Hi Bob,
My name is Jenny LaChance, and I have been working with Mona on the data. We are now doing in
depth GIS analysis, which involves actual address (beyond zipcode), Would adding actual address slow
down the request for the State data? I believe this would not longer be a limited data set. Any advice or
guidance would be truly appreciated.
Thank you so much!
Jenny
xxxEND_PAGE:dhhs02_b0942_3364_3430_09
003373
DATA USE AND NON-DISCLOSURE AGREEMENT CONCERNING
PROTECTED HEALTH INFORMATION OR OTHER CONFIDENTIAL INFORMATION
Michigan Department of Health and Human Services
Project Title: Analysis of Pediatric Blood Lead Levels in Flint, Ml
Data Recipient: Mona Hanna-Attisha, MD MPH and co investigators Jenny LaChance MS and Richard Sadler PhD
Organization: Hurley Medical Center
Address: One Hurley Plaza
Flint, Mi 48503
Phone: 810-262-7257 e-mail:
[email protected]
In accordance with this agreement, data are provided by the Michigan Department of Health and Human Services
(MDHHS), Family, Maternal and Child Health/Family and Community Health on September/October 2015 to the
Data Recipient.
The parties agree to the provisions specified in this Agreement, the Health insurance Portability and Accountability Act
(HIPAA), and all other applicable public health, research, and confidentiality laws.
What is the Source of the Requested Data? (e.g., Vital Records, Health Statistics, Cancer Surveillance, Medicaid, etc.)
MDHHS Childhood Lead Poisoning Prevention Program database
What is the Data Recipient's Purpose for, and Specific Use of, the Data?
4. Describe why these data are requested (e.g., Research, Statistics, Public Health, Health Care Operations, Administration
of the Medicaid Program).
These data are being requested for two reasons: the primary purpose is related to public health. We are looking at
the impact so that measures can be implemented to address any increase in children with elevated blood levels. The
data is also being for research purposes so our findings can be shared with other communities.
2. Describe how the data will be used/disclased, or incorporate by reference and attach a copy of the research protocol,
work plan, or request letter that details the purpose and use of data, etc.
Data for SPSS will be deidentified once 1) one value per person has been selected, 2) whether or not they live in the
higher risk part of Flint for lead has been coded, and 3) the timing of when they had their lead level (pre/post) has
been determined. GIS analysis will use address but will not include any other PHI identifiers.
Data will saved only on encrypted zip drives or secure hospital computers located in personal office of one of the
researchers. Only the 3 researchers directly involved with study will have any access to data. Encrypted zip drives
will be kept secure with a researcher or in a locked office at all times. Once identifiable data is not needed, files with
identifiable information will be destroyed.
3. Describe the data requested indicating amount, type, by what medium the data will be provided, and whether the data
recipient is granted access to the data warehouse or state archives.
Data Overview Description
a. Specify the data elements (e.g., age, gender, etc.) and time periods (e.g., January 2003 through January 2006).
Time period: January 2013 through Sept 15,2015; Data Elements: Child ID number, date of birth, date of blood
draw, address with zip code, blood lead level, and specimen type. Gender, race and insurnace type are also
requested if available.
b. — Specify if the data requested is identifiable, de-identified, or a limited data set as defined by HIPAA.
identifiable since addresses are being requested for GIS analysis
DCH-1294 (05/15) Page 1 of 5
xxxEND_PAGE:dhhs02_b0942_3364_3430_10
003374
c. Speaify the medium requested .G, elecisonic, hard capy, ete.).
eleotronic
d. Spacify if direot access to the data wardirouse or state archives is requested.
Not unless necessary for this request of data
BOHH4204 (GB/t5) Page 2 of 5
xxxEND_PAGE:dhhs02_b0942_3364_3430_11
003375
Research Project: Complete this box if requested data will be used for human subjects research.
Is Institutional Review Board (IRB) (human subjects research) approval required? i] YES LINo
If YES, MDHHS Approval Number... cece cece Approval Number
(Attach MDHHS Approval Form)
Is HIPAA Informed Consent/Authorization Waiver Required? KX] YES LINO
lf YES, MDHHS Approval Number (if above IRB approval not required)... eee Approval Number
(Attach HIPAA Waiver Authorization, if relevant.)
With regard to data provided under this agreement, the Data Recipient agrees to:
4. Use and disclose the data only in accordance with this agreement, or as otherwise required by law;
2. Limit access to these data only to those described and authorized in this agreement; (MDHHS may require the specific
identification of the person(s) or the agency/division/office that is permitted access. {dentify if needed.)
