Integrating genomics into clinical practice: Standards and regulatory challenges

Abstract

Bridging between the worlds of healthcare and life sciences is crucial to realizing the personalized healthcare vision. Initiatives regarding legislation and regulation in this interdisciplinary field, along with significant advancement in the development of data standards for genotype-phenotype associations, give rise to a banking paradigm in the form of both biobanks and independent health record banks (IHRBs). These data banks are the information technology infrastructures that are expected to enable the implementation of personalized healthcare. As opposed to the regional strategy currently piloted in the US, IHRBs offer an alternative constellation to achieving a nationwide health information network and the bills introduced in the US Congress relating to these data banks have stimulated public discussion on how best to personalize the care process. © The Thomson Corporation.