| 1 | 1 | | II |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 863 |
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| 5 | 5 | | To provide consumers with the right to delete their genomic data, and for |
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| 6 | 6 | | other purposes. |
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| 7 | 7 | | IN THE SENATE OF THE UNITED STATES |
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| 8 | 8 | | MARCH5, 2025 |
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| 9 | 9 | | Mr. C |
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| 10 | 10 | | ASSIDY(for himself and Mr. PETERS) introduced the following bill; |
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| 11 | 11 | | which was read twice and referred to the Committee on Commerce, |
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| 12 | 12 | | Science, and Transportation |
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| 13 | 13 | | A BILL |
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| 14 | 14 | | To provide consumers with the right to delete their genomic |
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| 15 | 15 | | data, and for other purposes. |
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| 16 | 16 | | Be it enacted by the Senate and House of Representa-1 |
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| 17 | 17 | | tives of the United States of America in Congress assembled, 2 |
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| 18 | 18 | | SECTION 1. SHORT TITLE. 3 |
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| 19 | 19 | | This Act may be cited as the ‘‘Genomic Data Protec-4 |
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| 20 | 20 | | tion Act’’. 5 |
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| 21 | 21 | | SEC. 2. CONSUMER RIGHTS REGARDING PRIVACY OF 6 |
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| 22 | 22 | | GENOMIC DATA. 7 |
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| 23 | 23 | | (a) R |
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| 24 | 24 | | EQUIREMENTS.— 8 |
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| 25 | 25 | | (1) C |
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| 26 | 26 | | ONSUMER CONTROLS .— 9 |
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| 28 | 28 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 29 | 29 | | •S 863 IS |
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| 30 | 30 | | (A) IN GENERAL.—A direct-to-consumer 1 |
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| 31 | 31 | | genomic testing company shall provide a simple 2 |
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| 32 | 32 | | and effective mechanism to allow a consumer 3 |
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| 33 | 33 | | to— 4 |
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| 34 | 34 | | (i) access the genomic data of the con-5 |
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| 35 | 35 | | sumer; and 6 |
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| 36 | 36 | | (ii) subject to paragraph (4)— 7 |
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| 37 | 37 | | (I) delete the account of the con-8 |
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| 38 | 38 | | sumer, including any genomic data as-9 |
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| 39 | 39 | | sociated with such account; and 10 |
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| 40 | 40 | | (II) request the destruction of 11 |
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| 41 | 41 | | any biological sample of the consumer. 12 |
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| 42 | 42 | | (B) R |
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| 43 | 43 | | EQUIRED MECHANISM .—The direct- 13 |
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| 44 | 44 | | to-consumer genomic testing company shall 14 |
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| 45 | 45 | | make available to a consumer the mechanism 15 |
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| 46 | 46 | | described in subparagraph (A) through the pri-16 |
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| 47 | 47 | | mary means by which the company commu-17 |
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| 48 | 48 | | nicates with the consumer. 18 |
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| 49 | 49 | | (2) N |
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| 50 | 50 | | OTIFICATION.— 19 |
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| 51 | 51 | | (A) C |
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| 52 | 52 | | ONSUMER CONTROLS AND USE OF 20 |
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| 53 | 53 | | DEIDENTIFIED GENOMIC DATA .—A direct-to- 21 |
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| 54 | 54 | | consumer genomic testing company shall make 22 |
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| 55 | 55 | | available, in a clear and conspicuous, not mis-23 |
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| 56 | 56 | | leading, and easy-to-read manner a notice 24 |
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| 57 | 57 | | that— 25 |
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| 59 | 59 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
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| 60 | 60 | | •S 863 IS |
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| 61 | 61 | | (i) provides a detailed and accurate 1 |
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| 62 | 62 | | representation of the rights set forth in 2 |
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| 63 | 63 | | clauses (i) and (ii) of paragraph (1)(A); 3 |
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| 64 | 64 | | and 4 |
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| 65 | 65 | | (ii) discloses that the deidentified 5 |
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| 66 | 66 | | genomic data of a consumer may be shared 6 |
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| 67 | 67 | | or disclosed to conduct medical or scientific 7 |
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| 68 | 68 | | research, consistent with the privacy regu-8 |
