doctor holding digital device

New book examines legal, ethical and policy implications of electronic health records and medical “big data”

Recent years have marked a dramatic transition from paper to electronic medical records. Simultaneously, Electronic Health Record (EHR) systems allow for the creation of medical “big data”—massive collections of electronic data that can be used for medical research, public health initiatives and other health-related endeavors.

Image of Sharona Hoffman
Sharona Hoffman

To educate medical, legal, information technology and policy professionals and students about EHR systems, medical big data and the regulations that govern them, Sharona Hoffman, a professor of law and bioethics at Case Western Reserve University, wrote a new book, Electronic Health Records and Medical Big Data: Law and Policy (Cambridge University Press).

“This book is intended to provide thorough, interdisciplinary analysis of EHR systems and medical big data, offering in-depth technical and legal insight,” Hoffman said. “The law is vital for safeguarding and enhancing the quality and security of EHR systems and the medical big data resources that are drawn from them.”

EHR systems became widely adopted only in recent years, mainly due to the Obama administration’s incentive program, begun in 2011, that offered health care providers financial support for the adoption of health information technology.

Book cover of Sharona Hoffman's book about Electronic Health Records and Big DataElectronic Health Records and Medical Big Data addresses privacy and security concerns and other important challenges, such as those involving data quality and data analysis. Hoffman also offers recommendations to improve the technology’s safety, security and efficacy for both clinical and secondary uses of medical data.

For example, Hoffman recommends:

  • Extensive testing of EHR systems in clinical settings to determine their usability and safety before they are approved.
  • That EHR systems continue to be reviewed after they are launched to ensure they function as expected and to track any serious problems.
  • Expanding the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rules and the Americans with Disabilities Act to enhance their privacy and anti-discrimination protections.

The book is available on Amazon and from Cambridge University Press.

This article was originally published Dec. 8.