De Moor Georges, O'Brien John, Fridsma Doug, Bean Carol, Devlies Jos, Cusack Caitlin M, Bloomrosen Meryl, Lorenzi Nancy, Coorevits Pascal
The EuroRec Institute, Belgium.
Stud Health Technol Inform. 2011;170:83-106.
If Electronic Health Record systems are to provide an effective contribution to healthcare, a set of benchmarks need to be set to ensure quality control and interoperability of systems. This paper outlines the prevailing status of EHR certification in the US and the EU, compares and contrasts established schemes and poses opportunities for convergence of activity in the domain designed to advance certification endeavours generally. Several EU Member States have in the past proceeded with EHR systems quality labeling and/or certification, but these differ in scope, in legal framework under which they operate, in policies (legislation and financial incentives), in organization, and perhaps most importantly in the quality criteria used for benchmarking. Harmonization, therefore, became a must. Now, through EuroRec (with approaches ranging from self-assessment to third party certification depending on the level of confidence needed) and its Seals, the possibility to achieve this for EHR systems has started in the whole of Europe. The US HITECH Act also attempts to create incentives for all hospitals and eligible providers to adopt and use electronic information. A centerpiece of the Act is to put in place strong financial incentives to adopt and meaningfully use EHRs. The HHS/EHR Certification Programme makes use of ISO/IEC 170XX standards for accreditation, testing and certification. The approved test method addresses the functional and the interoperability requirements defined in the Final Rule criteria and standards. To date six Authorized Testing and Certification Bodies (ATCBs) are testing and certifying products in the US.
如果电子健康记录系统要对医疗保健做出有效贡献，就需要设定一套基准，以确保系统的质量控制和互操作性。本文概述了美国和欧盟电子健康记录认证的现状，比较并对比了既定方案，并为该领域旨在推动认证工作的活动融合提供了机会。过去，一些欧盟成员国已着手进行电子健康记录系统的质量标签和/或认证，但这些在范围、运作的法律框架、政策（立法和财政激励措施）、组织方面存在差异，也许最重要的是在用于基准测试的质量标准方面存在差异。因此，协调统一成为必要。现在，通过欧洲电子健康记录认证机构（EuroRec，根据所需的置信水平，采用从自我评估到第三方认证等多种方法）及其认证标志，在整个欧洲已开始有实现电子健康记录系统协调统一的可能性。美国的《健康信息技术经济和临床健康法案》（HITECH Act）也试图为所有医院和符合条件的医疗服务提供者采用和使用电子信息创造激励措施。该法案的核心是提供强有力的财政激励措施，以促使采用并切实使用电子健康记录。美国卫生与公众服务部/电子健康记录认证计划利用ISO/IEC 170XX标准进行认可、测试和认证。经批准的测试方法涉及最终规则标准中定义的功能和互操作性要求。迄今为止，在美国有六个授权测试和认证机构（ATCBs）正在对产品进行测试和认证。
