Article Text

Assessing function of electronic health records for real-world data generation
  1. Daphne Guinn1,2,
  2. Erin E Wilhelm2,
  3. Grazyna Lieberman3,
  4. Sean Khozin4
  1. 1 Program for Regulatory Science and Medicine, Georgetown University, Washington, District of Columbia, USA
  2. 2 Department of Pharmacology and Physiology, Georgetown University, Washington, District of Columbia, USA
  3. 3 Genentech, South San Francisco, California, USA
  4. 4 US Food and Drug Administration, Silver Spring, Maryland, USA
  1. Correspondence to Dr Daphne Guinn, Program for Regulatory Science & Medicine, Georgetown University, Washington DC 20007, USA; dag137{at}

Statistics from

Electronic health records (EHRs) have changed how medical information is captured, and they have the potential to be a rich source of information to improve drug development and clinical care. Accelerated in USA by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, the majority of US healthcare providers use EHRs in practice. Although the Office of the National Coordinator for Health Information Technology within the US Department of Health and Human Services (HHS) set forth standards with the intention to create EHRs that could be used to advance healthcare processes,1–3 there is still much room for improvement to adequately capture patient-provided and clinically relevant data needed to support learning healthcare systems that adapt as new clinical knowledge is gained.4 Currently, stakeholders within regulatory agencies, professional organisations, the pharmaceutical industry and payer groups are exploring how data collected during the delivery of routine healthcare or data related to a patient’s health status, defined as real-world data (RWD), can be analysed to generate clinical evidence, known as real-world evidence, to enhance healthcare and medical product development.5 6 This shared interest has led workshops exploring the incentives that are important to each stakeholder group.6–8 Multistakeholder collaborations have formed to empower RWD projects, such as the work being done by the Food and Drug Administration (FDA) Oncology Center of Excellence, healthcare technology company, Flatiron Health, and the American Society of Clinical Oncology CancerLinQ, which will focus on determining the characteristics and clinical outcomes associated with patients with advanced cancer using RWD collected from the EHR.9 The RWD effort is supported with legislative action. The 21st Century Cures Act requires the US FDA to explore and produce guidance on how RWD can inform decision-making, including label expansion for approved products and postmarket commitments.10 Investigating RWD applications is also a …

View Full Text

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.