EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
Italics indicate opposite chamber/conference committee amendments.
*hb0866*
HOUSE BILL 866
I3 (2lr2894)
ENROLLED BILL
— Economic Matters/Finance —
Introduced by Delegate Qi
Read and Examined by Proofreaders:
_______________________________________________
Proofreader.
_______________________________________________
Proofreader.
Sealed with the Great Seal and presented to the Governor, for his approval this
_______ day of _______________ at _________________ _______ o’clock, ________M.
______________________________________________
Speaker.
CHAPTER ______
AN ACT concerning 1
Commercial Law – Consumer Protection – Genetic Information Privacy 2
– Consumer Protection and Forensic Genealogy 3
FOR the purpose of regulating the use of genetic data by direct–to–consumer genetic testing 4
companies, including by requiring a direct–to–consumer genetic testing company to 5
provide consumers with certain information regarding the company’s policies and 6
procedures, obtain certain consents from consumers before collecting, using, or 7
disclosing the consumer’s genetic data, and develop and implement certain policies 8
and procedures to protect genetic data and provide for certain disclosures to law 9
enforcement and other government agencies; altering the direct–to–consumer or 10
publicly available open–data personal genomics databases that may be used to 11
conduct forensic genetic genealogical DNA analysis and search to require that the 12
databases seek express consent from their service users regarding the substance of 13
a certain notice; and generally relating to genetic information privacy. 14
2 HOUSE BILL 866
BY repealing and reenacting, with amendments, 1
Article – Commercial Law 2
Section 13–301(14)(xxxiv) and (xxxv) 3
Annotated Code of Maryland 4
(2013 Replacement Volume and 2021 Supplement) 5
BY adding to 6
Article – Commercial Law 7
Section 13–301(14)(xxxvi); and 14–4401 through 14–4408 to be under the new 8
subtitle “Subtitle 44. Genetic Information Privacy Act” 9
Annotated Code of Maryland 10
(2013 Replacement Volume and 2021 Supplement) 11
BY repealing and reenacting, without amendments, 12
Article – Criminal Procedure 13
Section 17–101(a), (c), (e), and (g) and 17–102(a) 14
Annotated Code of Maryland 15
(2018 Replacement Volume and 2021 Supplement) 16
BY adding to 17
Article – Criminal Procedure 18
Section 17–101(c–1) 19
Annotated Code of Maryland 20
(2018 Replacement Volume and 2021 Supplement) 21
BY repealing and reenacting, with amendments, 22
Article – Criminal Procedure 23
Section 17–102(d) and 17–103(a)(4) 24
Annotated Code of Maryland 25
(2018 Replacement Volume and 2021 Supplement) 26
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 27
That the Laws of Maryland read as follows: 28
Article – Commercial Law 29
13–301. 30
Unfair, abusive, or deceptive trade practices include any: 31
(14) Violation of a provision of: 32
(xxxiv) The federal Servicemembers Civil Relief Act; [or] 33
(xxxv) [§] SECTION 11–210 of the Education Article; or 34
HOUSE BILL 866 3
(XXXVI) TITLE 14, SUBTITLE 44 OF THIS ARTICLE; OR 1
