Data Sharing and Reuse of Health Data for Research

Abstract

Facilitating data sharing and the reuse of electronic health data for research is an important foundation for reengineering and streamlining research processes. It will be critical to accelerating learning health cycles and broadening the knowledge that can be used to improve healthcare and patient health outcomes. In this chapter, data sharing refers to sharing data and metadata between partners and systems (not necessarily sharing of research results) in ways that preserve the meaning and integrity of the data. A range of ethical, legal, and technical considerations have thus far hindered the development and application of many approaches for such reuse and data sharing to date. However, standards adoption and technical capabilities are progressing, and incentives are now beginning to align to facilitate data sharing. Principles and values of data sharing and the responsible use of data and data standards have been published, and there is recognition of the value of “real-world data” (RWD) to generate additional evidence upon which to base clinical and regulatory and healthcare decisions. These will require broad adoption, adherence, communication, and collective support of such principles, standards, and values to positively transform research processes and informatics. Participants in clinical research studies typically expect and want their data to be shared widely and appropriately such that we can all benefit. Based on learning from research results, it is expected that patient care will be improved. This is the basis for learning health systems (LHSs), in which research is clearly a vital component. The knowledge gained from research can inform healthcare and clinical decisions to complete the learning cycle. This chapter will describe the benefits and implementation considerations of data sharing and reuse of health data, particularly that from electronic health records (EHRs), for clinical research, bio-surveillance, pharmacovigilance, outcome assessments, public health, quality reporting, and other research-related studies. Use cases are provided to illustrate the positive impact that data sharing will have for patients, clinicians, research sponsors, regulatory agencies, insurers, and all involved in LHSs. Consensus-based principles for data sharing, technical aspects, and business requirements are also provided, along with specific examples of data sharing collaborations, initiatives, and tools. In the future, we hope that research will become embedded within health systems and that organizations will continue to embrace, harmonize, and broadly adopt standards and technologies to meet this challenge.