis21 closed may only be made in accordance with 

22 this section.’’. 

23 (c) DISCLOSURES OF DE-IDENTIFIED HEALTH IN24 FORMATION TO PUBLIC HEALTH AUTHORITIES.—Para25 graph (2) of section 543(b) of the Public Health Service 


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1 Act (42 U.S.C. 290dd–2(b)), as amended by subsection 

2 (b), is further amended by adding at the end the following: 

3 ‘‘(E) To a public health authority, so long 

4 as such content meets the standards established 

5 in section 164.514(b) of title 45, Code of Fed6 eral Regulations (or successor regulations) for 

7 creating de-identified information.’’. 

8 (d) DEFINITIONS.—Subsection (b) of section 543 of 

9 the Public Health Service Act (42 U.S.C. 290dd–2) is 

10 amended by adding at the end the following: 

11 ‘‘(3) DEFINITIONS.—For purposes of this sub12 section: 

13 ‘‘(A) COVERED ENTITY.—The term ‘cov14 ered entity’ has the meaning given such term 

15 for purposes of HIPAA privacy regulation. 

16 ‘‘(B) HEALTH CARE OPERATIONS.—The 

17 term ‘health care operations’ has the meaning 

18 given such term for purposes of HIPAA privacy 

19 regulation. 

20 ‘‘(C) HIPAA PRIVACY REGULATION.—The 

21 term ‘HIPAA privacy regulation’ has the mean22 ing given such term under section 1180(b)(3) of 

23 the Social Security Act. 

24 ‘‘(D) INDIVIDUALLY IDENTIFIABLE

25 HEALTH INFORMATION.—The term ‘individually 


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1 identifiable health information’ has the meaning 

2 given such term for purposes of HIPAA privacy 

3 regulation. 

4 ‘‘(E) PAYMENT.—The term ‘payment’ has 

5 the meaning given such term for purposes of 

6 HIPAA privacy regulation. 

7 ‘‘(F) PUBLIC HEALTH AUTHORITY.—The 

8 term ‘public health authority’ has the meaning 

9 given such term for purposes of HIPAA privacy 

10 regulation. 

11 ‘‘(G) TREATMENT.—The term ‘treatment’ 

12 has the meaning given such term for purposes 

13 of HIPAA privacy regulation.’’. 

14 (e) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD15 MINISTRATIVE INVESTIGATIONS, ACTIONS, OR PRO16 CEEDINGS.—Subsection (c) of section 543 of the Public 

17 Health Service Act (42 U.S.C. 290dd–2) is amended to 

18 read as follows: 

19 ‘‘(c) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD20 MINISTRATIVE CONTEXTS.—Except as otherwise author21 ized by a court order under subsection (b)(2)(C) or by the 

22 consent of the patient, a record referred to in subsection 

23 (a) may not— 


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1 ‘‘(1) be entered into evidence in any criminal 

2 prosecution or civil action before a Federal or State 

3 court; 

4 ‘‘(2) form part of the record for decision or oth5 erwise be taken into account in any proceeding be6 fore a Federal agency; 

7 ‘‘(3) be used by any Federal, State, or local 

8 agency for a law enforcement purpose or to conduct 

9 any law enforcement investigation of a patient; or 

10 ‘‘(4) be used in any application for a warrant.’’. 

11 (f) PENALTIES.—Subsection (f) of section 543 of the 

12 Public Health Service Act (42 U.S.C. 290dd–2) is amend13 ed to read as follows: 

14 ‘‘(f) PENALTIES.—The provisions of sections 1176 

15 and 1177 of the Social Security Act shall apply to a viola16 tion of this section to the extent and in the same manner 

17 as such provisions apply to a violation of part C of title 

18 XI of such Act. In applying the previous sentence— 

19 ‘‘(1) the reference to ‘this subsection’ in sub20 section (a)(2) of such section 1176 shall be treated 

21 as a reference to ‘this subsection (including as ap22 plied pursuant to section 543(f) of the Public Health 

23 Service Act)’; and 

24 ‘‘(2) in subsection (b) of such section 1176— 


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1 ‘‘(A) each reference to ‘a penalty imposed 

