MD
Maryland House Bill HB866

Maryland 2022 Regular Session

Maryland House Bill HB866 Compare Versions

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1- LAWRENCE J. HOGAN, JR., Governor Ch. 501
21
3-– 1 –
4-Chapter 501
5-(House Bill 866)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
4+ [Brackets] indicate matter deleted from existing law.
5+ Underlining indicates amendments to bill.
6+ Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7+amendment.
8+ Italics indicate opposite chamber/conference committee amendments.
9+ *hb0866*
810
9-Commercial Law – Consumer Protection – Genetic Information Privacy
10-– Consumer Protection and Forensic Genealogy
11+HOUSE BILL 866
12+I3 (2lr2894)
13+ENROLLED BILL
14+— Economic Matters/Finance —
15+Introduced by Delegate Qi
1116
12-FOR the purpose of regulating the use of genetic data by direct–to–consumer genetic testing
13-companies, including by requiring a direct–to–consumer genetic testing company to
14-provide consumers with certain information regarding the company’s policies and
15-procedures, obtain certain consents from consumers before collecting, using, or
16-disclosing the consumer’s genetic data, and develop and implement certain policies
17-and procedures to protect genetic data and provide for certain disclosures to law
18-enforcement and other government agencies; altering the direct–to–consumer or
19-publicly available open–data personal genomics databases that may be used to
20-conduct forensic genetic genealogical DNA analysis and search to require that the
21-databases seek express consent from their service users regarding the substance of
22-a certain notice; and generally relating to genetic information privacy.
17+Read and Examined by Proofreaders:
2318
24-BY repealing and reenacting, with amendments,
25- Article – Commercial Law
26-Section 13–301(14)(xxxiv) and (xxxv)
27- Annotated Code of Maryland
28- (2013 Replacement Volume and 2021 Supplement)
19+_______________________________________________
20+Proofreader.
21+_______________________________________________
22+Proofreader.
2923
30-BY adding to
31- Article – Commercial Law
32-Section 13–301(14)(xxxvi); and 14–4401 through 14–4408 to be under the new
33-subtitle “Subtitle 44. Genetic Information Privacy Act”
34- Annotated Code of Maryland
35- (2013 Replacement Volume and 2021 Supplement)
24+Sealed with the Great Seal and presented to the Governor, for his approval this
3625
37-BY repealing and reenacting, without amendments,
38- Article – Criminal Procedure
39-Section 17–101(a), (c), (e), and (g) and 17–102(a)
40- Annotated Code of Maryland
41- (2018 Replacement Volume and 2021 Supplement)
26+_______ day of _______________ at _________________ _______ o’clock, ________M.
4227
43-BY adding to
44- Article – Criminal Procedure
45-Section 17–101(c–1)
46- Annotated Code of Maryland
47- (2018 Replacement Volume and 2021 Supplement)
28+______________________________________________
29+Speaker.
4830
49-BY repealing and reenacting, with amendments, Ch. 501 2022 LAWS OF MARYLAND
31+CHAPTER ______
5032
51-– 2 –
52- Article – Criminal Procedure
53-Section 17–102(d) and 17–103(a)(4)
54- Annotated Code of Maryland
55- (2018 Replacement Volume and 2021 Supplement)
33+AN ACT concerning 1
5634
57- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
58-That the Laws of Maryland read as follows:
35+Commercial Law – Consumer Protection – Genetic Information Privacy 2
36+– Consumer Protection and Forensic Genealogy 3
5937
60-Article – Commercial Law
38+FOR the purpose of regulating the use of genetic data by direct–to–consumer genetic testing 4
39+companies, including by requiring a direct–to–consumer genetic testing company to 5
40+provide consumers with certain information regarding the company’s policies and 6
41+procedures, obtain certain consents from consumers before collecting, using, or 7
42+disclosing the consumer’s genetic data, and develop and implement certain policies 8
43+and procedures to protect genetic data and provide for certain disclosures to law 9
44+enforcement and other government agencies; altering the direct–to–consumer or 10
45+publicly available open–data personal genomics databases that may be used to 11
46+conduct forensic genetic genealogical DNA analysis and search to require that the 12
47+databases seek express consent from their service users regarding the substance of 13
48+a certain notice; and generally relating to genetic information privacy. 14
49+ 2 HOUSE BILL 866
6150
62-13–301.
6351
64- Unfair, abusive, or deceptive trade practices include any:
52+BY repealing and reenacting, with amendments, 1
53+ Article – Commercial Law 2
54+Section 13–301(14)(xxxiv) and (xxxv) 3
55+ Annotated Code of Maryland 4
56+ (2013 Replacement Volume and 2021 Supplement) 5
6557
66- (14) Violation of a provision of:
58+BY adding to 6
59+ Article – Commercial Law 7
60+Section 13–301(14)(xxxvi); and 14–4401 through 14–4408 to be under the new 8
61+subtitle “Subtitle 44. Genetic Information Privacy Act” 9
62+ Annotated Code of Maryland 10
63+ (2013 Replacement Volume and 2021 Supplement) 11
6764
68- (xxxiv) The federal Servicemembers Civil Relief Act; [or]
65+BY repealing and reenacting, without amendments, 12
66+ Article – Criminal Procedure 13
67+Section 17–101(a), (c), (e), and (g) and 17–102(a) 14
68+ Annotated Code of Maryland 15
69+ (2018 Replacement Volume and 2021 Supplement) 16
6970
70- (xxxv) [§] SECTION 11–210 of the Education Article; or
71+BY adding to 17
72+ Article – Criminal Procedure 18
73+Section 17–101(c–1) 19
74+ Annotated Code of Maryland 20
75+ (2018 Replacement Volume and 2021 Supplement) 21
7176
72- (XXXVI) TITLE 14, SUBTITLE 44 OF THIS ARTICLE; OR
77+BY repealing and reenacting, with amendments, 22
78+ Article – Criminal Procedure 23
79+Section 17–102(d) and 17–103(a)(4) 24
80+ Annotated Code of Maryland 25
81+ (2018 Replacement Volume and 2021 Supplement) 26
7382
74-SUBTITLE 44. GENETIC INFORMATION PRIVACY ACT.
