Written Public Testimony for the Sunset Review of
The Texas Department of Health

July 1, 1998

Contents

Sunset Advisory Commission Members

Opening Letter to Sunset Advisory Commission

EXECUTIVE SUMMARY

CONCLUSIONS AND RECOMMENDATIONS

SUPPORTING DOCUMENTATION

1. TDH Uses Rule Writing Authority To Circumvent Legislation
2. TDH Devises Ways To Circumvent Informed Parental Consent Requirements
3. TDH Avoids Private Citizen Involvement And Embraces Industry Involvement
4. TDH Misleads Legislators To Get Bill Passed
5. TDH Maintains Immunization Database Before Direct Legislative Authority
6. TDH Collaborates With Other Departments To Collect Information Without Consent
7. TDH Uses Public Health To Cash In On Federal Reward Incentives
8. TDH Keeps Many Of The Records They Obtained Without Informed Consent
9. TDH Not Taking Required Provisions To Secure Data
10. Legislative Penalties For Registry Information Misuse Not Enforced
11. Cost Of Implementation
12. TDH's Immtrac Is Part Of A National Registry Plan To Include Everyone
13. Challenges To The New Vaccines That Save Money - Not Lives
14. Questionable Outreach Activities
15. TDH And CDC Want Federal Law To Preempt State's Consent Provisions
16. TDH Plans For Immtrac Data To Be Available To International Databases
17. Immunization Registries Are Not Cost Effective
18. Private Foundations Use Registries To Manipulate Nation's Health Care Options
19. Vaccine Safety Issues

Joey Longley, Director
Sen. J.E. "Buster" Brown, Chair
Sen. Chris Harris
Sen. Frank Madla
Sen. Judith Zaffirini
Honorable Bob Lanier
Rep. Patricia Gray, Vice Chair
Rep. Fred Bosse
Rep. Allen Hightower
Rep. Brian McCall
Bill Jester

P.O. Box 13066
Austin, TX 78711-3066
(512) 463-1300

Dawn Richardson
Alison Mullins
Rebecca Rex

We respectfully ask the Commission to consider our written testimony in your review of the Texas Department of Health under the Sunset Process. For ease of reference, this document has been divided into three main sections. The first section, entitled "Executive Summary", briefly introduces our concerns by summarizing each area of concern as it relates to the Texas Department of Health. The second section comprises our "Conclusions and Recommendations". The third section, entitled "Supporting Documentation", details the reasons and factual support behind our concerns. We hope that the following report not only alerts the Sunset Advisory Commission to these concerns but convinces you to take necessary corrective actions.

Sincerely,
Dawn Richardson
Alison Mullins
Rebecca Rex

On June 18, 1997, Governor George Bush signed HB 3054 into law, which authorized the Texas Department of Health (TDH) to establish a statewide immunization tracking computer registry (ImmTrac). This document will show that TDH's Immunization Division has consistently tried to undermine privacy protections written into this law and misled the legislature as well as the public it serves regarding ImmTrac uses and implementation.

To correct these pervasive abuses, we submit that the Commission needs to go beyond the initial recommendation in your report encouraging stakeholder outreach activities in TDH's rulemaking process; it should propose Sunset Legislation limiting TDH's autonomous rule making authority to require involvement with the individuals or groups their rules regulate. While TDH touts ImmTrac's ostensible benefits to Texas citizens, the federal government and drug companies dictate how ImmTrac is operated in the service of their respective policies and business interests, and this poses a serious threat to Texans' cherished privacy and freedom of choice in health care. For these reasons, we additionally urge the Commission to propose Sunset Legislation to shut down the ImmTrac program and prohibit the connection of Texas medical databases with other state or federal databases.

