Federal Activities Virtually every agency in the U.S. Department of Health & Human Services participates actively in initiatives that are working toward the long-term goals of personalized health care. The integration of these efforts will act as a powerful force to achieve personalized patient care. 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:
Department of Health and Human Services (HHS) - 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) PHC Workgroup, formed 10/31/6
- Survey of existing efforts and identification of key constituents
- Propose a role for HITSP and other standards development organizations (i.e. CHI report on nomenclature standards)
- Plan for development of genomic standards
- Evaluate privacy and security issues unique to genomic test results
- Present two use case scenarios : Primary care applications of genomic tests, and clinical research applications
- 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:
 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 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. - SACGHS report on legal analysis of current protections (PDF-1.76MB), May 2005 : Findings : current protection is uncertain and does not adequately protect against genetic discrimination
- AHIC Confidentiality, Privacy, and Security working group[DHHS1] : Broad charge: make recommendations to the Community regarding the protection of personal health information in order to secure trust, and support appropriate interoperable electronic health information exchange. Narrow charge: make actionable confidentiality, privacy, and security recommendations to the Community on specific policies that best balance the needs between appropriate information protection and access to support, and accelerate the implementation of the consumer empowerment, chronic care, and electronic health record related breakthroughs.
top of page Centers for Disease Control and Prevention (CDC) - Evaluation of Genetic Applications in Practice and Prevention (EGAPP): The project's goal is to support the first phases of a coordinated process for evaluating genetic tests and other genomic applications that are in transition from research to clinical and public health practice.
- 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.
Centers for Medicare & Medicaid Services (CMS) - The Biomarkers Consortium: 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.
- 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.
Food and Drug Administration (FDA) - The Biomarkers Consortium: 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.
- 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.
- Government Regulation of Genetic Testing Laboratories and Kits[DHHS2] : The FDA regulates commercially available genetic testing kits and related molecular assays. The Clinical Laboratory Improvement Amendments (CLIA) are administered jointly by the CDC, CMS, and FDA, and regulate clinical laboratory quality and reliability.
top of page Health Resources and Services Administration (HRSA) National Institutes of Health (NIH) - Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) report on Pharmacogenomics (PDF-180KB), in progress
- SACGHS report on ‘Coverage and Reimbursement of Genetic Tests (PDF-852KB),’ February 2006: The SACGHS believes that coverage and reimbursement are critical to ensuring appropriate access to genetic tests and services and their integration into clinical practice, that there currently exist significant barriers and unmet data needs, and that HHS can be influential in minimizing or eliminating these barriers.
- 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 populate a knowledge base. These projects are helping develop genetic tests that are now being used to identify diseases earlier and select the right medications for the right patients. These studies are helping us to understand disparities in the outcomes of certain populations of patients. Medical research projects are underway to support the connections between the genetic basis of disease and their clinical manifestation.
- NIH Genes and Environment Initiative: The genetics program will be a pipeline for analyzing genetic variation in groups of patients with specific illnesses. In addition, the exposure biology program would produce and validate new methods for monitoring environmental exposure that interacts with genetic variation to result in human diseases.
- SACGHS resolution on education of health providers (PDF-56KB), June 2004 : Identified urgent needs in genetics and genomics training, and urged the Secretary to: ensure the adequacy of genetics and genomics education and training of all health care and public health professionals; promote education to equip consumers with necessary knowledge and skills; support federal programs to provide faculty training that incorporates the ethical, legal, and social implications of genetics and genomics; and support case studies that demonstrate the relevance and applicability of genetics and genomics to health care and public health.
- The Biomarkers Consortium: 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.
- SACGHS report on legal analysis of current protections (PDF-1.76MB), May 2005 : Findings : current protection is uncertain and does not adequately protect against genetic discrimination
- Direct-to-Consumer marketing of genetic tests: Some genetic tests are now being sold directly to the consumer (DTC) on the internet or in retail stores, and claim to provide consumers with information to address their genetically determined health risks.
- 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. The dbGaP will, for the first time, provide a central location where interested parties can view all study documentation and 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.
- 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.
- 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.
- 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.
- Government Regulation of Genetic Testing Laboratories and Kits: The FDA regulates commercially available genetic testing kits and related molecular assays. The Clinical Laboratory Improvement Amendments (CLIA) are administered jointly by the CDC, CMS, and FDA, and regulate clinical laboratory quality and reliability.
top of page
Legislation - Senator Obama Genomics and Personalized Medicine Act of 2006 (PDF-88KB): This bill aims to improve access to and appropriate utilization of valid, reliable, and accurate molecular genetic tests by all populations, thus helping to secure the promise of personalized medicine for all Americans.
- 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.
- 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
|
Print 
Download Reader 
