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Max Researcher at Advanced Research Institute wishes to combine data from an Electronic Health Record (EHR) at a mental health institution, claims data from the state Medicaid Management Information System (MMIS), survey data, and patient laboratory and medical device data into one data set for a SAMHSA funded evaluation study.

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Max Researcher is the only data recipient to whom the data can be disclosed, and two years after the end of the active collection phase, Max must destroy the data, as specified in the DUA and consent documents. Max may not reuse the data or connect them with a different study. The participants do not have access to data collected for this study, but will receive the published results of the study.

 

Title

Response

Description

The researcher combines behavioral health data and clinical data for his study.

Primary actor/participant

Researcher

Support actor/participant

Mental health institution EHR, MMIS, medical device data. 

Preconditions

  • Patient consent for data disclosure to researcher from all systems in question.
  • HIPAA authorization
  • Psychotherapy notes cannot be disclosed by a HIPAA covered entity without the individual’s authorization. Consent required for access to Medicaid data. State mental health privacy requirements govern consent for mental health information from the mental health institution. Very specific and limited part of the mental health notes are considered psychotherapy notes.
  • Researcher has IRB approval to collect consented biometric and survey data and request their behavioral health EHR data from the institution and Medicaid claims information.
  • DUA with mental health institution authorizing the Researcher’s organization and its approved representatives to request and receive a minimum data set from their EHR and use the data set for a research study.
  • Direct patient consent to collect survey and medical device data as well as Medicaid data.
  • DUA with Medicaid to collect data from patients that have consented.
  • Unique identifiers are generated by the researcher to link the data sets and protect the patients’ identity.      

Post conditions

  • Information was collected from three data sets and combined using a unique identifier (survey data, vitals, claims, and EHR).
  • Researcher has a combined data set available to analyze for a specific research study.

Alternatives

  • Patients do not renew their consent.
  • The behavioral health data is pulled from individual PCP EHR systems.
  • The behavioral health data is obtained from substance abuse treatment programs covered by Part 2 as it receives federal funding.
  • The behavioral health data is obtained from a health information exchange organization.

Considerations

Mentally ill persons are considered special populations and IRBs are required to assure that sufficient safeguards are in place to protect the rights a welfare of these participants in research.

Data Elements Considered

Clinical data from the mental health institution’s EHR, claims data from Medicaid, and survey/medical device data from participants

Purpose of the Data Collection

  • Clinical care, administrative/claims/billing purposes, research
  • Some data is secondary data from EHR: administrative and services data.
  • Some data is primary such as medical device data and survey data.

Purpose of Data Use

Analysis under a specific IRB approved research protocol

Terms of Transfer to the Data Holders

Direct consent from participants to researcher for survey/medical device data and Medicaid claims data, DUA between mental health institution for EHR data and Max’s research institution, DUA between Medicaid and Max’s research institution, HIPAA authorization

Terms of Transfer to Researchers

  • IRB approval
  • DUA for mental health institution’s EHR
  • DUA for Medicaid MMIS data, but not  BAA

Frequency

Data transfer quarterly

 

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