**[American Health Information Community]{.underline}**

**Workgroup on Biosurveillance**

**Summary of the Web Conference Held March 23, 2006**

**(3^rd^ Web Conference of This Workgroup)**

> **1. Call to Order and Welcome**
>
> Co-chair Julie Gerberding, Director, Centers for Disease Control and
> Prevention (CDC), called the meeting to order at 1:04 p.m.
>
> **2. Roll Call of Participants**
>
> Roll call was taken. (See list of participants at the end of this
> document.)
>
> **3. Review of Meeting Agenda and Desired Outcomes**
>
> Dr. Gerberding noted that the Community in its last meeting (March 7,
> 2006) asked the Workgroup to seek input from stakeholders. Therefore,
> a portion of the day's agenda is devoted to presentations from a
> variety of critical stakeholders. (See Agenda Item 4.)
>
> Documents made available for the meeting were:

-   Harmonized Use Case for Biosurveillance (Visit, Utilization, and Lab
    Result Data), dated March 19, 2006

-   The Federal Response to Hurricane Katrina: Lessons Learned
    (Executive Summary Prepared for Biosurveillance Workgroup), dated
    March 19, 2006

-   Validation of Minimum and Target Data Elements, dated March 22, 2006

-   Summary of Last Workgroup on Biosurveillance Web Conference, held
    February 24, 2006.

> **Harmonized Use Case for Biosurveillance -- John Loonsk**
>
> Dr. Loonsk summarized this document and how it relates to Workgroup
> recommendations thus:
>
> To advance the Administration's goal to expand adoption of health
> information technology (HIT), the Department of Health and Human
> Services (DHHS) released a series of contracts in the fall of 2005 to
> support critical processes in the areas of standards harmonization,
> certification of HIT, and development of a Nationwide Health
> Information Network (NHIN).
>
> A key step to ensuring coordination of these processes is the
> identification and development of use cases, which provide a common
> focus for different activities (e.g., HIT certification); help lead to
> specific HIT requirements, architecture, and standards; and inform
> policy discussions.
>
> On January 18, 2006, contractors submitted use cases to the Community
> and to the Office of the National Coordinator (ONC) staff in the areas
> of biosurveillance, consumer empowerment, and electronic health
> records. Subsequently, the ONC staff launched a process to integrate
> the individual contributions into "harmonized" use cases with the
> assistance of health information technology experts from across the
> Federal Government and the Community and its workgroups.
>
> The current document details the results of this effort for
> biosurveillance. Such harmonized use cases provide detailed guidance
> on the functions needed to advance accelerated adoption of HIT while
> leaving the door open for different models of implementation.
>
> From the Community's perspective, such use cases are expected to yield
> valuable insights in the ongoing effort to identify and remove
> barriers to HIT adoption. For the NHIN consortia of contractors, they
> provide a foundation for identifying critical architecture elements
> and establishing expectations of prototype architectures. For the
> Health Information Technology Standards Panel, they scope its efforts
> to develop named standards and implementation level guidance necessary
> for interoperability. For the Certification Commission for Health
> Information Technology, they provide insight into criteria for the
> certification of electronic health records and other aspects of the
> HIT landscape.
>
> Dr. Loonsk emphasized that use cases are not models and that the
> Workgroup will have further opportunities to discuss the
> biosurveillance harmonized use case. He noted that the biosurveillance
> use case parallels Workgroup discussions held to date, to a great
> degree.
>
> Workgroup members had no questions or comments on the document at this
> time.
>
> **Comments on Summary of Workgroup Web Conference Held February 24,
> 2006, and Workgroup Web Conference Schedule**
>
> Thomas Frieden stated that he disagreed with some of the decision
> points presented in the summary of the Workgroup Web conference held
> February 24. He said that he was not given sufficient opportunity to
> review the last Workgroup Web conference summary, particularly
> pertaining to minimum and target data elements for biosurveillance and
> options for data flow. He also asked for a future Workgroup Web
> conference schedule.
>
> **ACTION ITEM:** The future Workgroup Web conference schedule will be
> sent to all Workgroup members again, as well as periodic reminders.
>
> It was noted that a new document is before the Workgroup today
> regarding minimum and target data elements. (See Agenda Item 5.)
>
> Dr. Frieden disagreed with the decision point on page 7 of the
> February 24 summary. The decision point reads, "The Workgroup members
> decided against \[Data Flow\] Option 1 but agreed that the Option 2
> concept of data flowing simultaneously is appropriate and that use of
> an Option 3 intermediary might be useful as well."
>
> Edward Sondik asked for more detail on the data flow options.
>
> **ACTION ITEM:** If there is no closure on issues surrounding data
> flow options today, the Workgroup will return to discussion of the
> data flow options background paper presented at the February 24 Web
> conference to further explore members' concerns.
>
> **4. Presentations**
>
> The following three presentations are scheduled for today's meeting:

-   The Federal Response to Hurricane Katrina: Lessons Learned
    (Executive Summary Prepared for Biosurveillance Workgroup) -- Rick
    Friedman

-   The Association of State and Territorial Health Officials (ASTHO) on
    Biosurveillance -- Bill Packer

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-   Presentation on the National Association of Chemical Hygiene
    Officers (NACHO) -- Phil Stevens

> **The Federal Response to Hurricane Katrina: Lesson Learned (Executive
> Summary Prepared for Biosurveillance Workgroup) -- Rick Friedman**
>
> Dr. Friedman noted that the report he summarized for the Workgroup was
> written by the Assistant to the President for Homeland Security and
> Counterterrorism, Frances Fragos Townsend, who submitted the report to
> the President. Although its subject is the Federal response to
> Hurricane Katrina, the report will prove valuable for other emergency
> situations. Dr. Friedman highly recommended that Workgroup members
> take time to read the entire report.
>
> Dr. Friedman's executive summary provides the full report's table of
> contents and excerpts from:

-   Chapter 2: National Preparedness -- A Primer

-   Chapter 5: Lessons Learned

-   Chapter 6: Transforming National Preparedness

-   Recommendations from Appendix A, specifically directed to DHHS but
    relevant to other Federal agencies

> **Chapter 2** of the report discusses how the national disaster
> preparedness system is supposed to work. Traditionally, disaster
> response in the United States has been handled by State and local
> governments, with the Federal Government playing a supporting role.
> Chapter 2 notes that in February 2003, the President directed the
> Secretary of Homeland Security to create a comprehensive National
> Incident Management System (NIMS) to provide a consistent, nationwide
> approach for Federal, State, and local governments to work effectively
> together to prepare for, respond to, and recover from domestic
> incidents regardless of cause, size, or complexity. The rest of the
> report stresses Federal support.
>
> **Chapter 5** notes that effective incident management of catastrophic
> events requires coordination of a wide range of organizations and
> activities, public and private. Under the current response framework,
> the Federal Government merely "coordinates" resources to meet the
> needs of local and State governments based on their requests for
> assistance. Dr. Friedman pointed out that these limitations "proved to
> be major inhibitors to the effective marshalling of Federal, State,
> and local resources to respond to Katrina."
>
> Specifically, as Dr. Friedman noted on page 3, item 10 of his summary,
> response to Katrina did not go as planned because "key decisionmakers
> at all levels simply were not familiar" with the national response
> plan and therefore could not follow it. This speaks specifically to
> the Community's effort in developing a breakthrough biosurveillance
> system. Dr. Friedman commented, "Whatever we come up with will need to
> be understood, including how it can be put into practice."
>
> Dr. Friedman highlighted items 13 and 14 on page 3 of his summary:

-   **Item 13** addresses how most local and State public health and
    medical assets were overwhelmed by the conditions they faced, which
    placed even greater responsibility on federally deployed personnel.
    "Immediate challenges included the identification, triage, and
    treatment of acutely sick and injured patients; the management of
    chronic medical conditions in large numbers of evacuees with special
    health care needs; the assessment, communication, and mitigation of
    public health risk; and the provision of assistance to State and
    local health officials to quickly reestablish health care delivery
    systems and public health infrastructures."

-   **Item 14** states, "In coordination with the Department of Homeland
    Security and other homeland security partners, the \[DHHS\] should
    strengthen the Federal government's capability to provide pubic
    health and medical support during a crisis. This will require the
    improvement of command and control of public health resources, the
    development of deliberate plans, an additional investment in
    deployable operational resources, and an acceleration of the
    initiative to foster the widespread use of interoperable electronic
    health records systems."

> Dr. Friedman characterized **Chapter 6** in his summary as probably
> the most directly applicable to the Workgroup's task. It discusses the
> need to transform the Nation's cultural view of preparedness because,
> as item 16 on page 4 states, all levels of government, the private
> sector, and communities and individual citizens "have not developed a
> shared vision of or commitment to preparedness." Important to the
> Workgroup's task, Dr. Friedman commented, is the need for a great deal
> of feedback and periodic assessment of processes put in place.
>
> Dr. Friedman noted other key points in Chapter 6:

-   From item 19: "An effective National Preparedness System requires
    that management and response personnel, especially those in the
    field, are well-versed in their missions."

-   From item 21: "Over the long term, our professional development and
    education programs must break down interagency barriers to build a
    unified team across the Federal Government."

-   From item 22: "The success of the National Preparedness System over
    time will depend upon the quality of its metrics-based assessment
    and feedback mechanisms. In particular, the System must possess the
    means to measure progress towards strategic goals and capability
    objectives. It must systematically identify best practices and
    lessons learned in order to share them with our homeland security
    partners throughout the Nation. It must also have an effective
    process for conducting corrective or remedial actions when a system
    challenge is identified."

-   From item 23: "The second element of our continuing transformation
    for homeland security perhaps will be the most profound and enduring
    -- the creation of a Culture of Preparedness. A new preparedness
    culture must emphasize that the entire Nation -- Federal, State, and
    local governments; the private sector; communities; and individual
    citizens -- share common goals and responsibilities for homeland
    security."

-   From item 24: "Today, we operate under two guiding principles: (a)
    that incident management should begin at the lowest jurisdictional
    level possible, and (b) that, for most incidents, the Federal
    Government will generally play a supporting role to State and local
    efforts. While these principles suffice for the vast majority of
    incidents, they impede the Federal response to severe catastrophes."

-   From item 26, "The objectives of this dialogue must be first to
    establish reasonable expectations of what government can and cannot
    do in response to catastrophes...Second, this dialogue must develop
    a shared understanding of the need for active Federal management of
    the National Preparedness System...Finally, this dialogue must
    result in a shared understanding of roles and responsibilities in
    preparedness for catastrophic events...."

> Dr. Friedman concluded by noting, but not verbally detailing,
> DHHS-specific recommendations from the report's Appendix A. The
> opening paragraph of these recommendations reads as follows:

-   "In coordination with the Department of Homeland Security and other
    homeland security partners, the \[DHHS\] should strengthen the
    Federal Government's capability to provide public health and medical
    support during a crisis. This will require the improvement of
    command and control of public health resources, the development of
    deliberate plans, an additional investment in deployable operational
    resources, and an acceleration of the initiative to foster the
    widespread use of interoperable electronic health records systems."

