Maryland 2022 Regular Session

Maryland Senate Bill SB766 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2
3	3	EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4	4	[Brackets] indicate matter deleted from existing law.
5	5	sb0766
6	6
7	7	SENATE BILL 766
8	8	I3 2lr2890
9	9	CF HB 866
10	10	By: Senator Sydnor
11	11	Introduced and read first time: February 7, 2022
12	12	Assigned to: Finance
13	13
14	14	A BILL ENTITLED
15	15
16	16	AN ACT concerning 1
17	17
18	18	Commercial Law – Consumer Protection – Genetic Information Privacy 2
19	19
20	20	FOR the purpose of regulating the use of genetic data by direct–to–consumer genetic testing 3
21	21	companies, including by requiring a direct–to–consumer genetic testing company to 4
22	22	provide consumers with certain information regarding the company’s policies and 5
23	23	procedures, obtain certain consents from consumers before collecting, using, or 6
24	24	disclosing the consumer’s genetic data, and develop and implement certain policies 7
25	25	and procedures to protect genetic data and provide for certain disclosures to law 8
26	26	enforcement and other government agencies; and generally relating to genetic 9
27	27	information privacy. 10
28	28
29	29	BY repealing and reenacting, with amendments, 11
30	30	Article – Commercial Law 12
31	31	Section 13–301(14)(xxxiv) and (xxxv) 13
32	32	Annotated Code of Maryland 14
33	33	(2013 Replacement Volume and 2021 Supplement) 15
34	34
35	35	BY adding to 16
36	36	Article – Commercial Law 17
37	37	Section 13–301(14)(xxxvi); and 14–4401 through 14–4408 to be under the new 18
38	38	subtitle “Subtitle 44. Genetic Information Privacy Act” 19
39	39	Annotated Code of Maryland 20
40	40	(2013 Replacement Volume and 2021 Supplement) 21
41	41
42	42	SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 22
43	43	That the Laws of Maryland read as follows: 23
44	44
45	45	Article – Commercial Law 24
46	46
47	47	13–301. 25
48	48	2 SENATE BILL 766
49	49
50	50
51	51	Unfair, abusive, or deceptive trade practices include any: 1
52	52
53	53	(14) Violation of a provision of: 2
54	54
55	55	(xxxiv) The federal Servicemembers Civil Relief Act; [or] 3
56	56
57	57	(xxxv) [§] SECTION 11–210 of the Education Article; or 4
58	58
59	59	(XXXVI) TITLE 14, SUBTITLE 44 OF THIS ARTICLE; OR 5
60	60
61	61	SUBTITLE 44. GENETIC INFORMATION PRIVACY ACT. 6
62	62
63	63	14–4401. 7
64	64
65	65	(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 8
66	66	INDICATED. 9
67	67
68	68	(B) (1) “BIOLOGICAL SAMPLE ” MEANS A MATERIAL PART OR A 10
69	69	DERIVATIVE OF OR DISCHARGE FROM A MATERIAL PART OF A HUMAN KNOWN TO 11
70	70	CONTAIN DNA. 12
71	71
72	72	(2) “BIOLOGICAL SAMPLE ” INCLUDES HUMAN TISSUE, BLOOD, 13
73	73	URINE, AND SALIVA. 14
74	74
75	75	(C) (1) “DEIDENTIFIED DATA ” MEANS DATA THAT : 15
76	76
77	77	(I) CANNOT REASONABLY BE : 16
78	78
79	79	1. USED TO INFER INFORMA TION ABOUT A CONSUME R; 17