SUBTITLE 44. GENETIC INFORMATION PRIVACY ACT. 2
14–4401. 3
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 4
INDICATED. 5
(B) (1) “BIOLOGICAL SAMPLE ” MEANS A MATERIAL PAR T OR A 6
DERIVATIVE OF OR DIS CHARGE FROM A MATERI AL PART OF A HUMAN K NOWN TO 7
CONTAIN DNA. 8
(2) “BIOLOGICAL SAMPLE ” INCLUDES HUMAN TISSU E, BLOOD, 9
URINE, AND SALIVA. 10
(C) (1) “DEIDENTIFIED DATA ” MEANS DATA THAT : 11
(I) (1) CANNOT REASONABLY BE : 12
1. (I) USED TO INFER INFORMA TION ABOUT A CONSUME R; 13
OR 14
2. (II) LINKED TO AN IDENTIFI ABLE CONSUMER ; AND 15
(2) IS SUBJECT TO: 16
(I) ADMINISTRATIVE AND TE CHNICAL MEASURES TO ENSURE 17
THAT THE DATA CANNOT BE ASSOCIATED WITH A PARTICULAR CONSUMER ; 18
(II) PUBLIC COMMITMENT BY THE COMPANY TO MAINT AIN AND 19
USE DATA IN A DEIDEN TIFIABLE FORM AND NO T ATTEMPT TO REIDENTIFY DATA ; 20
AND 21
(III) LEGALLY ENFORCEABLE C ONTRACTUAL OBLIGATIO NS 22
THAT PROHIBIT A RECI PIENT OF THE DATA FR OM ATTEMPTING TO REI DENTIFY THE 23
DATA. 24
(D) (1) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” MEANS 25
AN ENTITY THAT: 26
(1) (I) (1) OFFERS GENETIC TESTIN G PRODUCTS OR SERVIC ES 27
DIRECTLY TO A CONSUM ER; OR 28
4 HOUSE BILL 866
(2) (II) (2) COLLECTS, USES, OR ANALYZES GENETIC DATA THAT 1
RESULTED FROM A DIRE CT–TO–CONSUMER GENETIC TES TING PRODUCT OR 2
SERVICE THAT WAS PROVIDED TO THE COMP ANY BY A CONSUMER . 3
(2) “DIRECT–TO–CONSUMER GENETIC TES TING COMPANY ” DOES NOT 4
INCLUDE AN ENTITY ON LY WHEN THE ENTITY I S ENGAGED IN COLLECT ING, 5
ANALYZING, RETAINING, OR DISCLOSING GENETI C DATA OR BIOLOGICAL SAMPLES 6
IN THE CONTEXT OF RE SEARCH, AS DEFINED IN 45 C.F.R. 164.501, CONDUCTED IN 7
ACCORDANCE WITH : 8
(I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMAN 9
SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46; 10
(II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY 11
THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR 12
(III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION 13
OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56. 14
(E) “DNA” MEANS DEOXYRIBONUCLE IC ACID. 15
(F) “EXPRESS CONSENT ” MEANS AN AFFIRMATIVE RESPONSE BY A 16
CONSUMER TO A SPECIF IC, DISCRETE, FREELY GIVEN, AND UNAMBIGUOUS NOTI CE 17
REGARDING THE COLLEC TION, USE, OR DISCLOSURE OF THE CONSUMER ’S GENETIC 18
DATA FOR A SPECIFIC PURPOSE. 19
(G) (1) “GENETIC DATA” MEANS DATA, IN ANY FORMAT, THAT CONCERNS 20
THE GENETIC CHARACTE RISTICS OF A CONSUME R. 21
(2) “GENETIC DATA” INCLUDES: 22
(I) RAW SEQUENCE DATA THAT R ESULT FROM SEQUENCIN G OF 23
A CONSUMER ’S COMPLETE EXTRACTED DNA OR A PORTION OF THE CONSUMER’S 24
COMPLETE EXTRACTED DNA; 25
(II) GENOTYPIC AND PHENOTY PIC INFORMATION THAT 26
RESULTS FROM ANALYZI NG RAW SEQUENCE DATA ; AND 27
(III) INFORMATION E XTRAPOLATED , DERIVED, OR INFERRED 28
FROM THE ANALYSIS OF RAW SEQUENCE DATA ; AND 29
(III) (IV) SELF–REPORTED HEALTH INFO RMATION SUBMITTED 30
TO A DIRECT –TO–CONSUMER GENETIC TES TING COMPANY BY A CO NSUMER 31
REGARDING THE CONSUM ER’S HEALTH CONDITIONS : 32 HOUSE BILL 866 5
1. THAT IS USED FOR SCIENTIFI C RESEARCH OR 1
PRODUCT DEVELOPMENT ; AND 2