1. TDH USES RULE WRITING AUTHORITY TO CIRCUMVENT LEGISLATION
   TDH attempted to use the rule writing process to circumvent the privacy and consent provisions guaranteed by the Texas Legislature in the passage of amended HB 3054.
2. TDH DEVISES WAYS TO CIRCUMVENT INFORMED PARENTAL CONSENT REQUIREMENTS
   TDH knew the parental consent restrictions of HB 3054, yet ignored them when they wrote the proposed rules. TDH connived with insurance companies to bury ImmTrac consent within enrollment forms. They continue to state their desire to eliminate informed consent.
3. TDH AVOIDS PRIVATE CITIZEN INVOLVEMENT AND EMBRACES INDUSTRY INVOLVEMENT
   TDH met with insurance companies and HMOs while they were writing registry rules, but did not include parents despite verbal agreements. TDH advertised the rule posting only to the minimum required by law despite the controversy surrounding the issue.
4. TDH MISLEADS LEGISLATORS TO GET BILL PASSED
   During 1997 legislative committee hearings and the immunization tracking system's rule review process, the Immunization Division of TDH downplayed the amount of personal information they intended to collect and in fact had already collected. However, TDH greatly expanded the information to be collected by ImmTrac beyond what the statute contemplated. TDH also created a loophole in its rules allowing itself to gather whatever additional information it will want in the future.
5. TDH MAINTAINS IMMUNIZATION DATABASE BEFORE DIRECT LEGISLATIVE AUTHORITY
   TDH misinformed the legislature and the public in their request to establish an immunization tracking system. They had already, often without parental consent, entered over 3 million children's records since 1995.
6. TDH COLLABORATES WITH OTHER DEPARTMENTS TO COLLECT INFORMATION WITHOUT CONSENT
   By linking private birth record information with ImmTrac, TDH populated the state immunization registry with total disregard for the parental consent provisions required by Texas law. The Federal Government encourages this type of action. The Social Security Administration used its rule making process to modify the Privacy Act of 1974 to allow the SSA to provide a child's SSN to all states without parental consent for the purpose of establishing immunization registry records for all newborns.
7. TDH USES PUBLIC HEALTH TO CASH IN ON FEDERAL REWARD INCENTIVES
   TDH will collect millions of federal dollars of discretionary income as a reward for entering Texas children's immunization histories into ImmTrac. This financial incentive may explain TDH's determination to promote ImmTrac and its resistance to parental consent despite the objections of Texas citizens and the provisions of Texas law.
8. TDH KEEPS MANY OF THE RECORDS THEY OBTAINED WITHOUT INFORMED CONSENT
   TDH has refused to remove the majority of names from ImmTrac even though parental consent can't be verified for those entries. Parental consent forms do not offer a way to either opt out of or withdraw from ImmTrac, nor do they clearly explain that personal data can be transferred to other state, federal, and non-governmental registry users. TDH has methods for keeping tabs on those who do manage to opt out of the system.
9. TDH NOT TAKING REQUIRED PRECAUTIONS TO SECURE DATA
   TDH wrote proposed rules allowing them to release ImmTrac data to outside entities who are not authorized or bound by protective state laws. TDH applied for and accepted federal grant money to explore ways to integrate immunization data with other databases despite legislative restrictions. TDH will be further exposing Texans to the threats of identity theft and financial fraud.
10. LEGISLATIVE PENALTIES FOR REGISTRY INFORMATION MISUSE NOT ENFORCED
    After TDH illegally released ImmTrac data, parents and legislators complained to no avail. Even though the bill provides criminal penalties for negligently releasing ImmTrac data, the lack of an adequate enforcement mechanism renders these penalties meaningless.
11. COST OF IMPLEMENTATION
    Even though TDH downplays state and local expenses, over $8.5 million dollars of state money has been spent, and millions of federal taxpayer dollars are being and will continue to be spent on the ImmTrac system.
12. TDH'S IMMTRAC IS PART OF A NATIONAL REGISTRY PLAN TO INCLUDE EVERYONE
    The federal government is implementing its plan for establishing a national surveillance and enforcement system to ensure that all children and adults comply with every government vaccine recommendation. TDH's ImmTrac System is the Texas component of this national registry program.
13. CHALLENGES TO THE NEW VACCINES THAT SAVE MONEY - NOT LIVES
    Immunization registries allow for uniform enforcement of questionable vaccination policies. Knowledgeable and responsible parents and physicians question the trend of requiring most of new vaccines (i.e., chicken pox, diarrhea) because they are justified primarily for convenience and cost effectiveness. The Hepatitis B shot is routinely administered to newborns regardless of their risk of catching it.
14. QUESTIONABLE OUTREACH ACTIVITIES
    Parents who do not exactly follow the government recommendations for vaccines will be subjected to continual harassment, and even home visits, until they comply. TDH never mentioned its detailed plans for home visits and "other means" of coercion when this bill was discussed or when the rules were posted.
15. TDH AND CDC WANT FEDERAL LAW TO PREEMPT STATE'S CONSENT PROVISIONS
    The National immunization Program, the National Vaccine Advisory Committee, and the All Kids Count Program are moving toward their ultimate goal of a national immunization tracking system network to include all children despite state protective laws requiring consent. Unless this is stopped, Texas legislators may see the privacy and consent provisions they supported superceded by federal law.
16. TDH PLANS FOR IMMTRAC DATA TO BE AVAILABLE TO INTERNATIONAL DATABASES
    The CDC has been working with other states and countries to develop a standard data file format which will allow international monitoring of vaccination status, and TDH is following that system despite citizens' right to keep their medical information private.
17. IMMUNIZATION REGISTRIES ARE NOT COST EFFECTIVE
    The reasons given by the National Immunization Program for financing immunization registries don't justify spending billions of dollars. With immunization registries in place, compliance with newly developed vaccines can more easily be enforced, increasing revenue for vaccine manufacturers and health care providers.
18. PRIVATE FOUNDATIONS USE REGISTRIES TO MANIPULATE NATION'S HEALTH CARE OPTIONS
    Private foundations, such as the Robert Wood Johnson Foundation, whose founding companies will profit from a national immunization registry, manipulate public policy to serve their self-interests.
19. VACCINE SAFETY ISSUES
    Vaccines carry medical risks, making their tracking and enforcement more controversial. 

High quality public health is a goal that we all share, however, a vaccination surveillance, monitoring and enforcement system orchestrated by the federal government is not an acceptable means to that end. As this report asserts, pronouncing that a program is in the best interest of the public does not necessarily make it so.

While we appreciate TDH's commitment to public health programs, we disagree with methods TDH has employed misleading legislators and citizens. Last year, we felt that consent provisions in the law would be enough protection for parents who did not want their children to be a part of ImmTrac. We have changed our position because of TDH's repeated attempts to circumvent these protections, the invasive enforcement programs planned by the federal government, and the CDC's plot to add many more vaccine mandates for all citizens. We are at the critical point where a Texan's right to self determination of medical procedures and privacy of personal and medical information can only be adequately protected if the legislature takes the necessary corrective actions.

For these reasons, we respectfully request that you propose:

1. Sunset Legislation limiting TDH's autonomous rule making authority to require involvement with the individuals or groups their rules regulate
2. Sunset Legislation to shut down the ImmTrac program and to prohibit the connection of Texas medical databases with other state or federal databases

In response to concern over medical privacy, The Texas Republican Party adopted the following statement as part of their 1998 party platform at their recent Fort Worth, Texas Convention:

The Party opposes any and all unauthorized access and distribution of an individual's private medical records by a government agency or any agent working on behalf of a government agency. The Party also opposes the formation of any state or federal (national) registry into which personal medical information would be deposited.

We would all be wise to heed the warnings of the experts on the threats to our civil liberties that these registries pose. Agneta Breitenstein, director of the Health Law Institute in Boston, spoke in opposition to immunization registries at the April 6, 1998 CDC Initiative on Immunization Registries meeting in New Orleans. "There are three things that are always true when registries are created: "One, there will always be more information collected than is needed to complete the task; two, it will always be kept longer than we are told; and, three, it will always be used for purposes other than intended."

