Genetic Information Privacy Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 2155 To provide for certain requirements with respect to the treatment of personally identifiable information by genetic testing services. IN THE HOUSE OF REPRESENTATIVES APRIL 9, 2019 Mr. RUSH introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To provide for certain requirements with respect to the treat- ment of personally identifiable information by genetic testing services. 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 ‘‘Genetic Information 4 Privacy Act of 2019’’. 5 SEC. 2. TREATMENT OF PERSONALLY IDENTIFIABLE IN- 6 FORMATION BY GENETIC TESTING SERVICES. 7 (a) CONSENT REQUIRED.— 8 (1) EXPRESS CONSENT FOR DISCLOSURE.— 9 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 2 •HR 2155 IH (A) IN GENERAL.—A genetic testing serv- 1 ice may not disclose personally identifiable in- 2 formation of a customer to a third party unless 3 the service obtains the express consent of the 4 customer. 5 (B) RELATIONSHIP TO INFORMED CON- 6 SENT REQUIREMENT.—In the case of the disclo- 7 sure of genetic information for medical re- 8 search, paragraph (2) applies instead of sub- 9 paragraph (A). 10 (2) INFORMED CONSENT FOR USE OR DISCLO- 11 SURE OF GENETIC INFORMATION FOR MEDICAL RE- 12 SEARCH.—A genetic testing service may not use ge- 13 netic information of a customer for medical research, 14 or disclose such information to a third party for 15 medical research, unless the service— 16 (A) obtains the informed consent of the 17 customer in accordance with section 46.116 of 18 title 45, Code of Federal Regulations, as in ef- 19 fect on the date of the enactment of this Act; 20 and 21 (B) documents the consent of the customer 22 in accordance with section 46.117 of title 45, 23 Code of Federal Regulations, as in effect on the 24 date of the enactment of this Act. 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 3 •HR 2155 IH (3) OPTION REGARDING GENETIC INFORMA- 1 TION.—In seeking the consent of a customer under 2 paragraph (1) or (2) for the disclosure of personally 3 identifiable information, a genetic testing service 4 shall give the customer the option of providing con- 5 sent for the disclosure of the genetic information of 6 the customer while withholding consent for the dis- 7 closure of any other personally identifiable informa- 8 tion of the customer. 9 (4) PROHIBITION ON CONDITIONING SERVICE 10 ON CONSENT.—A genetic testing service may not 11 condition the provision of service to a customer on 12 obtaining the consent of the customer required by 13 paragraph (1) or (2), except to the extent that dis- 14 closure of personally identifiable information is nec- 15 essary to provide the service. 16 (b) NOTIFICATION.— 17 (1) NEW CUSTOMERS.—In the case of an agree- 18 ment for service entered into between a genetic test- 19 ing service and a customer on or after the effective 20 date described in section 6, the genetic testing serv- 21 ice shall notify the customer of the rights of the cus- 22 tomer under subsection (a)— 23 (A) at the time when the agreement is en- 24 tered into; 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 4 •HR 2155 IH (B) using the same method of communica- 1 tion by which the agreement is entered into; 2 and 3 (C) in a manner that is— 4 (i) clear and conspicuous; and 5 (ii) separate from any privacy policy, 6 data use policy, or other similar document. 7 (2) EXISTING CUSTOMERS.— 8 (A) IN GENERAL.—In the case of an agree- 9 ment for service entered into between a genetic 10 testing service and a customer before the effec- 11 tive date described in section 6, the genetic 12 testing service shall notify the customer of the 13 rights of the customer under subsection (a)— 14 (i) not later than the date that is 1 15 year after such effective date; 16 (ii) using the primary method of com- 17 munication of the genetic testing service 18 with the customer; and 19 (iii) in a manner that is— 20 (I) clear and conspicuous; and 21 (II) separate from any privacy 22 policy, data use policy, or other simi- 23 lar document. 24 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 5 •HR 2155 IH (B) INABILITY TO CONTACT.—A genetic 1 testing service may not be considered to be in 2 violation of subparagraph (A) by reason of 3 being unable to contact a customer, if the serv- 4 ice sends the notification required by such sub- 5 paragraph— 6 (i) if the primary method of commu- 7 nication of the service with the customer is 8 in writing, to the last known home mailing 9 address of the customer in the records of 10 the service; and 11 (ii) if the primary method of commu- 12 nication of the service with the customer is 13 email or other electronic means, to the last 14 known email address, or using the last 15 known other electronic contact informa- 16 tion, as the case may be, of the customer 17 in the records of the service. 