83+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 27
84+That the Laws of Maryland read as follows: 28
7585
76-14–4401.
86+Article – Commercial Law 29
7787
78- (A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS
79-INDICATED.
88+13–301. 30
8089
81- (B) (1) “BIOLOGICAL SAMPLE ” MEANS A MATERIAL PAR T OR A
82-DERIVATIVE OF OR DIS CHARGE FROM A MATERI AL PART OF A HUMAN K NOWN TO
83-CONTAIN DNA.
90+ Unfair, abusive, or deceptive trade practices include any: 31
8491
85- (2) “BIOLOGICAL SAMPLE ” INCLUDES HUMAN TISSU E, BLOOD,
86-URINE, AND SALIVA.
92+ (14) Violation of a provision of: 32
8793
88- (C) (1) “DEIDENTIFIED DATA ” MEANS DATA THAT :
94+ (xxxiv) The federal Servicemembers Civil Relief Act; [or] 33
8995
90- (I) (1) CANNOT REASONABLY BE :
96+ (xxxv) [§] SECTION 11–210 of the Education Article; or 34
97+ HOUSE BILL 866 3
9198
92- 1. (I) USED TO INFER INFORMA TION ABOUT A CONSUME R;
93-OR
9499
95- 2. (II) LINKED TO AN IDENTIFI ABLE CONSUME R; AND
96- LAWRENCE J. HOGAN, JR., Governor Ch. 501
100+ (XXXVI) TITLE 14, SUBTITLE 44 OF THIS ARTICLE; OR 1
97101
98-– 3 –
99- (2) IS SUBJECT TO:
102+SUBTITLE 44. GENETIC INFORMATION PRIVACY ACT. 2
100103
101- (I) ADMINISTRATIVE AND TE CHNICAL MEASURES TO ENSURE
102-THAT THE DATA CANNOT BE ASSOCIATED WITH A PARTICULAR CONSUMER ;
104+14–4401. 3
103105
104- (II) PUBLIC COMMITMENT BY THE COMPANY TO MAINT AIN AND
105-USE DATA IN A DEIDEN TIFIABLE FORM AND NO T ATTEMPT TO REIDENTIFY DATA ;
106-AND
106+ (A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 4
107+INDICATED. 5
107108
108- (III) LEGALLY ENFORCEABLE C ONTRACTUAL OBLIGATIO NS
109-THAT PROHIBIT A RECI PIENT OF THE DATA FR OM ATTEMPTING TO REI DENTIFY THE
110-DATA.
109+ (B) (1) “BIOLOGICAL SAMPLE ” MEANS A MATERIAL PAR T OR A 6
110+DERIVATIVE OF OR DIS CHARGE FROM A MATERI AL PART OF A HUMAN K NOWN TO 7
111+CONTAIN DNA. 8
111112
112- (D) (1) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” MEANS
113-AN ENTITY THAT :
113+ (2) “BIOLOGICAL SAMPLE ” INCLUDES HUMAN TISSU E, BLOOD, 9
114+URINE, AND SALIVA. 10
114115
115- (1) (I) (1) OFFERS GENETIC TESTIN G PRODUCTS OR SERVIC ES
116-DIRECTLY TO A CONSUM ER; OR
116+ (C) (1) “DEIDENTIFIED DATA ” MEANS DATA THAT : 11
117117
118- (2) (II) (2) COLLECTS, USES, OR ANALYZES GENETIC DATA THAT
119-RESULTED FROM A DIRE CT–TO–CONSUMER GENETIC TES TING PRODUCT OR
120-SERVICE THAT WAS PROVIDED TO THE COMP ANY BY A CONSUMER .
118+ (I) (1) CANNOT REASONABLY BE : 12
121119
122- (2) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” DOES NOT
123-INCLUDE AN ENTITY ON LY WHEN THE ENTITY I S ENGAGED IN COLLECT ING,
124-ANALYZING, RETAINING, OR DISCLOSING GENETI C DATA OR BIOLOGICAL SAMPLES
125-IN THE CONTEXT OF RE SEARCH, AS DEFINED IN 45 C.F.R. 164.501, CONDUCTED IN
126-ACCORDANCE WITH :
120+ 1. (I) USED TO INFER INFORMA TION ABOUT A CONSUME R; 13
121+OR 14
127122
128- (I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMAN
129-SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46;
123+ 2. (II) LINKED TO AN IDENTIFI ABLE CONSUMER ; AND 15
130124
131- (II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY
132-THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR
125+ (2) IS SUBJECT TO: 16
133126
134- (III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION
135-OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56.