The introduced version of HB 3054, sponsored by Representative Hugo Berlanga, enabled TDH to enroll children in the registry without parental knowledge or consent.

§ 161.007(e) Individually identifiable immunization information regarding a child may be provided to the department by, or released by the department to, a public health district, a local health department, hospital, physician, or other health care provider to the child or to a school or child care facility without the consent of the child's parent, managing conservator, or guardian.

After parents and legislators raised issues concerning consent and confidentiality, Senator Jerry Patterson, with the assistance of Senator Chris Harris, wrote an amendment to address the issue that the parents should have ultimate control over their children's private medical information. The final, adopted version of the bill states in §161.007(a) (3)

.. The department by rule shall develop guidelines to: require the written consent of a parent, managing conservator, or guardian of a patient before any information relating to the patient is included in the registry;

On February 20, 1998, TDH posted in the Texas Register their proposed rules concerning the registry. (Note: Due to public outcry and legislative letters reflecting constituent concerns, these have been withdrawn and are currently being re-written.) Repeatedly, the rules attempted to enable TDH to collect information without consent by putting the burden of action on parents to withdraw rather than the statutorily required burden of action on TDH to obtain consent.

Preamble

Those who wish to decline participation or withdraw consent must communicate this to the department.

§ 100.2(a)(4):

.. Parents who decline to participate should sign a statement stating: "I do not want to have my child participate in the Immunization Registry" or a similar statement. Parents choosing this option should mail their statement to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756.

§100.3. Providers, Health Plans, and Insurance Companies.

.. Unless informed otherwise by the provider or the department, the organization may assume that consent has been given for any vaccine for which the provider submits a claim or encounter record.

SUMMARY: TDH attempted to use the rule writing process to circumvent the privacy and consent provisions guaranteed by the Texas Legislature in the passage of amended HB 3054.

On July 30, 1997, and November 5, 1997, meetings were held between TDH ImmTrac personnel and Texas insurers. The meetings were held after the legislation passed but before the rules were written and posted. Reviewing their notes gives a clear picture that TDH and their legal counsel were well aware of the legislative intent regarding consent. These excerpts were taken from the notes posted on the TDH web site: http://www.tdh.state.tx.us/immunize/minutes.htm.

ImmData II Share Meeting Minutes Wednesday, July 30, 1997

Objective: To establish a dialog for planning and implementing an immunization data exchange between ImmTrac and Texas insurers.

III. Texas' Immunization Tracking Requirements, HB 3054

by Monty Waters of TDH Office of General Counsel.

(Summary notes) This bill requires that consent be given prior to entry to the registry. One way for HMO's to ensure that they have consent from their participants is to include a consent statement in their enrollment form. TDH is looking to add a consent option to the birth record.

Q. Why can't people who receive public assistance be required to put their information in the registry?

A. (Monty Waters) The law is not written that way. The information may be in another database, but consent must be given prior to entry into the ImmTrac Database. It would be a good idea for Plans to include consent in their enrollment documentation.

IX. Hopes and fears for further involvement in the registry process.

In small groups we prepared hopes and fears for further involvement in the registry process.

Excerpts from Hopes

- All children will be registered.

- Successfully overcome the issues around consent.

- Change legislation.

Excerpts from Fears

- Consent legislation will overwhelm the process.

- Never be populated enough to be effective (consent).

- Bureaucratic nightmare (consent).

- Bias in data because of consent requirements (consent).

- We will all go to jail for the rest of lives (consent).

- Increased hassle factor.

- If unique identifiers don't work the data will be unusable.

- Large employers mandate enrollment forms and may not allow inclusion of consent forms at enrollment.

The inconsistent acknowledgement of consent requirements between these meeting notes and the proposed rules is especially interesting in light of a comment given to reporter Rebecca Rodriguez by TDH General Counsel for the April 25, 1998, edition of the Austin American-Statesman.

"We certainly never intended to do anything under the table or underhandedly,'' Waters said.

This story is on-line at: http://www.austin360.com/news/002state/04april/25/vaccine25.htm

Senator Jerry Patterson and Senator Chris Harris submitted a Letter of Legislative Intent after reviewing the proposed rules because the rules did not uphold the spirit of HB 3054 to establish a purely "voluntary" registry.

SUMMARY: TDH knew the parental consent restrictions of HB 3054, yet ignored them when they wrote the proposed rules. TDH connived with insurance companies to bury ImmTrac consent within enrollment forms. They continue to state their desire to eliminate informed consent.

After the Senate Committee Hearing, Becky Brownley, the TDH government relations representative, promised the concerned parents who had testified at the hearing, Mrs. Richardson and Mrs. Rex, to include them in the development of registry rules. These parents were never contacted during the rule making process even though meetings were held with insurance companies and HMOs. More excerpts from the meeting notes referenced above show TDH compiled an extensive list of potential committee members without including the largest group of affected stakeholders, parents. This list did include: Physicians groups/assoc., Nursing groups/assoc., Parent Teacher Assoc., All Kids Count, Media groups, Consumer groups, Pharmaceutical Co., WIC, Medicaid, Business/Tech. Firms, Health Ed./Universities, TX Assoc. of School Boards Legislators/Reps., NCQA, PPO's, HEDIS Coalitions, and TX Ed. Assoc.

In February of this year, Mrs. Richardson called the Immunization Division after reading an article in a TDH publication discussing HMO's automatically forwarding children's private immunization records to the health department. Mike Messinger, from the ImmTrac Program, told her that the rules were nearly finished, consent was considered in their writing, and they were just about to be posted in the Texas Register.

After reviewing the posted rules, parents launched a grass roots letter writing campaign to TDH and their legislators to voice their complaints. They logged about 120 letters in the short thirty-day comment period. Considering the magnitude of this project, it is disturbing that this was more letters than TDH had ever received on any previous comment period. Virtually every parent and health care professional in the state will be affected by the rules, yet TDH only met the minimum requirement of posting the notice of proposed rules in the Texas Register. People generally trust their health department to keep them informed, yet most Texans couldn't comment because they didn't even know of the registry's existence.