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| 69 | 69 | | lations promulgated under section 264(c) 9 |
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| 70 | 70 | | of the Health Insurance Portability and 10 |
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| 71 | 71 | | Accountability Act of 1996 (42 U.S.C. 11 |
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| 72 | 72 | | 1320d–2 note). 12 |
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| 73 | 73 | | (B) P |
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| 74 | 74 | | URCHASE OF COMPANY .—In the 13 |
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| 75 | 75 | | event that a direct-to-consumer genomic testing 14 |
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| 76 | 76 | | company is purchased or otherwise acquired by 15 |
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| 77 | 77 | | another entity, the direct-to-consumer genomic 16 |
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| 78 | 78 | | testing company shall send to each consumer, 17 |
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| 79 | 79 | | not fewer than 30 days prior to the date on 18 |
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| 80 | 80 | | which the purchase or acquisition is complete, a 19 |
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| 81 | 81 | | notice that includes— 20 |
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| 82 | 82 | | (i) the identity of the entity pur-21 |
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| 83 | 83 | | chasing or otherwise acquiring the com-22 |
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| 84 | 84 | | pany; and 23 |
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| 85 | 85 | | (ii) a detailed and accurate represen-24 |
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| 86 | 86 | | tation of the how a consumer can exercise 25 |
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| 88 | 88 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
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| 89 | 89 | | •S 863 IS |
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| 90 | 90 | | the rights set forth in clauses (i) and (ii) 1 |
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| 91 | 91 | | of paragraph (1)(A) under the new owner-2 |
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| 92 | 92 | | ship. 3 |
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| 93 | 93 | | (3) P |
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| 94 | 94 | | ROCESSING OF DELETION OR DESTRUC -4 |
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| 95 | 95 | | TION REQUESTS.— 5 |
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| 96 | 96 | | (A) I |
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| 97 | 97 | | N GENERAL.—With respect to a con-6 |
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| 98 | 98 | | sumer’s request to delete the genomic data or 7 |
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| 99 | 99 | | to destroy the biological sample of the con-8 |
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| 100 | 100 | | sumer, a direct-to-consumer genomic testing 9 |
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| 101 | 101 | | company shall— 10 |
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| 102 | 102 | | (i) fulfill such request not later than 11 |
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| 103 | 103 | | 30 days after the date on which the con-12 |
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| 104 | 104 | | sumer makes such request; and 13 |
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| 105 | 105 | | (ii) notify the consumer of such dele-14 |
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| 106 | 106 | | tion or destruction not later than 30 days 15 |
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| 107 | 107 | | after the deletion or destruction. 16 |
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| 108 | 108 | | (B) O |
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| 109 | 109 | | UTSTANDING REQUESTS DURING 17 |
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| 110 | 110 | | PURCHASE OF COMPANY .—In the event that a 18 |
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| 111 | 111 | | direct-to-consumer genomic testing company is 19 |
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| 112 | 112 | | purchased or otherwise acquired by another en-20 |
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| 113 | 113 | | tity while a consumer’s request to delete the 21 |
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| 114 | 114 | | genomic data or to destroy the biological sample 22 |
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| 115 | 115 | | of the consumer is outstanding— 23 |
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| 116 | 116 | | (i) the entity that is purchasing or 24 |
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| 117 | 117 | | otherwise acquiring the company shall 25 |
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| 119 | 119 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 |
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| 120 | 120 | | •S 863 IS |
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| 121 | 121 | | comply with the requirements described in 1 |
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| 122 | 122 | | subparagraph (A); and 2 |
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| 123 | 123 | | (ii) the 30-day period to fulfill such 3 |
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| 124 | 124 | | request shall begin on the date on which 4 |
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| 125 | 125 | | the consumer makes such request to the 5 |
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| 126 | 126 | | direct-to-consumer genomic testing com-6 |
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| 127 | 127 | | pany. 7 |
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| 128 | 128 | | (4) E |
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| 129 | 129 | | XCEPTIONS.—A direct-to-consumer 8 |
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| 130 | 130 | | genomic testing company shall not permit a con-9 |
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| 131 | 131 | | sumer to exercise a right described in paragraph 10 |
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| 132 | 132 | | (1)(A)(ii) if the company determines that the exer-11 |
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| 133 | 133 | | cise of the right would require the deletion of infor-12 |
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| 134 | 134 | | mation— 13 |
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| 135 | 135 | | (A) subject to a warrant, lawfully executed 14 |
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| 136 | 136 | | subpoena, or other court order; or 15 |
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| 137 | 137 | | (B) the company is required to retain in 16 |
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| 138 | 138 | | order to comply with any other applicable legal 17 |
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| 139 | 139 | | or regulatory requirement. 18 |
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| 140 | 140 | | (b) E |
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| 141 | 141 | | NFORCEMENT.— 19 |
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| 142 | 142 | | (1) U |
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| 143 | 143 | | NFAIR OR DECEPTIVE ACTS OR PRAC -20 |
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| 144 | 144 | | TICES.—A violation of this section or a regulation 21 |
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| 145 | 145 | | promulgated thereunder shall be treated as a viola-22 |
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| 146 | 146 | | tion of a rule defining an unfair or deceptive act or 23 |
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| 147 | 147 | | practice under section 18(a)(1)(B) of the Federal 24 |
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| 148 | 148 | | Trade Commission Act (15 U.S.C. 57a(a)(1)(B)). 25 |
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| 151 | 151 | | •S 863 IS |
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| 152 | 152 | | (2) POWERS OF THE COMMISSION .— 1 |
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| 153 | 153 | | (A) I |
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| 154 | 154 | | N GENERAL.—The Commission shall 2 |
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| 155 | 155 | | enforce this section in the same manner, by the 3 |
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| 156 | 156 | | same means, and with the same jurisdiction, 4 |
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| 157 | 157 | | powers, and duties as though all applicable 5 |
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| 158 | 158 | | terms and provisions of the Federal Trade 6 |
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| 159 | 159 | | Commission Act (15 U.S.C. 41 et seq.) were in-7 |
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| 160 | 160 | | corporated into and made a part of this section. 8 |
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| 161 | 161 | | (B) P |
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| 162 | 162 | | RIVILEGES AND IMMUNITIES .—Any 9 |
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| 163 | 163 | | person who violates this section or a regulation 10 |
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| 164 | 164 | | promulgated thereunder shall be subject to the 11 |
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| 165 | 165 | | penalties and entitled to the privileges and im-12 |
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| 166 | 166 | | munities provided in the Federal Trade Com-13 |
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| 167 | 167 | | mission Act (15 U.S.C. 41 et seq.). 14 |
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| 168 | 168 | | (C) A |
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| 169 | 169 | | UTHORITY PRESERVED .—Nothing in 15 |
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| 170 | 170 | | this section shall be construed to limit the au-16 |
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| 171 | 171 | | thority of the Commission under any other pro-17 |
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| 172 | 172 | | vision of law. 18 |
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| 173 | 173 | | (D) R |
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| 174 | 174 | | ULEMAKING.—Not later than 1 year 19 |
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| 175 | 175 | | after the date of enactment of this section, the 20 |
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| 176 | 176 | | Commission may promulgate in accordance with 21 |
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| 177 | 177 | | section 553 of title 5, United States Code, such 22 |
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| 178 | 178 | | rules as may be necessary to carry out this sec-23 |
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| 179 | 179 | | tion. 24 |
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| 180 | 180 | | (c) D |
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| 181 | 181 | | EFINITIONS.—In this section: 25 |
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| 184 | 184 | | •S 863 IS |
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| 185 | 185 | | (1) BIOLOGICAL SAMPLE.—The term ‘‘biological 1 |
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| 186 | 186 | | sample’’ means any material part of the human, dis-2 |
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| 187 | 187 | | charge therefrom, or derivative thereof, such as tis-3 |
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| 188 | 188 | | sue, blood, urine, or saliva, known to contain 4 |
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| 189 | 189 | | deoxyribonucleic acid (DNA). 5 |
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| 190 | 190 | | (2) C |
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| 191 | 191 | | OMMISSION.—The term ‘‘Commission’’ 6 |
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| 192 | 192 | | means the Federal Trade Commission. 7 |
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| 193 | 193 | | (3) C |
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| 194 | 194 | | ONSUMER.—The term ‘‘consumer’’ means 8 |
