By Ann Neuer
January 5, 2009 | The much anticipated convergence of data between clinical trials and electronic health records (EHR) is heading toward reality with the recent formation of the EHR Clinical Research Value Case Workgroup. Convened in November by the American National Standards Institute (ANSI), the workgroup is a cross-section of experts from industry, academia, standards organizations, and government who have come together to identify priorities for the harmonization of technical standards needed to ensure the interoperability of EHRs and global clinical research applications.
“It’s a neutral group of stakeholder representatives that will set priorities for interoperability specification development in the clinical research space,” says Rebecca Kush, president and CEO of the Clinical Data Interchange Standards Consortium (CDISC) and co-chair of this initiative.
Kush explains that when the workgroup held its first meeting in November, she and fellow co-chair Gregory Downing, director of the Initiative on Personalized Health Care at the Department of Health and Human Services (HHS), came prepared with five suggested priorities. By the end of that session, however, one key priority, known as the value case, emerged—to identify a core (common) set of data fields that could be exchanged between EHRs and systems that support clinical research. “This refers to a set of data fields found in EHRs that would have application to international research studies, such as demographic data. This information could be collected once in the EHR and could then populate a case report form for a clinical research study,” Kush remarks. With this value case creating a foundation, future priorities are expected to take shape around EHRs for purposes of patient recruitment, adverse event reporting, pharmacovigilance, and pharmacogenomics.
In order for the information to flow effectively, standards must be identified, and this is where it gets complicated. For some time, the clinical research sector had been anxious to become part of the multiple federal forays into expanding information technology in health care, such as the Healthcare Information Technology Standards Panel (HITSP), which reports to HHS; the American Health Information Community (AHIC), which set priorities for HITSP and terminated in November; and the AHIC Successor, currently in the midst of developing its governance, and whose funding as a public-private partnership is uncertain. Downing, who opened the door for the clinical research presentation to AHIC in July, says that the connecting of research with federal efforts is critical at this time to avoid the development of divergent and disparate standards that will inhibit the compatibility of EHRs with clinical research platforms. “A number of organizations, such as CDISC and Health Level 7 (HL7) have already developed standards, so we should leverage them instead of re-inventing the wheel,” says Downing.
And things are moving forward within the workgroup. The value case is currently being written by a contractor for HHS, with input from the workgroup. An initial draft of the value case is expected in early January, to be followed by a mid-January conference call to seek comments from members of the workgroup. “By early February, we’re hoping to have this finished so it can be sent to HITSP, which will form technical committees to select the standards that support this value case and they will write up the interoperability specifications,” Kush explains.
One of the key issues is the dire need for funding if the work is to continue. There is no federal funding to support this project, and it is unknown if the new administration will fund this work. The workgroup hopes there will be a “glide path” for this work when the AHIC Successor is established. In the interim, ANSI and Kush are looking to stakeholders for financial support. She estimates that $250,000 to $300,000 is needed from public and private-sector sources for ANSI to be able to contract with HITSP for the development of the interoperability specifications. “We cannot go forward in February with the HITSP work without money. In this economy, we need a lot of contributors and people in clinical research, personalized medicine, pharmacogenomics, anyone who would ever want to use EHR data for their studies should contribute,” Kush comments.
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