2 under subsection (a)’ shall be treated as a ref3 erence to ‘a penalty imposed under subsection 

4 (a) (including as applied pursuant to section 

5 543(f) of the Public Health Service Act)’; and 

6 ‘‘(B) each reference to ‘no damages ob7 tained under subsection (d)’ shall be treated as 

8 a reference to ‘no damages obtained under sub9 section (d) (including as applied pursuant to 

10 section 543(f) of the Public Health Service 

11 Act)’.’’. 

12 (g) ANTIDISCRIMINATION.—Section 543 of the Public 

13 Health Service Act (42 U.S.C. 290dd–2) is amended by 

14 adding at the end the following: 

15 ‘‘(i) ANTIDISCRIMINATION.— 

16 ‘‘(1) IN GENERAL.—No entity shall discrimi17 nate against an individual on the basis of informa18 tion received by such entity pursuant to a disclosure 

19 made under subsection (b) in— 

20 ‘‘(A) admission or treatment for health 

21 care; 

22 ‘‘(B) hiring or terms of employment; 

23 ‘‘(C) the sale or rental of housing; or 

24 ‘‘(D) access to Federal, State, or local 

25 courts. 


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1 ‘‘(2) RECIPIENTS OF FEDERAL FUNDS.—No re2 cipient of Federal funds shall discriminate against 

3 an individual on the basis of information received by 

4 such recipient pursuant to a disclosure made under 

5 subsection (b) in affording access to the services 

6 provided with such funds.’’. 

7 (h) NOTIFICATION IN CASE OF BREACH.—Section 

8 543 of the Public Health Service Act (42 U.S.C. 290dd– 

9 2), as amended by subsection (g), is further amended by 

10 adding at the end the following: 

11 ‘‘(j) NOTIFICATION IN CASE OF BREACH.— 

12 ‘‘(1) APPLICATION OF HITECH NOTIFICATION

13 OF BREACH PROVISIONS.—The provisions of section 

14 13402 of the HITECH Act (42 U.S.C. 17932) shall 

15 apply to a program or activity described in sub16 section (a), in case of a breach of records described 

17 in subsection (a), to the same extent and in the 

18 same manner as such provisions apply to a covered 

19 entity in the case of a breach of unsecured protected 

20 health information. 

21 ‘‘(2) DEFINITIONS.—In this subsection, the 

22 terms ‘covered entity’ and ‘unsecured protected 

23 health information’ have the meanings given to such 

24 terms for purposes of such section 13402.’’. 


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1 (i) SENSE OF CONGRESS.—It is the sense of the Con2 gress that any person treating a patient through a pro3 gram or activity with respect to which the confidentiality 

4 requirements of section 543 of the Public Health Service 

5 Act (42 U.S.C. 290dd–2) apply should access the applica6 ble State-based prescription drug monitoring program as 

7 a precaution against substance use disorder. 

8 (j) REGULATIONS.— 

9 (1) IN GENERAL.—The Secretary of Health and 

10 Human Services, in consultation with appropriate 

11 Federal agencies, shall make such revisions to regu12 lations as may be necessary for implementing and 

13 enforcing the amendments made by this section, 

14 such that such amendments shall apply with respect 

15 to uses and disclosures of information occurring on 

16 or after the date that is 12 months after the date 

17 of enactment of this Act. 

18 (2) EASILY UNDERSTANDABLE NOTICE OF PRI19 VACY PRACTICES.—Not later than 1 year after the 

20 date of enactment of this Act, the Secretary of 

21 Health and Human Services, in consultation with 

22 appropriate experts, shall update section 164.520 of 

23 title 45, Code of Federal Regulations, so that cov24 ered entities provide notice, written in plain lan25 guage, of privacy practices regarding patient records 


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1 referred to in section 543(a) of the Public Health 

2 Service Act (42 U.S.C. 290dd–2(a)), including— 

3 (A) a statement of the patient’s rights, in4 cluding self-pay patients, with respect to pro5 tected health information and a brief descrip6 tion of how the individual may exercise these 

7 rights (as required by paragraph (b)(1)(iv) of 

8 such section 164.520); and 

9 (B) a description of each purpose for 

10 which the covered entity is permitted or re11 quired to use or disclose protected health infor12 mation without the patient’s written authoriza13 tion (as required by paragraph (b)(2) of such 

14 section 164.520). 

