I 

115TH CONGRESS 

2D SESSION H. R. 6082 

To amend the Public Health Service Act to protect the confidentiality of 

substance use disorder patient records. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 13, 2018 

Mr. MULLIN (for himself and Mr. BLUMENAUER) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 and Patient Safety Act’’. 

6 SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS 

7 RELATING TO SUBSTANCE USE DISORDER. 

8 (a) CONFORMING CHANGES RELATING TO SUB9 STANCE USE DISORDER.—Subsections (a) and (h) of sec10 tion 543 of the Public Health Service Act (42 U.S.C. 


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1 290dd–2) are each amended by striking ‘‘substance 

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

3 (b) DISCLOSURES TO COVERED ENTITIES CON4 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 regu12 lation. Any redisclosure of information so dis13 closed may only be made in accordance with 

14 this section.’’. 

15 (c) DISCLOSURES OF DE-IDENTIFIED HEALTH IN16 FORMATION TO PUBLIC HEALTH AUTHORITIES.—Para17 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 Fed23 eral Regulations (or successor regulations) for 

24 creating de-identified information.’’. 


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

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

3 amended by adding at the end the following: 

4 ‘‘(3) DEFINITIONS.—For purposes of this sub5 section: 

6 ‘‘(A) COVERED ENTITY.—The term ‘cov7 ered entity’ has the meaning given such term 

8 for purposes of HIPAA privacy regulation. 

9 ‘‘(B) HEALTH CARE OPERATIONS.—The 

10 term ‘health care operations’ has the meaning 

11 given such term for purposes of HIPAA privacy 

12 regulation. 

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

14 term ‘HIPAA privacy regulation’ has the mean15 ing given such term under section 1180(b)(3) of 

16 the Social Security Act. 

17 ‘‘(D) INDIVIDUALLY IDENTIFIABLE

18 HEALTH INFORMATION.—The term ‘individually 

19 identifiable health information’ has the meaning 

20 given such term for purposes of HIPAA privacy 

21 regulation. 

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

23 the meaning given such term for purposes of 

24 HIPAA privacy regulation. 


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1 ‘‘(F) PUBLIC HEALTH AUTHORITY.—The 

2 term ‘public health authority’ has the meaning 

3 given such term for purposes of HIPAA privacy 

4 regulation. 

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

6 has the meaning given such term for purposes 

7 of HIPAA privacy regulation.’’. 

8 (e) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD9 MINISTRATIVE INVESTIGATIONS, ACTIONS, OR PRO10 CEEDINGS.—Subsection (c) of section 543 of the Public 

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

12 read as follows: 

13 ‘‘(c) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD14 MINISTRATIVE CONTEXTS.—Except as otherwise author15 ized by a court order under subsection (b)(2)(C) or by the 

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

17 (a) may not— 

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

19 prosecution or civil action before a Federal or State 

20 court; 

21 ‘‘(2) form part of the record for decision or oth22 erwise be taken into account in any proceeding be23 fore a Federal agency; 


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

2 agency for a law enforcement purpose or to conduct 

3 any law enforcement investigation of a patient; or 

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

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

6 Public Health Service Act (42 U.S.C. 290dd–2) is amend7 ed to read as follows: 

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

9 and 1177 of the Social Security Act shall apply to a viola10 tion of this section to the extent and in the same manner 

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

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

13 ‘‘(1) the reference to ‘this subsection’ in sub14 section (a)(2) of such section 1176 shall be treated 

15 as a reference to ‘this subsection (including as ap16 plied pursuant to section 543(f) of the Public Health 

17 Service Act)’; and 

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

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

20 under subsection (a)’ shall be treated as a ref21 erence to ‘a penalty imposed under subsection 

22 (a) (including as applied pursuant to section 

23 543(f) of the Public Health Service Act)’; and 

24 ‘‘(B) each reference to ‘no damages ob25 tained under subsection (d)’ shall be treated as 


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1 a reference to ‘no damages obtained under sub2 section (d) (including as applied pursuant to 

3 section 543(f) of the Public Health Service 

4 Act)’.’’. 

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

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

7 adding at the end the following: 

8 ‘‘(i) ANTIDISCRIMINATION.— 

9 ‘‘(1) IN GENERAL.—No entity shall discrimi10 nate against an individual on the basis of informa11 tion received by such entity pursuant to a disclosure 

12 made under subsection (b) in— 

13 ‘‘(A) admission or treatment for health 

14 care; 

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

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

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

18 courts. 

19 ‘‘(2) RECIPIENTS OF FEDERAL FUNDS.—No re20 cipient of Federal funds shall discriminate against 

21 an individual on the basis of information received by 

22 such recipient pursuant to a disclosure made under 

23 subsection (b) in affording access to the services 

24 provided with such funds.’’. 


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

2 543 of the Public Health Service Act (42 U.S.C. 290dd– 

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

4 adding at the end the following: 

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

6 ‘‘(1) APPLICATION OF HITECH NOTIFICATION

7 OF BREACH PROVISIONS.—The provisions of section 

8 13402 of the HITECH Act (42 U.S.C. 17932) shall 

9 apply to a program or activity described in sub10 section (a), in case of a breach of records described 

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

12 same manner as such provisions apply to a covered 

13 entity in the case of a breach of unsecured protected 

14 health information. 

