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Public Comments

FasterCures Provides Comments on the ‘Core Research and Data Elements Exchange Use Case’
Apr 03, 2009

Electronic Health Records (EHR) Clinical
Research Value Case Workgroup
American National Standards Institute
1819 L Street, NW, 6th floor
Washington, DC 20036

Dear Workgroup members:

FasterCures appreciates the opportunity to provide comment on the ‘Core Research and Data Elements Exchange Use Case’ and the privilege to serve as a member of the EHR Clinical Research Value Case Workgroup. The Workgroup provides a critical venue for the research community to find common voice in promoting EHRs’ potential for facilitating data exchange among clinicians and researchers.

Our mission at FasterCures is to save lives by saving time in the research, discovery, and development of new medical solutions for deadly and debilitating diseases. We understand the power EHRs can have in advancing biomedical research: the ability of researchers to access and analyze the clinical information contained in millions of personal health records, with appropriate privacy and human subject protection safeguards, could speed the discovery of new diagnostics and therapies to patients who desperately need them. Specifically, researchers could develop correlations between proteins, genetic markers, and patient outcomes that would point the way to new therapies. Conducting post-marketing research would be more powerful since researchers would more easily identify the impact of drugs and devices on entire populations. Overall, clinical trials would be made easier, cheaper, and faster.

Our specific comment for your consideration involves Section 3.0: Use Case Stakeholders. One of the resources FasterCures has identified as critical to biomedical research is the use of biobanks and tissue repositories to support trials and store biospecimens and patient data for other investigations. It is not clear where these resources would fall under the Stakeholder descriptions, but as these banks annotate their specimens with extensive data relevant to both clinical care and research, it may be worthwhile to list them as an example in the Contextual Description of the Stakeholder group to which they belong.

This Use Case and the work put into the accompanying documentation represent a significant step forward in achieving that vision. The identification of core data elements lays the groundwork for future use cases and value cases to address matching patients to trials, safety reporting, and other data exchange scenarios critical to research. We strongly support the principles outlined in this document and look forward to future opportunities to support the efforts of this Workgroup.

Sincerely,
Gregory C. Simon
President, FasterCures

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