美国儿童免疫报告立法：现状。

Childhood immunization reporting laws in the United States: current status.

机构信息

University of the Sciences, Department of Health Policy and Public Health, Philadelphia, PA 19104, United States.

出版信息

Vaccine. 2012 Nov 19;30(49):7059-66. doi: 10.1016/j.vaccine.2012.09.054. Epub 2012 Oct 3.

DOI:10.1016/j.vaccine.2012.09.054

PMID:23041124

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.

摘要

背景

免疫信息系统（IIS）或登记处的开发是为了提高免疫服务的效果和效率。管理 IIS 和免疫记录的复杂法律是在州一级制定的，相互作用，并可能影响所有免疫利益相关者的效用。随着各州制定健康信息交换法，它们也可能与 IIS 法相互作用。

目的

为免疫利益相关者提供适用于医疗保健提供者和卫生部门的法律概述。进行了比较，以说明自前几次研究以来的趋势。

方法

通过法律数据库确定了 56 个“受赠方”（根据 317b 公共卫生服务法获得资金的州和大城市）的 IIS 相关法规、规章和条例，然后对授权、报告和同意要求进行系统审查。根据 131 个变量对关键条款进行了编码和映射。

结果

包括小节在内，984 项法律涉及免疫记录，涵盖了州和市政府的许多行政部门。大多数受赠方都有不止一项法律涉及免疫记录报告、交换和隐私保护。并非所有这些法律都一致，但有一个趋势是增加受赠方的 IIS 授权法律、强制报告和默示同意规定。在 56 个受赠方中，有 37 个（66%）有 IIS 授权法，有 46 个（82%）有涉及医疗保健提供者和人口统计报告的法律。然而，即使在这些法律的规定中，也存在很大的差异。编码工具的一致性为 93.7%，K-α 值为 0.791。