American Health Information Community

**Workgroup on Biosurveillance**

Summary of Web Conference held on February 24, 2006

Second Web Conference of this Workgroup

1\. **Opening Remarks**

Co-chair Edward Mitchell Roob, Indiana Family and Social Services
Administration, opened the meeting shortly after 1 p.m. He noted that he
would need to leave soon for a meeting and, in his absence, Jeff Wells
would sit in. Laura Conn, Centers for Disease Control and Prevention
(CDC), participated in the meeting prior to Co-chair Julie Gerberding,
Centers for Disease Control and Prevention (CDC), joining the call. Roob
thanked Office of the National Coordinator (ONC)/Department of Health
and Human Services (DHHS) staff members for their hard work and stated
that the focus of the meeting would be on realistic 1-year goals.

**2. Action Items from First Meeting/Overview of Background Materials
and Meeting Format**

Kelly Cronin, ONC, and Laura Conn, CDC, outlined the meeting's briefing
materials and the day's agenda, which included:

-   Review of Final Scenarios (Business Scenarios for Biosurveillance)
    and of Biosurveillance Data Elements Matrix (resulting from review
    of data elements used in various existing systems, such as BioSense)

-   Review of Minimum Dataset and Target Dataset Based on Scenarios
    (Biosurveillance Background and Options Briefing: Minimum and Target
    Data Elements)

-   Review of Options for Data Flow (Biosurveillance Background and
    Options Briefing: Data Flow)

-   Review of Paper on Privacy and Security (Biosurveillance Background
    Briefing: Privacy and Security of Biosurveillance Data)

-   Review of Options for Scope (Biosurveillance: Considerations for
    Discussion on Scope)

-   Review of Policy Issues/Barriers (the Workgroup will be addressing
    these with more focus and depth in the next few months)

-   Next Steps/Review Preliminary Recommendations (with preliminary
    recommendations slated to go to Secretary Leavitt in 3 days --
    February 27, 2006)

-   Public Input

**3. Review of Final Scenarios and of Biosurveillance Data Elements
Matrix**

Laura Conn reviewed the Business Scenarios for Biosurveillance document
with members of the Workgroup. The scenarios document demonstrated, by
example of hypothetical public health events, the capabilities that
should be supported by a biosurveillance system. Laura Conn then led
group members in a discussion of the Data Elements Matrix. The
highlights of that discussion are listed below:

-   The draft matrix of data elements captured by four existing systems
    (New York City, North Carolina \[NC\], Frontline, and BioSense)
    offers a preliminary identification of desired minimum and target
    data elements. The depictions of the four systems may need to be
    further refined or reviewed. (Leah Devlin, North Carolina Department
    of Health and Human Services, will provide corrections regarding the
    NC system.)

-   An integral part of response is capacity. BioSense targets a number
    of capacity data elements. The emergency medical community would
    support tapping a number of capacity data elements.

-   Capacity limitations or qualifications regarding capacity to respond
    represent a scope topic for later discussion.

-   Roles and responsibilities of various entities need to be
    identified. This may be a data flow topic for later discussion.

-   Issues of data elements need to be separated from issues of
    function.

-   Clinical providers are critical to identification of an event.

-   Two-way communication, including person to person, is critical. It
    is in use in some 50 percent of the country's emergency departments
    (EDs) and might be addressed through mechanisms such as instant
    messaging.

-   The first issue is to decide critical data elements for the
    Workgroup's breakthrough system. Once the scope of the dataset is
    clearer, the next step would be to ascertain how the system would
    function.

-   Decisions about data elements should consider both costs and
    benefits.

-   Many of the proposed minimum and target data elements under
    discussion are used by existing biosurveillance programs to meet
    specific public health needs. Feasibility and standardization also
    need to be considered. Key questions include, "Are the data
    needed?", "Can they be provided?", and, "Can they be standardized?"

