3.3 Proactive Disclosure
Centers for Disease Control and Prevention (CDC) Public Access Platform
In order to keep pace with emerging public health challenges and the need to share research and information the Centers for Disease Control and Prevention (CDC) has developed CDC Stacks. CDC Stacks is a free, digital repository of scientific research and literature produced by CDC. This online archive is composed of curated collections tailored for public health research needs, is retained indefinitely, and made available for public health professionals, researchers, and the general public to promote public health literacy.
Public health and scientific advancement are best served when scientific information is openly shared and used by the public, public health professionals, health care providers, educators, policy makers and private sector organizations. With greater public access, CDC can maximize the effect and impact of public health science and improve the health of the nation. Through its public access policy CDC has provided access to over 7,700 peer reviewed publications. This has resulted in over 1.2 million article accessed that would have otherwise required payment.
CDC Stacks brings together documents spanning public health topics as well as the history of CDC. Collections include the first 30 years of Morbidity and Mortality Weekly Report (MMWR), CDC Open Access, and Influenza Surveillance Reports. CDC Stacks also contains a collection of both current as well as archival CDC guidelines and recommendations. CDC Stacks is a fully featured archive allowing users to search the full text of all documents as well as browse journal articles by public health subjects. Public health is a broad topic and so are the types of documents found in the repository with new documents added every week.
By leveraging an open source software model CDC has not only been able to develop new code rapidly but has been able to share that code with the public as well as other federal agencies. In the spirit of shared services the CDC is currently supporting the National Oceanic and Atmospheric Administration (NOAA) document repository system and is in the process of launching the Department of Transportation (DOT) document repository system. This inter-agency collaboration not only provides new ideas and strength in numbers it also comes at a considerable cost savings to the government.
FDA Center for Veterinary Medicine Initiative – NARMS Now: Integrated Data
The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative project of state and local public health departments, FDA’s Center for Veterinary Medicine, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA). This national public health surveillance system tracks changes in the antimicrobial susceptibility of intestinal bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA). The NARMS program helps promote and protect public health by providing information about emerging bacterial resistance, the differences between resistant infections and susceptible infections, and the impact of interventions designed to limit the spread of resistance.
Consistent with the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) goals and HHS’ and USDA’s Open Government policies, in 2015 NARMS published online a new format called NARMS Now: Integrated Data. This format contains the entire collection of NARMS enteric bacterial isolates collected over 18 years (1996-2013) from all three agencies for Salmonella, Campylobacter, E. coli and Enterococcus.
The NARMS data are available in a spreadsheet format that can be downloaded and analyzed by commonly used software applications. Data fields include sample identifiers, sample source, dates of collection, and antimicrobial susceptibility testing results. In 2016, NARMS began to include resistance determinants and accession numbers that can be used to access whole genome sequences housed in the NARMS GenBank bioproject on the National Center for Biotechnology Information (NCBI) website. NARMSNow: Integrated Data is updated on a regular basis as new information is generated.
In the near future, NARMS Now: Integrated Data will be incorporated into the integrative displays associated with the NARMS integrated Reports to allow readers to visualize the findings across the various sample sources in NARMS.
FDA Proactive Posting of Medical Device Premarket Notification Applications
CDRH receives approximately 2000 FOIA requests each year, 90 percent of which are for FDA-cleared medical device marketing applications. In 2015 CDRH began to proactively post redacted FDA-cleared marketing applications. The Medical Device Premarket Notification process requires manufacturers to show substantial equivalence to FDA cleared products. Access to FDA-cleared marketing applications is an integral part of the submission process for the medical device industry. As of July 2016, 553 redacted marketing applications have been posted, with the plan to post more each month. In fiscal year 2016 we have noticed a 19 percent decline in our incoming requests, which leads to more timely access of information to the public and reduced cost to the FOIA program.
FDA Public Posting of Food, Cosmetic, and Dietary Supplement Adverse Event Data
Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse health events and product complaints related to CFSAN-regulated products, namely conventional foods, dietary supplements, and cosmetics. For the first time, FDA is planning to post CAERS data on FDA.gov. The same information will be made available through OpenFDA, but in a downloadable format. This first posting of CFSAN’s CAERS contains adverse event reports submitted since 2004. FDA will update the information quarterly to ensure that the public has the most current information available about adverse events reported in relation to these commodities.
The purposes underlying the posting of the data are: 1) to achieve greater transparency and 2) to make it easier for those in the scientific community and other requestors to access and examine the data. This new initiative provides an opportunity to provide researchers, consumers and health professionals easy access to information that was once only available through FOIA requests, making it simpler for them to use this data in their work to advance and promote the public health.
