FACT SHEET: New Patient-Focused Commitments to Advance the President’s Precision Medicine Initiative

“Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?” -- President Barack Obama, January 30, 2015

In January 2015, President Obama launched the Precision Medicine Initiative (PMI), a bold new research effort to revolutionize how we improve health and treat disease, empowering health care providers to tailor treatment and prevention strategies to individuals’ unique characteristics. In launching PMI, the President acknowledged that success in this effort will require all hands on deck – including the active participation of care providers, health professionals, researchers, innovators, patients, and research participants.

Today, marking six months of progress to advance PMI, the White House is hosting a Champions of Change event honoring extraordinary individuals from across the country who are making a difference in the lives of patients and driving precision medicine forward. In addition to celebrating these Champions, Federal agencies and private-sector groups are stepping up to the President’s call to action to advance the PMI by making important commitments to:

• Make health data more portable;
• Ensure patients can easily access and share their own health information, including contributing it for research;
• Rigorously protect patient privacy, security and choice; and
• Support new research platforms connecting researcher and participants as partners.

Administration commitments launching today include:

Guiding Principles for Protecting Privacy and Building Trust: Today, the White House is unveiling draft PMI guiding principles that seek to build privacy into the design of the PMI research cohort, which will include one million or more Americans who agree to share data about their health.   An interagency working group convened by the White House developed these principles out of a series of expert roundtables, review of the bioethics literature, analysis of existing privacy and trust frameworks, and working group discussions. The principles articulate a set of core values and responsible strategies for building public trust and maximizing the benefits of a large national research cohort, while minimizing the risks inherent in large-scale data collection, analysis and sharing.  The White House is seeking public feedback on the Privacy and Trust Principles online through August 7, 2015. 

New Tools for Patients: In collaboration with federal partners, the Department of Health and Human Services Office of the National Coordinator for Health IT (ONC) and Office for Civil Rights (OCR) will work to address barriers that prevent patients from accessing their health data. OCR will develop additional guidance materials to educate the public and health care providers about a patient’s right to access his or her health information under the Health Insurance Portability and Accountability Act (HIPAA).  In collaboration with the White House Social and Behavioral Sciences Team, ONC will publish sample communications tools to encourage patients to access their digital health information and workflow diagrams for providers. These resources draw on extensive user research and proven practices to encourage patients to view, download, and transmit their health information. ONC is also developing an open-source prototype that will allow individuals to combine their medical records with patient-generated data and connect these data with the apps of their choice.

Research Awards to Unlock Data Insights: Today the Department of Veteran Affairs (VA) is announcing awards to support four research projects on key questions relevant to precision medicine using the rich data from the Million Veterans Program (MVP), the largest US repository of genetic, clinical, lifestyle and military exposure data. The projects, which focus on the genetic contributions of heart disease, kidney disease, and substance abuse, are designed to assess the utility and accessibility of the data captured in MVP, in addition to answering important scientific questions. These studies will also help inform plans for PMI’s national research cohort, including the types of data that should be included and the design of the data platform. To date, over 390,000 Veterans have enrolled in MVP, and have provided a blood sample, answered a health questionnaire, and authorized access to their electronic health records (EHRs). Understanding how these data, when combined, can help uncover new insights into factors that affect disease onset and progression will be an important test for all precision medicine focused cohorts.

Private-sector commitments launching today include:

Duke Center for Applied Genomics and Precision Medicine: Duke has developed a platform called MeTree that helps individuals have challenging but necessary conversations with loved ones and care providers about family health histories, so that physicians can tailor care to patients’ unique risk profiles. Duke is announcing that, leveraging emerging standards, MeTree will now connect with the information in patients’ electronic health records, allowing patients and providers to seamlessly access information in EHRs through application programming interfaces (APIs).  This effort aims to enrich communication between patients and their clinicians and to help them make the best possible care decisions as a team.

Flip the Clinic: Flip the Clinic, a project of the Robert Wood Johnson Foundation, is announcing a collaboration with more than 160,000 clinicians and staff practicing at sites across the United States, who have pledged to inform patients about their right to get digital copies of their medical records. Flip the Clinic will work hand-in-hand with clinicians at these sites to redesign how clinicians respond to patients’ requests for their own records, with the goal of making health-information access, sharing, downloading, and use a more seamless experience for both patients and clinicians. Flip the Clinic is further committing to educate patients about the President’s Precision Medicine Initiative and how to get involved. Collaborators in this effort include a wide range of delivery systems, clinics, organizations, and technology partners.

Genetic Alliance: Along with collaborators, Genetic Alliance is launching new capabilities for Platform for Engaging Everyone Responsibly (PEER), a data registry that empowers participants to share their data with medical researchers, advocacy groups, and others. With assistance from Cerner and NATE, going forward, PEER will accept coded, clinical data from participants’ electronic health records (EHRs). Participants will be able to send this information to PEER directly from their provider-supplied portals, leveraging national standards, or ask that their providers send it. PEER is a free-to-the-participant user service that is provided through condition-specific advocacy and support groups. Each participant is provided with tools to dynamically control how much of their information they wish to share, and with whom. Currently there are about 20 provider-supplied portals that work with PEER. Through a grant from the Robert Wood Johnson Foundation, this number will more than double by the end of 2015. Additional collaborators on this effort include: Private Access, Cerner Corporation, National Association of Trusted Identities (NATE).

GetMyHealthData: The GetMyHealthData campaign is pledging to help thousands of consumers over the next 12 months access and download their own clinical health data, so they can use it to understand and improve their health, their care, and the system as a whole -- including donating their data for research. The campaign is a collaboration of consumer organizations, health care experts, former policy makers and technology organizations.  GetMyHealthData will guide consumers through the often complex process by providing a tool to automate the request for their data and to troubleshoot any problems that occur. The initiative will also offer basic guidance on apps that can safely and securely store patient data, including those that enable data donation for research while protecting privacy. Finally, the campaign will provide resources for clinicians and consumers that explain consumers’ rights and best practices to get copies of their structured electronic clinical data. Collaborators include: National Partnership for Women & Families, Amida, Code for America, Genetic Alliance, Health Data Consortium and NATE.

Sage Bionetworks: Recognizing the importance of health-data liberation, and the role of data in driving research studies, Sage Bionetworks is announcing that it will support clinical studies that import electronic health-record information to its open source research platform and that it will release open-source informed-consent prototypes to support these studies. Sage’s goal is to catalyze new clinical studies that are native to mobile phones, vastly expanding the ability of citizens to voluntarily participate and engage as partners in research. Sage Bionetworks leverages the power of open networks of contributors to solve complex scientific problems, including the Cancer Genome Atlas and NIH’s Alzheimer’s Accelerating Medicine Partnership.