**4. Review of Minimum Dataset and Target Dataset Based on Scenarios
(Biosurveillance Background and Options Briefing: Minimum and Target
Data Elements)**

Laura Conn noted that a determination of minimum and target data
elements is critical to moving forward the Workgroup's specific charge.
She noted that the draft minimum and target data elements in this
briefing document are a subset of the Biosurveillance Data Elements
Matrix. In review and discussion, she suggested members should consider
the several overarching principles with respect to their recommendations
to the Community. The principles stated that recommendations should:

-   Be feasible to implement in 2006

-   Accomplish the specific charge, while facilitating the most direct
    path to the broad charge

-   Illuminate the significant barrier(s) that must be resolved to
    achieve breakthrough success (policy and technical)

-   Deliver the value to the consumer over the next 1--2 years

-   Leverage all stakeholders, while appropriately balancing
    expectations, responsibilities, and authority.

Laura Conn led group members in a discussion of the Data Elements. The
highlights of that discussion are listed below:

-   The Workgroup should aim for consensus on minimum data elements
    needed for the first year to meet its specific charge. Then it would
    look at target data elements that may be needed in subsequent years
    to meet its broad charge.

-   Feasibility of minimum data elements varies greatly depending on the
    healthcare entity originating the data.

-   Admission discharge and transfer data (ADT) provides patient
    identifiers. Such data also provide a narrative of a chief
    complaint. These data may be fairly easy to get and may be the
    absolute minimum dataset needed.

-   Could data consolidators help, such as consolidators of registration
    information? The Workgroup needs to focus not only on initial
    detection but also on response and management.

-   One challenge will be getting data from small practices. As a
    result, alternative methods to electronic health records need to be
    considered, such as transmission via the Internet.

-   The Workgroup's specific charge refers to data from "electronically
    enabled health care delivery and public health systems \[that\] can
    be transmitted in standardized and anonymized format to authorized
    public health agencies within 24 hours." This raises the question:
    Do alternative methods of capturing data take into consideration
    what can be done on an automated and real-time basis? Do they take
    away the background noise?

-   Strategies for longer-term target data elements could include
    getting other types of data through alternative methods.

-   Clinicians are most likely to identify an event, raising the
    question: Are data from them already electronically enabled?

-   Getting pre-existing electronic clinical care data from clinical
    care sites is not going to substitute for initial detection of an
    event.

-   The specific charge denotes "essential ambulatory care and emergency
    department visit, utilization, and lab result data" and
    "electronically enabled health care delivery and public health
    systems."

-   Bidirectional flow and traditional case reports that are entered via
    the Web need to be considered at some point.

**Decision Point:** A subsequent meeting will review pre-existing,
alternative methods of capturing and transmitting relevant data, such as
through the Internet. (See also Agenda Item 9 below.)

Highlights from the discussion include the following issues and
questions:

-   On the matrix under discussion, under the Institution Data category
    "Number of Facility Beds," it may be useful to get data on types of
    beds needed and available. Department of Defense (DoD) systems make
    these data readily available at the data entry level.

-   Should this data element be added as minimum and target?

-   In NC, these data are available, but not as part of routine
    surveillance.

**Decision Point:** The Workgroup members agreed that types of beds
should be added to the Institution Data category as a data element.

Highlights from the discussion include the following issues and
questions:

-   Much of the pre-existing, alternative data are not flowing to public
    health, or if so, are not going where they are most needed. It is
    reasonable to review which data are available in the near term and
    then ascertain which levers can be pulled to get needed data that
    are not currently available.

-   Under the Institution Data category "Hospital System," could
    collecting hospital ID numbers under Medicare suffice?

-   Such an ID number might not suffice if biosurveillance personnel
    needed to deploy to a physical location.

**Decision Point:** The Workgroup seemed to agree to explore further
whether the Institution Data category should include a data element that
provides sufficient physical location data.

Highlights from the discussion include the following issues and
questions:

-   What data elements are needed under the Daily Facility Summary
    category? Three out of the four pre-existing biosurveillance systems
    seem not to collect any of these data elements. Are any of them
    critical?

-   NC gets "Date/Time of Report" data in this category.

-   In terms of the other three data elements in this category --
    "Admissions Last 24 Hours," "Discharges Last 24 Hours," and "Death
    Last 24 Hours"-- we need to be able to map available capacity in
    large-scale events.