127+ (I) ADMINISTRATIVE AND TE CHNICAL MEASURES TO ENSURE 17
128+THAT THE DATA CANNOT BE ASSOCIATED WITH A PARTICULAR CONSUMER ; 18
136129
137- (E) “DNA” MEANS DEOXYRIBONUCLE IC ACID.
130+ (II) PUBLIC COMMITMENT BY THE COMPANY TO MAINT AIN AND 19
131+USE DATA IN A DEIDEN TIFIABLE FORM AND NO T ATTEMPT TO REIDENTIFY DATA ; 20
132+AND 21
138133
139- (F) “EXPRESS CONSENT ” MEANS AN AFFIRMATIVE RESPONSE BY A
140-CONSUMER TO A SPECIF IC, DISCRETE, FREELY GIVEN, AND UNAMBIGUOUS NOTI CE
141-REGARDING THE COLLEC TION, USE, OR DISCLOSURE OF THE CONSUMER ’S GENETIC
142-DATA FOR A SPECIFIC PURPOSE. Ch. 501 2022 LAWS OF MARYLAND
134+ (III) LEGALLY ENFORCEABLE C ONTRACTUAL OBLIGATIO NS 22
135+THAT PROHIBIT A RECI PIENT OF THE DATA FR OM ATTEMPTING TO REI DENTIFY THE 23
136+DATA. 24
143137
144-– 4 –
138+ (D) (1) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” MEANS 25
139+AN ENTITY THAT: 26
145140
146- (G) (1) “GENETIC DATA” MEANS DATA, IN ANY FORMAT, THAT CONCERNS
147-THE GENETIC CHARACTE RISTICS OF A CONSUME R.
141+ (1) (I) (1) OFFERS GENETIC TESTIN G PRODUCTS OR SERVIC ES 27
142+DIRECTLY TO A CONSUM ER; OR 28
143+ 4 HOUSE BILL 866
148144
149- (2) “GENETIC DATA” INCLUDES:
150145
151- (I) RAW SEQUENCE DATA THAT RES ULT FROM SEQUENCING OF
152-A CONSUMER ’S COMPLETE EXTRACTED DNA OR A PORTION OF THE CONSUMER’S
153-COMPLETE EXTRACTED DNA;
146+ (2) (II) (2) COLLECTS, USES, OR ANALYZES GENETIC DATA THAT 1
147+RESULTED FROM A DIRE CT–TO–CONSUMER GENETIC TES TING PRODUCT OR 2
148+SERVICE THAT WAS PROVIDED TO THE COMP ANY BY A CONSUMER . 3
154149
155- (II) GENOTYPIC AND PHENOTY PIC INFORMATION THAT
156-RESULTS FROM ANALYZI NG RAW SEQUENCE DATA ; AND
150+ (2) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” DOES NOT 4
151+INCLUDE AN ENTITY ON LY WHEN THE ENTITY I S ENGAGED IN COLLECT ING, 5
152+ANALYZING, RETAINING, OR DISCLOSING GENETI C DATA OR BIOLOGICAL SAMPLES 6
153+IN THE CONTEXT OF RE SEARCH, AS DEFINED IN 45 C.F.R. 164.501, CONDUCTED IN 7
154+ACCORDANCE WITH : 8
157155
158- (III) INFORMATION EXTRAPOLATED , DERIVED, OR INFERRED
159-FROM THE ANALYSIS OF RAW SEQUENCE DATA ; AND
156+ (I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMAN 9
157+SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46; 10
160158
161- (III) (IV) SELF–REPORTED HEALTH INFO RMATION SUBMITTED
162-TO A DIRECT –TO–CONSUMER GENETIC TES TING COMPANY BY A CO NSUMER
163-REGARDING THE CONSUM ER’S HEALTH CONDITIONS :
159+ (II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY 11
160+THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR 12
164161
165- 1. THAT IS USED FOR SCIENTIF IC RESEARCH OR
166-PRODUCT DEVELOPMENT ; AND
162+ (III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION 13
163+OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56. 14
167164
168- 2. ANALYZED IN CONNECTIO N WITH THE CONSUMER ’S
169-RAW SEQUENCE DATA .
165+ (E) “DNA” MEANS DEOXYRIBONUCLE IC ACID. 15
170166
171- (3) “GENETIC DATA” DOES NOT INCLUDE DEI DENTIFIED DATA WHEN
172-USED FOR RESEARCH PR OJECTS.
167+ (F) “EXPRESS CONSENT ” MEANS AN AFFIRMATIVE RESPONSE BY A 16
168+CONSUMER TO A SPECIF IC, DISCRETE, FREELY GIVEN, AND UNAMBIGUOUS NOTI CE 17
169+REGARDING THE COLLEC TION, USE, OR DISCLOSURE OF THE CONSUMER ’S GENETIC 18
170+DATA FOR A SPECIFIC PURPOSE. 19
173171
174- (H) “GENETIC TESTING ” MEANS A LABORATORY TEST OF T HE COMPLETE
175-DNA, REGIONS OF DNA, CHROMOSOMES , GENES, OR GENE PRODUCTS OF A
176-CONSUMER TO DETERMIN E THE GENETIC CHARAC TERISTICS OF THE CON SUMER.
