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Glossary of Terms Goals =====
E-mail subscriptions envelope The goals outlined below are the fundamental building blocks for the Personalized Healthcare Initiative:
Establish a secured electronic system to exchange, aggregate and analyze key data from a large number of existing secure health care databases; Support the science and health information technology base and enable it to expand;
Support efficient and effective drug development partnerships between public and private sector leadership, and Help integrate the Personalized Health Care into the mainstream of clinical practice.
In addition, the Department will make sure that all information gathered from healthcare databases is used properly and securely in order that the privacy and security of individually identifiable health information is maintained. Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Topics on This Page: Goal 1: Link Clinical and Genomic Information to Support Personalized Health Care
Goal 2: Protect individuals from discrimination based on unauthorized use of genetic information Goal 3: Ensure the accuracy and clinical validity of genetic tests performed for medical applications purposes
Goal 4: Develop common policies for access to genomic databases for federally sponsored programs ---------------------------------------------------------------------
Goal 1: Link Clinical and Genomic Information to Support Personalized Health Care Initiative Activities
Personalized Health Care (PHC) Request for Information (RFI,) 11/1/2006: For the purpose of achieving a broader understanding of rapid changes occurring in the health care setting that may have an impact on the future of personalized health care, HHS requests input from the public and private sectors on plans for developing and using resources involving health information technology (IT) and genetic and molecular medicine, with specific reference to incorporating these capacities in evidence-based clinical practice, health outcomes evaluations, and research. American Health Information Community (AHIC) Personalized Health Care (PHC) Workgroup, formed 10/31/06 Broad Charge for the Workgroup: Make recommendations to the American Health Information Community for a process to foster a broad, community-based approach to establish a common pathway based on common data standards that encourage the incorporation of interoperable, clinically useful genetic laboratory test data and analytical tools into electronic health records to support clinical decision-making for the health care provider and patient.
Specific Charge for the Workgroup: Make recommendations to the American Health Information Community to consider means to establish standards for reporting and incorporation of common medical genomic tests data into electronic health records, and provide incentives for adoption across the country including federal government agencies. Related Activities
AHIC Electronic Health Record (EHR) working group: The AHIC recommended that Electronic Health Records (EHR) adoption be its top priority. Broad charge: to ensure widespread adoption of certified EHRs over time. Specific charge: to deploy a standardized means of accessing/deploying lab results/interpretations within one year. National Committee on Vital Health Statistics (NCVHS): This committee is intended to serve as a forum for the collaboration of interested parties to accelerate the evolution of public and private health information systems toward more uniform, shared data standards, operating within a framework of protecting privacy and security.
The Biomarkers Consortium: exit disclaimer The Biomarkers Consortium is a public-private biomedical research partnership of the Foundation for the National Institutes of Health, Inc. that involves a variety of public and private stakeholders including the NIH, FDA, and CMS; the pharmaceutical, biotechnology, diagnostics, and medical device industries; non-profit organizations and associations; and advocacy groups. The Consortium will search for and validate new biological markers—biomarkers—to accelerate dramatically the competitive delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease. The NIH Pharmacogenetics Research Network (PGRN) was formed in 2000 to enable a network of multi-disciplinary research groups to conduct studies addressing research questions in pharmacogenetics and pharmacogenomics and to populate a knowledge base. These projects are helping develop genetic tests that are now being used in identifying diseases earlier and selecting the right medications for the right patients. These types of studies are helping in our understanding of disparities in the outcomes in certain populations of patients and will help overcome them. Medical research projects are underway to support the connections between the genetic basis of disease and their clinical manifestation.
FDA’s Critical Path: The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product. Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS): The Committee shall explore, analyze, and deliberate on the broad range of policy needs associated with the scientific, clinical, public health, ethical, economic, legal, and social issues raised by the development, use, and potential misuse of genetic and genomic technologies and make recommendations to the Secretary and other entities as appropriate.