80	80	OR 18
81	81
82	82	2. LINKED TO AN IDENTIFIABLE CONSUME R; AND 19
83	83
84	84	(2) IS SUBJECT TO: 20
85	85
86	86	(I) ADMINISTRATIVE AND TE CHNICAL MEASURES TO ENSURE 21
87	87	THAT THE DATA CANNOT BE ASSOCIATED WITH A PARTICULAR CONSUMER ; 22
88	88
89	89	(II) PUBLIC COMMITMENT BY THE COMPANY TO MAINT AIN AND 23
90	90	USE DATA IN A DEIDENTIFIABLE FORM AND NOT ATTEMPT TO REIDENTIFY DATA ; 24
91	91	AND 25
92	92	SENATE BILL 766 3
93	93
94	94
95	95	(III) LEGALLY ENFORCEABLE C ONTRACTUAL OBLIGATIO NS 1
96	96	THAT PROHIBIT A RECI PIENT OF THE DATA FR OM ATTEMPTING TO REI DENTIFY THE 2
97	97	DATA. 3
98	98
99	99	(D) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” MEANS AN 4
100	100	ENTITY THAT: 5
101	101
102	102	(1) OFFERS GENETIC TESTIN G PRODUCTS OR SERVIC ES DIRECTLY TO 6
103	103	A CONSUMER ; OR 7
104	104
105	105	(2) COLLECTS, USES, OR ANALYZES GENETIC DATA PROVIDED TO THE 8
106	106	COMPANY BY A CONSUMER . 9
107	107
108	108	(E) “DNA” MEANS DEOXYRIBONUCLE IC ACID. 10
109	109
110	110	(F) “EXPRESS CONSENT ” MEANS A N AFFIRMATIVE RESPONSE BY A 11
111	111	CONSUMER TO A SPECIFIC, DISCRETE, FREELY GIVEN, AND UNAMBIGUOUS NOTICE 12
112	112	REGARDING THE COLLEC TION, USE, OR DISCLOSURE OF THE CONSUMER ’S GENETIC 13
113	113	DATA FOR A SPECIFIC PURPOSE. 14
114	114
115	115	(G) (1) “GENETIC DATA” MEANS DATA, IN ANY FORMAT, THAT CONCERNS 15
116	116	THE GENETIC CHARACTERIST ICS OF A CONSUMER . 16
117	117
118	118	(2) “GENETIC DATA” INCLUDES: 17
119	119
120	120	(I) RAW SEQUENCE DATA THA T RESULT FROM SEQUEN CING OF 18
121	121	A CONSUMER ’S COMPLETE EXTRACTED DNA OR A PORTION OF THE CONSUMER’S 19
122	122	COMPLETE EXTRACTED DNA; 20
123	123
124	124	(II) GENOTYPIC AND PHENOTY PIC INFORMATION THAT 21
125	125	RESULTS FROM ANALYZI NG RAW SEQUENCE DATA ; AND 22
126	126
127	127	(III) SELF–REPORTED HEALTH INFO RMATION SUBMITTED TO A 23
128	128	DIRECT–TO–CONSUMER GENETIC TES TING COMPANY BY A CONSUMER REGARDING 24
129	129	THE CONSUMER ’S HEALTH CONDITIONS : 25
130	130
131	131	1. THAT IS USED FOR SCIENTIFIC RESEARCH OR 26
132	132	PRODUCT DEVELOPMENT ; AND 27
133	133
134	134	2. ANALYZED IN CONNECTIO N WITH THE CONSUMER ’S 28
135	135	RAW SEQUENCE DATA . 29
136	136
137	137	(3) “GENETIC DATA” DOES NOT INCLUDE DEIDENTIFIED DATA. 30 4 SENATE BILL 766
138	138
139	139
140	140
141	141	(H) “GENETIC TESTING ” MEANS A LABORATORY T EST OF THE COMPLETE 1
142	142	DNA, REGIONS OF DNA, CHROMOSOMES , GENES, OR GENE PRODUCTS OF A 2
143	143	CONSUMER TO DETERMINE THE GEN ETIC CHARACTERISTICS OF THE CONSUMER . 3
144	144
145	145	(I) “MARKETING” DOES NOT INCLUDE THE PROVIDING CUSTOMIZED 4
146	146	CONTENT OR OFFERS ON THE WEBSITES OR THRO UGH THE APPLICA TIONS OR 5
147	147	SERVICES PROVIDED BY THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 6
148	148	WITH THE FIRST–PARTY RELATIONSHIP T O THE CONSUMER . 7
149	149
150	150	14–4402. 8
151	151
152	152	THIS SUBTITLE DOES NO T APPLY TO: 9
153	153