18 (3) WEBSITE NOTIFICATION.—In addition to 19 the notifications required by paragraphs (1) and (2), 20 a genetic testing service shall provide clear and con- 21 spicuous notification of the rights of customers 22 under subsection (a) on the internet website of the 23 service (if the service maintains such a website). 24 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 6 •HR 2155 IH Such notification shall be separate from any privacy 1 policy, data use policy, or other similar document. 2 (4) CONTENTS.—The Commission shall include 3 in the regulations promulgated under subsection (d) 4 requirements for the contents of the notifications re- 5 quired by this subsection. 6 (c) INFORMATION SECURITY REQUIREMENTS.—The 7 Commission shall promulgate regulations that require a 8 genetic testing service to implement policies and proce- 9 dures to secure the personally identifiable information of 10 customers of the service against unauthorized access. 11 (d) REGULATIONS.— 12 (1) IN GENERAL.—Not later than 1 year after 13 the date of the enactment of this Act, the Commis- 14 sion shall promulgate, under section 553 of title 5, 15 United States Code— 16 (A) regulations to implement subsections 17 (a) and (b); and 18 (B) the regulations required by subsection 19 (c). 20 (2) CONSIDERATIONS.—In promulgating regu- 21 lations under paragraph (1), the Commission shall 22 take into consideration— 23 (A) the size of, and the nature, scope, and 24 complexity of the activities engaged in by, dif- 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 7 •HR 2155 IH ferent types or categories of genetic testing 1 services; 2 (B) the cost of implementing the require- 3 ments of subsections (a) and (b) and such regu- 4 lations; and 5 (C) in the case of the regulations required 6 by subsection (c), the current state of the art 7 in administrative, technical, and physical safe- 8 guards to secure information against unauthor- 9 ized access. 10 SEC. 3. ENFORCEMENT. 11 (a) ENFORCEMENT BY FEDERAL TRADE COMMIS- 12 SION.— 13 (1) UNFAIR OR DECEPTIVE ACTS OR PRAC- 14 TICES.—A violation of section 2 or a regulation pro- 15 mulgated under such section shall be treated as an 16 unfair or deceptive act or practice in violation of a 17 regulation under section 18(a)(1)(B) of the Federal 18 Trade Commission Act (15 U.S.C. 57a(a)(1)(B)) re- 19 garding unfair or deceptive acts or practices. 20 (2) POWERS OF COMMISSION.—The Commis- 21 sion shall enforce section 2 and the regulations pro- 22 mulgated under such section in the same manner, by 23 the same means, and with the same jurisdiction, 24 powers, and duties as though all applicable terms 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 8 •HR 2155 IH and provisions of the Federal Trade Commission Act 1 (15 U.S.C. 41 et seq.) were incorporated into and 2 made a part of this Act. Any person who violates 3 such section or such a regulation shall be subject to 4 the penalties and entitled to the privileges and im- 5 munities provided in the Federal Trade Commission 6 Act. 7 (b) ENFORCEMENT BY STATE ATTORNEYS GEN- 8 ERAL.— 9 (1) CIVIL ACTION.—In any case in which the 10 attorney general of a State, or an official or agency 11 of a State, has reason to believe that an interest of 12 the residents of that State has been or is threatened 13 or adversely affected by any person who violates sec- 14 tion 2 or a regulation promulgated under such sec- 15 tion, the attorney general, official, or agency of the 16 State, as parens patriae, may bring a civil action on 17 behalf of the residents of the State in a district 18 court of the United States of appropriate jurisdic- 19 tion— 20 (A) to enjoin further violation of such sec- 21 tion or such regulation by the defendant; 22 (B) to compel compliance with such section 23 or such regulation; or 24 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 9 •HR 2155 IH (C) to obtain civil penalties in the same 1 amount as the civil penalties that may be ob- 2 tained by the Commission under section 5(m) of 3 the Federal Trade Commission Act (15 U.S.C. 4 45(m)). 5 (2) INTERVENTION BY FTC.— 6 (A) NOTICE AND INTERVENTION.