RWE research is playing an increasingly important role in health care decision-making. Multiple international initiatives, guidelines, and legal frameworks have been released by the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) over the years. RWE has already been included in various approval procedures by regulatory authorities, reflecting its actual acceptance and growing importance in evaluating and accelerating new therapies. The FDA and EMA play a pro-active role in exploring gaps and potentials of RWE to guide stakeholders.2,3 The ongoing implementation of RWE in early benefit assessments of newer therapies will potentially speed up approval processes for effective interventions and reduce costs of drug development, which will in turn reduce time-to-market, leading to early patient access. Newer research from non-traditional data sources and various types of digital health technologies (DHTs) will increase in the near future. Initiatives have been kicked off to fund RWE projects, and there is a conscious attempt by the regulators and the industry to involve all stakeholders in the development of future guidelines to increase the trust, credibility, reproducibility, and transparency of RWE studies.