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. Short title This Act may be cited as the Overdose Prevention and Patient Safety Act . 2. Confidentiality and disclosure of records relating to substance use disorder (a) Conforming changes relating to substance use disorder Subsections (a) and (h) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) are each amended by striking substance abuse and inserting substance use disorder . (b) Disclosures to covered entities consistent with HIPAA Paragraph (2) of section 543(b) of the Public Health Service Act ( 42 U.S.C. 290dd–2(b) ) is amended by adding at the end the following: (D) To a covered entity or to a program or activity described in subsection (a), for the purposes of treatment, payment, and health care operations, so long as such disclosure is made in accordance with HIPAA privacy regulation. Any redisclosure of information so disclosed may only be made in accordance with this section. . (c) Disclosures of de-identified health information to public health authorities Paragraph (2) of section 543(b) of the Public Health Service Act ( 42 U.S.C. 290dd–2(b) ), as amended by subsection (b), is further amended by adding at the end the following: (E) To a public health authority, so long as such content meets the standards established in section 164.514(b) of title 45, Code of Federal Regulations (or successor regulations) for creating de-identified information. . (d) Definitions Subsection (b) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended by adding at the end the following: (3) Definitions For purposes of this subsection: (A) Covered entity The term covered entity has the meaning given such term for purposes of HIPAA privacy regulation. (B) Health care operations The term health care operations has the meaning given such term for purposes of HIPAA privacy regulation. (C) HIPAA privacy regulation The term HIPAA privacy regulation has the meaning given such term under section 1180(b)(3) of the Social Security Act. (D) Individually identifiable health information The term individually identifiable health information has the meaning given such term for purposes of HIPAA privacy regulation. (E) Payment The term payment has the meaning given such term for purposes of HIPAA privacy regulation. (F) Public health authority The term public health authority has the meaning given such term for purposes of HIPAA privacy regulation. (G) Treatment The term treatment has the meaning given such term for purposes of HIPAA privacy regulation. . (e) Use of records in criminal, civil, or administrative investigations, actions, or proceedings Subsection (c) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended to read as follows: (c) Use of records in criminal, civil, or administrative contexts Except as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a) may not— (1) be entered into evidence in any criminal prosecution or civil action before a Federal or State court; (2) form part of the record for decision or otherwise be taken into account in any proceeding before a Federal agency; (3) be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation of a patient; or (4) be used in any application for a warrant. . (f) Penalties Subsection (f) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended to read as follows: (f) Penalties The provisions of sections 1176 and 1177 of the Social Security Act shall apply to a violation of this section to the extent and in the same manner as such provisions apply to a violation of part C of title XI of such Act. In applying the previous sentence— (1) the reference to this subsection in subsection (a)(2) of such section 1176 shall be treated as a reference to this subsection (including as applied pursuant to section 543(f) of the Public Health Service Act) ; and (2) in subsection (b) of such section 1176— (A) each reference to a penalty imposed under subsection (a) shall be treated as a reference to a penalty imposed under subsection (a) (including as applied pursuant to section 543(f) of the Public Health Service Act) ; and (B) each reference to no damages obtained under subsection (d) shall be treated as a reference to no damages obtained under subsection (d) (including as applied pursuant to section 543(f) of the Public Health Service Act) . . (g) Antidiscrimination Section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended by adding at the end the following: (i) Antidiscrimination (1) In general No entity shall discriminate against an individual on the basis of information received by such entity pursuant to a disclosure made under subsection (b) in— (A) admission or treatment for health care; (B) hiring or terms of employment; (C) the sale or rental of housing; or (D) access to Federal, State, or local courts. (2) Recipients of Federal funds No recipient of Federal funds shall discriminate against an individual on the basis of information received by such recipient pursuant to a disclosure made under subsection (b) in affording access to the services provided with such funds. . (h) Notification in case of breach Section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ), as amended by subsection (g), is further amended by adding at the end the following: (j) Notification in case of breach (1) Application of HITECH notification of breach provisions The provisions of section 13402 of the HITECH Act ( 42 U.S.C. 17932 ) shall apply to a program or activity described in subsection (a), in case of a breach of records described in subsection (a), to the same extent and in the same manner as such provisions apply to a covered entity in the case of a breach of unsecured protected health information. (2) Definitions In this subsection, the terms covered entity and unsecured protected health information have the meanings given to such terms for purposes of such section 13402. . (i) Sense of Congress It is the sense of the Congress that any person treating a patient through a program or activity with respect to which the confidentiality requirements of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) apply should access the applicable State-based prescription drug monitoring program as a precaution against substance use disorder. (j) Regulations (1) In general The Secretary of Health and Human Services, in consultation with appropriate Federal agencies, shall make such revisions to regulations as may be necessary for implementing and enforcing the amendments made by this section, such that such amendments shall apply with respect to uses and disclosures of information occurring on or after the date that is 12 months after the date of enactment of this Act. (2) Easily understandable notice of privacy practices Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts, shall update section 164.520 of title 45, Code of Federal Regulations, so that covered entities provide notice, written in plain language, of privacy practices regarding patient records referred to in section 543(a) of the Public Health Service Act ( 42 U.S.C. 290dd–2(a) ), including— (A) a statement of the patient’s rights, including self-pay patients, with respect to protected health information and a brief description of how the individual may exercise these rights (as required by paragraph (b)(1)(iv) of such section 164.520); and (B) a description of each purpose for which the covered entity is permitted or required to use or disclose protected health information without the patient’s written authorization (as required by paragraph (b)(2) of such section 164.520). (k) Development and dissemination of model training programs for substance use disorder patient records (1) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary ), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (A) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ), as amended by this section, for the confidentiality of patient records. (B) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in subparagraph (A). (2) Requirements The model programs and materials described in subparagraphs (A) and (B) of paragraph (1) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (A) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (B) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (C) notify and involve families and caregivers when individuals experience an overdose. (3) Periodic updates The Secretary shall— (A) periodically review and update the model programs and materials identified or developed under paragraph (1); and (B) disseminate such updated programs and materials to the individuals described in paragraph (1)(A). (4) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this subsection, the Secretary shall solicit the input of relevant stakeholders. (l) Rules of construction Nothing in this Act or the amendments made by this Act shall be construed to limit— (1) a patient’s right, as described in section 164.522 of title 45, Code of Federal Regulations, or any successor regulation, to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act ( 42 U.S.C. 290dd–2(a) ) for purposes of treatment, payment, or health care operations; or (2) a covered entity’s choice, as described in section 164.506 of title 45, Code of Federal Regulations, or any successor regulation, to obtain the consent of the individual to use or disclose a record referred to in such section 543(a) to carry out treatment, payment, or health care operation. (m) Sense of Congress It is the sense of the Congress that— (1) patients have the right to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act ( 42 U.S.C. 290dd–2(a) ) for treatment, payment, or health care operations; and (2) covered entities should make every reasonable effort to the extent feasible to comply with a patient’s request for a restriction regarding such use or disclosure.

Passed the House of Representatives June 20, 2018. Karen L. Haas, Clerk.