[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



 
  A REVIEW OF FEDERAL BIOTERRORISM PREPAREDNESS PROGRAMS: BUILDING AN 
            EARLY WARNING PUBLIC HEALTH SURVEILLANCE SYSTEM
=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            NOVEMBER 1, 2001

                               __________

                           Serial No. 107-71

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

               JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida               BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio                TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma              DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina         CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
  Vice Chairman                      JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire         (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)







                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Barry, Anita, Director, Communicable Disease Control, Boston 
      Public Health Service......................................    18
    Broome, Claire, Senior Advisor, Integrated Health Information 
      Systems, Office of the Director, Centers for Disease 
      Control and Prevention.....................................    12
    Davidson, Arthur J., Director, Public Health Informatics, 
      Denver Public Health Department............................    23
    Russell, John S., Executive Vice President and General 
      Counsel, Quintiles Transnational...........................    60
    Wagner, Michael M., Director, RODS Laboratory, Center for 
      Biomedical Informatics, University of Pittsburgh...........    48
    Zelicoff, Alan P., Senior Scientist, Center for National 
      Security and Arms Control, Sandia National Laboratories....    54

                                 (iii)

  


  A REVIEW OF FEDERAL BIOTERRORISM PREPAREDNESS PROGRAMS: BUILDING AN 
            EARLY WARNING PUBLIC HEALTH SURVEILLANCE SYSTEM

                              ----------                              


                       THURSDAY, NOVEMBER 1, 2001

                  House of Representatives,
                  Committee on Energy and Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:40 a.m., in 
room 2322, Rayburn House Office Building, Hon. James C. 
Greenwood (chairman) presiding.
    Members present: Representatives Greenwood, Stearns, Burr, 
Whitfield, Bass, Tauzin (ex officio), Deutsch, Stupak, 
Strickland, DeGette, Rush, and Dingell (ex officio).
    Also present: Representative Harman.
    Staff present: Tom Dilenge, majority counsel; and Edith 
Holleman, minority counsel.
    Mr. Greenwood. Good morning. This hearing of the Oversight 
and Investigations Subcommittee of the House Energy and 
Commerce Committee will come to order, and the Chair recognizes 
himself for 5 minutes for an opening statement.
    Three weeks ago, this subcommittee held a hearing to 
evaluate the effectiveness of Federal programs designed to 
bolster the preparedness of States and local communities to 
deal with bioterrorist attacks. At that time the second and 
third cases of anthrax infection in Florida had just been 
discovered.
    Several hundred people who worked with those individuals 
were being tested and put on Cipro as a precautionary measure. 
It was still unclear at that time whether the Florida situation 
was an isolated incident or part of some broader criminal or 
terrorist enterprise.
    Since that hearing the anthrax scare has spread and the 
death toll has increased. The numbers infected seem to increase 
daily, as do the number of locations with anthrax detected in 
them.
    An anxious Nation is left to wonder if in Emerson's words, 
``Things are in the saddle and ride mankind.'' People are 
afraid and some with good reason. Unlike the 1930's, we have 
more to fear than fear itself. An unscrupulous enemy, with 
access to the most insidious means of human destruction, and a 
demonstrated willingness to use them, is in fact a fearful 
thing.
    But what is truly worrying about the recent outbreak is the 
possibility that this is a prelude to a worse attack, and that 
this effort was designed more to test our capabilities and 
probe our weaknesses than to cause sustained damage.
    Surely there can be little doubt that this mail borne 
anthrax attack was well coordinated and is in fact this 
Nation's first real example of bioterrorism at work. All the 
more reason that this Nation must promptly improve its public 
health surveillance activities, which is the focus of today's 
hearing.
    Sadly for thousands of Americans, the 1993 attack on the 
World Trade Center did not serve as a wakeup call on the need 
to better protect our critical physical infrastructure. We 
cannot afford to let this happen to our critical public health 
system.
    In this new kind of war where terror is the enemy's chief 
aim, the most potent weapons may very well be biological 
agents, and increasingly the battlefront will not be in some 
far off land, but here at home. The anthrax outbreak is our 
fire bell in the night, and we may not get another warning.
    And a very real fear we now confront is the one H.G. Wells 
wrote of in 1920 when he observed that human history becomes 
more and more a race between education and catastrophe.
    This is a race that we cannot afford to lose, nor will we. 
America has always risen to meet the challenge, and our public 
health system, while in need of repair, has more than an 
adequate foundation to begin to wage a successful war at home 
against our enemies, and the diseases that they may seek to 
inflict on us.
    But to do that more of our Nation's leadership, and the 
President, and Congress, must be galvanized by the dangers we 
face and must commit themselves to leading the effort to fight 
this new kind of war in a new kind of way.
    This is about much more than appropriating new money, 
though money is needed. To be successful, we must harness the 
creative genius of the American people in the public sector, 
and in the private sector, and in academia.
    Our traditional public health surveillance system, which in 
many parts of this country still relies on doctors mailing in 
post cards to their local public health departments is too 
limited with regard to what is reported, and too slow to be 
effective, to late in the patient evaluation process, and too 
incomplete to meet our country's emerging needs in this area.
    It is the equivalent of relying on the pony express in the 
age of the worldwide web. Some bioterrorist attacks, like 
sending anthrax powder in the mail, tend to be readily 
apparent, at least to those who open the laced mail.
    Other attacks, such as pumping bacteria or viruses through 
ventilation systems, are more covert, and may not be detected 
until exposed individuals get sick and go to their doctors or 
local hospitals.
    The goal must be to detect these covert releases as soon as 
practicable. The successful early detection regime will enable 
us to identify the exposed population sooner, and get those 
individuals treatment faster.
    Early detection will also allow us to contain the spread of 
disease, which while less important with non-contagious 
diseases, such as anthrax, will prove critical if a terrorist's 
agents were a highly contagious disease, such as smallpox.
    And even after initial detection, a good surveillance 
system will enable our public health officials to more 
effectively manage such outbreaks and quickly intervene with 
appropriate care and guidance.
    While astute and well-trained clinicians will always be the 
bedrock of our health care surveillance system, we need to 
ensure that recent advances in medical infomatics and improved 
health care technology supplement our human intelligence 
system.
    As we will learn in today's hearing, our public 
institutions and our private sector have already begun to make 
substantial progress in developing early warning systems to 
detect outbreaks of bioterrorism, and in developing rapid 
responses to outbreaks.
    This is essential if we are going to protect our Nation and 
our people. We will also hear today about the Federal 
Government's promising, but so far quite limited, efforts to 
improve both the traditional surveillance system and to fund 
pilot projects at the State and local levels to develop and 
test more advanced, more proactive, and decidedly more 
unconventional surveillance systems.
    I have been concerned, however, that our Federal health 
officials have done little to oversee and to better direct such 
activities. In particular, it seems like we lack a national 
strategic plan to test and evaluate these advanced systems, and 
are presently unable to provide clear guidance to State and 
local public health officials as to what we believe a good 
surveillance system would look like.
    The Director of the Federal Centers for Disease Control and 
Prevention recently initiated a working group to review the 
potential of some of the new surveillance techniques that are 
being or already have been developed, and I welcome that 
initiative.
    I look forward to the testimony of all of our witnesses 
today, and I will now recognize the ranking member, Mr. 
Deutsch, for 5 minutes for his opening statement.
    Mr. Deutsch. Thank you, Mr. Chairman. Thank you for having 
this hearing. As I recall this was a hearing that was 
interestingly scheduled before the events of September 11, and 
the work of this subcommittee on this issue has been something 
within our jurisdiction literally from the creation of the CDC.
    I think though since September 11, not has just the work of 
this committee changed, but obviously the work of the Congress, 
and obviously the work of the country has changed.
    And my hope is that as we have talked outside of the 
hearing room, my hope is that we really broaden what we are 
doing, because I think that our jurisdiction is as critical as 
any jurisdiction in the Congress right now.
    I mean, we have the legal responsibility to work on public 
health issues, and work on our jurisdiction regarding the CDC, 
and HHS has responsibility for public health, and I think we 
need to take that job very seriously as we are.
    But I think some of the focus needs to be ongoing in real 
time, and the real time issues that I would focus on as we have 
discussed is right now the HHS is working on trying to develop 
250 million additional smallpox vaccines.
    That is an issue which I don't believe there is a more 
critical issue that the Federal Government is working on today. 
And I know that everyone involved at HHS is incredibly sincere 
and incredibly bright, and incredibly hardworking in the 
efforts to successfully complete that endeavor.
    But I think it is critical that we engage our resources 
working with them toward the same goal of trying to acquire 
those vaccines in as quick a real time basis as possible. And 
we can talk, and we will have some testimony about the ability 
of preparing the systems, in terms of what they can do down the 
road, and what they might be able to more.
    But I think there are some potentially cataclysmic events 
that I will work and help prevent, and I think that is really 
the focus, not just of the subcommittee, but I see the chairman 
of our full committee here as well, and I know that next week 
we have a briefing that both of our staffs are working on 
together toward that goal.
    So I welcome the testimony that we are expecting to have 
today, but I urge us, and I am going to focus even some of 
those questions regarding some of the more immediate 
potentially relevant issues, and again not just smallpox, which 
I think is in fact the more relevant, but as they also relate 
to real time issues on anthrax, and real time potential issues 
on the plague. So I look forward to your testimony. Thank you.
    Mr. Greenwood. The Chair thanks the gentlemen from Florida, 
and looks forward to his specific recommendations in those 
regards. The Chair recognizes the chairman of the full 
committee, Mr. Tauzin, for an opening statement.
    Chairman Tauzin. Thank you, Mr. Chairman, not only for 
today's hearing, but for having the foresight even before 
September 11 to schedule this hearing, and to continue the work 
of our committee in this important area of bioterrorism.
    And I want to particularly thank you because today's 
hearing, as Mr. Deutsch points out, is just the beginning of a 
process, in which our full committee has been now recently 
charged by the leadership to produce a major terrorism/
bioterrorism package for the U.S. Congress to consider before 
we leave here this November, perhaps December.
    The Health Department has already sent to us a food safety 
package that we are now working with Mr. Dingell and his own 
version of food safety, to see if we can come up with a common 
ground document that will enhance dramatically the inspection 
of food at America's borders as part of our oncoming efforts, 
but nevertheless now an emergency need of this Congress and of 
this Nation.
    It is contemplated that now with the events of this anthrax 
attack on American citizens, and we have just seen the fourth 
victim in New York die, that while human toll so far has been 
limited, the havoc brought by these attacks has been rather 
broad.
    And the damage done to public confidence in the mail, and 
to the capacity of the CDC, and our health response systems to 
deal with these, is seriously in question. The bioterrorism 
package that we will design will hopefully answer those 
questions, and begin to move the CDC and the health 
department--and by the way, the EPA, which is now in charge of 
the cleanup of these buildings here in the Nation's capital--
into a position where all of those agencies working in 
conjunction with State and local government agencies, including 
the National Guard, the Veterans Hospitals, and other great 
institutions of that nature, will be more thoroughly 
coordinated.
    Today we will focus on how technology can help us identify 
and react quickly to the evidence of an epidemic or 
bioterrorism attack, and in the process this committee will 
engage in next week, we will look at the CDC more precisely and 
at the Health Department's capacity to respond more precisely.
    We will be looking at such questions as how much and how 
extensive should be our drug stockpile to react to attacks, or 
to the spread of infectious or biological diseases. We will be 
looking at how well we currently incentivize vaccine research, 
and whether or not we ought to do more to encourage not only 
the production, but the research and development of new 
vaccines to protect our country against these new forms of 
attack.
    We will be looking at whether or not the infrastructure of 
the CDC is sound, or whether or not some of the systems of 
communications within the CDC are adequate. We know that one-
third of all the labs and medical facilities in this country 
are not on the emergency alert system of the CDC. They need to 
be connected.
    And every lab, and every medical facility, needs to be part 
of a medical alert when it goes out. We want to look at how 
well we are currently educating hospitals, doctors, and nurses, 
in the special needs of bioterrorism attacks and infectious 
disease spread.
    We are going to look at whether we are doing a good enough 
job in public education to make sure that its citizens 
understand and can deal with some of these threats and 
understand the nature of these threats so that they don't have 
to be afraid. They can deal with them without fear.
    We are going to be looking as I said at EPA and its 
authority to respond quickly and to clean up properly when 
buildings or systems like our mail systems become contaminated.
    We were very blessed to have the Marine Corps response team 
available to us here in Washington when our own buildings were 
contaminated, but we need to make sure that all of that is 
organized and we have proper lines of authority, and proper 
funding for these agencies when they are called upon to act.
    We know that we have four major medical response teams in 
this country established in the four district regions of our 
country. How well are they organized, and how well are they 
prepared to respond if in fact a medical alert goes out to our 
country.
    We are going to be looking at all of that next week and 
through the next 8 to 10 days, and under the instructions of 
the leadership our Energy and Commerce Committee will be 
producing the major package on bioterrorism for the House to 
consider.
    So, Mr. Chairman, the work that you do today examining how 
technology and how improved communications infrastructures can 
assist in our Nation dealing with these problems is a critical 
step.
    And most importantly, I want to thank you for being awake 
at the switch when so many others were asleep, and working on 
this problem even before September 11. Our work now is urgent. 
Our work now is extraordinarily important and the 
responsibilities of our committee are deeply felt.
    Mr. Deutsch, I want to assure you, and I see that Mr. 
Dingell has arrived, and all the members on the other side, 
that in the next 8 or 10 days we are going to have to all be 
working in locked step, and we are going to work as we always 
do in a close bipartisan fashion for a good piece of 
legislation for the floor. This is the first step, Mr. 
Chairman, and I thank you for it.
    Mr. Greenwood. The Chair thanks the chairman of the full 
committee, and notes the diligence with which he attends all of 
our hearings, as well as the other five; I don't know how you 
manage to do it. The Chair recognizes the ranking member of the 
full committee, the gentleman from Michigan, Mr. Dingell, for 5 
minutes for an opening statement.
    Mr. Dingell. Mr. Chairman, thank you for your courtesy, and 
thank you for holding this very important and informative 
hearing. Effective disease surveillance is an essential part of 
the successful operation to protect the public health system at 
the local, State and national levels, whether we are talking 
about disease control or bioterrorism attacks.
    The public health system, which has been functioning for 
more than a century in this country, is grounded in the skills 
and dedicated skills of medical personnel who identify unusual 
symptoms and diseases and then alert the public health 
departments of the Federal, State, and local units of 
government.
    Their information allows the public health system to 
identify and deal with outbreaks of things like salmonella, E. 
coli, food poisoning, flu, HIV, hepatitis, and tuberculosis 
epidemics.
    Just like politics, however, disease surveillance is local. 
Sick people go to doctors or an emergency room and not to the 
Centers for Disease Control and Prevention, or government 
contractors. Doctors go to their local health departments for 
help, and not the Federal Government.
    And that is where the emphasis of our effort must be. Many 
people, especially those who stand to benefit from lucrative 
government projects, say this old system no longer works. A 
Florida State epidemiologist, who talked to our staff, but who 
was not able to be here, vehemently denies that position.
    The traditional system has functioned exactly as it should 
have when anthrax appeared in Florida last month, and an alert 
doctor saw something in Mr. Stevens that looked like anthrax. 
He immediately alerted the State health department.
    The State lab identified anthrax from a blood sample, and 
this became the indicator case that alerted the entire national 
public health system. Fancy syndromic surveillance systems 
would never have alerted the health department to anthrax 
because there was only one case there at that time.
    Hospitals also do not need computers to tell them that 
something unusual is going on if a thousand people show up in 
the emergency room with plague-like symptoms. So we must be 
very careful about developing high-powered surveillance systems 
that provide daily reams of information that cannot be 
analyzed, are not useful, and in the words of one public health 
official, ``wear people out.''
    They will likely cost much, and probably confer little 
benefit. A good public health disease surveillance system is 
not one that sits on the shelf sprewing out endless reams of 
useless information while we wait for another bioterrorism 
attack.
    It is one that is an integral part of a health department's 
day to day operations tracking communicable diseases and 
outbreaks of other diseases, and educating the medical 
establishment and the public as to health risks.
    A good system puts most of the investment into State and 
local systems, and not into inside the Beltway projects that do 
not meet the needs or realities of existing structures.
    That said, however, there are many improvements that can be 
made to our long-neglected public health system to make it more 
effective and timely. It needs quicker electronic reporting 
that link laboratories, hospitals, and medical providers to the 
Public Health Department.
    It needs interactive systems so that alerts and treatment 
information can be sent from the health department back to the 
providers. It needs better trained medical providers and lab 
personnel, and it needs more epidemiologists.
    It needs more staff so that the public health departments 
can be staffed 24 hours a day for a quick response. It needs 
money to upgrade laboratory facilities and to train lab 
personnel.
    This morning, we will hear from public health officials who 
have taken relatively small amounts of money and are using them 
to establish electronic systems to speed up disease 
surveillance, to rebuild their labs, and to train medical 
personnel.
    This is to be commended. Mr. Chairman, we in the Congress 
need to encourage these kinds of efforts and to fund them at a 
higher level than we do today. We can also no longer put off 
rebuilding our public health system. It has fallen into sad 
states of disarray because of neglect by the Congress and other 
agencies responsible for that kind of undertaking.
    This is the first and best defense we could have against 
bioterrorism. I heard the comments of our Chairman just a 
minute or 2 ago, and I am pleased to hear his comments and to 
know that we on this side will be very happy to work with him 
and with the leadership to come up with a meaningful, 
effective, useful, and intelligent program, legislative in 
character, to deal with the problems of bioterrorism. I thank 
you for your courtesy, Mr. Chairman.
    Mr. Greenwood. The Chair thanks the gentleman and 
recognizes the gentleman from Florida, Mr. Stearns, for 5 
minutes for his opening statement.
    Mr. Stearns. Good morning, and thank you, Mr. Chairman. 
Again, like my colleagues, we appreciate holding this hearing 
and the fact that you were going to have this hearing well 
before September 11 is a commendation to you and to your staff.
    And I believe that while it is essential and worthwhile to 
hear from the public health department officials, it is also a 
great opportunity for all of us to hear from those in the 
private sector, in academic health, and in the Department of 
Energy contracted laboratories.
    My colleagues, these witnesses have valuable real world 
experiences in disease surveillance, and now more than ever is 
the time to learn from them. I am particularly interested to 
hear how we might employ data base systems to report outbreaks, 
thereby injecting automation in a system that now is manual, 
voluntary, and not highly complied with.
    As the chairman has mentioned there is a problem that the 
terribly low compliance rate with reporting some diseases. We 
have got to correct that. The system which relies on ``passive 
surveillance'' by doctors often has been criticized as too 
slow, and has been plagued by poor compliance from overworked 
health care personnel.
    And as the chairman of our committee has mentioned, we need 
to correct that. I also read in the Washington Post this 
morning that Dr. Zelicoff, who is one of our witnesses, a 
senior scientist with the Center for National Security and Arms 
Control, Sandia National Laboratories, in Albuquerque, New 
Mexico, he said, Mr. Chairman, ``Investigators need to begin to 
focus less on the microbiology than the physics which is 
impressive.''
    He goes on to say that ``We didn't think that anybody could 
come up with the appropriate coatings for anthrax spores to 
make them float through the air with the greatest of ease. 
Exposing 28 people with a single opened envelope is no mean 
trick.''
    So I think he has pointed out and pointed to all of us a 
nuance of this debate that we have to understand as to how this 
could be accomplished. The tentacles of this anthrax menace are 
spreading from the Postal Service and locations in the Federal 
Government, to Indiana, Kansas City, Missouri, a hospital in 
Manhattan, and the British Embassy in Beijing, recently.
    What more devastation might lurk from anthrax or other 
biological agents. Who knows. These are very chilling fears 
that Americans have. We must be prepared and so I think this 
hearing is crucial and timely.
    And I would be anxious to hear from the other witnesses how 
we can get higher compliance and so we can improve the system 
so that it is faster and more automated, and more universal, 
and I thank you, Mr. Chairman.
    Mr. Greenwood. The Chair thanks the gentleman from Florida 
for his opening statement, and recognizes the gentleman from 
Michigan, Mr. Stupak, for his opening statement.
    Mr. Stupak. Thank you, Mr. Chairman, and thank you for 
holding this timely and important hearing on Federal 
bioterrorism. As we sit here today the reality of bioterrorism 
has hit home for many Americans and us here on Capitol Hill.
    And the reality is that we are not prepared. Today's 
hearing focuses on how best to prepare our local communities to 
monitor and integrate a public health surveillance system.
    The logistical elements of coordinating our efforts are 
staggering to say the least, but necessary because local 
monitoring is where the epidemics and major health problems 
first get noticed.
    Effective communications, means establishing links among 
law enforcement, local health departments, clinics, and 
hospitals, so that the critical data in the emergency situation 
can identify, contain, and respond to an emergency efficiently.
    However, we lack the personnel and the resources to do 
this. I remain highly interested in just how we aim to have a 
completely integrated public health system in this country. The 
systems that we will discuss today seem like good ideas, but 
again good ideas are not necessarily a mark of success.
    We need a proactive health surveillance system, and not 
systems where data and information lie untouched. I look 
forward to the testimony of today's witnesses to see how we can 
best accomplish these goals without unnecessarily burdening the 
front lines of our health care system; that is, our providers 
and our doctors.
    Thank you, Mr. Chairman, and I will yield back the balance 
of my time as I look forward to hearing from our witnesses.
    Mr. Greenwood. The Chair thanks the gentleman, and 
recognizes the gentleman from Kentucky, Mr. Whitfield, for 5 
minutes for his opening statement.
    Mr. Whitfield. Mr. Chairman, thank you very much. This 
obviously is a timely hearing, and I am not going to make a 
long statement, except to say that I am looking forward to the 
testimony on the electronic surveillance information system.
    I know that there have been pilot projects in some States 
with a desire to expand that, and I do look forward to that 
testimony, particularly on that issue as well as others.
    Mr. Greenwood. The Chair thanks the gentleman, and 
recognizes the gentlelady from Colorado, Ms. DeGette, for her 
opening statement for 3 minutes.
    Ms. DeGette. Thank you, Mr. Chairman, and I would 
particularly like to welcome Dr. Davidson, who is with us here 
today, and who I only found out was appearing here last night.
    And so I would particularly like to welcome him. I met with 
Dr. Davidson and a number of representatives of the Denver 
Health Departments team that is charged with some kind of early 
response to bioterrorism.
    And I must say, and not to be a local bragger, but we have 
a fantastic program in Denver and Colorado designed to 
coordinate agency responses with physician responses, and I 
know that the committee will love hearing about it today.
    I am very proud of it, but I also know that to have any 
kind of effective network that it has to be a national network, 
and I know that we are looking forward to hearing about that 
today.
    We had a hearing on October 10 in this subcommittee about 
the threat of a biological or chemical attack, and at that time 
Americans feared that post-September 11 that a biological or 
chemical assault was imminent. Well, guess what. Here we are 
today.
    At the time of October 10, bioterrorism experts pointed out 
the difficulties of pulling off such an attack. They said that 
the No. 1 obstacle is disseminating the agent, and pointed to 
the attempts and relative failures made by terrorists across 
the world as an illustration of the difficulty.
    Unfortunately, what most Americans feared back then has now 
come to pass. The attack that we are in the midst of appears to 
be small in scale, but it is clear that we must be better 
prepared in the event of a larger, more widespread assault.
    Issues surrounding biological weaponry, and how various 
agents can be spread, and their effect on the human anatomy, 
for example, need greater understanding and clarity. We had an 
exercise about a year ago.
    Some of you have probably seen Dr. Davidson and Dr. Steve 
Cantrell from the Denver Health Department talking about 
Operation Top Off, where we actually had an exercise involving 
the plague.
    And what was really disturbing in that exercise is how many 
thousands of people were affected by it, and equally disturbing 
is because of the movements in our society today, how almost 
immediately the plague in this exercise was spread throughout 
the United States and even around the world.
    And so early response and coordination is clearly the key, 
and is what we need to work at. There are gaps at the State and 
local level because of a lack of coordination at the Federal 
level.
    For example, the September 2001 General Accounting Office 
report on bioterrorism, Federal research and preparedness 
activities, points out that at the Federal level alone several 
agencies share responsibility for coordinating various 
functions, which limits accountability and hinders unity of 
effort.
    What is even more amazing to me is some of these agencies 
that are dealing with emergency preparedness don't even have e-
mail capability, and so they cannot coordinate with their 
fellow agencies.
    I look forward to hearing from each of the panelists. I 
think that this is an urgent need that we need to address 
before we see widespread bioterrorism or chemical terrorism, 
and not after, and I know that everybody can contribute to this 
effort, and I yield back.
    Mr. Greenwood. The Chair thanks the gentlelady, and with 
unanimous consent, would recognize the gentlelady, Ms. Harman, 
from California, who while not a member of this subcommittee, 
is a member of the full committee, and a very active 
participant as a member of the Intelligence Committee in all of 
these issues, and she is recognized for 3 minutes for an 
opening statement.
    Ms. Harman. Thank you, Mr. Chairman, and I appreciate the 
opportunity to attend this meeting and participate even as an 
outsider in what I think are the most important issues that our 
country faces.
    This hearing, as I understand it, will highlight the most 
important functions of our public health system in confronting 
and combating terrorism. Disease surveillance, and outbreak 
detection, as we are now learning are the greatest challenges 
of our terrorism response. This is the foundation of all other 
health consequence management actions by doctors and government 
officials.
    Much of the language that we use in discussing health 
security is the same as in discussing national security. 
Syndromic surveillance, epidemiological intelligence. This link 
just highlights what more and more people are coming to 
realize--that our public health system is an essential part of 
our homeland defense strategy.
    I am particularly glad that we will hear from infomatics 
experts on how to upgrade our surveillance system. I have long 
advocated the need to eliminate barriers of communication 
between our intelligence and defense agencies, and for 
upgrading our intelligence technologies for the digital era. In 
fact, I often say that we have analog capacity to confront a 
digital threat. Our public health system must have integrated, 
advanced, digital communications systems so it can respond 
quickly and effectively to the bioterrorist threat and disease 
outbreaks.
    Only yesterday, Mr. Chairman, some of us who visited the 
Center for Disease Control last week introduced a bill to 
accelerate $300 million in infrastructure investments in a new 
infectious disease building at the CDC.
    This new facility is critical to our surveillance effort, 
and I would hope that all members of the subcommittee, and in 
fact the full Commerce Committee, will get behind the Lender-
Harman bill.
    I also hope, Mr. Chairman, that as we develop the 
bioterrorism package that you and Chairman Tauzin talked about, 
we might consider this bill as part of the package. It may seem 
strange to think that a building is a critical part of a 
bioterrorism effort. But this building will conduct the 
critical cutting edge research and design the strategies to 
confront the threat, and as we think about moving forward as 
you say in real time to our ability to respond, I think it 
relies on three things.
    One, talented people; two, technology that integrates all 
aspects of the response, starting with understanding what is 
going on out there, and who is coming to our hospitals; and, 
three, having the infrastructure to house the people in that 
technology in a safe and secure fashion.
    So I thank you for letting me participate, and I am very 
eager to hear these witnesses. I yield back.
    Mr. Greenwood. The Chair thanks the gentlelady, and notes 
or appreciates the reference with regard to the CDC 
infrastructure. In fact, if the schedule permits, some of the 
members of this committee will be flying to Atlanta tomorrow to 
visit the CDC.
    Without objection, the opening statements of any other 
members not present will be entered into the record.
    [Additional statement submitted for the record follows:]
   Prepared Statement of Hon. Michael Bilirakis, a Representative in 
                   Congress from the State of Florida
    Thank you, Chairman Greenwood, for holding this important hearing 
today. The Oversight and Investigation Subcommittee's hearings on 
bioterrorism have been instrumental in assessing the needs of our 
nation in the event of a bioterrorist attack. In particular, these 
hearings have informed the bipartisan process that Chairman Tauzin, 
Ranking Member Dingell, Representative Brown and myself have been 
engaged in to develop new comprehensive and appropriate legislative 
authorities that will protect us from a bioterrorist event.
    Since the horrific events of September 11th, the United States has 
been engaged in a war on terrorists who threaten our way of life. Our 
thoughts and prayers are with those whose lives have been forever 
altered by the evilness of terrorism. Unfortunately, the weapons of 
terrorism are not limited to hijacked airplanes and bombs, but also 
biological agents. Through these hearings and our legislation the 
Energy and Commerce Committee is taking the lead to ensure that our 
nation can tackle this very difficult issue.
    I share the concerns of many Americans who are worried about 
possible bioterrorism attacks such as anthrax exposure and outbreaks of 
smallpox. There recently have been several cases of anthrax exposure 
through the postal mail which have not only complicated the mail 
delivery process, but have caused all Americans to fear for the health 
and well-being of their families.
    An outbreak of smallpox is another potential threat. The United 
States currently maintains national smallpox vaccine stocks sufficient 
to immunize 6 to 7 million people. Efforts are being undertaken to 
expand this reserve so that more Americans can be protected from the 
threat of smallpox.
    Cases of anthrax exposure can be treated and infection can be 
prevented through antibiotics. Great quantities of antibiotics for 
anthrax and smallpox vaccines are being stockpiled by the Centers for 
Disease Control and Prevention (CDC) in the event of additional 
biological attacks. We must ensure that the United States has a 
sufficient stockpile of vaccines and antibiotics, and that these 
medications are securely protected. We must also make certain that our 
public health infrastructure can detect disease outbreaks that may 
represent a bioterrorism attack.
    This is a time for all of us to pull together as Americans. I 
personally thank and honor those who are on the front lines fighting 
this war. The United States is a great country, and we are all blessed 
to enjoy our freedoms.
    Again, thank you Chairman for holding this important hearing.