> Dr. Gerberding thanked Dr. Friedman for his excellent presentation.
> There were no questions or comments.
>
> **ASTHO Presentation**
>
> Kentucky Public Health Commissioner and ASTHO Public Health
> Informatics Policy Committee Chair, Bill Packer, summarized the ASTHO
> position on biosurveillance. His committee held a meeting in
> Indianapolis in February with, among others, Secretary Leavitt and Dr.
> Gerberding, to discuss biosurveillance and examine the Regional Health
> Information Organization (RHIO) operating in Indianapolis, including
> set up and electronic information sharing problems.
>
> Subsequently, the ASTHO Committee approved a biosurveillance paper,
> which has been approved at the highest ASTHO levels. ASTHO understands
> the importance of biosurveillance and supports efforts to improve it.
>
> Biosurveillance ties into two different surveillance methods: the
> standard public health epidemiological investigation, where there is a
> human component in addition to electronic sharing; and automated
> systems, which expedite data sharing in a timely manner and may
> identify preliminarily issues that require prompt response.
>
> Different States are in various stages of implementing biosurveillance
> programs. Since 2002 in Kentucky, biosurveillance has been conducted
> in the Jefferson County area around Louisville dealing with a
> phenomenon called "Derby Season," which involves hundreds of thousands
> of visitors from around the world each year for about 2 weeks before
> and during the running of the Kentucky Derby. Each year during this
> season, 16 hospitals in the Louisville area submit emergency room
> chief complaints data to the local health department, which then does
> surveillance looking for any peaks. This effort is building a
> background database on the average load of fever or chief complaint
> during the season. Kentucky's rural area surveillance efforts are not
> as advanced, Dr. Packer said, noting that he suspects this is true in
> other States as well.
>
> Other organizations are working on similar efforts to add deliverable
> outcomes value to the public health system, such as the National
> Council of State and Territorial Epidemiologists.
>
> ASTHO has four positions on biosurveillance:

-   Establish protocols in order to facilitate sharing of information,
    identify the legal authority of each partner, provide access to
    data, help with consequence management in light of an event, and
    help set expectations and requirements for response.

-   Provide for systems integrity, which means biosurveillance systems
    need to be based on strong science of demonstrated value to public
    health goals, reduce the possibility of false positives, and lend
    themselves to evaluation -- of technology, software, and research
    investment.

-   Consider maintaining traditional flows of information sharing. For
    example, in Louisville, information flows from the hospitals, then
    to the local health department, then to the State health department,
    with the possibility of further connecting to the CDC. (Dr. Packer
    supported instantaneous sharing of information as long as the
    traditional flow from local to State to Federal levels is
    maintained.)

-   Provide appropriate safeguards to protect patient confidentiality
    and decrease public concerns over privacy issues.

> ASTHO will be available to further assist the Workgroup.
>
> **Discussion**
>
> Jeff Wells asked if Dr. Packer had a sense of the readiness,
> nationwide, of local and State health departments to receive
> electronic information from their community hospitals or other data
> sources.
>
> Dr. Packer responded that in Kentucky, all local health departments
> have access to the Internet, which allows his department, for example,
> to notify them to alerts received through the Health Alert Network,
> FEX, or similar mechanisms. His department also has contact
> information at the community level. But software systems are not yet
> in place to capture, for example, complete blood counts or blood
> culture results and then to share these results electronically across
> the State -- to other hospitals or other local health departments.
>
> **ACTION ITEM:** Dr. Packer will provide written copies of his
> presentation and the ASTHO position paper to the Workgroup.
>
> Brian Keaton expressed concern about rural areas possibly being the
> first sites for identification of certain potential communicable
> diseases, such as avian flu. He asked Dr. Packer about the ability of
> a new public health network to provide guidance to clinicians,
> particularly in rural areas, who might be the first to see or identify
> first cases.
>
> Dr. Packer responded that on that point, he feels there is a
> bell-shaped curve across the United States, with Kentucky on the
> rising side of the curve. He said physicians and their relationships
> with the clinical world are going to be as valuable as, and possibly
> more so than, electronic surveillance. He recounted the case of a
> truck driver who pulled over in a small town in Kentucky with a
> 104-degree fever in May 2004. He was a native of Trinidad, citizen of
> Canada, and current resident of Atlanta, heading home through Kentucky
> after a long haul to Canada. He presented with a vesicular rash, and
> the emergency room physician became concerned about the possibility of
> smallpox. The physician called the local health department, which then
> called Dr. Packer's office. The CDC was notified, and the matter wound
> up in the White House Situation Room, while the hospital went into
> lock down for about 4 hours.
>
> In the end, the patient had varicela, not variola, Dr. Packer
> recounted, adding that the story shows the importance of good
> relationships between local health and local primary care and
> specialty physicians.
>
> **NACHO Presentation**
>
> Dr. Stevens, with the Tarrant County Public Health Department's
> Advanced Practice Center (one of seven around the country), gave a
> presentation on a grant-based syndromic surveillance program in the
> Dallas/Fort Worth Metroplex. This program is gradually being expanded
> into a broader-based health surveillance program using two major
> syndromic surveillance systems -- ESSENCE and RODS. In addition, his
> department is supporting expansion of the CDC's BioSense surveillance
> system in the metro area, building on the existence of a strong
> hospital council and the presence of several major hospital systems.
>
> "We strongly believe in collaboration between BioSense and the systems
> we have started," Dr. Stevens said. He added that data in the systems
> are important, but so is managing the relationship with different
> reporting sources, including but not limited to hospitals. He stressed
> that the variety of surveillance system stakeholders in his area have
> come to expect his department to serve as a focal point of the
> relationship, which, Dr. Stevens believes, ultimately will benefit
> expansion of the BioSense program.
>
> Some 36 hospitals now report chief complaints 24/7, 365 days of the
> year, in an automated fashion as part of Dr. Stevens' department's
> syndromic surveillance program. Within the next year, new modules will
> be installed at several of the hospitals for collecting mature data,
> such as laboratory and radiology reports.
>
> There has been a great deal of variability in the basic data sets
> being captured by the system. This again points, Dr. Stevens
> emphasized, to the importance of good relationships and ongoing
> interaction with data providers, particularly as data requirements
> become more complex, such as under the BioSense program.
>
> Once data are flowing with consistency and validation, the next push
> in the syndromic surveillance program will be development of protocols
> for alerts or aberrations, for example. Ultimately, situational
> awareness of what these alerts or aberrations imply is a critical,
> desired outcome that, again, will require a great deal of
> collaboration among not only local entities but State, regional, and
> Federal entities as well.
>
> **Discussion**
>
> Scott Becker asked Dr. Stevens about his system's experiences with
> laboratory data. Dr. Stevens said his department's plans are to
> address that, in part, by putting a Health System Resident Connection
> (HSRC) into the system. Under HSRC, a resident application will sit on
> some of the hospital servers to extract laboratory data from existing
> databases. The goal will be not to place that data on the public
> health servers but rather to extract it from the hospitals' servers if
> and when needed.
>
> Jean Marie Maillard commented that North Carolina has built a system
> called Detect to improve the quality of what is done with collected
> data, such as case definitions.
>
> **General Discussion of Presentations: Highlights**
>
> Kelly Cronin asked all three presenters to identify important
> potential pitfalls the Workgroup should consider as it moves forward
> with a breakthrough biosurveillance system.
>
> Responses included the following:

-   Collaboration with local health departments needs to include
    relationship management and protocol response definition.

