EHR Certification Requirements

Regulations change constantly within the healthcare industry. Developers may feel like they are constantly playing catchup as they try to understand what each new law requires. One of the ever-changing environments is that of electronic health record (EHR) certification requirements or CEHRT (certified electronic health record technology). EHR certification is critical to protect patients, developers, and healthcare providers. An EHR vendor must maintain current CEHRT standards for their products while also developing improvements for upcoming CEHRT criteria and enhancements that check boxes for HIPAA, legal, clinicians, and interoperability.

What Is EHR Certification?

EHRs facilitate safe and high-quality patient care in many ways. For example, they allow patients, physicians, and pharmacies to reliably share, update, and access healthcare records. As a result, healthcare providers can easily collaborate, reduce medical errors, and diagnose patients more effectively. EHRs also cut costs by creating efficiencies in processes, promoting interoperability, and contributing data to support population health initiatives. The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) govern CEHRT. These two offices also establish standardized criteria for the certification of electronic health record systems, many of which are updated annually. Therefore, EHR developers must make sure their certification remains intact and that they’re forward focused on upcoming annual updates and future requirements set in place by the ONC.

A certified EHR system is one that demonstrates specific functionality and security requirements while under a test administered by an ONC-ACB (designated testing body). In short, this is critical for protecting the privacy and confidentiality of patients’ medical records. CMS and the ONC strictly enforce EHR certification. Vendors can also have their certification revoked for not adhering to such standards under a strict timeline.

What Are the EHR Certification Requirements?

The 2015 Edition Cures Update is the most recent version and builds upon the original 2015 CEHRT. The Cures Update “provides the structure for evaluating conformance of the Health IT Module to the certification criteria defined in 85 FR 25642 of the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule as published in the Federal Register on May 1, 2020.” The ONC provides a Certification Companion Guide for developers which lays out certification and testing requirements by individual criterion. This guide also gives them access to test procedures. There are a wide variety of criteria addressed throughout this process. For instance, they include standardized Common Clinical Dataset (now USCDI), electronic prescribing, templates for document exports like CCDs, security measures, and standards for transmission to public health agencies.

Understanding these requirements involves a few common principles. First, EHR systems must store data in a structured manner. This helps practices capture and efficiently transfer records between different systems. Structured data storage is essential for maintaining privacy while promoting optimal patient care and supporting interoperability between disparate systems.

Also, EHR systems need to be able to process information and track various patient care benchmarks (for instance, MIPS quality measures). This is a critical part of any successful healthcare system. CMS requires CEHRT to track and calculate measures that contribute to the goal of improving patient care and promoting interoperability.

Finally, EHR certification requires that all software systems prove to be functional and secure. These systems must meet CMS requirements for facilitating privacy and confidentiality of health records. This is important for systems to prevent accidental disclosure of data and reduce the risk of data breaches. ONC routinely audits EHRs in development and in real-world settings/scenarios to ensure safety and usability.

How Do I Ensure That My System Maintains EHR Certification?

Ultimately, achieving and keeping EHR certification requires meeting the conditions set forward by both CMS and the ONC. The first place to look to see if your EHR has been updated to 2015 Edition Cures is on CHPL. Luckily, certification consultants can provide invaluable insight into what CMS is looking for and the common testing challenges that arise during the process.

Our professionals understand various regulatory and legislative environments. We’ve also worked with IT developers in the past to achieve certification, remediate certification issues, and create roadmaps on what is coming. Let us take the weight off your shoulders when it comes to this process. Feel free to contact us directly for more information, or to schedule a free discovery meeting.