Presented here are the U.S. Department of Health and Human Services’ (HHS) guiding principles and approach taken by our Operating Divisions (OPDIVs) for increasing public access to the results of federally funded research. HHS is providing a common framework for OPDIVs to work synergistically in implementing their public access plans while recognizing their unique missions and stakeholder needs. There are two distinct components to our public access policy. The first relates to making the publications resulting from our funded research freely available to the public. The second relates to making the scientific data publicly available in digital formats. With respect to the publication component, HHS has an existing public access infrastructure in place upon which we will build. For the data component, the infrastructure is still emerging. In developing our approach, we have sought to consider the interests and needs of our various stakeholders, including federally funded researchers, universities, libraries, publishers, data users, and civil society groups, among others.
The digitization of scientific publications and the generation of increasing volumes of digital scientific data have occurred alongside a growing expectation of openness in government and publicly-funded research within the scientific community and the public.
Pursuant to Section 103 of the America COMPETES Reauthorization Act of 2010 (Pub L. 111-358), the Executive Office of the President, Office of Science and Technology Policy issued a memorandum (“the OSTP memo”) on February 22, 2013 to the heads of federal agencies directing them to develop plans to enhance access to results of federally funded scientific research. The memo calls upon federal agencies to make the results of research that are published in peer-reviewed publications directly arising from federal funding to be stored for long-term preservation and to be made publicly accessible to search, retrieve, and analyze in ways that maximize impact and accountability of the federal research investment. Agencies are further asked to maximize access to digitally-formatted scientific data resulting from research supported wholly or in part by federal funding and to develop a strategy for improving the public’s ability to locate and access this data.
There are several related executive directives and policy memoranda from the Office of Management and Budget (OMB) that impact the ways in which HHS is approaching its response to the OSTP memo. The May 9, 2013 Executive Order on Making Open and Machine Readable the New Default for Government Information, and the accompanying implementation memo pertaining to “Open Data Policy – Managing Information as an Asset” (M-13-13) provides an overarching framework for government agencies to institutionalize the principles of effective information management and to promote interoperability and openness. These efforts build upon President Obama’s 2009 Open Government Directive, which calls upon the agencies to take action to become more transparent, participatory and collaborative. Division H, Section 527 of the 2014 HHS Appropriations Act, calls upon agencies funded under the Appropriations Act to develop policies for making their peer-reviewed publications publicly accessible.
The development of a common approach to our public access policy supports two goals of the HHS Strategic Plan FY 2014-2018. These include: Strategic Goal 2 which relates to advancing scientific knowledge and innovation and Strategic Goal 4, Objective B which relates to enhancing access to and use of data to improve HHS programs and support improvements in the health and well-being of the American people. Guidance from OMB for development of the Open Government Plan for 2014-2016 requires federal agencies to address their open data planning efforts and strategies over the next two years.
Data and information services are among the most critical assets for the HHS enterprise. HHS is composed of eleven OPDIVs including eight that are in the U.S. Public Health Service and three human service OPDIVs. Collectively, HHS is responsible for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS works closely with state and local governments and many HHS funded services are provided at the local level by state or county agencies, or through private sector grantees. HHS administers more grant dollars than all other federal agencies combined, and through many programs, enables equitable treatment of beneficiaries nationwide, as well as the collection of national health and other data.
HHS is committed to ensuring that, to the fullest extent possible, the results of its funded scientific research are made available to and are useful for the public, industry, and the scientific community.
II. Development of HHS Plans and Guiding Principles
The OSTP memo directs federal agencies with greater than $100 million in annual research and development expenditures to prepare plans to ensure that peer-reviewed publications and digital scientific data are accessible to the public, industry, and the scientific community. OSTP has determined that this threshold be applied on an OPDIV by OPDIV basis, and not to all of HHS. Four HHS OPDIVs meet the Research and Development (R&D) threshold, accounting for 99 percent of our R&D expenditures. These include: the National Institutes of Health (NIH); the Centers for Disease Control and Prevention (CDC); the Agency for Healthcare Research and Quality (AHRQ), and the Food and Drug Administration (FDA). Given that these OPDIVs have unique missions, oversee vastly different types of research portfolios, operate under separate legal authorities, and typically receive independent funding streams for their infrastructure, it was practical for each of these four agencies to draft their own implementation plans. Recognizing that many other HHS OPDIVs with smaller research portfolios conduct important research, all HHS agencies were invited to participate in the response. The Office of the Assistant Secretary for Preparedness and Response (ASPR) is also developing a public access plan for their portfolio of funded projects.