2. ANALYZED IN CONNECTIO N WITH THE CONSUMER ’S 3
RAW SEQUENCE DATA . 4
(3) “GENETIC DATA” DOES NOT INCLUDE DEI DENTIFIED DATA WHEN 5
USED FOR RESEARCH PR OJECTS. 6
(H) “GENETIC TESTING ” MEANS A LABORATORY TEST OF T HE COMPLETE 7
DNA, REGIONS OF DNA, CHROMOSOMES , GENES, OR GENE PRODUCTS OF A 8
CONSUMER TO DETERMIN E THE GENETIC CHARAC TERISTICS OF THE CON SUMER. 9
(I) “MARKETING” DOES NOT INCLUDE THE PROVIDING CUSTOMIZED 10
CONTENT OR OFFERS ON THE WEBSITES OR THROUGH THE APPLI CATIONS OR 11
SERVICES PROVIDED BY THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 12
WITH THE FIRST–PARTY RELATIONSHIP T O THE CONSUMER . 13
14–4402. 14
THIS SUBTITLE DOES NO T APPLY TO:: 15
(1) PROTECTED PROTECTED (1) PROTECTED HEALTH INFORMATION 16
THAT IS COLLECTED BY A COVERED ENTITY OR BUSINESS ASSOCIATE A S DEFINED IN 17
45 C.F.R. PARTS 160 AND 164; 18
(2) AN INSTITUTION OF HIG HER EDUCATION , AS DEFINED IN § 10–101 19
OF THE EDUCATION ARTICLE; OR 20
(3) AN ENTITY OWNED OR OP ERATED BY AN INSTITU TION OF HIGHER 21
EDUCATION, AS DEFINED IN § 10–101 OF THE EDUCATION ARTICLE.; OR 22
(2) GENETIC DATA OR BIOLO GICAL SAMPLES COLLEC TED FOR THE 23
PURPOSE OF RESEARCH , AS DEFINED IN 45 C.F.R. 164.501, THAT IS CONDUCTED IN 24
ACCORDANCE WITH : 25
(I) THE FEDERAL POLICY FO R THE PROTECTION OF HUMAN 26
SUBJECTS ESTABLISHED IN 45 C.F.R. PART 46; 27
(II) THE GOOD CLINICAL PRACTICE GUIDELINES ISSUED BY 28
THE INTERNATIONAL COUNCIL FOR HARMONISATION ; OR 29
6 HOUSE BILL 866
(III) THE U.S. FOOD AND DRUG ADMINISTRATION PROTECTION 1
OF HUMAN SUBJECTS UNDER 21 C.F.R. PARTS 50 AND 56. 2
14–4403. 3
(A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL P ROVIDE 4
A CONSUMER WITH CLEA R AND COMPLETE INFOR MATION REGARDING THE 5
COMPANY’S POLICIES AND PROCE DURES FOR COLLECTING , USING, OR DISCLOSING 6
GENETIC DATA , INCLUDING: 7
(1) A HIGH–LEVEL OVERVIEW OF TH E COMPANY’S PRIVACY POLICY 8
THAT INCLUDES BASIC AND ESSENTIAL INFORM ATION ABOUT HOW THE COMPANY 9
COLLECTS, USES, AND DISCLOSES GENETI C DATA; AND 10
(2) A PRIVACY NOTICE THAT , AT A MINIMUM , INCLUDES 11
INFORMATION ABOUT TH E COMPANY’S DATA COLLECTION , CONSENT, USE, ACCESS, 12
DISCLOSURE, TRANSFER, SECURITY, AND RETENTION AND DE LETION PRACTICES . 13
(B) THE INFORMATION REQUI RED TO BE PROVIDED U NDER SUBSECTION (A) 14
OF THIS SECTION SHAL L BE: 15
(1) MADE PUBLICLY AVAILAB LE; AND 16
(2) PLACED IN A PROMINENT AREA OF THE DIRECT –TO–CONSUMER 17
GENETIC TESTING COMP ANY’S WEBSITE. 18
14–4404. 19
A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY , AT A MINIMUM , 20
SHALL OBTAIN THE FOL LOWING CONSENTS FROM A CONSUMER BEFORE 21
COLLECTING, USING, OR DISCLOSING THE CONSUMER ’S GENETIC DATA: 22
(1) INITIAL EXPRESS CONSE NT THAT CLEARLY : 23
(I) DESCRIBES THE USES OF THE GENETIC DATA COL LECTED 24
THROUGH THE GENETIC TESTING PRODUCT OR S ERVICE; AND 25
(II) SPECIFIES: 26
1. WHO HAS ACCESS TO THE RESULTS OF THE GENET IC 27
TESTING; AND 28
2. HOW THE GENETIC DATA MAY BE SHARED ; 29
HOUSE BILL 866 7
(2) EXPRESS CONSENT FOR T RANSFERRING OR DISCL OSING THE 1
CONSUMER ’S GENETIC DATA TO A PERSON OTHER THAN TH E COMPANY’S VENDORS 2