    Mr. Greenwood. And with that, the Chair welcomes the first 
panel of witnesses. And they are Dr. Claire Broome, who is the 
Senior Advisor of Integrated Health Information Systems, Office 
of the Director, Centers for Disease Control and Prevention, in 
Atlanta.
    And Dr. Anita Barry, Director, Communicable Disease 
Control, of the Boston Public Health Service; and Dr. Arthur J. 
Davidson, Director, Public Health Informatics, Denver Public 
Health Department.
    I assume that each of you have been advised that this is an 
investigative hearing and it is the practice of this committee 
to take testimony under oath. And so I should ask if any of you 
have any objections to offering your testimony under oath.
    [No response.]
    Mr. Greenwood. Seeing no such objections, I would advise 
you that under the rules of the House and the rules of the 
committee that you are entitled to be advised by counsel. Do 
any of you care to be advised by counsel today?
    [No response.]
    Mr. Greenwood. In that case, if you would please rise and 
raise your right hand, I will swear you in.
    [Witnesses sworn.]
    Mr. Greenwood. You are now under oath, and we will turn to 
Dr. Broome first, and you are recognized for 5 minutes for your 
testimony. Thank you for being with us.

 TESTIMONY OF CLAIRE BROOME, SENIOR ADVISOR, INTEGRATED HEALTH 
   INFORMATION SYSTEMS, OFFICE OF THE DIRECTOR, CENTERS FOR 
    DISEASE CONTROL AND PREVENTION; ANITA BARRY, DIRECTOR, 
COMMUNICABLE DISEASE CONTROL, BOSTON PUBLIC HEALTH SERVICE; AND 
ARTHUR J. DAVIDSON, DIRECTOR, PUBLIC HEALTH INFORMATICS, DENVER 
                    PUBLIC HEALTH DEPARTMENT

    Ms. Broome. Good morning, Mr. Chairman, and members of the 
subcommittee. Thank you for the invitation to discuss CDC's 
public health surveillance activities. As the events of the 
last month have shown, and as the subcommittee has so 
eloquently described, public health surveillance is a crucial 
monitoring function for CDC, its partners, and the country.
    Ongoing data collection activities help us detect threats 
to the health of the public in time to prevent the further 
spread of disease. Usually the original source of information 
is the health care provider.
    For example, the Florida physician's ability to recognize a 
suspected case of anthrax and his role in rapidly reporting it 
to the local health department, was critical to our original 
recognition of the current bioterrorist events.
    There is no substitute for this heightened awareness for 
diagnosis of conditions of public health importance by doctors. 
They are the front lines, and they need to be aware, and they 
need to know who to notify in the local health department, the 
State health department, and the CDC.
    We work with our public health partners to define 
conditions that should be reported to public health 
departments. Health Departments then work with their local 
partners in the health care system to be sure that they have 
the information needed.
    You have received copies of an October 19, 2001 issue of 
our MMWR, recognition of illness associated with the 
intentional release of a biologic agent. I think this is a 
concrete example of the kind of information that we are 
constantly distributing to our partners to ensure that they 
have the latest information.
    Of course, this information also goes out electronically. 
If a case of illness is particularly unusual or severe, such as 
a case of anthrax or rabies, the provider will call the local 
health department immediately.
    However, routine public health surveillance, the reporting 
is still done largely by paper or fax. This largely paper based 
system is burdensome both to providers and health departments, 
and therefore reports are often incomplete and not timely.
    I have discussed the role that surveillance plays in early 
detection, but surveillance data are also crucial for the 
public health response. Surveillance data helps us to determine 
where cases are occurring, and where they are not occurring, so 
we can target the response appropriately.
    It tells us when cases are occurring. Are they increasing, 
or are they decreasing. It also helps us to take our laboratory 
test results and match them with the case information so that 
we can track down the source and define areas at risk.
    Such information is vital to directing our investigation 
and control efforts, but it requires a well designed system to 
rapidly input and analyze the voluminous data required, such as 
the thousands of swabs tested for anthrax in the current 
investigations.
    We also recognize the need to take advantage of recent 
information technology advances to bring our surveillance 
systems into the 21st century, and I would like to describe a 
little bit about our new system that has been developed based 
on infomatics principles.
    Several years ago we initiated the development of the 
national electronic disease surveillance system, NEDSS, a web-
based surveillance system for use at State and local levels. 
The goal of NEDSS is electronic real time reporting of 
information for public health action.
    NEDSS includes direct electronic linkages with the health 
care system. For example, information about relevant diagnostic 
tests can be shared electronically with public health as soon 
as a clinical laboratory receives a specimen.
    For example, requesting testing for anthrax.
    NEDSS emphasizes national standards, and using national 
standards for data content, security, and information 
technology architecture. As we build NEDSS, we are ensuring 
that the data standards we use are compatible with the leading 
standards for health care systems, so the public health can 
receive data electronically from the health care delivery 
systems with less burden on data providers.
    The reliance on de facto industry standards for information 
technology means that NEDSS can incorporate sophisticated 
commercial products for security, for analysis, for mapping. 
This is particularly critical for guiding the public health 
response to an epidemic.
    Standards also mean that systems can inter-operate between 
States so we can detect problems occurring in multiple 
locations. The CDC has worked with our State and local partners 
on the development of NEDSS. We have provided funding and 
support to all 50 States for activities related to NEDSS 
planning and development.
    A NEDSS based system that incorporates the standards and 
functions mentioned will be deployed in at least 20 States 
during 2002. This project is critical for ensuring our ability 
to capture data efficiently, electronically, and to use it 
effectively for public health response.
    And a public health surveillance system that spans the 
Nation will be essential to detect threats to the public, 
wherever they might occur and whatever they might be. 
Recognizing the need for immediately increased capacity while 
NEDSS is implemented, CDC and its public health partners 
initiated various activities to improve their ability to detect 
events of importance.
    For example, with the first CDC funding for countering 
bioterrorist activities, many State health departments were 
able to purchase the most advanced pattern recognition analytic 
capacity available today, a trained human being.
    We funded States to hire epidemiologists, whose duties 
included coordinating bioterrorism surveillance, informing 
health care providers of what to look for, and who to contact 
if something suspicious turned up.
    CDC also funded eight States for special surveillance 
projects, and projects looked at the utility of possible early 
warning systems, such as emergency medical systems, 911 calls, 
hospital emissions, emergency department visits, absenteeism 
rates, pharmacy data.
    After September 11, these systems were explicitly called on 
to provide heightened surveillance information. CDC is 
undertaking a critical review of these activities to identify 
the most useful and practical approaches that may be 
implemented on a national basis.
    Key questions to address include how rapidly are data 
available for analysis; can the systems identify true outbreaks 
in the noise of ongoing illness; what effort to enter data is 
required from already busy health providers; can the systems be 
used in geographic areas beyond those where they were 
developed.
    In addition, CDC has established networks of clinicians, 
infectious disease specialists, travel medicine specialists, 
emergency department physicians, whose functions are to serve 
as early warning systems for public health by providing 
information about unusual cases encountered in the clinical 
practice of their members.
    In conclusion, our public health surveillance systems 
provide a critical piece of the public health infrastructure 
for recognizing and controlling deliberate bioterrorist 
threats, as well as naturally occurring new or re-emerging 
infectious diseases.
    We have made substantial progress to date in enhancing the 
Nation's capability to detect and respond to problems that 
threaten the public's health. These cross-cutting efforts to 
build the surveillance infrastructure will be useful to detect 
any problem, and not just potential bioterrorist events.
    The ongoing use of this surveillance capacity will assure 
that it is familiar and functional should bioterrorist events 
continue to occur. A strong and flexible public health 
infrastructure is the best defense against any disease 
outbreak. Thank you very much for your attention. I will be 
happy to answer any questions you may have.
    [The prepared statement of Claire Broome follows:]
 Prepared Statement of Claire Broome, Senior Advisor to the Director, 
 Centers for Disease Control and Prevention, Department of Health and 
                             Human Services
    Good morning, Mr. Chairman and Members of the Subcommittee. I am 
Dr. Claire Broome, Senior Advisor to the Director for Integrated Health 
Information Systems at the Centers for Disease Control and Prevention 
(CDC). Thank you for the invitation to update you on CDC's public 
health surveillance activities. I will describe the function of our 
current surveillance systems, update you on recent efforts to build 
surveillance capacity in state and local health departments, and 
discuss the status of the National Electronic Disease Surveillance 
System.
    As the nation's disease prevention and control agency, CDC has the 
responsibility on behalf of the Department of Health and Human Services 
(HHS) to provide national leadership in the public health and medical 
communities to detect, diagnose, respond to, and prevent illnesses, 
including those that occur as a result of a deliberate release of 
biological agents. This task is an integral part of CDC's overall 
mission to monitor and protect the health of the U.S. population.
    Much has been in the news lately about the disease detective 
function of CDC and its epidemiologists, including Epidemic 
Intelligence Service Officers. What has not been often emphasized is 
the need for continued watchfulness to first detect problems that our 
disease detectives then investigate. We refer to this function--this 
constant state of alert--as public health surveillance.
    Public health surveillance is a crucial monitoring function for CDC 
and its partners. It is these ongoing data collection activities that 
help us detect threats to the health of the public. Without our public 
health surveillance systems, we might not identify outbreaks or other 
important problems in time to prevent the further spread of disease. We 
cannot investigate problems, identify their causes, and implement 
control measures if we have not detected them. Recent events have 
underscored this essential role of public health surveillance, as well 
as the integral role of health care providers in the overall public 
health system. For most of our surveillance data, the original source 
of information is the health care provider; the Florida physician's 
ability to recognize a suspected case of anthrax and his awareness of 
his role in reporting it to the local health department was critical to 
our initial recognition of the current bioterrorist events. Indeed, 
identification of subsequent anthrax cases has also relied on 
heightened awareness among health care professionals that the wounds 
and respiratory syndromes they were seeing were actually cutaneous and 
inhalation anthrax, not merely spider bites and pneumonia.
                      current surveillance systems
    The best initial defense against any threats to the health of the 
public, whether naturally occurring or deliberately caused, continues 
to be accurate, timely recognition of a problem. Key elements of our 
current surveillance systems include awareness and diagnosis of a 
condition of public health importance, whether by a clinician or 
laboratory, with subsequent notification of the local health 
department, which in turn reports to the state health department, which 
shares information with CDC. We work with our public health partners to 
define conditions that should be reported to public health departments; 
health departments share these definitions and guidelines with health 
care providers, infection control practitioners, emergency department 
physicians, laboratorians, and other members of the health care system. 
A timely example of such guidelines was included in the October 19, 
2001, issue of the Morbidity and Mortality Weekly Report (MMWR), in the 
report that dealt with ``Recognition of Illness Associated with the 
Intentional Release of a Biologic Agent.'' Copies of the MMWR have been 
provided to the Subcommittee.
    The traditional operation of our surveillance systems generally 
consists of paper or facsimile reporting by providers to health 
departments. If a case of illness is particularly unusual or severe 
(such as a case of anthrax or rabies), the provider will call the local 
health department immediately. As mentioned, health care provider 
recognition of the illness and awareness that certain health events 
require immediate notification of public health authorities, is 
critical to our ability to detect problems and mount a public health 
response. It was another alert clinician in 1993, a pediatric 
gastroenterologist, who provided the early warning about a potential 
diarrheal disease outbreak to the Washington State Department of 
Health. Within one week, the Health Department identified hamburgers 
from Jack-in-the-Box as the cause of the outbreak, and the fast-food 
chain voluntarily recalled all hamburger meat from their restaurants in 
the state. However, for routine public health surveillance, this 
largely paper-based system is burdensome both to providers and health 
departments, and therefore reports are often incomplete and not timely. 
In addition, the volume of paper reports and the need to enter the 
information collected into various information systems leads to errors 
and duplication of efforts.
    These shortfalls influence more than our ability to detect an 
event; surveillance also plays a pivotal role in event management. 
Surveillance data help us to determine where cases are occurring and 
who is affected (e.g., particular age groups or occupations such as 
children or postal workers), when cases are occurring (i.e., are cases 
still occurring; are the numbers increasing or decreasing with time?), 
and matching such information to the laboratory data about the 
particular agent, to trace its origin as well as to identify whether 
cases in different geographic locations might have resulted from the 
same source. Such information is vital to directing our investigation 
and control efforts, but it requires a well-designed system to input 
and analyze the voluminous data required, such as the thousands of 
swabs tested for anthrax.
    Given the crucial function of public health surveillance, we have 
recognized the need to take advantage of recent information technology 
advances to bring our surveillance systems into the 21st century. First 
I will describe the overall direction that we are headed to transform 
our public health surveillance systems, and then I will describe some 
of our short-term efforts to enhance current surveillance systems in 
the aftermath of September 11, as described in the MMWR report 
mentioned previously.
        integrated, electronic surveillance information systems
    CDC and its partners have recognized the need to build more timely, 
comprehensive surveillance information systems that are less burdensome 
to data providers. Several years ago, we initiated the development of 
the National Electronic Disease Surveillance System (NEDSS). The 
ultimate goal of NEDSS is the electronic, real-time reporting of 
information for public health action. NEDSS will include direct 
electronic linkages with the health care system; for example, medical 
information about important diagnostic tests can be shared 
electronically with public health as soon as a clinical laboratory 
receives a specimen, or makes a diagnosis. In the future, NEDSS coupled 
with a computer-based vital statistics system and computerized medical 
records, not only in hospitals but also in ambulatory care offices, 
could facilitate immediate awareness of unusual illnesses such as 
anthrax or smallpox, as well as our ability to detect more subtle 
problems that may be dispersed across the country.
    NEDSS emphasizes a standards-based approach, relying on the use of 
standards for data, information architecture, security, and information 
technology (de facto industry standards). This reliance on standards 
will ensure that data need only be entered once, at the point of care 
for a patient, without a need for re-entry of data by our local and 
state partners. Use of standards is critical to ensure that our public 
health partners can use technology more effectively and 
collaboratively. As we build NEDSS we are ensuring that the data 
standards we use are compatible with those used in health care systems, 
so that we can make sense of health-related data and therefore detect 
potentially related cases across the country. In addition, a standard 
information architecture and appropriate, high level security will 
enable public health partners to share data in a secure fashion, which 
is critical for identifying problems that cross jurisdictional 
boundaries. And finally, the reliance on de facto industry standards 
for information technology ensures the availability of multiple 
commercial products to meet the needs of our public health partners, 
including state-of-the-art analytic tools and geographic information 
system capacity.
    CDC has worked with our state and local partners on the development 
of NEDSS. We have provided funding and support to all 50 states for 
activities related to NEDSS planning and development. NEDSS is an 
ambitious project; defining appropriate standards and ensuring 
appropriate data sharing among the myriad health care systems, over 
2000 local health departments, 50 state health departments, and 
numerous federal public health agencies is a complex process. As a 
start, a NEDSS Base System that incorporates the standards and 
functions mentioned will be deployed in at least 20 states during 2002. 
This project will ensure our ability to capture data efficiently, 
electronically, and to use it effectively for public health response. 
And a public health surveillance system that spans the nation will help 
detect threats to the public, wherever they might occur.
    Indeed, 2 related projects also provide a key part of the effort to 
ensure the development of the public health communications 
infrastructure. Health Alert Network (HAN) is a nationwide program, the 
goals of which include provision of Internet connectivity and rapid 
communications capability among local and state health departments, 
which will also facilitate linkage of local health departments and 
health care providers. This connectivity will be crucial for rapid 
sharing of surveillance data among public health agencies. In addition, 
the Epidemic Information Exchange, or Epi-X, provides secure, high-
speed, Web-based communication about outbreaks and other acute or 
emerging health events among public health officials from CDC, state 
and local health departments and the military. One of the unique 
features of Epi-X is the ability to provide a forum for secure 
communications for state epidemiologists to post information on 
surveillance and response activities for approximately 500 public 
health officials around the country, including the U.S. military. 
Another unique feature of Epi-X is emergency notification by telephone 
and/or pager to defined groups of public health officials.
    Support to date for these important national projects has 
strengthened our public health infrastructure for detection of events 
of concern and subsequent communication to ensure appropriate public 
health response.
                     near term surveillance efforts
    Recognizing the need for near term increased capacity while NEDSS 
is implemented, CDC and its public health partners initiated various 
activities to improve their ability to detect events of importance to 
the health of the public. For example, with the first CDC funding for 
countering bioterrorist activities, in Fiscal Year 1999, many state 
health departments were able to purchase the most advanced pattern 
recognition analytic capacity available today--a trained human being: 
an epidemiologist whose duties included coordinating bioterrorism 
surveillance and rapid response activities. The activities range from 
enhancing communications (between state and local health departments 
and between public health agencies and health-care providers) to 
conducting special surveillance projects. These special projects have 
included active surveillance for changes in the number of emergency 
medical system/911 calls, hospital admissions, emergency department 
visits, and occurrence of specific syndromes. After September 11, these 
systems were explicitly called on to provide heightened surveillance 
information. CDC is undertaking a critical review of these activities 
to identify the most useful and practical approaches that may be 
implemented on a national basis. One key question to address is the 
feasibility of capturing medically relevant data in a timely and 
appropriately representative fashion, since we do not know when or 
where the next event might occur. Furthermore, what effort do proposed 
systems require from health care providers to report, or enter data in 
the systems? Can the systems be used in geographic areas beyond those 
where they were developed? In addition, given the substantial burden of 
investigating potentially concerning events, we are evaluating 
mechanisms for minimizing the proportion of alerts generated by the 
system that are false alarms.
    Other related activities useful for early detection of emerging 
infections or other critical biological agents include CDC's Emerging 
Infections Programs (EIP). CDC funds EIP cooperative agreements with 
state and local health departments to conduct population-based 
surveillance and research that goes beyond the routine functions of 
health departments, and often involve partnerships among public health 
agencies and academic medical centers. In addition, CDC has established 
other networks of clinicians--whether infectious disease or travel 
medicine specialists, or emergency department physicians--whose 
functions are to serve as ``early warning systems'' for public health 
by providing information about unusual cases encountered in the 
clinical practices of its members. The guidance provided in the October 
19 MMWR is intended to heighten awareness among these clinical partners 
about what to watch for, and what to report to public health. It is 
important to note that these relationships, particularly between health 
care providers and local health departments, are the foundation on 
which our surveillance systems operate. The local health department is 
the front-line of defense for the public health system. Many other 
projects and proposals for rapid surveillance omit the vital connection 
to public health, especially the local public health agency, which is 
responsible for the initial public health response.
                               conclusion
    In conclusion, CDC is committed to working with other federal 
agencies and partners as well as state and local public health 
departments to ensure the health and medical care of our citizens. The 
best public health strategy to protect the health of civilians against 
illness, regardless of cause, is the development, organization, and 
enhancement of public health prevention systems and tools.
    Our public health surveillance systems provide a critical piece of 
the public health infrastructure for recognizing and controlling 
deliberate bioterrorist threats as well as naturally occurring new or 
re-emerging infectious diseases. We have made substantial progress to 
date in enhancing the nation's capability to detect and respond to 
problems that threaten the public's health. Recognizing that there is 
no simple solution for our surveillance needs, we have supported 
augmenting the staff in state and local health departments, as well as 
special projects to explore the usefulness of various clinical data 
sources. We are undertaking a critical review of current efforts to 
determine what would be feasible and useful to implement more broadly 
in coming weeks. We are implementing the National Electronic Disease 
Surveillance System, which will provide direct linkages with the health 
care system in 2002, improving the timeliness, efficiency, and 
usefulness of our surveillance efforts. These cross-cutting efforts to 
build the surveillance infrastructure will be useful to detect any 
problem, not just potential bioterrorist events; the ongoing use of 
this surveillance infrastructure will assure that it is familiar and 
functional should bioterrorist events continue to occur. A strong and 
flexible public health infrastructure is the best defense against any 
disease outbreak.
    Thank you very much for your attention. I will be happy to answer 
any questions you may have.

    Mr. Greenwood. Thank you, Dr. Broome. I appreciate your 
testimony.
    Dr. Barry, you are recognized for 5 minutes for your 
testimony.