15 (k) DEVELOPMENT AND DISSEMINATION OF MODEL

16 TRAINING PROGRAMS FOR SUBSTANCE USE DISORDER

17 PATIENT RECORDS.— 

18 (1) INITIAL PROGRAMS AND MATERIALS.—Not 

19 later than 1 year after the date of the enactment of 

20 this Act, the Secretary of Health and Human Serv21 ices (referred to in this subsection as the ‘‘Sec22 retary’’), in consultation with appropriate experts, 

23 shall identify the following model programs and ma24 terials (or if no such programs or materials exist, 


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1 recognize private or public entities to develop and 

2 disseminate such programs and materials): 

3 (A) Model programs and materials for 

4 training health care providers (including physi5 cians, emergency medical personnel, psychia6 trists, psychologists, counselors, therapists, 

7 nurse practitioners, physician assistants, behav8 ioral health facilities and clinics, care managers, 

9 and hospitals, including individuals such as gen10 eral counsels or regulatory compliance staff who 

11 are responsible for establishing provider privacy 

12 policies) concerning the permitted uses and dis13 closures, consistent with the standards and reg14 ulations governing the privacy and security of 

15 substance use disorder patient records promul16 gated by the Secretary under section 543 of the 

17 Public Health Service Act (42 U.S.C. 290dd– 

18 2), as amended by this section, for the con19 fidentiality of patient records. 

20 (B) Model programs and materials for 

21 training patients and their families regarding 

22 their rights to protect and obtain information 

23 under the standards and regulations described 

24 in subparagraph (A). 


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1 (2) REQUIREMENTS.—The model programs and 

2 materials described in subparagraphs (A) and (B) of 

3 paragraph (1) shall address circumstances under 

4 which disclosure of substance use disorder patient 

5 records is needed to— 

6 (A) facilitate communication between sub7 stance use disorder treatment providers and 

8 other health care providers to promote and pro9 vide the best possible integrated care; 

10 (B) avoid inappropriate prescribing that 

11 can lead to dangerous drug interactions, over12 dose, or relapse; and 

13 (C) notify and involve families and care14 givers when individuals experience an overdose. 

15 (3) PERIODIC UPDATES.—The Secretary 

16 shall— 

17 (A) periodically review and update the 

18 model programs and materials identified or de19 veloped under paragraph (1); and 

20 (B) disseminate such updated programs 

21 and materials to the individuals described in 

22 paragraph (1)(A). 

23 (4) INPUT OF CERTAIN ENTITIES.—In identi24 fying, reviewing, or updating the model programs 


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1 and materials under this subsection, the Secretary 

2 shall solicit the input of relevant stakeholders. 

3 (l) RULES OF CONSTRUCTION.—Nothing in this Act 

4 or the amendments made by this Act shall be construed 

5 to limit— 

6 (1) a patient’s right, as described in section 

7 164.522 of title 45, Code of Federal Regulations, or 

8 any successor regulation, to request a restriction on 

9 the use or disclosure of a record referred to in sec10 tion 543(a) of the Public Health Service Act (42 

11 U.S.C. 290dd–2(a)) for purposes of treatment, pay12 ment, or health care operations; or 

13 (2) a covered entity’s choice, as described in 

14 section 164.506 of title 45, Code of Federal Regula15 tions, or any successor regulation, to obtain the con16 sent of the individual to use or disclose a record re17 ferred to in such section 543(a) to carry out treat18 ment, payment, or health care operation. 

19 (m) SENSE OF CONGRESS.—It is the sense of the 

20 Congress that— 

21 (1) patients have the right to request a restric22 tion on the use or disclosure of a record referred to 

23 in section 543(a) of the Public Health Service Act 

24 (42 U.S.C. 290dd–2(a)) for treatment, payment, or 

25 health care operations; and 


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1 (2) covered entities should make every reason2 able effort to the extent feasible to comply with a 

3 patient’s request for a restriction regarding such use 

4 or disclosure. 

Passed the House of Representatives June 20, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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