SUMMARY: TDH met with insurance companies and HMOs while they were writing registry rules, but did not include parents despite verbal agreements. TDH advertised the rule posting only to the minimum required by law despite the controversy surrounding the issue.

On May 16, 1997, the Senate Health and Human Resources Committee held a public hearing concerning

HB 3054. The following quotes show that the committee was misinformed regarding personal information that was to be collected and in fact had already been collected by the Health Department. The Senate Media Office provided a tape to Mrs. Richardson who transcribed the portions found below.

A parent (Rebecca Rex of Houston) stated her concern over information going from her child's doctor's office to the department without her consent. A discussion regarding the amount of information collected in ImmTrac arose.

Senator Jerry Patterson asked, Immunization Director, Robert Crider, who had been called as a resource witness, "Two questions, #1 Why do you need the name - I can understand demographics, I can understand certain types of demographic information. such as age and weight you know height, things like that, that might medically give some indication or a variety of other demographic information. But the name, to me is completely of no significance or interest to you."

Crider responds, "I think that would be negotiable sir, if we could have the other demographic information in terms of ages, birth areas of where they live. I don't see how that would be important to us to know the name."

Senator Zaffirini asks Crider if that is acceptable to the Department. His reply is "Yes, as long as we could get information that would give us the data ages or whatever."

Senator Zaffirini asks "Will you work with Senator Patterson to develop that amendment that still gives you enough information that you need and satisfies the concerns of those who address the issues of privacy and confidentiality?"

Crider answers, "Yes, if we are talking about non-identification by name, yes."

Crider interjects, "But I would like to clarify address being not say a specific mailing address or residence, but a zip code or census track area."

The enrolled statute HB 3054, which includes the consent and privacy amendment, permits only limited information to be gathered. §161.008(b) states:

An immunization record contains the:

(1) name and date of birth of the person immunized;

(2) date of immunization;

(3) types of immunization administered;

(4) name and address of the health care provider administering the immunization.

Even though the Director of the Immunization Division tried to quell parents' and legislators' fears over too much personal information being collected by saying TDH didn't need identifying information of name and address, §100.5(f) of the first version of the proposed rules required that beginning on January 1, 1999, providers must report the child's name and address, child's social security number (if known), gender of the child, child's date of birth, and mother's maiden name (if known). §100.5(b) stated: "Other information specified on forms and data file layouts should be provided when available"

After discovering that this immunization registry had been maintained by TDH for several years prior to direct legislative authority, Senator Patterson issued a letter of inquiry to the department. The following passage quotes a question posed by Senator Patterson and the response from Dr. William R. Archer III, Commissioner of Health.

Please outline all the information which is contained in a single ImmTrac database record.

As proposed in the department's rules, the required information would be: last name, first name, date of birth, sex and address of the child who is immunized, name of parent, guardian or managing conservator and relationship to child, vaccine administered, and lot number and manufacturer of the vaccine administered (proposed 25 T. A. C. §1005(b)). ImmTrac also would have fields for the following voluntary information: ethnicity, phone number, birth certificate number, birth weight, number of prenatal visits, place of birth, child's Social Security number, child's Medicaid number, mother's name, mother's maiden name, mother's Social Security number, mother's date of birth, father's name, father's Social Security number.

SUMMARY: During 1997 legislative committee hearings and the immunization tracking system's rule review process, the Immunization Division of TDH downplayed the amount of personal information they intended to collect and in fact had already collected. However, TDH greatly expanded the information to be collected by ImmTrac beyond what the statute contemplated. TDH also created a loophole in its rules allowing itself to gather whatever additional information it will want in the future.
 

The following quotes are from the preamble of the proposed rules for Registry Legislation.

The Texas Department of Health (department) proposes new §§100.1-100.10, concerning the establishment of an Immunization Registry.

The 75th Legislature, 1997 enacted Chapter 900, adding Health and Safety Code, §§161.007-161.009 requiring the department to establish an immunization registry and provide for the confidentiality of information it contains. These rules implement the legislation.

Clearly, the indication is that there is not a registry and the department intends to now "establish" one.

The following quotes are taken from Dr. Archer's response to Senator Patterson's Letter of Inquiry.

When was the ImmTrac program actually implemented and brought online?

..The current electronic data base was developed from December 1994 to December 1995, with the first data input (from the Bureau of Vital Statistics and ICES) in October 1995.

Please state the statutory, regulatory and budgetary authority for the ImmTrac program, if any.

. and immunization grant guidelines require the department to implement an immunization registry as a condition of receiving federal immunization funds (CDC "1998 Immunization Grant Guidance" there were similar requirements in the previous edition).

The response contains various statues regarding Health Department tasks, but nothing specific to ImmTrac or the maintenance of a tracking system where data would be released to outsiders. The above reply does not respond to the question about budgetary authority, although, they refer to a federal requirement for receiving funds.

How many records are currently contained in the ImmTrac database?

3.3 million

SUMMARY: TDH misinformed the legislature and the public in their request to establish an immunization tracking system. They had already, often without parental consent, entered over 3 million children's records since 1995.
 

After the comment period closed, several parents found that their children had already been entered into the registry without their consent, and that the records also included personal information about the parents including private social security numbers. Parent's suspicions that ImmTrac employees were collecting Birth Certificate data from the Bureau of Vital Statistics to enter children that they could not obtain other ways were confirmed in Dr. Archer's response to Senator Patterson's letter of inquiry.

How was the current ImmTrac database compiled and how often is the database updated?

The current database was compiled from a number of sources prior to September 1, 1997, .Medicaid client information from National Heritage Insurance Company (which is required to participate as a result of the federal consent cited above)..