-   Interaction between the BioSense system and local health departments
    needs to be clear to prevent health care provider confusion or
    perception of competing interests.

-   The many layers of decisionmaking that exist across jurisdictional
    levels complicate timeliness of data flow.

-   Do not overreach to try to meet goals that are not achievable in the
    short term; i.e., build on what is available now, even if it is not
    ideal.

-   Deal with capacity issues.

> **5. Revised Minimum Dataset (MDS)**
>
> Dr. Gerberding characterized the Biosurveillance Validation of Minimum
> and Target Data Elements document before the Workgroup as a review of
> the minimum dataset conceptually agreed to by the Workgroup during the
> February Web conference. The term "minimum," as used in this document,
> pertains to data elements that "we will try to get early and fast."
> The term "target," as used in this document, pertains to data elements
> that "we ultimately will shoot for" as quickly as they come on board.
>
> Dr. Gerberding reminded Workgroup members that the Secretary does not
> want "the perfect to be enemy of the good." Therefore, "getting
> something going is really our highest priority." She noted that the
> major categories of data include Institution Data, Daily Facility
> Summary, Census by Unit, Patient Data, Clinical Data, Laboratory and
> Radiology Test Orders, and Laboratory/Microbiology Results. She noted
> the relatively short list of elements under Daily Facility Summary and
> Census by Unit. She observed that facility data and census data may be
> easier to obtain in some cases than the more specific Clinical Data.
> Nonetheless, the Workgroup should aim to get as many data elements on
> board as quickly as possible.
>
> The question now before the Workgroup is which data elements listed
> should be eliminated "because less is best."
>
> Dr. Frieden noted that he needed to leave soon, but he and his
> designee, Rick Heffernan, have real concerns about the data elements
> set. What is doable in 12 months is a simpler system that looks at,
> for example, flu-like syndrome counts aggregated from chief
> complaints. Facility data might be split off usefully into a separate
> system that looks primarily at, for example, number of patients in the
> hospital in general and in intensive care units in particular, as well
> as excess capacity.
>
> Dr. Frieden observed that while admissions and discharge data might
> not be impossible to get, it is important to minimize the data
> reporting burden on health care facilities. He added that patient data
> could be very difficult to collect and analyze. Quality and
> completeness of this data also could be issues, as well as privacy
> concerns. Even when names are removed from data, other identifiers
> remain, such as month and year of birth and zip code.
>
> Laboratory data are very useful, Dr. Frieden continued, but very
> difficult to obtain. What is needed is an investment in nationally
> standardized electronic laboratory reporting, because at present, labs
> differ a great deal not only in their testing methods but also in the
> diversity of their information systems.
>
> Dr. Frieden concluded by suggesting that Workgroup members exchange
> written comments and/or form a subgroup to examine data elements.
>
> Dr. Loonsk noted that during the last Web conference discussion of
> data elements in February, it was recognized that the data needed are
> not just data for initial event detection but also for outbreak
> management, situational awareness, and supporting response management
> at different levels of public health.
>
> Dr. Maillard suggested that under the Census by Unit category, it
> might be more useful to know numbers of staff beds than numbers of
> beds available by unit. In addition, under the Clinical Data category,
> the Workgroup might want to add a data element -- initial triage nurse
> notes -- which is useful for filtering out false alerts.
>
> **ACTION ITEM:** After further discussion about how to proceed with
> decisions on minimum and target data elements, the Workgroup agreed
> that Dr. Frieden would provide a written version of his concerns and,
> before the next Web conference, a subgroup would review his concerns
> and the proposed dataset and make a recommendation to the Workgroup.
>
> Subgroup members will include Dr. Frieden and Dr. Heffernan as well as
> designated experts in the subject from the American College of
> Emergency Physicians, the North Carolina (NC) Department of Health and
> Human Services, Indiana State Offices (including Jeff Wells), and the
> Department of Defense.
>
> **6. Data Gathering to Inform Recommendations**
>
> Dr. Gerberding asked Laura Conn to brief the Workgroup on background
> data being collected by the CDC to underpin Workgroup recommendations
> to the Secretary.
>
> Data are being collected on the city and State locations of Level One
> and Level Two Trauma Centers, as well as on top population and rural
> population centers. Seaport and cargo ports data also are being
> collected.
>
> **ASTHO and NACHO will assist** in determining the capabilities that
> exist in State and local jurisdictions, such as RHIOs and early event
> detection systems, as well as help to determine what kind of data
> these systems can and cannot receive at present. (See Agenda Item 8
> for further reference.)
>
> Results will be presented to the Workgroup before or during the next
> Web conference in April, date to be determined.
>
> There was no further discussion of this agenda item.
>
> **7. Policy Issues and Barriers**
>
> Background briefings and group discussion have been scheduled as
> follows:

-   Overview of Open Policy Issues and Barriers -- Kelly Cronin

-   Privacy Concerns -- Deborah Trussman, General Counsel, CDC, Public
    Health Division, DHHS

-   Role of RHIO -- Jeff Wells, Indiana Family and Social Services
    Administration

-   Hospital Perspective -- Roslyne Schulman, American Hospital
    Association (AHA)

-   Group discussion to agree on all policy issues and barriers.