FDA uses adverse event reports such as these as part of its overall strategy to monitor the safety of foods, cosmetics, and dietary supplements. FDA hopes that the increased transparency this initiative will afford will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and targeting particular products for further scrutiny.
The information to be posted summarizes what was reported to the agency and does not represent any conclusion by FDA about whether the product actually caused the adverse events. The data to be posted include the product name, industry code, symptom(s), outcome, reporter’s sex and age, date the consumer first experienced the adverse event, date the report was entered into the system, and CAERS ID number. All reports are voluntarily submitted to FDA from consumers, health professionals, and industry, with the exception of mandatory reports dietary supplement manufacturers receive.
Users of the database can download data from the fda.gov website as a .csv file or can access the data through OpenFDA. Academics and other statisticians are likely to use these OpenFDA data, which are in an API format.
NIH STAR METRICS/Federal RePORTER
The NIH has taken the lead role in developing STAR METRICS (Science and Technology for America's Reinvestment: Measuring the Effect of Research on Innovation, Competitiveness and Science), a partnership between science agencies and research institutions to explore new ways to document science investments and communicate results to the public. The long-term goal of STAR METRICS is to develop a common empirical infrastructure that will be available to all recipients of federal funding and science agencies.
STAR METRICS has had two levels of activity. The Level I goal was to describe the scientific workforce supported by federal funding through collaboration with grantee institutions. The STARMETRICS public private partnership on Level I successfully spurred the development of the academic consortium project UMetrics https://www.btaa.org/projects/umetrics, a common, large-scale, automated data platform on the research enterprise. As demonstrated in a recent publication in Science, the Umetrics consortium is focused on gathering and analyzing big data to understand the structure of the research workforce, the nature and evolution of collaborations, and the results of research.
Going forward from 2016, STAR METRICS is focused on developing an open data infrastructure and tools to enable the documentation and analysis of the inputs, outputs, and outcomes of federal investments in science, made available through Federal RePORTER (http://federalreporter.nih.gov/), which allows agencies government-wide to document their research investments in a standard format that allows for text searching of abstracts across agencies. The STAR METRICS initiative increases government transparency by allowing members of the public to view and search the scientific investments made by federal government agencies. This program allows for scientific investments to be linked to outputs and outcomes at a trans-agency level that allows for an empirical basis for science policy.
NIH Increasing Access to Biomedical Research Information
The NIH National Library of Medicine (NLM) continues to maintain and expand PubMed Central (PMC), a freely available digital archive of biomedical and life sciences journal literature. PMC provides access to the full text of 4 million articles from journals that agree to share their content and from authors who deposit their manuscripts as a result of the NIH Public Access Policy. Each day more than 1 million users visit PMC, including scientists performing research, health professionals looking for the latest information on medical conditions, and the general public seeking information on health problems.
Following the Office of Science and Technology Policy’s introduction of a mandate to federal agencies to increase their access to the results of federally-funded research, many agencies sought out PMC to manage their requirements under the directive. The NLM has now signed agreements with five HHS agencies: the CDC, the FDA, the Agency for Health Research Quality, the Administration for Community Living and the Assistant Secretary for Preparedness and Response. Additionally four other federal agencies have entered into similar agreements: the Department of Veteran Affairs, the National Institutes of Standards and Technology, the National Aeronautics and Space Administration, and the Environmental Protection Agency.
For each of these agencies, NLM will process their submitted manuscripts through its NIH Manuscript Submission System and make the articles publicly available via PMC within 12 months of publication.
The Certified Health Information Technology Product List (CHPL)
The Office of the National Coordinator for Health Information Technology (ONC) administers the CHPL; the comprehensive database of all health information technology (IT) products certified by ONC. In 2016, ONC launched a new, more open, and transparent version of the CHPL that makes more of the certification data accessible in open data formats to the public and provides access to the data through application programming interfaces (APIs). The CHPL now provides open data formats for corrective actions for certified products, mandatory disclosures of a certified product’s cost and limitations, and, for products certified to the 2015 Edition Health IT Certification Criteria (2015 Edition), testing and usability results. This data are now available through open APIs, a downloadable dataset, and through use of the CHPL website. The open CHPL is a resource for app and web developers, health care and health IT researchers, health care providers and the consumer to access data and information about the health IT products certified by ONC to improve the quality, cost, and efficiency of care delivery.
