•  
  •  
 

Symposium Title

The Big Data Revolution and Its Impact on the Law

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.

Included in

Law Commons

COinS
 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.