CCHC is a three year old health care policy organization founded as a result of health care consolidation, a growing loss of medical confidentiality, and the elimination of many health care choices in the areas of insurance, treatment, and providers. We educate on health care policy and have a comprehensive website focused on health care reform policy issues and medical confidentiality. (http://www.cchc-mn.org)

Today, I am grateful to have this opportunity to address the CDC committee which is looking at the vital privacy issues surrounding the implementation of immunization registries. Let me share our five concerns regarding immunization registries for your consideration:

1. Potential Loss of Medical Confidentiality

The bottom line for confidentiality is parent and patient consent. While immunizations seem rather innocuous in terms of medical confidentiality, the National Immunization Program website page on Integration Support demonstrates that the registry will not contain only immunization information. Future plans are to integrate the registry with complete patient records. A Pennsylvania immunization newsletter in discussing HIPAA, states that immunization registries "can contribute toward what could ultimately be more comprehensive clinical and preventive data bases." In Minnesota, a staff member of a community-based immunization registry recently stated to a visitor that they are waiting for the implementation of a National Provider Identifier and a Unique Patient Identifier in order to link immunization registries with other health care databases.

If there is no requirement for informed and voluntary consent, it should be clear that this seemingly harmless breach of medical confidentiality will be used to support further breaches of confidentiality with information much more sensitive. The effect of such breaches by state and federal agencies will have a detrimental effect on the entire health care system. Patients will fear repercussions from their health care histories. Persons concerned with preserving the excellence of our health care system should take into consideration the inaccurate or delayed diagnoses that can result from a patient's unwillingness to divulge sensitive information to physicians and providers.

Physicians and other providers have a duty to protect the confidentiality of patients. If immunization registries are used as a tool to break into the private communications of patients and doctors, patients, and the physician-patient relationship will suffer greatly.

Patients also want their medical record information protected by physicians and providers for a variety of other important reason which include access to employment, sustaining community status, obtaining insurance, preservation of reputation, and protection against discrimination. It is noteworthy that according to enrollees, some health plans have begun to view lack of immunizations as a preexisting condition for which insurance coverage is denied. This is a serious concern for persons who want to be insured, but who conscientiously object to immunizations, fear immunizations, or have personal knowledge of the physical and mental damage done to children by immunizations, albeit a small percentage of children.

While government officials have sincere desires to protect the confidentiality of medical data they hold, it is clear that they cannot. Government data systems have been broken into by outsiders, and reports of government employees perusing IRS information on others show the unreliability of depending on even well-trained employees to protect individual data. A study done for the DHHS on the Unique Patient Identifier states that confidentiality will be protected by instilling responsibility into the handlers of the data. This is not comforting to citizens desiring confidentiality. In addition, the move toward a system of electronic transactions make breaches of confidentiality even easier. While the government's goal to assure privacy is a laudable objective, it has been proven that patients have reasons not to trust a government database or state employees with their private sensitive data.

At least two initiatives appear certain from the National Immunization Program website. First, full integration of individually identifiable patient information is planned. The integration support page speaks of South Carolina "developing a comprehensive patient-centered data base of health care encounters extending across all health care settings." Second, the entry of immunization information is not just on children. According to your software contract page the eligible software should include the ability to "assemble timely and accurate information on the immunization status of children (and where feasible also adolescents and adults) with any community."

2. Intrusion into Family Autonomy

As much as some individuals, agencies, and organizations would like to order, organize and direct the lives and decisions of individuals and families of this nation, Americans were long ago granted the freedom to order their own lives within wide parameters. The provision of health care is a family responsibility, and choices are made according to family belief systems. The forced implementation of an immunization registry on all citizens without their consent demonstrates a lack of respect for other belief systems, and a complete disregard for individual liberty.

As a former school nurse, I know that the majority of children are completely immunized by age five -- kindergarten. Those parents who do not keep their children's immunizations up to date often will not do so without some enforcement mechanism. Enforcement mechanisms are costly, time-consuming, and a demonstration of government intrusion in family life. It has been stated that citizens should not be resistant to giving immunizations to the government because they do it when children enter school. However, it is important to note the difference between giving a school paper record of immunization data and having immunization data and personal information placed on an electronic registry with linkage possibilities.

Immunization registries are government surveillance which may be used to pressure family compliance to government immunization standards in spite of differing family belief systems. Such pressure and surveillance is unwarranted and unnecessary. It is also most likely unconstitutional. If implemented, your desired result will not be achieved. Instead, we believe there will be an increased resistance to immunize and a growing fear of government and its officials. Eventually this may be even more true for immigrants who have had previous experience with oppressive government surveillance systems.

3. No Statutory Authority for Mandate

It appears that the entry of citizen data onto immunization registries without parent or individual consent or even knowledge is progressing at the direction of President Clinton without express Congressional authority for mandated citizen participation. In 1993, President Clinton launched a comprehensive Childhood Immunization Initiative. On July 23, 1997, President Clinton directed the Secretary of DHHS to "work with the states on integrated immunization registries." Yet there has been no Congressional mandate forcing parents and children to participate.

Members of Congress are the representatives of the people and therefore, although the CDC has clearly stated on their website that it "supports the ultimate goal of enrollment of all U.S. preschool children in a state or community immunization registry," it is clear that citizens cannot at this time be forced to participate against their will. Instead, there must be individual consent obtained before the medical information is accessed or entered onto a community, state, or federal registry. In 1997, Minnesota legislators asked for advice form CCHC in order to draft a parent consent amendment which was attached to state registry and immunization legislation in the House and the Senate. Registry proponents then pulled the registry language from the omnibus bills before final passage clearly demonstrating that they did not support parents and individuals having the opportunity to protect their personal medical information.

4. Expense

The National Immunization Program website reports that "in a recent 12 month period states spent over $40 million of federal immunization grants", and untold amounts of state funds. In addition the Robert Wood Johnson Foundation has given several million dollars to initiate these immunization registries. The continuing costs of this tracking and reminder and recall system will be immense, adding to the already high tax burden of the working public. Costs will include staff, technology, training, litigation, publications, and costs associated with reminders and compliance checks. This is a high price on the American people for monitoring all citizens and attemptingto do what families can and should be encouraged to do for themselves.

5. Opt-Out Option Burdens Citizens

In response to citizen opposition against mandated entry of personal and vaccination data on registries, some state agencies have proposed an opt-out clause for registries. CCHC supports an opt-in clause. Opting in, or explicit consent, gives individuals and parents the opportunity to agree to the process before their information is collected and their confidentiality breached. This is an important choice. Citizens should not be required to notify the government that they do not want to be monitored. That should be assumed. The government should be required to ask for permission from citizens before any monitoring or tracking is permitted. This will increase trust between citizens and the government. In addition, an opt-out option, by necessity, creates a file of what could be seen as "less than compliant" individuals. CCHC also believes that the explicit consent form should inform all citizens that if they change their mind and no longer desire to be on the registry, all personal and vaccination information will be deleted at the written request of the parent or individual.

Conclusion

No one who is under mandatory government surveillance is free. Privacy is quintessential to freedom. If we wish to preserve the freedom that has made our nation great and has beckoned people from every nation who have been persecuted and pursued by their own governments, then we must not strive to emulate the countries which they, and many of our forefathers, left. Thank you.

An additional comment: The National Immunization Program has recently changed many of their links to PDF access only. This makes it difficult for average citizens to access the information on your website. We would ask that a text version of all documents be maintained on the site for easy access.