Aside from the upfront cost of implementing electronic health records (EHRs), one of the major barriers for adopting health IT cited by physicians is a lack of standards. On Friday, HL7 published a standard for clinical research in an EHR system.

The standard has been approved by the American National Standards Institute (ANSI). Basically, the standard outlines the requirements for how EHR data is used for regulated clinical research and offers a roadmap for how the data can support the workflow for patient care and clinical research processes. This standard is important because it recognizes the value of secondary use of data and seamlessly leverages the data in the EHR system to support clinical research.

Developing standards is not an easy exercise. There are a lot of moving parts. Many stakeholders make contributions. In this case, it included pharma, biotech, clinical research technology and healthcare technology vendors, as well as the Clinical Data Interchange Standards Consortium. It also involved federal regulatory stakeholders from the U.S. and the European Union. All stakeholders spent two years identifying and addressing data protection, regulatory and ethical research requirements.

In an industry where healthcare reform and transformation are moving targets, it seems standards are tortoises. Unfortunately, they can't be rushed, no matter how much we'd like them to be fully formed at birth, so to speak. There is one camp that urges providers to adopt health IT before standards are formalized. It's not ideal, but in this case it's necessary in an ARRA world where deadlines for meaningful use are paramount. Get a game plan formulated and implement a certified EHR system. The Certification Commission for Healthcare Information Technology (CCHIT) uses the standards as resources for its own certification criteria, as other certification bodies will likely do. That helps. Be patient. The rest will fall into place.