Background: Immunization Information Systems (IIS) were developed to improve quality and efficiencies in health care management. State policies that govern IIS systems are complex, and may interact with other immunization record policies.
Objectives: This study updates and expands on a 9-year-old survey and compares the new data to applicable federal regulation.
Methods: IIS relevant statutes and regulations in 50 states, 5 cities and Washington D.C. were identified through legal databases and reviewed for content. Coding categories were derived considering previous studies, including authorization of the IIS, covered entities, patient privacy and information sharing, reporting, enforcement and similar provisions within the Privacy Rule and Family Educational Rights and Privacy Act. The Delphi technique was used to obtain expert input for the coding document. The 131 variable coding instrument received 93.7% agreement and a K-α of .791.
Results: Including all subsections, nearly 900 laws across localities relate to immunization records, with much variation among localities. Within and across localities, laws were grouped into 13 topic headings, including health, facility licensing, vital statistics, education, administration, and insurance. While some states have specific IIS laws, others have IIS provisions within health or disease control laws. Many do not specify IIS, but do regulate the collection, sharing and/or storage of immunization data within education or department of health or vital statistics records. Considerable variation exists among the number of statutory provisions versus administrative codes by locality. Aggregate data for the localities is presented in tabular format and shaded maps.
Conclusions: The observable differences are indicative of our federalist system. Given the new Meaningful Use incentives to increase participation in IIS, this study identifies the current framework governing the systems and illuminates opportunities for future policy development, as federal and state agencies work to improve IIS utility and uniformity.