172+ (G) (1) “GENETIC DATA” MEANS DATA, IN ANY FORMAT, THAT CONCERNS 20
173+THE GENETIC CHARACTE RISTICS OF A CONSUME R. 21
177174
178- (I) “MARKETING” DOES NOT INCLUDE THE PROVIDING CUSTOMIZED
179-CONTENT OR OFFERS ON THE WEBSITES OR THROUGH THE APPLI CATIONS OR
180-SERVICES PROVIDED BY THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY
181-WITH THE FIRST–PARTY RELATIONSHIP T O THE CONSUMER .
175+ (2) “GENETIC DATA” INCLUDES: 22
182176
183-14–4402.
177+ (I) RAW SEQUENCE DATA THAT R ESULT FROM SEQUENCIN G OF 23
178+A CONSUMER ’S COMPLETE EXTRACTED DNA OR A PORTION OF THE CONSUMER’S 24
179+COMPLETE EXTRACTED DNA; 25
184180
185- THIS SUBTITLE DOES NO T APPLY TO::
186- LAWRENCE J. HOGAN, JR., Governor Ch. 501
181+ (II) GENOTYPIC AND PHENOTY PIC INFORMATION THAT 26
182+RESULTS FROM ANALYZI NG RAW SEQUENCE DATA ; AND 27
187183
188-– 5 –
189- (1) PROTECTED PROTECTED (1) PROTECTED HEALTH INFORMATION
190-THAT IS COLLECTED BY A COVERED ENTITY OR BUSINESS ASSOCIATE A S DEFINED IN
191-45 C.F.R. PARTS 160 AND 164;
184+ (III) INFORMATION E XTRAPOLATED , DERIVED, OR INFERRED 28
185+FROM THE ANALYSIS OF RAW SEQUENCE DATA ; AND 29
192186
193- (2) AN INSTITUTION OF HIG HER EDUCATION , AS DEFINED IN § 10–101
194-OF THE EDUCATION ARTICLE; OR
187+ (III) (IV) SELF–REPORTED HEALTH INFO RMATION SUBMITTED 30
188+TO A DIRECT –TO–CONSUMER GENETIC TES TING COMPANY BY A CO NSUMER 31
189+REGARDING THE CONSUM ER’S HEALTH CONDITIONS : 32 HOUSE BILL 866 5
195190
196- (3) AN ENTITY OWNED OR OP ERATED BY AN INSTITU TION OF HIGHER
197-EDUCATION, AS DEFINED IN § 10–101 OF THE EDUCATION ARTICLE.; OR
198191
199- (2) GENETIC DATA OR BIOLO GICAL SAMPLES COLLEC TED FOR THE
200-PURPOSE OF RESEARCH , AS DEFINED IN 45 C.F.R. 164.501, THAT IS CONDUCTED IN
201-ACCORDANCE WITH :
202192
203- (I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMA N
204-SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46;
193+ 1. THAT IS USED FOR SCIENTIFI C RESEARCH OR 1
194+PRODUCT DEVELOPMENT ; AND 2
205195
206- (II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY
207-THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR
196+ 2. ANALYZED IN CONNECTIO N WITH THE CONSUMER ’S 3
197+RAW SEQUENCE DATA . 4
208198
209- (III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION
210-OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56.
199+ (3) “GENETIC DATA” DOES NOT INCLUDE DEI DENTIFIED DATA WHEN 5
200+USED FOR RESEARCH PR OJECTS. 6
211201
212-14–4403.
202+ (H) “GENETIC TESTING ” MEANS A LABORATORY TEST OF T HE COMPLETE 7
203+DNA, REGIONS OF DNA, CHROMOSOMES , GENES, OR GENE PRODUCTS OF A 8
204+CONSUMER TO DETERMIN E THE GENETIC CHARAC TERISTICS OF THE CON SUMER. 9
213205
214- (A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL P ROVIDE
215-A CONSUMER WITH CLEA R AND COMPLETE INFOR MATION REGARDING THE
216-COMPANY’S POLICIES AND PROCE DURES FOR COLLECTING , USING, OR DISCLOSING
217-GENETIC DATA , INCLUDING:
206+ (I) “MARKETING” DOES NOT INCLUDE THE PROVIDING CUSTOMIZED 10
207+CONTENT OR OFFERS ON THE WEBSITES OR THROUGH THE APPLI CATIONS OR 11
208+SERVICES PROVIDED BY THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 12
209+WITH THE FIRST–PARTY RELATIONSHIP T O THE CONSUMER . 13
218210
219- (1) A HIGH–LEVEL OVERVIEW OF TH E COMPANY’S PRIVACY POLICY
220-THAT INCLUDES BASIC AND ESSENTIAL INFORM ATION ABOUT HOW THE COMPANY
221-COLLECTS, USES, AND DISCLOSES GENETI C DATA; AND
211+14–4402. 14
222212
223- (2) A PRIVACY NOTICE THAT , AT A MINIMUM , INCLUDES
224-INFORMATION ABOUT TH E COMPANY’S DATA COLLECTION , CONSENT, USE, ACCESS,
225-DISCLOSURE, TRANSFER, SECURITY, AND RETENTION AND DE LETION PRACTICES .
