Linking Data Through a Public Private Partnership Getting Started: Database Access and Confidentiali

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Linking Data Through a Public - Private
Partnership Getting Started Database Access and
Confidentiality Issues

• Milton Kotelchuck, PhD, MPH
• Pregnancy to Early Life Longitudinal (PELL)
  Linkage Project
  
• December 11, 2003
• MICHEP, Tempe, Arizona

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PELL TeamA Public-Private Partnership
BUSPH Mary Barger, CNM, MPH Christine Chaisson,
MPH Gene Declercq, PhD Stephen Evans, MPH Milto
n Kotelchuck, PhD, MPH Jane Lazar Mass DPH Wa
nda Barfield, MD, MPH Angela Nannini, NP, PhD CD
C Kay Tomashek, MD, MPH
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PELL Overview

• Public/Private partnership
• Funded to assess impact of prenatal environment
  on subsequent child (and maternal) health
  
• Utilizes a broad range of public health data
• Longitudinal data system (developmentally based)
• Allows for multiple types of linkages and
  analysis, including dyadic, maternal, child,
  multiple sibling and family
  
• Breadth of data system is expandable
• Offers a conceptual and practical model for other
  states

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Core Data Sets
Birth Certificate
Hospital Discharge (HD) Mothers Birth
Hospital Discharge (HD) Childs Birth
Fetal Death
(Core Linkage)

• Core linkage of Birth Certificate and Hospital
  Discharge Data
  
• Dyadic Linkage Mother and Child
• Includes Fetal Deaths
• Started in 1998 - 320,000 Infant Records and
• 280,000 Maternal Records to date

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Health Status Health Services/Programmatic
Data Linkages
WIC
Birth Defects Registry
Child and Maternal Death Files
Birth Certificate
(HD) Birth Mothers
Early Intervention
Linked Birth-Infant Death
MassPro Quality Data
Fetal Death
(HD) Birth Child
Healthy Start
HD/Observational Stays/Emergency Room Data
(Core)
Child Care Coordination
Future Data Sets (NICU, ART, ...)
Future Contextual Data Sets (Area Resource File,
Census, )
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Vital and Health Status Data Sets
Programmatic Data Sets

• Birth Certificates
• Fetal Deaths
• Linked Birth-Infant Deaths
• Childhood Mortality
• Maternal Mortality
• Birth Defects Registry

Early Intervention WIC MA Healthy Start Child C
are Coordination

Clinical Data Sets
Contextual Data Sets
MassPro Data NICU data (future) WIC (some items)
Birth certificates (some items) Hospital Discha
rge (some Items)

Area Resource File (future) Census (future)
Health Services Usage (and Costs)
Hospital Admissions Observational Stays Emergenc
y Room
PNC (Birth Certificate)
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Maternal or Child Linked Longitudinal Capacity
Subsequent Records Childs Hospital Discharges, O
bservational Stay, ER Usage Mothers Hospital Dis
charges, Observational Stays, ER Usage
1999
Birth Certificate
Hospital Discharge (HD) Mothers Birth
Prior Information Mothers Pregnancy Hospital Dis
charges, Observational Stays, Emergency Room
Usage 1998, 1999

Hospital Discharge (HD) Childs Birth
Fetal Death
Subsequent Records Childs Hospital Discharges, O
bservational Stay, ER Usage Mothers Hospital Dis
charges, Observational Stays, ER Usage
2000
(Core, 1999)
Program Participation Data, PNC Usage (1998, 199
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Program Participation Data 1999, 2000,
(using 1999 data as an example)
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Maternally Linked Data Base
Birth Certificate
Hospital Discharge (HD) Mothers Birth 1
Birth Certificate
Hospital Discharge (HD) Mothers Birth 2
Hospital Discharge (HD) Childs Birth
Fetal Death
Hospital Discharge (HD) Childs Birth
Fetal Death
(Core, 1999)
(Core, 2000)
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Delivery
One Year
Five Years
Conception
Intrauterine (Fetal) Pregnancy (Mother)
Infancy/Mother
Postpartum
Early Childhood/ Interconceptual (Mother)
Birth Certificate/ Fetal Death
Hospital Discharge
Observational Stay/ER
Healthy Start
WIC
Early Intervention
MassHealth
Infant/Child Death
Maternal/Mother Death
Future Data Sets
PELL Longitudinal Data
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Issues in Implementing a Linked Data System

