[Federal Register Volume 71, Number 211 (Wednesday, November 1, 2006)]
[Notices]
[Pages 64282-64284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information (RFI): Improving Health and Accelerating 
Personalized Health Care Through Health Information Technology and 
Genomic Information in Population- and Community-Based Health Care 
Delivery Systems

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: Advances in medicine, biomedical science, and technology 
present opportunities for enabling health care practices to be 
increasingly patient-specific by taking into account individual 
differences in health states, disease processes, and outcomes from 
interventions. Often referred to as personalized health care, the 
desired impact of these types of health practices is improved 
effectiveness and safety of medical practices. These health benefits 
may be manifested through new approaches for predicting disease risk at 
an early time point, enabling preemption of disease processes prior to 
full manifestation of symptoms, analyzing the effectiveness of 
different interventions in specific populations based on their genetic 
makeup, and preventing the progression of disease and the related 
complications.
    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, the Department of Health and 
Human Services (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.

DATES: Responses should be submitted to the Department of Health and 
Human Services on or before 5 p.m., EDT, January 2, 2007.

ADDRESSES: Electronic responses are preferred and may be addressed to 
[email protected]. Written responses should be addressed to Department of 
Health and Human Services, 200 Independence Avenue, SW., Room 434E, 
Washington, DC 20201, Attention: Personalized Health Care RFI.
    A copy of this RFI is also available on the HHS Web site at http://www.aspe.hhs.gov/PHC/rfi. Please follow the instructions for submitting 
responses.
    The submission of written materials in response to the RFI should 
not exceed 75 pages, not including appendices and supplemental 
documents. Responders may submit other forms of electronic materials to 
demonstrate or exhibit key concepts of their written responses.
    Public Access: Responses to this RFI will be available to the 
public in the HHS Public Reading Room, 200 Independence Avenue, SW., 
Washington, DC 20201. Please call (202) 690-7453 between 9 a.m. and 5 
p.m. to arrange access. The RFI and all responses will also be made 
available on the HHS Web site at http://www.aspe.hhs.gov/PHC/rfi. Any 
information you submit will be made public.
    Do not send proprietary, commercial, financial, business 
confidential, trade secret, or personal information that should not be 
made public.

FOR FURTHER INFORMATION CONTACT: Dr. Gregory Downing, Personalized 
Health Care Initiative, (202) 260-1911.

SUPPLEMENTARY INFORMATION: Advances in medicine, biomedical science, 
and technology present opportunities for enabling health care practices 
to be increasingly patient-specific by taking into account individual 
differences in health states, disease processes, and outcomes from 
interventions. Often referred to as personalized health care, the 
desired impact of these types of health practices is improved 
effectiveness and safety of medical practices. These health benefits 
may be manifested through new approaches for predicting disease risk at 
an early time point, enabling preemption of disease processes prior to 
full manifestation of

[[Page 64283]]

symptoms, analyzing the effectiveness of different interventions in 
specific populations, and preventing the progression of disease and the 
related complications.
    The application of interoperable electronic information 
technologies (IT) in the health care setting provides new opportunities 
to collect and analyze information about diagnostic and therapeutic 
interventions, as well as health care outcomes. With many potential 
applications, integrated data analysis of multiple parameters of health 
care practices has the potential to support new approaches to 
evaluating health outcomes, developing the evidence base for best 
practices, identifying individual differences in response to therapies, 
supporting research on new interventions, automating the process of 
detecting and reporting notifiable disease conditions and health care-
associated infections to public health surveillance systems, and 
enhancing safety.
    In the past year, the American Health Information Community (AHIC), 
a chartered Federal advisory committee, has made recommendations to the 
Secretary to advance the development of electronic health records 
(EHR). AHIC's activities and recommendations support a nationwide 
approach to developing digital and interoperable health IT systems that 
ensure the privacy and security of patient information. Already 
underway are efforts to support consumer empowerment, health safety and 
improvement, and public health protection through broadly deployed, 
harmonized information systems. As a result of the deployment of these 
capabilities throughout the health care system, new avenues are 
emerging to apply information about individual health experiences 
toward improved transparency about the quality and cost of health care 
and transformation of health care delivery, as well as decision support 
for health practitioners.
    Occurring in parallel with the advances in health IT are advances 
in molecular and genetic medicine. This science-based approach to 
medicine is now in the early stages of entry in health care through the 
introduction of diagnostics and treatments that target specific genetic 
and molecular features of disease processes. Applications of this 
science and technology provide useful information to aid in patient 
care through more accurate diagnosis and treatment at an individual 
level. The availability of genetic information (especially the 
availability of this information as part of the EHR), and the ability 
to aggregate these data and correlate them with outcomes or other 
relevant findings from multiple sources, could greatly expand our 
capacity for personalized health care, providing more specific 
individual information for prevention, diagnosis, and treatment; 
pointing toward clinically useful markers; enabling safer and more 
effective use of existing therapies; and identifying potential fruitful 
areas for development of new or refined therapies.
    New pathways are emerging for affordable and more effective health 
care practices through personalized health care. The ability to 
integrate new scientific knowledge, especially our growing 
understanding of the human genome, into the health care setting in an 
efficient and timely fashion will rely on robust, reliable and secure 
information sources in electronically interoperable systems. Many 
public and private organizations are engaged in the planning for future 
collections and integration of health data for this purpose. This 
request seeks information that will facilitate a broader understanding 
of directions being taken and the productive role that Federal health 
agencies might play in facilitating progress, avoiding unnecessary 
barriers, and achieving optimal benefit from the opportunities now 
before us.

