Precision Medicine Requires Regulatory Reform, Data Analytics

July 29, 2015 in News

President Obama’s Precision Medicine Initiative will not succeed without a regulatory system that can facilitate big data analytics for genomic research, according to a white paper by the Center for Data Innovation and Health IT Now Coalition, Health Data Management reports (Slabodkin, Health Data Management, 7/27).

Background

In February, Obama in his fiscal year 2016 budget proposal asked Congress for $215 million in funding for a precision medicine initiative that centers on the creation of a massive database containing the genetic data of at least one million volunteer participants. Of the funding:

  • $131 million would go toward NIH to recruit at least one million volunteers and analyze their full genetic makeups, as well as expand clinical trials for possible cancer medications;
  • $70 million would go toward NIH’s National Cancer Institute to further study genetic causes of cancers and use study findings to assist with drug development;
  • $10 million would go toward FDA to develop databases to help the agency create the regulatory structure for evaluating precision medicine advances; and
  • $5 million would go toward ONC to help develop interoperability standards and policies to address privacy issues and help with secure data exchange across various systems (iHealthBeat, 2/3).

An implementation plan from NIH is due in September.

White Paper Recommendations

The white paper makes several recommendations to ensure a successful precision medicine program, stressing the importance of public-private partnerships. Specifically, the two organizations recommend that stakeholders:

  • Encourage patient and private-sector engagement because of their shared interest in the way big-data applications can shape health care innovation;
  • Implement strong federal requirements to improve interoperability and data sharing so that genomic and other health data can be accessed and sent across different systems; and
  • Re-evaluate existing privacy and consent laws to account for advances in science and technology.

Joel White, executive director of the Health IT Now Coalition, said, “In order to make full use of [the genomic and clinical] information and taxpayer dollars that are funding the initiative, we need a functional and broad-based data-sharing model that can only be reached through cooperation of both private and public sectors” (Health Data Management, 7/27).

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