GAO称FDA需要一个整体的IT建设计划

张琨

FDA needs comprehensive IT plan, says GAO

• By Kathryn Foxhall
• Jun 02, 2009

Food agency lacks thorough plan or architecture to modernize its information systems, accountability office reports
The Food and Drug Administration does not yet have a comprehensive plan to modernize its information technology systems and infrastructure, a new Government Accountability Office report states. The FDA responded that a plan is in development.

The GAO report released on June 2 states the agency does not have an architecture that can be used to guide and constrain its modernization efforts. The GAO also said the agency is not strategically managing its IT human capital by determining its skill needs or the gaps between what it has and what it will need in the future.

The report lists 16 FDA modernization projects, from automated employee processing to its system for reporting adverse events from drugs and other products.

FDA said it agreed with most of the report’s recommendations, but noted it is currently developing an information management strategic plan under the auspices of its bioinformatics board.

FDA’s Science Board said in 2007 that the agency lacked the IT capability and infrastructure to fulfill its regulatory mission.

GAO also released a report on June 1 stating that the FDA has yet to set adequate privacy and security protections for its planned Sentinel program, which gathers health-effects information on drugs and other products after they are on the market.

Plans for Sentinel, which was mandated by Congress, were announced by the agency a year ago. The FDA design calls for a coordinating center to send queries to data sources including health insurance companies, academic institutions, federal and state government agencies, and health care providers. Summaries of the information would go back to the coordinating center, and from there, back to the FDA and other entities.

According to the Food and Drug Administration Amendments Act of 2007, that postmarket risk-assessment system should have access to data from 25 million patients by mid-2010 and to 100 million by mid-2012.

FDA emphasizes it is working toward establishing a distributed network to gather the information and ensure that no protected information will be transferred. It will stay with its original owners who will do the data searches themselves and only supply summaries, said the agency.