HHS Open Government Plan Offers Vastly More Information On FDA, CMS

Article preview from "The Gray Sheet" - April 12, 2010

The Department of Health and Human Services' open government plan, unveiled April 7, includes an online "FDA Track" site to measure FDA's performance and a "CMS Dashboard" that provides easier access to certain Medicare payment data.

HHS Open Government Plan Offers Vastly More Information On FDA, CMS

Article preview from "The Gray Sheet" - April 12, 2010

The Department of Health and Human Services' open government plan, unveiled April 7, includes an online "FDA Track" site to measure FDA's performance and a "CMS Dashboard" that provides easier access to certain Medicare payment data.

The initiative is designed around the principles of information transparency, public participation in HHS activities, and greater collaboration among local, state and national government bodies. It is part of a larger directive from the Obama administration that all federal agencies become more transparent.

HHS Chief Technology Officer Todd Park said the plan would see "major streams of update" as health care reform continues to be implemented. The department is seeking comments on the plan, available at www.hhs.gov/open, to guide future changes.

A primary goal is to make information already available at various HHS Web sites easier to find, Park said during an April 7 webcast.

The massive amount of information within FDA, CMS, NIH and other HHS agencies "presents a crisis of overwhelming opportunity," Park said. "How can you possibly sort through all that and figure out what to do?"

The HHS open government Web site includes a compendium of data available for download "so it's a much easier way for people to find stuff that could be cool and useful," Park said.

HHS plans to align future release of new data with the department's strategic priorities, which include prevention and wellness, the advancement of research and cures, and the improvement of health care quality, among others, Park said.

The open government plan will also address suggestions HHS has received from the public, such as a request that FDA make its product recall data more accessible by posting it in a more structured, downloadable format.

According to Park, FDA has committed to making the recall data available in XML format by the fourth quarter of this fiscal year.

FDA To Report Monthly On Its Performance

As part of the HHS plan, FDA released on April 7 a new online tool, at www.fda.gov/fdatrack, that measures performance on a monthly basis at over 100 agency offices using more than 300 measures.

"For a long time, FDA has been seen as a black box," FDA Principal Deputy Commissioner Joshua Sharfstein said during the webcast. "People don't really understand outside FDA what goes on inside."

"That's a source of some frustration to the employees of FDA, who are justifiably quite proud of the kind of work that they're doing," he added. "They really see the potential of a system like FDA Track to show, office by office, the kind of work that's going on."

For example, the CDRH Premarket Dashboard will give a month-to-month account of the percentage of 510(k) in-vitro diagnostic decision summaries posted on the Web within the designated 45-day time frame.

The pre-market dashboard also tracks the progress of the center's iReview workflow management tool intended to automate the 510(k) review status process. According to the Web site, a demo of iReview is on track to meet its May user acceptance testing milestone.

The CDRH Management Dashboard will track, among other things, the center's progress in developing guidance for industry and finding ways to remove development barriers for devices that respond to important unmet public health needs.

CDRH also has dashboards devoted to its Office of Science and Engineering Laboratories, Office of Compliance, and Office of Surveillance and Biometrics.

One cross-agency program area focuses on how well FDA meets the goals of the Freedom of Information Act. It will track the number of FOIA requests FDA receives each month and what percentage of those are assigned to CDRH, for example, as well as how many requests still remain pending from previous months.

"We realize that we're going to be open to questions about our performance, but I think we're ready to do that," Sharfstein said.

"There may be some goals that we make that we don't reach, and we'll have to explain why that's the case, but that's part of being an agency in an era of open government," he added.

As part of its open government initiative, FDA has pilot programs testing the delivery of information to handheld devices so that clinicians in health care settings can access updates as quickly as possible, Sharfstein said.

The Alliance for a Stronger FDA applauded the new FDA Track initiative, saying it "represents a positive step toward improved management by objectives, more accountability and greater transparency."

- Monica Hogan

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