Informed consent to the secondary use of EHRs: informatic rights and their limitations

Abstract

It is frequently asserted that the secondary use of data contained in electronic health records (EHRs) requires the informed consent of the subjects of these records. This paper argues that while correct in principle, this has four important ethically based limitations: when it seriously threatens the equal and competing right of others, when it undermines the ability of health care providers to carry out their mandates, when it imperils the possibility of establishing and maintaining a health care system in the first place, and when it makes bona fide research impossible. Nevertheless, as a general rule, when consent can be had, it should be had. This paper provides a theoretical basis for these claims by looking at the nature and role of EHRs and provides some possible approaches for incorporating them into the health care delivery process.