Yesterday marks one year since President Obama, launched the $215 million Precision Medicine Initiative (“PMI”) to create new and innovative tools healthcare providers can use to tailor disease treatment and prevention to an individual’s unique characteristics. More than 40 private and public organizations, non-profit groups, academic institutions, and government agencies gathered this week at the White House to announce plans to accelerate the PMI, focusing in large part on the goal of establishing a large national research participant cohort. The stated mission of the PMI is:
To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.
Precision medicine is a healthcare approach that takes into account differences in individuals’ genes, environment, and lifestyle. Advances in precision medicine give healthcare professionals the tools to tailor treatment to, for example, a person’s genetic makeup, which may transform how medicine is practiced. Although precision medicine is not currently used in the treatment of most diseases, the PMI is helping fund cross-cutting research to allow more widespread use of precision medicine.
A key element of the PMI are the Data Security Policy Principles and Framework (“Data Security Principles”), which are designed to guide organizations participating in PMI-related activities on the basic obligations of protection for personal privacy. Developed through a broad collaborative process, the Data Security Principles set forth the following goals for each precision medicine organization: 1) to identify the organization’s specific data security risks; 2) to protect critical infrastructure services; 3) to detect any cybersecurity event; 4) to respond to detected cybersecurity events; and 5) to recover any impairment due to a cybersecurity event. The Data Security Principles further suggest that every data security plan should: 1) be participant-centric; 2) ensure that data security is adaptable and updatable; 3) identify risks, prescribe evaluation plans, and establish clear and transparent security protocols; 4) control data while providing adequate access; and 5) responsibly maintain data security. Additionally, the Data Security Principles support the exchange among organizations of data security experiences and challenges in an effort to enhance mutual education and understanding of data security risks and methods of protection.
Another key element of the PMI is a set of Privacy and Trust Principles (the “Privacy Principles”). The Principles articulate core research values, such as good governance, transparency, participant empowerment, and responsible sharing, access, and use of human subject data. These core values are meant to provide a fundamental framework to sustain public trust in the initiative and ensure PMI activities maximize the potential of precision medicine.
One focus of the PMI has been on an National Institutes of Health Precision Medicine Initiative Cohort Program, which, by 2019, aims to establish a national research cohort of one million or more participants. NIH was allocated $130 million to build the national research participant group. Various other public and private entities are also working on PMI-funded activities. For example, the National Cancer Institute announced in August 2015 that it would focus its PMI activities on expanding precision medicine clinical trials, overcoming drug resistance, developing new laboratory models for research, and developing national database for cancer-related genetic information. In September 2015, The Health Information Technology Standards Committee provided health IT standards for PMI activities. In December 2015, the Food and Drug Administration announced the creation of an online, cloud-based portal called precisionFDA to facilitate scientific discourse about next-generation sequencing.
The PMI promises to open up new avenues for precision medicine by employing tools available to, but currently underutilized by, the medical research community.