David M. Parker*, Steven G. Pine**, and Zachary W. Ernst***
ABSTRACT
Big Data collections derived from medical records present regulatory and privacy challenges while holding significant promise for advancements in biomedical research. The growth of Big Data has been spurred by technological advances and the increasing use of electronic medical records. In this article, we explore how the concept of a rights to privacy and confidentiality for research subjects has developed, through both HIPAA and the Common Rule, as well as in the European Community’s General Data Protection Regulation (GDPR). We analyze how developments in regulations governing human subjects research reflect both a heightened societal concern for individual privacy and confidentiality and a recognition that research may be of sufficient importance to society to outweigh those individual concerns. We review how new efforts to improve informed consent procedures in the Common Rule fall short and propose a more frank and straightforward approach.