154	154	(1) PROTECTED HEALTH INFO RMATION THAT IS COLL ECTED BY A 10
155	155	COVERED ENTITY OR BUSINESS ASSOCIATE A S DEFINED IN 45 C.F.R. PARTS 160 11
156	156	AND 164; 12
157	157
158	158	(2) AN INSTITUTION OF HIGHE R EDUCATION, AS DEFINED IN § 10–101 13
159	159	OF THE EDUCATION ARTICLE; OR 14
160	160
161	161	(3) AN ENTITY OWNED OR OP ERATED BY AN INSTITUTION OF HIGHE R 15
162	162	EDUCATION, AS DEFINED IN § 10–101 OF THE EDUCATION ARTICLE. 16
163	163
164	164	14–4403. 17
165	165
166	166	(A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL PROVIDE 18
167	167	A CONSUMER WITH CLEAR AND COMPLETE I NFORMATION REGARDING THE 19
168	168	COMPANY’S POLICIES AND PROCE DURES FOR COLLECTING, USING, OR DISCLOSING 20
169	169	GENETIC DATA , INCLUDING: 21
170	170
171	171	(1) A HIGH–LEVEL OVERVIEW OF THE COMP ANY’S PRIVACY POLICY 22
172	172	THAT INCLUDES BASIC AND ESSENTIAL INFORMATIO N ABOUT HOW THE COMPANY 23
173	173	COLLECTS, USES, AND DISCLOSES GENETI C DATA; AND 24
174	174
175	175	(2) A PRIVACY NOTICE THAT , AT A MINIMUM , INCLUDES 25
176	176	INFORMATION ABOUT TH E COMPANY’S DATA COLLECTION , CONSENT, USE, ACCESS, 26
177	177	DISCLOSURE, TRANSFER, SECURITY, AND RETENTION AND DELETI ON PRACTICES. 27
178	178
179	179	(B) THE INFORMATION REQUI RED TO BE PROVIDED UNDER SUBSECTION (A) 28
180	180	OF THIS SECTION SHAL L BE: 29
181	181
182	182	(1) MADE PUBLICLY AVAILAB LE; AND 30 SENATE BILL 766 5
183	183
184	184
185	185
186	186	(2) PLACED IN A PROMINENT AREA OF THE DIRECT–TO–CONSUMER 1
187	187	GENETIC TESTING COMP ANY’S WEBSITE. 2
188	188
189	189	14–4404. 3
190	190
191	191	A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY , AT A MINIMUM , 4
192	192	SHALL O BTAIN THE FOLLOWING CONSEN TS FROM A CONSUMER B EFORE 5
193	193	COLLECTING, USING, OR DISCLOSING THE CONSUMER ’S GENETIC DATA: 6
194	194
195	195	(1) INITIAL EXPRESS CONSE NT THAT CLEARLY : 7
196	196
197	197	(I) DESCRIBES THE USES OF THE GENET IC DATA COLLECTED 8
198	198	THROUGH THE GENETIC TESTING PRODUCT OR S ERVICE; AND 9
199	199
200	200	(II) SPECIFIES: 10
201	201
202	202	1. WHO HAS ACCESS TO THE RESULTS OF THE G ENETIC 11
203	203	TESTING; AND 12
204	204
205	205	2. HOW THE GENETIC DATA MAY BE SHARED; 13
206	206
207	207	(2) EXPRESS CONSENT FOR T RANSFERRING OR DISCL OSING THE 14
208	208	CONSUMER ’S GENETIC DATA TO A PERSON OTHER THAN TH E COMPANY’S VENDORS 15
209	209	AND SERVICE PROVIDER S; 16
210	210
211	211	(3) EXPRESS CONSENT FOR USING GENETIC DATA B EYOND THE 17
212	212	PRIMARY PURPOSE OF T HE GENETIC TESTING P RODUCT OR SERVICE RE QUESTED BY 18
213	213	THE CONSUMER ; 19
214	214
215	215	(4) EXPRESS CONSENT FOR T HE RETENTION OF A BIOLOGICAL 20
216	216	SAMPLE PROVIDED BY T HE CONSUMER AFTER THE INITIAL TE STING SERVICE 21
217	217	REQUESTED BY THE CONSUMER IS COMPLETE D; 22
218	218
219	219	(5) EXPRESS CONSENT TO BE MARKETED TO BY : 23
220	220
221	221	(I) THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 24