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| 195 | 195 | | an individual who provides a biological sample to a 9 |
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| 196 | 196 | | direct-to-consumer genomic testing company. 10 |
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| 197 | 197 | | (4) D |
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| 198 | 198 | | EIDENTIFIED GENOMIC DATA .—The term 11 |
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| 199 | 199 | | ‘‘deidentified genomic data’’ means data that cannot 12 |
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| 200 | 200 | | be used to infer information about, or otherwise be 13 |
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| 201 | 201 | | linked to, a particular individual, provided that the 14 |
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| 202 | 202 | | business that possesses the information does all of 15 |
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| 203 | 203 | | the following: 16 |
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| 204 | 204 | | (A) Takes reasonable measures to ensure 17 |
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| 205 | 205 | | that the information cannot be associated with 18 |
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| 206 | 206 | | a particular individual. 19 |
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| 207 | 207 | | (B) Publicly commits to maintain and use 20 |
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| 208 | 208 | | the information only in deidentified form and 21 |
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| 209 | 209 | | not to attempt to reidentify the information, ex-22 |
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| 210 | 210 | | cept that the business may attempt to reiden-23 |
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| 211 | 211 | | tify the information solely for the purpose of 24 |
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| 212 | 212 | | determining whether its deidentification proc-25 |
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| 215 | 215 | | •S 863 IS |
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| 216 | 216 | | esses satisfy the requirements of this subpara-1 |
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| 217 | 217 | | graph, provided that the business does not use 2 |
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| 218 | 218 | | or disclose any information reidentified in this 3 |
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| 219 | 219 | | process and destroys the reidentified informa-4 |
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| 220 | 220 | | tion upon completion of that assessment. 5 |
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| 221 | 221 | | (C) Contractually obligates any recipients 6 |
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| 222 | 222 | | of the information to take reasonable measures 7 |
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| 223 | 223 | | to ensure that the information cannot be associ-8 |
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| 224 | 224 | | ated with a particular individual and to commit 9 |
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| 225 | 225 | | to maintaining and using the information only 10 |
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| 226 | 226 | | in deidentified form and not to reidentify the 11 |
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| 227 | 227 | | information. 12 |
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| 228 | 228 | | (5) D |
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| 229 | 229 | | IRECT-TO-CONSUMER GENOMIC TESTING 13 |
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| 230 | 230 | | COMPANY.— 14 |
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| 231 | 231 | | (A) I |
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| 232 | 232 | | N GENERAL.—The term ‘‘direct-to- 15 |
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| 233 | 233 | | consumer genomic testing company’’ means a 16 |
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| 234 | 234 | | person that does any of the following: 17 |
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| 235 | 235 | | (i) Manufactures or develops genomic 18 |
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| 236 | 236 | | testing products or services for sale di-19 |
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| 237 | 237 | | rectly to consumers. 20 |
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| 238 | 238 | | (ii) Analyzes or interprets genomic 21 |
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| 239 | 239 | | data obtained from a consumer. 22 |
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| 240 | 240 | | (iii) Collects, uses, maintains, or dis-23 |
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| 241 | 241 | | closes genomic data collected or derived 24 |
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| 244 | 244 | | •S 863 IS |
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| 245 | 245 | | from a direct-to-consumer genomic testing 1 |
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| 246 | 246 | | product or service. 2 |
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| 247 | 247 | | (iv) Purchases or acquires genomic 3 |
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| 248 | 248 | | data from a direct-to-consumer genomic 4 |
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| 249 | 249 | | testing company. 5 |
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| 250 | 250 | | (B) E |
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| 251 | 251 | | XCLUSION FOR HEALTH CARE PRO -6 |
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| 252 | 252 | | FESSIONALS.—The term ‘‘direct-to-consumer 7 |
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| 253 | 253 | | genomic testing company’’ shall not include a 8 |
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| 254 | 254 | | health care professional (as defined in section 9 |
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| 255 | 255 | | 225 of the Public Health Service Act (42 10 |
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| 256 | 256 | | U.S.C. 234)) that performs an action described 11 |