More specifically, were any of the names in the ImmTrac database obtained solely or in part from birth certificates obtained by the Texas Bureau of Vital Statistics?

Yes.

TDH is not the only government agency willing to find methods to get around consent. As we will explain later, the Centers For Disease Control under the Department Of Health and Human Services (DHHS) is pushing states to get their immunization registries up and running as quickly as possible, and it is their preference to do this without giving the parents the option to consent.

The Privacy Act of 1974, as passed by Congress, protects a person's Social Security number from certain misuse. The Social Security Administration, under recommendation from DHHS, used the rule making process to change the Privacy Act by posting new uses for Social Security numbers in the Federal Register. They enacted these rules which will be used by the states to create immunization tracking system files on children without parental consent. On March 9, 1995, Volume 60 Number 46, pages 12964-12965, the Federal Register reports a new routine use of the Social Security Privacy Act of 1974.

The proposed routine use would permit SSA to send the SSNs of newborns, and as a one time disclosure, the SSNs of children born since December 31, 1990, to the State BVS in which a birth is recorded without having to secure parental consent.. Public health program uses of the SSNs would include, but are not limited to, establishing public immunization registries. Using the SSN as the primary identifying record number would facilitate the process and lower the cost of creating and operating a national network of coordinated statewide immunization registries.

SUMMARY: By linking private birth record information with ImmTrac, TDH populated the state immunization registry with total disregard for the parental consent provisions required by Texas law. The Federal Government encourages this type of action. The Social Security Administration used its rule making process to modify the Privacy Act of 1974 to allow the SSA to provide a child's SSN to all states without parental consent for the purpose of establishing immunization registry records for all newborns.
 

The following quote is from the preamble of the proposed rules for the implementation of the Registry Legislation.

Mr. Crider has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of these sections, is a centralized immunization registry . to maintain and access a child's immunization history. The public benefits anticipated . include: better health care for children . and greater opportunity for outreach activities in areas of Texas with low immunization levels.

Mr. Crider didn't mention that Texas could collect up to $100 per two-year old child proven to be fully immunized by including them in their state immunization registry.

The following quote is taken from Dawn Richardson's report to the National Vaccine Advisory Committee, the National Immunization Program, and members of Congress on immunization registry abuses.

The Comprehensive Childhood Immunization Act of 1993 initially appropriated $417 million dollars to provide funding to individual states to create their own nationally connectable tracking systems. The Act was amended to appropriate additional incentives outlined whereby individual states could collect discretionary income as high as $100 per two year old child proven to be fully immunized by including them in their state immunization registry. In Texas, where 3.3 million children have already been entered into the database, the majority without parental consent or knowledge, almost one third of a billion dollars could be spent to "reward" Texas.

SUMMARY: TDH will collect millions of federal dollars of discretionary income as a reward for entering Texas children's immunization histories into ImmTrac. This financial incentive may explain TDH's determination to promote ImmTrac and its resistance to parental consent despite the objections of Texas citizens and the provisions of Texas law.
 

Of the 3.3 million children's records in the registry, around 700,000 had incomplete immunization information because the personal or "shell data" was taken primarily from the birth certificates without parental consent. After Senator Patterson's inquiry, Dr. Archer agreed to delete these 700,000 records. We do not know if these records are maintained in a "non-registry" database or anywhere else at the Department or if steps were taken to ensure this information can not be retrieved from back-up tapes. The ImmShare notes from the July 30, 1997 meeting, (before rule controversy and Senate inquiry) make us question how "deleted" these records are.

Q. Reporting capabilities: how will we know what part of the population will be included and will it be enough to be valid?

A. (Ann Syptak, ImmTrac Program Manager) We expect to receive most records. We will know how many and where those are who have opted out.

TDH has stated they will not delete any of the other 2.6 million records, even though TDH cannot verify that they have obtained informed consent. As stated above, because these 2.6 million files are complete, we feel this reluctance stems from the potential loss of federal grant incentives.

Even though TDH supplies the federally required consent forms for vaccination that are used by public health clinics and some private health care providers, the TDH portions have inherent problems. In addition to giving consent for the vaccine, the form briefly mentions registry inclusion. The form has a single signature line, giving the parent no option to give consent for the vaccine and yet deny registry inclusion. This forces parents into an "all or nothing" package. Parents are not informed to the extent that their personal data will be collected or how widely it could be distributed as we will show in the next section.

The following two statements were taken from the Haemophilus Influenzae Type b Vaccine (HiB) info sheet C-108 (8/96). (Note: form date again shows existence of registry before legislative authority, all vaccine forms are worded similarly and have dates for publication right around the same time.)

8. I agree that the record of giving each vaccine (those given today and previously) can be put in the Texas Department of Health immunization tracking system.

9. I agree that the record of giving each vaccine (those given today and previously) can be given to other health care providers, schools, or places that provide child care.

The mechanism TDH has offered to ensure that consent has been obtained for its records is that TDH has never given parents the formal chance to say they don't want their children included. This is not informed consent. Every parent we've spoken to who has found their children in the registry emphatically asserts that they have never given consent. TDH has stated that they will modify their consent forms, but we have not been provided with any to review at this date.

SUMMARY: TDH has refused to remove the majority of names from ImmTrac even though parental consent can't be verified for those entries. Parental consent forms do not offer a way to opt out of ImmTrac, nor do they clearly explain that personal data can be transferred to other state, federal, and non-governmental registry users. TDH has methods for keeping tabs on those who do manage to opt out of the system.
 

TDH is attempting to set up the plans to release ImmTrac data to other state and national registries. They have no control over outside users' re-release provisions or confidentiality procedures. HB 3054 only allows for the release of this information to specific local entities:

§161.008 (c) The department, only with the consent of a child's parent, managing conservator, or guardian may:

(2) release the data constituting an immunization record for the child to a public health district, a local health department, a physician to the child, or a school or child care facility in which the child is enrolled.