222	222	BASED ON THE CONSUME R’S GENETIC DATA; AND 25
223	223
224	224	(II) A THIRD PARTY BASED ON THE CONSUMER HAVING 26
225	225	ORDERED OR PURCHASED A GENETIC TESTING PR ODUCT OR SERVICE ; AND 27
226	226	6 SENATE BILL 766
227	227
228	228
229	229	(6) INFORMED CONSENT IN C OMPLIANCE WITH THE F EDERAL POLICY 1
230	230	FOR THE PROTECTION O F HUMAN RESEARCH SUB JECTS FOR TRANSFER O R 2
231	231	DISCLOSURE OF THE CO NSUMER’S GENETIC DATA TO THIRD PARTIES FOR 3
232	232	RESEARCH PURPOSES OR RESEARCH CONDUCTED U NDER THE CONTROL OF THE 4
233	233	COMPANY FOR THE PURPOSE OF PUBLI CATION OR GENERALIZA BLE KNOWLEDGE . 5
234	234
235	235	14–4405. 6
236	236
237	237	(A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 7
238	238	ESTABLISH LEGAL POLICIES AND PROCESS ES FOR DISCLOSING GENET IC DATA TO 8
239	239	LAW ENFORCEMENT OR A NOTHER GOVERNMENT AGE NCY WITHOUT A CONSUM ER’S 9
240	240	EXPRESS WRITTEN CONS ENT. 10
241	241
242	242	(B) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 11
243	243	DEVELOP, IMPLEMENT, AND MAINTAIN A COMPR EHENSIVE SECURITY PR OGRAM TO 12
244	244	PROTECT CONSUMERS ’ GENETIC DATA AGAINST UNAUTHORIZED ACCESS, USE, OR 13
245	245	DISCLOSURE. 14
246	246
247	247	(C) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 15
248	248	ESTABLISH A PROCESS FOR A CONS UMER TO: 16
249	249
250	250	(1) ACCESS THE CONSUMER ’S GENETIC DATA; 17
251	251
252	252	(2) DELETE THE CONSUMER ’S ACCOUNT AND GENETI C DATA; AND 18
253	253
254	254	(3) REQUEST THE DESTRUCTI ON OF THE CONSUMER ’S BIOLOGICAL 19
255	255	SAMPLE. 20
256	256
257	257	(D) NOTWITHSTANDING ANY O THER PROVISIONS OF L AW, A 21
258	258	DIRECT–TO–CONSUMER GENETIC TES TING COMPANY MAY NOT , WITHOUT THE 22
259	259	CONSUMER ’S WRITTEN CONSENT , DISCLOSE A CONSUMER ’S GENETIC DATA TO : 23
260	260
261	261	(1) AN ENTITY OFFERING HEAL TH INSURANCE , LIFE INSURANCE , OR 24
262	262	LONG–TERM CARE INSURANCE; OR 25
263	263
264	264	(2) AN EMPLOYER OF THE CONS UMER. 26
265	265
266	266	14–4406. 27
267	267
268	268	(A) A VIOLATION OF THIS SE CTION IS AN UNFAIR , ABUSIVE, OR DECEPTIVE 28
269	269	TRADE PRACTICE WITHI N THE MEANING OF TITLE 13 OF THIS ARTICLE AND IS 29
270	270	SUBJECT TO THE ENFOR CEMENT AND PENALTY P ROVISIONS CONTAINED IN TITLE 30
271	271	13 OF THIS ARTICLE. 31 SENATE BILL 766 7
272	272
273	273
274	274
275	275	(B) THIS SECTION DOES NOT PREVENT AN INDIVIDUA L FROM PURSUING 1
276	276	ANY OTHER REMEDY PRO VIDED BY LAW. 2
277	277
278	278	14–4407. 3
279	279
280	280	THE DISCLOSURE OF GEN ETIC DATA IN ACCORDA NCE WITH THIS S UBTITLE 4
281	281	SHALL COMPLY WITH AL L STATE AND FEDERAL LAW S FOR THE PROTECTION OF 5
282	282	PRIVACY AND SECURITY . 6
283	283
284	284	14–4408. 7
285	285
286	286	THIS SUBTITLE MAY BE KNOWN AND CITED AS T HE MARYLAND GENETIC 8
287	287	INFORMATION PRIVACY ACT. 9
288	288
289	289	SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 10
290	290	October 1, 2022. 11