The advent of open data in health care has increased healthcare innovation, with the publication of complete datasets aggregated by private and public entities that lead to efficiency through crowdsourcing working code, facilitating research into personalized medicine, and publishing reproducible data pipelines for experimental validation. However, there lacks an internationally recognized definition for health data governance at the scope of individual health data and open source big data, which bring about a discussion about the implications of open data on data privacy. First, healthcare data sourced directly from public healthcare systems: by whom and for what purpose is these data used for within the context of healthcare research. Second, health data from private research: the regulations needed for mutual disclosure. Third, personal user-generated health data: safeguards in a digital era needed to prevent misappropriation and abuse. This paper addresses the opportunities of open data in healthcare research in a digital age without transparent regulation. The consequence of open data on privacy leads to a framework of four safeguards for stakeholders: public education, operational transparency, regulation for accountability, and validation of research ethics. It also pioneers public policy direction for a balanced agenda between privacy and healthcare research.

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