-   Hospitals may not be the only source for these data elements.

-   If the discussion is about data elements that can be obtained in a
    year, it is important to consider those already electronically
    captured by hospitals.

-   A recent meeting with a number of State departments of health
    indicated that they do not collect the data elements in this
    category, except "Date/Time of Report." It would be a challenge for
    providers to provide the other data elements in this category in 1
    year, so they should not be considered as minimums needed in the
    short term.

-   The same might be true of the Census by Unit category of data
    elements.

-   The question of availability could be handled through a survey after
    identification of which critical data elements are needed. The work
    group could identify to AHIC what it deems critical but also note
    what is readily available and what is not.

**Decision Point:** The Workgroup established that it should identify to
the Community what minimum data are needed to achieve dynamic
utilization under the categories of Daily Facility Summary and Census by
Unit. The Workgroup members agreed to add a data element to capture
emergency room data. They also decided that the Workgroup should address
the issue of data availability and potential actions -- ranging from
incentives to mandates -- that may need to be undertaken to obtain
hospital or provider data that are needed but not currently available.

Highlights from the discussion include the following issues and
questions:

-   In the category of Patient Data, should the Workgroup assume that
    the approach to be used concerning privacy and security is the
    randomized data linker (RDL) listed here as a minimum and target
    data element? Also, is it the one discussed in the briefing paper on
    privacy and security?

-   Whether the RDL or some other approach is used, patients need to be
    identified without violating privacy concerns.

-   In the Patient Data category, "Race" is listed as a target data
    element only. Is it a factor in public health emergencies?

-   Clinically, race is a factor in disparity of health care provided,
    and some diseases fall along racial lines.

-   Data on race are not needed as a minimum data element. The data
    might be incomplete even if deemed a target element.

**Decision Point:** Workgroup members agreed on the minimum and target
data elements as presented on the matrix under the Patient Data
category.

Highlights from the discussion include the following issues and
questions:

-   In regards to the Clinical Data category, can any of the proposed
    minimum data elements be eliminated due to function, not
    availability of data?

-   If something like SARS is the problem, this category should identify
    "Temperature," "Blood Pressure," and "Pulse OX" as minimum data
    elements.

**Decision Point:** Workgroup members agreed to the minimum and target
data elements under the Clinical Data category as presented. It is
unclear whether the Workgroup members agreed to demark "Temperature,"
"Blood pressure," and "Pulse OX" as minimum and target data elements.
"Temperature" and "Blood pressure" are demarked as targets only in the
matrix as presented.

Highlights from the discussion include:

-   In regards to the Laboratory and Radiology Test Orders category, it
    was observed that "order number" is a patient identifier and, as
    such, should be discussed further in regards to patient privacy and
    security.

**Decision Point:** The Workgroup agreed to the data elements under the
Laboratory and Radiology Tests Orders category as presented.

Highlights from their discussion include:

-   In regards to the Laboratory/Microbiology Results category, the data
    elements listed constitute a bigger set of data than required for
    national notifiable diseases.

-   National labs have been trying to make electronic their positive
    notifiable disease results, yet these results do not cover all
    potentially useful lab data. In addition, many State and local
    jurisdictions do not receive even the positive notifiable disease
    results data.

-   Microbiology results are the least consistently formatted results.

-   One technical challenge is that each system describes the data
    elements differently.

-   Narrow the scope initially. Once the infrastructure is built, you
    can add to the data elements.

-   Could some of the identified data elements collected by BioSense but
    not by the NC system be considered as targets, not minimums, such as
    "Specimen Site," "Specimen," "Result Unit," and "Susceptibility Test
    Interpretation"?

**Decision Point:** Workgroup members agreed that general lab results
are very valuable to public health, and they seemed to agree to the data
elements presented under the Laboratory/Microbiology Results category
with the following exceptions: "Specimen Site," "Specimen," and "Result
Unit" will be dropped as minimum data elements but kept as targets, and
"Susceptibility Test Interpretation" will be retained both as a minimum
and target data element.