AND SERVICE PROVIDER S; 3
(3) EXPRESS CONSENT FOR U SING GENETIC DATA BE YOND THE 4
PRIMARY PURPOSE OF T HE GENETIC TESTING P RODUCT OR SERVICE RE QUESTED BY 5
THE CONSUMER ; 6
(4) EXPRESS CONSENT FOR T HE RETENTION OF A BI OLOGICAL 7
SAMPLE PROVIDED BY T HE CONSUMER AFTER TH E INITIAL TESTING SE RVICE 8
REQUESTED BY THE CON SUMER IS COMPLETED ; 9
(5) EXPRESS CONSENT TO BE MARKETED TO BY : 10
(I) THE DIRECT–TO–CONSUMER GENETIC TES TING COMPANY 11
BASED ON THE CONSUME R’S GENETIC DATA; AND 12
(II) A THIRD PARTY BASED ON THE CONSUMER HAVING 13
ORDERED OR PURCHASED A GENETIC TESTING PR ODUCT OR SERVICE ; AND 14
(6) INFORMED CONSENT IN C OMPLIANCE WITH THE F EDERAL POLICY 15
FOR THE PROTECTION O F HUMAN RESEARCH SUB JECTS FOR TRANSFER O R 16
DISCLOSURE OF THE CO NSUMER’S GENETIC DATA TO TH IRD PARTIES FOR 17
RESEARCH PURPOSES OR RESEARCH CONDUCTED U NDER THE CONTROL OF THE 18
COMPANY FOR THE PURPOSE O F PUBLICATION OR GEN ERALIZABLE KNOWLEDGE . 19
14–4405. 20
(A) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 21
ESTABLISH LEGAL POLI CIES AND PROCESSES F OR DISCLOSING GENETI C DATA TO 22
LAW ENFORCEMENT OR A NOTHER GOVERNMENT AG ENCY WITHOUT A CO NSUMER’S 23
EXPRESS WRITTEN CONS ENT. 24
(B) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 25
DEVELOP, IMPLEMENT, AND MAINTAIN A COMPR EHENSIVE SECURITY PR OGRAM TO 26
PROTECT CONSUMERS ’ GENETIC DATA AGAINST UNAUTHORIZED ACCESS , USE, OR 27
DISCLOSURE. 28
(C) A DIRECT–TO–CONSUMER GENETIC TES TING COMPANY SHALL 29
ESTABLISH A PROCESS FOR A CONSUMER TO : 30
(1) ACCESS THE CONSUMER ’S GENETIC DATA; 31
(2) DELETE THE CONSUMER ’S ACCOUNT AND GENETI C DATA; AND 32 8 HOUSE BILL 866
(3) REQUEST THE DESTRUCTI ON OF THE CONSUMER ’S BIOLOGICAL 1
SAMPLE. 2
(D) NOTWITHSTANDING ANY O THER PROVISIONS OF L AW, A 3
DIRECT–TO–CONSUMER GENETIC TES TING COMPANY MAY NOT , WITHOUT THE 4
CONSUMER ’S WRITTEN CONSENT , DISCLOSE A CONSUMER ’S GENETIC DATA TO : 5
(1) AN ENTITY OFFERING HE ALTH INSURANCE , LIFE INSURANCE , 6
DISABILITY INSUR ANCE, OR LONG–TERM CARE INSURANCE ; OR 7
(2) AN EMPLOYER OF THE CO NSUMER. 8
14–4406. 9
(A) A VIOLATION OF THIS SE CTION IS AN UNFAIR , ABUSIVE, OR DECEPTIVE 10
TRADE PRACTICE WITHI N THE MEANING OF TITLE 13 OF THIS ARTICLE AND IS 11
SUBJECT TO THE ENFOR CEMENT AND PE NALTY PROVISIONS CON TAINED IN TITLE 12
13 OF THIS ARTICLE. 13
(B) THIS SECTION DOES NOT PREVENT AN INDIVIDUA L FROM PURSUING 14
ANY OTHER REMEDY PRO VIDED BY LAW. 15
14–4407. 16
THE DISCLOSURE OF GEN ETIC DATA IN ACCORDA NCE WITH THIS SUBTIT LE 17
SHALL COMPLY WITH AL L STATE AND FEDERAL LAW S FOR THE PROTECTION OF 18
PRIVACY AND SECURITY . 19
14–4408. 20
THIS SUBTITLE MAY BE KNOWN AND CITED AS T HE MARYLAND GENETIC 21
INFORMATION PRIVACY ACT. 22
Article – Criminal Procedure 23
17–101. 24
(a) In this title the following words have the meanings indicated. 25
(c) “Direct–to–consumer genetic genealogy services” means genetic genealogy 26
services that are offered by private companies directly to members of the public and law 27
enforcement agencies rather than through clinical health care providers, typically via 28
customer access to secure online websites. 29
