IB 

Union Calendar No. 559 

115TH CONGRESS 

2D SESSION H. R. 5795 

[Report No. 115–724] 

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

substance use disorder patient records. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 15, 2018 

Mr. BLUMENAUER (for himself, Mr. MULLIN, Mr. MOULTON, Mr. BARR, Mr. 

HULTGREN, Mr. JOHNSON of Ohio, and Mr. KELLY of Pennsylvania) introduced the following bill; which was referred to the Committee on Energy and Commerce 

JUNE 12, 2018 

Additional sponsors: Mr. RENACCI, Ms. BONAMICI, Mrs. BROOKS of Indiana, 

Mr. BILIRAKIS, Mr. POLIQUIN, Mr. BURGESS, Mr. WALDEN, Mrs. COMSTOCK, Mr. TURNER, Mr. CRAMER, Mr. BISHOP of Georgia, Mr. BERA, 

Ms. DELBENE, Mr. ROKITA, Mr. LEWIS of Georgia, Mr. DEFAZIO, Mr. 

GONZALEZ of Texas, Mr. MAST, Mrs. NOEM, Ms. ROSEN, Mr. CRIST, Mr. 

KIND, Ms. JENKINS of Kansas, Mr. DUNN, and Mr. KILMER

JUNE 12, 2018 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on May 15, 2018] 


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A BILL 

To amend the Public Health Service Act to protect the 

confidentiality of substance use disorder patient records. 


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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 and 

5 Patient Safety Act’’. 

6 SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS 

7 RELATING TO SUBSTANCE USE DISORDER. 

8 (a) CONFORMING CHANGES RELATING TO SUBSTANCE

9 USE DISORDER.—Subsections (a) and (h) of section 543 

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

11 each amended by striking ‘‘substance abuse’’ and inserting 

12 ‘‘substance use disorder’’. 

13 (b) DISCLOSURES TO COVERED ENTITIES CONSISTENT

14 WITH HIPAA.—Paragraph (2) of section 543(b) of the 

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

16 amended by adding at the end the following: 

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

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

19 purposes of treatment, payment, and health care 

20 operations, so long as such disclosure is made in 

21 accordance with HIPAA privacy regulation. Any 

22 redisclosure of information so disclosed may only 

23 be made in accordance with this section.’’. 

24 (c) DISCLOSURES OF DE-IDENTIFIED HEALTH INFOR25 MATION TO PUBLIC HEALTH AUTHORITIES.—Paragraph 


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1 (2) of section 543(b) of the Public Health Service Act (42 

2 U.S.C. 290dd–2(b)), as amended by subsection (b), is fur3 ther amended by adding at the end the following: 

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

5 as such content does not include any individ6 ually identifiable health information and meets 

7 the standards established in section 164.514 of 

8 title 45, Code of Federal Regulations (or suc9 cessor regulations) for creating de-identified in10 formation.’’. 

11 (d) DEFINITIONS.—Subsection (b) of section 543 of the 

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

13 by adding at the end the following: 

14 ‘‘(3) DEFINITIONS.—For purposes of this sub15 section: 

16 ‘‘(A) COVERED ENTITY.—The term ‘covered 

17 entity’ has the meaning given such term for pur18 poses of HIPAA privacy regulation. 

19 ‘‘(B) HEALTH CARE OPERATIONS.—The 

20 term ‘health care operations’ has the meaning 

21 given such term for purposes of HIPAA privacy 

22 regulation. 

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

24 term ‘HIPAA privacy regulation’ has the meanVerDate Sep 11 2014 01:06 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H5795.RH H5795

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1 ing given such term under section 1180(b)(3) of 

2 the Social Security Act. 

3 ‘‘(D) INDIVIDUALLY IDENTIFIABLE HEALTH

4 INFORMATION.—The term ‘individually identifi5 able health information’ has the meaning given 

6 such term for purposes of HIPAA privacy regu7 lation. 