**5. Review of Options for Data Flow (Biosurveillance Background and
Options Briefing: Data Flow)**

Workgroup members were presented with the following three options for
data flow in an electronically enabled biosurveillance system:

-   **Option 1 --** Data flow from clinical care  local public health
    agency  State public health  Federal public health.

-   **Option 2** -- Data flow from clinical care to all levels of public
    health simultaneously.

-   **Option 3** -- Data flow from clinical care to an intermediary
    organization.

After a description of each option, Co-chair Gerberding led a discussion
on the pros and cons of each option. The highlights of the discussion
are listed below:

Option 1:

-   Option 1 received little comment as representing the traditional
    data flow for notifiable disease surveillance. It was noted that the
    functions of biosurveillance are broader than for notifiable disease
    surveillance.

Option 2:

-   With Option 2, it was suggested that "simultaneous" flow is not
    practical. The point, however, is to move data through the system
    instantaneously so that everyone receives the information at the
    same point in time.

-   In general, transparency and redundancy of data flow are important.

-   Could different circumstances require the use of different data flow
    options?

-   Infrastructure for data flow has to be established and used
    routinely to establish comfort level and ready availability. Change
    in time of an emergency is not wise.

Options 2 and 3 combined:

-   A recent meeting of some State public health officials and technical
    officers indicated that Options 2 or 3 are acceptable, as long as
    State and local officials have equal access to the information.

-   Could Options 2 and 3 be combined to get the advantage of speed as
    well as customization of data and technical stewardship?

-   Some data providers (e.g., Kaiser, an HCA, hospital system, health
    plan, or large lab) have aggregated data from multiple
    jurisdictions, but they do not necessarily want to have a data
    exchange interface with those multiple jurisdictions. If Options 2
    and 3 are melded, that needs to be considered.

-   On the other hand, it is easier and less burdensome for those
    providing data to provide it to one organization that can then
    dispense the data where needed.

-   Realistically, very few RIOS over the next few months will be able
    to handle the data under discussion and its flow. That is part of
    the evolution that will need to take place.

**Decision Point:** The Workgroup members decided against 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.

**6. Review of Paper on Privacy and Security (Biosurveillance Background
Briefing: Privacy and Security of Biosurveillance Data)**

Co-chair Gerberding led a discussion on the privacy and security paper,
which described an approach to protecting patient privacy and some
related issues regarding both patient privacy and public health needs.
The paper focused on the use of a Randomized Data Linker (RDL), an
approach that is now used to balance privacy and public health needs.
When using an RDL, direct patient identifiers are not included in the
data reported for biosurveillance monitoring. These Data include a
randomized data linker that is meaningless to recipients of the data but
can be used to go back to the original data provider to support
appropriate, authorized public health follow-up. The highlights of this
discussion are listed below:

-   Conceptually, maintaining patient confidentiality is a high
    priority. For biosurveillance purposes, anonymized data also need to
    be associated with at least an event level. To illustrate, there
    needs to be a way to track a problem at least back to the local
    hospital.

-   The Workgroup's specific charge specifies that data from
    electronically enabled health care delivery and public health
    systems can be transmitted in standardized and anonymized format to
    authorized public health agencies. RDL is one approach to providing
    anonymized data.

-   Consistency is needed. Issues associated with use of an RDL include
    specification of the level at which the data linker is consistently
    used in data reporting: is the same data linker used for all data
    concerning a patient coming from a data-providing organization, just
    data related to one particular patient encounter, or even just one
    lab result or data element?

-   RDL is one example of an approach that meets all important criteria,
    including for biosurveillance purposes.

-   Although RDL is not commercially available, to build it is a
    relatively small technical task. Someone with technical expertise is
    needed to look at different options and make recommendations to the
    Workgroup.

**Decision Point:** Workgroup members agreed to support the concept of
RDL, with appropriate caveats. Additionally, the members agreed to have
a technical expert provide feedback on the concept of an RDL at a
subsequent meeting.

**7. Review of Options for Scope (Biosurveillance: Considerations for
Discussion on Scope)**

Co-chair Gerberding characterized the main considerations in this
background paper and asked members to focus on the complexity of scope,
including coverage, efficacy and cost-effectiveness, patient access, and
feasibility of broad national coverage phased in over the next few
years. The background paper presented several considerations for the
advancing sharing of this data across public health. These
considerations included:

-   Need method of quantifying major metropolitan areas

-   Non-hospital based ambulatory care -- how do we incorporate in
    scope?