213+ THIS SUBTITLE DOES NO T APPLY TO:: 15
226214
227- (B) THE INFORMATION REQUI RED TO BE PROVIDED U NDER SUBSECTION (A)
228-OF THIS SECTION SHAL L BE:
215+ (1) PROTECTED PROTECTED (1) PROTECTED HEALTH INFORMATION 16
216+THAT IS COLLECTED BY A COVERED ENTITY OR BUSINESS ASSOCIATE A S DEFINED IN 17
217+45 C.F.R. PARTS 160 AND 164; 18
229218
230- (1) MADE PUBLICLY AVAILAB LE; AND
231- Ch. 501 2022 LAWS OF MARYLAND
219+ (2) AN INSTITUTION OF HIG HER EDUCATION , AS DEFINED IN § 10–101 19
220+OF THE EDUCATION ARTICLE; OR 20
232221
233-– 6 –
234- (2) PLACED IN A PROMINENT AR EA OF THE DIRECT –TO–CONSUMER
235-GENETIC TESTING COMP ANY’S WEBSITE.
222+ (3) AN ENTITY OWNED OR OP ERATED BY AN INSTITU TION OF HIGHER 21
223+EDUCATION, AS DEFINED IN § 10–101 OF THE EDUCATION ARTICLE.; OR 22
236224
237-14–4404.
225+ (2) GENETIC DATA OR BIOLO GICAL SAMPLES COLLEC TED FOR THE 23
226+PURPOSE OF RESEARCH , AS DEFINED IN 45 C.F.R. 164.501, THAT IS CONDUCTED IN 24
227+ACCORDANCE WITH : 25
238228
239- A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY , AT A MINIMUM ,
240-SHALL OBTAIN THE FOL LOWING CONSENTS FROM A CONSUMER BEFORE
241-COLLECTING , USING, OR DISCLOSING THE CO NSUMER’S GENETIC DATA :
229+ (I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMAN 26
230+SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46; 27
242231
243- (1) INITIAL EXPRESS CONSE NT THAT CLEARLY :
232+ (II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY 28
233+THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR 29
234+ 6 HOUSE BILL 866
244235
245- (I) DESCRIBES THE USES OF THE GENETIC DATA COL LECTED
246-THROUGH THE GENETIC TESTING PRODUCT OR S ERVICE; AND
247236
248- (II) SPECIFIES:
237+ (III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION 1
238+OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56. 2
249239
250- 1. WHO HAS ACCESS TO THE RESULTS OF THE GENET IC
251-TESTING; AND
240+14–4403. 3
252241
253- 2. HOW THE GENETIC DATA MAY BE SHARED ;
242+ (A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL P ROVIDE 4
243+A CONSUMER WITH CLEA R AND COMPLETE INFOR MATION REGARDING THE 5
244+COMPANY’S POLICIES AND PROCE DURES FOR COLLECTING , USING, OR DISCLOSING 6
245+GENETIC DATA , INCLUDING: 7
254246
255- (2) EXPRESS CONSENT FOR T RANSFERRING OR DISCL OSING THE
256-CONSUMER ’S GENETIC DATA TO A PERSON OTHER THAN TH E COMPANY’S VENDORS
257-AND SERVICE PROVIDER S;
247+ (1) A HIGH–LEVEL OVERVIEW OF TH E COMPANY’S PRIVACY POLICY 8
248+THAT INCLUDES BASIC AND ESSENTIAL INFORM ATION ABOUT HOW THE COMPANY 9
249+COLLECTS, USES, AND DISCLOSES GENETI C DATA; AND 10
258250
259- (3) EXPRESS CONSENT FOR U SING GENETIC DATA BE YOND THE
260-PRIMARY PURPOSE OF T HE GENETIC TESTING P RODUCT OR SERVICE RE QUESTED BY
261-THE CONSUMER ;
251+ (2) A PRIVACY NOTICE THAT , AT A MINIMUM , INCLUDES 11
252+INFORMATION ABOUT TH E COMPANY’S DATA COLLECTION , CONSENT, USE, ACCESS, 12
253+DISCLOSURE, TRANSFER, SECURITY, AND RETENTION AND DE LETION PRACTICES . 13
262254
263- (4) EXPRESS CONSENT FOR T HE RETENTION OF A BI OLOGICAL
264-SAMPLE PROVIDED BY T HE CONSUMER AFTER TH E INITIAL TESTING SE RVICE
265-REQUESTED BY THE CON SUMER IS COMPLETED ;
255+ (B) THE INFORMATION REQUI RED TO BE PROVIDED U NDER SUBSECTION (A) 14
256+OF THIS SECTION SHAL L BE: 15
266257
267- (5) EXPRESS CONSENT TO BE MARKETED TO BY :
258+ (1) MADE PUBLICLY AVAILAB LE; AND 16
268259
269- (I) THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY
270-BASED ON THE CONSUME R’S GENETIC DATA ; AND
260+ (2) PLACED IN A PROMINENT AREA OF THE DIRECT –TO–CONSUMER 17
261+GENETIC TESTING COMP ANY’S WEBSITE. 18
271262
272- (II) A THIRD PARTY BASED ON THE CONSUMER HAVING
273-ORDERED OR PURCHASED A GENETIC TESTING PR ODUCT OR SERVICE ; AND
263+14–4404. 19
274264
275- (6) INFORMED CONSENT IN C OMPLIANCE WITH THE F EDERAL POLICY
276-FOR THE PROTECTION O F HUMAN RESEARCH SUB JECTS FOR TRANSFER O R
277-DISCLOSURE OF THE CO NSUMER’S GENETIC DATA TO TH IRD PARTIES FOR LAWRENCE J. HOGAN, JR., Governor Ch. 501
265+ A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY , AT A MINIMUM , 20
266+SHALL OBTAIN THE FOL LOWING CONSENTS FROM A CONSUMER BEFORE 21
267+COLLECTING, USING, OR DISCLOSING THE CONSUMER ’S GENETIC DATA: 22
278268
279-– 7 –
280-RESEARCH PURPOSES OR RESEARCH CONDUCTED U NDER THE CONTROL OF THE
281-COMPANY FOR THE PURPOSE OF P UBLICATION OR GENERA LIZABLE KNOWLEDGE .