In an effort to ensure continuity across the federal agencies, our OPDIVs participated in the interagency meetings sponsored by OSTP as well as an internal working group coordinated by the HHS Office of the Deputy Secretary. The internal working group convened key parts of HHS with public access interests. Taking into account the entire life cycle of a research project, the workgroup included participation from components, such as the Office of Grants and Acquisition Policy and Accountability, Office of General Counsel, Assistant Secretary for Planning and Evaluation and Office of the Chief Information Officer, and Office of the Chief Technology Officer. In addition, we engaged planning communities across HHS to ensure close alignment of our public access plans with ongoing strategic planning and budgetary efforts. Each of the OPDIVs was asked to include budgetary considerations for operationalizing their public access plans as part of OPDIV budget requests for FY 2016.
The workgroup set forth guiding principles around which the OPDIVs could develop plans for implementing a common approach to our public access policy. Our goal is to provide continuity where feasible, keeping in mind the particular needs of OPDIV research communities and data users. Public access will help to further HHS’s strategic goals for health care, scientific knowledge and innovation by promoting a science information infrastructure that:
- Encourages broad use and application of HHS supported research results across all areas of the economy, and in so doing improves the health and well-being of all Americans;
- Accelerates the pace at which scientific communities are able to translate basic research into understanding, and hasten the delivery of treatments from bench to bedside;
- Supports innovative breakthroughs that can drive the U.S. economy, fuel exploration into new areas of science, and create new products, services, and analytic tools that can enhance health and contribute to advances in related fields;
- Encourages private investment and new markets in value-added, innovative analysis, use and application of the knowledge found in HHS funded publications and digital data; and
- Increases transparency and accountability of our science agencies.
HHS recognizes that delicate balances exist in the research information ecosystem. We must work closely with external partners to ensure that policies are revised or developed in an environment of trust and respect. Interests in promoting openness must be carefully balanced with recognition of proprietary interests, business confidential information, and intellectual property in determining the types of research information to make publicly available. In creating policies, consideration must be given to preserving the balance between the relative value of long-term preservation and access and the associated cost and administrative burden. Many health researchers are funded by multiple federal agencies; thus, harmonization of policies and uses of common infrastructure for managing the resources is highly desired among the OPDIVs.
III. HHS Advances in Promoting Public Access to Research Results
Our common approach to public access has two broad components: Access to publications arising from federally funded research, and access to scientific data in digital formats. HHS has been a leader in these two domains, both in terms of infrastructure and underlying policies. Provided here are several examples of how HHS has demonstrated leadership in each of these areas.
In 2000, the NIH launched PubMed Central (PMC), a free full-text archive of biomedical and life science journal literature. This was followed by the issuance of NIH’s first public access policy in 2005. The NIH goal was to improve access to cutting-edge biomedical research and to provide a long-term, stable repository of the scientific literature that researchers could continue to draw on in their work, recognizing the cumulative nature of science. The NIH’s experiences with PMC have illustrated the benefits that a centralized repository of the biomedical literature could have, not only for scientists, but also for healthcare practitioners, companies involved in the development of medical products and services, and the public.
Based on NIH’s experience, we have gained an understanding of the systems and processes that must be established to advance public access. In the early days, voluntary deposition of articles yielded a relatively small number of submissions. However, since passage of the Consolidated Appropriations Act of 2008, which made NIH’s public access policy mandatory, compliance with the public access policy has grown dramatically. Based on NIH’s experiences, we have learned that it is not enough to develop a repository. It is critical to have authorities and policies to require the deposit of articles, and a strong set of accompanying compliance measures. Partnerships with publishers and professional organizations that sponsor journals and information sources are also critical.
CDC’s experience with public access has demonstrated the value of making public health information as widely available as possible. In 2012, the CDC launched Stacks, a free, digital repository of scientific research and literature produced or funded by CDC. The Stacks repository demonstrates the important role that electronic access can play in increasing availability of public health and scientific information to the public. Articles stored and shared through CDC Stacks are increasing collaborations among research scientists, helping CDC to further its mission to save lives and protect the health of U.S. citizens and international populations.
Five years ago, HHS launched healthdata.gov. Today, that catalog serves as the primary public-facing listing of HHS’s information resources. HHS’s healthdata.gov catalog has been recognized by the Administration as a model for how the federal government can make agency data publicly available. This catalog, which provides links to nearly 1,800 datasets, affords members of the public with access and the ability to discover HHS datasets. This resource serves as a common place of discovery for those in need of data resources related to a broad array of HHS programs. In addition to the provision of data, healthdata.gov provides a wealth of information that can help the public interpret and maximize use of our data. The healthdata.gov platform can serve as a hub for connecting HHS datasets through technologies, such as application program interfaces (API), to other data resources.
