Managed Healthcare Executive: New Policy Will Help EHRs Improve Clinical Studies: 5 Things to Know

(AUGUST 3, 2018) – Healthcare executives now have a roadmap to incorporating EHRs into clinical trials and product submissions, including use of patient medical histories and pharmacy records, with FDA’s issuing of a new policy.

According to the FDA, with the widespread use of EHRs, there are opportunities to improve data accuracy and promote clinical trial efficiency when EHRs are used in clinical investigations. “EHRs may enable clinical investigators and study personnel to have access to many types of data (e.g., clinical notes, physician orders, radiology, laboratory, and pharmacy records) that can be combined, aggregated, and analyzed. EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” according to the FDA.

The guidance also encourages stakeholders to work toward interoperability between EHR and electronic data capture (EDC) systems. It also fulfills a requirement set by the 21st Century Cures Act to issue guidance on real-world evidence in regulatory decision making, according to Art Papier, MD, practicing dermatologist and CEO of VisualDx, a healthcare informatics company.

“The 21st Century Cures Act requires FDA to develop a framework on how to evaluate real-world evidence and to issue a guidance about the use of real-world evidence in regulatory decision making,” Papier says. “From 21st Century Cures Act, this framework is focused on real-world evidence data to support approval of new indications or to satisfy post-marketing safety studies–so not for first approval of a new chemical or biological entity. Issuing this EHR guidance gets FDA a little closer to these goals.”

Read the full article to read the 5 reasons why Art says this guidance is so important.