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

16 terms ‘covered entity’ and ‘unsecured protected 

17 health information’ have the meanings given to such 

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

19 (i) SENSE OF CONGRESS.—It is the sense of the Con20 gress that any person treating a patient through a pro21 gram or activity with respect to which the confidentiality 

22 requirements of section 543 of the Public Health Service 

23 Act (42 U.S.C. 290dd–2) apply should access the applica24 ble State-based prescription drug monitoring program as 

25 a precaution against substance use disorder. 


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1 (j) REGULATIONS.— 

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

3 Human Services, in consultation with appropriate 

4 Federal agencies, shall make such revisions to regu5 lations as may be necessary for implementing and 

6 enforcing the amendments made by this section, 

7 such that such amendments shall apply with respect 

8 to uses and disclosures of information occurring on 

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

10 of enactment of this Act. 

11 (2) EASILY UNDERSTANDABLE NOTICE OF PRI12 VACY PRACTICES.—Not later than 1 year after the 

13 date of enactment of this Act, the Secretary of 

14 Health and Human Services, in consultation with 

15 appropriate experts, shall update section 164.520 of 

16 title 45, Code of Federal Regulations, so that cov17 ered entities provide notice, written in plain lan18 guage, of privacy practices regarding patient records 

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

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

21 (A) a statement of the patient’s rights, in22 cluding self-pay patients, with respect to pro23 tected health information and a brief descrip24 tion of how the individual may exercise these 


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

2 such section 164.520); and 

3 (B) a description of each purpose for 

4 which the covered entity is permitted or re5 quired to use or disclose protected health infor6 mation without the patient’s written authoriza7 tion (as required by paragraph (b)(2) of such 

8 section 164.520). 

9 (k) DEVELOPMENT AND DISSEMINATION OF MODEL

10 TRAINING PROGRAMS FOR SUBSTANCE USE DISORDER

11 PATIENT RECORDS.— 

12 (1) INITIAL PROGRAMS AND MATERIALS.—Not 

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

14 this Act, the Secretary of Health and Human Serv15 ices (referred to in this subsection as the ‘‘Sec16 retary’’), in consultation with appropriate experts, 

17 shall identify the following model programs and ma18 terials (or if no such programs or materials exist, 

19 recognize private or public entities to develop and 

20 disseminate such programs and materials): 

21 (A) Model programs and materials for 

22 training health care providers (including physi23 cians, emergency medical personnel, psychia24 trists, psychologists, counselors, therapists, 

25 nurse practitioners, physician assistants, behavVerDate Sep 11 2014 00:45 Jun 14, 2018 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6082.IH H6082

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1 ioral health facilities and clinics, care managers, 

2 and hospitals, including individuals such as gen3 eral counsels or regulatory compliance staff who 

4 are responsible for establishing provider privacy 

5 policies) concerning the permitted uses and dis6 closures, consistent with the standards and reg7 ulations governing the privacy and security of 

8 substance use disorder patient records promul9 gated by the Secretary under section 543 of the 

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

11 2), as amended by this section, for the con12 fidentiality of patient records. 

13 (B) Model programs and materials for 

14 training patients and their families regarding 

15 their rights to protect and obtain information 

16 under the standards and regulations described 

17 in subparagraph (A). 

18 (2) REQUIREMENTS.—The model programs and 

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

20 paragraph (1) shall address circumstances under 

21 which disclosure of substance use disorder patient 

22 records is needed to— 

23 (A) facilitate communication between sub24 stance use disorder treatment providers and 


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1 other health care providers to promote and pro2 vide the best possible integrated care; 

3 (B) avoid inappropriate prescribing that 

4 can lead to dangerous drug interactions, over5 dose, or relapse; and 

6 (C) notify and involve families and care7 givers when individuals experience an overdose. 

8 (3) PERIODIC UPDATES.—The Secretary 

9 shall— 

10 (A) periodically review and update the 

11 model programs and materials identified or de12 veloped under paragraph (1); and 

13 (B) disseminate such updated programs 

14 and materials to the individuals described in 

15 paragraph (1)(A). 

16 (4) INPUT OF CERTAIN ENTITIES.—In identi17 fying, reviewing, or updating the model programs 

18 and materials under this subsection, the Secretary 

19 shall solicit the input of relevant stakeholders. 

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

21 or the amendments made by this Act shall be construed 

22 to limit— 

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

24 164.522 of title 45, Code of Federal Regulations, or 

25 any successor regulation, to request a restriction on 


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1 the use or disclosure of a record referred to in sec2 tion 543(a) of the Public Health Service Act (42 

3 U.S.C. 290dd–2(a)) for purposes of treatment, pay4 ment, or health care operations; or 

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

6 section 164.506 of title 45, Code of Federal Regula7 tions, or any successor regulation, to obtain the con8 sent of the individual to use or disclose a record re9 ferred to in such section 543(a) to carry out treat10 ment, payment, or health care operation. 

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

12 Congress that— 

13 (1) patients have the right to request a restric14 tion on the use or disclosure of a record referred to 

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

16 (42 U.S.C. 290dd–2(a)) for treatment, payment, or 

17 health care operations; and 

18 (2) covered entities should make every reason19 able effort to the extent feasible to comply with a 

20 patient’s request for a restriction regarding such use 

21 or disclosure. 

Æ 


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