TitleAuthorDateSource

Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry 

 May 2016 FDA
ONC to develop patient-generated health data policy frameworkDan BowmanOctober 2, 2015 FierceHealthIT 

‘Argonaut Project’ to Build on JASON Task Force’s FHIR Recommendations

David RathsDecember 4, 2014Healthcare Informatics Magazine
Strategies to Support Cooperation of Multiple Organizations’ Institutional Review Boards (IRBs)Jeanette M. Daly, Tabria Winer, LeAnn Michaels, Amanda RossSeptember 10, 2014 AHRQ Practice-Based Research Network Resource Center 
Institutional Review Board (IRB) Challenges in QI & Research Holly A. Taylor, Mark S. Schreiner, and Alex FiksMay 27, 2015 AHRQ Practice-Based Research Network Resource Center 
Standard Operating Procedures for Clinical Research Informatics April 30, 2015S&I Framework (ONC)

Data Access Framework

  S&I Framework (ONC)
§ 170.315 (g)(7) Application Access - Patient SelectionONC ONC Health IT Certification Program 2015 Edition Test Methods
§ 170.315 (g)(8) Application Access - Data Category RequestONC ONC Health IT Certification Program 2015 Edition Test Methods Home
§ 170.315 (g)(9) Application Access - All Data RequestONC ONC Health IT Certification Program 2015 Edition Test Methods Home

Toolkit for Communities Using Health Data

National Committee on Vital StatisticsMay 2015

CDC and Prevention
National Center for Health Statistics

CTSA Consortium Tackling Clinical Trial Recruitment Roadblocks February 2015NCATS
Mini-Sentinel   

 

 

 

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