-   Broader national coverage -- how to we expand coverage overtime?

Highlight of the Workgroup's discussion are listed below:

-   How do we define near-term scope? How do we define long-term scope
    through 2008?

-   BioSense currently has active data feeds and/or commitments from 19
    cities representing 21 hospital systems for a total of 110
    hospitals. Additional cities will be added in 2006, with a goal of
    350 total hospitals.

-   Guiding principles for determining BioSense 2005 and 2006 targets
    are large metro area, high-volume ED, health systems with multiples
    hospitals, existing hospital IT infrastructure, timeliness of data,
    and support of local/State public health.

-   Trauma Centers are also noted in the briefing paper, but the
    Workgroup need not make specific decisions at this time about going
    beyond the goals at BioSense in the short term.

-   The Workgroup should look beyond the focus goals of BioSense.

-   What are we trying to accomplish in the next 6--12 months? Are we
    trying to be able to deal with, for example, SARS, avian flu, the
    eventuality of a bio terrorist attack? If so, what is already in
    place, and what can be mobilized in 6--12 months that will begin to
    provide the needed capacity? For the future, we can build a system
    around that initial band aid.

-   Early detection of cases in metro areas is important, but a pandemic
    or larger-scale event requires more emphasis on national coverage
    needs and more utilization of response and monitoring.

-   Broader coverage with a minimal data elements set could be a
    short-term pilot phase goal.

-   An additional important accomplishment would be the exchange of data
    already being accumulated by different public health systems.

-   The sooner we take advantage of readily accessed data, the sooner we
    will be able to evaluate and understand what data are useful and how
    to utilize them.

-   A clear protocol is needed.

**Decision Point:** The Workgroup agreed that a draft scope document is
needed for member response regarding what elements should and should not
be included, with the understanding that not everything can be done at
once. The suggestion was that for the short term, the focus should be on
priority elements, with an eye toward expansion in the long term. It was
also agreed that scope should include taking advantage of and connecting
existing aggregated data sources for multidirectional sharing.

**8. Review Policy Issues/Barriers**

At the conclusion of the discussions on background papers, Co-chair
Gerberding asked for discussion of issues and barriers not already
raised.

Highlights of the discussion are listed below:

-   Where the burden will fall to provide information not already
    provided will be a function of policy choices and how they are
    implemented.

-   AHIC's concept is that the Federal Government's 60 percent share
    will drive the market. That, in a sense, is the macro policy
    decision. How we choose to leverage that economically and through
    the regulatory process, the reimbursement process, and so on is part
    of the overall Community's work.

-   This topic has been alluded to in the past: There is a need for
    incentives for providers, particularly hospitals, to participate if
    an expanded system is set up over the next few years.

-   BioSense has shown us that many hospitals actually want to
    participate. At the community level, participation is seen as value
    added.

-   Many hospitals are interested in trying to help, but their ability
    to do so is somewhat related to whether they are part of a chain or
    have technical expertise.

-   Getting hospitals to participate in a timely fashion might require
    providing them with a resource they will own.

-   Hospitals are concerned about the Health Insurance Portability and
    Accountability Act. They need to be reassured that sharing data is
    something they can do without risk.

-   Not everyone is clear on the format in which to provide data, in
    part due to lack of standardization.

-   Who will actually deliver data from clinical care is a big concern,
    because most hospitals will not let just anyone work in their
    electronically enabled systems.

-   Is it unreasonable to mandate submission of data in the interest of
    national security and public health?

-   Options for policies in this area range from voluntary participation
    to mandated reporting of certain data elements. Although the latter
    would be unprecedented for Federal public health, it is not
    unprecedented for State-level public health.

-   Other key questions are, "Who is going to finance the data flow for
    public health?", "How will this business model work for health care
    more broadly?", and, "What will be the role of government?"

