5. HHS Flagship Initiatives
In the HHS Open Government Plan, we identified key activities that represented new strategies and approaches to serve the public’s information needs and access points. We identified 5 “flagship initiatives” last year and each of these has made substantial progress. Provided here is an update on the progress of each of the flagship initiatives with a look to their future developments.
In March 2010, HHS took the first steps toward promoting the uses of HHS-developed data from surveys, administrative processes, and other sources and promoted its use to the public. Underpinning this initiative is the recognition that there are vast needs for information by consumers, health care providers, policy makers and others to guide decisionmaking in many aspects of health and health care. This effort was established a “health data ecosystem” in which data resources were integrated into electronic platforms aimed at consumer health, community health and health care users.
In June 2010, a conference was held with the Institute of Medicine to showcase more than 20 new applications that were developed to use HHS data and inform decision making. This sparked a major effort for data production, applications development, and uses. Across HHS, major efforts were committed to helping organize already existing data and tools with links to one common website. This effort to facilitate data transparency has yielded more than 230 datasets and tools that can now be found on a common website known as HealthData.gov. Healthdata.gov, the common site for identifying data resources, has many Web 2.0 features that enable users to see ratings and rankings and comments from other data users. A linkage to an “apps expo” provides interested parties with examples of how others have used the data.
HHS also unveiled an additional new resource known as the Health Indicators Warehouse (healthindicators.gov) with many new automated download features to support computer-to-computer linkages of data resources. In this warehouse are more than 1170 indicators of all sorts of health status indicators, administrative data, and others that are now being widely used by application developers, researchers, policy makers and others. Cumulatively, these new data resources are shining a light on major issues in health and health care – such as differences in quality of care, outcomes, and incidence of disease and conditions. This year, expanded efforts are being made to bring information on health and social services in various community resources into HealthData.gov as well. With the expansion of the focus from community level data to more broad and diverse sources, HHS now refers to these collective activities as the “Health Data Initiative.”
To further promote the use of health data, HHS has partnered with a number of non-governmental organizations to hold challenges and competitions to inspire new developers to create tools and resources that use HHS data. Additionally, events that bring data experts and technology developers together, called ‘code-a-thons’ have yielded new ideas and applications of health data. Over the last year, more than 30 of these events have been held and yielded an impressive array of technologies to further integrate uses of data into health and health care decision making.
In June 2011, the second annual Health Data Initiative Forum was held in conjunction with the Institute of Medicine. Over 75 new applications were submitted in response to the meeting sponsors’ solicitation, and nearly four dozen of the most promising new applications and services that have been developed using HHS data were showcased at the meeting. Additional efforts are now focused on use cases for how data can be used to address issues such as patient safety, obesity, regional differences in health outcomes, etc. The Health Data Initiative is beginning to engage a wide array of partnerships with foundations, philanthropy, private industry, health care delivery networks, academia, and state and local governments. This effort is continuing to promote the uses of data in a broad array of ways that creates value for the users.
The Centers for Medicare & Medicaid Services (CMS) has developed a series of dashboards, which are exciting new web applications that allow the public to visualize and analyze Medicare spending with unprecedented ease and clarity. By simplifying and making data more accessible through dashboards, the CMS aims to facilitate the ability of researchers and policymakers to ask questions and quickly obtain answers, thus helping to accelerate efforts to improve the nation's health care delivery and payment systems.
To date, CMS has developed two dashboards that are available to the public on the CMS website at https://www.cms.gov/Dashboard/01_Overview.asp#TopOfPage. Both dashboards have demonstrated success as evidenced by recently released metrics:
- The Medicare Inpatient Hospital Dashboard offers statistical views of the Inpatient Prospective Payment System (IPPS) data as it relates to claims payment and volume as collected by CMS. This external-facing dashboard has had 1,495 hits since January 2011 and is currently available and refreshed the second Monday of each month.
- The Medicare Prescription Drug Benefit Dashboard BETA is a beta release and offers statistical views of the Prescription Drug Event (PDE) data as it relates to drug costs and utilization as collected by CMS. Currently, HHS is planning to add the 2009 data in June; future releases may contain additional CMS Program data. This external facing dashboard has had 1,297 hits since January 2011 and is currently available and refreshed annually after reconciliation occurs in June.
In addition to these dashboards, CMS is in the process of developing two additional public-facing dashboards: the Physician Supplier (Part B) Dashboard and the CMS Enrollment Dashboard. The CMS is projecting a Fall 2011 release for both dashboards.