                    TESTIMONY OF ANITA BARRY

    Ms. Barry. Chairman Greenwood and honorable committee 
members, thank you for inviting me here to speak with you today 
about public health surveillance. My name is Dr. Anita Barry, 
and I am the Director of Communicable Disease Control for the 
Boston Public Health Commission, which is the local health 
authority for the city of Boston under the leadership of our 
mayor, Tom Menino.
    In 1999, the Boston Public Health Commission participated 
in a city-wide disaster tabletop exercise that simulated an 
outbreak of pneumonic plague. Through this exercise, we 
realized that in a medical or public health crisis, health care 
providers must have timely and accurate information, including 
clinical guidelines.
    Boston's disease monitoring system at that time relied 
primarily upon local hospitals, health care providers, or 
laboratories, to call when they diagnosed a reportable disease 
or identified a cluster of unusual illness.
    Unfortunately, this method often provides late and 
incomplete information, especially in an emergency. It became 
clear that we needed an active system to let us know about 
problems early on.
    Thanks to the Federal Centers for Disease Control and 
Prevention, Boston received a grant for $1 million over 5 years 
to develop and implement an early warning system to detect 
bioterrorism or any other infectious disease mass casualty 
event.
    For the last 2 years, we designed and set up this system, 
which has now been operational for 6 months. Additional 
components of the system, including daily information from the 
Poison Control Center located in Boston, Boston Emergency 
Medical Services, and death certificates, will be on-line in 
the next few months to supplement the already incoming health 
care site data.
    One of the first things we did to create our surveillance 
system was to convene a task force of key stakeholders to 
develop a workable system. We invited representatives from 
emergency departments, acute care sites, infectious disease 
departments, the State Health Department, and our local zoo, 
among others, to help us develop this system.
    As a group, we designed the Boston system to minimize the 
effort on the part of emergency department personnel and other 
hospital based personnel. We heard very clearly from the 
emergency department directors that drop in surveillance 
systems, in which a separate additional sheet of information 
for each patient is required to be filled out by their 
personnel, is completely unworkable.
    The Boston system works as follows. Each night the medical 
information system at each facility automatically sends our 
secure web-based server the number of persons seen in that 
emergency department or other acute care site.
    This figure is automatically compared to the expected 
number of visits for that site, adjusted for season of the year 
and day of the week. If it is higher than expected, a one page 
follow-up form is automatically sent to a pre-identified 
contact at that hospital.
    This form asks more detailed questions about the nature of 
cases seen in the acute care site to determine if anything 
unusual is going on. This follow-up information determines 
whether or not further investigation is required.
    Hospital staff appreciate the fact that they are asked to 
take time to provide detailed information only when the system 
indicates that something may be going on. While this volume 
based system will not identify an isolated case like the 
anthrax cases in other cities, the constant reminders that we 
send to health care providers through this system increases the 
chances of timely reporting.
    Our experience in the past 6 weeks has also highlighted how 
this system provides important public health data, whether or 
not there is a mass incident. Although we have had no 
bioterrorist events in Boston, during the first week of reports 
of anthrax cases, we observed a surge in patient volume at 
several hospital sites.
    Follow-up investigation revealed that this was not due to 
any unusual clusters of symptoms, but rather to an influx of 
frightened people requesting nasal swabs and cipro 
prescriptions, despite the absence of any confirmed or 
suspected anthrax exposures in Massachusetts.
    At the local health department, we used this information as 
an indicator of the need for increased public education and 
increased public timely information release. One of the most 
important purposes of the system is to create a flow of 
information between that local health department and local 
health care providers.
    The Boston Public Health Commission, with our surveillance 
task force, also developed a provider education initiative on 
bioterrorism. This program, which began about 1\1/2\ years ago, 
uses a train-the-trainer model to teach physicians and nurses 
to educate their peers.
    This training has been much in demand of late. 
Additionally, we use this electronic surveillance system to 
post and send regular clinical advisories and updates out to 
the surveillance task force members and others, including the 
city's 25 community health centers, the college health centers, 
Boston Emergency Medical Services, and others.
    These guidelines have served as the foundation for 
protocols developed by local hospitals regarding the medical 
management of people being seen with possible anthrax exposure.
    I believe that the Boston system is replicable with 
modifications in other cities and regions, as well as on state-
wide levels. Our experience has also implications regarding 
what is needed for local health departments to maintain an 
effective early warning system, as well as the ability to 
respond to public health events detected by these systems.
    First, key stakeholders must be at the table to design the 
system. Second, the system should serve as a communication 
network, as well as a surveillance system. Third, the system 
should be simple and as automated as possible so it is doable 
by busy health care systems.
    And finally at the same time, it should account for the 
human factor, which is essential both to maintain the system, 
and to obtain the data if the electronic system is delayed or 
temporarily not functioning.
    I also would like to share some thoughts about the broader 
implications of Boston's experience. Last week, Boston Mayor 
Menino and City Public Health and Safety Officials joined 
mayors from across the country at the U.S. Conference of 
Mayors' Emergency, Safety, and Security Summit.
    The following suggestions combined public health action 
steps recommended by the Boston Public Health Commission, and 
the U.S. Conference of Mayors. First, the technical 
capabilities in communication infrastructure of local health 
departments must be improved.
    Our ability to create this surveillance system was the 
result of a CDC grant. Without Federal funding, we could never 
have designed this system. Second, all local health departments 
should have direct access to communications systems like CEC's 
Epi-X to receive ongoing timely updates.
    Such a system is key to having accurate and timely 
information from local public health officials, and so we 
strongly support full funding and expansion of the health alert 
network.
    Third, we need to think regionally about surveillance and 
communications systems, and we need Federal support to 
implement such regional systems. Boston is currently in 
discussion with surrounding communities about sharing and 
expanding our surveillance system, because the impact of an 
infectious disease or bioterrorist events will not end at the 
Boston city borders.
    Fourth, Federal Agencies should direct more funding 
directly to local communities. National public health 
organizations recommend that at least $835 million of the 
Emergency Bioterrorism Funding Request go directly to local and 
State health departments.
    Local communities must receive a significant portion of 
that funding. Too often local health departments are left out 
of the equation, and we bear the major burden of the day to day 
response.
    For example, in Boston alone, the health department 
anticipates spending $700,000 by the end of this fiscal year on 
bioterrorism-related emergency medical service response, and a 
surveillance, epidemiology, communication, and coordination of 
activities within the communicable disease control program.
    Federal funding should be flexible. We need to track and 
respond to a range of public health concerns, including not 
only bioterrorist agents, but also influenza and other emerging 
problems.
    And finally local public health departments should be 
represented at the table in national emergency planning. A 
permanent commission, including mayors, local public health 
officials, and local public safety officials, should 
immediately be established by the Director of Homeland 
Security.
    Local officials are on the front lines of homeland 
security, and it is essential to forge direct lines of 
communication among the Office of Homeland Security, Federal 
Agencies, and local governments.
    In closing, I thank Chairman Greenwood and the committee 
for inviting me to speak today on behalf of local health 
departments, and I would be pleased to provide any further 
information you would like.
    [The prepared statement of Anita Barry follows:]
   Prepared Statement of Anita Barry, Director, Communicable Disease 
              Control, The Boston Public Health Commission
    Chairman Greenwood, Honorable Committee Members, thank you for 
inviting me here to speak to you today about public health 
surveillance. My name is Dr. Anita Barry. I am the Director of 
Communicable Disease Control for the Boston Public Health Commission, 
the health department for the City of Boston, under the leadership of 
Mayor Thomas Menino.
    In 1999, the Boston Public Health Commission participated in a 
citywide disaster tabletop exercise that simulated an outbreak of 
pneumonic plague. Among the participants were representatives from all 
the major Boston hospitals. Through this exercise, we realized that in 
a medical or public health crisis, health care providers must have 
timely and accurate information, including clinical guidelines. At that 
time, Boston had only what most local health departments have: a 
passive surveillance system. We waited for local hospitals, health care 
providers, or laboratories to call us when they diagnosed a reportable 
disease or identified an unusual cluster of illness. Unfortunately, 
this method can provide late and incomplete information, especially in 
an emergency. For example, influenza--one of the diseases we are most 
interested in identifying early--is not required to be reported in 
Massachusetts. Influenza outbreaks tended to be reported late--or not 
at all, making it impossible to introduce timely measures to contain 
the spread of disease. It became clear that we needed a system to let 
us know about problems early on.
    Thanks to the federal Centers for Disease Control and Prevention, 
Boston received a $1 million five-year grant to develop and implement 
an early warning system to detect a bioterrorist or other infectious 
disease mass casualty event. We were one of about seven localities in 
the country to be awarded such a grant, and the only city to monitor 
volume in emergency room and acute care facilities through an 
automated, electronic, real time system.
    For the last two years, we designed and set up the system, which 
has now been operational for about six months. Additional system 
components, including daily information from the Poison Control Center 
in Boston, Boston Emergency Medical Service, and death certificates 
will be on line in the next few months to supplement the health care 
site data. I will give you a brief overview of how the hospital-based 
system works and then share what we have learned that is relevant to 
other localities, as well as federal bioterrorism preparedness planning 
and funding.
    One of the first things we did to create our surveillance system 
was to convene a task force of key stakeholders to help develop a 
workable system. We invited representatives from emergency departments, 
acute care sites, hospital infectious disease specialists, state health 
department infectious disease specialists, representatives from Zoo New 
England, Emergency Medical Services, the Poison Control Center, the 
Chief Medical Examiner, and others.
    As a group, we designed the Boston system to minimize the effort on 
the part of emergency department and other hospital-based personnel. We 
heard very clearly from emergency department directors that drop-in 
surveillance systems in which a separate additional sheet of 
information on each patient is required to be filled out by ED 
personnel are unworkable. The system works as follows. Each night the 
Medical Information Systems at each facility send to our secure web-
based server by FTP the number of persons seen in their Emergency 
Department or other acute care site. This figure is automatically 
compared to the expected number of visits for that site, adjusted for 
season of the year and day of the week. If it is higher than expected, 
a one page follow-up form is automatically sent to a pre-identified 
contact at the hospital.
    This form asks more detailed questions about the nature of the 
cases seen in the acute care site to determine if anything unusual is 
going on. We usually receive these completed forms back from hospitals 
within 1-2 hours. If a form is not returned from a site, the system 
automatically pages a contact at that site to obtain further 
information. This follow-up information determines whether or not 
further investigation is required. Hospital staff appreciate the fact 
that they are asked to take the time to provide detailed information 
only when the system indicates that something may be going on.
    In order to determine the normal volume thresholds as well as what 
is a statistically significant increase in volume for each site, we 
obtained retrospective data from all of the sites and analyzed it. To 
validate the system's ability to detect clusters of illness, we 
retrospectively compared volume spikes above threshold at sites with 
the first confirmed presence of influenza in Boston in 1999. Changes in 
volume detected using the system correlated well with the first 
laboratory confirmed case of influenza. We believe the system will give 
us early warning of other public health concerns, including a range of 
infectious diseases.
    While this volume-based system will not identify an isolated case, 
like the anthrax cases in other cities, the constant reminders that the 
system allows us to send health care providers increases the chances of 
timely reporting.
    Our experience in the last 6 weeks has also highlighted how this 
system provides important public health data. Although we have had no 
bioterrorist events in Boston, during the first week of reports of 
anthrax cases, we observed a surge in patient volume at several 
hospital sites. Follow-up investigation revealed that this was not due 
to any unusual clusters of symptoms, but rather to an influx of 
frightened people requesting nasal swabs and Cipro prescriptions, 
despite the absence of any confirmed or suspected anthrax exposure in 
Massachusetts. At the local health department, we used this information 
as an indicator of the need for increased public education and 
increased public information efforts.
    Because one of the most important purposes of the system is to 
create a flow of information between the health department and local 
health care providers, the Boston Public Health Commission, with the 
Surveillance Task Force, also developed a curriculum on bioterrorism 
for physicians and nurses. This educational initiative which began 
about a year and a half ago, uses a ``train the trainer'' model. The 
health department provides a CD containing slides as well as handouts 
to these trainers, who are physicians and nurses, to educate their 
peers. This training has been much in demand of late.
    Additionally, we use our electronic surveillance system to post and 
send regular clinical advisories and updates out to surveillance task 
force members and others, such as community health centers, college 
health centers, and Boston Emergency Medical Services. These guidelines 
have served as the foundation for protocols developed by local 
hospitals regarding medical management of patients with possible 
anthrax exposure.
    I believe Boston's system is replicable, with modifications, in 
other cities and regions, as well as on a statewide level. Our 
experience also has implications regarding what is needed for local 
health departments to maintain effective early warning systems as well 
as the ability to respond to public health events detected by 
surveillance systems.

1. Key stakeholders must be at the table to design the system.
2. The system should serve as a communication network as well as a 
        surveillance system.
3. The system should be simple, and as automatic as possible, so it is 
        ``doable'' for busy health care systems.
4. At the same time, it should account for the ``human factor,'' which 
        is essential both to maintain the system and to obtain the data 
        if the electronic system is delayed or temporarily not 
        functioning.
    I'd also like to share some thoughts about the broader implications 
of Boston's experience. Last week, Boston Mayor Menino and City public 
health and safety officials joined mayors from across the country at 
the U.S. Conference of Mayors Emergency, Safety, and Security Summit. 
The following suggestions combine public health recommendations from 
the Boston Public Health Commission and the U.S. Conference of Mayors 
National Action Plan for Safety and Security in America's Cities:

 The technical capabilities and communication infrastructure of 
        local health departments need to be improved. Our ability to 
        create this surveillance system was the result of a CDC grant. 
        Without federal funding, we could not have designed this 
        system.
 All local health departments should have access to 
        communications systems like Epi-X to receive ongoing timely 
        updates. Such a system is key to having accurate and timely 
        information from local public health officials, so we strongly 
        support full funding and expansion of the Health Alert Network.
 We need to think regionally about surveillance and 
        communication systems, and we need federal support to implement 
        such regional systems. Boston is currently in discussion with 
        surrounding communities about sharing and expanding our 
        surveillance system because the impact of an infectious disease 
        or bioterrorist incident will not end at city borders.
 Federal agencies should direct more funding to local 
        communities. National public health organizations recommend 
        that at least $835 million of the emergency bioterrorism 
        funding request go directly to local and state health 
        departments. Local communities must receive a significant 
        portion of that funding. Too often, local health departments 
        are left out of the equation, and we bear the major burden of 
        day-to-day response. For example, in Boston alone, the health 
        department anticipates spending $700,000 by the end of this 
        fiscal year on bioterrorism-related emergency medical service 
        response and the surveillance, epidemiology, communication, and 
        coordination activities of the communicable disease program.
 Federal funding should be flexible--we need to track and 
        respond to a range of public health concerns, including 
        bioterrorist agents as well as influenza and other emerging 
        problems.
 And local public health departments should be represented at 
        the table in national emergency planning. A permanent 
        commission including mayors, local public health officials, and 
        local public safety officials should be immediately established 
        by the Director of Homeland Security. Local official are on the 
        frontlines of homeland security, and it is essential to forge 
        direct lines of communication among the Office of Homeland 
        Security, federal agencies, and local governments.
    In closing, I again thank Chairman Greenwood and the Committee for 
inviting me to speak on behalf of local health departments, and I would 
be pleased to provide any further information in the future.

    Mr. Greenwood. Thank you, Dr. Barry. I appreciate your 
testimony as well, and coming here, and Dr. Davidson, you are 
recognized for 5 minutes for your testimony. Thank you for 
being with us as well.

                TESTIMONY OF ARTHUR J. DAVIDSON

    Mr. Davidson. Thank you. Mr. Chairman, and members of the 
committee, I am Arthur J. Davidson, a family physician, 
epidemiologist, and the Director of the Denver Public Health 
Informatics at Denver Health.
    I consider it a privilege to testify before the committee, 
providing a local perspective about our public health 
surveillance system. I guide Denver's public health 
surveillance activities, and am the principal investigator of 
the Denver Center for Public Health Preparedness, where I have 
been involved in the preparation and training from weapons of 
mass destruction over the past 2 years, including the planning 
and execution of Operation Top-Off.
    What I would like to do today is describe Denver Health as 
an example of how an integrated safety net system may play a 
role in public health surveillance, and then discuss linkages 
and potential barriers with other critical health care 
entities, including State and Federal systems.
    Denver Health is a highly integrated safety net 
institution, serving a quarter of Denver's half-million 
residents. Some of its components include Denver's emergency 
response system, an acute care hospital, neighborhood and 
school based health clinics, the public health department, and 
a regional poisonous center.
    Each of these entry points has capacity to contribute to 
surveillance activities. Linked by a unique patient identifier, 
an integrated electronic medical record includes patient 
demographics, image medical records, laboratory, radiology, 
pharmacy, and ancillary systems.
    Denver Health information technology investments have 
exceeded $100 million in the past 5 years. From an infomatics 
perspective, data achieves value through conversion to 
information that guides action.
    Examples of such action within Denver Health include 
electronic reporting of laboratory data to nurse 
epidemiologists for communicable disease surveillance and 
control; or patient-specific pharmacy adherence measures for 
tailored HIV outreach worker interventions.
    While these customized applications have value, our vision 
is to achieve even greater yield through building around 
industry standards. Denver Health, in collaboration with the 
Agency for Health Care Research and Quality, our information 
systems vendor, Siemens, and the CDC, are developing a real 
time method to identify patients at risk for tuberculosis, and 
then alert providers of screening guidelines using a 
standardized rules language.
    These partnerships seek to use our information 
infrastructure to enhance our return on investment by industry 
standard messaging. The ultimate goal is appropriate and timely 
surveillance data with less expended effort.
    Physician identification of disease remains a critical 
component of surveillance. Physicians must be informed to fill 
this role. CDC's health alert network, HAN, has been a wise 
investment, rapidly bringing the latest anthrax information to 
3,000 local health departments and beyond.
    In Denver, I personally disseminate these alerts to all 
health care providers, enabling heightened awareness. While 
disease surveillance is a time honored public health skill, the 
concept of syndromic surveillance is new.
    In Denver, we are testing this concept using an existing 
emergency department electronic data base, and with asthma as a 
disease model, we found symptoms surveillance to be less 
sensitive than diagnosis surveillance, but then more timely.
    While we found spikes and seasonal patterns, thresholds 
still need to be established to assist in interpretation. I 
believe the jury is still out on this one. Although an 
integrated health care delivery system with advanced 
information technology has much potential, these data must be 
integrated with other local, State, and Federal health care 
institutions for a truly robust surveillance system.
    Through preliminary discussions with local health 
maintenance organizations regarding electronic sharing of 
symptom and diagnosis data, issues of patient confidentiality 
have arisen to detect disease and guide local response to 
intentional biologic releases.
    We need laws that protect individual confidentiality, but 
do not inhibit information flow to protect the larger 
population. Your committee may wish to review HIPAA legislation 
toward modifying laws that excessively regulate information 
sharing for public health surveillance activities.
    Regarding Federal and State data linkages, CDC's national 
electronic disease surveillance system, NEDSS, provides a 
coordinated surveillance framework, developing standards and 
conceptual models that maximize information technology.
    Accepting health information industry standards will 
enhance electronic information transfer and capacity for 
automated electronic surveillance. In Colorado, NEDSS, HAN, and 
our center's preparedness funds, are coordinated to help build 
an integrated data repository, support direct laboratory 
transfer of data to the Colorado Electronic Disease Reporting 
System, or CEDRS, develop hand-held devices as surveillance 
tools, establish secure wireless CEDRS access, add geographic 
information functionality, and assure an informed Colorado 
public health work force.
    These are new and exciting challenges for a public health 
infrastructure that has been significantly under-funded in 
information technology for so long. While an effective early 
warning surveillance system is desirable, a major preparedness 
concern persists, insufficient surge capacity within the entire 
public health core system.
    Today, in the absence of a bioterrorist event, most Denver 
hospitals are at capacity, and often cannot receive ambulances. 
Denver Health typifies safety net health care systems with 
extremely tight financial status and no additional support to 
build capacity to respond after a terrorist attack.
    Given these comments, I want to thank Congress and the 
leadership of this committee for the efforts already 
accomplished. Exercises such as Operation Top-Off have proven 
invaluable to stimulate interest and planning for the 
unthinkable.
    CDC's efforts to build and utilize HAN, develop and 
disseminate NEDSS, and focus on work force development, are 
bright spots with real potential to improve operational 
readiness and surveillance capacity.
    However, as shown in numerous other industries information 
can drive feedback, quality control, and triggers for 
intervention. Such an integrated health data environment, with 
proper protection of individual confidentiality, should 
accelerate outbreak investigation, enhancing our public health 
response.
    Your committee has the opportunity to promote and encourage 
this data integration. You should build on these initial 
positive steps and expand capacity to achieve early warning 
systems in every community.
    In closing, I want to thank you, Mr. Chairman, and the 
committee, for this opportunity to discuss some issues of 
concern regarding early decisions detection and response to 
terrorist events at the local level.
    Mr. Chairman, this concludes my testimony, and I am pleased 
to answer any questions that you or the committee might have.
    [The prepared statement of Arthur J. Davidson follows:]
   Prepared Statement of Arthur J. Davidson, Director, Public Health 
              Informatics, Denver Public Health Department
    Mr. Chairman and members of the Committee, I am Arthur J. Davidson, 
a family physician, epidemiologist and Director of Public Health 
Informatics at Denver Health. I consider it a privilege to testify 
today before the Committee to provide a local perspective and concern 
about our public health system surveillance system and its role in our 
preparedness for bioterrorism. One of my roles is to guide Denver's 
public health surveillance activities and I am the principal 
investigator for one of three CDC-funded local health department 
projects, the Denver Center for Public Health Preparedness. For the 
last two years, I have been involved in the local preparation and 
training for weapons of mass destruction and was a participant in the 
planning and execution of Operation TopOff.
    What I would like to do is describe Denver Health's system as an 
example of how an integrated safety net system may play a role in 
public health surveillance, discuss linkages with other critical health 
care entities, the state and federal systems, and the barriers existing 
at each of these levels.
    Denver Health is a highly integrated safety net institution serving 
Denver, the state of Colorado and the Rocky Mountain Region. Some of 
its components (see attachment 1), which are relevant to today's 
discussion, include the 911 medical response system for the City and 
County, an acute care hospital with a regional trauma center, 10 
neighborhood health clinics, 13 school based clinics, the public health 
department and a regional poison center. This system has multiple entry 
points, each with capacity to contribute to surveillance initiatives. 
In addition, the system served more than one in four people in Denver 
last year and thus provides an ability to sample a large segment of the 
population at any given time. Care is provided by one group of employed 
academic physicians, enabling standardized approaches to monitoring, 
reporting and care. The system is linked by a single patient identifier 
and an electronic integrated medical record. The electronic record 
includes patient demographics, imaged medical records, laboratory data, 
radiology, pharmacy and ancillary systems. A picture of the information 
system is include with my remarks (see attachment 2). Denver Health's 
information technology investments have exceeded $100 million dollars 
in the last 5 years.
    We have begun to use and assess the ability of this system to serve 
as a public health and disease surveillance system and to improve 
health care delivery. From an informatics perspective, the true value 
of data can only be achieved through conversion to information that 
guides action. A few examples of such action within Denver Health 
include electronic reporting of laboratory data to Denver Public Health 
nurse epidemiologists for use in communicable disease surveillance and 
control. Patient-specific pharmacy adherence measures for prophylaxis 
and treatment regimens, are provided to HIV outreach workers to target 
interventions. Feedback to providers, using an immunization registry 
and administrative data, enhance efforts to keep children up to date 
with immunizations. While these customized applications have value, our 
vision is to achieve even greater yield through building around 
industry standards.
    In that regard, Denver Health has a task order from the Agency for 
Health Research and Quality to work with our information systems 
vendor, Siemens and the CDC to develop a methodology to identify 
patients at risk for tuberculosis and alert the providers of the need 
for tuberculosis screening. Preliminary data suggest that we may have 
as many as 12,000 at risk patients in our system. We are 
collaboratively developing a real-time system to alert care providers 
of needed action for tuberculosis screening using a standardized rules 
language. Appropriately applied rules can be powerful tools to change 
provider behavior or improve surveillance efforts. This rules-based 
surveillance approach has the potential to dramatically reduce the 
incidence of this important infectious disease. Our goal, and that of 
Siemens and CDC, is to seek ways to take advantage of our information 
infrastructure capabilities and enhance our return on investment. These 
partnerships can improve electronic communication and provide models 
for using industry standard Health Level 7 messaging and extensible 
markup language. The ultimate goal is appropriate and timely 
surveillance data with less expended effort.
    Currently and into the foreseeable future, physician identification 
of disease remains a critical component of surveillance. The two most 
recent nationally recognized emerging infections, West Nile Fever and 
anthrax were identified by astute clinicians. But physicians must be 
informed to fulfill this role. The Health Alert Network (HAN) 
exemplifies how we can wisely invest in infrastructure to quickly bring 
the latest information to the front lines. Now in it's third and final 
year, CDC continues to use the HAN daily, to inform and advise nearly 
3000 local health departments of the latest and rapidly changing 
developments since identifying anthrax released through the mail. In 
Denver, I personally disseminate these alerts to all health care 
providers enabling heightened awareness.
    While disease surveillance is a time-honored public health skill, 
the concept of syndromic surveillance is new and one worth a few 
specific comments. As part of our CDC-funded Center for Public Health 
Preparedness, we are still early in testing this concept. The goal 
would be to identify patterns of patient symptoms to alert public 
health care providers of potential illness. Using the chief complaint, 
recorded in an existing emergency department electronic database, we 
tested asthma as a model disease for our syndromic surveillance. We 
found symptom surveillance to be less sensitive than diagnosis 
surveillance but more timely. While we found spikes and seasonal 
patterns in asthma diagnosis, we need to establish thresholds to 
appropriately interpret the output from any symptom-based surveillance 
systems. Symptom data were easily collected as part of routine patient 
care in our integrated information systems, but a more structured 
format (rather than free text fields) would improve their surveillance 
utility. To date, we are just entering the evaluation stage. The jury 
is still out on this one.
    Although this integrated health care delivery system and its linked 
information technology has much potential, data from such a system must 
be integrated with that of other local, state and federal health care 
institutions for a truly robust surveillance system. A local public 
health system needs to share information across all local health care 
institutions for early recognition and ongoing monitoring of an 
epidemic. We have had preliminary discussions with some local health 
maintenance organizations regarding electronic sharing of symptom and 
diagnosis data. There no doubt will be hurdles regarding 
confidentiality before this is achieved. To detect disease, assess 
threat and guide local response to intentional biologic releases, we 
need laws that protect individual confidentiality but do not inhibit 
information flow to protect the larger population. Since September 
11th, with our national emergency, Congress and the President have 
modified laws that determine how information is shared between 
financial institutions and law enforcement and even diminished some 
civil liberties for the purpose of surveillance and national security. 
Given our recent tragedies, this seems reasonable and prudent. 
Similarly, your committee may wish to review HIPAA legislation toward 
modifying laws that excessively regulate information sharing for public 
health surveillance activities.
    Regarding federal and state data linkages, CDC is in the early 
phases of building the National Electronic Disease Surveillance System 
(NEDSS) to provide a coordinated surveillance framework. Bringing 
local, state and national health departments to the table, NEDSS has 
worked to acknowledge and accommodate our unique data needs while 
developing standards and conceptual models that maximize information 
technology. Defining common information system architectures improves 
our return on investment with decreased maintenance costs. Accepting 
standards, like those within the health information industry, enhances 
our capacity for electronic information transfer, whether that be 
laboratory data or other health-related data such as symptoms or 
diagnoses. If public health surveillance ascribes to these industry 
standards, health care information systems may be better interfaced for 
automated, electronic surveillance seeking syndrome patterns and/or 
diagnostic trends for earlier alerts of potential biologic or chemical 
releases.
    NEDSS within Colorado has permitted us to define a statewide, 
integrated data repository that becomes the hub for information 
organization. Our goal of direct laboratory transfer of data to the 
Colorado Electronic Disease Reporting Systems (CEDRS) is anticipated 
during this NEDSS funding cycle ending June 30, 2002. Direct laboratory 
reporting would improve surveillance completeness as busy clinicians 
are less likely to contact their local or state health department for a 
reportable disease. This should enhance early warning systems given 
improved reporting accuracy. However, laboratory reporting does not 
solve all surveillance needs as some demographic information (e.g., 
address of patient) would not be provided. With combined NEDSS/HAN 
funds, we are developing CEDRS geographic information system capacity 
to report visually based on space and time. Before achieving visual 
presentations of laboratory data, linkage with administrative databases 
for patient address would be necessary. This is a non-trivial task 
given issues of patient confidentiality.
    To improve the timeliness of reporting, we are working to develop 
and test alternative data entry mechanisms. Using Health Alert Network 
and Denver Center for Public Health Preparedness funds, efforts are 
under way to build applications on hand-held devices as surveillance 
data collection tools. Training and testing public health employee 
skills in adapting to these devices is in progress. We have plans to 
develop secure wireless access for rapid data entry into CEDRS from 
multiple surveillance sites (e.g., hospitals). The pilot projects, 
using readily available technology already incorporated in other 
industries are new and exciting challenges for a public health 
infrastructure that has been significantly under funded in information 
technology for so long.
    Making sure that the personal and public health care workforces are 
adequately informed and trained in these new technologies is essential. 
In many rural and smaller urban communities in my state, public health 
workers need training on how to best use the surveillance measures that 
they collect or receive. Even if we had perfect information systems, 
the poorly skilled public health worker may lack the knowledge to put 
that information to good use. Similarly, medical and public health 
sectors that address medical aspects of a biological or chemical 
terrorist attack, sorely lack knowledge and planning to deal with such 
an incident. Enhancement of CDC- and HRSA-funded programs to create a 
knowledgeable and prepared public health system workforce is now of 
central importance to our national security. Coordinated public health 
systems will require additional funding to support planning, readiness 
training and an equipped infrastructure to deal with medical 
consequences of weapons of mass destruction.
    While an effective early warning surveillance system is desirable, 
there remains a major preparedness concern regarding adequate resources 
or ``surge capacity'' within the entire public health core system. From 
Operation TopOff, our local hospital system quickly overloaded with 
patients infected with pneumonic plague. In Denver, over the last 
decade, cost-reduction and a competitive health care market have 
resulted in the loss of over 1000 hospital beds. Thus, at baseline even 
without a bioterrorist event, most Denver hospitals are at capacity and 
cannot receive ambulances on a normal day. Given recent events, we work 
to enhance our local readiness but Denver Health typifies safety-net 
health care systems with extremely tight financial status. Without 
additional support, public safety net hospitals, needed in a terrorist 
attack, will not have the necessary capacity to respond.
    Given these comments, I want to thank Congress and the leadership 
of this committee for the efforts already accomplished. The federal 
government's investment in local training and planning for a potential 
WMD event have in my opinion made significant strides in our awareness 
and preparedness. Exercises such as Operation TopOff have proven 
invaluable to stimulate interest and planning for the unthinkable. 
Efforts to build and utilize the Health Alert Network and disseminate 
National Electronic Disease Surveillance System plans from the CDC as 
well as workforce development by CDC and HRSA are bright spots with 
real potential to improve our operational readiness and surveillance 
capacity. Public health surveillance however can benefit even more from 
information technology. As has been shown in numerous other industries, 
information can drive feedback, quality control and triggers for 
intervention. That same technology, in an integrated health data 
environment, with proper protection of individual confidentiality, 
should accelerate outbreak identification enhancing our public health 
response. Your committee has the opportunity to promote and encourage 
that data integration. We should build on these initial positive steps 
and expand capacity to achieve early warning surveillance systems in 
every community.
    In closing, I would like to thank you, Mr. Chairman, and the 
Committee, for this opportunity to discuss some issues of concern to 
medical and public health communities in our preparedness for early 
detection and response to terrorist events at the local level. Mr. 
Chairman, this concludes my testimony. I am pleased to address any 
questions that you or the Committee might have.
[GRAPHIC] [TIFF OMITTED] 76304.001

