II 118THCONGRESS 1 STSESSION S. 323 To ensure the privacy of pregnancy termination or loss information under the HIPAA privacy regulations and the HITECH Act. IN THE SENATE OF THE UNITED STATES FEBRUARY9, 2023 Ms. H IRONO(for herself, Mr. BENNET, Mrs. GILLIBRAND, Ms. WARREN, Mr. W YDEN, Mr. BROWN, Mrs. FEINSTEIN, Ms. CORTEZMASTO, Ms. D UCKWORTH, Mrs. MURRAY, and Mr. BOOKER) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To ensure the privacy of pregnancy termination or loss infor- mation under the HIPAA privacy regulations and the HITECH Act. 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 ‘‘Secure Access for Es-4 sential Reproductive Health Act of 2023’’ or the ‘‘SAFER 5 Health Act of 2023’’. 6 VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 323 IS SEC. 2. ENSURING THE PRIVACY OF PREGNANCY TERMI-1 NATION OR LOSS INFORMATION UNDER THE 2 HIPAA PRIVACY REGULATIONS AND THE 3 HITECH ACT. 4 (a) I NGENERAL.— 5 (1) P ROHIBITION ON DISCLOSURE .—Subject to 6 paragraph (2) and notwithstanding any regulations 7 promulgated pursuant to section 264(c) of the 8 Health Insurance Portability and Accountability Act 9 of 1996 (42 U.S.C. 1320d–2 note; Public Law 104– 10 191), a covered entity or a business associate of a 11 covered entity may not disclose pregnancy termi-12 nation or loss information of an individual in Fed-13 eral, State, local, or Tribal proceedings, including 14 civil, criminal, administrative, legislative, or other 15 proceedings, without the valid authorization of the 16 individual made in accordance with section 164.508 17 of title 45, Code of Federal Regulations (or a suc-18 cessor regulation). 19 (2) E XCEPTIONS.—Paragraph (1) shall not 20 apply in the case of a disclosure of pregnancy termi-21 nation or loss information of an individual by a cov-22 ered entity or a business associate of a covered enti-23 ty if— 24 (A) the pregnancy termination or loss in-25 formation is necessary for use in defense of a 26 VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 323 IS professional liability action or proceeding 1 against the covered entity or business associate 2 and the pregnancy termination or loss informa-3 tion is disclosed by— 4 (i) the covered entity or business asso-5 ciate to the covered entity’s or business as-6 sociate’s attorney or professional liability 7 insurer or insurer’s agent; or 8 (ii) the authorized attorney of the cov-9 ered entity or business associate to a court 10 or body hearing the action or proceeding; 11 or 12 (B)(i) the pregnancy termination or loss 13 information is necessary to investigate physical 14 harm to the individual by another person di-15 rectly relating to the loss or termination of the 16 pregnancy; and 17 (ii) the individual is unable to provide con-18 sent due to death or incapacity. 19 (b) HITECH.— 20 (1) P RIVACY EXCEPTION.—The Secretary shall 21 revise section 171.202 of title 45, Code of Federal 22 Regulations, to clarify that an entity’s practice of 23 not fulfilling a request to access, exchange, or use 24 electronic health information in order to comply with 25 VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 323 IS subsection (a) shall not be considered information 1 blocking (as defined in section 171.103 of title 45, 2 Code of Federal Regulations (or a successor regula-3 tion)) if the information is pregnancy termination or 4 loss information. 5 (2) G REATER SECURITY.—The Secretary shall 6 revise section 170.401 of title 45, Code of Federal 7 Regulations, to require that as a condition of certifi-8 cation (as described in that section), a health IT de-9 veloper (as so described) shall implement practices 10 that allow for the segregation of data relating to 11 pregnancy termination or loss information to ensure 12 compliance with subsection (a). 13 (c) P REEMPTION; MODIFICATION OF STATEPRE-14 EMPTIONEXCEPTIONS.— 15 (1) P REEMPTION.— 16 (A) I N GENERAL.—This section shall pre-17 empt any State law to the extent that the State 18 law conflicts with or prevents application of this 19 section. 20 (B) E FFECT.—Nothing in subparagraph 21 (A) shall be construed to preempt a State law 22 to the extent that the State law provides great-23 er privacy protections for pregnancy termi-24 VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 323 IS nation or loss information than provided under 1 this section. 2 (2) M ODIFICATION.—The Secretary shall revise 3 section 160.203 of title 45, Code of Federal Regula-4 tions, to ensure that no exception to the general pre-5 emption rule stated in that section applies with re-6 spect to pregnancy termination or loss information 7 other than the exception described in paragraph 8 (1)(B). 9 (d) O UTREACH.—The Secretary shall conduct an out-10 reach campaign to ensure that covered entities, business 11 associates of covered entities, the public, and affected indi-12 viduals are aware of the requirements of this section and 13 any revisions to regulations made pursuant to this section. 14 (e) P ROCEDURE.— 15 (1) I NTERIM FINAL RULE .—Not later than 90 16 days after the date of enactment of this Act, the 17 Secretary shall revise each regulation as required by 18 this section through publication of an interim final 19 rule in the Federal Register. 20 (2) F INAL RULE.—Not later than 270 days 21 after the date on which an interim final rule is pub-22 lished under paragraph (1), the Secretary, after pro-23 viding opportunity for public comment, shall publish 24 VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 323 IS in the Federal Register a final rule with such modi-1 fications as the Secretary determines appropriate. 2 (f) D EFINITIONS.—In this section: 3 (1) HIPAA TERMS.—The terms ‘‘business asso-4 ciate’’, ‘‘covered entity’’, and ‘‘protected health infor-5 mation’’ have the meanings given those terms in sec-6 tion 160.103 of title 45, Code of Federal Regula-7 tions (or a successor regulation). 8 (2) P REGNANCY TERMINATION OR LOSS INFOR -9 MATION.—The term ‘‘pregnancy termination or loss 10 information’’ means protected health information of 11 an individual that relates to information that could 12 reveal having or seeking an abortion or care for 13 pregnancy loss, including, without limitation, any re-14 quest for, or receipt of, items, services, education, 15 counseling, or referrals relating to the termination 16 or loss of a pregnancy of the individual, including 17 abortion, miscarriage, stillbirth, and ectopic preg-18 nancy. 19 (3) S ECRETARY.—The term ‘‘Secretary’’ means 20 the Secretary of Health and Human Services. 21 Æ VerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S323.IS S323 pbinns on DSKJLVW7X2PROD with $$_JOB