IV. Common Approach to Public Access to Scientific Publications
The first component of our common public access policy approach relates to making peer-reviewed publications resulting from OPDIV funded research freely available to the public. For this aspect of our public access policy, the OPDIVs will utilize existing infrastructure developed by the National Library of Medicine (NLM). Key elements of the NLM infrastructure include: 1) PubMed Central, a web-based repository of biomedical journal literature providing free, unrestricted access to full-text articles; 2) PubMed, a publicly available database of journal citations; and 3) the NIH Manuscript Submission System (NIHMS) for the deposit of final peer-reviewed manuscripts or published articles. Each OPDIV is developing its own agreement with NLM for use of these systems, as detailed in their plans. The common approach will be to utilize NIHMS for the deposit of final peer-reviewed manuscripts or published articles emanating from OPDIV funded research. PubMed Central will serve as the common repository for OPDIV funded publications, and full-text articles will be available through this repository. PubMed will serve as the primary mechanism through which metadata about these articles, including supplemental information, will be made freely available to the public. These platforms have been in use for over a decade, have demonstrated their value as a public-private partnership, and meet all the requirements of the OSTP memo. A full description of the features and interactions between PMC, PubMed and NIHMS are more fully described in the NIH plan.
Use of a common infrastructure for ingesting and displaying publications and metadata is advantageous because it:
- Enables our agencies to leverage an existing archive that is successfully accessed by millions of users each day.
- Permits members of the public to access an expanded corpus of HHS funded research, including new areas such as public health, comparative effectiveness and emergency preparedness research. Members of the public that wish to read, download, or analyze in digital form the full-text articles emanating from HHS funded research will be able to conveniently do so through a single location.
- Fosters private-public partnerships with the scientific journals through expanding the breadth of journals with established relationships to PMC, and increase the range of articles deposited by publishers to PMC.
- Reduces discrepancies in how grantees must submit research articles and in so doing enhance compliance.
- Creates an economy of scale in the administration and use of the platform, benefitting the OPDIVs and the publishing communities.
- Maximizes the impact of the Federal research investment by allowing us to avoid unnecessary duplication of effort.
The OPDIVs will utilize a common embargo period of not more than 12 months, in accordance with the timeframes set forth in the OSTP memo, 2014 HHS Appropriations Act, and the 2008 Consolidated Appropriations Act. The OSTP memo requires agency implementation plans to address the means by which the public can petition for changing the embargo period for a specific field. In its feedback on the draft plans, OSTP specified that HHS should develop a common mechanism to be utilized across its OPDIVs. Our common approach to providing a mechanism for petitions to the embargo period is described in Appendix A.
Over the past decade, the NIH in partnership with NLM has developed a robust compliance infrastructure to support its public access policy. The systems that have been developed for research reporting, monitoring and tracking are interoperable and extensible. To the extent feasible, our OPDIVs will explore use of these systems as they develop their compliance infrastructure to support public access.
For our approaches to be effective, outreach and training related to public access for publications will be essential. As our OPDIVs adopt the NLM’s systems, we will seek to leverage training materials or related communications that can assist our research community and program officers in understanding how to utilize PMC, PubMed and NIHMS.
V. Common Approach for Public Access to Scientific Data in Digital Formats
The second component of our common public access policy approach relates to improving the public’s ability to locate and access digital data resulting from our funded scientific research. While we have made great advances in providing public access to health information through healthdata.gov and in data sharing for genetics and genomics data, many opportunities remain for data sharing across our OPDIVs. Unlike our approach for public access to publications, our Department does not have a common repository for research data holdings, nor common standards for data management and archiving, nor common requirements or enforcement practices for the sharing of data.
Given the emerging challenges of managing a rapidly expanding and increasingly complex set of data resources, our strategies for enhancing access to OPDIV funded data and optimizing search, archival, and dissemination capabilities will evolve over time. Key components of this strategy will involve:
- Assessment of the OPDIVs’ research holdings subject to our public access polices;
- Development of an internal HHS Enterprise Data Inventory that will serve as the internal catalog for all HHS data assets, and will be linked to healthdata.gov, the external-facing platform through which the public will be able locate and access federally funded research data;
- Enhanced expectations for our research communities on the provision of data management plans and data sharing requirements;
- OPDIV led pilots to optimize approaches for a range of issues including data archiving, data sharing tools, and attribution practices; and
- Support for training and workforce development related to scientific data management, analysis, storage, preservation, and stewardship of data.