269+ (1) INITIAL EXPRESS CONSE NT THAT CLEARLY : 23
282270
283-14–4405.
271+ (I) DESCRIBES THE USES OF THE GENETIC DATA COL LECTED 24
272+THROUGH THE GENETIC TESTING PRODUCT OR S ERVICE; AND 25
284273
285- (A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL
286-ESTABLISH LEGAL POLI CIES AND PROCESSES F OR DISCLOSING GENETI C DATA TO
287-LAW ENFORCEMENT OR A NOTHER GOVERNMENT AG ENCY WITHOUT A CONS UMER’S
288-EXPRESS WRITTEN CONS ENT.
274+ (II) SPECIFIES: 26
289275
290- (B) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL
291-DEVELOP, IMPLEMENT, AND MAINTAIN A COMPR EHENSIVE SECURITY PR OGRAM TO
292-PROTECT CONSUMERS ’ GENETIC DATA AGAINST UNAUTHORIZED ACCESS , USE, OR
293-DISCLOSURE.
276+ 1. WHO HAS ACCESS TO THE RESULTS OF THE GENET IC 27
277+TESTING; AND 28
294278
295- (C) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL
296-ESTABLISH A PROCESS FOR A CONSUMER TO :
279+ 2. HOW THE GENETIC DATA MAY BE SHARED ; 29
280+ HOUSE BILL 866 7
297281
298- (1) ACCESS THE CONSUMER ’S GENETIC DATA ;
299282
300- (2) DELETE THE CONSUMER ’S ACCOUNT AND GENETI C DATA; AND
283+ (2) EXPRESS CONSENT FOR T RANSFERRING OR DISCL OSING THE 1
284+CONSUMER ’S GENETIC DATA TO A PERSON OTHER THAN TH E COMPANY’S VENDORS 2
285+AND SERVICE PROVIDER S; 3
301286
302- (3) REQUEST THE DESTRUCTI ON OF THE CONSUMER ’S BIOLOGICAL
303-SAMPLE.
287+ (3) EXPRESS CONSENT FOR U SING GENETIC DATA BE YOND THE 4
288+PRIMARY PURPOSE OF T HE GENETIC TESTING P RODUCT OR SERVICE RE QUESTED BY 5
289+THE CONSUMER ; 6
304290
305- (D) NOTWITHSTANDING ANY O THER PROVISIONS OF L AW, A
306-DIRECT–TO–CONSUMER GENETIC TES TING COMPANY MAY NOT , WITHOUT THE
307-CONSUMER ’S WRITTEN CONSENT , DISCLOSE A CONSUMER ’S GENETIC DATA TO :
291+ (4) EXPRESS CONSENT FOR T HE RETENTION OF A BI OLOGICAL 7
292+SAMPLE PROVIDED BY T HE CONSUMER AFTER TH E INITIAL TESTING SE RVICE 8
293+REQUESTED BY THE CON SUMER IS COMPLETED ; 9
308294
309- (1) AN ENTITY OFFERING HE ALTH INSURANCE , LIFE INSURANCE ,
310-DISABILITY INSURA NCE, OR LONG–TERM CARE INSURANCE ; OR
295+ (5) EXPRESS CONSENT TO BE MARKETED TO BY : 10
311296
312- (2) AN EMPLOYER OF THE CO NSUMER.
297+ (I) THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 11
298+BASED ON THE CONSUME R’S GENETIC DATA; AND 12
313299
314-14–4406.
300+ (II) A THIRD PARTY BASED ON THE CONSUMER HAVING 13
301+ORDERED OR PURCHASED A GENETIC TESTING PR ODUCT OR SERVICE ; AND 14
315302
316- (A) A VIOLATION OF THIS SE CTION IS AN UNFAIR , ABUSIVE, OR DECEPTIVE
317-TRADE PRACTICE WITHI N THE MEANING OF TITLE 13 OF THIS ARTICLE AND IS
318-SUBJECT TO THE ENFOR CEMENT AND PENALTY PROVISIONS C ONTAINED IN TITLE
319-13 OF THIS ARTICLE.
303+ (6) INFORMED CONSENT IN C OMPLIANCE WITH THE F EDERAL POLICY 15
304+FOR THE PROTECTION O F HUMAN RESEARCH SUB JECTS FOR TRANSFER O R 16
305+DISCLOSURE OF THE CO NSUMER’S GENETIC DATA TO TH IRD PARTIES FOR 17
306+RESEARCH PURPOSES OR RESEARCH CONDUCTED U NDER THE CONTROL OF THE 18
307+COMPANY FOR THE PURPOSE O F PUBLICATION OR GEN ERALIZABLE KNOWLEDGE . 19
320308
321- (B) THIS SECTION DOES NOT PREVENT AN INDIVIDUA L FROM PURSUING
322-ANY OTHER REMEDY PRO VIDED BY LAW.
