|President Barack Obama|
The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.
The agency is conscious that as the fulfillment of its duties comes to necessitate increased handling of healthcare records, genome data and consumer-provided information, its IT infrastructure will feel the strain. Some of the $2 million the FDA wants to invest in its headquarters will go toward ensuring it can securely store such resources. The FDA also plans to set some of the money aside for the creation of cloud computing and storage infrastructure, which will play a role as data submissions grow and grow.
Finally, the regulator is planning IT infrastructure to ensure "customers who contribute data to FDA will be rewarded with information tailored to them." The FDA thinks it will need $2 million and four full-time equivalent staffers to work on the precision medicine IT agenda in 2016, which are the only new additions to the budget proposal for the FDA's headquarters. The regulator is seeking a further $7.4 million for the rest of its precision medicine program.
The $7.4 million will go toward developing standards for next-generation sequencing (NGS), including technical metrics for data quality and test performance. The FDA also plans to investigate whether existing databases--such as the National Institutes of Health's ClinGen--can be used to support the clinical validity of NGS tests. The availability of all of these funds is dependent on the outcome of budget negotiations in Congress.