HOUSE BILL 866 9
(C–1) “EXPRESS CONSENT ” HAS THE MEANING STAT ED IN § 14–4401 OF THE 1
COMMERCIAL LAW ARTICLE. 2
(e) “Forensic genetic genealogical DNA analysis and search” or “FGGS” means: 3
(1) the forensic genetic genealogical DNA analysis of biological material 4
using SNP or other sequencing techniques to develop an FGG profile; 5
(2) a subsequent search using the FGG profile in a publicly available 6
open–data personal genomics database or a direct–to–consumer genetic genealogy service 7
to find individuals related to the source of the FGG profile; and 8
(3) a genealogical search using public records and other lawful means to 9
obtain information in accordance with this title. 10
(g) “Publicly available open–data personal genomics database” means a database 11
in which persons voluntarily submit their genomics data or genetic profiles, typically 12
processed through direct–to–consumer genetic genealogy services, for the purposes of 13
comparison or searching against the genetic profiles of other individuals to evaluate 14
potential familial relationships between the reference sample and other service user 15
samples. 16
17–102. 17
(a) (1) FGGS may not be initiated without judicial authorization and without 18
certifying before the court that the forensic sample and the criminal case satisfy the criteria 19
set forth in this section. 20
(2) If an FGGS is certified before a court in accordance with this section, 21
the court shall authorize the initiation of the FGGS. 22
(d) FGGS may only be conducted using a direct–to–consumer or publicly available 23
open–data personal genomics database that: 24
(1) provides explicit notice to its service users and the public that law 25
enforcement may use its service sites to investigate crimes or to identify human remains; 26
and 27
(2) seeks acknowledgement and EXPRESS consent from its service users 28
regarding the substance of the notice described in item (1) of this subsection. 29
17–103. 30
(a) A defendant in a criminal case charged with a crime of violence under § 31
14–101 of the Criminal Law Article or a defendant convicted of a crime of violence under § 32
14–101 of the Criminal Law Article and seeking postconviction DNA testing is entitled to 33 10 HOUSE BILL 866
seek judicial authorization for an FGGS by filing an affidavit with a trial court or 1
postconviction court certifying that: 2
(4) an FGGS shall only be conducted using a direct–to–consumer or 3
publicly available open–data personal genomics database that: 4
(i) provides explicit notice to its service users and the public that 5
law enforcement may use its service sites to investigate crimes or to identify human 6
remains; and 7
(ii) seeks acknowledgment and EXPRESS consent from its service 8
users regarding the substance of the notice described in item (i) of this paragraph; 9
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 10
October 1, 2022. 11
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
Speaker of the House of Delegates.
________________________________________________________________________________
President of the Senate.