“Precision Medicine” or Privacy Pitfalls? Ethical Considerations Related to the Proposed Health Database

Thomas Hale-Kupiec, MJLST Staff Member

President Barack Obama proposed spending $215 million on a ‘precision medicine’ initiative. The largest part of the money, $130 million, would go to the National Institutes of Health in order to create a population-scale study. This study would create a database containing health information with genetic, environmental, lifestyle, medical and microbial data from both healthy and sick volunteers with the aim that it will be used to accelerate medical research and to personalize treatments to patients. Though some would call this a “bio-bank,” Francis Collins, director of the National Institutes of Health, said that instead, the project is greater than that, as it is combining data from among what he called more than 200 large American health studies that are ongoing and together involve at least two million people. “Fortunately, we don’t have to start from scratch,” he said. “The challenge of this initiative is to link those together. It’s more a distributed approach than centralized.” Further, the President immediately attempted to alleviate concerns related to privacy: “We’re going to make sure that protecting patient privacy is built into our efforts from Day 1. . . I’m proud we have so many patients-rights advocates with us here today. They’re not going to be on the sidelines. This is not going to be an afterthought. They’ll help us design this initiative from the ground up, making sure that we harness the new technologies and opportunities in a responsible way.”

Three major issues seem to be implicated in this proposed database study. First, both informed consent and incidental findings seem to be problematic in this model. When ascertaining information from the American health studies, the government may be bypassing what users initially consented to when agreeing to participate in the study. Further, incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors are implicated in these studies; these aspects need to be considered in order to avoid any liability going forward, and provide participates with expectations of how their information may be used. Second, collection and retention of this information seem to be an issue. Questions on when, where, and how long this information is being held creates a vast array of privacy concerns. Further, security of this information may be implicated, as some of this data may be personal. Third, deletion or removal of this information may be an issue if the program ever becomes discontinued, or if users are allowed to opt-out. Options after closure include destroying the specimens, transferring them to another facility, or letting them sit unused in freezers. These raise a multitude of questions about what to do with specimens and when level of consent should be implicated.

Overall, this database seems to hold immeasurable potential for the future of medicine. This said, legal and ethical considerations must be considered during of this new policy’s development and implementation; with this immeasurable power comes great responsibility.