    Mr. Greenwood. Thank you for your testimony, Doctor 
Davidson, and the Chair recognizes himself for 5 minutes for 
inquiry. Dr. Davidson, in your testimony, you said that while 
disease surveillance is a time honored public health skill, the 
concept of syndromic surveillance is new.
    The hypothesis that I think this hearing is meant to test 
is this one. It is that by it is possible to create, using 
state-of-the-art information systems, a nationwide early 
surveillance system that would by means of identifying spikes 
in early symptomatology for diseases that would result from a 
bioterrorist event, to get a head start and to move more 
quickly to deploy into that geographical location, or those 
geographical locations, and thereby diminish the infectious--
the rate of infection and save lives.
    And so that is the question that we are asking here, Dr. 
Davidson, and you also talked about a truly robust surveillance 
system, and I think that is what we are thinking about.
    So the question that I would like to pose to each of you is 
do you believe that that hypothesis is a valid one, and 
therefore would you in fact recommend to the Congress that what 
we do is as quickly as is practicable, without throwing money 
at the wall, but to do it as quickly as it is possible, build 
such an early surveillance system nationwide that would 
obviously have great value for health care in general, and for 
such diseases in general, but would be of particularly acute 
value in protecting our country from a bioterrorist event, and 
I will start with Dr. Broome.
    Mr. Davidson. Thank you, Mr. Chairman. I think your 
question is an excellent one, but I think the answer is not 
either/or. I do not think there is a single magic bullet which 
will address all surveillance issues.
    I think the critical issue is to be prepared to detect and 
respond to whatever may come along. If it is isolated single 
cases, as I have indicated, physician awareness, health care 
provider awareness, and contact with a strengthened local 
health department, and a public health infrastructure, is 
critical.
    If it is routine--for example, a low level contamination 
across a commercial food product--and let's go away from 
bioterrorism for a minute and just consider something that does 
happen, the kind of systematic information about specific 
cases--you are looking for the proverbial needle in a haystack, 
and the best way to do that is to be able to define the needle.
    It may not cause a big bump in disease. It may just cause a 
bump in a particular organism, and then finally you have the--
and that is the kind of effort that NEDSS is designed to 
address, among others.
    Then finally you have the potential that some of these 
supplementary surveillance systems might provide early warning 
information that would be more timely. But I agree with the 
other panelists that we need to look critically at what kinds 
of supplementary information would actually improve our ability 
to detect certain kinds of scenarios.
    Mr. Greenwood. Let me see if I understand what you said. I 
gather from what you are saying that it may--would I be 
paraphrasing you correctly if you said that it is necessary, 
but not a sufficient response?
    In other words, that it is worth doing this as long as we 
don't consider it to be sufficient, but rather a part of a 
broader approach to surveillance?
    Mr. Davidson. I think the critical elements of a 
surveillance system we know, and those are the first two points 
that I made; that we need to have educated capacity and 
information communication.
    And then second, we need to have a systematic collection of 
what you might call traditional surveillance information, but 
in a far more timely, less burdensome, and more precise, way.
    Then the final or third leg of the stool if you will is are 
there additional tools out there where we can benefit from 
syndrome surveillance technology and innovative approaches, and 
we are very interested in looking at those. But we think they 
need critical evaluation.
    Mr. Greenwood. Okay. Dr. Broome, would you respond to the 
same question, please?
    Ms. Broome. Yes. I think the timely identification of 
clusters of infectious disease is critical, and I think it is 
possible. The way our system works, all our 11 sites close 
their books at midnight essentially, and their MIS system beams 
one number to ours at the health department.
    We know by 1 a.m. if a site is over-threshold, and frankly, 
we can automatically page out to our onsite contact, but they 
would stop working with us if we made their beepers go off at 1 
a.m. all the time.
    So, typically at about 8 a.m., if a site has exceeded, they 
get a one page telling us so they can report to us if they have 
seen any type of syndromes. So I think it is helpful for us to 
identify changes in uses of health care very, very quickly in 
the city of Boston.
    And as I mentioned, we did pick that up with the influx of 
people looking for cipro and nasal swabs. One thing that you 
should be aware of is that once we believe there is a cluster, 
the story doesn't stop there.
    So we send out a one pager and Mass General, or whomever, 
reports back to us that we are seeing a cluster of febrile 
respiratory illness. That is one of our boxes that they could 
check on the one pager. I then need to have a public health 
nurse from the local health department then do more 
investigation.
    We think that something is going on now, and she or he 
needs to get a line listing on those cases, and find out what 
was common about those cases so we can start to take 
appropriate control measures and move along with diagnostics.
    I agree that the individual provider reporting is key in 
surveillance. You can't ever lose that. You have to have those 
providers. But I think that the cluster based systems, at least 
in my experience, can also do that.
    We are constantly on the incoming side hearing about 
excedences and threshold, and we also are feeding back to 
people: here are the symptoms of cutaneous anthrax, folks--post 
it in your emergency department, and here is who you call if 
you think that is what you have.
    So I think that we need to merge many of these components. 
Our system has been validated to date and we clearly need to 
more work in this area. But we have looked at patterns of 
influenza illness in the city of Boston using retrospective 
data from our surveillance system.
    And it turns out that what our system detected very well 
correlated with the first isolytes of influenza in the city of 
Boston in 1999. I think that there needs to be much more 
emphasis on data mining.
    You know, health care providers aren't going to fill out 
that extra sheet in the ED. We need to figure out how to suck 
out pieces from the medical record and have that make sense.
    And some of the folks in Boston have tried to do that or we 
are currently doing it. Once instance is that one of the 
fellows at a major hospital tried to electronically pull out 
RESP, standing for respiratory illness, electronically from 
records to see if that would help give us more information.
    And I think a lot more work in that area will provide us 
very useful information. We are also looking in some of our 
sites at the use of laboratory data, because hospital labs can 
tell you in a matter of hours how many of certain lab tests are 
being requested.
    So we are analyzing data from a few sites to say, well, 
they have ordered a lot more complete blood counts, and what is 
that telling us. So we think that he base for one of these 
systems, I feel pretty comfortable with what we have built, and 
if our funding doesn't drop out after these few years, I think 
we can use it to mine a lot more information.
    Mr. Greenwood. Thank you. Dr. Davidson.
    Mr. Davidson. Yes. I think I agree with the other panelists 
that our current systems for disease surveillance, where we are 
dependent on physicians, have been serving us fairly well 
throughout the--at least in the last years, the incident of 
anthrax was identified by an astute physician.
    And Westnow fever as well by astute physicians, and who 
have provided that front line for us.
    I have reservations still about the value of a syndromic 
surveillance system only because we have not tested it enough. 
We know that the systems that have been available for a long 
time are a way that our society has dealt with diseases for 
centuries.
    But for us to say that mining the data at this point has 
Dr. Barry mentions will definitely yield a benefit? I am 
uncertain. I think we still need to study this. I think that 
living in Denver, and working in a busy public care health 
system, physicians are overburdened with paperwork and 
activities just to get through their day.
    And to put another computer that will be collecting 
additional information in an emergency room is just untenable 
to my colleagues; to Dr. Cantrell, who Ms. DeGette mentioned 
earlier.
    I think that in terms of syndromic surveillance that we 
need to work to identify what are thresholds. Can we even 
establish a threshold. As we enter the influenza season, how 
does that threshold change if we are trying to look for 
symptoms consistent with inhalational anthrax.
    How will we respond. At present, Dr. Barry mentions using 
her system to inform and have the nurse epidemiologist conduct 
some surveillance activity. I wonder how that may change as we 
get further into the influenza epidemic.
    What will happen. How will the worried well be appearing 
and how will that impact on our need to act on syndromic 
surveillance monitoring.
    Mr. Greenwood. Thank you, Dr. Davidson. Dr. Broome, if you 
can be very brief, we have a vote on, and so we are going to 
try and work the time out here.
    Ms. Broome. Just very briefly. I was trying to also reframe 
it not as syndromic surveillance versus routine. You have to 
define what you are trying to find. We have a very interesting 
system which has automatically detected outbreaks, but it is 
based on detailed information about salmonella, a food borne 
disease.
    We picked up an outbreak in 13 States that nobody was aware 
of, but we needed to have not syndromic information, but 
detailed information about the pattern of isolation of that 
kind of salmonella. So it is complicated.
    Mr. Greenwood. Thank you. The Chair recognizes the 
gentleman from Florida, Mr. Deutsch, for 5 minutes for 
questions.
    Mr. Deutsch. Thank you. Dr. Broome, just to follow up, but 
I guess in a different capacity, what would you need to 
implement the national electronic disease surveillance system 
across all 50 States today?
    Ms. Broome. The implementation of this across all 50 States 
is partly a matter of the resources. That includes trained 
personnel and it includes being sure that information security 
is at a level that can handle this sensitive information.
    So there is certainly a monetary figure, but there is also 
a huge active role for our State and local partners in either 
working with the NEDSS bay system that I described, which is an 
option that the States can choose, or some States have 
developed their own solutions using the standards.
    Mr. Deutsch. So at this point, you are really just saying 
that it is a resource decision for us to make really. The 
bottom line is that based upon the positive effect you have 
seen in your test sites, it would appear as if there is almost 
no reason not to fully implement this system?
    Ms. Broome. We feel that this is a critical part of the 
public health infrastructure that it will support our local and 
State partners in detecting and responding to disease.
    Mr. Deutsch. Let me jump to some of the issues that I 
mentioned in my introduction, and really ask very specifically 
if there were cases of smallpox in American today, I that all 
of us understand at this point that if someone had a full case 
of smallpox that they would look very obvious, assuming they 
didn't wear makeup of some sort.
    Would it be possible to pick up a precursory of that a week 
before, 10 days before, 5 days before, because of a respiratory 
increase in hospitals in a certain location in America?
    Ms. Broome. As you are indicating, we have to be prepared 
for whatever might appear, and smallpox is very high on the 
list of syndromes. In the information that I mentioned, we do 
include information about early diagnosis of smallpox to our 
partners and to help care providers.
    The most--really, the only way to identify that smallpox is 
occurring is to pick up the very earliest stages of the rash.
    Mr. Deutsch. So the actual rash, as opposed to any other 
symptoms, would be the indicator?
    Ms. Broome. Essentially, yes.
    Mr. Deutsch. All right. So, Dr. Barry, you are shaking your 
head, and so basically the system doesn't really help with 
smallpox because we are back to a clinician basically picking 
up a phone and saying that I have got a patient with smallpox?
    Ms. Barry. Well, I think I have a patient with smallpox. I 
guess the point that I was trying to make earlier is that there 
are a lot of different scenarios for different diseases, and it 
is not going to be a one size fits all.
    Mr. Deutsch. And actually, Dr. Barry, do you want to 
respond to that, specifically the smallpox?
    Ms. Barry. Sure. I think it depends on how the smallpox 
exposure occurred. I think if someone did widespread 
dissemination of smallpox, you are going to have a whole 
cluster of people coming in to hospitals, and it is going to 
set off our threshold.
    But more importantly, I think because of the system, 
because of the surveillance system feeding back and forth to 
these health care providers, they are going to know who to call 
and say I have all these adults with what looks like chicken 
pox, but you know what, and that is how we are going to pick 
that up. So it could be an isolated case, but it could be quite 
a number of cases.
    Mr. Deutsch. Right. But I guess that the value of the 
system, in terms of basically bioterrorism, and it is not an 
unlimited number of agents that we are talking about, but for 
those particular agents I am trying to get a sense of--and as 
we are sort of in a funding mode, and let's just talk about 
bioterrorism.
    And not to say that the work that we are doing in all these 
other areas are not very significant; such as with influenza, 
and in terms of food poisoning, et cetera, but I am trying to 
get a sense of the value added in any of these other types of--
well, the plague.
    If there was an instance of plague in America, would we 
pick that up through this system. And related to that, I guess 
it is sort of a contrast between just a traditional clinical 
approach.
    I mean, one of the questions that I have, which is sort of 
a related question, is how much are we doing that on the public 
health side, and there are no physicians in America, I assume, 
who have seen the plague, because it has not existed, although 
we know that it exists in a sort of--in a bioterrorist world, 
but not in terms of the clinical world.
    Now, I assume that there is probably still some clinicians 
out there who have seen smallpox, but the percentage has to be 
extraordinarily low at this point in time. So I am trying to 
get a sense from the system that we have in place how does it 
help us from a bioterrorism perspective?
    Ms. Broome. But I think even though not all physicians have 
seen it personally, the whole point of some of the training 
materials is to make available, for example, descriptions of 
the rash form smallpox, and descriptions of typical x-rays for 
anthrax, and making physicians aware to look for hemostasis 
with plague.
    There are both pictorial and teaching aids which help us 
get from line physicians up to speed in both considering the 
diagnosis and then in being comfortable in making it. So that 
is a very explicit part of the material that has been developed 
with the support for bioterrorism preparedness.
    Mr. Deutsch. Dr. Davidson or Dr. Barry, did either one of 
you want to add to that? I know that my time is up as well, and 
this will be my last question.
    Mr. Davidson. In Denver, we are trying to inform our 
physicians, and we are working based on the CDC advice that we 
receive almost daily on the health alert network to build an 
algorithm that is useful within our own environment.
    Something that tells people exactly what to do, and who to 
call, and how do you evaluate if someone had a known exposure 
to anthrax spores, versus someone who is not. One of the 
clinical signs and symptoms that we would expect on how to 
evaluate a patient who comes in with concern, and whether they 
are symptomatic or not, and whether they need to get 
prophylactics or not.
    I think all of this information, even though I have not 
seen a case of anthrax, and I doubt that my colleagues have 
seen a case of anthrax, we now know how to deal with this. We 
are distributing that information. That sort of information 
provided to the front line is key.
    And that comes from a disease surveillance system that says 
we found cases, and now we need to act and give the information 
to our front lines.
    Ms. Barry. One thing that I wanted to add is that with our 
current surveillance system that we have a secure website, and 
so if Hospital A thinks they have seen a case of bubonic 
plague, I post an alert that says Hospital A has a 45 year old 
man who they suspect has plague, and do any of the other nine 
acute care hospitals in the city of Boston seen anything like 
this, and that goes up right away on our website.
    Mr. Greenwood. Thank you. The gentleman, Mr. Whitfield, is 
recognized for 5 minutes of inquiry.
    Mr. Whitfield. Mr. Chairman, I know that we have a vote 
pending, and so I won't take too long, but it is my 
understanding, of course, that smallpox is quite contagious, 
and would spread rapidly. And I suppose that the bubonic plague 
would be the same.
    And on the anthrax, it is my understanding that there is an 
abundant supply of drugs to deal with anthrax, but it is my 
understanding that there is a significant shortage to deal with 
smallpox; is that correct, if there was a mass outbreak of 
smallpox?
    Ms. Broome. For smallpox, the issue is the availability of 
vaccine.
    Mr. Whitfield. Right.
    Ms. Broome. And it is very complex assessing what the 
likely scenario is and using the available vaccine effectively, 
and being sure that we have sufficient quantities being 
produced.
    Mr. Whitfield. And we are making efforts to do that at this 
time?
    Ms. Broome. Yes.
    Mr. Whitfield. Okay. How would you compare our reporting 
system with, say, the reporting system in Europe?
    Ms. Broome. Well, maybe I am--well, anyway, I think the 
U.S. actually has invested in a reporting system which in many 
ways is a leader in terms of approaches from the public health 
side.
    I do think--and this was alluded to by Dr. Davidson--our 
ability to work with our health care colleagues to get 
information is a critical part of that. So we train providers, 
but to the extent that our health care information systems are 
more difficult to interface with, that does make life more 
difficult. So certain countries in Europe may have an easier 
time of getting that information.
    Mr. Whitfield. Dr. Davidson, you had touched on briefly the 
patient's right of privacy, versus the right to dispense 
information necessary to protect the public health. Do you 
consider there to be a significant problem in that area?
    Mr. Davidson. Well, as I mentioned, the local health 
maintenance organizations with whom we would like to 
collaborate on collecting symptom information and diagnosis 
information, they want to collaborate with us, but they are 
concerned about the HIPAA regulations.
    Mr. Whitfield. And do you feel that way, too, Dr. Barry and 
Dr. Broome?
    Ms. Barry. Well, our system to identify clusters, which the 
hospital MIS system, and not a health care provider, has to 
push to us is a number. It does not include names.
    We only get into looking for names once we have reason to 
believe that there is an outbreak, and then as we would do with 
an outbreak of anything, we have access to names as needed.
    Ms. Broome. I think also one of the things that the CDC is 
trying to do is be sure that people have accurate information 
about the HIPAA privacy regulation. In fact, the regulation 
permits the continued sharing of identifiable information 
needed for public health activities.
    There is certainly a level of concern and need for 
information in clarifying how that applies with some of these 
novel systems. So it is a very important issue, but the reg, 
per se, does permit legally authorized public health 
authorities to collect individually identifiable health 
information.
    Mr. Whitfield. So it is not a major concern from your 
perspective?
    Mr. Davidson. Let me just explain a little bit more because 
this gets back to the issue of syndromic surveillance. I agree 
with Dr. Broome that we can collect that information for 
reportable communicable diseases. There is no question about 
that. We have the right to do that.
    The question is around these syndromes or symptoms that we 
are looking for. Those are not required reportable diseases. 
How we use that when we want to figure out how many people does 
this really represent, and did someone call the nurse advice 
line more than once for the same patient.
    Did the person who presented to the nurse advice line then 
go to the emergency room and that is still the same patient. So 
we are looking for unduplicated counts, and not just numbers of 
people who may be in duplicate when we use multiple different 
surveillance pathways to collect and create this picture of 
syndromes or symptoms in the population. That is my concern.
    Ms. Barry. Just one thing. I think that the reporting 
requirements and the ability to follow up probably vary by 
State, and Massachusetts clusters, even without an identified 
agent or outbreaks, are reportable to the local health 
department.
    And we have the authority to follow up, even if there is 
not a specific agent, and even if there is just a cluster or 
outbreak of disease.
    Mr. Whitfield. Thank you very much. I see that my time has 
expired.
    Mr. Burr [presiding]. The gentleman's time has expired, and 
the Chair would recognize, if the gentlelady is ready.
    Ms. DeGette. One moment, please.
    Mr. Burr. I would be happy to go and let the gentlelady 
take a few minutes.
    Ms. DeGette. Okay. Well, that is what happens when you do 
tag-team questioning, you miss the answers.
    Mr. Burr. The gentlelady is recognized.
    Ms. DeGette. So I apologize if I re-ask some of the 
questions that have just been asked, but I am getting the 
sense, particularly from Dr. Barry and Dr. Davidson, that these 
syndromic surveillance systems are not really what you think is 
needed right now in local health departments.
    And I am wondering if you can talk specifically about why 
you think that might be the case. Dr. Barry.
    Ms. Barry. Well, I think that syndromic surveillance gives 
us an opportunity to identify many problems early on. However, 
in some sites, syndromic surveillance has been carried out by 
having people in the emergency department fill out a separate 
sheet on every patient that comes in and that is never going to 
fly, and certainly not in Boston.
    Ms. DeGette. Do you think it gives you any better 
diagnostic tools than the coordinated approach that you are 
using now, which by the way sounds very similar to what we are 
doing in Denver.
    Ms. Barry. I don't think it gives us enough of an advantage 
to try to put the burden on health care providers. I believe 
that the future here lies in mining data in already existing 
records that are coming in, and not in current syndromic 
surveillance.
    Ms. DeGette. Dr. Davidson. I would agree with Dr. Barry 
that we need to find systems that use already existing datasets 
to identify these clusters or symptom patterns. A concern of 
ours is that the infrastructure for routine disease 
surveillance using systems such as NEDSS needs to be expanded.
    We need to make sure that that is solid, and the syndromic 
surveillance system may assist, and I can't say whether it will 
or will not, but at this point I want to be sure that the 
fundamental surveillance systems that we have used for decades 
are improved and move into this 21st Century.
    Ms. DeGette. Well, I know that we have two of the shining 
stars here with Boston and Denver. Do you know--and perhaps, 
Dr. Broome, you can speak to this, but are there other health 
systems whose traditional methods of surveillance could be 
improved as Dr. Davidson suggests?
    Ms. Broome. Well, to me, I think it is extremely valuable 
to hear what is happening in Boston and in Denver, and to me 
this shows what can be done with resources and smart people, 
and a commitment.
    I wish that were true of every local health department in 
the country, and I hope that it will be true.
    Ms. DeGette. But do you think that the way to go to improve 
the coordinated responses in these other communities is through 
the techniques that Dr. Barry and Dr. Davidson talked about, or 
this syndromic surveillance system, or some other method?
    Ms. Broome. I think the two critical pieces are that there 
are resources to hire trained staff. The trained recognition 
capacity of a human being is still what I am counting on.
    Ms. DeGette. That is how we found the anthrax in Florida.
    Ms. Broome. The second is the kind of system that NEDSS 
represents is an automation, and it does have the electronic--
what Dr. Barry is calling data mining capacity built in, but it 
goes way beyond detecting flu like illness. It lets you find 
out if there is an increase in lab tests submitted for Anthrax 
testing.
    Ms. DeGette. Right.
    Ms. Broome. So it does have some of those capabilities, but 
in addition it supports the standard surveillance functions.
    Ms. DeGette. So it would seem to me that that would be a 
place where we should put our resources to helping the other 
municipal systems like that.
    Ms. Broome. We think that this will make a huge difference 
in capacity.
    Ms. DeGette. Okay. Thank you. Dr. Davidson--oh, you wanted 
to add something?
    Mr. Davidson. So that I think if we had a perfect robust 
information system is not enough. We need to have trained 
individuals who are able to use the data that come out of those 
systems or to look at those systems and say here is a pattern. 
I think we need to underscore training here, because in all of 
the health departments of the country there are insufficiently 
trained staff.
    We know that from within my own State that we have people 
for whom I can give information about surveillance activities 
that we have conducted, and they look at it as if it doesn't 
make sense. I think that is something that we need to focus on 
as well.
    Ms. DeGette. Thank you. Just one last question, although it 
is kind of a big question. Dr. Davidson, as I mentioned in my 
opening statement, when I visited--and I guess it was just last 
week, and it seems like about a month ago--with you and the 
rest of your crew over at Denver Health, what struck me was the 
highly integrated public health system you have put into place 
with your closed electronic system.
    And as a result the reporting of data is made easier. I 
wonder if you can let me know what challenges Denver Health 
encountered in establishing that system, and what lessons other 
systems who are less integrated can learn. If you can--I know 
that I spent 1\1/2\ hours, and maybe you can tell me just in a 
brief moment.
    Mr. Davidson. There are 50 years of history in making 
Denver Health what it is today. It started back in the late 
1940's when Florence Hayden decided to put the public health 
department inside of a personal health care agency, and we 
spanned from personal health care all the way to population 
bays for public health.
    The coming of the community health clinics in the 1960's 
then contributed an outpatient focus. I don't think that there 
is another institution in the country similar to Denver Health. 
I feel privileged to work there in an integrated system like 
that, but I think there is some lessons that can be learned.
    Keeping turfs separate makes for less integration. Finding 
standards to make better integration is very, very important. 
Making each information system adhere and ascribe to those 
standards is essential if we are ever going to be able to mine 
the data from each of these separate turfs that exist in most 
other cities.
    Ms. DeGette. And just for one example, the 911 reporting 
system goes into Denver Health, and not into the fire 
departments?
    Mr. Davidson. That's correct.
    Ms. DeGette. And so that helps you find early reporting on 
issues like this.
    Mr. Davidson. That's correct.
    Ms. DeGette. Thank you. Thank you very much for your 
indulgence, Mr. Chairman.
    Mr. Burr. The gentlelady's time has expired. The Chair 
would recognize himself for questions. Let me take this 
opportunity to welcome this panel since I chose to forego an 
opening statement so that we could get into the questions. So, 
Dr. Broome, welcome, and like Ms. Harman, we had an opportunity 
several weeks ago to visit you at the CDC in Atlanta from 
another committee.
    You mentioned the Florida detection, and how it was 
important it was that a health provider identified the problem 
and that that was certainly a key. If you will comment very 
briefly on the inability in Washington, DC, though health care 
providers treated two individuals, one of which I think has 
passed away, and tell us where the breakdown was there.
    Ms. Broome. I am afraid that the current events are under 
intense investigation, and it really would not be appropriate 
for me to comment on the details.
    Mr. Burr. Well, let me ask it in a different fashion if I 
can. Was there a city in America where more education was done 
on the risk that existed, and the symptoms that went along, the 
profile of where one worked, that we would have felt confident 
that every health provider would have seen this matrix that we 
were looking at, and if anybody was close to the line would 
have said this is one that we need to look at. Clearly that was 
not done.
    Ms. Broome. It is an ongoing challenge. I mean, education 
is not something that happens once, and people are perfectly 
informed and clearly we are trying to reach every deliverer of 
health care in the country. That is an enormous task that we 
are continually trying to look at better ways to do.
    I think that it is also important to point out that the 
kind of initial symptoms can be non-specific and can vary. So 
we do not minimize the challenge of doing this. I have enormous 
respect for the folks who are on the front lines and who are 
trying to do an incredibly difficult job.
    Mr. Burr. As I do, and this is not a shot at any attending 
physician that saw these individuals, but I think you made my 
point for me, is that we can't rely just on the provider 
network to identify something that we feel we have successfully 
communicated to a health delivery network.
    And if it just happens to be a bad day and somebody misses 
something, or there was an individual that was not included in 
the dissemination of the information that you distributed or 
that the public health distributed, then we have a potential 
problem.
    And were this a contagious pathogen that we dealt with, 
that problem would be magnified greatly. Therefore, there are a 
lot of tools out there that we not only can use, we should use, 
and we should find a fast way to incorporate them.
    I am a little curious on NEDSS, because this is a program 
that the CDC has been focused on since 1999, I think, when it 
was first talked about or initiated, and our goal was 20 
States. I think everybody's goal is probably 50 States now, or 
I hope it is.
    Ms. Broome. Well, we received Congressional funding in 2000 
to move ahead with NEDSS, and we actually have funded all 50 
States, six cities, and one territory, for at least planning 
functions.
    Mr. Burr. But the connectivity of these States is the 
crucial thing. I mean, we still haves a third of public health 
in America not technologically connected to CDC. So, two-thirds 
are covered and for a third, we have to rely on another means 
other than your internal tools to disseminate information or 
warnings.
    Ms. Broome. Well, I think it is important to also focus on 
the systems that Dr. Davidson and Dr. Barry have mentioned, in 
terms of the urgent communications, and building the 
connectivity with the local health departments.
    The health alert network support from Congress, and the 
Epi-X secure communications systems, are also critical parts of 
getting this information out.
    NEDSS is--and forgive me if I get too much into the jargon, 
but NEDSS is a tougher job. It is basically using standards to 
actually collect the raw data that will help inform the 
decisions, and that will give us what we want to communicate to 
our partners.
    Mr. Burr. The real capabilities that we have is data. I 
mean, that really is a key to our ability to understand what is 
going on isn't it?
    Ms. Broome. Well, I think it is, because it also can take 
information, and not just from providers, but it also can take 
information from laboratories, and it can take information 
about what is going on.
    So we do see this as a critical part, but it takes more 
time to get that kind of complex system to functionality.
    Mr. Burr. HHS has received $1.5 billion out of the $20 
billion emergency bioterrorism money. Of that, my understanding 
is that $40 million by CDC is directed toward preparedness, 
NEDSS, health alert network, and other things.
    Now, of the money that is left over after the stockpile, 
which is $1.1 billion, there is $400 million. So, less than 10 
percent of the bioterrorism emergency money is directed to the 
thing that all of you, and I think all of us, would agree is 
the most crucial challenge that we have today to put in place.
    Why only 10 percent of over and above the stockpile money 
is devoted to this crucial effort?
    Ms. Broome. I think that is a good question.
    Mr. Burr. And I don't want to put you on the spot if the 
question is something that needs to be answered by somebody 
else, and I assure you that the Secretary will be in next week, 
and I am sure that he will get this question.
    But if it is important that 50 States be connected, and we 
see that as a first step to our ability to rebuild our public 
health infrastructure, and to make sure that the dissemination 
of information about potential biologic attacks in fact is 
transmitted, then it seems like the single greatest thing that 
this Congress and the CDC can do is to take enough money and 
devote it to connectivity of public health with our Federal 
entities.
    And to make sure that at least we can get this information, 
or in the reverse, at least they can access the data that they 
need to successfully monitor public health in their communities 
and localities that they live in.
    So I am a little bit troubled in the fact that maybe in 
your testimony or in CDC's public statements you should be out 
there demanding to extend this to 50 States today. You can take 
that back in whatever form you would like to Jeff, and to the 
rest of them, and I will certainly take it to the Secretary.
    My time has expired, and the Chair would recognize Mr. 
Stupak for questions.
    Mr. Stupak. Thank you. You know, as I sat here and listened 
to the testimony, and looked forward to the testimony, 
especially from Dr. Barry and Dr. Davidson, I got the 
impression that we don't really need NEDSS.
    And that there is a system in place now that works that the 
money should really go toward providing stuff at the local 
level, and not another federally developed system, and with it, 
Federal regulations, and with it more reporting on doctors and 
health care professionals.
    And, of course, the money never really gets back to the 
local people. Is that a fair summation?
    Mr. Davidson. I would say not. I think from a local public 
health perspective as a Director of Public Health Informatics, 
NEDSS is my hope for the future. The current systems that we 
have are probably--I think a dozen, that are CDC developed 
systems that require intensive maintenance on a daily basis in 
a local health department.
    Having 12 systems built with different standards and in 
different languages is very labor intensive at a local health 
department. Having a system that is common across all the 
surveillance activities that we do is important for us not to 
expend effort when we don't need to.
    Making everything come together with a standard language on 
operating assumptions, and all the necessary requirements for a 
information system is important at a local level.
    So from my perspective, NEDSS brings an integration. It 
reduces the burden locally, and I feel that while we certainly 
do need local public health infrastructure support, we need 
guidance to make that happen not only in a local area, but with 
our State partner and our Federal partners as well.
    Mr. Stupak. Dr. Barry, did you want to comment?
    Ms. Barry. I certainly am in favor of data consistency 
among systems, and from my perspective I really haven't as a 
local health department been involved in NEDSS at all, and what 
I think what we need right now in the city of Boston is the 
ability to expand and keep building our local surveillance 
system, which I would be very happy to connect to NEDSS, or 
whatever other consistent system will provide the most data for 
us nationally.
    Mr. Stupak. I went back before the hearing and checked with 
my local folks, and I have got a very rural area. My biggest 
city is 20,000 and I am rural. They just saw this as another 
Federal program that would do nothing for them.
    They need quarantine rooms, and they need supplies, and 
they need things like that at the local level so that if an 
epidemic does start, there is something there. We had testimony 
here about 3 weeks ago from an expert who testified before us, 
a Dr. Smithson, and basically they said, look, last year you 
appropriated $8.7 billion in your terrorism appropriations, but 
only 300 ever made it past the Beltway in Washington, $300 
million out of $8.7 billion.
    So, $8.4 billion stayed here in Washington, and I am real 
skeptical. Are we building another system where all the money 
is going to go to a few places, and cost us hundreds of 
millions of dollars, and nothing gets to local people where 
they really need it.
    Ms. Broome. We also think that local health departments are 
where the action is, and 75 percent of NEDSS funding has gone 
to State and local partners because we think they are the folks 
who need systems.
    Some of those State health departments are building their 
own systems, but as Dr. Davidson has pointed out, NEDSS 
provides standards for them to use in building those systems so 
that they can connect with the health care sector, and so they 
can do the data mining that Dr. Barry was mentioning.
    However, some States don't feel that they have the 
resources or the capacity to build their own systems. So they 
explicitly asked CDC to create an option that they could use. 
But I think it is very important that this is not building 
another Federal stove pipe of the kind that Dr. Davidson 
described.
    That is sort of past history of these categorical systems. 
It is based on modern infomatics standards, and it uses state-
of-the-art commercial software packages. You can drop in the 
leading mapping software so that that local health department 
will be able to take the data and actually use it to see where 
things are occurring in their district.
    And that also lets them hire people and use them for 
intelligent activities rather than data entry.
    Mr. Stupak. So that 75 percent you said that went to 
locals, was that just to set up the system, or are you paying 
the salary of these local people? And Dr. Davidson said this 
would be very labor intensive, and you need people there.
    In small areas like mine, if you want to hire one person 
and dedicate it to it, that is something out of our budget.
    Ms. Broome. Well, in fact, the NEDSS' awards include 
funding for skilled information technology personnel, because 
that capacity has not been available at State health 
departments in a number of the smaller States.
    Mr. Stupak. And how long is that for, just to set up the 
program?
    Ms. Broome. Pardon?
    Mr. Stupak. How long is that for, that contracting of 
personnel?
    Ms. Broome. It is built into the NEDSS awards, and it will 
depend on the duration of Congressional support. But we also 
see in many settings as people realize the value of these 
information systems very--it has made a change in local and 
State investment in this infrastructure.
    So, for example, the State of Missouri has invested major 
State funding in their information system because they see the 
value of it. So I see the Federal funds as providing real 
benefit, but also providing and leveraging additional resources 
for this critical function.
    Mr. Greenwood. The gentleman's time has expired, and the 
Chair recognizes the gentleman from Florida, for 5 minutes of 
inquiry.
    Mr. Stearns. Mr. Chairman, thank you. Dr. Broome, the 
initial version of NEDSS that will be implemented next year in 
20 States as I understand it will not contain what you 
described as aberration software, which is the ability to 
automatically sort and review the data for unusual activity, 
considering where we are at, why not? As I understand it this 
software is commercially available, and is already in use in 
some parts of this country.
    Ms. Broome. I would like to clarify that the 20 States are 
the States that have requested and have been funded for the 
NEDSS base system, which is this NEDSS compatible platform that 
we are developing. An additional 16 States have received 
funding to develop NEDSS compatible systems or to modify 
existing systems.
    So there are actually 36 States in the development phase. I 
am sorry that was not clear. In terms of the aberration 
detection software, this is a target for inclusion in NEDSS, 
and we will be looking at a range of commercially available 
tools, tools developed by a range of entities, such as the 
Department of Defense, to see which ones are appropriate.
    Because of the standards based approach to developing 
NEDSS, it is very feasible to drop in software which has been 
developed according to industry standards for interoperability. 
Now, your question is, okay, why isn't it done now, and that 
is----
    Mr. Stearns. Well, just a sense of urgency in when are you 
going to do this. I mean, you can drop it in, but the question 
is when is this going to occur.
    Ms. Broome. We do think that the first absolute priority is 
getting basic capacity out to all 50 States. At the same time, 
we----
    Mr. Stearns. And when would that be, that all 50 States 
would have the basic capacity?
    Ms. Broome. Well, with the resources that we have, we will 
be deploying in 20 States in 2002. We would certainly--we have 
certainly proposed ways to accelerate that.
    Mr. Stearns. And so you are saying today that you will 
accelerate it?
    Ms. Broome. With the resources, yes, we will accelerate it.
    Mr. Stearns. Dr. Broome, NEDSS, even when implemented, will 
only be as good as the data input into it by local health care 
practitioners and health departments. In this vein, you discuss 
CDC's funding of special surveillance systems at the State and 
local level, and how these systems have actually been put into 
place since September 11.
    Can you discuss in more detail what the benefits and 
shortcomings of these systems have been in this real world 
test, and what advantages they offer beyond NEDSS? And I would 
like the other witnesses to respond as well.
    Ms. Broome. First of all, I would like to clarify. NEDSS 
does permit inputting by practitioners over the web, but it 
also permits electronic input. Data from a clinical laboratory 
can be sent electronically without having to have a person 
think, oh, here is a reportable disease.
    We can automatically get all appropriate information about 
specimens or conditions. So it actually represents a real step 
forward in one of the big problems----
    Mr. Stearns. So a clinical laboratory could input it 
through the web?
    Ms. Broome. No, they don't have to do anything.
    Mr. Stearns. They just are going to do it through the 
telephone?
    Ms. Broome. No, no. This is basically--well, we are working 
with the multi-jurisdictional laboratories which cover 
basically all the States, and for them to send out an automatic 
electronic message over the Internet, appropriately encrypted 
and secure, that would be routed to the State health 
departments basically as soon as that laboratory result, or 
even a specimen, is submitted.
    So this means that it is just a huge step forward in the 
speed and completeness, and accuracy, and the ease with which 
relevant information can get to the people who need it at State 
and local health departments.
    So there is a real difference. It's not just counting on 
that overburdened physician to actually report a case. Your 
question then was what about NEDSS and what about these other 
alternate approaches to surveillance.
    Mr. Stearns. Particularly in light of what happened in 
September.
    Ms. Broome. First of all, we did support these pilots with 
the very first bioterrorism--with these surveillance grants. So 
those have been undertaken by States since late 1999/2000. 
There has been a range of sources looked at, and I think the 
kind of experience that you are hearing from Dr. Barry is 
really very useful in looking at how they might be useful.
    We have had other folks discover that some of the 
information that they were getting from their heightened 
surveillance was not timely. Some of the sources they thought 
might be promising either were not feasible or not timely.
    What we are doing is collecting systematic information on 
these pilots to try to provide some broader guidance about what 
worked and what didn't work.
    Mr. Stearns. Dr. Barry.
    Ms. Barry. Yes. I would like to comment that we were one of 
those special surveillance sites that was funded with the 
initial CDC funding in 1999, and have really tried to look 
locally in very creative ways to build a system that is not 
going to burden people.
    In our current system the ED people don't have to do 
anything. The MIS just sends us that data. So there are some 
aspects of the system that I think might be useful to other 
localities.
    Mr. Stearns. Dr. Davidson.
    Mr. Davidson. Since September 11, there have been 
relatively few changes in terms of NEDSS activities within the 
State. We still are targeting completion of laboratory 
reporting from the State labs into our version of NEDSS, called 
Colorado Electronic Disease Reporting System, by the end of 
this fiscal year, and that would be June 30, 2002.
    So our goal is still to achieve that, but we have not been 
able to accelerate that in the last 6 weeks. That is a 
difficult project. It is not easy to make these systems talk to 
one another.
    Mr. Greenwood. The gentleman from Florida's time has 
expired, and the Chair recognizes the gentleman from Illinois, 
Mr. Rush, for 5 minutes of inquiry.
    Mr. Rush. Thank you, Mr. Chairman. I want to commend not 
only you, but also the witnesses, for this hearing and for the 
testimony that they have provided so far. I have a couple of 
questions that I would like to ask both Dr. Davidson and Dr. 
Barry.
    You have stated, and I guess everyone can agree, that the 
ability to identify a bioterrorist attack depends on the 
ability to diagnose medical conditions. And we have also 
further agreed that this requires a laboratory test at the 
local level spanning the entire Nation.
    My question is do local health departments have access to 
the modern up-to-date labs, and if they don't, what resources 
do the local health departments need in order to make sure that 
they are up to speed, and that they can provide the most 
accurate and up-to-date laboratory tests that is possible?
    Ms. Barry. I think for many conditions a laboratory 
diagnosis is not going to be the most important feature. It is 
going to be the number of people with a clinical syndrome. But 
with regard to laboratory----
    Mr. Rush. A clinical syndrome?
    Ms. Barry. A clinical syndrome. So, even if we don't know 
what is causing all those people to have fever and pneumonia, 
we realize that we have a problem. With regard to laboratories, 
we are very fortunate to have the Massachusetts State 
Laboratory Institute, which has also received funding from CDC, 
to be in the network to be able to identify for us very quickly 
agents of concern for bioterrorism. It works very well, that 
system.
    Mr. Davidson. Within Colorado, we have an excellent 
laboratory as well, and the State lab has been the recipient of 
Federal funds. The epidemiologic laboratory capacity program, I 
think it is, that you have supported in the past, and currently 
through the larger bioterrorism preparedness grant, there is 
support for the laboratory as well.
    We are using NEDSS funds to support development of a 
laboratory information system. I think that the capacity to do 
the diagnostic testing is there, at least in Colorado.
    Mr. Rush. Dr. Broome.
    Ms. Broome. I am really delighted that you asked this 
question, because the laboratory really is a critical partner 
in this. I agree with Dr. Barry that sometimes you would love 
to do it before the laboratory makes the diagnosis, but that is 
the backup, and it also gives you specific information.
    So I consider it a critical part of the system, and it is 
one which requires particular attention. In addition to the 
funding and programs that Dr. Davidson mentioned, we also have 
made available on the web information that laboratories can use 
about what procedures to use.
    They can order reagents so that they can diagnose these 
conditions, and there is a network set up so that there is a 
way for a State to decide how they want to organize their 
laboratory system and get the information, and testing 
materials that they need.
    And then finally this information is most valuable if it 
can get into the surveillance information systems that we are 
talking about. So again this is a place where we need to be 
integrated, and where we have to be able to take the results of 
testing and be sure it gets to the people who need to use those 
results.
    Mr. Rush. And can we assume that if we have an adequate lab 
system that we can assume that there would be an adequate 
number of trained lab technicians, or is that too much of an 
assumption?
    Ms. Broome. I think as with all of these that you have 
areas that are very well equipped and staffed. But we are 
talking about the country, and a country-wide system, and that 
is where you really have to be thoughtful about the resources 
that are needed so that there are the trained personnel, and so 
that they have the laboratories, and they have the biosafety 
capacity, and they have the information systems to participate 
in a national network.
    Mr. Rush. If one thing that has come out of our tragedy of 
September 11, or one good thing, is the focus on the local 
public health system. And I think that we need to take this 
opportunity to strengthen our public health system for the long 
term.
    And I wanted to ask you what long term changes should we 
make to our surveillance system, particularly at the local 
level, but also where they want us to focus on, and the two-
tiered health system in this country.
    And whereby--and maybe you could tell me the impact, the 
possible impact that you can envision, because there is a 
significant population segment in our Nation that is not really 
adequately tuned into the public health system or to the 
private health system.
    And I will just give you an example. Maybe it is not 
congruent, but about 6 years ago in my city, there was a heat 
epidemic. And 700 people died from heat stroke. I mean, 
something that could be readily identifiable, but yet still it 
took my city at least--well, longer than necessary--a week or 2 
weeks, to really get in front of the issue and respond.
    And I am trying--I believe that this kind of example will 
be duplicated many times if in fact a bioterrorist attack or a 
natural tragedy will occur. And I just want you to respond to 
what can we do to buttress the public health system in order to 
make it touch as many Americans, or more Americans than it 
currently touches?
    Ms. Barry. Well, I think you have touched on a critical 
characteristic of the public health system, and that is that it 
has to cover the whole population. It has to be able to detect 
health problems wherever they may occur, and it has to be able 
to respond to protect the health of the entire population.
    I do think that there are ways in which the kind of 
information systems that we have been talking about, and the 
kind of response systems, are truly population based. The 
challenge really is to be sure that all local health 
departments and that the medical care delivery system is there 
to participate.
    Mr. Rush. Dr. Broome, would you care to respond?
    Ms. Broome. Yes. What I would say is please give us some 
funding at the local level so that we can hire nurses, so we 
can hire outreach workers. You know, if we have an event in the 
city of Boston, we have a very large Haitian community.
    Somebody has got to be able to speak to that community, and 
go out to that neighborhood, and speak to those folks, and help 
them out. Right now I am the only infectious disease physician 
in the City Health Department in Boston.
    And it is a resource issue. We need direct funding to the 
local health department to take care of those very people that 
you are talking about.
    Mr. Rush. Dr. Davidson.
    Mr. Davidson. I agree with my colleagues. We definitely 
need more support at the local health department level, but I 
think to answer some of the questions that you asked earlier, 
you need to support the safety net institutions.
    You can't expect people to show up at an emergency room and 
wait a dozen hours, and then say, well, you have to wait 
another 10 hours because there is just too many people in front 
of me.
    I think we need to have institutions that can be responsive 
to those patients who were suffering from heat stroke, and I am 
sure that the emergency rooms were overwhelmed, and the 
community health centers were overwhelmed, and the hospitals 
had insufficient beds.
    So if we are talking about dealing with a large issue in 
the public health infrastructure, it spans all the way from the 
local health department as Dr. Barry just mentioned, all the 
way to those safety net institutions.
    Mr. Greenwood. The gentleman's time has expired, and all 
the questioning for this panel has expired. So we thank you 
again, each of you, for coming, and for helping us to 
understand this complex issue, and you are excused.
    We will now call up the second panel, and it will take a 
couple of minutes for the second panel to set up some of their 
equipment for demonstrations.
    [Brief recess.]
    Mr. Greenwood. While we are waiting for Dr. Wagner to 
arrive, I will introduce the witnesses for our second panel. 
They are Dr. Alan P. Zelicoff, who is the senior scientist at 
the Center for National Security and Arms Control, at Sandia 
National Laboratories.
    And, Mr. Zelicoff, let me tell you that Congresswoman 
Heather Wilson had hoped to be here to introduce you, and have 
some questions for you, but she is tied up at the White House.
    Also, we are pleased to have Dr. Michael Wagner, Director 
of the RODS Laboratory, Center for Biomedical Informatics, from 
the University of Pittsburgh; and Mr. John S. Russell, 
Executive Vice President and General Counsel of Quintiles 
Transnational, which is from North Carolina.
    And we thank each of you for coming. I think that you have 
been informed that this is an investigative hearing, and it is 
our custom to hold to ask the witnesses to provide their 
testimony under oath. Do any of you have an objection to 
offering your testimony under oath?
    [No response.]
    Mr. Greenwood. You should then be advised that under the 
rules of this committee and the rules of the House, you have 
the right to be represented by counsel. Do any of you choose to 
be represented by counsel?
    [No response.]
    Mr. Greenwood. Seeing no such desire, then I would ask you 
to rise and I will administer the oath.
    [Witnesses sworn.]
    Mr. Greenwood. Okay. So saying, you are now under oath, and 
you may give your testimony, and I will start with you, Dr. 
Wagner. You are recognized for 5 minutes for your testimony. 
Thank you for being here.

