Regulatory Reforms Needed to Leverage Data for Precision Medicine

If the Obama administration’s $215 million Precision Medicine Initiative is to succeed, policymakers must modernize the regulatory system to better enable big data analytics to be used in genomic research.

That’s the conclusion of a new white paper on genomics released by the Center for Data Innovation and Health IT Now Coalition, which provides recommendations to policymakers. As the National Institutes of Health develops an implementation plan for the initiative, which is due to President Obama in September, the paper stresses the need for active public-private partnerships in development of precision medicine.

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“The president’s Precision Medicine Initiative aims to collect genomic and clinical data from more than one million volunteers. In order to make full use of this 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,” said Joel White, executive director of the Health IT Now Coalition.

Towards that end, the paper makes the following recommendations:

*Improve interoperability and data sharing. Stronger federal requirements are needed to ensure that genomic and other health data can be retrieved and compared across health record systems. Bottom-up, patient-driven reforms, such as giving patients (and their providers) a right to access and share interoperable health data, would incentivize standard setting and save lives.

*Ensure patients and the private sector are actively engaged. The public and private sectors share an interest in raising the tone of discourse on the role that genomics and other big-data applications might play in revolutionizing an expensive and underperforming health system. As the true customers of health care, consumers—especially patients desperately waiting for breakthrough cures—must be brought into this dialogue.

*Reevaluate current privacy and consent laws to account for modern scientific and technological advances. Once thought to be a cost-free way to moot fears about medical snooping, today’s privacy laws pose a particular challenge to the big-data analytic techniques needed to sift through, and find patterns in, many trillions of data points. Notably, penalties under HIPAA are not based on actual harms done, but, rather, on the number of records compromised. Precautionary measures not only divert scarce research dollars toward cyber-security, but the ensuing secrecy and compartmentalization discourages the types of multidisciplinary research most likely to yield results in studies of this size and scope.

“We are rapidly approaching an era when it is feasible for all healthcare decisions to factor in a patient’s individual genomic data to improve health care outcomes, but technical and regulatory barriers limit this potentially life-saving progress,” warns Daniel Castro, director of the Center for Data Innovation. “And without action from the Administration or Congress, these limits will only become more damaging.”