Americans are living longer, healthier lives, thanks to significant advances in health-related research. Life expectancy is at a record high of 77.7 years. Mortality rates in the United States have experienced an almost uninterrupted decline since 1960. However, rates of gain are inconsistent between genders and across age brackets, socioeconomic status, and racial and ethnic groups.
HHS’s health and human service systems continue to face many challenges, from providing access to quality health care for all Americans, to reducing the burden of illness and disease and extending healthy life, to protecting our population from known and unknown public health threats, to maximizing the impact of the social service safety net.
Effectively addressing these challenges requires that HHS employ innovative, knowledge-based approaches. To do so, HHS must expand its scientific understanding of how to best advance health care, public health, human services, biomedical research, and the availability of safe medical and food products. Chief among these efforts will be the identification, implementation, and rigorous evaluation of new approaches in science, health care, public health, and human services that reward efficiency, effectiveness, and sustainability.
HHS will focus on promising strategies with the potential to yield positive results from public investments. These strategies include using technology to improve collaboration, modernizing the regulatory approval process, and expanding behavioral research. In addition, HHS will work to promote service integration and delivery, community-based approaches, and collaboration with the private sector to advance scientific knowledge.
HHS uses internal and external evaluation data to determine how best to increase the pace of science and its ultimate use in practice. For example, a previous evaluation of FDA’s capacity to support current and future regulatory needs led HHS to set priorities for investments in the regulatory sciences as a new objective. An evaluation of AHRQ’s prevention portfolio identified crucial gaps in knowledge about the safety and effectiveness of clinical preventive services. Information from studies supported by NIH will guide the transformation of clinical and translational science programs to reduce the time needed for laboratory discoveries to become treatments for patients. HHS will also use findings from evaluations to advance patient care, for example, by determining the effectiveness of health information sites geared toward particular populations of interest and the providers who serve them.
HHS will continue to use evaluations to monitor progress on its efforts to advance scientific knowledge and implement innovative practices. HHS plans to evaluate regulatory science, science management, and the safety risks and ethical, legal, and societal implications of new technologies.
A number of HHS operating and staff divisions, including ACF, AHRQ, CDC, FDA, IHS, NIH, and SAMHSA work both independently and collaboratively to use research and development resources to improve health, public health, and human services. These agencies sustain and contribute to a full spectrum of scientific research and development activities.
Medical breakthroughs, fueled by scientific discovery, have made the difference between life and death for countless Americans. Nevertheless, the need for better health interventions remains. Continuing to improve the health and well-being of Americans requires HHS investments, ranging from improving its understanding of fundamental biological processes to identifying the best modes of prevention and treatment. HHS investments have improved the health of many Americans, but currently the path from basic discovery into safe, effective patient care can be long.
The Department has identified several leverage points to accelerate movement along the pipeline from scientific discovery to more effective patient care. NIH will balance support for large-scale efforts and smaller investigator-initiated projects, develop a strong scientific workforce through career training, and invest in technologies and information systems needed for comprehensive research approaches. HHS will provide researchers with access to financial and technical resources through NIH to conduct early-stage drug development for promising new therapies. A joint effort of FDA and NIH will improve regulatory review to facilitate the efficient approval of safe new medical products. HHS also will support research that is tied to clinical practice, considering the influence of payment systems and the delivery of services. Patient-centered research activities through NIH and AHRQ will help enhance the evidence base for the best preventive, screening, diagnostic, and treatment services.
HHS will continue to support ethical and responsible research practices, including ensuring the protection of the humans and animals participating in health research. NIH is just one of the agencies within HHS that is committed to promoting integrity in research programs and ensuring that truthful, valid research is conducted.
Secretary Sebelius has identified the acceleration of scientific discovery as one of her Strategic Initiatives.
Within HHS, AHRQ, ASPE, ASPR, CDC, FDA, IHS, NIH, and OASH have significant roles to play in advancing science to improve health and well-being for Americans. HHS will use the following key strategies to accelerate the process of scientific discovery to improve patient care.