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| 257 | 257 | | in subparagraph (A) for purposes of diagnosis 12 |
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| 258 | 258 | | or treatment of a medical condition. 13 |
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| 259 | 259 | | (6) G |
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| 260 | 260 | | ENOMIC DATA.— 14 |
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| 261 | 261 | | (A) I |
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| 262 | 262 | | N GENERAL.—The term ‘‘genomic 15 |
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| 263 | 263 | | data’’— 16 |
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| 264 | 264 | | (i) means any data, regardless of its 17 |
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| 265 | 265 | | format or whether the data has been 18 |
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| 266 | 266 | | deidentified, that results from the analysis 19 |
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| 267 | 267 | | of a biological sample from a consumer 20 |
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| 268 | 268 | | and concerns genomic material; and 21 |
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| 269 | 269 | | (ii) includes— 22 |
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| 270 | 270 | | (I) deoxyribonucleic acids (DNA), 23 |
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| 271 | 271 | | ribonucleic acids (RNA), genes, chro-24 |
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| 272 | 272 | | mosomes, alleles, genomes, alterations 25 |
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| 275 | 275 | | •S 863 IS |
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| 276 | 276 | | or modifications to DNA or RNA, and 1 |
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| 277 | 277 | | single nucleotide polymorphisms 2 |
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| 278 | 278 | | (SNPs); 3 |
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| 279 | 279 | | (II) uninterpreted data that re-4 |
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| 280 | 280 | | sults from the analysis of the biologi-5 |
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| 281 | 281 | | cal sample; or 6 |
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| 282 | 282 | | (III) any information extrapo-7 |
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| 283 | 283 | | lated, derived, or inferred therefrom. 8 |
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| 284 | 284 | | (B) E |
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| 285 | 285 | | XCLUSION OF DEIDENTIFIED 9 |
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| 286 | 286 | | GENOMIC DATA.—The term ‘‘genomic data’’ 10 |
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| 287 | 287 | | shall not include the deidentified genomic data 11 |
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| 288 | 288 | | of a consumer to the extent that such data is 12 |
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| 289 | 289 | | used to conduct medical or scientific research, 13 |
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| 290 | 290 | | consistent with the privacy regulations promul-14 |
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| 291 | 291 | | gated under section 264(c) of the Health Insur-15 |
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| 292 | 292 | | ance Portability and Accountability Act of 1996 16 |
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| 293 | 293 | | (42 U.S.C. 1320d–2 note). 17 |
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| 294 | 294 | | (7) G |
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| 295 | 295 | | ENOMIC TESTING PRODUCT OR SERV -18 |
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| 296 | 296 | | ICE.—The term ‘‘genomic testing product or serv-19 |
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| 297 | 297 | | ice’’ means any testing product or service that ana-20 |
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| 298 | 298 | | lyzes or interprets the genomic data or biological 21 |
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| 299 | 299 | | sample of a consumer. 22 |
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| 300 | 300 | | (d) R |
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| 301 | 301 | | ELATIONSHIP TO FEDERAL AND STATE 23 |
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| 302 | 302 | | L |
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| 303 | 303 | | AWS.— 24 |
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| 306 | 306 | | •S 863 IS |
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| 307 | 307 | | (1) FEDERAL LAW PRESERVATION .—Nothing in 1 |
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| 308 | 308 | | this Act, or a regulation promulgated under this Act, 2 |
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| 309 | 309 | | shall be construed to limit any other provision of 3 |
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| 310 | 310 | | Federal law, except as specifically provided in this 4 |
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| 311 | 311 | | Act. 5 |
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| 312 | 312 | | (2) S |
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| 313 | 313 | | TATE LAW PRESERVATION .—Nothing in 6 |
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| 314 | 314 | | this Act, or a regulation promulgated under this Act, 7 |
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| 315 | 315 | | shall be construed to preempt, displace, or supplant 8 |
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| 316 | 316 | | any State law, except to the extent that a provision 9 |
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| 317 | 317 | | of State law conflicts with a provision of this Act, 10 |
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| 318 | 318 | | or a regulation promulgated under this Act, and 11 |
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| 319 | 319 | | then only to the extent of the conflict. 12 |
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| 320 | 320 | | Æ |
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