Despite limitations placed by the Texas Legislature, § 100.9 (a) of the proposed rules stated:

The department, by written agreement with other providers and health plans, may transmit paper or electronic copies of immunization records or reports to registered users of the registry or to other state or national immunization registries.

Section 100.3(c) of the proposed rules indicates that the immunization registry will be linked with other databases, including, but not limited to ICES, WIC, Medicaid, and other insurance and health plan billing systems.

To leave the opening to add anyone to the list of those who have access to the registry after the rules would be set in place, not giving the public any protection, TDH wrote in the rules:

§100.2 (a) (1) "I authorize the Texas Immunization Registry to release past, present, and future information concerning my child's immunizations to myself and any

(E) director of the immunization division of the department or his designee.

(2) I authorize the above entities to further re-release this information.

On April 1, 1998, Texas was one of nine states awarded with a grant under the CDC's Information Network for Public Health Officials program. The purpose of the grant is stated to

Integrate existing health information systems, including practice management, electronic birth certificate and immunization tracking programs into a statewide public health network.

By applying for and accepting this federal grant to integrate ImmTrac's data into a "statewide public health network", TDH demonstrates once again that following the legal requirements to protect and secure our data are far less important than federal money.

There are several risks to individuals by having this data accessible to so many. Two major exposures are identity theft and financial fraud. An IRS audit dated September 30, 1997, obtained by the Associated Press, states "Under current procedures, an imposter who knows a taxpayer's name, address, and Social Security number can find out tax and income information from the Internal Revenue Service with a simple phone call." This private personal information will be accessible to too many people with this registry.

SUMMARY: TDH wrote proposed rules allowing them to release ImmTrac data to outside entities who are not authorized or bound by protective state laws. TDH applied for and accepted federal grant money to explore ways to integrate immunization data with other databases despite legislative restrictions. TDH will be further exposing Texans to the threats of identity theft and financial fraud.
 

Under the heading Penalties for Disclosure of Information, HB 3054 includes penalty clauses for the misuse of immunization registry data:

§161.009. (a) (1), A person commits an offense if the person negligently releases or discloses immunization registry information in violation of Section 161.007 or 161.008..

b) An offense under this section is a Class A misdemeanor.

Despite these protections, the Health Department illegally disclosed information.

On March 23, 1998, Dawn Richardson called the Immunization Division and found that her 20-month-old daughter was in their registry. TDH faxed Mrs. Richardson the report. The computer contained her daughter's assigned ImmTrac ID, parent's social security numbers and address. Mrs. Richardson provided minimal identifying information over the telephone to receive the fax (name of child, date of birth, her name, and county of residence) and had never given written consent to be included in the registry or to have information released to TDH.

Several legislators and their aides also found their children included without consent. They also found it just as easy to get a fax without providing written consent. The provisions of the law regarding data protection were not enforced despite having the penalty of being charged with committing a Class A Misdemeanor. This portion of the law took effect September 1, 1997. Several complaints were filed with different agencies, but no action was taken.

SUMMARY: After TDH illegally released ImmTrac data, parents and legislators complained to no avail. Even though the bill provides criminal penalties for negligently releasing ImmTrac data, the lack of an adequate enforcement mechanism renders this meaningless.
 

The following quote is from the first set of proposed rules for Registry Legislation:

Robert D. Crider, Jr., M.S., M.P.A., Director, Immunization Division, has determined that for the first five year period the sections are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the sections as proposed. Mr. Crider bases his estimate on the fiscal note prepared for the legislature on House Bill No. 3054, which became Chapter 900.

What Mr. Crider didn't tell us is that the state has already spent over $8.5 million dollars from 1994 through 1997 on the creation and implementation of ImmTrac. (Source, FOIA request filled by the Legislative Budget Board to Mrs. Richardson on April 23, 1998.)

The state has secured federal grants for near future costs of operation. Stating that there are no fiscal implications to the state disregards the fact that taxpayers are footing an enormous bill for a program they do not support.

SUMMARY: Even though TDH downplays state and local expenses, over $8.5 million dollars of state money has been spent, and millions of federal taxpayer dollars are being and will continue to be spent on the ImmTrac system.
 

The Comprehensive Childhood Immunization Act of 1993 tried to create a national immunization registry in April 1993, but parents and privacy groups successfully defeated that portion of the bill. In September and November of 1993, the Act was quietly amended to provide the funding to individual states to create their own nationally connectable tracking systems. Each state has CDC employees working locally to guide state policy development and implementation.

The CDC's National Immunization Program National Immunization Registry Clearinghouse web site,

http://www.cdc.gov/nip/registry/factsheet.htm discusses President Clinton's commitment to this goal.

During a White House Ceremony on July 23, 1997, the President directed the Secretary of the Department of Health and Human Services to work with the states on integrated immunization registries. As a result, the CDC's National Immunization Program is coordinating a series of workgroups with its partners, which will:

Establish a broad base consensus on issues necessary to create a nationwide network of community and state-based immunization registries..

Establish a target date to achieve the goal of establishing immunization registries in every community in the Nation.

TDH's Associate Commissioner of Disease Control, Dr. Diane Simpson, is a member of one of the National Vaccine Advisory Committee's Workgroup on Immunization Registries.

In many sources, The National Immunization Program states their plans for expanding these immunization registries to include adults and grow into full-scale medical databases for children operated by the federal government. Their National Immunization Registry Clearinghouse Fact Sheet dated March 3, 1998, states:

The National Immunization Program (NIP) is committed to promoting the development and maintenance of state- and community-based computerized registries which will eventually be capable of capturing immunization information for individuals of all ages.

We see registries as the possible first step in the development of an electronic pediatric medical record.

The CDC lists Immunization Objectives in their "Healthy People 2010" document that, "Any newly licensed vaccine will be incorporated into the HP 2010 goals. as appropriate." The draft outlines "Adult Immunization Goals, and section 20.3) has the heading, "Expand immunization laws for schools, preschools and day care settings to all States for all antigens".