**Decision Point:** The Workgroup agreed that for the February 27, 2006,
briefing of Secretary Leavitt, the staff would provide a landscape of
barriers to a breakthrough activity in biosurveillance. For a subsequent
Workgroup meeting, the staff will prepare a more defined framework for
fully vetting barriers -- technical, policy, and legal. Incentives
options will be addressed as well. In addition, Rick Friedman and
possibly other Workgroup members will briefly report back at the next
meeting on policy lessons learned as presented in the President's report
on Hurricane Katrina.

**9. Next Steps/Review Preliminary Recommendations**

Co-chair Gerberding reiterated the meeting's accomplishments, next
steps, and preliminary recommendations:

-   Nearly complete agreement on minimum and target data elements to be
    recommended, with followup needed to identify to AHIC what minimum
    data elements -- particularly for dynamic utilization -- may not be
    easily obtained within 1 year

-   Agreement on the directions of data flow to be recommended

-   Agreement that privacy and security issues are important and that
    the concept of RDL makes sense as long as (1) it is linked across
    the elements in an event and (2) simultaneous viewing is assured of
    demographic variables and of relevant clinical information as a
    record and not as unconnected events in the system

-   Agreement that scope will be specified in draft form for the near
    and longer terms and circulated to the work group for additions and
    corrections

-   Agreement that a landscape of issues and barriers will be presented
    to the Secretary and subsequently discussed further -- along with
    solutions -- in subsequent months, including incentives for
    participants in the envisioned system

-   Agreement that Rick Friedman and possibly other Workgroup members
    will report back to the next meeting lessons learned from the
    President's report on Hurricane Katrina

-   Agreement to schedule a briefing on existing alternative methods of
    reporting, such as Web-based case reporting, although such methods
    may lie beyond the Workgroup's specific charge.

**Relevant Announcements:** The next AHIC meeting is March 7. The April
AHIC meeting has been cancelled and rescheduled for May 16. The
Workgroup's next meeting is March 23.

**10. Public Input**

Co-chair Roob presided over public input.

**Comment:** Alan Zelikoff of Albuquerque, NM, called in about the SEERS
system with which he works. He sent information to Co-chair Gerberding
and invites other work group members to contact him at
<zalan8587@quest.net>.

**Comment:** T.G. Ward of the Lubbock, TX, public health department
called in. The department has been using a clinician-driven syndromic
reporting system (SEERS) for 2 years. The system addresses many of the
concerns raised in the Workgroup meeting today. The system is Web based
and real time. Clinicians in the emergency department use it. In 2003,
it allowed precise identification of the onset of flu season. It allows
for two-way, real-time communication. The system took less than a few
months to implement. It is being used in about 41 counties in the West
Texas panhandle. Data elements for the system were obtained through
interviews of dozens of public health officials in the veterinary and
clinical communities, then with infectious disease experts in veterinary
medicine and in human medicine with one charge. That's the minimal
amount of data needed to make binary decisions.

SEERS may be the only system that has been licensed by local public
health offices. It is practical, it works and it will continue to grow
in use in the Southwest, including by the CDC's border epidemiology
early warning system in Southern California.

**11. Adjournment**

Co-chair Roob adjourned the Workgroup meeting shortly after 4 p.m.,
invited members to dial in or watch on video cam the March 7 meeting of
AHIC, and reminded members of the next Workgroup meeting March 23.

*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 Members Participating in Web
Conference]{.underline}**

Julie Gerberding CDC

Co-chair

Edward Mitchell Roob, Indiana Family and Social Services Co-chair
Administration

Kelly Cronin ONC/DHHS

Staff Co-chair

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

Michael Barr American College of Physicians

Larry Biggio State of Wyoming

Leah Devlin NC Department of Health and Human Services

Rick Herpenen (for Thomas Frieden) New York City Department of Health
and Mental Hygiene

Rick Friedman CMS

Brian Keaton American College of Emergency Physicians

John Loonsk ONC/DHHS

Adele Morris Office of Economic Policy, Department of Treasury

David Parramore DoD

Gavin O'Brien (for Ed Sondik) CDC

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

Laura Conn CDC

Jeff Wells Indiana Family and Social Services Administration