The U.S. Food and Drug Administration has released its 2014-2018 Strategic Priorities plan with health information technology playing a prominent role.
The document lays out the goals and priorities that will guide the regulatory agency over the next four years. According to the FDA, it will implement these strategic priorities through a tiered planning framework.
The world in which FDA operates today is one of growing complexity, new challenges, and increased risks, writes Commissioner Margaret Hamburg, M.D., in an introduction to the plan. And thanks to revolutionary advances in science, medicine, and technology, we have enormous opportunities that we can leverage in order to overcome many of these challenges for the benefit of public health.
As the document states, the FDA must have access to the best available scientific data to inform regulatory decision-making and thus improve access to FDA-regulated products that benefit the public health, and enhance oversight of all FDA-regulated products. To provide greater access to that data, the agency intends to develop a global data information system and network that regulators worldwide can regularly and proactively share real-time information and resources across markets.
In particular, FDA indicated it will work with partners to identify critical data elements, such as unique facility identifiers, to better standardize reporting and facilitate data exchanges.
We will continue to expand our capabilities in intelligence-gathering and use, with an increased focus on risk analytics and modernized information technology capabilities, states the document These capabilities will enable FDA to more effectively allocate our resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.
The regulatory agency also plans to continue to expand its efforts to move from passive to active surveillance systems such as Sentinel, a proactive system that complements existing systems that FDA has in place to track reports of adverse events linked to the use of regulated products.
The system enables FDA to actively query diverse automated healthcare data holderslike electronic health record systems, administrative and insurance claims databases, and registriesto evaluate possible medical product safety issues quickly and securely, while maintaining the privacy of patients.
However, the FDAs Sentinel system is coming under fire from critics who say that progress is coming too slowly and the jury is still out on whether the regulatory agency will in fact succeed in achieving its goals.
The FDAs 2014-2018 Strategic Priorities document is available here.
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