Precision Medicine Initiative

The Precision Medicine Initiative (PMI), a federal program launched in January 2015,  is part of a new approach to disease treatment and prevention that “takes into account individual variability in genes, environment, and lifestyle for each person.” The success of this kind of ‘precision medicine’ will require researchers, providers and patients to “work together to develop individualized care” and will rely heavily on patient participation. While “[p]recision medicine empowers patients to personalize their healthcare through access to information,” it can only do so through the analysis of individual medical data.

For that reason, privacy and security have been core issues for the PMI. In what could be a model for other programs, the PMI created two key documents early on to set the stage for addressing these issues. The PMI’s Privacy and Trust Principles lay the groundwork for public trust while the PMI’s Data Security Policy Principles and Framework establishes security expectations for participating organizations.

The Privacy and Trust Principles “articulate a set of core values and responsible strategies for sustaining public trust and maximizing the benefits of precision medicine”. Developed by an interagency working group with expert consultation, they are broken down into six key areas: Governance, Transparency, Respecting Participant Preferences, Participant Empowerment through Access to Information, Data Sharing, Access, and Use, and Data Quality and Integrity.

The Data Security Policy Principles and Framework build off the Privacy and Trust Principles to provide “a broad framework for protecting participants’ data and resources in an appropriate and ethical manner that can be tailored to meet organization-specific requirements,” while recognizing that there is no “one size fits all” approach and that data security is a constantly evolving field. The Data Security Policy Principles and Framework were developed under a collaborative process similar to the Privacy and Trust Principles. The Framework is broken down into five key areas: Identify, Protect, Detect, Respond, and Recover.

In October 2016, the Precision Medicine Initiative launched the All of Us Research Program, “a historic effort to gather data from one million or more people living in the United States to accelerate research and improve health.” According to the NIH, All of Us “is a participant-engaged, data-driven enterprise supporting research at the intersection of human biology, behavior, genetics, environment, data science, computation and much more to produce new knowledge with the goal of developing more effective ways to treat disease.” With this increased focus on patient participation and data collection, issues of privacy and data security may become even more important.