3. Use appropriate safeguards to prevent use or disclosure of the information other than as provided by this agreement;
(MDHHS sponsor may require description of the security procedures that will be in place and followed.) Data will be kept
very secure through the use of encrypted thumb drives (or on hospital secure computers in individual researchers’
offices) and only seen by 3 researchers. Data will be with one of the researchers or in a Jocked office at all times.
Identifiers will be removed for files for analysis as not needed and all identifiable data destroyed once not needed. As
soon as data files and analysis are completed, fites with identifiers will be destroyed. For GiS analysis, data and
analysis file with address will be kept until after all work on data is complete, including dissemination and time for peer
response.
4. Report to the responsible MDHHS sponsor any use or disclosure of information that is not provided for by this data
use agreement;
5. Ensure that any agent(s) or subcontractor(s) who access these data agree to the same restrictions and conditions that
apply to the data recipient; (MOHHS sponsor may stipulate that release of data to a subcontractor cannot be done without
the written authorization of MDHHS.)
6. Make no attempt to identify or contact the individuals, providers, or health plans within the data provided unless
approved in this agreement; (Describe any agreed upon exceptions if needed.)
7. Data recipient must provide MDHHS at least thirty days to review and provide comments on papers, publications, or
presentations that the data recipient plans to submit for publication or presentation. Data recipient agrees that it will
not publish or disseminate any protected heaith information, personally identifiable information, or data that might
make it possible, directly or indirectly, to identify an individual. Data recipient must acknowledge the MDHHS program
as appropriate (e.g., source of data, etc.), assume full responsibility for the analysis and interpretation of the data, and
provide a copy of the publication or presentation to MDHHS. To the extent data recipient requires technical
assistance in analyzing or interpreting the data and when such assistance goes beyond providing non-manipulated
data, MDHHS reserves the right to request that these activities be considered a substantial contribution to the
research being conducted and that the provision of such assistance may warrant MDHHS be considered as a
research collaborator or co-author in any resulting publications or presentations;
8. Return or destroy all originals and copies of any potentially identifiable information upon completion of project, or upon
request, unless otherwise approved in this agreement. This includes, but is not limited to: magnetic tape, micro disk
files, paper records, etc. If not returned to the MOHHS, then the data must be destroyed; e.g., use a CD/DVD
shredder to destroy CD Roms, DVDs, efc., erase floppy/zip disks using a magnet, shred paper records, clean
computer hard drives with a program designed to wipe a disk by overwriting, etc.;
9. Not use the data provided to engage in any method, act, or practice which constitutes a commercial solicitation or
advertisement of goods, services, or real estate to consumers; and
10. Not use the data provided as a basis for legal, administrative or other actions which may affect particular individuals or
establishments as a result of their specific identification in this project.
DCH-1294 (05/18) Page 3 of 5
xxxEND_PAGE:dhhs02_b0942_3364_3430_12
003376
The MDHHS may cancel this agreement with proper netite.
Tire unauitirsitezed use or disetesere ef confidential information is punishable by imprisenneent er fine er beth under state
anid fetteral laws specific to the data released.
DEHHAF204 (BRATS) Page 4 of 5
xxxEND_PAGE:dhhs02_b0942_3364_3430_13
003377
|, the data recipient, have read, understand, and agree to the above conditions.
DATA RECIPIENT SIGNATURE:
Mona Hanna-Attisha, MD, MPH Director, Pediatric Residency Program, Hurley Children's Hospital
Name of Responsible Data Recipient (Type or Print) Title
Signature of Responsible Data Recipient Date
MDHHS SIGNATURES:
MDHHS SPONSOR
Robert L. Scott Departmental Specialist
Name of Responsible MDHHS Sponsor (Type or Print} Title
Signature of Responsible MDHHS Sponsor Date
MDHHS RESPONSIBLE PARTY
Brenda Fink, A.C.S.W. Director, Division of Family and Community Health
Name of MOHHS Director, Bureau Director, or Delegated Authority (Type or Print) Title
Signature of MOHHS Director, Bureau Director, or Delegated Authority Date
AUTHORITY: This form is acceptable to the Michigan Department of Health and Human Services as compliant with
: HIPAA privacy regulations, 45 CFR Parts 160 and 164 as amended,
COMPLETION: Is required if disclosure is requested.
The Michigan Department of Heaith and Human Services is an equal opportunity employer, services, and programs provider.
DCH-1294 (05/15) Page 6 of 5
xxxEND_PAGE:dhhs02_b0942_3364_3430_14
003378
Peeler, Nancy (DHHS)