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Mar 13, 2007

The Honorable Michael O. Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Leavitt:

The American Health Information Community (AHIC), in the October, 2006 community meeting, recommended the scope of the Biosurveillance Workgroup be expanded to encompass the broader perspective of population health. Population health is described using five interrelated domains: Public Health Surveillance and Response; Health Status and Disease Monitoring; Population Based Research; Population Based Clinical Care; and Health Communications/Education. The recommendations in this document follow from the work of the Biosurveillance Workgroup and fall predominantly under the domains of Public Health Surveillance and Response, and Health Communications/Education. Future recommendations will be required to better address the remaining domains. The Population Health and Clinical Care Connections Workgroup (PH/CCC) has the following broad charge:

Broad Charge for the Workgroup: Make recommendations to the Community thatfacilitate the flow of reliable health informationamong population health and clinical caresystems necessaryto protect and improve the public's health.

The Workgroup’s deliberations highlighted a number of key issues with respect to the broad charge:

  1. Public health agencies are not interconnected:

    1. Only a small proportion can receive electronic data from clinical care or public health partners

    2. “Silos” of data exist in clinical and public health systems

  2. The business case for data/information exchange between public health and clinical care is not well articulated and requires improvement.

  3. Public health programs are separated from information technology support in most states. This is at times compounded by a lack of emphasis on information systems to support public health activities.

This letter provides both context and recommendations for how these issues can be addressed to implement informational tools and business operations to support real-time nationwide public health event monitoring and rapid response management.

BACKGROUND AND DISCUSSION

The threat of significant naturally occurring or man-made health events is a critical issue for the nation. The ability to detect events rapidly, manage the events and appropriately mobilize resources in response can save lives. The specific charge for the predecessor Biosurveillance workgroup focused on transmitting key elements of clinical data to public health to provide a real-time view of the health of our communities. The broader charge of the PH/CCC workgroup, building on the foundation established by the specific charge of its predecessor, supports real-time nationwide public health event monitoring and rapid response management across public health and clinical care.

The real-time nationwide public health event monitoring and rapid response management is addressed through four underlying priority areas. These priority areas were defined and ranked by the workgroup based on an iterative process. The prioritization was followed by a visioning exercise to baseline the current state, and establish mid-state (by 2010) and end-state (2014 and beyond) visions for each priority area. The PH/CCC Workgroup defined and recommended the implementation order for the following priority areas:

  1. Case Reporting

  2. Bi-directional Communications

  3. Response Management

  4. Adverse Events Reporting

This letter includes recommendations that are overarching of all four priority areas, as well as more specific recommendations in the areas of Case Reporting and Bi-directional Communications. These recommendations were based on workgroup input, and informed by a testimony on Case Reporting from the Council of State and Territorial Epidemiologists (CSTE).

In February 2007, the Workgroup began hearing testimony and deliberating on possible recommendations in the two priority areas of Response Management and Adverse Events Reporting.

INITIAL RECOMMENDATIONS:

  1. Overarching

The overarching recommendations are interrelated and targeted at establishing the basis on which specific public health use cases can be defined by HHS, prioritized by AHIC and applicable standards can be harmonized by HITSP. An improved business case would provide the basis for articulating the benefits of automated data/information exchange between public health and clinical care. Public health standards for data exchange and vocabulary exist to varying degrees at the State, local and national levels, as do functional requirements for information systems that support public health activities. However, a next step is to articulate the need for public health standards in terms of use cases to be prioritized by AHIC and promoted for harmonization by HITSP. Harmonized standards for public health would then inform certification of public health systems used at the local, state and national levels as well as certification of clinical care systems to address public health needs. The reliance on HITSP for standards harmonization necessitates that adequate resources be available; and recommendations are therefore included to identify public health resources to help build HITSP’s capacity to harmonize standards for AHIC population health use cases. Finally, harmonized standards and nationally accepted standards in this domain must be made available through a centralized authoritative website. This website would need to be administered by a neutral party, but include processes to accept input and support collaborative discussion by multiple parties with varying interests.

Recommendation 1.0 The State Alliance for eHealth, in collaboration with state and local governmental public health agencies and clinical care partners, and in consultation with HHS, should develop a business case for data/information exchange between public health and clinical careas well asdevelop acommunications planto improve the understanding of the need for this exchange.

Recommendation 1.1 By June 30, 2007, HHS, in collaboration with federal, state, and local governmental public health agencies should develop an approach, including identification of possible resources within public health, to support the HITSP process to ensure there is capacity to harmonize standards for AHIC population health use cases.
Recommendation 1.2 By June 30, 2007, HHS, in collaboration with state and local governmental public health agencies, should engage or consult with CCHIT to establish an open, participatory process for certification of public health information systems for functionality, security, and interoperability that is coordinated with the certification of clinical care and health network systems.

