Amit Trivedi, healthcare programs manager for ICSA Labs, an ONC-Authorized Certification Body (ONC-ACB), says there are a number of aspects of Stage 2 "that are pretty unique ... things that you don't typically see in certification."
Many of the changes from Stage 1 to Stage 2 are the result of feedback and criticism from the healthcare industry and the public at large. Among the developments EHR vendors will notice are a few changes that should streamline and improve the ease of setting up and implementing Stage 2-compliant EHR systems in healthcare.
1. Transport. "Transport is being addressed, how you actually send things back and forth from one EHR to another, or from a provider to a patient," says Trivedi. "Making sure the patient ﬁle is formatted correctly, [and] that there are no no structural violations, no coding errors," are all important factors in getting EHRs right. Beyond that, however, the actual transmission of documents and messages need to take place within specific standards, which Stage 2 finally addresses. Proposed in the requirements are security standards, cross-enterprise document media interchange for direct messaging and additional modular specification.
2. Gap testing. "When you talk about certiﬁcation and testing, one conversation that is always going on is how regulation and certiﬁcation requirements stiﬂe innovation," says Trivedi. Minimum standard code sets address the problem where, if a version of software or standards is legislated with a speciﬁc version (such as 3.38), when a new version comes out a few years later, the legislation only speciﬁes in writing that the older version is acceptable. Now, that legislated version will be the minimum required version – when newer versions are released, "The coordinator can apply it very quickly," he adds. What happens to 2011 certiﬁed products? "It still remains certiﬁed, that doesn't change. It just depends on what you're certiﬁed against. ... If your product was certiﬁed in 2011 and that hasn't changed in the 2014 version, then you don't have to re-certify. If it has been revised or if there is new criteria, you have to retest."
3. Base EHR and additional modules. Stage 2 requirements will also free many specialized providers from the burden of a full EHR system that has many components they may not use. To be Stage 1 compliant, providers needed to posses a complete EHR system that "had to meet all meaningful use benchmarks and cover all criteria A to Z," says Trivedi. In Stage 2, however, providers must posses EHR technology that "meet the base EHR deﬁnition and would support the objectives, measures and their ability to successfully report the clinical quality measures," says Trivedi. With this iteration, providers must only purchase what they need, he adds. "You don't need to have everything, you just need to have what you're attesting to for meaningful use."
4. Transparency. Stage 2 requirements make the certification process more open and accessible to industry and the public. "Standards for certiﬁcation are required to be public," Amit says. "Now there's a requirement for anything certiﬁed against Stage 2 to have the test results made public. It requires a vendor to attest how they have made things." With Stage 1, certiﬁcation groups only posted what criteria were certiﬁed. Now they need to post results of the testing as well. Additionally, certiﬁcation bodies would need to disclose additional types of costs, such as "monthly or yearly subscriptions for patient education manuals," says Trivedi. While vendors don't need to disclose a full-cost of EHR, this makes the costs involved more transparent and easy to understand.