Information Requested

    For the purpose of achieving a broader understanding of rapid and 
emerging changes occurring in the health care setting that may have an 
impact on the future of personalized health care, HHS requests input 
from interested parties on plans for developing and using resources 
involving health IT and genetic and molecular medicine, with specific 
reference to incorporating these capacities in evidence-based clinical 
practice, health outcomes evaluations, research, and transformation of 
health care delivery.
    Input is sought on the interest and current planning activities of 
health care systems and related organizations on the needs and 
applications of these transformative aspects of personalized health 
care. Specific areas for comment include:
     Concepts on anticipated approaches for the use of EHR and 
population- and community-based health care system databases for 
longitudinal data collection in addressing:

--Disease susceptibility.
--Clinical course and outcomes.
--Treatment response.
--Evidenced-based clinical decision support.
--Optimal healthcare delivery systems.

     Anticipated applications of genomic-based clinical testing 
in medical decision-making, safety assessment, and risk management.
     Establishment of biospecimen resources obtained from 
clinical medical services for application in research, clinical trials, 
health services planning, clinical effectiveness, and health outcomes 
evaluations.
     Organizational or institutional practices to address 
ethical, legal, and social implications regarding the use of patient 
information, including genetic data, to support personalized health 
care.
     Examples of utilizing large clinical data repositories for 
practical clinical research to discover effective technologies, 
therapeutics, diagnostics, and prevention strategies for different 
populations.
     Issues and challenges associated with incorporating 
genomic information as a part of a broad longitudinal data collection.
     Needs for community-wide standards or best practices that 
will facilitate large-scale data integration and exchange to benefit 
personalized health care.
     Feasibility and potential benefits for establishing 
linkages of institutional or organizational data resources with private 
and publicly available health databases.
     Development of ontologies across different clinical data 
repositories that will facilitate the utility of the data for answering 
clinical research questions.
     Models for linking clinical data repositories across 
disparate care providers.
     Examples of the use of disease registries to track 
specific diseases and response to drug therapies across different 
subpopulations.
     Models for prioritizing analyses to fill gaps in evidence 
of effectiveness of therapeutic interventions for different 
populations.
     Strategies for accumulating patient data necessary for 
research that may not be available through EHRs.
     Concepts or models on the potential use of clinical data 
and related resources for research applications.
     Models of cost-benefit analysis for integrated data 
systems, EHR, and clinical resources to inform medical decision-making.
     Opportunities and challenges for the development of 
electronic tools to aid in the integration and analysis of large 
datasets of clinical parameters to assist in outcomes evaluations.

Potential Responders

    HHS anticipates responses from a broad range of individual 
organizations

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that have interests in health systems change and personalized health 
care. Some examples of these organizations include:
     Community health delivery systems.
     Health maintenance organizations.
     University-based health systems.
     State and local public health departments.
     Other Federal agencies.
     Advocacy groups and public interest organizations.
     Consumer and patient interests groups.
     Health care professional societies.
     Trade industry organizations.
     Purchasers of health care.
     Health information technology industry vendors.

    Dated: October 26, 2006.
John O. Agwunobi,
Assistant Secretary for Health, Office of Public Health and Science.
[FR Doc. E6-18371 Filed 10-31-06; 8:45 am]
BILLING CODE 4150-26-P