FDA Aims To Boost Health IT as Part of Four-Year Strategic Plan

October 3, 2014 in News

FDA has released a four-year strategic plan that includes goals for advancing and improving the agency’s use of health IT, Health Data Management reports (Slabodkin, Health Data Management, 10/3).

Details of Plan

FDA’s Strategic Priorities plan sets goals to guide the agency’s work between 2014 and 2018. The priorities will be implemented through a tiered planning framework, according to FDA.

The plan established four main objectives:

  • Enhancing oversight of FDA-regulated products;
  • Improving access to FDA-regulated products to benefit public health;
  • Promoting informed decisions about using FDA-regulated products; and
  • Strengthening the agency’s accountability (Strategic Priorities plan, September 2014).

Health IT Goals

As part of the plan, FDA aims to create a real-time data sharing system that can be accessed by regulators across the world.

FDA also will form partnerships to standardize the reporting and data exchange processes for intelligence-gathering (Health Data Management, 10/3). Specifically, the agency will implement unique device identifiers over the next seven years (Bowman, FierceHealthIT, 10/2).

The standardized processes will have “an increased focus on risk analytics and modernized information technology capabilities,” according to the plan.

In addition, FDA will continue to improve its surveillance systems that track adverse event reports using:

  • Electronic health records;
  • Insurance claims databases; and
  • Registries (Health Data Management, 10/3).

FDA Releases New Online Tool

In related news, FDA this week released a new online tool to improve the agency’s data transparency, Health Data Management reports.

The cloud-based dashboard offers data from fiscal year 2009 to FY2013 on the agency’s:

  • Inspections;
  • Recalls (Slabodkin, Health Data Management, 10/2);
  • Seizures and injunctions;
  • Statistics; and
  • Warning letters issued (FierceHealthIT, 10/2).

Users will be able to:

  • Download data for further analysis;
  • Export charts;
  • Manipulate data with filters; and
  • Reorganize the format and sorting of datasets.

In a blog post, Douglas Stearn — director of FDA’s Office of Enforcement and Import Operations — said, “This new dynamic tool represents a departure from the downloadable spreadsheet-based datasets that we have posted in the past. Instead, the FDA data dashboard presents information in an easy-to-read graphical format” (Health Data Management, 10/2).

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