On February 25, President Obama addressed a small audience at the White House, identifying the need for patient participation in health care and the importance of individualizing treatments for a particular patient. Obama said that precision medicine can lead to reduced costs, better care, and a more efficient health care system.  He stated “the health care system is actually more of a disease-care system in which the patient is passive, you wait until you get sick, a bunch of experts then help you solve it,” and that precision medicine is about “empowering individuals to monitor and take a more active role in their own health.” His remarks were quite genuine and showed his personal interest in precision medicine as he seemed to talk “off script” with his panelists.

A year ago the President launched the Precision Medicine Initiative (PMI) to accelerate medicine that delivers the right treatment at the right time to the right person, taking into account individuals’ health history, genes, environments, and lifestyles. This includes efforts by the NIH to build a 1 million-person voluntary national research cohort who will partner with researchers, share data, and engage in research to transform our understanding of health and disease through precision medicine.  It also includes efforts by the Department of Veterans Affairs (VA), which has enrolled over 450,000 Veterans in the Million Veteran Program (MVP), a participant-driven research cohort.Vice President Biden’s cancer moonshot initiative builds on this initiative.

The event was an opportunity to not only hear from President, but also to hear private sector commitments and to learn about agency action. Some highlights of federal government activity are:

  • NIH announced an award to Vanderbilt University in collaboration with Verily (formerly Google Life Sciences) to launch the first phase of the Precision Medicine Initiative cohort.
  • NIH, with the Office of the National Coordinator for Health IT (ONC), will coordinate “Sync for Science” pilots through an open standards development process with electronic health record developers. The primary goal is to help scale individual data access and donation for precision medicine research.
  • The White House published a draft Data Security Policy Principles and Framework for the PMI. This document is open for public comments through March 25, 2016 and will be finalized later this spring.
  • ONC and the National Institute of Standards and Technology (NIST), will develop a precision medicine-specific guide to the NIST Cybersecurity Framework later this year. The guide is intended to assist organizations in executing the Data Security Policy Principles and Framework. The agencies intend to reach out to Federal partners and stakeholders from across the health IT and research community in the coming months.
  • FDA launched a precisionFDAchallenge, which will use the new precisionFDA platform to encourage the genomics community to advance quality standards and achieve more consistent and accurate DNA test results, advancing the goal of better personalized care.
  • The Office for Civil Rights (OCR) issued guidance on individuals’ rights to access their health information under HIPAA, and have copies of their health information sent to anyone they designate, including to contribute it for research. It also clarifies rules on fees that can be charged for access.

Many health care systems and technology companies have pledged to take specific actions to support precision medicine and the White House vision for PMI, demonstrating the interest and opportunity that this may provide to the health care market. This is an issue to follow and presents opportunities for leading health care entities and technology companies to influence policy and become involved in efforts that will help shape the next generation of research and medical practice.

There will be a Twitter chat on data access on Thursday, March 17 at 1 pm ET using the hashtag #PrecisionMedicine.  More information can be found at https://www.whitehouse.gov/precision-medicine.

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Photo of Jodi G. Daniel Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group, where she provides strategic advice to clients navigating the legal and regulatory environments related to technology in the health care sector. Jodi is the former director of the Office of Policy in the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS). She served for a decade as the director at the ONC and 15 years at HHS, where she helped spearhead important changes in health information privacy and health information technology to improve health care for consumers nationwide.

For more than a decade, Jodi has been responsible for thought leadership, policy development, and identifying policy drivers for health IT activities within the federal government, and ultimately established the HHS’ national health IT policy. As former director at the ONC, she addressed privacy and security issues to ensure that there was clear guidance on how the initial Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules applied to health IT. Jodi set the strategic direction and set policy on consumer e-health and health IT safety. She is also credited with establishing the ONC’s regulatory capacity and led the development of all ONC regulations on health IT standards and certification.

As the first senior counsel for health information technology in the Office of the General Counsel (OGC) of HHS, Jodi developed HHS’s foundational legal strategies and coordinated all legal advice regarding health IT for HHS. She founded and chaired the health information technology practice group within OGC and worked closely with the Centers for Medicare and Medicaid Services in the development of the e-prescribing standards regulations and the Stark and anti-kickback rules regarding e-prescribing and electronic health records.