October 1996
WASHINGTON D.C. — A draft of a manual detailing confidentiality issues in the development of community immunization registries was approved recently by the National Vaccine Advisory Committee of the Department of Health and Human services here.
The manual is sponsored by the All Kids Count program and the Centers for Disease Control and Prevention (CDC).
An immunization registry is a computerized system that records and consolidates the immunization history of individuals. The immunization history may include the type of vaccine administered or due to be administered, dosage, vaccine lot number and manufacturer. It may also include potentially sensitive information, such as contraindications or objections to immunization.
This history includes demographic and locator information (such as names, dates of birth, sex, address and telephone numbers), which may also include family relationships. Socioeconomic data related to a person's ability to pay for medical services may also be included, as well as linking information (e.g. identification in other systems used for linking records, such as regional systems and the Special Supplemental Food Program for Women, Infants and Children [WIC]).
According to the draft, the purpose of the registries is to:
The success of immunization registries requires to the best extent possible:
According to the draft, information contained in the immunization registry would be regarded just as a provider's medical record would. This medical and demographic information is considered personal, and should be protected from unauthorized disclosures to maintain privacy.
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The challenge comes, however, in establishing and maintaining the balance of two conflicting needs: the societal need to share immunization information and eliminate opportunities for vaccine-preventable infectious diseases to spread, and the need for respect of privacy rights of children and their parents.
Health officials can increase community confidence and participation in the system by assuring that the data will be used to ensure that children will be vaccinated in a timely manner; that access to the registry will be limited to authorized users; and that information obtained by authorized users is only what is necessary to serve the purpose of its disclosure.
The accuracy and completeness of the data in the registry may be a double-edged sword. If registry information is not complete and accurate, providers and parents may lose confidence and cease to participate in it.
However, the more complete the information is in the database, the more likely it is that it may contain items that could be harmful to an individual if misused. Concerns about this data include releasing an address or phone number to an estranged spouse or parent, releasing immigration data to the Immigration and Naturalization Service, and releasing information for marketing purposes.
To assuage these concerns, a community registry may consider segregating medically sensitive information, locator or demographic information from other information in the database so extra security measures can be developed to protect it from unauthorized disclosure. Security procedures include software and hardware protection, physical measures (including protection from fire or flood), and an alert and informed staff.
Managers of community immunization registries — such as state and county public health departments or managed care organizations — must consider how to notify individuals before their medical information is placed into the database, and whether their informed consent is needed. Individuals must also have the right to review data on them and request corrections or updates when necessary.
Requiring informed consent may, however, decrease the number of individuals who participate in the registry, leaving these individuals susceptible to vaccine-preventable diseases if they cannot be reminded of scheduled immunizations. Also, getting informed consent from those already in one database, if their information was culled from another, presents unwieldy administrative burdens. And, it is unclear whether participants in government programs such as WIC would be given informed consent.
A registry must have a confidentiality policy that should define who will have access to the data, and what records and data fields they may access. Access would ordinarily be approved for:
The draft of the manual on registry confidentiality is part of a larger CDC report on the issues facing the development and operation of community immunization registries. These issues include needs assessment, data management, technology and implementation of an operating system, costs and support, community partnerships and promotion.
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