323- Ch. 501 2022 LAWS OF MARYLAND
309+14–4405. 20
324310
325-– 8 –
326-14–4407.
311+ (A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 21
312+ESTABLISH LEGAL POLI CIES AND PROCESSES F OR DISCLOSING GENETI C DATA TO 22
313+LAW ENFORCEMENT OR A NOTHER GOVERNMENT AG ENCY WITHOUT A CO NSUMER’S 23
314+EXPRESS WRITTEN CONS ENT. 24
327315
328- THE DISCLOSURE OF GEN ETIC DATA IN ACCORDA NCE WITH THIS SUBTIT LE
329-SHALL COMPLY WITH AL L STATE AND FEDERAL LAWS FOR THE PROTECTION O F
330-PRIVACY AND SECURITY .
316+ (B) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 25
317+DEVELOP, IMPLEMENT, AND MAINTAIN A COMPR EHENSIVE SECURITY PR OGRAM TO 26
318+PROTECT CONSUMERS ’ GENETIC DATA AGAINST UNAUTHORIZED ACCESS , USE, OR 27
319+DISCLOSURE. 28
331320
332-14–4408.
321+ (C) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 29
322+ESTABLISH A PROCESS FOR A CONSUMER TO : 30
333323
334- THIS SUBTITLE MAY BE KNOWN AND CITED AS T HE MARYLAND GENETIC
335-INFORMATION PRIVACY ACT.
324+ (1) ACCESS THE CONSUMER ’S GENETIC DATA; 31
336325
337-Article – Criminal Procedure
326+ (2) DELETE THE CONSUMER ’S ACCOUNT AND GENETI C DATA; AND 32 8 HOUSE BILL 866
338327
339-17–101.
340328
341- (a) In this title the following words have the meanings indicated.
342329
343- (c) “Direct–to–consumer genetic genealogy services” means genetic genealogy
344-services that are offered by private companies directly to members of the public and law
345-enforcement agencies rather than through clinical health care providers, typically via
346-customer access to secure online websites.
330+ (3) REQUEST THE DESTRUCTI ON OF THE CONSUMER ’S BIOLOGICAL 1
331+SAMPLE. 2
347332
348- (C–1) “EXPRESS CONSENT ” HAS THE MEANING STAT ED IN § 14–4401 OF THE
349-COMMERCIAL LAW ARTICLE.
333+ (D) NOTWITHSTANDING ANY O THER PROVISIONS OF L AW, A 3
334+DIRECT–TO–CONSUMER GENETIC TES TING COMPANY MAY NOT , WITHOUT THE 4
335+CONSUMER ’S WRITTEN CONSENT , DISCLOSE A CONSUMER ’S GENETIC DATA TO : 5
350336
351- (e) “Forensic genetic genealogical DNA analysis and search” or “FGGS” means:
337+ (1) AN ENTITY OFFERING HE ALTH INSURANCE , LIFE INSURANCE , 6
338+DISABILITY INSUR ANCE, OR LONG–TERM CARE INSURANCE ; OR 7
352339
353- (1) the forensic genetic genealogical DNA analysis of biological material
354-using SNP or other sequencing techniques to develop an FGG profile;
340+ (2) AN EMPLOYER OF THE CO NSUMER. 8
355341
356- (2) a subsequent search using the FGG profile in a publicly available
357-open–data personal genomics database or a direct–to–consumer genetic genealogy service
358-to find individuals related to the source of the FGG profile; and
342+14–4406. 9
359343
360- (3) a genealogical search using public records and other lawful means to
361-obtain information in accordance with this title.
344+ (A) A VIOLATION OF THIS SE CTION IS AN UNFAIR , ABUSIVE, OR DECEPTIVE 10
345+TRADE PRACTICE WITHI N THE MEANING OF TITLE 13 OF THIS ARTICLE AND IS 11
346+SUBJECT TO THE ENFOR CEMENT AND PE NALTY PROVISIONS CON TAINED IN TITLE 12
347+13 OF THIS ARTICLE. 13
362348
363- (g) “Publicly available open–data personal genomics database” means a database
364-in which persons voluntarily submit their genomics data or genetic profiles, typically
365-processed through direct–to–consumer genetic genealogy services, for the purposes of
366-comparison or searching against the genetic profiles of other individuals to evaluate
367-potential familial relationships between the reference sample and other service user
368-samples.
349+ (B) THIS SECTION DOES NOT PREVENT AN INDIVIDUA L FROM PURSUING 14
350+ANY OTHER REMEDY PRO VIDED BY LAW. 15
369351
370-17–102. LAWRENCE J. HOGAN, JR., Governor Ch. 501
352+14–4407. 16
371353
372-– 9 –
354+ THE DISCLOSURE OF GEN ETIC DATA IN ACCORDA NCE WITH THIS SUBTIT LE 17
355+SHALL COMPLY WITH AL L STATE AND FEDERAL LAW S FOR THE PROTECTION OF 18
356+PRIVACY AND SECURITY . 19
373357
374- (a) (1) FGGS may not be initiated without judicial authorization and without
375-certifying before the court that the forensic sample and the criminal case satisfy the criteria
376-set forth in this section.