  TESTIMONY OF MICHAEL M. WAGNER, DIRECTOR, RODS LABORATORY, 
 CENTER FOR BIOMEDICAL INFORMATICS, UNIVERSITY OF PITTSBURGH; 
    ALAN P. ZELICOFF, SENIOR SCIENTIST, CENTER FOR NATIONAL 
 SECURITY AND ARMS CONTROL, SANDIA NATIONAL LABORATORIES; AND 
JOHN S. RUSSELL, EXECUTIVE VICE PRESIDENT AND GENERAL COUNSEL, 
                    QUINTILES TRANSNATIONAL

    Mr. Wagner. Good morning, Mr. Chairman, and members of the 
subcommittee. My name is Michael Wagner, and I am a Physician 
and Assistant Professor of Medicine at the University of 
Pittsburgh.
    My training is in the fields of internal medicine and 
medical infomatics and artificial intelligence, and for the 2 
years my research has been focused exclusively on the building 
of an early warning system for detection of outbreaks of 
disease.
    I wish to thank the subcommittee for this opportunity to 
share information with you. The research that I am going to 
describe has been funded by the National Laboratory of 
Medicine, and the Agency for Health Care Research and Quality, 
and the Centers for Disease Control and Prevention, and the 
Defense Advanced Research Projects Agency.
    Please note that the views that I express today are my own, 
and not necessarily those of the agencies. In our research on 
early warning systems, we have been concerned about early 
detection of disease outbreaks caused by medium-to-large scale 
bioaerosol releases of anthrax, smallpox, plague, or any other 
aerosolizable agent.
    With this type of outbreak, early notice of detection is of 
paramount importance, and our improvement in early notice can 
translate into scores of lives saved. A product of this 
research is a system named RODS, which stands for real time 
outbreak and disease surveillance. It is an early warning 
system that has been deployed in Western Pennsylvania for 2 
years.
    The key feature of RODS is that it receives data directly 
and without delay from computers in emergency departments and 
hospitals. This anonymous data includes patient's symptoms, 
age, gender, address information, and results of tests.
    The data are transferred directly computer to computer, 
which means that seconds after a patient registers in an 
emergency department complaining of a cough, this fact is 
pooled with data from other patients in the region at a central 
location, and is available for automatic analysis.
    At present, RODS emphasizes data collection from emergency 
rooms and hospitals monitoring 800 visits per day for like 
symptoms of diarrhea, rash, and other key symptoms, and all the 
approach is general, and it can include data collection from 
other computer sources, such as direct entry of case reports by 
clinicians.
    The earliest of detections approach is achieved first by 
identifying as many people in the region as early as possible 
in their disease process while they have non-specific symptoms, 
such as cough or diarrhea, and then by using brute force 
computer power to find any interesting patterns among the sick 
individuals that would suggest an unusual outbreak is 
occurring.
    An interesting pattern, for example, might be an unusually 
high number of sick people in the past 24 hours who happen to 
live in the same zip code area. Our design for the RODS system 
was heavily influenced by prior work in the field of medical 
infomatics.
    From this experience, we knew that the most important 
ingredient for success would be obtaining the right data 
electronically in real time and without asking doctors to fill 
out forms or enter data into computers.
    We knew that computers in emergency rooms and hospitals 
would be able to provide useful data through standard computer-
to-computer interfaces. We also knew the importance of 
standards in building early warning systems, especially those 
having regional, State, and national coverage.
    We ascribe to the standards now recommended by the National 
Electronic Disease Surveillance System project, and we think 
that those standards are excellent. One new lesson that we have 
learned from the research is that health departments may have 
limited resources to do this kind of work due to their front 
line responsibilities.
    And that this problem in our case can be addressed by the 
creation of a trusted broker, which is an administrative entity 
created by a memorandum of understanding with the health 
department that allows pooling of data regionally for mutual 
defense.
    Another lesson from the research is the central importance 
of obtaining data about patient's symptoms even earlier than at 
present, even before they seek emergency care.
    Other lessons include the importance of large 
interdisciplinary research groups with experience in medical 
infomatics, public health, computer science, statistics, 
emergency response, and to conduct the research in as big a 
region as possible so that there is sufficient data available 
about naturally occurring outbreaks for system validation.
    So as a result of my basic and implied research on early 
warning systems for public health surveillance, I would like to 
offer the following recommendations to the subcommittee.
    First, Congress should provide funding directly to ongoing 
regional efforts to build early warning systems, and not 
necessarily limit it to those that are affiliated with health 
departments, and not necessarily funding all the money through 
State and local health departments, although that basically is 
a very sound approach.
    And stipulate that every funded project adhere to the 
National Electronic Disease Surveillance System standards. The 
rationale for this recommendation is that the regional efforts 
will be most effective in obtaining access to the data needed 
for early detection.
    And additionally the reality is that right now that many of 
these research projects are being called on to rapidly deploy 
and provide reliable 7-by-24 services in defense of the 
community without sufficient resources to take on the task.
    My second recommendation is that in the near term the 
greatest improvement in capability will depend on obtaining 
information from or about sick individuals as early as possible 
in their illness.
    There are many potential ways to do this, and therefore the 
Nation's health systems need to conduct research to find 
workable solutions. The Congress should fund centers of 
excellence to do this research, and these centers need to be 
interdisciplinary and need to have multiple year funding.
    And Congress may need to prove incentives for specific 
industries with needed data to construct real time privacy 
protected data feeds. Congress may need to also enact 
legislation to facilitate data collection that balances the 
needs of the community for defense, with the rights of 
individuals to confidentiality.
    My last recommendation is that Congress should encourage 
through Federal funding several regions to participate in an 
intensive level in early warning research. The reason is that 
the field of bio-defense is a lot like the field of particle 
physics, by which I mean that a large particle accelerator is 
necessary to answer certain questions in particle physics and 
in the field of bio-defense, a very large region with rich, 
multi-year datasets, are needed to persist in validation and 
hypothesis testing.
    In closing, I would suggest that Congress note that 
developing very early detection of major public health threats 
is an ambitious scientific undertaking that resembles in both 
urgency and technological breathe the space race in the 1960's 
and the Manhattan Project in the 1940's.
    And that there are lessons to be learned from those 
projects, such as the value of having clear goal statements, 
such as short term objectives to reduce detection time by 2 
days over current levels, and stretch goals of being able to 
reduce detection time within 1 day of release for any 
biological agent that threatens the health of our citizens.
    And I thank you very much for the opportunity to speak here 
today.
    [The prepared statement of Michael M. Wagner follows:]
    Prepared Statement of Michael M. Wagner, Assistant Professor of 
       Medicine and Intelligent Systems, University of Pittsburgh
    Good afternoon, Mr. Chairman and Members of the Oversight and 
Investigations Subcommittee. My name is Dr. Michael Wagner. I am a 
physician and an assistant professor of Medicine and Intelligent 
Systems at the University of Pittsburgh. I am also co-scientific 
director of an institute in Pittsburgh that focuses on bioterrorism 
research.
    My training is in the fields of biology, internal medicine, medical 
informatics, and more recently I received a PhD in artificial 
intelligence. Over the past decade, I have been building computer 
systems that detect cases of disease and potential medical errors. For 
the past two years, my work has been focused exclusively on the 
building of early warning systems for outbreaks of disease.
    I wish to thank the Subcommittee for this opportunity to share 
information with you about this research and to offer my observations 
and recommendations to the Subcommittee in its deliberations on public 
health early warning systems.
    My research has been funded by four federal agencies--the National 
Library of Medicine, the Agency for Healthcare Research and Quality, 
the Centers for Disease Control and Prevention, and the Defense 
Advanced Research Projects Agency, but the views I express today are my 
own and not necessarily those of the agencies.
     the real-time outbreak and disease surveillance (rods) system
Why are we doing the research?
    A scenario we have been most concerned about is early detection of 
disease outbreaks caused by large-scale aerosol release of Anthrax. 
Without very early detection of this type of outbreak, it has been 
estimated that there will be mortality rates of hundreds per hour 
within 4 or 5 days of release. In this kind of outbreak, hours count, 
and detection needs to occur very early to allow time for response and 
treatment to occur.
What is RODS?
    A product of this research is RODS, an early warning system that 
has been deployed in Western Pennsylvania for two years. The acronym 
RODS stands for Real-time Outbreak and Disease Surveillance. The 
purpose of RODS is to provide early warning of infectious disease 
outbreaks, possibly caused by acts of terrorism using biological 
weapons, so that treatment and control measures can be begun, to 
protect and save larger numbers of people.
    A key feature of RODS is that it receives data directly and without 
delay from computers in emergency departments and hospitals. The data 
include patient symptoms, age, gender, address, and results of tests. 
The data are transferred directly computer-to-computer and without 
delay, which means that seconds after a patient registers in an 
emergency department complaining of cough, this fact is pooled with 
data from other patients in the region at a central location and is 
available for automatic analysis. At present, RODS emphasizes data 
collection from emergency rooms and hospitals--monitoring 800 visits 
per day for flu-like symptoms, diarrhea, rash and other key symptoms--
although our approach is general and includes data collection from 
other computer sources as well as direct entry of case reports by 
clinicians.
How is early detection achieved?
    Early detection is achieved in this approach by identifying as many 
patients as possible early in the disease process when they have 
nonspecific symptoms such as cough or diarrhea, and then using brute-
force computer power to find any interesting patterns among the sick 
individuals that would suggest that an unusual outbreak is occurring. 
An interesting pattern, for example, might be an unusually high number 
of sick people showing up at emergency departments in the past 24 hours 
who happen to live in the same zip code area.
Why did we take this approach, and what have we learned?
    Our design for RODS was heavily influenced by prior work in the 
field of medical informatics. From this experience, we knew that the 
most important ingredient for success would be obtaining the right data 
electronically, in real time, and without asking doctors to fill out 
forms or to enter data into computers; so, we spent a great deal of 
time being clever about this. The approach builds on electronic medical 
records and other existing computer systems. These elements are widely 
available in the country and represent an enormous resource. We knew 
that computers in hospitals and emergency departments contained 
relevant data, and we knew that they would be able to provide the data 
through standard computer-to-computer interfaces, in fact, from the 
beginning we used many of the standards now being recommended by the 
National Electronic Disease Surveillance System (NEDSS) project, and we 
think those standards are excellent.
    We have learned that health departments have limited resources for 
any kind of participation in this kind of project due to their front-
line responsibilities. Therefore, we developed the concept of a trusted 
broker, which is an administrative entity that allows pooling of data. 
The trusted broker is created by formal memoranda of understanding 
between the health department, data providers, and an outside technical 
group. This organizational model has proven effective, especially with 
the facilitation of a highly respected local foundation with contacts 
in the community.
    We also understand that although the approach taken in RODS can 
significantly reduce the time delay to detection, it is not a complete 
solution to the country's needs. As you know, the earliest possible 
detection will eventually be accomplished by biosensors that detect 
bacteria and viruses when they first appear in our environment, but 
before they infect us. However, such technology is a ways off 
especially in a sufficiently cheap form that every person can carry a 
personal monitor, or every building and open space can be monitored 
continuously. In the meantime, early detection of a surreptitious 
release will depend on monitoring people and animals for the early 
effects of that release, and through detailed analysis of the 
epidemiological characteristics of sick individuals.
    From the research, we know that the earliness of detection in RODS 
can be improved further if we can obtain data about patient symptoms 
even earlier than at present, even before they seek emergency care. 
This latter point is the subject of a specific recommendation.
                            recommendations
    I would like to use the remaining time available to me to offer my 
recommendations to the subcommittee for rapid improvement in detection 
capabilities.
    1. Congress should provide funding directly to all ongoing 
metropolitan and regional efforts to build early warning capability, 
provided they adhere to National Electronic Disease Surveillance System 
standards. Early warning can be implemented most quickly by regional 
efforts, with federal coordination. Some of these efforts are research 
projects that are becoming regional or national resources for early 
warning, and they are not currently staffed or funded for rapid 
deployment or for the provision of 7x24 services.
    2. The earliness of outbreak detection depends fundamentally on 
obtaining data about early symptoms of disease. In the near-term, the 
greatest improvements in capability will depend on improving the 
earliness with which such data---and epidemiologically relevant 
information such as work location--are collected. There are many 
potential ways to do this, and the nation and its health systems need 
to find workable solutions. This goal may require legislation to 
facilitate such data collection. Congress may need to provide 
incentives to specific industries that have needed data to develop 
real-time, privacy-protected data feeds for public health early warning 
systems.
    3. There is a need for basic and applied research in early warning 
systems for biological threats. Congress should provide funding through 
the National Library of Medicine and the Agency for Healthcare Research 
and Quality to support several interdisciplinary Centers of Excellence. 
The National Library of Medicine is the principal federal funding 
source for research and training in the field of medical informatics, a 
field that has and can continue to provide tools and expertise needed 
to accomplish these objectives. The Agency for Healthcare Research and 
Quality has extensive experience in medical process improvement and 
change management. The centers of excellent must be large and 
interdisciplinary, comprising teams of public health physicians, 
epidemiologists, contractors, medical informatics researchers, 
mathematicians, and computer scientists, and they need to have multi-
year funding to attract and maintain highly qualified individuals.
    4. Congress should encourage, through federal funding, several 
cities and regions to participate in early warning research. The field 
of biodefense is like the field of particle physics: a large particle 
accelerator is necessary to answer certain questions, and in general 
the bigger the accelerator the better. In the field of biodefense, the 
equivalent of a large particle accelerator is a large geographic region 
for which rich, multiple-year data sets are available for research and 
system validation.
    In closing, I would suggest that the Congress note that early 
detection of major public health threats is an ambitious undertaking 
that resembles in both urgency and technological breadth the Space Race 
in the 60's and the Manhattan Project in the 40's. Those projects had 
clear goal statements that facilitated the work of multiple teams 
located in different regions of the country that were necessary to 
accomplish the mission. The DARPA Biosurveillance Program is an example 
of a program with a clear short-term objective to reduce detection time 
by two days over current levels and a stretch goal of being able to 
detect within a day of release, biological or toxicological agents that 
threatens the health of its citizens.
    Thank you very much for the opportunity to speak here today.
              information about federally funded research
National Library of Medicine
    The initial funding for this research into early warning systems 
began in fall 1999, and came from the National Library of Medicine. The 
agency approved a request to redirect an ongoing project (to develop 
capability to detect rare health events automatically using health 
system data) to the problem of early detection of bioterrorism. In the 
ensuring two years, NLM has provided direct grant support of $200,000.
    The National Library of Medicine has also supported this work by 
funding trainees in medical informatics and infrastructure development 
under grants for training in Medical Informatics and the Integrated 
Academic Information Management Systems program.
Agency for Healthcare Research and Quality
    In September 2000, the Biomedical Security Institute received a 
$1,020,000, 1.5-year contract from the Agency for Healthcare Research 
and Quality (AHRQ) to study basic questions including (1) What is the 
capacity of existing information systems to detect outbreaks of 
disease? (2) How can existing systems can be adapted to enhance early 
detection of a bioterrorist release? (3) What data elements are needed 
for early detection of a bioterrorist event? (4) What are the 
performance characteristics (including sensitivity, specificity, and 
timeliness) of different approaches to early detection of a 
bioterrorist threat? And (5) How can computerized clinical decision 
support be linked to early detection strategies?
    Results of the AHRQ contract are described in two reports. The 
first is entitled The Nation's Current Capacity for the Early Detection 
of Public Health Threats including Bioterrorism, and the second is a 
report due in late November entitled The Availability and Comparative 
Value of Data Elements Required for an Effective Bioterrorism Detection 
System. We have published additional results in papers titled Modeling 
the Effects of Epidemics on Routinely Collected Data, and The Emerging 
Science of Very Early Detection of Disease Outbreaks. The references 
are listed for your convenient use in the next section.
Centers for Disease Control and Prevention
    Also in September 2000, the Biomedical Security Institute entered 
into a cooperative agreement with the Centers for Disease Control and 
Prevention. In the first year of this agreement ('01), approximately 
$540,000 (of $920,000) was provided for research on early detection. 
The results of this research are described in five technical papers 
that are also listed in Appendix II. The papers describe data modeling 
for the National Electronic Disease Surveillance System, evaluation of 
an electronic laboratory reporting system for notifiable diseases, the 
use of routinely collected emergency department data for early 
detection of respiratory outbreaks, and the use over-the-counter sales 
of cough syrup and other products for early detection.
    In the current fiscal year ('02), the Centers for Disease Control 
and Prevention is providing an additional $400,000 (of $720,000) for a 
number of projects including development of a health-system-resident 
component for RODS, development of a trusted broker, analysis of how a 
``zebra chip'' could optimally be deployed in a detection scheme, and 
further support of ongoing work in natural language processing of chest 
radiographs to identify patients with inhalational anthrax.
Defense Advanced Research Projects Agency (DARPA) Biosurveillance 
        Program
    Recently (August 2001), we were awarded a contract by the Air Force 
providing $1.6 M over 1.5-years to participate in the Defense Advanced 
Research Projects Agency (DARPA) Biosurveillance Program. The program's 
goal is to develop and validate city-scale prototypes of early warning 
systems. The emphasis of the program is on the use of nontraditional 
data. Our specific tasks include development of automatic detection 
algorithms, computer-based simulations of epidemics for ``what-if'' 
analyses, and computer models of early response decision-making under 
uncertainty.