Recommendation 1.3 By June 30, 2007, HHS in collaboration with ASTHO,NACCHO and other appropriate organizations should support the establishment of a proof-of-concept demonstrating the added value of sharing data from clinical care to public health through health information exchanges.

Recommendation 1.4 By June 30, 2008, HHS in collaboration with ASTHO, NACCHO, the State Alliance for eHealth and other appropriate organizations should develop a plan to encourage the integration of state funded public health surveillance programs and health information exchanges.

Recommendation 1.5 In 2007, HHS and all its Agencies shall communicate internally and with all funding recipients that interoperability standards were accepted by the Secretary of Health and Human Services in December 2006 and will be recognized in December 2007. This recommendation acknowledges that the time between acceptance of interoperability standards in December 2006 and recognition of these standards in December 2007 will be used for planning and programming to incorporate these standards.

Recommendation 1.6 Beginning January 1, 2008, HHS and all its Agencies shall ensure that internal programs, as well as externally funded programs, implement relevant HHS recognized interoperability standards. This requirement applies to the implementation, acquisition and upgrade of health information technology systems that support public or population health consistent with Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs (http://www.whitehouse.gov/news/releases/2006/08/20060822-2.html).

Recommendation 1.7 By June 2007, HHS should identify a process to establish and manage an authoritative website to share recognized standards as well as provide a collaborative space for the sharing of standards being tested or used that are not yet recognized.

II. Case Reporting

Case Reporting is done at all levels of public health (local, state and national level). It is predominantly a passive activity that waits on physicians and laboratory staff to recognize a case and then know that it needs to be reported. Except for a limited number of conditions reportable by telephone (such as diseases of international concern, diseases caused by recognized bioterrorism agents, or cases associated with a known or suspected outbreak) reporting is typically manual and done by mail; therefore it is not very timely. Currently, notifiable disease lists vary in accordance with law, interest and surveillance capacity in each State and disease reports are often not standardized across States. Exceptions to this include diseases for which there is federal funding tied to surveillance. Specific reporting is usually mandated in legislation at the state level, and clinicians are occasionally required by law to report to more than one public health agency, at times in different formats and at varying levels of detail.

In the long-term it is envisioned that initial Case Reporting would integrate case criteria and reporting mechanisms into EHRs. These mechanisms should trigger recognition of a higher percentage of potential cases. For routine notifiable conditions, clinicians would be prompted to approve sending cases automatically to the appropriate local/state health departments, with anonymized case abstracts sent to the CDC. This approach recognizes the traditional investigation roles at local and state public health levels and that local and state jurisdictions have lead roles in public health investigations. In the circumstance that parallel reporting to all levels of public health is necessitated, the methods, and types of data involved in parallel reporting, and policies governing parallel reporting will be determined jointly by local, state, and Federal public health officials.

This automation would result in significant reductions in the time it currently takes to achieve a full reporting cycle, decrease the time it takes to make a report and increase the number of reports made. As EHRs become more prominent, public health will want to realize the benefits of a reduced reporting cycle and requests to exchange case reports electronically will become prevalent. EHR vendors will be challenged to automate case reporting if required to accommodate variations that currently exist in case reporting requirements from state to state.

The first step to facilitating automated electronic case reporting from EHRs is to standardize a common list of notifiable conditions required to be reported for use by all levels of public health. The next step is to establish case definitions for all reportable conditions that are standardized for use by each jurisdiction reporting that condition, and to determine the data elements to be included on each condition report. Additionally, terminology and defined formats for those data elements must be standardized to support electronic case reporting. Currently, CSTE and CDC have instituted an on-going process for defining the list of conditions reported by states to the CDC and the case definitions for these conditions do exist. This process provides a good candidate foundation on which to build the consistency needed to facilitate automated case reporting to all levels of public health.

The streamlining of case reporting requirements, to the extent possible, will enable EHR vendors to implement solutions that will work across jurisdictions rather than requiring customizations, or translation tools, to handle the variances that currently exist. Not only should this reduce complexity, but it should also result in cost savings for EHR vendors, to be carried over to those who are implementing EHR solutions.

The initial recommendations in this priority area are aimed at enabling automated, standardized case reporting and creating incentives for the adoption of standardized case reporting. A recommendation for harmonizing the standards to support notifiable disease reporting is included in recommendation 2.2, and includes defining the terminologies for standardized national case definitions. This recommendation complements recommendation 2.1 which is focused on defining the basic list of nationally notifiable conditions, their associated case definitions and the data elements to be reported to public health. While the focus of recommendations in this section falls under automated case reporting, the workgroup recognizes that the priority area of Case Reporting includes additional components that will become the focus of future efforts.