NIP's self-defined roles strongly jeopardize the privacy and security of medical and personal information. To aid in the developing of these systems, NIP has engaged in the following activities as stated in their March 3, 1998 Fact Sheet:

Acts as a catalyst to build political will and consensus among registry stakeholders;

Encourages integration of the immunization registry movement with the rapidly developing, broader field of medical informatics for the purposes of benefiting from the latest technological advances and promoting the inter-operability of registries with other developing medical information systems;

Implements and maintains a national "registry of registries" to collect information about immunization registries, and synthesizes and disseminates this information by maintaining an Internet-based National Immunization Registry Clearinghouse at the Centers for Disease Control and Prevention. This site can be accessed at http://www.cdc.gov/nip/registry .

SUMMARY: The federal government is implementing its plan for establishing a national surveillance and enforcement system to ensure that all children and adults comply with every government vaccine recommendation. TDH's ImmTrac System is the Texas component of this national registry program.
 

The CDC and vaccine manufacturers are developing over 200 new vaccines, and the vaccine industry is expected to triple its revenues in the next decade. Because vaccines have already been developed for the serious health threats, manufacturers have turned their eyes toward the profitable development of vaccines for inconvenience illnesses. Stanley Plotkin, Scientific and Medical Director, Pasteur Mérieux Connaught, Marnes la Coquette, France (one of the largest vaccine manufacturers in the world) issued the following statement on February 26, 1998 at a European Vaccine Conference:

Experimental vaccines are being produced in profusion.. There will be both new pediatric and new adult vaccines, some of which will be to improve quality of life, rather than to prevent death.

A May 5, 1998, press release shows that even the cost of diapers is used to justify new vaccines.

05/05/98 Release at 4 p.m. EDT

CHICAGO (Reuters) - A mass vaccination program against the most common childhood diarrhea would prevent more than a million cases of it in U.S. children. researchers said Tuesday.

When health care expenses and costs to parents or caregivers, such as extra diapers and lost work time, are considered along with direct medical expenses, a vaccination program would save society $296 million, the report from the U.S. Centers for Disease Control and Prevention said.

Since the FDA licensed the use of the varicella (chicken pox) vaccine in 1995, we have seen aggressive marketing campaigns to promote its use. Chicken pox can, on rare instances, result in serious complications, even death. The current frenzy of stories warning of the dangers of chicken pox is in marked contrast to previously published medical statements, however, they are quite effective in persuading many parents to schedule a doctor's visit for another shot.

According to the American Medical Association's Encyclopedia of Medicine (1989):

The American Academy of Pediatrics states in its brochure on chickenpox (1996):

Dr. Jeffrey Boscamp, Chief of Pediatric Infectious Diseases at Hackensack (N.J.) University Medical Center stated, "This vaccine is regarded by pediatricians as more optional, and there is still debate [about] whether we have enough long-term experience to know that it is as good as natural infection."

Despite public opposition, Massachusetts, along with three other states, recently added the varicella vaccine to the immunization schedule. The Chief of the Pediatric Infectious Disease Department of New England Medical Center, Dr. Cody Meissner, who also participated in the development of the chickenpox vaccine, stated:

"Studies suggest that widespread use of the varicella vaccine will be cost effective, primarily through a reduction in the number of work days missed by parents caring for sick children".

Not all parents and doctors even agree with current government vaccine recommendations. For example, Hepatitis B is transmitted primarily through sharing infected drug needles and sexual contact with an infected person. The CDC admits that only 5% of the population will ever belong to a risk group for catching Hepatitis B. Despite this, the Hepatitis B shot is now is routinely administered to babies 12 hours after birth. Adults have experienced complications after receiving the Hepatitis B shot, but it is impossible to evaluate any subsequent health problems babies experience as it is given before any unrelated problems could be diagnosed. Since the shot is administered at the hospital it conveniently allows states, with help from their BVS, to start the child's immunization registry record immediately often without a parent's knowledge.

SUMMARY: Immunization registries allow for uniform enforcement of questionable vaccination policies. Knowledgeable and responsible parents and physicians question the trend of requiring most of new vaccines (i.e., chicken pox, diarrhea) because they are justified primarily for convenience and cost effectiveness. The Hepatitis B shot is routinely administered to newborns regardless of their risk of catching it.
 

The National Immunization Program (NIP) and the Robert Wood Johnson Foundation's All Kids Count Program (AKC) have already outlined using a national registry program for "aggressive and automated" outreach activities. These outreach activities or "Reminder/Recall methods" include postcards and letters, telephone auto-dialers or personal phone calls, and home visits. Vaccine vans, otherwise known as "Mobile Units", are already being deployed for home visits in pilot programs where parents did not respond to telephone reminders soon enough.

The language of HB 3054 follows the recommendations of NIP and AKC to allow for these questionable compliance activities.

§ 161.007.e The department may use the registry to provide notices by mail, telephone, personal contact, or other means to a parent, managing conservator, or guardian regarding his or her child or ward who is due or overdue for a particular type of immunization according to the department's immunization schedule.

Harassment and home visits for non-compliance with the government's choice of a vaccine schedule give an indication why detailed information on outreach programs was never shared with legislators.

SUMMARY: Parents who do not exactly follow the government recommendations for vaccines will be subjected to continual harassment, and even home visits, until they comply. TDH never mentioned its detailed plans for home visits and "other means" of coercion when this bill was discussed or when the rules were posted.
 

Documents provided by the CDC to Senator Patterson refer to the inconveniences that consent laws, including the provisions of the Texas legislation, present as well as options to overcome them.

The "Community Immunization Registries Manual", prepared by the All Kids Count Program, the National Immunization Program and the National Vaccine Advisory Committee states:

The need for notification or informed consent might be obviated by existing or new regulations for legislation at the state or local level.