The public access requirements outlined in the OSTP memo are a subset of larger requirements set forth by the White House to make government information more open and machine-readable. We will leverage the requirements of the Office of Management and Budget’s Open Data Policy (M-13-13) as we develop infrastructure across HHS to enhance public access to government information. We will work with the appropriate parties within HHS, including the Office of the Chief Information Officer, Assistant Secretary for Financial Resources, and Health Data Leads from across the Operating Divisions to coordinate the implementation of these policies. Appendix B provides an overview of the strategies that we will utilize in carrying out the five policy requirements of the Open Data Policy.
In implementing our public access plans for scientific data, an important first priority for all OPDIVs will be developing a better understanding of the types of data under their purview and the location of those datasets. A portion of our funded scientific research data is maintained in OPDIV sponsored repositories, but the vast majority of datasets reside externally.
A second priority across HHS will be the development of an information system for managing an Enterprise Data Inventory (EDI). The Open Data Policy requires each federal agency to develop and maintain an Enterprise Data Inventory (EDI), cataloguing the various sets of data generated, acquired, managed or collected by the agency. The HHS Enterprise Architecture Repository (HEAR) will support a “federalized” approach to populating the Enterprise Data Inventory (EDI). The inventory will catalog data sets that are made public, restricted public, or non-public. HEAR will be linked to HHS’s healthdata.gov platform, which is already fulfilling the cataloguing requirement for publicly accessible data sets. Currently, the public can access over 1,800 data holdings through the healthdata.gov portal. It is envisioned that healthdata.gov will ultimately serve as a means through which the public can locate and access federally funded research data. The OPDIV public access plans further detail their plans for the deposition and cataloguing of their funded research. It is anticipated that HEAR will be enabled to import data inventory entries from other repositories by harvesting them from agencies. In addition, HEAR will serve as the place where data asset metadata can originate. OPDIVs will be expected to add EDI entries for the datasets related to their major Information Technology (IT) investments. The EDI can be expanded, enriched, and adapted to accept new datasets in the inventory as new requirements are identified to support broader program requirements.
Establishing common metadata elements for research data catalogs across our OPDIVs will be an important component of this strategy. We will work with the HHS Health and Human Services Domain IT Steering Committee, which is the formal approval body overseeing IT policy, strategy, and investment decisions for HHS, to determine how best to align the needs of our research communities with the existing systems at HHS for capturing and displaying data. The metadata for scientific data will include, at a minimum, the common core metadata schema in use by the Federal government, in accordance with Project Open Data. During 2015, we are bringing additional expertise into the Department through our HHS Entrepreneurs program to assist with the development of a business plan and strategy for linking and connecting the anticipated OPDIV catalogs and existing data sources.
A third priority for our OPDIVs will be the strengthening of requirements for investigator-initiated data management plans and data sharing requirements. Section 4 of the OSTP memo requires agencies to ensure that all researchers develop data management plans describing how they will provide for long-term preservation of, and access to, scientific data in digital formats resulting from federally funded research, or explaining why long-term preservation and access cannot be justified. This requirement will be a change for our intramural and extramural research communities. Currently, data sharing, management, and archiving practices vary widely across our OPDIVs, as do expectations for the contents and formats of data management plans. In areas where data management and sharing plans are not yet the norm, OPDIVs will need to develop new policies regarding the submission and review of data management plans, as well as new expectations and standards around data sharing. Researchers will be required to make the data underlying their publications publicly available, as discussed in the OPDIV plans. NIH will apply requirements for data management plans to all its researchers, not just those with research awards in excess of $500,000. CDC will pilot a data management plan template, which is aimed at standardizing the types and format of information submitted by researchers in their research proposals. As described in the FDA, AHRQ and ASPR plans, these agencies will, for the first time, require all investigators to submit data management plans. As OPDIVS move from the planning to implementation stages for public access, we will seek opportunities to share best practices and apply common requirements across HHS.
A fourth component to our approach will utilize pilots in areas where the technology is evolving, or where OPDIVs feel they need additional experience in order to make management decisions. Given the speed at which the field of data management is accelerating, our planning processes and policies must be nimble enough to incorporate technology developments. Areas that are ripe for pilot experimentation include, but are not limited to, domains such as optimizing attribution, use of digital object identifiers for research data, and alternate repository approaches such as a Data Commons. We will use our internal HHS public access working group as a forum for sharing best practices.