—The 7 State shall provide prior written notice of any 8 action under paragraph (1) to the Commission 9 and provide the Commission with a copy of its 10 complaint, except in any case in which such 11 prior notice is not feasible, in which case the 12 State shall serve such notice immediately upon 13 instituting such action. The Commission shall 14 have the right— 15 (i) to intervene in the action; 16 (ii) upon so intervening, to be heard 17 on all matters arising therein; and 18 (iii) to file petitions for appeal. 19 (B) LIMITATION ON STATE ACTION WHILE 20 FEDERAL ACTION IS PENDING.—If the Commis- 21 sion has instituted a civil action for violation of 22 section 2 or a regulation promulgated under 23 such section, no State attorney general, or offi- 24 cial or agency of a State, may bring an action 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 10 •HR 2155 IH under paragraph (1) during the pendency of the 1 action of the Commission against any defendant 2 named in the complaint of the Commission for 3 any violation of such section or such regulation 4 alleged in the complaint. 5 (3) RULE OF CONSTRUCTION.—For purposes of 6 bringing any civil action under paragraph (1), noth- 7 ing in this Act or the regulations promulgated under 8 this Act shall be construed to prevent an attorney 9 general of a State from exercising the powers con- 10 ferred on the attorney general by the laws of that 11 State to— 12 (A) conduct investigations; 13 (B) administer oaths or affirmations; or 14 (C) compel the attendance of witnesses or 15 the production of documentary and other evi- 16 dence. 17 SEC. 4. EFFECT ON OTHER LAWS. 18 (a) PREEMPTION OF CERTAIN STATE LAWS RELAT- 19 ING TO GENETIC TESTING.—This Act and the regulations 20 promulgated under this Act supersede any provision of a 21 statute, regulation, or rule of a State or political subdivi- 22 sion of a State, with respect to an entity to the extent 23 this Act and the regulations promulgated under this Act 24 apply to such entity, that expressly provides for require- 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 11 •HR 2155 IH ments relating to treatment of personal information by 1 services providing genetic testing that are similar to any 2 requirements contained in section 2 or a regulation pro- 3 mulgated under such section. 4 (b) PRESERVATION OF CERTAIN STATE LAWS.—This 5 Act and the regulations promulgated under this Act may 6 not be construed to preempt the applicability of— 7 (1) State trespass, contract, or tort law; or 8 (2) other State laws to the extent that those 9 laws relate to acts of fraud. 10 (c) ADDITIONAL PREEMPTION.— 11 (1) IN GENERAL.—No person other than the at- 12 torney general of a State, or another official or 13 agency of a State, may bring a civil action under the 14 laws of any State if such action is premised in whole 15 or in part upon the defendant violating any provision 16 of this Act or a regulation promulgated under this 17 Act. 18 (2) PRESERVATION OF CONSUMER PROTECTION 19 LAWS.—This subsection may not be construed to 20 limit the enforcement of any State consumer protec- 21 tion law by an attorney general of a State, or an- 22 other official or agency of a State. 23 (d) PRESERVATION OF FTC AUTHORITY.—Nothing 24 in this Act may be construed in any way to limit the au- 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 12 •HR 2155 IH thority of the Commission under any other provision of 1 law. 2 SEC. 5. DEFINITIONS. 3 In this Act: 4 (1) COMMISSION.—The term ‘‘Commission’’ 5 means the Federal Trade Commission. 6 (2) GENETIC INFORMATION.—The term ‘‘ge- 7 netic information’’— 8 (A) has the meaning given such term in 9 section 201 of the Genetic Information Non- 10 discrimination Act of 2008 (42 U.S.C. 2000ff); 11 and 12 (B) includes a physical sample, such as 13 fluid or tissue, obtained from a customer for 14 purposes of performing a genetic test. 15 (3) GENETIC TEST.—The term ‘‘genetic test’’ 16 has the meaning given such term in section 201 of 17 the Genetic Information Nondiscrimination Act of 18 2008 (42 U.S.C. 2000ff). 19 (4) GENETIC TESTING SERVICE.—The term 20 ‘‘genetic testing service’’ means any entity that— 21 (A) offers genetic tests directly to con- 22 sumers; or 23 (B) analyzes genetic information obtained 24 from a genetic test offered directly to con- 25 VerDate Sep 11 2014 04:19 Apr 17, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2155.IH H2155 kjohnson on DSK79L0C42 with BILLS 13 •HR 2155 IH sumers, except to the extent that the analysis is 1 perform [Text truncated for display. 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