> Ms. Cronin noted the background briefings on open policy issues and
> barriers that will be provided today as outlined above and recapped
> the Workgroup's discussions to date on some of these issues and
> barriers.
>
> First, the Workgroup has discussed the potential need for incentives
> for hospitals and others to participate in a biosurveillance program,
> particularly if the Workgroup is in agreement that the system should
> be broad based. Dr. Schulman is expected to address this issue today,
> possibly providing greater details later.
>
> Along the same lines, the Workgroup also has discussed whether
> hospitals will need additional resources to participate in a
> breakthrough biosurveillance system in a timely fashion and meet the
> 24-hour turnaround for data goal in the Workgroup's specific charge.
> In addition, there has been discussion of voluntary versus required
> submission of data and of the role of the Federal Government if, in
> fact, it ends up enabling data transmission for an NHIN.
>
> The Workgroup also has discussed hospitals' concerns about their
> responsibilities under the Health Insurance Portability and
> Accountability Act (HIPAA) and the potential need for hospitals to be
> reassured that sharing data with public health is appropriate in the
> context of biosurveillance. Ms. Trussman will provide background
> information on this subject.
>
> The Workgroup has discussed substantively the role of RHIOs as an
> option for data transmission -- in the context of having an
> intermediary or other entity receive biosurveillance data prior to
> transmission to local, State, and Federal public health departments.
> The Workgroup has been introduced to real-world examples of RHIOs
> acting in this capacity. Because Indiana has one of the most advanced
> RHIOs in the country, Dr. Wells has been asked to brief the Workgroup
> on it.
>
> **Privacy Concerns Briefing**
>
> Ms. Trussman provided a high-level overview of the public
> health-related provision of the HIPAA Privacy Rule. She discussed some
> of the authorities provided in the Public Health Services Act (PHSA)
> and other relevant legal frameworks.
>
> National standards for protecting the privacy of protected health
> information regulate how covered entities (i.e., health care
> providers) protect privacy when conducting certain electronic
> transactions with, for example, clearinghouses and health insurers. In
> short, protected health information can be used or disclosed only with
> patient authorization unless use or disclosure is required or
> permitted by the HIPAA Privacy Rule.
>
> Covered entities (such as hospitals) can disclose protected health
> information if that disclosure is required by Federal or State law for
> public health purposes. A covered entity may disclose protected health
> information to a public health authority if that disclosure is
> authorized by law for the purposes of preventing or controlling
> disease, injury, or disability, including but not limited to the
> reporting of disease; injury; vital events, such as birth or death;
> and the conduct of public health surveillance, public health
> investigations, and public health interventions.
>
> A public health authority must be in a position to respond to the
> concerns of the covered entity by providing information about its
> identity and status as a public health authority, verifying its legal
> authority to collect patient information, and documenting that the
> information it is requesting is the minimum necessary.
>
> The PHSA provides general, broad authorities under which the CDC, as a
> Federal-level public health authority, conducts activities to address
> public health matters.
>
> Some of the provisions of the PHSA enacted in 2002 specifically relate
> to the establishment of national communications and surveillance
> networks. These provisions authorize the Secretary to establish or
> provide funding for establishing an integrated system or systems of
> public health alert communications and surveillance between and among
> Federal, State, and local public health officials and public-health
> related laboratories, hospitals, and other health care facilities as
> the Secretary determines is appropriate.
>
> States have their own substantive public authorities under which to
> collect information or maintain it once received. Once patient
> information leaves the entity covered by HIPAA, such as a hospital,
> and is in the hands of a public health authority, it is generally
> covered by the State's legal framework pertaining to privacy,
> confidentiality, and use of the information.
>
> **Discussion**
>
> Dr. Heffernan asked about the relevance of the definition of "minimum
> data necessary" to surveillance. Ms. Trussman noted that a covered
> entity always must be able to define the minimum data necessary, but
> there may be a provision in the HIPAA rule that allows a covered
> entity to reasonably rely on representations made to it by the public
> health authority requesting the data. The covered entity does not have
> to accept those representations, but under the rule, they are
> authorized to reasonably rely on those representations.
>
> Dr. Loonsk asked if State laws explicitly allowing public
> health-related collection of patient data are necessary. Ms. Trussman
> responded that each State needs to look into whether
> biosurveillance-based requests, for example, are covered by specific
> or more general authorities. A 1999 preamble to HIPAA indicates that
> very specific legal authority is not needed.
>
> **ACTION ITEM:** Ms. Trussman will provide a written version of her
> presentation to the Workgroup, as well as other relevant CDC overviews
> and a white paper specifically on biosurveillance.[^1]
>
> **Role of the RHIO** **Briefing**
>
> Dr. Wells noted that although he is not directly affiliated with
> Indianapolis' RHIO organizations or the State's health department, he
> has been working with these entities.
>
> The infrastructure for the RHIO in Indianapolis is based in the
> Regenstrief Institute, which is an internationally recognized
> informatics and health care research organization, established with a
> philanthropic grant in 1969. Its annual budget is about \$12 million.
> An initial core Institute project was providing a robust electronic
> medical record for a local hospital affiliated with the Indiana
> University School of Medicine. Now the RHIO that has evolved out of
> the Institute's work acts as an information exchange that shares data
> among about 14 hospitals in the area. Access to a range of data is
> available, if needed, from those hospitals, including lab and
> radiology data and admission and discharge summaries.
>
> The Indiana Health Information Exchange (IHIE) is the other
> organization involved in the RHIO. It is a nonprofit organization
> founded by a diversity of stakeholders, including universities and
> hospital systems locally based in Indianapolis, the Marion County
> (Indianapolis) Public Health Department, and the State government,
> including the State Health Department. The two health departments can
> obtain information from the exchange using the RHIO as an
> intermediary.
>
> Forty-five hospital emergency departments from across the State, in
> urban as well as rural areas, currently send information to
> Regenstrief. That information is further standardized in appropriate
> formats and aggregated, then sent on simultaneously to the Marion
> County Public Health Department as well as the State Health
