Policy brief on the current status of certification of electronic Health Records in the US and Europe

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.