5. FDA draft guidance for EHR use in clinical investigations revealed

The FDA has put its two cents in regarding the use of electronic health records in clinical trials with the release of its draft guidance last week.  This guidance contains recommendations of interoperability and best practices for use of these systems, including informed consent, data security safeguards, and well-documented, trackable audit trails.  Something to consider is to use an EHR that is certified under the ONC Health IT Certification Program—when the FDA says this certification is “encouraged” and it will provide “confidence during inspections,” you don’t take this lightly.  Sure these are just recommendations/suggestions for an EHR’s use in clinical investigations, but they come from the folks who hold the power to make or break a company and a product.