Since June 2010, FDA has made substantial progress towards the goals of its Transparency Initiative. Among other things, FDA has issued two major reports proposing new disclosure initiatives and launched a second website (FDA Basics for Industry), in addition to its initial FDA Basics website. Below, we provide updated information on each of the 3 phases of the Transparency Initiative identified in the 2010 report.
Phase I: FDA Basics
This resource now includes (1) 156 questions and answers about FDA and the products that the agency regulates, (2) eight short videos that explain various agency activities and (3) conversations with 14 agency officials about the work of their offices. The site has received over 1.2 million visits since launch. The videos have received over 20,422 views, and the agency has received over 9,000 comments and ratings from the public. Feedback provided by the public is used to update the resource. There is now a section of FDA Basics that allows visitors to see the number of comments and ratings as well as the average score of ratings per product category (accessible online at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm1176986.htm). Visitors can also see the web traffic to this section by month in this metrics section.
Each month, senior officials from FDA product centers and offices host 30 minute online sessions about a specific topic and answer questions from the public about that topic. So far, FDA has hosted 13 webinars with the average number of attendees being around 200.
Phase 2: Public Disclosure
On May 19, 2010, FDA issued a draft set of 21 proposals for disclosing information on a range of topics, including adverse event reporting, enforcement actions and letters, import procedures, inspections, as well as the existence, status, and content of product applications, and recalls (report accessible online at http://www.fda.gov/AboutFDA/Transparency/PublicDisclosure/default.htm). FDA received 145 public comments on the draft proposals. FDA has reviewed the comments, and has conducted resource, legal, and priority assessments to determine which proposals to implement and in what order. FDA has implemented 4 of the proposals, including the launch of a database providing information about all the inspections related to marketed products that the agency has conducted, and has announced plans to implement 3 more before the end of the year.
Phase 3: Transparency to regulated industry
On January 6, 2011, after holding 3 listening sessions with industry and receiving written comments, FDA released a report containing 19 action items and five draft proposals to improve transparency to regulated industry (accessible online at http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencytoRegulatedIndustry/PhaseIIITransparencyReport/UCM239088.pdf), including a web-based resource called FDA Basics for Industry to provide basic information about the regulatory process, including information that is frequently requested by industry. FDA sought public comment on the report. The comment period closed on March 6, 2011.
On the same day that the report was released, FDA launched FDA Basics for Industry. This resource includes: easier access to frequently requested content including guidance documents, information about the review process, and registration and listing information; links to training modules for industry, such as the Center for Devices and Radiological Health’s CDRH Learn educational tool; answers to questions frequently asked by industry including a rating system so visitors can rate the helpfulness of the answers; and an interactive flowchart that helps industry determine whether or not their product is regulated by FDA.
Since launch, FDA Basics for Industry has received over 68,000 visits.
FDA-TRACK adheres to values that comprise its name – Transparency, Results, Accountability, Credibility and Knowledge-sharing. FDA’s senior leaders continue to be committed to making FDA-TRACK successful and sustainable, and ultimately a model for open government at the federal level. Below are some updates on planned continuous improvements since the April 2010 launch:
Alignment of FDA-TRACK measures to the annual agency performance measures such as those required by the Government Performance and Results Act of 1993 (GPRA)
FDA has completed the alignment of our GPRA measures to FDA-TRACK measures. Although some of our annual measures are directly tracked on FDA-TRACK, there are some that are not (since these measures are longer term annual measures, as opposed to monthly FDA-TRACK measures). FDA is in the process of addressing this issue and developing monthly indicators to better align to annual long-term measures.
Alignment of FDA-TRACK measures to individual employee performance plans
The Commissioner's FY11 SES plan includes as an element the alignment of FDA-TRACK program measures to program outcomes and this element cascades down to senior executives across the agency. Additionally, Center and Office Directors have begun to align more program-specific strategic priorities with FDA-TRACK goals, which are also incorporated into individual performance plans where applicable. For example, our Center for Devices and Radiological Health (CDRH) has a 2011 Strategic Priority initiative to enhance the efficiency and clarity of the medical device and radiation-emitting product recall processes. CDRH tracks the specific milestones and progress as a key project within the CDRH compliance dashboard in FDA-TRACK, and the milestones are included in the Office of Compliance Director's FY11 SES plan.
Improvements to FDA-TRACK data management and reporting software
In late 2010, FDA released a Request for Information (RFI) for potential business intelligence platforms and data warehousing capabilities to better support FDA-TRACK data management, analytics, and reporting. FDA has completed an evaluation of all the RFIs and is in the system demonstration stage.
