HHS outlines steps toward personalized healthcare

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HHS Secretary Mike Leavitt outlined a course for achieving gene-based medical care combined with health information technology, which he called "Personalized Health Care." In a speech before the annual meetings of the Personalized Medicine Coalition, the Secretary outlined new steps he is undertaking to build the foundation for personalized healthcare and ensure that gene-based medical data and health information technology are used appropriately.

Gene-based medicine can help individuals identify their particular susceptibilities to disease to help detect the onset of disease much earlier, enabling treatment to prevent disease progression, and it can help tailor medical products more precisely to the needs of each individual.

Secretary Leavitt said he’ll focus on delivering personalized healthcare for the next two years. Here are new steps that HHS is taking to lay the foundation for a personalized health care future:

  • HHS is engaged in a broad review for privacy protection as health information technology is increasingly adopted, including needs for genetic information, and the anticipated effect on the confidentiality, privacy and security of individually identifiable health information.
  • HHS will review existing structures for ensuring that genetic tests are accurate, valid and useful.
  • HHS will develop consistent policies for its agencies regarding access to and security of federally supported research.

The president's budget for 2008 includes $15 million in start-up funding to create a new electronic network, in hopes of most Americans having electronic health records by 2014.

Current efforts at HHS agencies supporting personalized health care include:

  • At the National Institutes of Health, genome-wide association studies are using information from years of clinical trials to find associations between genetic elements and health outcomes.
  • At the Food and Drug Administration, the Critical Path initiative is organizing work across 76 science and regulatory areas to improve product development, especially for gene-oriented drugs and diagnostic tests.
  • The Centers for Disease Control and Prevention has worked with the National Cancer Institute to define the leading 100 genetic variants of public health significance. CDC is using its National Health and Nutrition Examination Survey to determine how common these variants are in the U.S., to be released this summer.