    Mr. Greenwood. Well, we thank you, Dr. Wagner, and thank 
you for joining us this afternoon. I believe we are going to go 
to Dr. Zelicoff next. You are recognized for 5 minutes for your 
testimony.

                 TESTIMONY OF ALAN P. ZELICOFF

    Mr. Zelicoff. Thank you, Mr. Chairman. I am going to be 
departing from my prepared remarks. I would ask that if it is 
possible and proper that my prepared remarks be entered into 
the record.
    Mr. Greenwood. Without objection, your remarks will be part 
of the record.
    Mr. Zelicoff. I will spend just a few moments introducing 
myself. My name is Al Zelicoff, and as you heard, I am a senior 
scientist at the Center for National Security and Arms Control 
at Sandia National Laboratories, which is a Department of 
Energy government owned laboratory.
    I am a physician and physicist, and our center develops 
technologies for counter-proliferation of weapons of mass 
destruction, and for verification of the entire panoply of arms 
control agreements of which the United States is a party.
    I was in medical practice for about a decade, but my area 
of interest since joining Sandia has been in non-proliferation 
of biological weapons, and specifically in coming up with 
clinical tools that could be of use for people who are actually 
at the front lines of medicine.
    There were a number of things that my colleagues in the 
previous panel testified to with which I agree, and there were 
a number with which I profoundly disagree, and I hope that I 
will have a chance to flush some of those out in the question 
period.
    But let me tell you where I certainly do agree with some of 
the generic and not so generic statements that were made 
previously. Any system that we use for early surveillance has 
to have a couple of characteristics that are pretty obvious.
    You can't wear people out, and it should be local, and I 
will be coming back to that point in a moment. It has to 
maintain patient confidentiality. Obviously, the key 
stakeholders who will be using the system should be involved in 
its design.
    It has got to be simple, and it has to serve as a 
communication tool between physicians and public health 
officials. I think all of those things are very obvious. Let me 
lay a couple of other items on the table and then show you at 
Sandia how we believe we have achieved at least an 80 percent 
solution for all of those exacting requirements.
    The information has to be accessible to other agencies and 
decisionmakers on a need to know basis and that will vary from 
agency to agency. The system has to be cheap, fast, and most 
importantly of all, it has to be sustainable on its own merits.
    If the system doesn't work because it helps physicians in 
their daily practice, it is not going to survive, no matter 
what. It does no good to send CDC officials, however well 
trained they are, to sit in emergency rooms around the country 
when we all know that there aren't nearly enough CDC officials 
to go around. It is far too expensive, and therefore, not 
sustainable.
    Remember that we have a private health care system in this 
country, and I don't know if that is going to change in the 
future, but for the foreseeable future I expect it is going to 
be private and it is fractionated.
    Now, if I can call your attention to the screen, and if I 
could ask that some of the lights go out. Let me tell you a 
little bit about the Rapid Syndrome Validation Projection, or 
RSVP for short.
    This is a syndrome-based disease surveillance system that 
has been developed with the help of the New Mexico Department 
of Health in Albuquerque, and in my view some of the best 
disease sleuths that the country has to offer.
    As has been indicated earlier, we have broken all of the 
rules of epidemiology. We are not using disease based or 
laboratory based diagnosis. We are looking at syndromes which 
are listed here, and I will have more to say about those in a 
moment.
    We do, however, permit the physician to enter reportable 
diseases, and just to show you how awful that is in the real 
world, let me indicate to you that the reportable diseases that 
physicians are actually supposed to be aware of in the 
community.
    And let me tell you that the rapid syndrome validation 
project is designed to be used by primary care physicians in 
their offices and clinics, and the human in the loop is the 
local public health official, the local epidemiologist who 
unquestionably is the most knowledgeable person in the 
community about diseases.
    And the reason that I emphasized local a little bit earlier 
is that disease patterns in communities vary from place to 
place, and here is no one who knows the disease patterns in 
their community or to borrow a phrase I think from Dr. Barry 
earlier, who has the highly trained sophisticated genetically 
engineered neuro network algorithm called the Mark One Eyeball 
that can recognize disease patterns as they come and go through 
a community, and determine simply by extent of experience what 
is normal and what simply is not normal.
    So, if you will give me 1 more minute, I will bring up the 
software again. By the way this is not a canned presentation. 
This is actually on-line and is precisely what physicians see 
when they are using it in the community. And we have had this 
on-line now for about 9 months in New Mexico.
    And you will see in a moment that the only software that is 
required for the person to use it is any available web browse, 
which are all free, and so the barriers to entry here are 
extremely small, and I believe that the cost, which I can 
provide to you in some detail if you would like during the 
questioning period, are also very small as well.
    All right. So the physician logs in by choosing their user 
name, and what we have put in in the local emergency rooms and 
primary care clinics is a touch screen, because it is much, 
much faster than using a mouse.
    We were after about 45 seconds of the physician's time, 
which most of you will recognize is about the attention span of 
the average clinical physician today. Demographics are the 
first part of epidemiology, and it answers three questions; 
what, where, and when.
    In the early disease investigation what you are trying to 
determine if you are a local public health official is whether 
or not to worry, and then begin a disease investigation as I 
think has been indicated earlier.
    So I will enter a zip code of work, and notice that the 
system asks for additional information if you happen to hit yes 
on travel, for example, and it asks if you traveled 
internationally.
    We have certain high risk occupations, like a postal 
worker, for example; and I am going to pick one of the 
syndromes, which is influenza like and that is the one that you 
hear so much about.
    This is a term of art in medicine. It is not a head cold. 
It is severe illness, with fever, myalgia, muscle aches and 
headache, generally accompanied by respiratory symptoms.
    What we are after here to try to get the noise down and get 
the information content up is the clinical judgment of the 
physician. And I disagree with one of the previous testifiers 
who stated that physicians aren't going to welcome one more 
computer screen into their clinic.
    Indeed, I have many people asking me for this system, 
simply because as you will see, it gives something back to the 
physician, as well as giving something to the epidemiologist.
    All the other screens look pretty much the same, and 
symptoms are at the top, and so I am going to enter somebody 
who has a productive cough here, with severe muscle aches, and 
I am going to allow this physician to say that they got a chest 
x-ray and it was abnormal.
    And the system actually prompts the doctor to look for 
certain signs and symptoms that are actually classically 
associated with terrorism diseases or diseases of public health 
importance.
    Not that the average doctor would know that. They don't. 
But the system does. So in this case wide media stannum is a 
particular finding on the chest x-ray, and almost always 
associated with anthrax in the setting of an acute respiratory 
illness.
    In fact, it is anthrax until proven otherwise, although the 
vast majority of physicians won't recognize that. We are done. 
In practice, that takes about 30 seconds for the average 
physician to do, and when we are done, three things happen.
    The data goes off to the local server, which is sitting in 
the local public health department. Second, that data that I 
just entered got screened for combinations of signs and 
symptoms that the local public health authority once again, and 
besides local, are strongly correlated either with diseases of 
public health importance--measles, for example--or are 
associated with bioterrorism related illnesses.
    If that combination of signs and symptoms happens to be 
picked, the system automatically e-mails, faxes, and pages the 
local epidemiologist who is on-call--there is almost always one 
in every jurisdiction in the country--with all of the 
information that I just entered, including the name of the 
physician who logged in and their phone number.
    That happens within 30 seconds, and so the State 
epidemiologist, and in our case in New Mexico, can get on the 
phone and call Dr. Zelicoff at UM Hospital, and remind him that 
he might be seeing a case of anthrax, and would you please hold 
that patient there.
    And we will start the case investigation 2 days before that 
person pops into the hospital, or at worst, 3 days when they 
are having their autopsy done. But the most important thing of 
all is what comes back to the physicians.
    In all cases, this screen comes back and in the lower left-
hand corner what you see is the results of all culture data, of 
all major respiratory passages, and it varies from syndrome to 
syndrome.
    And from the entire State, going all the way back to March, 
and it would be foolish for a physician in October in New 
Mexico to make a diagnosis of flu, for example, because there 
is no flu in the communities at that time.
    There is a temporal plot that shows similar cases, and most 
important of all, there is an advisory message which is 
controlled by the local public health authority that I like to 
refer to as medical intelligence.
    I think one of the committee members referred to the links 
between epidemiology and intelligence, and indeed the advisory 
message is the sum total knowledge of all information of local 
public health officials have with reference to that particular 
State, and it varies from syndrome to syndrome.
    And finally the physician also gets a map, and this map is 
zoomable to any portion of the United States, down to zip code 
level, and it shows you that the epi-center right now of 
respiratory disease in the Albuquerque area is in fact in 
Albuquerque and it is coded.
    And then it is color coded and then indeed other maps can 
be laid on top of that for analysis. I will wrap up now, Mr. 
Chairman, by making one final point. I served for 9 years on 
the U.S. Delegation to the Biological Weapons Convention. It is 
the only treaty that regulates or in fact bans the ownership of 
biological weapons.
    As a participant in that process, I believe that the 
current administration was correct to reject the protocol to 
straighten the biological weapons convention. I believe that 
that protocol was not nearly worthless, but was actually quite 
a bit worse than that.
    In fact, it was worse than worthless. This is not merely an 
opinion. My conclusions are backed up by the only 
scientifically cogent, technically meaningful, mock inspections 
done by any of the State's parties to the convention, which 
were done here in the United States, yet actively ignored by 
the decisionmakers during the time of the negotiation.
    Let me be clear that the failure of that protocol lies 
squarely at the feet of the previous Administration. The 
delegation and the inter-agency working group suffered 
enormously from a near total lack of leadership and a complete 
absence of vision, which is a great tragedy.
    Despite protestations to the contrary, there was no 
thoughtful senior level involvement in the U.S. negotiating 
strategy beyond a single tired phrase that appeared yearly in 
the State of the Union address.
    Because of the events of the last several weeks, I am very 
sympathetic to the argument that for the short term and at the 
moment, there is little time for policymakers to rethink our 
approach to future protocol negotiations.
    But when management of the current price no longer 
dominates all the attention of the decisionmakers, I would urge 
the U.S. Government to appoint a seasoned negotiator with one 
key goal in mind; to establish an international system of 
disease monitoring that is electronically based and a value to 
clinicians, veterinarians, and their patients.
    So in summary I believe we have identified a set of 
electronic tools for both epidemiologists and clinicians in New 
Mexico that meet the very exacting requirements that you heard 
about from the previous speakers, and I would be very, very 
grateful if you will take time to ask me more questions about 
it, and I will be happy to entertain any other questions the 
committee might have.
    [The prepared statement of Alan P. Zelicoff follows:]
   Prepared Statement of Alan P. Zelicoff, Senior Scientist, Sandia 
                         National Laboratories
    Mr. Chairman and distinguished members of the Committee, thank you 
for the opportunity to testify today. My name is Alan Zelicoff, and I 
am a senior scientist at Sandia National Laboratories in Albuquerque, 
New Mexico. Sandia is a multiprogram laboratory of the National Nuclear 
Security Administration (NNSA) of the United States Department of 
Energy.
    I am a physician and physicist at Sandia's Center for National 
Security and Arms Control. Our center develops technologies for 
counter-proliferation of weapons of mass destruction, and for 
verification of the entire spectrum of arms control treaties to which 
the United States is a party. I practiced internal medicine for about a 
decade. My area of interest since joining Sandia twelve years ago has 
been in biological weapons nonproliferation. I have pursued technical 
work in the laboratory, as well as in my capacity as an Advisor for 
nine years on the U.S. Delegation to the Biological Weapons Convention.
    These activities have repeatedly demonstrated to me that we, as a 
country, have not taken the biological weapons proliferation problem 
seriously, and we have squandered important opportunities in the 
international arena to strengthen norms against the acquisition and use 
of biological materials as weapons. But more important, Mr. Chairman, 
is that our public health systems and traditional medical care delivery 
systems are minimally prepared to detect the early manifestations of 
disease that is intentionally introduced into a community.
    In any biological weapons attack, large or small, hours matter. I 
hope to make this particularly important point vivid for the Committee, 
and to make a suggestion for a simple measure that we can implement 
immediately, not merely to plug the obvious gaps, but as a step toward 
a systematic solution that will be of day-to-day benefit in the 
diagnosis and treatment of all infectious diseases of public health 
importance.
    There are many dirty little secrets in medicine. One of them is 
this: Practicing physicians don't report unusual diseases to local 
public health officials (including signs and symptoms that could be due 
to bioterrorism), and public health officials don't have the ability to 
provide timely disease information to physicians working in clinics and 
hospitals. In my ten years of medical practice, I never--not once--saw 
a physician or physician assistant pick up the phone to report a so-
called ``reportable'' disease. Even in areas of the country where 
reporting of a small set of key infectious diseases is a legal 
requirement, physicians rarely comply. Why? The process is burdensome, 
inefficient, and most importantly, almost never gives anything back to 
the physician that is of relevance to the patient she is caring for.
    The reporting network--and I use this term loosely--relies on 
physicians first to recognize that they are dealing with an unusual 
disease; second, to know the phone number of whom to call; third, to be 
willing to wait for a public health officer to be available; and 
fourth, to field follow-up phone calls and answer what seems to be a 
never ending stream of questions. The first three are unlikely to come 
to pass, and the fourth is a powerful disincentive against 
accomplishing the first three.
    Busy doctors--and they are busier, though not necessarily more 
productive, than ever before--don't have time for this. Yet, they are 
desperately in need of information about even common diseases 
circulating in the community. As but one example, we know that 60 
percent--yes, 60 percent--of antibiotics prescribed in the primary care 
setting are unnecessary or inappropriate. During flu season when 
viruses are causing disease, physicians routinely reach for the 
prescription pad and write orders for antibacterial antibiotics. Part 
of this is due to ignorance, and the other part is due to pressure from 
patients who are themselves ill informed about the diseases that are 
prevalent in their community. A system that provided physicians with 
this knowledge alone, and the means with which to show their patients 
what is going on in the disease mix at any given time would, in and of 
itself, greatly improve the quality of medical care in the United 
States and substantially reduce costs and the emergence of antibiotic 
resistance.
    You may be surprised to learn that the repository of knowledge 
regarding infectious diseases resides not with the primary care 
physician but in local (and I emphasize local) public health officials. 
These highly trained specialists--physicians with specialties in 
disease outbreak investigation (epidemiologists), veterinarians, and 
nurses--know by dint of their long experience, the pattern diseases in 
their area--which viruses are normal, what microbes are unusual, what 
seasonal course diseases take, all of which varies tremendously from 
place to place in the United States. Further, while public health 
officials rarely see patients in the clinical setting, they are well 
bearded in the truly novel diseases that primary care physicians and 
community veterinarians see once in a lifetime if at all: plague, 
anthrax, foot-and-mouth disease, and other potential bioterrorism 
related diseases. It is perhaps best to think of epidemiologists as 
disease hunters with the wits and senses of fine detectives, reinforced 
by strong backgrounds in medicine and statistics. They are much more 
than the usual doctor or veterinarian.
    What is required immediately (actually, it has been required for a 
long time) is an inexpensive tool that will establish and maintain 
communication between overworked clinicians and out-of-reach public 
health officers. The tool must be easy and intuitive to use, 
ubiquitous, very fast, and sustainable on its own merits. It does 
little, if any, longterm good to assign CDC epidemiologists to a few 
hospitals in New York City only during a crisis, when we all know that 
the costs involved are prohibitive and that there are far too few CDC 
personnel to be in even the fifty largest metropolitan areas, let alone 
everywhere.
    But physicians and patients are everywhere; so are veterinarians 
and the animals they care for. The challenge I have faced in my work is 
figuring out a way to help these earliest-possible ``sensors'' of 
disease report accurately to public health officials and meet all of 
the demanding requirements I have just outlined. I think we have a 
solution. It is not a ``complete'' solution, but it is an essential 
part of a systematic solution. At Sandia, we have developed an 
Internet-based, secure, inexpensive, simple reporting system that we 
call the Rapid Syndrome Validation Project (RSVP). The Department of 
Energy's Chemical and Biological Non-Proliferation Program--a small, 
forward-looking, and creative bunch of planners--has funded this work.
    What they realized about two years ago is that good health 
surveillance (of animals and humans) is also good counter-terrorism 
against biological weapons. Automated sensors are still a little way 
off, and more to the point, will never be as ubiquitous as people. But 
with some straightforward modeling, we at Sandia were able to show that 
if public health authorities can be apprised of the earliest cluster of 
illness that occurs a few days after a large scale bioterror attack 
(rather than at the time of first death or even the time of first 
positive laboratory test result), the vast majority of people exposed--
even to anthrax and smallpox--can be saved. This is because, by 
definition, there will always be a few percent of the exposed 
population who will show symptoms first. This will occur because some 
people receive a larger dose of the biological agent, or because some 
people are more susceptible to disease, biological variability being 
what it is.
    Equally important--and I can not emphasize this enough in light of 
our recent experience in Florida and in the Washington area--is that 
the system can show whether there is widespread exposure, or instead, 
that it is likely to have been more localized. This is critical 
information for decision makers. It goes directly to the question of 
how many people need to be tested, how many people need prophylaxis, 
and how many people should be followed-up. Mark Twain had it about 
right when he said, ``It ain't so much knowing about that what is, but 
not knowing about that what ain't.'' Reassuring the public with 
substantive knowledge of the limits of exposure will make all the 
difference in the use of resources should there be a large scale 
dissemination, and all the difference in degree of disruption of our 
lives should the use of decidedly low-tech but nonetheless terror-
inducing dissemination of anthrax by mail be repeated in other cities.
    Let me show you briefly, how the system works.
    I don't purport that syndrome-based surveillance is the complete 
answer to our bioterrorism problem, nor that it is the salvation of the 
decaying public health infrastructure in the United States. What it 
does do, however, is provide an easy, inexpensive way to get the real 
experts (public health officials) the data they need to decide whether 
or not a disease outbreak investigation is warranted, at the earliest 
possible time, well before our laboratory-based surveillance system 
would alert them to serious disease in the community. It also gives 
back to physicians something useful in the bargain.
    We need a decision at the highest levels to begin with a system 
like RSVP that is built with a view toward add-ons and augmentation for 
various potential users, from local authorities (such as public health 
officials and local governments) to national-level decision makers and 
those who allocate precious remedial resources (such as FEMA and the 
CDC).
    One final thought: for the past nine years or so, the United States 
has participated in negotiations in Geneva to implement measures to 
strengthen compliance with the Biological Weapons Convention. As a 
participant in Geneva and in the interagency work in Washington, I 
believe that the current Administration was correct to reject the draft 
Protocol. As I have testified and written previously, the Protocol is 
not merely worthless; it is worse than worthless, as it would provide 
easy refuge for cheaters and place unacceptable burdens on U.S. 
industrial and military facilities. This is not merely an opinion. My 
conclusion is backed up by the only scientifically cogent, technically 
meaningful mock inspections conducted by any States Party to the 
Convention--done here in the United States and actively ignored by the 
low-level staffers who pretended or presumed to direct the formation of 
our policy on the Protocol at the time. Let me be clear: The failure of 
the Protocol lies, in my view, at the feet of the previous 
Administration. The delegation and interagency working group suffered 
enormously from a near total lack of leadership and a complete absence 
of vision. Despite protestations to the contrary, there was no 
thoughtful senior level involvement in the U.S. negotiating strategy 
beyond a single tired phrase repeated yearly in the State of the Union 
address.
    Because of the events of the last several weeks, I am sympathetic 
to the argument that for the short term, and at the moment, there is 
little time for policy makers to re-think our approach to future 
Protocol negotiations. But when the management of the current crisis no 
longer dominates all of the attention of decision makers, I would urge 
the United States government to appoint a seasoned negotiator with one 
key goal in mind: to establish an international system of disease 
monitoring that is electronically based and of value to clinicians and 
veterinarians and their patients.
    Ladies and gentlemen of the Committee, we have dawdled far too long 
in addressing the collapse of the public health system. We have always 
had, and will continue to have, a mostly non-government, private health 
care system. Yet, the expertise for population health lies not in 
individual practitioners but with the oft-forgotten state and county 
public health epidemiologists who work with a dearth of data but a 
plethora of expectation. We can and must do better than this. A simple, 
Internet-based, syndrome-based reporting system is the key component of 
a renewed, effective surveillance network that will serve us during 
this critical hour, as well as after we have resolved this most acute 
crisis, as we surely will. The questions are: How many lives will be 
lost in the process, and how quickly can we restore a sense of 
confidence to the American people? With inexpensive, readily available 
tools, the medical and public health communities will be among your 
chief agents and allies in relieving uncertainty and restoring faith, 
which are so essential to getting people back to living their lives and 
fulfilling their hopes.
    Thank you Mr. Chairman.

