Online Program

Privacy issues in personalized medicine research: Proposing a novel framework for policy

Wednesday, November 4, 2015

Vivek Chaudhari, MS, Program in Personalized Medicine & Targeted Therapeutics and Department of Health Policy & Public Health, University of the Sciences in Philadelphia, Philadelphia, PA
Amalia M. Issa, PhD, MPH, Chair & Professor, Department of Health Policy and Public Health & Director, Program in Personalized Medicine & Targeted Therapeutics, University of the Sciences, Philadelphia, Philadelphia, PA

Clinical research in personalized medicine (PM) has been steadily increasing. However, concerns over the privacy of genetic information have persisted as an important unresolved challenge to consumers’ and patients’ willingness to participate in PM clinical research.


To examine the privacy issues associated with genetic information on the implementation of personalized medicine into clinical research.


We reviewed the literature on privacy issues in personalized medicine. We examined the perspectives of patients, employers, insurers and the federal government in the protection of privacy and discrimination based on genetic information. The impact of government regulations on clinical research of personalized medicine was also explored.


Several legislative and regulatory hurdles were found including increased institutional bureaucratic barriers, a lengthy informed consent process, and complex language which all serve as barriers to the conduct of PM clinical research. We propose a new policy framework to overcome some of the current regulatory hurdles.


Federal government regulations have significantly improved patient privacy protection but have hampered research in personalized medicine by lengthening the consent process and setting up additional liabilities for institutions conducting clinical research. There is a need for policies that will reduce the barriers to research without affecting the privacy of patients.

Learning Areas:

Ethics, professional and legal requirements
Other professions or practice related to public health
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy
Public health or related research

Learning Objectives:
Describe the current legislative and regulatory policies related to genomics and personalized medicine and related privacy issues. Identify the current barriers and facilitators to clinical research in personalized medicine.

Keyword(s): Genetics, Privacy

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a PhD student in the Health Policy program who did the study. I am interested in personalized medicine and is implementation into practice and the public health and policy issues surrounding personalized medicine.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.