Michael Ibara is Head of Digital Healthcare for CDISC where he works at the interface of digital health, standards and industry. His current work includes overseeing CDISC’s work on initiatives in digital healthcare, including several Healthcare Link initiatives including the FDA eSource project. He is also serves as product owner for the SHARE Metadata Repository. Michael has over 20 years experience at the intersection of technology and healthcare. Previously he was Head of Business Development Coordination and Innovation at Pfizer, where he worked for 15 years in various positions. During this time Michael led implementations of global systems and large-scale technologies. Michael pioneered research on the implications of digitized healthcare data on pharmacovigilance practice and drug safety, specifically with the goal of developing a new business model for pharmacovigilance which will contribute to improved public health. This lead to him designing and leading the ASTER project, which used CDISC Healthcare Link standards and was the first time adverse events were retrieved directly from an electronic health record and delivered to FDA. Michael has also focused on regulatory and policy implications for digital healthcare, outlining implications for the use of social media to deliver high-quality adverse event information, investigating the impact of regulatory safety definitions on quality of safety data collected from social media, and exploring new models of pharmacovigilance that incorporate digitized healthcare data. He received his Pharm.D. degree from the University of Michigan and completed a Fellowship in Drug Research and Development with Burroughs Wellcome, Inc. and the University of North Carolina.