FDA began publishing public briefing summaries on the FDA-TRACK website (www.fda.gov/fdatrack) in January 2011. In addition to the data updates, the public can now read (as well as submit comments on) summaries of progress and accomplishments discussed internally at the quarterly briefings. Other enhancements to facilitate public access since the April 2010 launch include: a "Search FDA-TRACK" function; monthly "FDA-TRACK Updates" email subscription feature; redesign of our home page, which now features monthly updates, Spotlight of the Month, and upcoming changes.
Improvements to measures based on public input and experience so that measures can be more closely tied to the public health mission of the agency
FDA conducts real-time monitoring of the FDA-TRACK email account (FDATRACK@fda.hhs.gov) and integrates public feedback where appropriate. The public can also submit feedback via the FDA Transparency Blog.
Internally, FDA regularly analyzes, evaluates, and enhances existing measures and data results during quarterly briefings to ensure the information tracked is meaningful and more closely tied to program goals and, ultimately, public health outcomes. To date, the agency conducts about 20 briefings every quarter, for almost 80 briefings since the April 2010 launch. FDA publishes updates to measures and performance data every month on the FDA-TRACK website.
FDA has identified and implemented five new cross-cutting TRACK programs focusing on Advisory Committees vacancies, Freedom of Information Act (FOIA) backlog, Office of Regulatory Affairs (ORA) Lab Throughput, FDA's efforts to reduce the rate of Salmonella Enteritidis (SE) illness in shell eggs, and implementing FDA components of Health Care Reform. Several more are underway, including a program to track FDA's implementation of its Medical Counter-Measures program.
In July 2010, FDA implemented a monthly FDA-TRACK Updates email subscription to keep the public informed of updates and provide additional venues for submitting feedback. Currently, FDA-TRACK has almost 8,000 subscribers and continues to grow (on average, 25% every month).
Implementation of improvements to FDA-TRACK performance data analysis to enable better predictive outcomes and other quantitative data-based decision making
FDA is assessing sophisticated analytic capabilities as part of its current RFI and market research on business intelligence and data warehousing platforms. As FDA-TRACK accumulates data, predictive analysis and other quantitative and qualitative-based decision making continues to strengthen. To date, the agency has implemented over 600 performance measures and 100 key projects.
A sample of significant accomplishments from the first year has been published on the FDA-TRACK website, and will be updated on a regular basis. Accomplishments include:
- Reduced advisory committee vacancy rate by 25%
- Successfully piloted an electronic lot release submission program to increase efficiency and effectiveness of releasing H1N1 vaccines to the public
- Exceeded annual target by 10% for first year implementation of Quality by Design for new drug applications
- Increased medical device reporting participation rates of hospitals in the Medical Product Safety Network (MedSun) by over 70%
- Developed and implemented measures to track FDA’s implementation of the Egg Safety Rule (Egg-TRACK), and ultimately reduce the rate of SE illness from shell eggs
- Eliminated and sustaining a zero backlog of generic new animal drug applications from over 130 applications.
As discussed in Section 3B of this report, a number of HHS operating components are working with program staff to increase proactive disclosures by identifying materials responsive to FOIA requests. As a result of these efforts, HHS has achieved major FOIA backlog reductions during 2010. One notable example is the FDA, which is actively participating in all aspects of the HHS FOIA initiative through tracking the number of incoming requests, number of processed requests, and number of pending/backlogged requests and providing weekly reports to HHS FOIA.
As a result of these efforts, FDA's FOIA backlog has decreased 11.3% since the end of FY10 (from 4691 pending requests to 4161). This brings the total reduction over the last four years to about 80%.
Currently, while most agency components are responding to most or all requests within the statutory timeframe of 20 days, there remain significant backlogs in the two components that receive the highest number of complex FOIA requests. The two components with the highest backlogs are continuing to review their procedures to identify strategies for backlog reduction. For example, additional staff training has been provided; workload queues have been rebalanced in order to respond to more requests within 20 days; and additional administrative support has been offered through headquarters (Division of Freedom of Information).
Going forward, FDA will continue to focus on the components with the largest backlogs. These components will continue to review SOPs and provide additional staff training. FDA will also continue to enhance transparency by posting high-profile records to the agency's internet website, which may have the effect of reducing the number of incoming FOIA requests. In addition, Division of Freedom of Information will continue to provide administrative support to assist components handling large volumes of FOIA requests. Finally, FDA is making enhancements to its existing FOIA tracking database that could assist with workload monitoring and backlog reduction.