358+14–4408. 20
377359
378- (2) If an FGGS is certified before a court in accordance with this section,
379-the court shall authorize the initiation of the FGGS.
360+ THIS SUBTITLE MAY BE KNOWN AND CITED AS T HE MARYLAND GENETIC 21
361+INFORMATION PRIVACY ACT. 22
380362
381- (d) FGGS may only be conducted using a direct–to–consumer or publicly available
382-open–data personal genomics database that:
363+Article – Criminal Procedure 23
383364
384- (1) provides explicit notice to its service users and the public that law
385-enforcement may use its service sites to investigate crimes or to identify human remains;
386-and
365+17–101. 24
387366
388- (2) seeks acknowledgement and EXPRESS consent from its service users
389-regarding the substance of the notice described in item (1) of this subsection.
367+ (a) In this title the following words have the meanings indicated. 25
390368
391-17–103.
369+ (c) “Direct–to–consumer genetic genealogy services” means genetic genealogy 26
370+services that are offered by private companies directly to members of the public and law 27
371+enforcement agencies rather than through clinical health care providers, typically via 28
372+customer access to secure online websites. 29
373+ HOUSE BILL 866 9
392374
393- (a) A defendant in a criminal case charged with a crime of violence under §
394-14–101 of the Criminal Law Article or a defendant convicted of a crime of violence under §
395-14–101 of the Criminal Law Article and seeking postconviction DNA testing is entitled to
396-seek judicial authorization for an FGGS by filing an affidavit with a trial court or
397-postconviction court certifying that:
398375
399- (4) an FGGS shall only be conducted using a direct–to–consumer or
400-publicly available open–data personal genomics database that:
376+ (C–1) “EXPRESS CONSENT ” HAS THE MEANING STAT ED IN § 14–4401 OF THE 1
377+COMMERCIAL LAW ARTICLE. 2
401378
402- (i) provides explicit notice to its service users and the public that
403-law enforcement may use its service sites to investigate crimes or to identify human
404-remains; and
379+ (e) “Forensic genetic genealogical DNA analysis and search” or “FGGS” means: 3
405380
406- (ii) seeks acknowledgment and EXPRESS consent from its service
407-users regarding the substance of the notice described in item (i) of this paragraph;
381+ (1) the forensic genetic genealogical DNA analysis of biological material 4
382+using SNP or other sequencing techniques to develop an FGG profile; 5
408383
409- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
410-October 1, 2022.
384+ (2) a subsequent search using the FGG profile in a publicly available 6
385+open–data personal genomics database or a direct–to–consumer genetic genealogy service 7
386+to find individuals related to the source of the FGG profile; and 8
411387
412-Enacted under Article II, § 17(c) of the Maryland Constitution, May 29, 2022.
388+ (3) a genealogical search using public records and other lawful means to 9
389+obtain information in accordance with this title. 10
390+
391+ (g) “Publicly available open–data personal genomics database” means a database 11
392+in which persons voluntarily submit their genomics data or genetic profiles, typically 12
393+processed through direct–to–consumer genetic genealogy services, for the purposes of 13
394+comparison or searching against the genetic profiles of other individuals to evaluate 14
395+potential familial relationships between the reference sample and other service user 15
396+samples. 16
397+
398+17–102. 17
399+
400+ (a) (1) FGGS may not be initiated without judicial authorization and without 18
401+certifying before the court that the forensic sample and the criminal case satisfy the criteria 19
402+set forth in this section. 20
403+
404+ (2) If an FGGS is certified before a court in accordance with this section, 21
405+the court shall authorize the initiation of the FGGS. 22
406+
407+ (d) FGGS may only be conducted using a direct–to–consumer or publicly available 23
408+open–data personal genomics database that: 24
409+
410+ (1) provides explicit notice to its service users and the public that law 25
411+enforcement may use its service sites to investigate crimes or to identify human remains; 26
412+and 27
413+
414+ (2) seeks acknowledgement and EXPRESS consent from its service users 28
415+regarding the substance of the notice described in item (1) of this subsection. 29
416+
417+17–103. 30
418+
419+ (a) A defendant in a criminal case charged with a crime of violence under § 31
420+14–101 of the Criminal Law Article or a defendant convicted of a crime of violence under § 32
421+14–101 of the Criminal Law Article and seeking postconviction DNA testing is entitled to 33 10 HOUSE BILL 866
422+
423+
424+seek judicial authorization for an FGGS by filing an affidavit with a trial court or 1
425+postconviction court certifying that: 2
426+
427+ (4) an FGGS shall only be conducted using a direct–to–consumer or 3
428+publicly available open–data personal genomics database that: 4
429+
430+ (i) provides explicit notice to its service users and the public that 5
431+law enforcement may use its service sites to investigate crimes or to identify human 6
432+remains; and 7
433+
434+ (ii) seeks acknowledgment and EXPRESS consent from its service 8
435+users regarding the substance of the notice described in item (i) of this paragraph; 9
436+
437+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 10
438+October 1, 2022. 11
439+
440+
441+
442+
443+Approved:
444+________________________________________________________________________________
445+ Governor.
446+________________________________________________________________________________
447+ Speaker of the House of Delegates.
448+________________________________________________________________________________
449+ President of the Senate.