Database of Genotype and Phenotype (dbGAP): Administered by the National Library of Medicine (NLM), this is a new database designed to archive and distribute data from genome wide association (GWA) studies. dbGaP will, for the first time, provide a central location where interested parties can see all study documentation and view summaries of the measured variables in an organized and searchable Web format. The database will also provide pre-computed analyses of the level of statistical association between genes and selected phenotypes. The Cancer Biomedical Informatics Grid (CaBIG): The National Cancer Institute (NCI) has launched the caBIG™ initiative to accelerate research discoveries and improve patient outcomes by linking researchers, physicians, and patients throughout the cancer community. caBIG™ serves as the cornerstone of NCI’s biomedical informatics efforts to transform cancer research into a more collaborative, efficient, and effective endeavor.
The Cancer Genome Atlas: The Cancer Genome Atlas (TCGA) is a comprehensive and coordinated effort to accelerate our understanding of the molecular basis of cancer through the application of genome analysis technologies, including large-scale genome sequencing. The cancers being studied in TCGA Pilot Project are lung, brain (glioblastoma), and ovarian. The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI) is an authoritative source of information on cancer incidence and survival in the United States. SEER currently collects and publishes cancer incidence and survival data from population-based cancer registries covering approximately 26 percent of the US population. SEER coverage includes 23 percent of African Americans, 40 percent of Hispanics, 42 percent of American Indians and Alaska Natives, 53 percent of Asians, and 70 percent of Hawaiian/Pacific Islanders.
CDC National Program of Cancer Registries, covers 96% of US population. Data collected by state cancer registries enable public health professionals to understand and address the cancer burden more effectively. CDC provides support for states to maintain registries that provide high-quality data. The National Office of Public Health Genomics (NOPHG), works to integrate genomics into public health research, programs, and policy. Special consideration will be given to research proposals addressing the following priorities: Family History, Genetic Testing, and Genetics for Early Disease Detection and Intervention.
Human Genome Epidemiology Network, (HuGENet™) is a global collaboration of individuals and organizations committed to the assessment of the impact of human genome variation on population health and how genetic information can be used to improve health and prevent disease. National Health and Nutritional Examination Survey (NHANES) The National Health Survey Act, 1956, provided the legislation authorizing for a continuing survey to provide current statistical data on the amount, distribution, and effects of illness and disability in the United States. NHANES was created to fulfill the purpose of this act.
National Coordinating Center for regional genetic and newborn screening collaboratives exit disclaimer The Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA), using a cooperative agreement with the American College of Medical Genetics (ACMG) http://www.acmg.net/ exit disclaimer has organized a National Coordinating Center for regional genetic and newborn screening collaboratives. The seven Regional Genetic and Newborn Screening Collaboratives supported by HRSA aim to enhance access to genetic services, and support the screening capacity of states. Related Documents
SACGHS report on Pharmacogenomics (PDF-180KB), in progress SACGHS report on Coverage and Reimbursement of Genetic Tests (PDF-850KB)
SACGHS Resolution on Education of Health Providers (PDF-56KB) Senator Obama Genomics and Personalized Medicine Act of 2006 (PDF-88KB)
NCVHS Report on Personal Health Records and a Personal Health Record System top of page
--------------------------------------------------------------------- Goal 2: Protect individuals from discrimination based on unauthorized use of genetic information
Initiative Activities Michael Leavitt, Secretary of Health and Human Services, states support for genetic nondiscrimination legislation (PDF)
Related Activities AHIC Confidentiality, Privacy, and Security working group: At its May 16, 2006, American Health Information Community (the Community) meeting, Community members approved a recommendation to create a new cross-cutting consumer empowerment group comprised of privacy, security, clinical, and technology experts. HHS decided to act on this recommendation and established a new workgroup that includes members from the Community's Consumer Empowerment, Chronic Care, and Electronic Health Records Workgroups.
Genetic Information Nondiscrimination Act (PDF-172KB): This law would prohibit discrimination in the workplace and health insurance settings based on an individual’s genetic information. Related Documents
SACGHS report on Legal Analysis of Current Protections (PDF-1.76MB) Discussion document (PDF-244KB) for NHGRI Workshop on Privacy, Confidentiality, and Identifiability in Genomic Research
June 23, 2001, President George W. Bush's radio address supports legislation on genetic discrimination. October 14, 2003, Executive Office of the President, OMB, Statement of Administration Policy; S. 1053 – Genetic Non-Discrimination Act of 2003
February 16, 2005, Executive Office of the President, OMB, Statement of Administration Policy; S. 306 - Genetic Information Non-Discrimination Act of 2005 top of page
--------------------------------------------------------------------- Goal 3: Ensure the accuracy and clinical validity of genetic tests performed for medical applications purposes
Related Activities The objective of the Clinical Laboratories Improvement Amendments (CLIA) program is to ensure quality laboratory testing. This program is administered by specific groups within the FDA, CMS, and CDC.
