What Obama's precision medicine plan needs to succeed

Hint: A more robust regulatory system
By Jack McCarthy
08:03 AM

President Obama's Precision Medicine Initiative to accelerate understanding of individual variability and its effect on disease and treatment is going to necessitate a regulatory system robust enough to facilitate big data analytics for genomics research – no small feat.

That's according to a white paper by the Center for Data Innovation and Health IT Now Coalition, in which the authors contend that to be maximally effective this initiative will require the public and private sectors to work in tandem to realize the next generation of medicine and overcome the institutional challenges that increasingly hinder progress.

Policymakers, in other words, must modernize the regulatory system. To that end, the authors recommend the following:

1. 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

2. Engage patients. 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 our expensive and underperforming health system

3. Re-think privacy law. The strict privacy requirements of the Health Information Portability and Accountability Act and complementary federal and state laws, including the Common Rule, present formidable obstacles to realizing the potential of genomic medicine

President Obama included $215 million in his latest budget to fund initiatives at the National Institutes of Health, the National Cancer Institute, the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology.