What is the primary difference between an ONC-authorized certification body (ACB) and an ONC-authorized testing laboratory (ATL)?

An ONC-authorized certification body (ACB) is responsible for evaluating and certifying EHR systems against ONC standards. In contrast, an ONC-authorized testing laboratory (ATL) conducts the rigorous testing required to assess the system’s functionality, interoperability, and security before certification.

Why is there a focus on the 2015 Edition Certification Requirements for EHR systems?

The 2015 Edition Certification Requirements are crucial as they introduce more advanced standards for health information exchange, patient engagement, and security features. These requirements reflect the latest advancements in technology and ensure that EHRs are well-equipped to handle contemporary healthcare challenges.

How does EHR certification impact the financial management of healthcare practices?

EHR certification can significantly impact financial management by making practices eligible for incentive payments from programs like Medicare and Medicaid. Additionally, certified EHRs often lead to more efficient billing processes and fewer errors, contributing to better cash flow management.

Can small or rural healthcare providers afford the EHR certification process?

Yes, several incentive programs and grants are available to help small or rural healthcare providers offset the costs associated with achieving EHR certification. These financial aids are designed to ensure that high-quality healthcare technology is accessible to providers across different settings.

How frequently must a certified EHR system be updated to maintain compliance?

Certified EHRs need to undergo periodic updates to stay compliant with evolving ONC requirements. These updates may include installing security patches, adding new functionalities, and ensuring continued interoperability with other healthcare systems.

Are there any penalties for healthcare providers who do not use certified EHR systems?

Yes, healthcare providers who do not use them may face penalties such as reduced reimbursement rates from Medicare and Medicaid. Additionally, non-compliance can result in missed opportunities for incentive payments and increased vulnerability to data breaches.

How does EHR certification enhance patient engagement?

Certified EHR systems enhance patient engagement by providing features like electronic access to personal health records, secure messaging with healthcare providers, and tools for tracking health goals. These functionalities empower patients to take a more active role in their healthcare.

What role do interoperability standards play in EHR certification?

Interoperability standards ensure that certified EHR systems can seamlessly exchange information with other health IT systems. This capability is crucial for coordinating care across different providers and healthcare settings, ultimately improving patient outcomes.

How does EHR certification contribute to public health initiatives?

Certified EHR systems support public health initiatives by enabling the accurate and timely reporting of health data. This data can be used for disease surveillance, monitoring outbreak patterns, and making informed public health decisions, thereby enhancing community health.

What should a healthcare provider look for when selecting an EHR vendor to ensure they can achieve certification?

When selecting an EHR vendor, healthcare providers should look for vendors with a proven track record of achieving ONC certification. Key factors to consider include the vendor’s experience with similar healthcare settings, the comprehensiveness of their EHR solutions, and their support services for maintaining compliance and facilitating updates.

AttractGroup Blog What is EHRs Certification? Certified EHR Explained

What is EHRs Certification? Certified EHR Explained

Author

Vladimir Terekhov

Co-founder and CEO at Attract Group

11 minutes read

10 October 2024

Table of contents

Types of EHR Certifications
Who is Responsible for Creating Certification for Standardized EHR technology?
Certification Criteria and Requirements
How to Get EHR Certified? Steps to Achieve Certification
Meaningful Use and Its Impact on Certification
Benefits of Certified EHRs
Conclusion
FAQs

In the evolving landscape of healthcare, ensuring the seamless exchange of patient data through secure and standardized systems has never been more essential. Certified EHRs, or certified Electronic Health Records, play a pivotal role in this transformation, guaranteeing that an EHR system meets stringent criteria set by the Office of the National Coordinator for Health Information Technology (ONC). EMR software certification ensures that electronic health records enhance meaningful use and promote interoperability and robust public health initiatives. The ONC’s incentive programs further motivate healthcare providers to adopt certified EHR technology, facilitating better patient outcomes and more efficient health data management. As the systems become increasingly integral to patient care, understanding the certs landscape becomes crucial for any healthcare entity committed to leveraging EHR technology for improved service delivery.

In this guide, I’ll explain who is responsible for creating certification for standardized EHR technology.

Types of EHR Certifications

When it comes to EHR adoption, understanding the types of Electronic Health Record validations available is crucial for clinicians and healthcare providers. There are two primary types: Complete EHR and Modular EHR approval. Both serve distinct purposes and cater to different needs within the healthcare system, helping providers meet the criteria set by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC). Implementing EHR software certification is essential for complying with these standards.

Complete EHR Certification

Complete EHR approval indicates that an EHR software system meets all the requirements established by ONC-authorized bodies. This approval ensures that the system has all the necessary functionalities to support comprehensive practices, from patient data management to efficient health information exchange. With Complete EHR systems, healthcare providers can streamline workflows and ensure interoperability, simplifying compliance with Medicare and Medicaid services regulations. Clinicians and centers using certified EHR technology benefit from improved patient care and may also qualify for various incentive programs under Medicare and Medicaid.

Modular EHR Certification

On the other hand, Modular EHR approval allows healthcare providers to validate individual components—referred to as EHR modules—rather than the entire system. This approach offers flexibility to customize specific functionalities to meet the unique needs of different medical practices or specialized healthcare settings. Each module must still meet the required criteria and pass testing by ONC-authorized laboratories. Once the modules demonstrate satisfactory results, they are submitted to an ONC-authorized body for approval. Modular validation can be a crucial step for providers aiming to incrementally adopt certified EHR systems, aligning specific modules with their existing workflows while ensuring compliance with Medicaid services and health information exchange standards. This method helps streamline adoption and eases the transition toward complete electronic health record systems.

Who is Responsible for Creating Certification for Standardized EHR technology?

Navigating the certification process for EHR systems often involves understanding the roles of various bodies, including the organization that is responsible for certifying electronic health records for viability. These key entities ensure that EHR technology meets rigorous standards for usability, data security, and interoperability, contributing to the overall landscape of healthcare technology compliance.

Office of the National Coordinator for Health Information Technology (ONC)

The Office of the National Coordinator for Health Information Technology (ONC) plays a pivotal role in the EHR certification ecosystem. Established under the Health Information Technology for Economic and Clinical Health (HITECH) Act, the ONC is tasked with formulating certification criteria that EHR systems must meet to enhance patient records management, data exchange, and clinical data interoperability. Ensuring EHR technology complies with these standards helps improve clinical quality, patient safety, and care coordination. The ONC also maintains a framework ensuring that EHR systems remain compliant with regulatory requirements, such as HIPAA, providing a strong foundation for secure and efficient healthcare delivery.

ONC-Authorized Certification Bodies (ACB)

ONC-Authorized Certification Bodies (ACBs) are integral in the process of getting an EHR system certified. These bodies assess EHR systems against the established ONC certification criteria, focusing on various aspects like usability, interoperability, and data exchange capabilities. ACBs ensure that the results to an ONC-authorized certification application are thoroughly evaluated and meet the required standards. These evaluations often encompass critical areas such as public health data capture, HL7 standards, and HIPAA compliance. By certifying that an EHR system adheres to these rigorous standards, ACBs support healthcare providers in achieving certification, leading to streamlined workflows and improved patient care outcomes.

ONC-Authorized Testing Laboratories (ATL)

ONC-Authorized Testing Laboratories (ATLs) conduct the necessary EHR testing to verify that EHR systems adhere to ONC’s stringent criteria. These laboratories play a crucial role in the certification process by rigorously testing EHR modules and systems for various functionalities, including clinical data management, care coordination, and public health data reporting. EHR systems undergo detailed evaluations to ensure they meet requirements for clinical quality measures, health data interoperability, and data security. Once the EHR system passes the testing phase, the results are submitted to an ACB for final certification. This rigorous process ensures that healthcare providers use certified EHR technology that is both effective and compliant with national standards.

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Certification Criteria and Requirements

Achieving certification for an EHR system involves adhering to stringent criteria and requirements to ensure the system is capable of handling various functionalities effectively. These criteria ensure that the EHR remains a secure, interoperable, and efficient tool for healthcare providers.

Overview of Certification Criteria

The certification criteria for EHR systems are designed to guarantee that these systems can manage standardized data securely and efficiently. They cover a wide array of functionalities, from clinical documentation and patient health management to interoperability and reporting capabilities. The ONC website provides comprehensive guidelines outlining the necessary specifications that EHR systems must meet to be tested and certified. These criteria are implemented to enhance functionalities like the ability to securely share patient data, ensuring that healthcare technology supports improved patient engagement and overall health system efficiency. Compliance with these criteria helps healthcare providers like Cerner and other vendors offer reliable EHR solutions that meet regulatory standards and enhance patient care outcomes.

2015 Edition Certification Requirements

The 2015 Edition Certification Requirements, established by the ONC, set forth detailed specifications that continue to build on the foundation laid by earlier stages, such as Stage 1 of Meaningful Use. These requirements focus on improving the ability of health platforms to manage and share patient information securely. Key elements include the integration of standardized data formats to enhance interoperability, support for patient engagement tools, and ensuring that software can generate accurate and comprehensive test reports. Additionally, the ONC mandates that all systems undergo rigorous testing to verify compliance with these requirements. This testing includes scenarios where the platform must facilitate the secure exchange of patient data and support functionalities that promote patient health and engagement.

The ONC website provides detailed descriptions of these requirements, ensuring that healthcare providers are well-informed about the standards their platforms must meet. EHR vendors like Cerner, aiming to achieve certification, must design their products to align with these rigorous standards. Verified through ONC-authorized testing, these platforms receive the designation of being tested and certified, indicating that they meet the comprehensive criteria set forth by the 2015 Edition Certification Requirements.

How to Get EHR Certified? Steps to Achieve Certification

If you are wondering how to get EHR Certified then here is a step-by-step guide to explain the process of achieving the certification.

Step 1: Understanding Certification Requirements

The first step involves thoroughly understanding the certification requirements outlined by the ONC. These criteria are designed to ensure that the electronic health platform is capable of supporting various healthcare functionalities, including patient data management, laboratory tests, and syndromic surveillance. Resources such as the ONC website and guidelines from the American Recovery and Reinvestment Act of 2009 provide a comprehensive foundation. Providers must become conversant with these requirements to ensure that their software aligns with the set standards. It is crucial to understand that achieving certification can unlock access to incentive payments from programs like Medicare and Medicaid, further underscoring the importance of compliance.

Step 2: Selecting a Certification Body

Selecting the right authorized body is a crucial step in the approval process. ONC-authorized bodies (ACBs) are responsible for evaluating whether your EHR system meets the specified standards. It’s essential to identify a reputable ACB that aligns well with your organizational needs and can efficiently manage the approval process. Renowned EHR providers like eClinicalWorks have collaborated effectively with ACBs to achieve and maintain approval. Providers should carefully assess factors like the ACB’s reputation, cost, and the scope of services offered to make an informed decision.

Step 3: Preparing EHR System for Testing

Preparation is a vital step where your EHR system must be meticulously aligned to meet the stringent requirements. This stage involves a deep dive into the system’s current capabilities, followed by necessary upgrades or modifications to align with ONC certification criteria. Your system should be prepared to handle a variety of functionalities—from patient health records management to regular surveillance for public health data reporting. This step can be particularly time-consuming as it may involve extensive coding, configuration, and user training to ensure that the system supports different care settings, such as ambulatory and inpatient environments.

Step 4: Undergoing Testing at an ONC-Authorized Testing Laboratory

Once your EHR system has been prepared, the next step is to undergo testing at an ONC-authorized Testing Laboratory (ATL). These laboratories are equipped to rigorously test the system against established ONC standards. It will undergo various scenarios designed to gauge its capability in handling tasks like laboratory tests and syndromic surveillance efficiently. ONCs use test methodologies to ensure security, functionality, and interoperability. This step is critical as successful completion of the test confirms that the system can securely manage and exchange information, thus meeting stringent ONC criteria.

Step 5: Submitting Test Results to an ONC-Authorized Certification Body

After testing, the generated test results must be submitted to an ONC-authorized certification body (ACB) for evaluation. These results will include detailed reports demonstrating the system’s compliance with ONC standards. This step involves meticulous documentation and may require clarification or additional information for the ACB to conduct a thorough evaluation. Successful submission and approval of these test results will pave the way for the official certification.

Step 6: Achieving Certification and Maintaining Compliance

Once you’ve submitted the test results to an ONC-authorized certification body and received approval, you will be officially certified. However, achieving certification is not the end of the journey; maintaining compliance is a continuous process. Regular audits and surveillance by the ACB will be essential to ensure that the EHR system continues to meet ONC requirements over time. Providers must stay updated with evolving standards and may need to periodically update their systems to comply with new regulations. This ongoing compliance is vital for sustaining the benefits of certification, including access to incentive payments, optimized patient care, and alignment with national healthcare initiatives like the American Recovery and Reinvestment Act.

Step	Description
Step 1: Understanding ONC Requirements	Understand ONC requirements to ensure the software supports healthcare functionalities like patient data management and syndromic surveillance. Compliance unlocks access to incentive payments from programs like Medicare and Medicaid.
Step 2: Selecting an Authorized Body	Choose an ONC-authorized body (ACB) that aligns with organizational needs. Consider reputation, cost, and service scope. ACBs evaluate whether the platform meets specified standards.
Step 3: Preparing the Platform for Testing	Align the system with ONC criteria through upgrades or modifications. Prepare it for functionalities like patient health records management and public health data reporting.
Step 4: Undergoing Testing at an ONC-Authorized Lab	Submit the platform for rigorous testing at an ONC-authorized Testing Laboratory (ATL). Testing ensures it meets ONC standards for security, functionality, and interoperability.
Step 5: Submitting Test Results to an ONC-Authorized Body	Submit the test results to an ONC-authorized body (ACB) for evaluation. Detailed reports must demonstrate compliance with ONC standards. Successful submission leads to approval.
Step 6: Achieving Approval and Maintaining Compliance	Once approved, maintain compliance through regular audits and updates to meet evolving ONC standards. Ongoing compliance ensures continued access to benefits, including incentive payments and optimized patient care.

Meaningful Use and Its Impact on Certification

Meaningful Use is a pivotal concept in the realm of Electronic Health Record (EHR) certification, encompassing a series of standards set by the Centers for Medicare & Medicaid Services (CMS) for using EHR technology effectively. Understanding and implementing Meaningful Use criteria is crucial for healthcare providers aiming to achieve and maintain EHR certification. This section delves into the fundamentals of Meaningful Use, its initial stages, and the role of incentive programs in promoting compliance and adoption.

Understanding Meaningful Use

The term “Meaningful Use” refers to the use of certified EHR technology in ways that measurably improve healthcare quality, safety, efficiency, and reduce health disparities. Specifically, it involves using EHRs to capture health information in a structured format, sharing that information for coordination of care, and using that information to engage patients in their care. The goal is to enable more efficient and safer healthcare practices that ensure better health outcomes. As part of the American Recovery and Reinvestment Act of 2009, Meaningful Use sets the stage for ONC to test and evaluate EHR systems rigorously, ensuring they meet the functional requirements necessary for impactful healthcare delivery.

Stage 1 of Meaningful Use

Stage 1 of Meaningful Use lays the foundational criteria that healthcare providers must meet to begin the transition towards EHR usage. It focuses on data capturing and sharing, covering essential aspects like recording patient information, maintaining up-to-date problem lists, and enabling electronic prescribing. A particularly time-consuming part of Stage 1 may involve ensuring the EHR system’s capability to meet all necessary criteria, from achieving interoperability to facilitating clinical data exchange. This stage establishes the groundwork for advanced functionalities assessed in subsequent stages, emphasizing the importance of robust EHR systems that can capture standardized data, thereby enhancing overall healthcare delivery.

