Childhood immunization reporting laws in the United States: current status

Abstract

Context: Immunization Information Systems (IIS), or registries, were developed to improve effectiveness and efficiency in immunization services. Complex laws that govern IIS and immunization records are developed at the state-level, interact with each other, and may impact utility for all immunization stakeholders. As states develop Health Information Exchange laws they may also interact with IIS laws.

Objectives: To provide immunization stakeholders an overview of the laws applicable to healthcare providers and health departments. Comparisons are provided to illustrate the trends since the previous studies.

Methods: IIS relevant statutes, regulations and ordinances of jurisdictions (states, large cities) of 56 "Grantees" receiving funding under the 317b Public Health Service Act were identified via legal databases then systematically reviewed for authorization, reporting and consent requirements. Key provisions were coded and mapped according to 131 variables.

Results: Including subsections, 984 laws across Grantees relate to immunization records, falling under many administrative sections of state and city government. Most Grantees have more than one law that addresses immunization records reporting, exchange and privacy protections. Not all of these laws are in alignment, but there is a trend toward increased Grantee IIS authorizing laws, mandated reporting and implied consent provisions. Of the 56 Grantees, 37 (66%) had IIS authorizing laws, and 46 (82%) had laws addressing healthcare provider and vital statistics reporting. However, much variation remains, even within the provisions of these laws. The coding instrument received 93.7% agreement and a K-α of 0.791.

Conclusions: The trend toward laws that encourage participation should continue to improve functionality and value, but inconsistencies among laws should be addressed, both across jurisdictions within states and between different states. They may impair the value of the information that is collected. Greater uniformity could improve the overall usefulness of IIS.