FDA, Data Standard Groups Promote Adoption of EHRs

Posted 07 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA), the US Department of Health and Human Services' (DHHS) Office of the National Coordinator for Health Technology (ONC) and the Clinical Data Interchange Standards Consortium (CDISC) have together issued a call for greater use of electronic health records (EHR) in clinical research.

In a 6 August statement, CDISC, a nonprofit devoted to clinical regulatory standards, said the agencies' challenge involved the, "Use at least two different EHR systems at different sites to conduct a multi-site, multi-visit, standards-based regulated clinical research study."

EHR systems are fully digital records of all patient data, usually collected by physicians. Under the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, doctors not using EHR technologies will be subject to Medicare reimbursement penalties. While this is unlikely to greatly affect clinical studies, which primarily rely on industry, and not Medicare, funding, CDISC said there were still a number of benefits to consider.

"Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct clinical research studies," remarked CDISC in its statement.

"EHRs can readily implement the standards and profiles to enable the collection of a high quality clinical research dataset that is needed for any regulated clinical research study," explained Wayne Kubrick, CDISC's chief technology officer.

EHR technology can also be useful in improving monitoring of remote clinical locations and ensuring patient confidentiality, as well as security and regulatory conformance, the group said. "It is time to change this scenario such that clinical research is not difficult for clinicians and we can learn more from clinical care," CDISC concluded.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles