Health Law Gurus

Looking Ahead to 2016 and Beyond: Could the Precision Medical Initiative Revolutionize the Way Patients Receive Medical Treatment?

The Precision Medicine Initiative (“PMI”) was officially unveiled in President Obama’s January 2015 State of the Union address. Precision medicine is an emerging approach for disease prevention and treatment that considers an individual’s genes, environment, and lifestyle. The hope is that PMI will usher in a new era of medicine in which researchers, providers, and patients work together to develop and implement individualized patient care.

Precision medicine, or “personalized medicine” as it was previously called, has been around for a number of years. In 2008, a report to President Bush recommended public policy initiatives for the development of tools and technologies and regulations and reimbursement for genomics-based diagnostic testing. A 2010 report by the President’s Counsel of Advisors on Science and Technology expanded upon the potential value of federal initiatives to standardize and extend the use of electronic health records and health information exchange to facilitate the delivery of patient-specific data to physicians and patients.

However, the medical industry does not currently have the information and resources necessary to deliver precision medicine. Detailed knowledge of human genomics and the effects of environmental factors on the health of individuals need to be discerned.

Consequently, President Obama’s 2016 budget allocated $215 million to the support of the PMI. Money was allocated to the National Institute of Health (“NIH”), the National Cancer Institute, the U.S. Food and Drug Administration, and the National Coordinator for Health Information Technology in order to increase our understanding of health and diseases, identify genomic drivers in cancer, and acquire the needed expertise to advance the development of curated databases and the interoperability standards and requirements to address privacy issues and enable the secure exchange of data across systems.

According to the White House, the objectives of the PMI are:

• More and better treatments for cancer, including tailored treatments based on genetically-based clinical cancer trials, research into the fundamental aspects of cancer biology, and a national “cancer knowledge network” which will generate and share knowledge in order to fuel scientific discovery and guide treatment decisions;
• The creation of a voluntary national research cohort of over one million Americans who will be involved in the design of the PMI by contributing diverse sources of data, including medical records, profiles of patient genes, metabolites (chemical makeup), microorganisms in and out of the body, environmental and lifestyle data, patient-generated information, and personal device and sensor data;
• A commitment to protecting privacy, including the launch of a multi-stakeholder process to solicit input from patient groups, bioethicists, privacy and civil liberty advocates, technologists, and other experts in order to identify and address legal and technical issues related to the privacy and security of patient data;
• Regulatory modernization, which includes reviewing the regulatory landscape to determine whether changes need to be made to support the development of this new research and care model;
• A public-private partnership between existing research cohorts, patient groups, and the private sector in order: (i) to expand cancer genomics and launch the voluntary million-person cohort, (ii) develop new models of patient participation and empowerment, and (iii) consider and develop an approach to precision medicine that ensures consumers have access to their own health data.

NIH explains that in order to achieve its objectives, the PMI will use a modified “hub and spoke” model. A Coordinating Center will serve as the “hub” and will host, receive, store, and manage all PMI participant data. Information will be collected by eligible healthcare provider organizations (“HPOs”) and by direct volunteer recruiting organizations. The PMI will be housed under the NIH, and will be under the authority of a director, a Steering Committee, and an Executive Committee.

In addition, the PMI will be subject to a number of laws and regulations, including the Health Insurance Portability and Accountability Act (“HIPAA”). Because data security is a primary concern associated with the PMI, security oversight will be strictly governed by a group of leading experts in cyber security and big data called the “Security Subcommittee of the Steering Committee.” A Data Security Framework will identify state of the art administrative, technical, and physical safeguards intended to ensure the confidentiality and integrity of PMI data. In addition, reporting requirements will obligate the PMI to notify affected individuals if there is a breach of their personally identifiable information.

If the PMI comes to fruition, it could make a difference for the millions of Americans who suffer from diseases without an effective means of prevention or treatment. The initiative could revolutionize the way patients are treated in the United States. However, the PMI is not without its challenges. Only time will tell whether funding challenges, privacy issues, research obstacles, and stagnation will prohibit this revolution.

The Health Law Gurus™ will continue to continue advances and challenges associated with the PMI. Check back with us for updates.