Course Description

410.760 - Ethical, Legal and Regulatory Aspects of Personalized Medicine

This course provides an overview of the important ethical, legal and regulatory issues that are critical to development and implementation of personalized medicine technologies. The course reviews current trends and issues with these interrelated disciplines. Ethical issues will cover how personalized medicine challenges the bioethics foundations of medicine and its implications for enabling personalized medicine treatment. Key and emerging ethical issues such as confidentiality, informed consent, direct to consumer marketing, access to treatment and conveying results to the patient will be explored. Legal issues as it applies to the public policies of privacy, discrimination, and intellectual property will be evaluated. Finally, the regulatory oversight and reimbursement policies of personalized medicine, including targeted therapies, in vitro diagnostics, and laboratory developed tests by the FDA and CMS and other organizations will be discussed.