- Expand the knowledge base in biomedical and behavioral sciences by investing in fundamental and service system research, human capital development, and scientific information systems;
- Support promising biomedical and prevention research to save lives, reduce the burden of chronic diseases, and identify new, more effective prevention and treatment strategies;
- Support research efforts to improve the identification of, and response to, differences in efficacy of pharmaceutical and other care and treatment for under-represented populations;
- Assist in developing the research capacity of individuals and institutes from diverse backgrounds, such as the Native American Research Centers for Health; tribal, and urban Indian epidemiology programs; Historically Black Colleges and Universities; Hispanic-serving institutions; and tribal colleges and universities;
- Foster evidence-based health care through research;
- Promote translation of research into practice, including fostering government and private sector collaboration, and adapt it to the varying needs of diverse communities in culturally and linguistically appropriate ways;
- Foster and obtain the necessary collaboration of government and private sector research activity to achieve fastest possible discovery;
- Provide access to resources that facilitate the translation of basic laboratory discoveries into therapies and services research into practice improvements; and
- Support comprehensive and efficient regulatory review of new medical treatments.
- Expand awareness and institutional responsiveness on human research participants and research integrity.
HHS depends on collaboration to realize its goals. Every day, HHS agencies work collaboratively with their federal, state, local, tribal, urban Indian, nongovernmental, and private sector partners to improve the health and well-being of Americans. HHS is using technology to identify new approaches to enable citizens to contribute their ideas to the work of government that will yield innovative solutions to our most pressing health and human service challenges. HHS employs an array of innovative participation and collaboration mechanisms to improve delivery of consumer information on patient safety and health, provide medical research connections and collaborations for patient engagement, provide technology for teamwork, and find creative ideas in the workplace. These innovations include engaging Web 2.0 technologies with several functional capabilities, including blogging to rate and rank ideas and priorities, crowdsourcing to identify public opinion and preferences, group collaboration tools such as file-sharing services, idea generation tools, mobile technologies such as text messaging, and online competitions. HHS is supporting and evaluating innovative programs such as Text4baby, an innovative health education service that provides underserved pregnant women and new mothers with evidence-based health messages using mobile technology.
Innovation is a key element of HHS’s intraagency Open Government initiative. Through this initiative, the Obama administration is promoting agency transparency, public participation, and public-private collaboration across Federal departments. More information on HHS’s strategies to foster Open Government can be found in Goal 4.
Operating and staff divisions, including AHRQ, ASPE, CDC, CMS, FDA, IHS, SAMHSA, and ONC, are contributing to making HHS more open and innovative. HHS will use the following key strategies to foster innovation.
- Deliver computerized geography-based inventories of patient care services to help patients determine which services are available at the nearest site and determine locations and travel distances to other sites where services may be available;
- Establish a Community of Practice for Participation and Collaboration that will enable HHS Open Government innovators to share experiences, policies, and tools, and will increase dissemination of best practices and knowledge throughout the HHS workforce;
- Expand the functionality of personal health records as a way to deliver personalized health and behavioral health information directly to consumers;
- Employ high-tech options (i.e., text messaging and cell phone applications) to reach healthcare professionals, patients, and other members of the public to share alerts and safety information that may affect both treatment and diagnostic choices for healthcare professional and service recipient;
- Use Web-based tools to improve surveillance, monitoring, analysis, and reporting;
- Harness employees’ insights and experiences to help develop high-impact solutions to important public health challenges;
- Support community members in developing and sharing solutions to meet their own unique needs; and
- Establish a Center for Medicare and Medicaid Innovation within CMS as provided for under the Affordable Care Act.
Regulatory science is the development and use of the scientific tools, standards, and approaches necessary for the assessment of regulated products, such as medical products and foods, to determine safety, quality, and performance. Without advances in regulatory science, promising therapies may be discarded during the development process simply for the lack of tools to recognize their potential; moreover, outmoded review methods can delay approval of critical treatments unnecessarily. Conversely, many dollars and years may be expended assessing a novel therapy that with better tools might be shown to be unsafe or ineffective at an earlier stage.
Advancements in regulatory science also will help to prevent foodborne illnesses, and when outbreaks of foodborne illness occur, to identify the source of contamination quickly and to limit the impact of the outbreak. Regulatory science innovations will allow for faster access to new medical technologies that treat serious illnesses and improve quality of life. These advances will benefit every American by increasing the accuracy and efficiency of regulatory review and by reducing adverse health events, drug development costs, and the time-to-market for new medical technologies.