    Mr. Greenwood. Thank you, Dr. Zelicoff, and we certainly 
will ask you questions. Mr. Russell, you are recognized for 5 
minutes to provide your testimony, please.

                  TESTIMONY OF JOHN S. RUSSELL

    Mr. Russell. Thank you, Mr. Chairman. Perhaps I should 
pause and see if I am hooked up here to the system.
    Mr. Burr. Mr. Chairman, while he is hooking up to that, 
could I just take the opportunity to introduce John.
    Mr. Greenwood. I wish you would, please.
    Mr. Burr. He is from North Carolina, and he is the 
Executive Vice President and General Counsel of Quintiles. 
Quintiles is one of the largest data warehouses of medical data 
in the United States, and it collects identified data from 
hundreds of insurance companies, pharmacy benefit managers, 
hospitals, and physicians.
    They also conduct numerous clinical trials. Quintiles has 
over 18,000 employees located in 38 countries, and they have 
some of the most state-of-the-art de-identification software in 
the private or public sector.
    John, let me take this opportunity to welcome you since I 
didn't earlier, and I certainly encourage my colleagues to pay 
special attention to the resources that they have at their 
fingertips today, and how that might be able to help us.
    Mr. Russell. Thank you very much, Congressman Burr, for 
that gracious introduction. Chairman Greenwood, Congressman 
Deutsch, members of the subcommittee, my name is John Russell, 
and I am the Executive Vice President of Quintiles 
Transnational, which is the world's largest manager of clinical 
trials for the pharmaceutical and bio-tech industries.
    And, Mr. Chairman, while my comments will be brief, I ask 
that my written statement be made part of the record.
    Mr. Greenwood. And it will.
    Mr. Russell. Thank you, sir.
    What I want to speak to you this morning about is one of 
our areas of expertise, which is health care and infomatics. We 
have developed for commercial purposes a national system to 
register on a daily basis prescription use and diagnostic 
trends.
    This system draws on a de-identified data base that 
consists of pharmacy claims and medical claims posted for 
insurance payment. The data base contains currently over 2.4 
billion transactions, and is refreshed by 3 million claims per 
day, representing health care experiences for more than 100 
million anonymous persons in the United States.
    It is also longitudinal. It has a 3-year life to it. 
Through matching these medical claims with pharmacy 
prescriptions, we can track disease trends and patterns. For 
example, we can track the prescription of a certain drug in any 
city of the United States.
    In fact, in any zip code, and for the country as a whole. 
We can by matching the prescriptions to the medical claims see 
a disease pattern as it develops nationally overnight. The 
system is automatic. It is fast, with reports that can be 
delivered daily.
    It is based on a pioneer technology that we developed in 
the late 1990's. The technology is proven and in use. Now, let 
me say why I think briefly how this system can begin to be part 
of the solution.
    We believe that this system can provide a complimentary 
solution to a problem that we are all addressing today. It is 
not--this system does not in any way substitute for the 
absolutely indispensable work of local intelligence.
    The problem as we see it is that the detection of a disease 
outbreak is episodic, relying primarily on reports from the 
field. If I may use a battlefield analogy, I would call this--
and I believe the chairman himself used this term, but I would 
call this human intelligence.
    It is indispensable, but incomplete. What is also needed is 
an electronic national early warning system that we would 
characterize as satellite intelligence to compliment this human 
intelligence.
    I am reminded of how perhaps we follow a storm, even on the 
nightly news. I mean, we have a weatherman or a weatherwoman 
who just reports from the field. And then we have a weather 
satellite that tells us how the storm is approaching, and what 
the speed and direction of it is.
    And with these two things put together, we are better 
informed, and I think we can have that system. Now, how does 
our system work? The system as I said matches medical and 
pharmacy claims to anonymous patients over the whole country.
    It is both historical and current. That is, it tells a 
story now and over time, and has the ability to benchmark 
normal trends and spot the unusual, which is key to this 
exercise; benchmarking and spotting anomalies.
    It can be in its current state readily adapted with disease 
markers, and what we would call sentinels. Also, intelligence 
software in the form of neural networks that would actually 
spot these anomalies and also throw out false positive 
indicators.
    And also with a communications capability that we have 
already developed which would make this system send messages 
out through E-mail and voice mail either to public health 
officials or to doctors in the field, or to both, because it 
would be adaptable in that way to both a national and a local 
form of communication.
    So equipped, let me give you an example of how it might 
work and what it might do. Imagine five cities in five 
different States, all located on a different reservoir. Suppose 
in an overnight reading we saw that each of those cities showed 
an increase against a benchmark of gastrointestinal symptoms 
which we had previously marked for surveillance.
    Our system would light up like a Christmas tree. It would 
signal out to the health authorities. It would allow perhaps 
precious hours, and maybe even a day, so that these symptoms 
could be readily diagnosed by the expert doctors in the field.
    Now, perhaps I could pause and show you some real examples 
of how our current data base works. Let me refer you up to the 
screen. This is a slide that represents a study that we 
initiated immediately after the September 11 attacks, where we 
decided to follow cipro use in New York City.
    This is from our prescription data base. You see 
interestingly an uptick on the actual day of September 11. That 
might be because of the anticipation of casualties, because 
cipro has many uses other than for anthrax.
    Or also it could be for some preliminary stockpiling. But 
then you see actually interestingly a large spike up, reaching 
its apogee at October 12 when we had begun to hear warnings of 
bioterrorist attacks, indeed first reports.
    Now if I could show you this slide. As my diagnoses 
increase in New York City after the terrorist attack, this is 
from the medical side of the data base, also matched against 
prescription claims.
    And what we can infer is that after the September 11 
attacks there is something of an uptick that you can notice in 
asthma and upper-respiratory type ailments along the ICD-9 or 
medical diagnosis patterns that we would see.
    This could be because of air quality or because of stress. 
It is an interesting piece of data, and it can be produced on 
an overnight basis. Let me go to something else which shows you 
a bit of benchmarking.
    This is a lime disease study, and this was provided to CDC 
as a means of tracking lyme disease in the year 2000. What you 
see is that our automatic reporting system picked up over 
27,000 cases to follow, and you can see that the spread of 
those cases is somewhat beyond the traditional northeastern 
United States locations.
    Now, this is what the CDC reported, a little over 13,000 
cases through the voluntary system. If you recall the slide 
before, the spread is greater, and the concentration is very 
similar, but again an interesting piece of complimentary data 
to the local reporting system, that we would refer for further 
analysis.
    Now, to stress the point that this is both local and 
national, I showed you a New York City slide about cipro use. 
Now, this is the same slide on a national basis which actually 
does show if you recall the New York City slide the bump up on 
the week of October 12.
    But that would be normalized on a national trend, and so 
both local and national. Mr. Chairman, let me sum up by saying 
that there are many things that I could say in summary, but let 
me leave you with these thoughts.
    The system in the data base necessary for real time 
bioterrorism surveillance system exists today. It works 
nationally and locally. It is a proven technology and it 
operates on agreed reporting standards. This automated 
surveillance system will operate without any additional 
reporting by health professionals.
    All the reporting is already done in order to affect 
payment through the national payment system that you in your 
wisdom so regularized through the HIPAA legislation and its 
attendant regulations.
    This system can be quickly adapted to use as a national 
electronic early warning system to provide that satellite 
intelligence that I was talking about. Mr. Chairman, with a 
system like this, we can deliver more information faster. We 
can inform those doctors in the field so that they can make 
those ready diagnoses that we all talked about today.
    We can get ahead of the threats that lie before us, and we 
can play offense rather than defense. I thank the committee for 
hearing our presentation today, and I would be glad to answer 
any questions that you may have.
    [The prepared statement of John S. Russell follows:]
Prepared Statement of John Russell, Executive Vice President, Quintiles 
                          Transnational Corp.
Introduction
    Chairman Greenwood, Congressman Deutsch, members of the 
Subcommittee: My name is John Russell. I am Executive Vice President of 
Quintiles Transnational Corp., the world's largest clinical research 
organization and also the leader in monitoring medical and 
pharmaceutical data to improve drug development and healthcare.
    Thank you for the opportunity to participate in this critical 
discussion about improving our nation's ability to detect and respond 
to bioterrorism.
The Challenge
    The key to our preparedness for biological attack is rapid 
detection, determination of the source, and response. Every minute that 
we can speed up that process can reduce the number of individuals 
infected, and provide better odds for recovery for those who are. The 
intentional release of a biological agent may not be recognized for 
several days or more, during which time a biological agent can spread 
to others who were not initially exposed. Some biological agents 
produce symptoms that can be easily confused with influenza or other, 
less virulent illnesses, leading to a delay in diagnosis or 
identification.
    Over the past few weeks, we have seen how our nation's current 
disease surveillance system works. It relies primarily on reports from 
the field. Health care professionals contact local, state or national 
public health officials to report unusual diagnoses, reportable 
diseases, or odd disease patterns, often prompted by specific alerts. 
Analysis and response follows from this survey process.
    This process is rightfully being improved to real-time standards; 
but bringing an electronic environment to this network is deliberate 
and fragmented work. Even as improvements take hold, for the 
foreseeable future large segments of the public health surveillance 
system will remain local, voluntary and people-intensive. While it 
compiles critical information and provides definitive analysis of 
confounding events, this ``human intelligence'' system--if I may borrow 
a military term--should not stand alone in the current crisis.
    The fact is that the technology exists today to deploy a parallel 
system--a national early warning system--that could quickly signal 
bioterrorist events directly to CDC and to any state and local public 
health office online. The system works by collecting pharmacy and 
medical data and relating it to de-identified patients to create 
inferences of disease patterns. It is built on the national health 
insurance payment system that exists now. This system would not replace 
current reporting; rather, it would augment and complement local level 
data with a near real-time national picture. In effect, it would give 
local, state and national public health authorities a big-picture 
perspective, a kind of ``satellite intelligence''--if I may continue 
the military analogy--that complements ``human intelligence.''
    The effect of running these systems in parallel is to permit public 
health officials to react quickly to the truly surprising fact--flu-
like symptoms in West Coast port cities or gastrointestinal symptoms 
near five scattered reservoirs--which can give the opportunity to 
respond proactively. The advantages of this approach can be stated 
succinctly. This electronic system is automatic, not voluntary. It 
never gets tired. It covers the whole country, or any part, down to a 
zip code. It operates daily. It is a proven technology. With a national 
early warning system built on this foundation at their disposal, public 
health officials at all levels could be deployed in advance, to play 
offense rather than defense.
National Early Warning System: How It Works
    The electronic early warning system we will describe will be built 
on a system we currently use to generate weekly statistical analyses of 
disease trends and treatment patterns across hundreds of conditions and 
over 8,000 prescription drugs, which can be enhanced as needed. In 
effect, this national early warning system could produce a virtual, 
daily snapshot of disease trends and treatment patterns across the 
United States. Its reach is both broad and specific in that it can 
survey the whole country, or any Metropolitan Statistical Area (MSA), 
or even any zip code. The data driving this system is de-identified 
health data. Over 100 million patients are assigned a unique code that 
attracts diagnostic and prescription events from insurance claims. The 
results are both rapid and historical; in other words the story is told 
in near real time and longitudinally over time.
    Our health monitoring system analyzes the largest, integrated 
warehouse of current medical and pharmaceutical data in the world--a 
database that contains information derived from more than 2.4 billion 
de-identified hospital, medical and pharmaceutical transactions. The 
system is refreshed with about 3--million new transactions per day. 
These include claims from thousands of pharmacies, hospitals and 
physicians, and more than 680,000 total providers of pharmacy, medical 
and dental services. [See Exhibit 1] This longitudinal data, linked for 
each patient through a unique encryption engine, can provide, with 
adaptation, a powerful tool for our national security.
    To support this national early warning system, we will install 
neural networks--software programs that ``learn'' and become 
increasingly accurate over time in pattern identification and trend 
prediction, that can distinguish, for example, between seasonal 
variations in flu cases and real anomalies.
    To give you an example of what this electronic early warning system 
captures, if there is an outbreak of flu-like symptoms, the trend can 
show up locally in our database as early reports begin to come into the 
CDC and other public health authorities, often within a day. Similarly, 
if there is a significant increase in antibiotic use, asthma diagnoses, 
or anxiety disorders--all of which we have recorded in the New York 
area since September 11 [Exhibits 2, 3, and 4]--the system can track 
the progression of those events through the health system in something 
close to real time, and we can analyze the data by age group, or zip 
code, or date. To illustrate the sensitivity of the current data 
sample, in the year 2000 we recorded a little more than 27,000 cases of 
Lyme disease in the United States [Exhibit 8], while the CDC case count 
projected about 13,000 cases. [Exhibit 9]
    This system could be used to scan millions of patient medical and 
pharmacy encounters per day, and--with the application of appropriate 
analytics--provide U.S. public health officials with a near real-time 
picture of disease patterns and treatment trends.
    Let me stress further that deploying this system to monitor 
indicators of potential bioterrorist events will not require any new 
reporting mechanisms; that is, we don't need to ask doctors or 
hospitals or pharmacies to do anything they don't already do today. As 
suggested by our Lyme disease findings, the electronic claims payment 
system--the mechanisms by which health care providers get compensated 
for providing services--is likely to capture more and broader data than 
a voluntary or special reporting system. Today, most pharmacy claims 
and payments are submitted electronically and paid before the patient 
leaves the store. Similarly, many hospitals and large provider groups 
electronically transmit key health care data--the diagnosis and the 
care rendered--daily. Certainly, while we wish to see more data--such 
as claims from small general medical practices--submitted just as 
quickly, a critical mass of health care encounter information flows 
electronically today, and a national model that can take immediate 
advantage of this fact can be built rapidly.
    This system would allow for significantly faster and more accurate 
detection of possible bioterrorist events than currently possible. In a 
matter of weeks, we can demonstrate a prototype system to provide 
critical bioterrorism tracking data to designated public health 
officials at the local, state and national level. Moreover, the system 
can be programmed to trigger electronic or voice-mail alerts to 
designated federal and state government officials when anything out of 
the ordinary is detected. This could provide significant benefits in 
mitigating injuries or deaths from bioterrorism and tracking points of 
origin of bioterrorist events, and for ongoing use in improving 
effectiveness and efficiency of public health delivery by physicians on 
the front line.
Prior Public Health Uses
    Using this patient-level database and Web-based analytical tools, 
we have performed several discrete projects in health care monitoring 
and analysis, including vaccination monitoring (e.g., hepatitis), 
public health screening (e.g., peptic ulcer disease), disease 
prevalence trends (e.g., respiratory conditions), preventive health 
(e.g., hormone replacement therapy), safety surveillance and risk 
monitoring of drugs, and medical treatment patterns (e.g., surgical 
techniques). The results of some of these projects have been provided 
to federal agencies such as CDC and FDA. Indeed, CDC, while it had the 
funding, used our database as part of a pilot project on anti-
bioterrorism. Speaking of our system, a former CDC official stated, 
``In addition to their public health role, . . . information products . 
. . promote an important national security interest--the detection and 
prevention of biological terrorism . . . the breadth, reliability and 
timeliness of . . . healthcare data are critical to this effort . . . 
CDC can use this data for early detection of unusual prescription 
patterns that could be evidence of an intentionally introduced disease 
. . . such as smallpox . . . [which] would be a national and global 
calamity if the earliest possible detection of the first wave of ill 
person is delayed . . . [T]he saving of even a single day in detection 
and response time can translate into the saving of hundreds or 
thousands of lives and the prevention of a global pandemic.''--Sworn 
testimony of Joel Greenspan, M.D., M.P.H., former CDC commissioned 
officer and medical epidemiologist.
    This capability is the result of developments in the commercial 
sector and government regulations during the 1990s. By mid-decade the 
private health insurance industry introduced a nationwide electronic 
data interchange--or EDI--network that processed in real-time 
pharmaceutical and medical insurance claims that were in electronic 
form. The purpose was to route claims immediately from providers for 
the proper payment sources for reimbursement. Congress encouraged this 
development through the passage of the Health Insurance Portability and 
Accountability Act (HIPAA) in 1996, and the Department of Health and 
Human Services issued a series of regulations to provide oversight to 
this national EDI system.
    As this payment system developed, the aggregation of data from 
these claims for analytical purposes to improve public health became a 
possibility. By late decade, longitudinal databases were in use, and 
the marriage of developing technology to healthcare improvement began 
to show results. The latest HIPAA regulations generally encourage the 
use of aggregated healthcare data, explicitly recognizing the benefits 
of these data sets in improving healthcare quality and efficiency.
    The pharmaceutical industry has been an initial user of the 
system's capabilities. Now the national public health surveillance 
system stands to benefit greatly.
Technological and Regulatory Origins of the System
    The current monitoring system was created for commercial purposes, 
following the confidentiality standards established by the HIPAA 
privacy rule, and, consequently, registers particularity of zip codes 
to the two or three-digit level. See, e.g., 45 CFR Sec. 164.514. 
However, I would note that several exceptions to the HIPAA privacy rule 
are permitted for activities in the public interest, such as: for 
public health activities (e.g., CDC), for health oversight activities 
(e.g., FDA), for law enforcement, to avert serious threat to health or 
safety, for national security and intelligence activities, and for 
protective services for the President and others. See, e.g., 45 CFR 
Sec. 164.512. Therefore, in accordance with HIPAA provisions and the 
government's specifications, the database could be enhanced to include 
additional data fields and zip-code particularity to refine and augment 
the accurate tracking and location of infectious disease patterns of 
bioterrorism agents, such as smallpox and anthrax.
Benefits to Entire Public Health System
    The usefulness of this system would extend considerably beyond 
detection of possible bioterrorist events. Once in place, it could be 
used by federal and state public health officials to analyze disease 
patterns and treatment trends, aid vaccination monitoring and public 
health screening, conduct cost-benefit analyses of alternative 
treatments, enhance safety and risk monitoring of drugs, and improve 
allocation of disease prevention resources.
    To demonstrate the current effectiveness of this system, we have 
attached several exhibits of particular research projects, some of 
which we alluded to briefly above.
    Exhibits 2, 5, 6, and 7 demonstrates the use of Cipro--the powerful 
antibiotic typically prescribed for treatment (or prevention) of 
serious bacterial infections, including gastrointestinal ailments, 
pneumonia, bronchitis, and for conditions resulting from burns and 
compound fractures, but also for anthrax--before and after the tragic 
day of September 11--normalized for the day of the week and seasonal 
variations. On September 12, our prescription database detected 
[Exhibit 2] a small (~35%), though significant, increase in Cipro use 
in New York City on September 11. This may be attributed to 
prophylactic treatment against infections of the victims of the 
terrorist attack and possibly some early stockpiling of Cipro. Then, 
there was a rapid decrease, which was followed by a gradual, then 
dramatic ~500% increase on October 12th in Cipro prescriptions in a 60 
mile-radius of the World Trade Centers. This increase is likely due to 
stockpiling of the drug from fears of bioterrorism attack with anthrax. 
For the same time period, Exhibits 3 and 4 demonstrate an increase in 
New York City of asthma symptoms and anti-anxiety drug prescription, 
respectively, after September 11. These findings have been provided to 
the CDC.
    In a 60-mile radius of the Pentagon, Cipro use increased by ~100% 
immediately following President Bush's warning on October 12th of 
increased risk of terrorist attacks. [Exhibit 5] Moreover, our system 
shows that Cipro utilization increased by more than ~200% in Miami-Dade 
County on October 9th, which aligns with the first reported anthrax 
case in that area. [Exhibit 6] Note, too, that on a national level, 
Cipro use also increased after October 12th, but to a lesser extent 
(~50%). [Exhibit 7]
    In Exhibit 8, we showed to the CDC tracking of the spread of Lyme 
disease in the year 2000 from actual cases reported in our system. 
Compare this to the data shown in Exhibit 9 of the accumulated cases of 
Lyme disease reported to CDC from State Health Departments. Note that 
the claim-based database detected approximately twice as many Lyme 
disease cases than did the physician-reporting system for the same 
period. The spread of cases is also greater in the claims-based data, 
although the areas of highest concentration remain constant.
    In Exhibit 10, using the medical diagnosis database, we presented 
to the CDC the detection of an E.coli outbreak in a county fair in 
Washington County in New York State in 1999. Note the concomitant 
increase in diagnosis of E.coli in fair attendees from the surrounding 
counties.
    Hard-to-find patients diagnosed with rare diseases also can be 
tracked with this system. Exhibit 11 demonstrates the detection of 85 
Brucellosis patients nationally in the year 2000 compared with 63 cases 
reported to the CDC for the same period. We provided our results to the 
CDC. Note that Brucellosis has been identified as a possible biological 
agent for bioterrorism.
Summary
    We urge the government to deploy an electronic national early 
warning system as a 21st century tool in its defense arsenal against 
21st century warfare--bioterrorism.
    The database, infrastructure and statistical tools needed to build 
and operate a national early warning system are already in place. Upon 
commencing the project, experienced statisticians and healthcare 
analysts could be turned to the bioterrorism challenge. In a matter of 
weeks, modifications could be made to the basic infrastructure to 
create a prototype system that detects a range of events and enhances 
public health response.
    First, we should determine, in consultation with public health 
authorities, the ``marker'' or ``sentinel'' symptoms of a possible 
bioterrorist event, such as flu-like symptoms and upper respiratory and 
gastrointestinal distress, which are likely to be seen in hospital 
emergency rooms and pharmacies, and which should be screened for 
continuously.
    Additionally, with neural network enhancements, we can deploy 
increasingly sensitive modeling; that is, truly intelligent software 
that can detect spikes such as those detected in Florida, or unusual 
patterns in the data in order to alert public health officials, and at 
the same time minimize false alarms. Our neural networks can ``learn'' 
and become increasingly accurate over time--distinguishing, for 
instance, between seasonal variations in disease reports and real 
anomalies. Finally, we can increase cooperation with local and state 
public health networks that are striving themselves to migrate to near 
real-time electronic data interchange. For public health purposes, the 
government can encourage the use of patient health information reported 
through Medicare, Medicaid, public hospitals, and U.S. Public Health 
Service facilities to enhance the de-identified patient database.
    Our existing electronic system can be configured to allow queries 
by local, state or national public health officials who want 
information specific to a given geographic area or a particular symptom 
cluster, and it can be pre-set to send out e-mail or voice mail alerts 
to those officials when certain patterns are recognized. Future 
modifications could add even more communication capability for public 
health officials across the national system.
Conclusion
    History offers us many examples in which seemingly disparate, and 
sometimes tragic, events converge to produce profound change for the 
good. I believe we are at one of those moments in history.
    This body had the foresight in 1996 to pass legislation regulating 
healthcare electronic data interchange processes and technology. This 
technology--created at first to improve the efficiency and speed of 
medical and pharmacy reimbursements--now offers us a platform for a 
greater good. Good intelligence from several sources and levels is 
absolutely key to our fight against terrorism. This especially applies 
to our fight against bioterrorism. We have already seen the sad results 
of bioterrorism in our country. We need to bring every tool to bear for 
the challenges ahead. We have an excellent system of human intelligence 
that is even now improving. We need to complement this system with 
healthcare's version of an electronic national early warning system.
    Technology and the public health can be joined at this historic 
moment. The result could be, and I believe it should be, a national 
early warning system that can be employed in the fight against 
bioterrorism--and used every day by public health officials seeking to 
halt the spread of disease and save lives.
    Thank you.
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    Mr. Greenwood. Thank you, Mr. Russell. I appreciate your 
testimony as well. The Chair recognizes himself for 5 minutes 
for inquiry. Let me pose to each of you the question that I 
posed to the first panel, and that is this.
    This hearing is really designed to test a hypothesis, and 
the hypothesis is that using the state-of-the-art information 
technology, some of which we have just seen displayed, we could 
in fact build a national and robust system that--and I will add 
a little bit to the question, that does in fact not intrude 
unnecessarily into the health care profession, but that can by 
identifying abnormal increases in symptomatology anywhere in 
the country give us the opportunity not only to do a better job 
with infectious diseases in general, but to get a head start on 
a potential outbreak caused by a bioterrorist attack.
    And let me add to that, that if you believe that that is 
the case, I would like to know your opinion as to what it might 
take us in order to have that system ready as soon as possible. 
We will start with you, Dr. Wagner.
    Mr. Wagner. Well, the direct answer to your question is 
that I believe that the hypothesis has already been partly 
tested. We do know, for example, that epidemics leave 
footprints in routinely collected data, and you just saw some 
examples.
    And we know that for quite a number of epidemics, and 
different types of diseases, including water borne, food borne, 
influenza, contagious diseases, like rubella and measles. And 
we know it for quite a number of data sources, including health 
services research data, which I guess is a broad category that 
would include the data that we just saw on the screen.
    We know it for grocery data; sales of tylenol, cough 
syrups. We know it for clinical data, data being collected by 
clinicians. And we also know that there are quite a number of 
automatic methods for analyzing the data to actually detect 
epidemics.
    And we feel that the way in which we have partly answered 
the hypothesis is through all the years in medical infomatics 
research which have identified ways to integrate these data at 
a national scale.
    And we have also seen examples, and so that is my reason 
for believing that the hypothesis is half-answered or two-
thirds of the way answered. I think it is probably answered 
sufficiently well that we are sort of at the same point of the 
Manhattan project and the space race of the 1960's, where at 
the beginning--namely that the scientists and engineers--that 
they were pretty confident that the job could be done, and a 
decision was made to do the job.
    They weren't certain, but the collective opinion was that 
given the circumstances that it was worth making a try for it. 
What steps would be needed to go from here to there? I think 
incentivizing industries, like Mr. Russell, that have access to 
certain types of data that are known to show early evidence of 
epidemics is one step.
    I think incentivizing regions and other data providers that 
are outside the scope of fortuitous national data collection 
schemes such as this one is another step that we would have to 
take on that path.
    We have to do it at a regional level because the number of 
scientists and the number of engineers that are going to be 
required, the talent is out there, but it is going to take a 
concerted effort by all the talent to build that kind of a 
system.
    I think that actually the analytic part that sits on top of 
this rocket if you will is made dependent upon that 
infrastructure, but also an important piece, but not actually 
the most critical piece. I think we pretty much know how to do 
the analytics, but getting the data is going to be the critical 
piece.
    Mr. Greenwood. Thank you. Mr. Russell.
    Mr. Russell. Mr. Chairman, I agree with a lot of what Dr. 
Wagner said, but in particular the good news is that we are 
probably further along than we think as far as being able to 
put together the national system that you are talking about.
    I mean, I can speak for what I just showed and what our 
company's capabilities are. We have to start from somewhere, 
and we could start right now. I mean, our system would answer 
queries on a near real time basis and does.
    We have worked with CDC on a bioterrorism pilot project in 
the year 2000 and where some of these issues were explored. I 
think to get a national system that works on the automatic 
reporting that is already done through the health insurance 
network, you are talking about a matter of weeks.
    I mean, you are talking about putting or taking a system 
that I showed you and putting together surveillance indicators 
that we call the sentinels. You are talking about neuro 
networks which would then begin to intelligently sort the data 
and normalize it against baselines.