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

9 the meaning given such term for purposes of 

10 HIPAA privacy regulation. 

11 ‘‘(F) PUBLIC HEALTH AUTHORITY.—The 

12 term ‘public health authority’ has the meaning 

13 given such term for purposes of HIPAA privacy 

14 regulation. 

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

16 has the meaning given such term for purposes of 

17 HIPAA privacy regulation.’’. 

18 (e) USE OF RECORDS IN CRIMINAL, CIVIL, OR ADMIN19 ISTRATIVE INVESTIGATIONS, ACTIONS, OR PROCEEDINGS.— 

20 Subsection (c) of section 543 of the Public Health Service 

21 Act (42 U.S.C. 290dd–2) is amended to read as follows: 

22 ‘‘(c) USE OF RECORDS IN CRIMINAL, CIVIL, OR ADMIN23 ISTRATIVE CONTEXTS.—Except as otherwise authorized by 

24 a court order under subsection (b)(2)(C) or by the consent 


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1 of the patient, a record referred to in subsection (a) may 

2 not— 

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

4 prosecution or civil action before a Federal or State 

5 court; 

6 ‘‘(2) form part of the record for decision or other7 wise be taken into account in any proceeding before 

8 a Federal agency; 

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

10 agency for a law enforcement purpose or to conduct 

11 any law enforcement investigation of a patient; or 

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

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

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

15 to read as follows: 

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

17 1177 of the Social Security Act shall apply to a violation 

18 of this section to the extent and in the same manner as 

19 such provisions apply to a violation of part C of title XI 

20 of such Act. In applying the previous sentence— 

21 ‘‘(1) the reference to ‘this subsection’ in sub22 section (a)(2) of such section 1176 shall be treated as 

23 a reference to ‘this subsection (including as applied 

24 pursuant to section 543(f) of the Public Health Serv25 ice Act)’; and 


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

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

3 under subsection (a)’ shall be treated as a ref4 erence to ‘a penalty imposed under subsection 

5 (a) (including as applied pursuant to section 

6 543(f) of the Public Health Service Act)’; and 

7 ‘‘(B) each reference to ‘no damages obtained 

8 under subsection (d)’ shall be treated as a ref9 erence to ‘no damages obtained under subsection 

10 (d) (including as applied pursuant to section 

11 543(f) of the Public Health Service 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 discriminate 

17 against an individual on the basis of information re18 ceived by such entity pursuant to a disclosure made 

19 under subsection (b) in— 

20 ‘‘(A) admission or treatment for health care; 

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

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

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

24 courts. 


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

3 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 pro6 vided with such funds.’’. 

7 (h) NOTIFICATION IN CASE OF BREACH.—Section 543 

8 of the Public Health Service Act (42 U.S.C. 290dd–2), as 

9 amended by subsection (g), is further amended by adding 

10 at the end the following: 

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

12 ‘‘(1) APPLICATION OF HITECH NOTIFICATION OF

13 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 in 

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

18 manner as such provisions apply to a covered entity 

19 in the case of a breach of unsecured protected health 

20 information. 

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

22 ‘covered entity’ and ‘unsecured protected health infor23 mation’ have the meanings given to such terms for 

24 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 program 

3 or activity with respect to which the confidentiality require4 ments of section 543 of the Public Health Service Act (42 

5 U.S.C. 290dd–2) apply should access the applicable State6 based prescription drug monitoring program as a pre7 caution 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 regula12 tions as may be necessary for implementing and en13 forcing the amendments made by this section, such 

14 that such amendments shall apply with respect to 

15 uses and disclosures of information occurring on or 

16 after the date that is 12 months after the date of en17 actment 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 Health 

21 and Human Services, in consultation with appro22 priate experts, shall update section 164.520 of title 

23 45, Code of Federal Regulations, so that covered enti24 ties provide notice, written in plain language, of pri25 vacy practices regarding patient records referred to in 


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1 section 543(a) of the Public Health Service Act (42 

2 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 description 

6 of how the individual may exercise these rights 

7 (as required by paragraph (b)(1)(iv) of such sec8 tion 164.520); and 

9 (B) a description of each purpose for which 

10 the covered entity is permitted or required to use 

11 or disclose protected health information without 

12 the patient’s written authorization (as required 

13 by paragraph (b)(2) of such section 164.520). 

