How to Get EHR Certified Software in the USA & EU: Criteria, Process, & Examples
A glance at recent headlines reveals the negative consequences of neglecting proper EHR certification requirements. For instance, eClinicalWorks' $155 million resolution in 2017 supports the issue of non-compliance with EHR certification and its requirements.
These instances not only lead to massive financial repercussions but genuine threats to public health.
Why does this matter?
EHR certification is more than just a regulatory hoop to jump through. This is a pact of trust between EHR software development companies, healthcare professionals, and patients to ensure that resources are utilized correctly, while maintaining a competitive edge without compromising on the quality of certified electronic health systems.
In this article, we will delve deeply into:
- Criteria indicating when you need an electronic health record certification
- Main EHR certifications globally [FHIR, HITECH, HIPAA, CEHRT, ONC-ATCB, GDPR]
- How to get EHR certified in the USA
- Five-step process of certified EHR development
- Certified EHR systems examples [Epic, Cerner, Meditech]
Let’s explore why EHR certification remains an inevitable pillar in creating software for the healthcare industry.
EHR Certification: Essential Information
EHR сertification (also referred to as IT certification or electronic medical records certification) underlines the need for the software used for medical purposes and by medical establishments to undergo a set of steps to comply with specific criteria, security, and functional requirements.
The Office of the National Coordinator for Health Information Technology (ONC) manages this whole process. The ONC operates under the U.S. Department of Health and Human Services (HHS) and ensures that the EHR technology used across the board is consistent, reliable, and meets the EHR requirements to capture, store, and share patient data efficiently.
It is pivotal to emphasize that the EHR certificate is applied to the end product, not the company or developers involved in EHR system development. To get an EHR certification, the vendor developing software should follow the criteria and regulations created by the ONC. Afterward, the ONC-Authorized Testing Laboratory (ATL) conducts EHR testing and provides the results to ONC.
EMR and EHR are frequently used interchangeably, but they serve different purposes. :
- EMR (Electronic Medical Record): A digital representation of a patient's chart within one particular healthcare provider's office. This record holds clinical data and the medical history from one practice.
- EHR (Electronic Health Record): Offers a more comprehensive view and keeps patient records from all healthcare providers involved in a patient's care, ensuring an integrated, collaborative approach.
Our team of healthcare app developers brings unparalleled expertise to the table. At MLSDev, we have created a cutting-edge digital solution intersecting technology and healthcare. This certified EHR platform seamlessly integrates various medical establishments, from healthcare centers to vaccination hubs, under one digital roof.
This medical appointment booking system helps patients effortlessly book medical appointments, and medical professionals can easily manage their schedules.
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For businesses looking to break new ground in EHR development - inspired by our work? Get in touch for a consultation and see how we can transform your idea into a fully-fledged solution for certified electronic health records.
Why and When Do You Need an EHR Certification?
You might wonder if getting EHR certified is just another checkbox or if it carries genuine significance.
Here, let’s elucidate when acquiring such a certification is indeed useful:
1. Participating in Governmental Programs
If you’re an organization looking to benefit from government programs like Medicare and Medicaid incentives, adopting certified EHR systems is a necessity. This compliance ensures that you're meeting EHR requirements in the best way to avail of these incentives.
Beyond Medicare and Medicaid incentives, other grants and financial incentives are available at federal and state levels for healthcare providers using certified electronic health records systems. These can help offset the cost of EHR software development and its maintenance.
2. Upholding Quality Standards
For vendors with a genuine commitment to excellence, the criteria set out by EHR certification act as a roadmap for developing software of unparalleled quality. By meeting these functional requirements for EHR systems, you can ensure that every aspect of your solution is crafted with attention to detail, reliability, and security.
3. Capturing a Wider Market Segment
In an era where almost every major healthcare institution has embraced EHR software, not being certified can be a roadblock. Acquiring EHR certification can be your passport to serving larger, more prominent providers and institutions, expanding your market reach with certified EHR technology.
Enhancing Patient Trust
4. Enhancing Patient Trust
Certified EHR systems assure patients that their personal and medical data are managed in a secure and standardized environment. When patients recognize a system has an electronic health record certification, this can foster greater trust and confidence in the care they receive using certified EHR technology.
5. Sharing Data & Its Interoperability
Electronic health record certification ensures that a program can effectively communicate with other healthcare systems. This promotes smoother data sharing between different care providers. This also ensures a comprehensive and up-to-date view of a patient's health record whenever and wherever needed.
6. Mitigating Risks
Using a certified EHR system can reduce potential legal and operational risks. Software that adheres to stringent EHR software requirements helps reduce the chances of system failures, data breaches, and other technical glitches that could have serious repercussions.
7. Staying Ahead in the Competitive Market
In a rapidly evolving healthcare technology market, having a certified EHR solution can give you an edge over competitors. This certification showcases commitment to best practices and can be a significant selling point when attracting new clients or partners.
8. Facilitating Research and Policy Implementation
Certified EHR systems often have standardized ways of recording and retrieving data. This uniformity can be invaluable for researchers and policymakers who rely on large datasets to understand health trends and outcomes to formulate evidence-based health policies.
Thus, EHR certification isn't just a piece of paper or a digital badge - it affirms your commitment to delivering solutions prioritizing patient care, data security, and interoperability.
As the healthcare landscape evolves, being EHR certified is your way of showcasing dedication, trustworthiness, and professionalism in this pivotal sector.
Existing EHR Certifications across the USA & European Union
As we focus on how to get EHR certified, it is essential to understand some prominent certifications and standards and examine their origin, significance, and operational realm across the USA and the European Union.
Developed by the international community HL7, FHIR (Fast Healthcare Interoperability Resources) is a global standard facilitating the electronic exchange of healthcare information through certified EHR technology. Designed to bolster interoperability, this standard uses modern web-based approaches such as RESTful web services, making it easier for healthcare systems worldwide, including the US and EU, to communicate seamlessly.
HIPAA (Health Insurance Portability and Accountability Act), a US law established in 1996, sets the standard for protecting sensitive patient data through certified electronic health record technology. HIPAA mandates that any organization dealing with patient records must ensure that specific security provisions are in place. This lays the groundwork for digital health data protection in the USA, which is essential for those considering how to get EHR certified.
As part of the American Recovery and Reinvestment Act of 2009, HITECH (Health Information Technology for Economic and Clinical Health Act) aims to encourage the adoption and meaningful use of health information technology. While promoting EHR adoption, it also strengthens the scope of privacy and security protections initially introduced by HIPAA for certified EHR systems.
CEHRT (Certified Electronic Health Record Technology) references EHR systems certified by the ONC's criteria. For businesses pondering how to get EHR certified, it is crucial to note that to qualify for Medicare and Medicaid Electronic Health Records Incentive Programs in the US, healthcare providers must employ CEHRT. This ensures their certified EHR technology meets the requisite standards for patient care and interoperability.
Organizations falling under the ONC-ATCB (Office of the National Coordinator – Authorized Testing and Certification Body) umbrella are authorized by the ONC to test and certify EHR technology. This ensures that the tech meets the criteria to support the objectives of the HITECH Act, assuring that it offers the required technological capability and security for certified EHR systems.
In addition to these US-centric standards and certifications, the European Union enforces its own directives, like the General Data Protection Regulation (GDPR). However, with international standards like FHIR gaining traction in the EU, the boundaries of health data standards are expanding, promoting a more globalized approach to digital healthcare and EHR development and certification.
EHR Certification Requirements in the USA
The road to EHR certification in the USA is detailed and intricate, with healthcare software platforms needing to adhere to a set of core criteria.
These 2015 edition criteria, meticulously crafted, ensure that the software meets the highest standards of patient care, security, and interoperability.
1. Clinical Processes
The process is governed by bodies such as the Office of the National Coordinator for Health Information Technology (ONC).
Medical web development and app software must adhere to the following core criteria:
- Computerized Provider Order Entry (CPOE): Enables electronic ordering of pharmaceuticals, laboratory tests, and radiology imaging, while reducing errors and bolstering privacy.
- Patient Demographics: Capturing comprehensive patient details such as race, ethnicity, language preferences, and other essential data.
- Medication Lists & Allergies: Comprehensive lists that cover current and past medications and known drug allergies to ensure safe prescribing.
- Clinical Decision Support (CDS) Capabilities: Empowering clinicians with data-driven insight to help make accurate treatment decisions.
- Patient-Specific Education: Resources like videos and articles to educate patients and drive patient-centered care.
2. Care Coordination
EHR systems should be designed to foster seamless communication and collaboration among healthcare teams to get an EHR certificate. This entails sharing patient data across providers, tracking referrals, managing transitions in care, and ensuring a cohesive care experience for the patient, irrespective of where they receive care.
3. Clinical Quality Measurement (CQM)
The capability to measure and report clinical quality is vital. EHR should be capable of generating data-driven insight, tracking patient outcomes, and monitoring adherence to clinical guidelines. This aids providers in continually improving the quality of care offered.
4. Privacy and Security
Given the sensitive nature of medical data, an EHR system’s commitment to privacy and security is paramount. This means implementing robust encryption protocols, role-based access controls, audit trails, and mechanisms to detect and report breaches.
Aside from basic one-factor authentication:
- Audit Trails: Comprehensive logs that record all health information actions, immune to tampering.
- Data Integrity: Ensuring health data remains accurate and unchanged during storage or transmission.
