Download Newborn Screening Laws Regarding Use of Residual Dried Blood

MATERNAL AND CHILD HEALTH
Newborn Screening Laws Regarding Use of Residual Dried
Blood Samples and Related Information
Survey of State Laws by Topic
The following topics have been covered by one or more states by statute and/or regulation. To see relevant
excerpts of law for the states that have covered a topic within a category, click on the topic. State statutes and
regulations were accessed online between February 2014 and December 2014.
Coverage
States
Retention & Disposal
 Retention and disposition of DBS 
CA, CT, DE, HI, IL, IN, IA, ME, MI, MN, MS, MO, MT, NE, NH,
NM, ND, OH, OK, SD, TX, WA
 Parents may request destruction of DBS
 Child may request destruction of DBS when turns 18
 Disposition of information related to DBS
MN, MO, SC, TX, WA
MN, SC, WA
AK, MN, MO, NE, ND, WI
Ownership & Control
 DBS become property of the state
UT, WA
 DBS become property of the state unless parents object 
CA, ME
 Information becomes property of the state unless parents object  CA, ME
 Department has authority over use of information 
PA, TX, UT, WI
Use & Disclosure
 Permissible uses of DBS
 Uses of DBS for which parental permission is not required 
 Prohibited uses of DBS
 Permissible uses of information related to DBS
 Use of DBS with consent for testing of conditions not on NBS
panel 
 Sharing information within department, with other systems,
departments or states 
 Obligation to publish results of research 
 Department may notify parents of research results if information
may benefit health of child 
 Department may give information to child when turns 18 if
information may be beneficial to health of child 
CA, DE, ID, IL, IN, IA, ME, MI, MN, MO, MT, NE, ND, SC, UT,
WA, WI
CA, ME, MN, MO, SC, UT, WA
ID, IA, MN, MS, NH, NM, SD
AK, AZ, CA, FL, HI, IN, IA, ME, MD, MN, MS, MO, NE, NJ, OK,
OR, TN, TX, VA, WI
MA
NJ, OH, TX, VA
ME, NE
SC
SC
Privacy & Security
 Confidentiality of information 
 Department must code DBS before release
 Results published without identifying information
 Only de-identified information may be published 
 Security of storage of DBS 
 Security of health information 
 Written confidentiality agreement required 
AK, AZ, AR, CA, CO, DE, DC, FL, HI, ID, IL, IN, IA, LA, MD, MA,
MI, MN, MS, MO, NV, NH, NJ, ND, OK, PA, SC, TN, TX, VA, WA,
WV, WI
SC
ME
VA
CA, IA, ME, NE, WA
AK, CA, MS, NE, NH, ND, VA, WA
CA, WA
Review & Approval
 Research projects using DBS must be approved by Department CA, IA, MO, NE, ND, UT, WA
 Department has authority to approve researchers who may
have
CA, ME, NE, WA
access to DBS
 IRB approval required to use DBS for research 
CA, IA, MN, ND, SC, UT, WA
 IRB approval required for research using information 
CA, DE, MA, MN, NE, ND, TX, WA
 Criteria for research approval specified 
CA, NE, ND, WI
 Department may use other IRBs to approve research activities
CA
 Notice posted on website regarding approval to disclose
TX
 Researcher must provide Department with documents produced
ND
from research project for review of compliance with terms of use
 Material transfer agreement required
NE
Notification & Consent
 Parents must be provided information re the retention of DBS 
 Parents must be informed of the benefits of storage of DBS 
 Information provided to parents about retention/release of
information 
 Parents must be informed of scope of the information to be
released 
 Statistical data not considered confidential and may be
released without consent
 Parental consent required under certain circumstances to
release DBS 
 Opt-out permitted 
 Expiration of consent to release identifiable information
IA, MI, MN, NE, SC, TX, UT, WA
MN, SC
IA, MD, MN, TX, WI
AK, CA, DC, MD, MN, MO
AK, AR, CA, CO, DE, DC, MS, MO, NE, NV, NJ, ND, TN, TX, UT,
VA
ID, IA, ME, MN, NE, NH, UT, WA
CA, IA, ME, MN, MO, SC, WA
AK
Fees
 State may charge a fee for use of DBS
 Fee may not exceed cost of administering the program
 State may charge a reasonable fee for use of DBS
 Sale of DBS and information prohibited 
CA, MO, NE, ND
CA
MO, NE
MN
SUPPORTERS
The Network for Public Health Law is a national initiative of the Robert Wood Johnson Foundation with direction and technical assistance by
the Public Health Law Center at William Mitchell College of Law.
This document was developed by Denise Chrysler J.D., Director, at the Network for Public Health Law – Mid-States Region, University of
Michigan School of Public Health and Michelle Huckaby Lewis, M.D., J.D., Research Scholar, at the Berman Institute of Bioethics, Johns
Hopkins University, as part of a toolkit on newborn screening laws regarding the use of residual dried blood samples. Preparation of the
toolkit was assisted by a Public Health Law Research Program grant from the Robert Wood Johnson Foundation.
The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice,
please consult specific legal counsel.
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