At AHRQ, the mission of the US Preventative Services Task Force is to evaluate the benefits of individual services based on age, gender, and risk factors for disease; make recommendations about which preventive services should be incorporated routinely into primary medical care and for which populations; and identify a research agenda for clinical preventive care. The CDC Office of Genetics and Disease Prevention addresses the public health impact of advances in genetic research, and supports the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) to evaluate GT that are transitioning from research to clinical and public health practice.
The CDC Division of Laboratory Systems develops standards for laboratory certification. AHRQ Technology Assessment Program evaluates beneficial and adverse outcomes of health care interventions to inform consumers, providers and payers.
Health Resources and Services Administration (HRSA) Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children: The Committee shall advise and guide the Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. Genetics Home Reference provides consumer-friendly information about the effects of genetic variations on human health.
GeneTests: Publicly-funded medical genetics information resource developed for physicians, other healthcare providers, and researchers, available at no cost to any interested persons. Related Documents
Direct to Consumer marketing of genetic tests : • SACGHS Letter to the Secretary concerning Direct to Consumer Marketing of Genetic Tests (1) (PDF-120KB), February 8, 2006 • SACGHS Letter to the Secretary concerning Direct to Consumer Marketing of Genetic Tests (2) (PDF-124KB), December 8, 2004 • Government Accountability Office (GAO) Nutrigenetic Testing Report (PDF-624KB), July 27, 2006 • Federal Trade Commission (FTC) Report on Direct to Consumer Genetic Tests (PDF-208KB), July 2006 Government Regulation of Genetic Testing Laboratories and Kits: • Secretary's Advisory Committee on Genetic Testing (SACGT) Report on Enhancing the Oversight of Genetic Tests (PDF-228KB), July 2000 • FDA regulation of in vitro multivariate diagnostic assays (1) (PDF-108KB), September 7, 2006 and Analyte Specific Reagents (ASR) (2) (PDF-216KB), September 7, 2006. • SACGHS Session on Oversight of Genetic Technologies and Genetic Testing Laboratories (PDF-160KB) November 13, 2006 • GAO report on Clinical Lab Quality: CMS and Survey Organization Oversight Should be Strengthened (PDF-2.94MB)
Future Activities Departmental Genetic Testing Working Group, to be formed
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Goal 4: Develop common policies for access to genomic databases for federally sponsored programs Related Activities
NIH Genome Wide Association Studies (GWAS), Goal: To advance science by identifying common genetic factors that influence health and disease through the creation of a centralized NIH GWAS data repository (RFI), August 30, 2006. FDA policies on electronic submission of regulatory information (PDF-92KB): Public hearing 12/18/2006 to solicit general views and information on issues concerning the electronic submission of product information.
FDA best practices and development of standards for submission of genomic data (PDF-176KB), November 2006: The FDA plans to develop guidance for genomic data submissions along with data submitted under investigational new drug applications, drug applications, and biologics license applications. Centers for Medicare and Medicaid Services (CMS) Part D Data (PDF-100KB), October 18, 2006: Proposed rule would allow the Secretary to use the claims information being collected for Part D payment purposes for other research, analysis, reporting, and public health functions.
NIH Genes and Environment Initiative: Two main components – the genetics program would be a pipeline for analyzing genetic variation in groups of patients with specific illnesses, and the exposure biology program would produce and validate new methods for monitoring environmental exposure that interact with genetic variation to result in human disease. Related Documents
National Research Council (NRC) Report : Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health exit disclaimer SACGHS Task Force on Gene Patents and Licensing Practices (PDF-44KB), November 13, 2006.
CRS Report on ‘Gene Patents : A Brief Overview of Intellectual Property Issues,’ (PDF-68KB) exit disclaimer CRS Report on Patent Reform : Innovation Issues (PDF-184KB) exit disclaimer
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