Advancing regulatory science and innovation is an objective shared by a number of agencies within HHS. FDA and NIH are collaborating on an initiative to fast-track medical innovation to the public. As part of the effort, the agencies established a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Council works together to ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process.
Other agencies promoting regulatory science and innovation include AHRQ, CDC, and HRSA. HHS will employ the following key strategies to improve food and medical product safety.
- Ensure that HHS personnel have the scientific expertise to address new challenges presented by cutting-edge medical technologies, such as nanotechnologies;
- Update medical product review standards and provide new regulatory pathways for new medical technologies;
- Adhere to high standards of transparency and scientific integrity in medical product innovation, development, and regulatory review;
- Implement a new, public health-focused approach to food safety that sets priorities for prevention, strengthens surveillance and enforcement, and improves response and recovery;
- Develop improved methods for rapidly detecting foodborne contaminants;
- Develop science-based standards for preventive controls for food safety across the “farm to table” continuum;
- Develop tools to modernize product development through enhanced support of partnerships; and
- Create structural supports to strengthen FDA’s leadership and coordination for cross-cutting efforts in emerging technologies.
Working together with its public and private partners, HHS is committed to improving the quality of public health and human service practice by conducting applied, translational, and operations research and evaluations. HHS uses research and evaluation evidence to inform policy and program implementation efforts as well. HHS has identified and refined approaches that help people make healthy choices, assist communities as they work to improve the health and well-being of their residents, support safety and stability of individuals and families, and help children reach their full potential. HHS also monitors and evaluates programs to assess efficiency and responsiveness and to ensure the effective use of information in strategic planning, program or policy decision making, and program improvement.
CDC’s Guide to Community Preventive Services and SAMHSA’s National Registry of Evidence-based Programs and Practices are ever-expanding resources of expert recommendations on evidence-based interventions to improve public health. Recommendations are based on systematic reviews of the evidence related to the benefits and potential harms of services. AoA is working with its national Aging Services Network to implement evidence-based prevention programs, at the community level, that have proven effective in reducing the risk of disease, disability, and injury among the elderly. IHS is disseminating information on best or promising practices, including 19 practice models for diabetes and other models on health promotion, disease prevention, and injury prevention. The Administration for Children and Families (ACF) and SAMHSA use rigorous evaluations of social service programs for children and families to design program improvement strategies. SAMHSA has developed Web-based toolkits on implementing evidence-based practices with fidelity. By prioritizing funding for evidence-based programs, directories of evidence-based programs, implementation toolkits, and other resources, HHS promotes the adoption of these strategies and provides the information the public needs to implement these programs and practices successfully. Some human service programs, such as teen pregnancy prevention and home visitation programs, incorporate requirements for the use of evidence-based programs for grantees.
HHS investments in public health and human service research have yielded many important findings about what works. HHS will work to identify promising, effective approaches that are culturally competent and effective for populations with varying circumstances and needs.
A number of HHS agencies are involved in advancing this objective, including ACF, AHRQ, AoA, ASH, CDC, HRSA, IHS, NIH, OASH, and SAMHSA. HHS will implement the following strategies to increase its understanding of what works in public health and human service practice.
- Promote and support evaluation of existing programs and services research, and incorporate program evaluation efforts into program implementation and future policy direction;
- Support and train researchers, including those from diverse backgrounds, and provide communities with tools to adapt research and evaluation techniques to their own circumstances, to evaluate programs and practices, and to conduct systematic reviews more effectively;
- Strengthen oral health research and use evidence-based oral health promotion and disease prevention to clarify the interrelationships between oral disease and other medical diseases;
- Implement the National Prevention Strategy using evidence-based strategies and actions;
- Build user-friendly mechanisms for disseminating evaluation findings and recommendations to the public, including those who may lack Internet access; and
- Promote the replication of evidence-based programs and practices, and assist public health and human service programs to implement evidence-based strategies while continuing to fund and test innovative approaches in order to expand the evidence base, as done in the teen pregnancy prevention and home visiting initiatives.
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