Biosurveillance would benefit from receiving data via Electronic Laboratory Reporting (ELR) to use as surrogates for initial disease information. Authorized public health investigations would be better enabled through electronic queries to clinical care, requesting details to determine risk factors, enable contact tracing, investigate exposure sources, and identify patients for treatment or prophylaxis. To summarize, the case reporting priority area includes:

Future recommendations will consider those areas of the Case Reporting priority area not included in the recommendations below.

Recommendation 2.0 By April 30, 2007, CSTE, in collaboration with CDC, should define an on-going process to be used in establishinga common list of nationally notifiableconditions to be reported to all levels of public health and their associated standardized case definitions including the data elements to be reported.

Recommendation 2.1 By August 1, 2007, CSTE, in collaboration with CDC, should provide to HHS the common list of nationally notifiable conditions and the first set of case definitions including the list of common and disease specific data elements to be reported. Subsequent sets of case definitions will be delivered on a scheduled basis as defined by the process resulting from Recommendation 2.0 above.

Recommendation 2.2 HHS should ensure the harmonization of data, technical, and interoperability standards for notifiable disease case reporting based on the availability of resources resulting from recommendation 1.1 above.

Recommendation 2.3 The Certification Commission for Health Information Technology (CCHIT) should include certification criteria for automated case reporting of Nationally Notifiable conditions in electronic health records by 2009.

Recommendation 2.4 HHS should convene a meeting to determine a process for defining requirements and implementation criteria for supporting automated case reporting from electronic health records or other clinical care information systems. The meeting should include industry vendors as well as state and local public health officials. The requirements and criteria that result from this process should be used to inform Recommendations 2.2 and 2.3 above.

Recommendation 2.5 HHS, in collaboration with ASTHO, NACCHO, provider organizations, vendor organizations and other appropriate organizations should develop a business case for automated electronic Case Reporting. The business case should articulate the burden associated with manual reporting and the benefits and limitations of automating reporting.

III. Bi-directional Communications

Bi-directional communication refers to the dissemination and interactive exchange of information, both horizontally and vertically, between the general public, clinical care entities, public health entities, and incident command entities. Communication modes include:

Communications may vary from secure exchanges for a limited audience to more publicly available information. Both data and information are disseminated using the modes of communication listed above. In biosurveillance, for example, clinical care would provide case reports and clinical data to appropriate public health entities. Public health would derive information from multiple sources of data (e.g. clinical care, veterinary, FDA, environmental sources) and send this information to clinicians to assist them in decision-making. Public health may provide a variety of communications such as health alerts, investigation findings, updates to case criteria, and guidelines for the general public. When appropriate, public health information would be shared with incident command entities that would then provide direction to all appropriate parties.

It is recognized that achievement of the future-state as described will require an iterative process beginning with clinically relevant first steps. The most likely candidate for those first efforts are case reporting by clinical care providers to public health followed by appropriate feedback from public health to clinical care providers. Even with a stepwise approach, it is anticipated that all levels of bi-directional communication will benefit from development using a common set of communication standards.

The recommendations for Bi-directional Communications are initial steps toward standardizing alerting, and the exchange of contact information among public health and clinical care. Alerts, in these recommendations, refer to a communication sent to appropriate, targeted audiences based on the nature of the event, the delivery time, the type of response required, the jurisdictions affected, the severity of the event, and the sensitivity of the information. Directories are needed to track contact information about people and organizations who receive communications. Contact information is regularly updated and therefore directories holding that information need to be exchanged among communications partners on a regular basis, in a standardized manner.

Recommendation 3.0 HHS should ensure the harmonization of standards for formatting the structure of health alerts including broad categories of content and meta data about the content based on the availability of resources resulting from recommendation 1.1 above. These standards should be considered for e-mail and web based alerting, but should not impede risk communications needs to optimize alert content.

Recommendation 3.1 HHS should ensure the harmonization of standards for exchanging public health and clinician directory information (contact information categorized by person, roles, organization, organization type, and jurisdiction) based on the availability of resources resulting from recommendation 1.1 above.

Recommendation 3.2 By June 30, 2007, HHS in collaboration with ASTHO,NACCHO and other appropriate organizations should support the establishment of a proof-of-concept demonstrating the added value of sharing information through bi-directional communications among clinical care and public health.

Sincerely yours,

/s/

Charles N. Kahn III

Co-Chair, AHIC Biosurveillance Workgroup

Sincerely yours,

/s/

John R. Lumpkin, MD, MPH

Co-Chair, AHIC Biosurveillance Workgroup

Sincerely yours,

/s/

Julie L. Gerberding, MD, MPH

Co-Chair, AHIC Biosurveillance Workgroup

References: