Healthcare System Certifications working hand-in-hand with eSRA
Currently, there are few certification programs for EHR systems. In the US, in order for facilities using certified EHR systems to receive government reimbursement for patients on government-sponsored health insurance plans, they must get certified for "Meaningful Use".
In Europe the EuroRec seal is obtained through a voluntary self-certification and can coexist in parallel with regional or state specific certifications solely driven by the requirements of the entity paying for the EHR-System (hospital management, regional or federal/national agencies and ministries).
While these certifications provide a first step towards having some consistency in EHR systems in various institutions where clinical research is being performed, they are directed towards healthcare and were not designed to include regulatory requirements for clinical research.
That said, many of the requirements for these healthcare certifications are the same as requirements for clinical research. For this reason, they can be used as a basis for an investigator site assessment and will make it easier for the owners of systems with such certification to qualify their systems for clinical research.
- USA: ONC-ATCB certification inspection is limited to Department of Health and Human Services (HHS) criteria and standards establishing a minimum floor for EHR technology.
This is a certification that is conferred on compliant EHR systems. No site verification or usability testing is done under this program. Healthcare institutions and providers using ONC-ATCB certified EHR technology are eligible for government incentives if they meet "Meaningful Use" objectives defined by the Centers for Medicare and Medicaid Services (CMS). This combined program is being rolled out in three stages (2011 through 2016) with incremental criteria for EHR testing and certification, and Meaningful Use objectives for providers.
- EU: The Eurorec Level-1 and 2 seals are obtained after an EHR vendor:
- obtains access to the certification criteria contained in the EuroRec repository
- performs a test scenario for each use case that is in scope for the level of the Seal
- provides deviations in the documentation which is returned to EuroRec, which has the final decision as to allowing a system to carry the Seal or not.
While the EHRCR Functional Profile (HL7, ANSI, EuroRec) is not a legally enforced certification in any jurisdiction, vendors who have chosen to assess their systems against this profile will find that almost all system-required functionality are covered by EHRCR, and the eSRA vendor pre-fill evaluation completion will be a minimal task. (see here for more information).
For these reasons, this Investigator Site Assessment tool is provided to allow sponsors and sites an efficient method for assessing site systems for "clinical research readiness" (or in other words, the ability to hold data that is ultimately used in a clinical trial).
For those investigator sites that are using EHR systems that have been certified via one of the certification methods above, it will be very efficient to complete this Investigator Site eSource-Readiness Assessment as there is overlap between the EHR certification criteria and the clinical research requirements, meaning that many of the assessment questions can be checked off if a site is using a certified EHR system.
The mapping to these certifications is provided as part of the Vendor eSRA Tool. It should be noted that the EHR Certification is awarded to an EHR system and not an investigator site. While these are country-specific Certifications, if a system has been certified for use in one country, it will still carry this certification if it is implemented in another country. For example, investigator sites in non-US countries may be using a US-certified EHR system as many EHR vendors market their software globally.
Additionally, vendors of Electronic Health Record Systems that posses certifications other than those discussed above, are highly encouraged to contact the eSRA Team to work together on providing an eSRA mapping to this certification such that it can then be incorporated into the eSRA Tool.