EHR data will play part in FDA drug monitoring plan

The FDA plans to use EHR data as part of a study of approved medications.

The Food and Drug Administration (FDA) is accepting applications for a project that will use electronic health record data to monitor drug effectiveness. According to an official notice from the Department of Health and Human Services (HHS), the deadline for participants will be this coming June 15, and the official start of the program is planned for July 15. The bidder selected by the Administration will receive as much as $1 million.

This grant is being offered alongside the Innovations in Medical Evidence Development and Surveillance (IMEDS) initiative, created by the Reagan-Udall Foundation. The FDA's goal is to develop an analytics solution that will allow it to draw from "more than 150 million records" to verify the effectiveness of drugs that the FDA has previously approved.

The official notice of this program was released by the FDA earlier this month, in which they explained some of the background behind the project that the grant will fund. 

"Section 905 of the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market," it states. The Sentinel Initiative is described as "a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting."

Any project that utilizes information from health records should be secure and well-managed enough to leave patient identities protected as various operations are performed with it. Flexible healthcare consulting firms will be able to work off of the specific requests healthcare stakeholders have and dedicate resources to proper evaluations. If an initiative will put providers at possible risk of HIPAA violations, consultants can offer a better course of action.

4 thoughts on “EHR data will play part in FDA drug monitoring plan

  1. Simply want to say your article is as astonishing. The clearness in your post is just excellent and i could assume you’re an expert on this subject. Well with your permission allow me to grab your feed to keep up to date with forthcoming post. Thanks a million and please continue the rewarding work.

Leave a Reply

Your email address will not be published. Required fields are marked *