For our approaches to be effective, training and workforce development around all aspects of data management will be essential. In our efforts to enhance data management capabilities across the research enterprise, we will seek to leverage NIH’s training efforts from its Big Data to Knowledge Initiative (BD2K) to enrich education related to computational and quantitative skills.
VI. Common Approach to Grant, Acquisition and Federal Employee Research Requirements
While HHS OPDIVs operate under distinct legal authorities, we will strive to provide our research communities with continuity and a seamless approach with respect to language used in our grants, contracts, cooperative agreements, and intramural research requirements. Our OPDIVs will work collaboratively with our grants and acquisition policy offices to formulate common guidance, procedures, and instructions that will assist our program offices in issuing funding opportunity announcements and contract solicitations with common requirements for public access. Our efforts will also take into account necessary guidance for federal employees working in the affected research agencies. As part of these efforts, we will seek to integrate the requirements of the Open Data Policy into award and acquisition guidance.
VII. Common Approach to Communications & Outreach
Now that our public access plans are finalized, we anticipate hosting a public meeting at which our OPDIVs can present more detailed information about their implementation strategies. Communications and notifications to the OPDIV research communities will be issued through customary channels.
VIII. Implementation Timeline
HHS OPDIVs are at different stages with respect to the maturity of their public access policies and infrastructure. NIH has a well-established policy in place for access to publications. No significant changes to NIH’s publication policy are anticipated, but modifications will be made to NIH’s data sharing policy in accordance with the OSTP memo. CDC has recently established a policy for access to publications and will need to promote adoption of it throughout its research community. In addition, CDC’s data sharing policy will need to be modified in accordance with the OSTP memo. The FDA, AHRQ and ASPR will need to develop their public access policy statements and promote adoption of these new policies throughout their research communities.
As detailed in the OPDIV plans, we anticipate their policies to become effective no later than the end of calendar year 2015.
Implementation of the OPDIV plans will be dependent on available resources, subject to budget considerations.
As we move from planning to implementation, we will seek to evaluate the utility of our OPDIVs’ plans and their ability to meet the information needs of our stakeholders. It is our aspiration to ensure that the public can derive maximum value from federally funded information sources.
At an inflection point in its history, HHS is well-poised to strengthen its public access practices through modifying existing policies or creating new ones, and through leveraging existing tools or creating new ones, in order to make sharing of federally funded research results a widespread practice for its funded researchers.
In implementing our OPDIVs’ public access plans, we seek to extend to all domains of HHS’s scientific research enterprise the benefits of public access that have accrued to the biomedical domain over the past decade thanks to the infrastructure developed by NIH and NLM. While HHS’s infrastructure for providing public access to digital scientific data is not as mature as the infrastructure for access to publications, we are hopeful that in building the systems to support data access we can take advantage of emerging technologies and data archiving and management practices to provide our scientific research data to the public at lower cost and in a more timely way.
Appendix A: Management Approaches for Handling Stakeholder Petitions to Public Access Embargo Policy
The U.S. Department of Health and Human Services’ (HHS) Operating Divisions are preparing plans to comply with the February 22, 2013 memo from the White House Office of Science and Technology Policy on Increasing Access to the Results of Federally Funded Scientific Research (“the OSTP Memo”). The OSTP Memo requested that the agency implementation plans address means by which proposed variations from this embargo policy could be addressed:
“a)ii) shall also provide a mechanism for stakeholders to petition for changing the embargo
period for a specific field by presenting evidence demonstrating that the plan would be inconsistent with the objectives articulated in this memorandum.”
A component of the HHS management plan for the public access policy is the embargo period, which is the period of time between the publication of the manuscript in a journal and the availability of the same publication to the general public (i.e., access via PubMed Central and/or any other public access repository). Note that this use of the term embargo is distinct from imposed restraints placed by publishers on authors from speaking or distributing to media content about an impending publication.
Requirements for HHS’s embargo period are drawn from various sources. For example, Section 217 of the 2009 HHS Appropriations Act and Section 527 of the 2014 HHS Appropriations Act set forth an embargo period of not later than 12 months. The OSTP memo directs that each agency shall use a 12-month post-publication embargo period as a guideline for making research papers publicly available. The rights holder (author or publisher) can set a shorter delay on a per paper basis and publishers can apply a shorter embargo to their journals. Each of the HHS divisions participating in the response to the public access policy is planning to use the common embargo period of not later than 12 months.