• Conceptualization of Linked Data Systems
• Technical Linkage Issues
• Data Access/Confidentiality Issues
• Data Utilization/Practice Issues
• Statistical Issues
• Finance/Management/Training Issues
• Analytic Uses and Results

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Access to Database/Confidentiality Issues

• Major issues in constructing linked databases
• Linked databases involve/require confidential
  data
  
• Access involves both political and professional
  concerns
  
• More complex in Public/Private partnership
• HIPAA further complicates access to health
  databases
  
• Technical issues are no longer the principal
  barrier to linked data systems

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Special procedures for working in partnership
with MDPH

• Massachusetts DPH has extensive experience and
  expertise in addressing confidentiality concerns
  and requirements
  
• MDPH RADAR (Research and Data Access Review)
  Committee provides an institutional mechanism to
  review research/confidentiality requests using
  state public health data bases
• PELL and RADAR committee developed and codified
  an extensive set of procedures to facilitate PELL
  implementation and analysis

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Key PELL Confidentiality Decisions

• All data linkages using confidential data done
  and held at Mass. Dept. of Public Health (MDPH)
  
• There is no permanent linked database
• It is a virtual database, using a linker
  program with generated ID numbers, and a series
  of computer programs that can extract linked data
  for subsequent analyses
• Only de-identified or now limited use data
  sets used for data analyses at MDPH or offsite

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Confidentiality/Access Steps

• Special confidentiality permission (24AB)
  obtained from Commissioner of MDPH to construct
  PELL database
  
• Inter-and-Intra-agency agreements to access
  databases
  
• Confidentiality pledges by PELL staff
• MDPH RADAR Committee IRB and second 24AB approval
  for specific analytic proposals (e.g., twins
  analysis)
  
• Boston University IRB and HIPAA approval for PELL
  analyses with de-identified data files
  
• CDC IRB approval

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PELL HIPAA

• MA state confidentiality laws overrides HIPAA
• PELLs virtual linked database not an issue for
  HIPAA compliance.
  
• Linked analytic files are subject to HIPAA
• Some data converted to be more HIPAA sensitive
• HIPAA waivers will now also be obtained for all
  analytic studies

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MDPH Procedures Developed by the PELL/MDPH RADAR
Partnership
Research Approval Procedures for

• major PELL initiated research projects
• pilot analyses
• DPH initiated analyses
• amending approved analytic agreements

Operational Procedures for

• dissemination/ release of data/results (to media,
  etc.)
  
• ensuring agencies/programs that contribute data
  will have prior approval of analytic use of their
  data

No procedures yet for

• third party data requests

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PELL Internal Confidentiality/Access Procedures

• Internal approval of pilot data requests
• Formal approval of all major study proposals
• Identification of lead PI (and team members) for
  each major study
  
• Mechanism for adding new external researchers on
  a specific analytic project

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Confidentiality/Access Issues

• Working through takes at least as much time as
  technical linkage issues
  
• Respecting and working constructively with MDPH
  confidentiality procedures was critical
  
• Success to date reflects the culmination of years
  of prior work together and history of mutual
  trust
  
• Our lessons learned can be adapted by other states

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Database access and confidentiality issues can
be successfully addressed. PELL exists. We
currently provide a platform for expanded
etiologic, longitudinal, and programmatic
research on maternal and infant health and health
services in Massachusetts.
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Linking Data Through a Public - Private
Partnership The University Perspective
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Advantages of a Public-Private Partnership

• Increases access to linked public health data for
  academic researchers, as well as for the MDPH
  
• Strengthens relationships with MDPH programs
• enhances University understanding of current
  public health issues
  
• permits University to provide better technical
  assistance and consultation
  
• enhances University involvement in
  evidenced-based MCH policy development
  
• Allows the University to be involved in
• cutting edge MCH epidemiology projects
• innovative longitudinal research
• Fun to forge new cooperative partnerships on data
  access, analysis, and dissemination

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Challenges of a Public-Private Partnership

• PELL still not yet fully institutionalized
• MDPH only beginning to appreciate PELL capacity
• Vulnerable to organizational and personnel
  shifts
  
• Annual permissions for access to PELL data sets
  administratively burdensome
  
• Authority for resolution of PELL problems
  diffuse
  
• Brokering intra-government data sharing
  agreements (with provisions for PELL usage) can
  be difficult
  
• Boundaries between linking data and performing
  analyses for MDPH are still evolving

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Linking Data Through a Public -
Private Partnership
PELL a partnership important to improving
MCH Epidemiology, Research, Practice, and Policy