Incentive Programs and Their Role

Incentive programs play a significant role in encouraging healthcare providers to adopt and successfully implement Meaningful Use criteria. These programs, primarily funded through Medicare and Medicaid, offer substantial financial incentives for healthcare organizations that meet specific Meaningful Use benchmarks. By achieving these set criteria, providers not only enhance their EHR systems’ functionality but also qualify for incentive payments that can total up to 155 million dollars nationally. These incentives offset the costs associated with EHR adoption and the time-consuming part of system upgrades, making the financial burden more manageable for healthcare providers.

Benefits of Certified EHRs

Certified EHRs play a transformative role in healthcare, driving significant improvements across various aspects of patient care, public health, and data security. By meeting stringent U.S. standards, they ensure that healthcare providers can effectively harness technology to enhance overall service delivery. Here, we explore the specific benefits of certified EHRs, focusing on improved patient care and outcomes, enhanced public health data, and ensuring patient safety and security.

Improved Patient Care and Outcomes

One of the foremost benefits of the EHR certification process is the substantial improvement in patient care and outcomes. They streamline the collection, storage, and retrieval of patient data, making important health information readily accessible to healthcare providers. This accessibility allows for more informed decision-making, reduces the likelihood of medical errors, and improves coordination among different care providers. By enabling healthcare providers to demonstrate “meaningful use,” certified EHRs also facilitate patient engagement through features like electronic access to personal health records and secure messaging with providers. These functionalities contribute to a more proactive approach in patient care, leading to better health outcomes.

Enhanced Public Health Data and Syndromic Surveillance

Certified EHR systems play a crucial role in public health data management and syndromic surveillance. These systems are designed to capture and report standardized health data, ensuring that it can be used effectively for public health purposes. Enhanced data interoperability allows healthcare providers and public health agencies to monitor disease trends, track outbreak patterns, and respond swiftly to public health emergencies. The EHR certification process ensures that these systems can accurately and efficiently collect and transmit essential public health information, bolstering efforts to maintain overall public health and enhance surveillance capabilities. Additionally, certified EHRs facilitate the aggregation of large volumes of health data, which can be analyzed to derive insights into population health trends and inform policy decisions.

Ensuring Patient Safety and Security

Ensuring patient safety and security is a critical aspect of certified EHR systems. The certification process mandates robust security protocols to protect sensitive patient information from unauthorized access, breaches, and cyber threats. These systems must adhere to strict compliance regulations, such as HIPAA, to safeguard patient data. Certified EHRs incorporate advanced security features, including encryption, multi-factor authentication, and regular security audits, to ensure data integrity and confidentiality. By demonstrating “meaningful use,” they contribute to a safer healthcare environment, minimizing risks associated with data breaches and enhancing patient trust in electronic health systems. The focus on patient safety and security not only helps in complying with regulatory requirements but also ensures that healthcare providers can maintain the highest standards of care.

Conclusion

In conclusion, the journey toward achieving EHR certification is one of critical import in the modern healthcare landscape. From understanding the intricate certification requirements to navigating the multi-faceted steps of the certification process, adopting certified EHR systems offers myriad benefits that catalyze improvements in patient care, public health data management, and data security.

Healthcare providers who successfully achieve certification stand to gain not just regulatory compliance but also enhanced patient outcomes, streamlined workflows, and access to significant financial incentives. By enabling better coordination of care and ensuring secure patient data management, they lay the groundwork for a more resilient and responsive healthcare system.

If you are a healthcare provider looking to expedite your EHR certification process and capitalize on the transformative benefits of certified EHR technology, consider reaching out to Attract Group. Our expertise in healthcare technology solutions ensures that your journey from preparation to certification is seamless, efficient, and aligned with the highest standards of care. Contact us to learn how we can assist you in navigating the complexities of EHR certification and help you achieve compliance with ease.