    You are talking also about a communications system coming 
out that would allow alerts to go out. That type of thing is 
not far away. I mean, as I said, it is a matter of weeks that 
we could adapt the system that I showed you to that particular 
specification.
    Mr. Greenwood. Dr. Zelicoff, and if you would also in your 
response just make a note about with regard to the cyber-
security of the system, because obviously if we had a national 
system, we would want it to be quite tamper proof.
    Mr. Zelicoff. Okay. I will pick up on the positive points 
with Dr. Wagner and Mr. Russell. I do think that we are a lot 
closer. Understand that in order to have a so-called national 
surveillance system that you do not have to have the system 
everywhere.
    Fortunately, statistics help us out a great deal. By my 
calculations, they show that if we can survey 5 percent of the 
clinics, and I would choose the 5 percent of doctors that are 
most flexible in doing reporting, and believe it or not there 
is such a 5-percent.
    Then you have indeed covered the country with a high level 
of confidence and you have minimized the amount of noise. What 
does that mean? 2,500 clinics around the country, and it is a 
few thousand dollars per site to buy a computer, and another 
few hundred dollars a month to have an Internet connection, and 
poof, you are done.
    I would agree also with Mr. Russell that there are 
automatic analysis tools out there that are in development, and 
having written several papers on neuro networks myself, let me 
warn you a little bit about the mystery of neuro networks.
    They require an extensive training set against which they 
can compare the data that is coming in. That means that you 
have to have a lot of data already, and you have to know what 
it is that you are looking for.
    Having so done that, it is possible, and in fact 
automatically train computers to do that. But I personally 
believe that we are a long way away from that. That is why we 
have put the human in the loop, which is the local public 
health official, because they are the best neuro network that 
we know of, and as was correctly stated earlier.
    But having said that, we also do have a neuro network model 
working in the background all the time, and that has nowhere 
near enough data to actually make a call itself, but local 
public health officials do.
    With regard to security, our fundamental--and I think the 
fundamental issue that confronts anybody who engages in a 
system like this is protecting patient confidentiality. And the 
we do that is three-fold.
    There are no names, and we can smear out identifiers that 
are not necessary. For example, the precise age. We smear it 
out because it doesn't matter for an epidemiologist to someone 
who is 18 or 19 years old in an epidemic, and if they are 75 
versus 30, it speaks volumes.
    And then finally all of our data is encrypted, going in 
both directions, and authenticated; by which I mean that the 
only people who can do data submission are people who have 
recognized hardware addresses on their computer.
    Anybody can go to the demo site and check it out, but it 
would take quite a hacker to--it is not impossible, but it 
would take quite a hatchet to break the authentication system 
that we have.
    So I believe that we have again the 90 percent solution as 
far as security is concerned, and our most important concern, 
if only to get this through institutional review boards, is 
protecting patient confidentiality.
    Mr. Greenwood. Thank you, Dr. Zelicoff. The Chair would 
announce that we have a series of votes--we have three votes 
now--and it will be at least 15 to 20 minutes until we can 
complete that process.
    So with your indulgence, we will recess until one o'clock 
and if you ask around, you can find out where the Rayburn 
places to eat are, and maybe you can grab yourself a bite in 
the meantime. We will recess until one o'clock.
    [Whereupon, at 12:33 p.m., the subcommittee recessed, to 
reconvene at 1:15 p.m., the same day.]
    Mr. Greenwood. If the witnesses will resume their stations, 
we will resume the questioning, and the Chair recognizes the 
ranking member, Mr. Deutsch, for 5 minutes to inquire.
    Mr. Deutsch. For the three of you, are you suggesting that 
basically we junk the NEDSS system? Is that your 
recommendations? Are you suggesting that we basically get rid 
of the present system, the NEDSS system, assuming that we 
adopted NEDSS?
    Mr. Zelicoff. I think you may be a little bit confused 
about something. NEDSS is intended for epidemiologists, and not 
doctors, to do reporting to the CDC. No clinician that I know 
has or ever would entertain NEDSS in their office. I am sure 
that there is some rare exceptions to this, because it is a big 
on-line reporting form that gives nothing back.
    As a tool between laboratories, or epidemiologists, and the 
CDC, yes, it is just fine. But it is really bolstering the 
laboratory side of surveillance, and I think the point that you 
are missing, or maybe I have not made it clear, is that there 
are two types of surveillance.
    There is the laboratory type and there is the clinical 
type, meaning what the doctor sees in the office or in the 
clinic. The importance of that is two-fold, as I think Dr. 
Bloom mentioned earlier.
    You need the clinical information for knowing when to 
trigger your laboratory system, and that is surveillance; and 
then you need the clinical reporting system to know how many 
people to test.
    If we were faced with a large scale exposure and not 
necessarily infection, but exposure, to anthrax spores in 
Washington, we will never be able to test a million clinical 
samples in a reasonable period of time.
    What you need to be able to do is to decide where you are 
going to apply your laboratory resources, and that is what the 
clinical surveillance will do as Dr. Bloome correctly pointed 
out. So, NEDSS is between the local public health authority or 
laboratory and the CDC, and not from the clinician's office.
    Mr. Deutsch. Do you want to respond?
    Mr. Russell. Yes, I would like to respond. I think that 
these systems are complimentary. I don't believe that the NEDSS 
system as I understand it, and as it relates to our system at 
least, is in any way in conflict.
    What our system does is that it takes a very, very large 
sample, one out of every three people in the United States, 
over a couple of billion data points, and shows disease trends 
that can be national or completely local on a near real time 
basis.
    And I do think that the NEDSS question though brings up 
something that I have noted in this discussion this morning, 
which is that there seems to be a false conflict between the 
local and the national here.
    I mean, I really don't see that. The system that we have, 
for example, really acts at a State level, at the local level, 
and at the national level. You can make it very specific for 
certain indicators in any city, in any State, in any zip code, 
and then across the whole country.
    So that kind of dichotomy between should we fund local 
efforts and knit them together nationally, or do we have a 
national system, and is it inside the Beltway or outside the 
Beltway. I think the technology exists here not to have that 
even be a debate, and that is the way that I would look at it.
    Mr. Deutsch. Dr. Wagner.
    Mr. Wagner. I have some experience with NEDSS because I 
helped write the Pennsylvania successful NEDSS proposal about a 
year ago, and I have participated, and I think NEDSS is an 
excellent project that has no shortcomings, and it is very 
complimentary with everything that everyone else is trying to 
accomplish.
    And what it is really providing is a set of specifications 
for infrastructure. This is the data base model that every 
system that does public health surveillance in each State 
should adhere to so that the data can be merged to form a 
national picture.
    The NEDSS project does not limit what kind of data is used 
in public health surveillance. So in addition to the laboratory 
data, the main stay of public health surveillance for the past 
few decades, and reportable diseases, the NEDSS project is 
going to incorporate all of these unusual types of data that we 
have been talking about.
    Mr. Deutsch. Let me at least give the opportunity to Dr. 
Davidson and Dr. Barry, who are still here, to try to respond 
to that. Would you like to respond to that and to my question? 
My question is whether this is a complimentary system, or is 
this an alternative system?
    Mr. Greenwood. If either of you would care to comment or 
response, please take one of the available chairs at the table 
and use the microphones.
    Ms. Barry. Thank you very much. I think technology has a 
lot to offer, but I have some very specific concerns. For 
example, in the system that the Quantiles has developed, I am 
sure that they can pick up aberrations in data, but who is 
going to follow up on those aberrations in data at the local 
health department. It is me and my five nurses.
    Where are we going to get the resources to follow up on 
whatever signal that might or might not be detecting. And the 
other concern that I have is timeliness of data. I see denying 
data, which is a disease coding process, typically takes some 
time.
    We tried to get this into our Boston system, but we don't 
know diagnosis until 30 to 60 days after the person leaves the 
emergency department, and that is too late. We have got to know 
within 24 hours if something is going on.
    So I think technology is the answer, and we should use it, 
and we should try to work to resolve some of these issues, but 
I have some concerns both about timeliness and for resources 
for follow-up with signal detection systems, which I think some 
of these are.
    With regard to the New Mexico system, the touch screen 
technology is really quite nice, but there is no way in the 
city of Boston--and I think I have excellent relationships with 
the health care providers in the hospitals, but there is no way 
that they are going to fill in a separate extra data screen to 
try to give us data. We have got to mine what is there.
    Mr. Russell. I would like to clarify one thing, because 
this is complicated and I wanted to respond to what Dr. Barry 
said. If you took the city of Boston and you were trying to get 
daily reads on a disease trend, then what you would have in our 
system would be all the private doctors offices.
    You would have all the drug stores, and you would have the 
entire panoply of what the providers are, both on the 
pharmaceutical and the medical sides. So you would not be 
relying entirely on what the hospital said and how they filed 
their ICD-9 forms.
    The ICD-9 forms are actually filed promptly by a lot of 
doctors' offices and not as promptly by others. But you would 
have a sample so large that you would have a trend line 
developing. So it is complicated, and I take what you say that 
it is hard to get the hospital themselves to process the ICD-9 
forms.
    Mr. Greenwood. Dr. Davidson, did you want to respond?
    Mr. Davidson. Yes. I think one of the things that we need 
to work toward--and this was brought up by one of the members 
of the committee earlier, was establishing criteria for 
surveillance systems.
    There are some criteria for surveillance systems that have 
been promulgated by CDC. And most recently about 4 months ago 
there was a publication. We need to put those criteria out 
there and see how they work with both of these systems. See 
whether they meet the appropriate criteria for a surveillance 
system.
    In terms of timeliness, our experience is that the ICD-9 
codes are coming in later than the syndrome-based systems. That 
we found in our analysis, and that there is a delay, and 
typically in our system--and that may not be typical of all 
systems, especially in the private sector where they may be 
getting these bills in quicker than we do in the public sector.
    But we found that it could be a 10 to 20 day delay even in 
a good clinic. So I think that is a concern for us. That is the 
timeliness factor, and one of the criteria. The issues of 
specificity and sensitivity are discussed in that document, and 
I think those are some things that need to be addressed as 
well, in terms of both of the systems that have been presented.
    Let me get back to one point that Dr. Zelicoff mentioned 
earlier about my comment, stating that this would not work in 
some emergency rooms. I think I agree with Dr. Barry that many 
physicians would not want that there.
    I want to specifically speak about Denver Health, and where 
we have this integrated electronic medical record. Here we are 
trying to create a computer on every physician's desk, to enter 
data into an organized data system to allow us to collect all 
the information you need.
    That system is built by our vendor. Now we have another 
system that may be able to collect important public health 
information. But we don't want to have to put that one on top 
of the one that we are already entering data into.
    So there may be a place for us--and once again using those 
industry standards--to take what our vendor is building, and 
put it through a process such as this. I don't know whether 
that is possible. I think once again working toward standards 
is the most important thing, and NEDSS pushes us toward that.
    Mr. Russell earlier mentioned about a false conflict 
between national and local efforts. I don't see this as a 
conflict at all when we talk about NEDSS. They are methods to 
integrate data across all jurisdictions. There is no conflict 
here.
    Mr. Greenwood. The time for the gentleman from Florida has 
expired, and let me indicate to Drs. Barry and Davidson that if 
you are willing to, you can stay at the table in case others 
want to consult with you as well. The Chair recognizes the 
gentleman from North Carolina, Mr. Burr, for 5 minutes, to 
inquire.
    Mr. Burr. That you, Mr. Chairman, and I am not sure what I 
have come back in the midst of, but I will try to focus my 
thoughts and legitimately say that I don't know that any of us 
have the answers.
    I mean, if we did, I think that you would hear it in our 
opening statements, and you would certainly see us on a 
legislative track to try to present some solution. Thank god 
for once that Congress has turned to not only the public 
entities, but the private entities and said what are our 
capabilities today.
    What we found in a very short period of time is that there 
is a wealth of data. There is a wealth of effort that has been 
put to try to create a system that works, a system that can 
cross-check things, and a system that stretches outside of just 
big cities and gets into rural America.
    I would ask all of you as you are asked questions and as 
you answer them to please understand that if everything we do 
is turf related--well, this is already here, and so we can't be 
replaced; or CDC already has this initiative, and so we can't 
change.
    What we are looking for is a solution now. It disturbs me, 
and I think I made that very clear, that we didn't have a goal 
today of 50 States on NEDSS. I don't know how the problem can 
get more pronounced than it is right now. This is a domestic 
threat.
    Our ability to do the right thing is how we will be judged 
and ultimately how the infrastructure for health will be 
judged, and potentially each one of you who are connected to 
it.
    But we also have a responsibility not only to see that 
large areas have access of connectivity, and access to data 
bases, and accesses to everything that is happening in the 
health community, but to make sure that the small ones do, too.
    I would have hoped that there was a request from Congress 
to connect the third of public health that is not 
technologically connected to CDC today. But I have yet to hear 
that request. I am sure that it won't take Jeff Koplan longer 
than next Thursday when he testifies in front of this committee 
to understand that that request should be made.
    But even with a substantial amount of resources there was 
very little devoted to what all five of you are here to talk 
about, our ability to respond to the public health threat in 
communities that you live in, or communities around the 
country.
    I am delighted with what the labs are doing. I am delighted 
to know that we are trying to create a system out there, and 
whether it overlaps something else or whether it can be 
integrated into it, for once we are ahead of the game, and we 
are working on something.
    And, John, to Quintiles, you know, the question is why 
didn't we look to a data base that we had that gave us some 
clues before we had a problem? And I think that those are 
certainly some of the questions that we have got to ask of 
those entities that are responsible.
    Not you at the table, but the entities that are responsible 
for the network of public health in this country, because what 
I heard both of you in the first panel talk about was that data 
is invaluable to us when we get to the point that we have a 
problem.
    And our ability to look at it and to analyze it, and to go 
specifically where we see a problem, is our ability to treat 
that threat. I think Ms. Harman and I are the only ones on the 
Intelligence Committee and she is not here right now.
    But I can only thank God every night that this was not a 
contagious disease that we were trying to address initially, 
but that it was one that gave us some degree of flexibility, 
and treatability.
    And that time was not necessarily of the essence, but the 
reality is that we have also had examples that this myth that 
we worked under, that education alone, that dissemination of 
the threat alone to our health care providers assured us that 
nobody fell through the net.
    And when we relied on that, we had two people that fell 
through the net. We will deal with the other things, but I 
think that we have got to stay focused on the fact that you can 
fall through this net.
    So, Mr. Chairman, I don't have a question. I just want to 
thank everybody who is here--the witnesses from the first 
panel, and our witnesses from the second panel. And I do hope 
that in a coordinated way CDC and HHS will look at how we use 
the combination of tools that are there today to try to put 
together a solution to the problem that is here today.
    And if in fact it requires resources on our part, and that 
there is a request, because I think we are willing to address 
it, and if it requires new partnerships that are public and 
private, then I would like for those partnerships to be created 
today or tomorrow, and not next year or 2003.
    Because I assure you that the threat will change, the 
challenge will change, and there is some things that we know 
that we just can't accomplish without an infrastructure in 
public health to accommodate those types of threats.
    And my hope is that next week we will hear that request for 
at least the infrastructure, and then we can talk about 
facilities at CDC and other places. And I yield back.
    Mr. Greenwood. Okay. I thank the gentleman, and I also 
thank him for bringing to the attention of this committee Mr. 
Russell and his work, which has been very helpful to us. The 
Chair recognizes the gentlelady from Colorado for 5 minutes to 
inquire.
    Ms. DeGette. Thank you. Dr. Zelicoff, in order to implement 
your system, and to really have it work from an epidemiological 
standpoint, it would have to be pretty much universal with 
doctors and emergency rooms, correct?
    Mr. Zelicoff. No.
    Ms. DeGette. Why not?
    Mr. Zelicoff. I don't know if you were here when a somewhat 
similar question was asked earlier.
    Ms. DeGette. I probably wasn't; otherwise, I would not have 
asked it again.
    Mr. Zelicoff. Statistics helps us out here a great deal. 
All you have to do is sample about 5 percent of the population.
    Ms. DeGette. So does that mean that you would only have to 
have your computer program in 5 percent of the doctors' offices 
in this country?
    Mr. Zelicoff. As long as you have them reasonably 
distributed, accounting for geographic, racial, and 
socioeconomic examples, yes.
    Ms. DeGette. Well, here is the problem that I have, and as 
I looked at what it cost to do that, did someone ask that also?
    Mr. Zelicoff. Yes, $2,000 a site. So we actually got a 
little bit further in the questioning. We estimate 2,500 
clinics roughly, at $2,000 a site, and call it $15 million.
    Ms. DeGette. So it would cost about $15 million to do this?
    Mr. Zelicoff. Right.
    Ms. DeGette. And would it mainly be in private doctors' 
offices or in public hospitals, or both?
    Mr. Zelicoff. We have it in both, and the reason that we 
have it in both----
    Ms. DeGette. Well, I don't need to know the reason. I want 
to know----
    Mr. Zelicoff. We have it in both right now.
    Ms. DeGette. Okay. And at those 25,000 (sic) sites or 
whatever, they would be in both also?
    Mr. Zelicoff. Oh, sure.
    Ms. DeGette. And those would be sites that volunteered to 
do it?
    Mr. Zelicoff. The way we have done it is to ask local 
public health officials who know the docs in the community best 
to nominate sites.
    Ms. DeGette. Like the doc in my community who is sitting 
next to you, they may not need it in Denver, because they have 
already got a vendor that has an integrated system, and they 
are tied into the CDC, and so they wouldn't need it, right?
    Mr. Zelicoff. Not in my view.
    Ms. DeGette. So, my question----
    Mr. Zelicoff. Let me finish the question. In my view, I 
think your conclusion is incorrect.
    Ms. DeGette. But it would be voluntary on their part, and 
you are not going to force them to do it?
    Mr. Zelicoff. Oh, sure. Of course. They are doctors and 
they can do anything that they want.
    Ms. DeGette. Well, that is generally the view of every 
doctor that I have ever met. So, you are right. But here is my 
problem. Denver Health says we have got a very good system, and 
it is working great, and it is integrated, and we can't put 
your system in our vendor. So go somewhere else.
    Go to New Mexico, or go to wherever, and then we have some 
kind of biological or chemical weapon that is dispensed over 
Mile High Stadium during a Bronco game. So by using your 
statistical derivatives, you would not get that through your 
system because you wouldn't have it in that city, right?
    Mr. Zelicoff. Let me try to shed a little light on this 
question, because I think there is a little bit of a 
misperception. As long as any of the systems that are out 
there, ours included, have compliance with the existing medical 
data base architectures--COAS is the standard one, H-7--and 
ours does, there is no problem in sharing the data.
    It is solely then as a matter of the interface, and getting 
the system sustainable so that people will use it.
    Ms. DeGette. Right. But what you are saying is that you are 
extrapolating data through 25,000 sites.
    Mr. Zelicoff. No, 2,500.
    Ms. DeGette. I'm sorry, 2,500 sites throughout the entire 
country.
    Mr. Zelicoff. Yes.
    Ms. DeGette. When we are talking about biological or 
chemical welfare, we are not necessarily talking--and the 
recent attacks are a perfect example. We are not talking about 
attacks over San Diego, California, or Chicago, Illinois, or 
Denver.
    We are talking about attacks apparently at this point 
isolated in a few cities. So if they weren't tied into your 
network, that wouldn't necessarily be the best tool in 
predicting the attack, correct?
    Mr. Zelicoff. Well, if what you are saying is that we are 
gathering data and no one is looking at it, correct. It won't 
work. But the data----
    Ms. DeGette. Well, the----
    Mr. Zelicoff. And let me finish the answer. I am supposed 
to tell the truth and the whole truth. The answer is that the 
data structure is such that all existing commercial medical 
data base compliance systems will be able to use the data that 
we are gathering, and it is up he local public health officials 
if they want to release it.
    Ms. DeGette. Right, but they are not required to fold in, 
and so you don't know. Now, this hearing is called, ``Review of 
Federal Bioterrorism Preparedness Programs: Building an Early 
Warning Public Health Surveillance System.'' And this is--and 
we are all really concerned. I mean, I was listening to what 
Mr. Burr was saying, and I agree with much of it. Unlike what 
many people think right now, Congress is not an unlimited pot 
of money.
    We have to try to figure out where we are going to put our 
resources, which frankly are becoming more strained every day. 
My concern with the recent attacks that we have seen--and like 
Mr. Burr, I think we have to extrapolate.
    We have to say let's not assume the next attack is going to 
be some letters with anthrax in it. Let's say it is going to be 
a poison gas attack, or a communicable disease attack. The 
question we have to answer is, No. 1, are our existing public 
health systems sufficient to have early detection of that.
    And if the answer is no, then we had better do something 
fast. But it seems to me that in the recent attacks we actually 
had pretty good early detection by physicians in Florida, and 
other places, of risks.
    And tragically some people died, but at least we were 
able--I mean, a physician was able to diagnose anthrax, for 
example.
    Mr. Zelicoff. All right.
    Ms. DeGette. So my question is if we had your system or any 
other new system in place, and we had a massive attack, what 
would be better, having a computer system in place to know that 
we are having a massive attack, or having the extra resources 
going toward public health officials or beds or quarantine 
units, so that we could actually treat those patients.
    I think that those are the very real decisions that we are 
making in a public health context right now.
    Mr. Russell. Could I respond to that? I think that to 
answer your question where is it better to put the money--I 
mean, that is always the choice. I think, however, that if we 
are at war and the President says so, and I believe him, then 
you have got to have at least several types of intelligence to 
deal with.
    And I think to say that you are going to choose among 
several systems, and choose one that is the very best one, and 
the silver bullet is not going to get you there. But I do think 
you can do something.
    One message to take away is that we don't have to start 
from scratch. I think all these systems are good. The virtue of 
the existing data base that we have introduced is that it is 
not a development project.
    If you are looking for money that will go to work now, then 
you could--and it is not just our data base, as you have data 
bases that are there.
    Ms. DeGette. And what your data base basically does is it 
tells physicians that there is a lot of cipro being prescribed 
here and what does that mean, right?
    Mr. Zelicoff. Well, that's not--let me say that in order to 
make a working prototype of a surveillance system from what you 
saw on the screen, you would make it much more specific, and I 
alluded to this in the testimony.
    You would take sentinels and markers, and they would say 
exactly what you wanted to look for, in Denver, or in Boise, or 
wherever.
    Ms. DeGette. Right, based on drug prescriptions.
    Mr. Zelicoff. Well, based on a combination of drug 
prescription and medical diagnoses.
    Ms. DeGette. Okay.
    Mr. Zelicoff. And the match of those against----
    Ms. DeGette. And what do we do with that information that 
we don't have the ability to do now?
    Mr. Zelicoff. Okay. Let's say that you wanted to measure an 
increase of flu-like symptoms in Denver against a baseline, and 
because the data base is longitudinal, you could establish a 
baseline.
    And then you would have an alert that would come up, and it 
would be communicated out to whoever in Denver wanted to have 
it. Would it be the public health official, or would it be a 
network of physicians.
    Ms. DeGette. Well, excuse me. My time is way up, and the I 
appreciate the Chair's indulgence. Don't we have that ability 
right now under the NEDSS system and other systems?
    Mr. Davidson. No.
    Mr. Zelicoff. No, I am sorry to say that you don't. You 
don't have that ability.
    Ms. DeGette. I would like to have Dr. Davidson respond.
    Mr. Davidson. Currently, we don't have that available. 
NEDSS is built to allow us to collect that information, the 
same way that they would be collecting it from ICD-9 codes 
using billing data.
    Part of the issue as I mentioned earlier is whether this is 
timely. Does this meet criteria for an effective surveillance 
system, and that is the question.
    Ms. DeGette. I just have one last question, and then I know 
that my time is long up, because something really leaped out at 
me in your written testimony, Dr. Zelicoff, and it is a little 
bit off-subject, but I would like to get a clarification.
    Mr. Zelicoff. Sure.
    Ms. DeGette. Which is that you said that 60 percent of 
antibiotic prescriptions written in the primary care context 
are unnecessary and inappropriate partly because of the lack of 
knowledge.
    Mr. Zelicoff. Right.
    Ms. DeGette. I am wondering if you can extrapolate from 
your data how many cipro prescriptions written in the past 
month would fit into this category.
    Mr. Zelicoff. Well, I couldn't other than to make the 
general statement that I think it has been vastly over-
prescribed.
    Ms. DeGette. But you don't have a scientific conclusion 
based on any data?
    Mr. Zelicoff. I have not seen the raw data on the clinical 
cases. I would have to do that. I would have to correct one 
thing that you said early on, which was with regard to the 
success of the existing public health system. No scientist 
would ever declare a success based on an end of two.
    There were two cases that were diagnosed promptly. We know 
from many studies that have been done that when you take 
pictures, for example, of classic smallpox rash into academic 
medical centers all over the country, and just say what is 
this, nobody, and I mean nobody, gets the diagnosis right. Now, 
this week, they might get the diagnosis right, but 6 months 
from now, I don't know.
    Ms. DeGette. Well, thank you for the clarification. I guess 
I am just not seeing how if in that hospital where the anthrax 
was found and diagnosed, if they didn't have this system, how 
it would be of any additional help. I tend to be sort of a 
budget hawk, and so that is what I am looking at here. Thank 
you very much.
    Mr. Greenwood. The gentlelady's time has expired. I think 
that part of the answer is that we are talking about two very 
different scenarios, and the anthrax scenario is very isolated 
at least so far; whereas, we are talking about epidemics, and 
in the case of infectious disease, that if a particular clinic 
was not equipped with this data, this data collection system, 
the assumption is that other clinics would be picking it up in 
the environments.
    I want to ask Dr. Wagner a question, and that is just 
simply would you just take a couple of minutes and explain in 
detail how your system works, because I am not really sure that 
we have that quite on the record quite yet.
    Mr. Wagner. Thank you for that question, because I felt 
like I had not explained it sufficiently in my spoken 
testimony. As I said, the system relies most heavily on data 
that is delivered computer to computer in real time.
    The most early data about illness that is collected at 
present by the system is the symptoms of the patient when they 
first present to the emergency room. And those symptoms are 
either coded in ICD-9, and so the comment that ICD-9 codes are 
inherently late is not accurate.
    ICD-9s are just a coding scheme, and when it is applied, it 
determines whether it is early or late; or the pretext, where 
the patient has a cough and shortness of breath, and we use 
natural language processing to extract the nature of the 
symptoms.
    So for a large sample of patients, there are symptoms where 
when they should up at the emergency room, and prior to the 
time that they see a physician, are known immediately 
regionally, and available for analysis. That is the earliest 
data.
    Then the additional data that flows in behind those initial 
data about patients are their tests that were ordered, and then 
subsequently the results of the patient that is seen in the 
emergency room as blood cultures are ordered, and that 
information is known at the time that it is ordered, which is 
usually pretty early in the case.
    And then subsequently when the results come back, they are 
available, and there is natural language processing that 
determines whether the gram stain of a blood culture is growing 
gram positive rods, which is a specific finding, or a 
relatively specific finding; when coupled with chest x-ray 
findings, which are also being automatically processed by 
natural language processing.
    So the combination of gram positive rods in the blood, with 
a wide medium stannum, or some other finding on the chest x-
ray, triggers an alert that there is an anthrax patient 
potentially that needs to be followed up.
    One related thought that I just want to mention is the 
issue of whether public health will be overwhelmed by the 
output of these systems in electronic lab reporting, and if all 
of these features are necessary.
    And we have been operating for 2 years, and we see very few 
false alarms. I can understand why the impression is out there 
that these systems should have more false alarms than they do, 
because that was our expectation.
    But we are seeing an alarm a month, and we are monitoring 
for respiratory disease, diarrhea, rash, encephalitic. 
botulinic, and the anthrax detector, the single case detector, 
went off once.
    Mr. Greenwood. Thank you, Dr. Wagner. I thank all of the 
panelists for your generosity with your time, and for your 
testimony, and for your health. This hearing is adjourned.
    [Whereupon, at 1:47 p.m., the subcommittee was adjourned.]

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