The same sentiment was expressed by TDH employees shortly after HB 3054 was signed into law with parental consent requirements. At the July 30, 1997 ImmData II Share Meeting as stated in their notes:

Q. Could more flexible federal legislation supercede the current Texas consent law?

A. (Susan Abernathy of the CDC) Federal law set a minimum standard. Since the Texas law is stricter it will stand. The Federal law will only supercede states that require less than the Federal standard. The Clinton administration is very interested in looking further into federal legislation on childhood immunizations.

Administrative simplification provisions of the Kennedy-Kassebaum Health Insurance Portability and Accountability Act (HIPAA), P.L. 104-191, may jeopardize a citizen's fundamental rights to protect their personal and medical information. DHHS recommendations include overriding consent for release of medical information when they define the situation to "be in the interest of public health." Many pieces of proposed "privacy" legislation for implementation of HIPAA requirements include exceptions to this same consent.

NIP states its position in their paper discussing their interests in the implementation of P.L. 104-191.

State laws intended to ensure privacy have presented barriers to immunization registries in some areas. Preemptive Federal legislation is needed.

The National Vaccine Advisory Committee (NVAC) has adopted a policy on confidentiality that would permit localities and states to simply include all children in an immunization registry.

On April 6, in New Orleans, the Centers for Disease Control sponsored a national meeting in which representatives from the CDC, pharmaceutical companies, HMOs, and computer companies discussed registry issues, including privacy concerns. During public comment periods, parent Rebecca Rex from Texas voiced her concerns about the potential database abuses. Peter Waegemann, Executive Director of the Medical Records Institute, which helps government agencies establish registries all over the world, argued that any opportunity for parents to opt out of this system would undermine the entire project. TDH's Dr. Diane Simpson was a panel member at this meeting, and ImmTrac employee Vicky Cowling was also in attendance.

SUMMARY: The National immunization Program, the National Vaccine Advisory Committee, and the All Kids Count Program are moving toward their ultimate goal of a national immunization tracking system network to include all children despite state protective laws requiring consent. Unless this is stopped, Texas legislators may see the privacy and consent provisions they supported superceded by federal law.
 

The proposed rules in section 100.7 (b) state that Health Level 7 format will be used by ImmTrac.

Automated data exchange will conform to standards prescribed by the department. Data exchange will follow the national standard for data exchange, knows as the Health Level 7 (HL7), when this format is completed.

The 1997 ImmShare meetings were attended by CDC personnel who spoke of data formats being used by other countries.

VI. Health Level 7 (HL7), by Susan Abernathy of the (CDC)

(Summary notes) HL 7 provides a method of uniformly formatting data so that it may be shared between databases. HL 7 will not only be used in the United States, but by Canada, Japan, New Zealand, Australia, England, France, Germany, to mention a few. One of the HL 7 formats is specific to immunizations. Currently standards are being established for implementation in February 1999.

SUMMARY: The CDC has been working with other states and countries to develop a standard data file format which will allow international monitoring of vaccination status, and TDH is following that system despite citizens' right to keep their medical information private.
 

NIP Surveys conducted in 1996 show that nationwide, 78% of all two-year-olds have already received all of the currently recommended vaccines. They define their role in Immunization Registry development to increase childhood immunizations to 90% for 2 year olds by the year 2000. Billions of taxpayer dollars are being spent to increase vaccination rates by only 12% of the nation's two year old population. This does not make sense when other accessibility programs can be more cost effective. Coupling this with the fact that the nation has almost full compliance with the recommended schedules when a child enters school in kindergarten, it becomes clear that there must be other motives.

Data from a 1998 Federal Elections Commission Freedom of Information Act request show that our U.S. Representatives and Senators who appear to be supportive of this immunization registry program are receiving numerous campaign contributions from vaccine manufacturers. These manufacturers are the real benefactors of a national immunization registry because government mandates will guarantee customers for their products.

A CDC registry handout notes that providers will also benefit from the registry/recall system:

Reminder/recall systems should enhance . the numbers of clients seen. As a result, providers' revenues should increase. Consequently, a degree of cost-sharing may be in order between registries and providers.

SUMMARY: The reasons given by the National Immunization Program for financing immunization registries don't justify spending billions of dollars. With immunization registries in place, compliance with newly developed vaccines can more easily be enforced, increasing revenue for vaccine manufacturers and health care providers.
 

The Robert Wood Johnson Foundation (RWJF) is the $4 billion dollar estate of the founder of Johnson and Johnson, the pharmaceutical and health supply company in Trenton, NJ. RWJF distributes $186 million dollars a year on grants to programs to change how health care is delivered in this country, a large portion going to their own vaccine registry program, All Kids Count (AKC).

In 1991, two years before any federal immunization tracking legislation existed, the RWJF launched the AKC project to develop vaccine tracking and monitoring systems for preschool children. Former Director of the CDC, Dr. William Foege, is the director of AKC. Other private foundations joined this effort, resulting in 24 funded projects. By ensuring the success of the national registry program, AKC virtually guarantees RWJF access to every child's medical files. The Henry J. Kaiser Foundation, as well as many others, engage in these same types of activities.

SUMMARY: Private foundations, such as the Robert Wood Johnson Foundation, whose founding companies will profit from a national immunization registry, manipulate public policy to serve their self- interests.
 

The concern over new vaccine development and the mandating of such vaccines would be a less controversial issue if vaccination was a completely safe medical procedure. Though experts on both side of the issue disagree on the numbers of vaccine related adverse reactions and death, all experts agree that there is some risk for any vaccine. The passing of the National Childhood Injury Act of 1986 set up a compensation fund to assist families and ease the litigation ordeals after a child has died or experienced damage following a vaccine. To date, nearly one billion dollars in compensation has been paid out. The web page for the program, http://bhpr.hrsa.gov/vicp/index.htm, details these alarming numbers verifying vaccine damages.

SUMMARY: Vaccines carry medical risks, making their tracking and enforcement more controversial.

April 5, 2008