Chapter 6 – Legal Aspects of Health Applications of Genomics

Abstract

This chapter explores some legal issues that must be addressed in order to implement genomic testing effectively in the clinic, organized in the order in which they typically arise. The first is what tests clinicians are permitted to order and use. The second is what genomic information patients can access: (i) what medical records they can obtain and (ii) what genomic information they can acquire outside the clinical setting, for example, through direct-to-consumer genetic testing, and what they can expect their clinicians to do with these results. The third is reimbursement or coverage. The last is the role of potential liability in shaping physician behavior regarding the use of genomic testing. Because constitutions, statutes, regulations, and case law vary from country to country, this chapter will apply this framework primarily in two different settings, the United States and Quebec. However, references will be made to other jurisdictions as well.

Keywords: Regulation, genomic data access, reimbursement, liability, privacy