We anticipate that proposals for modifications to the maximum 12-month embargo would originate from two general groups of stakeholders: members of the public or relevant operating or staff divisions seeking a shorter embargo policy for scientific works for a specified field developed as a result of research funded by their agency. Situations may arise where specific funding initiatives are considered to have important scientific, public health or societal value necessitating mass communications in a period of time less than 12 months. Petitions that emanate from members of the public would follow customary procedures utilized by HHS Executive Secretary for handling citizen petitions. Requests for modification to the embargo period stemming from HHS Operating or Staff Divisions would be handled internally through notification channels to the Office of the Secretary.
Appendix B: HHS actions for complying with the five policy requirements of the Open Data Policy (OMB M-13-13)
The HHS Office of the Chief Information Officer has the lead responsibility for overseeing implementation of the Open Data Policy. It plans to address the five policy elements of the Open Data Policy as follows:
- Collect or create information in a way that supports downstream information processing and dissemination activities
The Office of the Chief Information Officer (OCIO) will review and analyze industry standards and nominate formats for data collection and creation, which will support process and dissemination activities. The major tenant of the open data policy is that the open data format is platform independent, machine readable and publically available without restrictions for reuse instead of the existing proprietary data formats.
- Build information systems to support interoperability and information accessibility
OCIO has a methodology, which supports information system project management called the Enterprise Performance Lifecycle Framework (EPLC). In this framework, the project manager, at different review phases called Stage Gates, provides deliverables according to ten specific phases. OCIO will review those Stage Gate reviews to support the incorporation of interoperability and information accessibility into the Enterprise Performance Life Cycle (EPLC) methodology.
- HHS currently has information system acquisition guidance and governance processes, called the EPLC.
- The guidance will be modified to encourage use of open data formats as outputs rather than proprietary data formats often used in commercial software products.
- The governance processes will be modified to ensure that newly developed information systems will be open and interoperable to the maximum extent practicable.
- The governance processes will also be modified to ensure data sets managed by newly developed information systems are catalogued in the Enterprise Data Inventory (EDI).
- Strengthen data management and release practices
Develop an information system for managing an Enterprise Data Inventory (EDI).
- The Open Data Policy requires each agency to develop and maintain an EDI, cataloguing the various sets of data acquired, managed or collected. The EDI will serve as the overarching catalog for all HHS data assets. It will be linked to HHS’s healthdata.gov portal, which serves as the publicly facing portal through which the public can locate and access HHS data that meets the public access level threshold. It is envisioned that the public will be able to locate and access OPDIV funded research data via healthdata.gov.
- The HHS Enterprise Architecture Repository (HEAR) will support a “federalized” approach to populating EDI.
- The inventory will catalog data sets that are made public, restricted public or non-public. The healthdata.gov system is already fulfilling the cataloguing requirement for publicly-accessible data sets by aggregating metadata into a larger index.
- HEAR will be enabled to import data inventory entries from other repositories by harvesting them from agencies. In addition, HEAR will serve as the place where data asset metadata can originate.
- OPDIVs are expected to add EDI entries for the datasets related to their major Information Technology investments. The EDI can be expanded, enriched, and adapted to accept new datasets in the inventory as new requirements are identified to support broader program requirements. Those changes will be made using the internal OCIO configuration control processes.
- Strengthen measures to ensure that privacy and confidentiality are fully protected and that data are properly secured
The EPLC methodology incorporates security and privacy deliverables throughout the process. A Privacy Impact Assessment (PIA) is required in the Concept phase when a new IT system enters the lifecycle. OCIO ensures the PIA remains in compliance with the various federal guidelines and requirements pertaining to privacy and confidentiality.
- Incorporate new interoperability and openness requirements into agency core processes.
Modify information system acquisition processes to promote the use of “open” data formats and programmable, interactive access to data and to populate the EDI.
- The EPLC guidance will be modified to encourage use of open data formats rather than proprietary data formats often used in commercial software products.
- The governance processes will be modified to ensure that newly developed information systems will be open and interoperable to the maximum extent practicable.
- The governance processes will also be modified to ensure data sets managed by newly developed information systems are catalogued in the EDI.
 PMC will serve as the central gateway for all the OPDIV funded research. In addition, CDC will use its Stacks Repository (as a mirror registry to PMC) for the storage and retrieval of peer-reviewed manuscripts funded by CDC, as well as the other public health resources that CDC maintains.
 It is understood in the context of this policy that ‘field’ refers to a domain of research and publications such as biomedical research, public health or engineering.