14 (k) DEVELOPMENT AND DISSEMINATION OF MODEL

15 TRAINING PROGRAMS FOR SUBSTANCE USE DISORDER PA16 TIENT RECORDS.— 

17 (1) INITIAL PROGRAMS AND MATERIALS.—Not 

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

19 this Act, the Secretary of Health and Human Services 

20 (referred to in this subsection as the ‘‘Secretary’’), in 

21 consultation with appropriate experts, shall identify 

22 the following model programs and materials (or if no 

23 such programs or materials exist, recognize private or 

24 public entities to develop and disseminate such pro25 grams and materials): 


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1 (A) Model programs and materials for 

2 training health care providers (including physi3 cians, emergency medical personnel, psychia4 trists, psychologists, counselors, therapists, nurse 

5 practitioners, physician assistants, behavioral 

6 health facilities and clinics, care managers, and 

7 hospitals, including individuals such as general 

8 counsels or regulatory compliance staff who are 

9 responsible for establishing provider privacy 

10 policies) concerning the permitted uses and dis11 closures, consistent with the standards and regu12 lations governing the privacy and security of 

13 substance use disorder patient records promul14 gated by the Secretary under section 543 of the 

15 Public Health Service Act (42 U.S.C. 290dd–2), 

16 as amended by this section, for the confiden17 tiality of patient records. 

18 (B) Model programs and materials for 

19 training patients and their families regarding 

20 their rights to protect and obtain information 

21 under the standards and regulations described in 

22 subparagraph (A). 

23 (2) REQUIREMENTS.—The model programs and 

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

25 paragraph (1) shall address circumstances under 


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1 which disclosure of substance use disorder patient 

2 records is needed to— 

3 (A) facilitate communication between sub4 stance use disorder treatment providers and 

5 other health care providers to promote and pro6 vide the best possible integrated care; 

7 (B) avoid inappropriate prescribing that 

8 can lead to dangerous drug interactions, over9 dose, or relapse; and 

10 (C) notify and involve families and care11 givers when individuals experience an overdose. 

12 (3) PERIODIC UPDATES.—The Secretary shall— 

13 (A) periodically review and update the 

14 model programs and materials identified or de15 veloped under paragraph (1); and 

16 (B) disseminate such updated programs and 

17 materials to the individuals described in para18 graph (1)(A). 

19 (4) INPUT OF CERTAIN ENTITIES.—In identi20 fying, reviewing, or updating the model programs 

21 and materials under this subsection, the Secretary 

22 shall solicit the input of relevant stakeholders. 

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

24 the amendments made by this Act shall be construed to 

25 limit— 


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

2 164.522 of title 45, Code of Federal Regulations, or 

3 any successor regulation, to request a restriction on 

4 the use or disclosure of a record referred to in section 

5 543(a) of the Public Health Service Act (42 U.S.C. 

6 290dd–2(a)) for purposes of treatment, payment, or 

7 health care operations; or 

8 (2) a covered entity’s choice, as described in sec9 tion 164.506 of title 45, Code of Federal Regulations, 

10 or any successor regulation, to obtain the consent of 

11 the individual to use or disclose a record referred to 

12 in such section 543(a) to carry out treatment, pay13 ment, or health care operation. 

14 (m) SENSE OF CONGRESS.—It is the sense of the Con15 gress that— 

16 (1) patients have the right to request a restric17 tion on the use or disclosure of a record referred to 

18 in section 543(a) of the Public Health Service Act (42 

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

20 care operations; and 

21 (2) covered entities should make every reasonable 

22 effort to the extent feasible to comply with a patient’s 

23 request for a restriction regarding such use or disclo24 sure. 


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Union Calendar No. 559 

115TH CONGRESS 

2D SESSION H. R. 5795 

[Report No. 115–724] 

A BILL 

To amend the Public Health Service Act to protect 

tient records. the confidentiality of substance use disorder paJUNE 12, 2018 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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