Secondary Uses of Genetic Data: Practical Solutions to Address a Complex Legal Framework
- March 29, 2021
- Tina Hambuch , Invitae
- Swaroop Aradhya , Invitae
- Robert Nussbaum , Invitae
- Michael Hamilton , Invitae
A clinical genetic testing laboratory based in the US that treats patients globally is subject to a complex set of laws and regulations that apply to its secondary uses of genetic and genomic data. These laws include the Clinical Laboratory Improvement Amendments (CLIA), the Health Insurance Portability and Accountability Act (HIPAA), the Federal Policy for the Protection of Human Subjects (Common Rule), US state genetic privacy laws, and the European Union’s (EU) General Data Protection Regulation (GDPR). These laws are overlapping and sometimes inconsistent in the standards they set for how data can be used and shared. In this context, it can be difficult to create a cohesive and harmonized approach to secondary uses of genetic and genomic data. This article explains the technical aspects of genetic testing, summarizes the various laws and regulations genetic testing laboratories must follow, and proposes practical steps that companies can take to operate within this complex regulatory patchwork in a manner that both protects patient privacy interests and supports the advancement of genetic medicine
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