Key Considerations When Designing Real World Evidence Research Involving The Secondary Use of U.S.-Based Electronic Health Record Data

Abstract

The research use ofhealthcare records in the United States is protected by a wide variety ofregulations and ethical constructs. While healthcare providers are intimately familiar with these, lifescience companies and other researchers are often not.  This lack of awareness often results inprotocols and contracts that, although well intentioned, can cause increaseddelays and costs due to resistance from the curators of the electronic healthrecords. The better that protocols, contracts and budgets are written withthese considerations in mind, the better opportunity we have to generate realworld evidence using electronic health records with less cost, greater speedand most importantly in a manner that does not compromise individual privacy toachieve societal benefits.