> Department. The Regenstrief staff indicates that it would be very easy
> to send that information on to the CDC.
>
> The emergency departments establish their information technology
> connection with Regenstrief through an HL7 format (which allows
> results to go directly into electronic health records) using the
> Internet in a secure fashion.
>
> Dr. Wells noted that in addition to emergency department information,
> the State Health Department receives data from over-the-counter
> pharmacies; the State's poison center; and from schools, based on
> school absenteeism.
>
> **Discussion**
>
> Workgroup members explored with Dr. Wells how the Regenstrief and the
> IHIE could act as an intermediary for the Federal Government to serve
> local, State, and Federal biosurveillance data flow needs. Dr.
> Gerberding commented that if a RHIO acts as an intermediary, it would
> need to make patient data anonymous before transmitting it to local,
> State, and Federal public health authorities. It was noted that many
> if not all RHIOs keep patient data anonymous already.
>
> **ACTION ITEM:** Dr. Wells will ask the staff from the Regenstrief and
> the IHIE to pull together for the Workgroup a proposal or concept
> paper on interaction with a breakthrough biosurveillance system.
>
> Dr. Gerberding asked Workgroup members if they were interested in
> exploring other RHIOs in operation around the country, possibly for
> the purposes of addressing their operations in near-term
> recommendations to the Secretary. She noted in particular a series of
> projects underway between the Utah Department of Health and the Utah
> Health Information Network. Although those particular projects may not
> involve the minimum dataset for biosurveillance under Workgroup
> discussion, more mature RHIOs could be examined.
>
> Dr. Keaton noted that he is currently on sabbatical setting up a RHIO
> in northeast Ohio.
>
> **ACTION ITEM:** ONC staff will follow up with Dr. Keaton to explore
> further various organizations collaborating with RHIOs and how they
> may be able to advance the Workgroup's tasks.
>
> Adele Morris asked for identification of the policy issues involving
> RHIOs. Ms. Cronin said a primary issue is whether the RHIOs
> potentially involved in the breakthrough biosurveillance system would
> be viewed as providers or as serving public health in terms of issues
> such as patient privacy and confidentiality. While most RHIOs have a
> provider orientation at present, if they also operated as they do in
> Indiana to serve public health, they could be recognized under current
> law as acting with appropriate authority.
>
> **ACTION ITEM:** If RHIOs interested in serving public health need
> further clarity about their status under the law, the Workgroup could
> follow up with any needed recommendations or a clarifying letter to
> the Community.
>
> Dr. Loonsk commented that RHIOs could be good models for moving the
> breakthrough project forward. In addition, the Workgroup could
> consider how multijurisdictional organizations, such as hospital
> systems or health plans, could contribute as well. Some already have
> interest in and have implemented relatively advanced systems.
> Importantly, it remains necessary to work through issues of data flow
> so that, for example, local jurisdictions and States get the data they
> need and that Federal needs are addressed as well.
>
> Ms. Cronin commented that involving large hospital systems with market
> shares in various markets also raises the question of business models
> for the NHIN, including the question of who would potentially finance
> health information exchange or the transmission of data as it relates
> to public health. She noted that the NHIN consortium currently is
> looking at business models and sustainability of health information
> exchange.
>
> Discussion ensued on the circumstances under which data from hospitals
> would be retrieved -- whether hospitals would be responsible for
> pushing the data out of their systems or allowing another entity, for
> public health surveillance purposes to pull the data from their
> systems. It was noted that hospitals are very particular about who
> operates their information systems in their settings, but there will
> be a critical need at times to help hospitals make data available in a
> way that they normally do not. A push model may be preferable for a
> variety of reasons, however.
>
> It was noted that a potential strength of involving RHIOs in the NHIN
> is the fact that they are essentially political entities designed to
> build trust among stakeholders and to formulate mutually agreed-upon
> policies and procedures. Critical for the purposes of public health
> biosurveillance is the presence of trusted public health entities at
> the beginning and throughout the process.
>
> **ACTION ITEM:** There was preliminary discussion of a possible
> Workgroup recommendation to the Community in May regarding the
> importance of early public health entity involvement in the formation
> of RHIOs. It was noted that such a recommendation should be directive
> and name specific organizations or entities that could take action on
> the recommendation, such as the Health Information Technology
> Standards Panel.
>
> Discussion ensued on how to reduce the burden or cost of participation
> in a program from a provider's perspective. It was noted that that is
> a key goal and that current work being done by contractors on NHIN
> standards harmonization and certification, for example, will help lay
> the groundwork for realization of greater cost versus benefit
> efficiencies over time.
>
> **Hospital Perspective Briefing**
>
> Roslyne Schulman, Senior Associate Director for Health Policy in AHA,
> presented AHA's initial views on behalf of its 4,800 hospital, health
> system, and other health care organization members and its 33,000
> individual members on the ability and willingness of hospitals to
> participate in a biosurveillance program involving the transmission of
> a minimum dataset to local, State, and Federal public health agencies.
>
> Ms. Schulman also commented on the need for incentives for voluntary
> participation in such a program and potential incentive options that
> might be attractive to hospitals. In addition, she provided limited,
> anecdotal information about the types of biosurveillance systems that
> hospitals have adopted.
>
> Over the past 5 years, the entire Nation has focused on strengthening
> emergency readiness and security. Hospitals play a central role in
> that effort. AHA is very supportive of broadening the scale and scope
> of hospital disaster plans so that they link with and involve other
> community partners, especially public health departments. AHA strongly
> supports improving the capacity of hospitals and public health
> systems, labs, and clinicians to engage in biosurveillance and disease
> and syndromic reporting.
>
> Surveillance systems not only improve readiness for emergency events
> but also can serve to improve public health in other ways, such as
> through tracking population health status and health service
> utilization. However, hospitals and public health departments will
> need adequate resources and significant upgrades to surveillance
> systems.
>
> Input from State and regional medical hospital associations indicates
> that multiple challenges face hospitals that will impact on their
> willingness and ability to participate in implementing biosurveillance
> and other emergency readiness initiatives, as follows:

-   One out of every three hospitals loses money on their operations,
    due primarily to Medicare and Medicaid underfunding.

-   Hospitals also face rising labor costs as they increase wages to
    attract scarce workers.

-   The number of uninsured patients continues to grow, contributing to
    a greater level of uncompensated care that further undermines the
    financial stability of hospitals.

-   Costs are skyrocketing in terms of medical liability insurance and
    pharmaceutical and medical supplies.

-   The typical hospital, particularly the typical rural hospital, has
    very few reserves to tap in order to participate in a truly
    comprehensive biosurveillance program.

> To maximize voluntary participation in a biosurveillance system, AHA
> members and 16 State and two metropolitan hospital associations
> suggest the following on a preliminary basis:

-   Adequate initial and sustained funding to hospitals is needed to put
    new or updated systems in place.

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-   Ongoing financial support is needed for longer-term maintenance
    (some systems set up in the past received initial support that then
    fell off over time).

-   Hospitals need help to fund any additional hospital reporting
    requirements or mandates.

-   Hospitals need to have the opportunity to get back useful data.

-   Close collaboration is needed between partners from the beginning,
    including with local and State hospital associations. If such
    associations are involved at the beginning and over time in the
    development and implementation of biosurveillance systems, voluntary
    hospital member support is possible; without such involvement,
    voluntary participation is unlikely. (States with successful
    comprehensive programs have followed the early and sustained
    involvement model.).

-   Working with local and State hospital associations provides public
    health departments with the opportunity to leverage data collection
    initiatives already undertaken by these associations.

-   Successful surveillance systems need to the maximum extent possible
    to use and build on sources of information already collected by
    hospitals and emergency departments.

-   The ideal system will be invisible to the hospital, with data
    obtained from the hospital's system in a way that does not require
    any change in daily internal processes.

-   Automated retrieval and transmission of existing data from clinical
    databases is preferable to systems requiring manual entry of data.
    Automated systems should ultimately prove less costly and less
    burdensome for providers.

-   If progress is to be made within 1 year, the minimum data elements
    set under discussion by the Workgroup really needs to be minimal,
    based on value-added, criticality, and science.

-   Data security and privacy need to be ensured. Hospital data have to
    be obtained, processed, transmitted, analyzed, stored, and used in a
    manner compliant with Federal law, including HIPAA, and State
    information privacy and security regulations.

-   Hospitals in States or communities where comprehensive systems are
    already in place are concerned about redundant data requests. Any
    new nationwide system should be willing to take data from whatever
    sources can make it available, preferably State or local health
    departments that are already involved in collecting the data from
    hospitals.

> Ms. Schulman confirmed other presenters' impressions that the status
> of comprehensive automated electronic biosurveillance systems is a
> "mixed bag" in the 16 States and two metropolitan areas from which she
> gathered information. Some systems are way ahead of the curve, such as
> in North Carolina, New York City, Florida, Indiana, Pennsylvania, and
> Kentucky. But other States have "a very long way to go" and are still
> using only paper- or faxed-based manual reporting systems. Some are
> reporting just notifiable diseases and are doing so in a paper-based
> fashion.
>
> **Discussion of Briefing and Group Discussion to Agree on All Policy
> Issues and Barriers**
>
> There was discussion about relative rates of adoption of electronic
> health records across subsets of hospitals. Ms. Schulman indicated
> that, although she is not an expert, hospitals that are part of large
> systems and academic medical centers involved in research are more
> likely than others to be moving in that direction and be able to
> participate earlier rather than later in a breakthrough
> biosurveillance system.
>
> **ACTION ITEM:** Ms. Schulman will consult with appropriate AHA
> colleagues and may identify a subset of hospitals able to engage in a
> breakthrough system in an earlier rather than later time frame.
>
> Dr. Loonsk mentioned a study of hospitals with electronic emergency
> room systems that could help as well.
>
> **ACTION ITEM:** Dr. Sondik confirmed Dr. Loonsk's impression that
> there is a study showing that the number of hospitals with electronic
> emergency room systems is higher than anticipated. He will provide a
> report to the Workgroup on that study.
>
> Dr. Keaton commented that different sets of systems exist in emergency
> departments: one system for most results reporting, X-ray images,
> printed lab reports, surgery reports, and admission discharge; and
> other systems that focus on operational issues, such as where patients
> are. One focus now is to make these systems work together.
>
> Discussion ensued on the need to get more precise estimates of
> emergency room capacity and perhaps trauma center or general hospital
> capacity as well in order to sift through what is possible in the
> short- and long-term scopes of the breakthrough. Ascertaining provider
> willingness to participate in the breakthrough also could be explored.
> Whether the provider systems identified can collect the dataset the
> Workgroup discussed in February and again today and can send that data
> to various entities also could be explored, as well as providers'
> willingness to collect data elements they may not collect at present.
>
> Dr. Gerberding noted that the consensus of the Community at its last
> meeting was for the Workgroup to aim for a broad-based system with a
> minimum dataset. Now the Workgroup's task is to fine-tune that.
> Recapping a decision made earlier today (see Agenda Item 5), Dr.
> Gerberding noted that a dataset subgroup will examine the proposed
> dataset more carefully, and at a later date, there will be further
> detailed discussion of all the data elements that actually would
> enable functions related to scenarios for business surveillance
> already discussed and agreed to by the Workgroup.
>
> However, Dr. Gerberding emphasized, the Workgroup still needs to think
> through what can be done in the short term to meet the Workgroup's
> specific charge in terms of scope.
>
> Ms. Cronin noted that data obtained on capacity would be more specific
> if capacity was examined in light of an agreed-upon minimum dataset.
> However, while a subgroup of the Workgroup examines the minimum
> dataset, Dr. Keaton and others still could proceed to find out what
> data are being collected at present by, for example, emergency
> departments. Dr. Loonsk noted that a minimum dataset could be mapped
> against existing capacities, and gaps between data desired and data
> obtainable at present then could be identified. The Workgroup then
> could proceed to outline what policies or incentives might be needed
> to close the gaps.
>
> After ongoing discussion with Ms. Morris about costs versus benefits
> and what financial resources might be needed for providers and other
> data sources to meet the minimum dataset discussed by the Workgroup to
> date or to close "gaps," Dr. Friedman suggested that the core dataset
> discussed in February and again today be used at least at the moment
> to help obtain information about capacity.
>
> The Workgroup then agreed to move on to the next agenda item**.**
>
> **8. Next Steps (Agreement on Timeline and Assignments for Developing
> Recommendations to the Community by May 8)**
>
> **Possible Action Item**
>
> Dr. Keaton volunteered to work with the informatics section of the
> American College of Emergency Physicians as well as relevant vendors
> and AHA over the next 3 weeks to obtain data needed to address the
> question of breakthrough scope in the short term.
>
> Discussion indicated that if this work goes forward, relevant data
> could include health care provider capacity to deliver the core
> minimum data elements set discussed by the Workgroup in February and
> again today, as well as provider willingness to participate in a
> breakthrough system.
>
> Discussion indicated that if this work goes forward, specific
> questions to be asked of providers could include, "Can you share this
> data \[from the core minimum data elements set\] today with current
> resources? Could you participate in a national biosurveillance program
> this year if you had some additional resources at the State or local
> level?"
>
> **Discussion indicated that further questions could be refined after
> this Web conference, offline.**
>
> Discussion indicated that AHA might not be able to participate as
> quickly as needed, which led to consideration of how to winnow down
> the capacity survey to a subset or sampling of hospitals that have
> some degree of electronic health records capability.
>
> Dr. Sondik volunteered to help define an appropriate sampling frame.
>
> **Next Steps**
>
> Dr. Gerberding said the day's discussion relevant to key items for
> decision would be summarized in an e-mail to members within a week. A
> short conference call might be in order shortly after that.
>
> **Next Steps/Timeline**
>
> Dr. Gerberding noted that:

-   The week of April 3, ASTHO and NACHO will report back to the
    Workgroup with data and possibly recommendations, as discussed in
    Agenda Item 6.

-   All data being submitted to the Workgroup between now and 3 weeks
    from now will be synthesized in order to pull together a first draft
    of high-level recommendations for the Community.

-   The Workgroup will have a previously unscheduled Web conference
    meeting in late April (Workgroup members have received an e-mail
    querying them about specific date selections), before the next
    Community meeting, in order to finalize recommendations by May 4,
    the May Web conference date. The April Web conference is expected to
    take several hours.

-   The May 4 Web conference meeting likely will be devoted to recapping
    a final letter of recommendation to the Community.

> **9. Public Input**
>
> **Comment:** Richard Lawlor called in to say that he listened to the
> meeting today. He commented that in terms of the ability of electronic
> health records to support biosurveillance, the primary target for
> implementation is the physician or small clinic setting. In light of
> this, is the minimum dataset under discussion the same set that a
> small physician's office or clinic would be expected to/could provide?
> If so, the next issue might be compatibility and standards mapping
> needs. This might need to be reviewed before the universe of data is
> harmonized from different clinical settings.
>
> **Response:** Dr. Loonsk noted that the Workgroup's charge includes
> ambulatory care, but the dataset that the Workgroup has discussed has
> not focused on that. This should be discussed further by the
> Workgroup.
>
> **Comment:** Dr. Lawlor suggested that whatever architecture or
> standards result from the Workgroup's recommendation, data from
> different sources need to "play in the same reporting stream."
>
> **Response:** Dr. Keaton noted that the Workgroup is currently focused
> on its specific charge. The broader charge will require involving
> other means of communication, activation, and notification.
>
> **10. Adjournment**
>
> Dr. Gerberding adjourned the meeting at 3:47 p.m.

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######### **Disclaimer**

*The views expressed in written conference materials or publications and
by speakers and moderators at DHHS-sponsored conferences do not
necessarily reflect the official policies of the DHHS; nor does mention
of trade names, commercial practices, or organizations imply endorsement
by the U.S. Government.*

**[Workgroup on Biosurveillance]{.underline}**

**[Members and Designees Participating on the Call]{.underline}**

**[Co-Chairs]{.underline}**

Julie Gerberding

Co-chair

CDC

Jeff Wells (for Edward Mitchell Roob)

Co-chair

Indiana Family and Social Services Administration

Kelly Cronin

Staff Co-chair

ONC/DHHS

**[Workgroup Members and Designees]{.underline}**

Michael Barr

American College of Physicians

Scott Becker

Association of Public Health Laboratories

Gavin O'Brien (for Mary Brady)

National Institute of Standards and Technology

Jean Marie Maillard (for Leah Devlin)

North Carolina Department of Health and Human Services

Thomas Frieden (until 2 p.m.)

Rick Heffernan (for Thomas Frieden after 2 p.m.)

New York City Department of Health and Mental Hygiene

Rick Friedman

Centers for Medicare and Medicaid Services (CMS)

Brian Keaton

American College of Emergency Physicians

John Loonsk

ONC/DHHS

Adele Morris

Office of Economic Policy

Department of Treasury

David Parramore

Department of Defense

Edward Sondik

CDC

**[Additional Participants]{.underline}**

Laura Conn

CDC

Bill Packer

ASTHO

Phil Stevens

NACHO

Deborah Trussman

DHHS

Roslyne Schulman

AHA

[^1]:
    > See also "HIPAA Privacy Rule and Public Health: Guidance from the
    > CDC and DHHS," by Stephen B. Thacker, Epidemiology Program Office,
    > <http://www.hhs.gov/ocr/hipaa/>