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Data governance: Unlocking data to advance research while safeguarding human subjects

Mark J. Fox (mfox@acc.org) is Privacy and Research Compliance Officer at American College of Cardiology Foundation, Washington, DC. Thora A. Johnson (thora.johnson@orrick.com) is Partner at Orrick, Herrington & Sutcliffe LLP, Washington, DC. Deborah A. Marko Koeberer (deborah.markokoeberer@uhhospitals.org) is Director, Facility Compliance, Privacy, Compliance Operations at University Hospitals Health System (Cleveland), Shaker Heights, OH.

Regulations governing the use of data across the healthcare ecosystem continue to evolve to catch up with technological advances that enable researchers to use and exchange data to gain valuable insights. Recent revisions to 45 C.F.R. Part 46 Subpart A (the Common Rule) and the implementation of new interoperability rules under the 21st Century Cures Act have removed barriers that previously existed to the use of health-related data in research while protecting the right of individuals to keep their health information confidential and secure. In this piece, we provide background on these changes and explain how they can be leveraged by organizations to expand the responsible use of data in research settings. We then explore how organizations engaged in these activities can promote good data stewardship by implementing the fundamental principles of an institutional data governance structure.

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