5. Patient Engagement
Modern EHR systems should prioritize patient empowerment and give them the tools to access their health records, schedule appointments, communicate with providers, and actively participate in their care. This can include features like patient portals, educational resources, and telemedicine capabilities. This is what your system should have in order to obtain an EHR certificate in the USA.
6. Public Health
EHR systems should facilitate public health data reporting, aiding in disease surveillance, immunization reporting, and syndromic surveillance. This ensures that healthcare entities can contribute to and leverage broader health trends and datasets, aiding larger public health initiatives.
7. Design and Performance
Usability is critical. An EHR system should be intuitively designed to minimize errors, reduce cognitive load on users, and streamline workflows. Performance metrics like system uptime, speed, and responsiveness, also play a pivotal role in ensuring seamless operations and getting an EHR certificate.
8. Electronic Exchange
Interoperability is at the heart of modern healthcare. EHR systems should ensure a smooth electronic exchange of health information, both within the organization and with external entities. This promotes a continuum of care, ensuring that patient data is available whenever and wherever needed.
In essence, these criteria, while stringent, are designed to ensure that EHR systems in the USA meet the rigorous demands of modern healthcare, promote patient safety, improve care outcomes, and streamline operations for healthcare entities.
Stages of EHR System Implementation & Certification
Implementing an Electronic Health Record (EHR) system is a multifaceted endeavor, ensuring that healthcare software meets the rigorous demands of modern healthcare and can then successfully achieve certification.
To begin, EHR certification is not merely a one-time endeavor. Again, it is a holistic process that ensures an EHR system’s compliance.
The process to get an EHR certificate can be carried out after the product's launch, with options available for both online and offline services. Organizations like the Office of the National Coordinator for Health Information Technology (ONC) in the USA play a pivotal role in this space.
So, how exactly does an EHR become certified? Let's delve into the main stages.
1. Develop an EHR-compliant Software
Before stepping into the realm of certification, the foundational task is to develop an EHR system that is inherently compliant. At MLSDev, we don't just assist with the software development process but also help prepare all the materials crucial for ensuring compliance.
Our software development company provides a strategic approach that includes:
- Idea Validation: Before any tangible development begins, the primary idea is assessed to ensure its viability and alignment with certification standards.
- Discovery and Prototype: Post validation, a thorough discovery phase is embarked upon, leading to the development of a prototype. This provides a clear vision of the EHR system's functionalities and features.
- Design, Development, and Testing: MLSDev brings our technological prowess into play, ensuring that the system's design and development align seamlessly with certification standards. Rigorous testing ensures robustness and compliance.
- Launch and Maintenance: After development, the product is launched - but our involvement doesn’t end there. We assist with maintenance and ensure that the system remains compliant even as standards evolve.
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Our portfolio boasts projects that require intricate attention to obtain an EHR certification. With our expertise, these ventures have successfully navigated the complexities of EHR compliance and certification.
2. Hire a Consultant (if needed)
To bolster the chances of seamless certification, consider bringing a consultant on board from the early stages. Their niche expertise ensures that the software adheres to every nuance of EHR standards, further streamlining the certification process.
These experts come with insight that can substantially optimize the certification process. While their involvement is an additional expense to the healthcare app development cost, the value they bring to the table that often outweighs the costs.
3. Request Testing from ONC-Authorized Testing Laboratories
Navigating the certification waters for an EHR system requires an understanding of the roles various organizations play in the process. Certification isn't a straightforward, one-step affair; instead, it involves a cascade of steps with distinct entities overseeing each stage.
Here's a more in-depth look at how these entities interplay:
- Office of the National Coordinator for Health Information Technology (ONC): Serving as the apex body, the ONC crafts the certification criteria and sets the overarching regulations governing the certification process.
- ONC-Authorized Testing Laboratory (ATL): These are the specialized labs responsible for rigorously testing the EHR system against the criteria set by the ONC. After performing exhaustive tests, these ATLs forward the test results to an ONC-Authorized Certification Body. Importantly, each EHR module is treated as a distinct entity, which means it gets tested and certified separately. Moreover, each certification criterion is also evaluated individually. The crux of achieving EHR certification often revolves around these lab tests. Should an ATL find your software aligning with the set standards, they will relay a detailed test report to the certification body.
- ONC-Authorized Certification Body (ACB): Once the test reports are in, the ACB takes the baton. They review the test findings and, if everything aligns with the ONC's standards, they will publish the EHR system’s details on the official ONC website. However, their role isn't limited to this initial certification. They continuously oversee the EHR software, ensuring it remains compliant over time. Regular surveillance audits are conducted to affirm this sustained compliance.
- Centers for Medicare and Medicaid Services (CMS): Their role emerges post-certification. CMS steps in to offer incentives to healthcare institutions and hospitals that deploy and actively use certified EHR systems.
While attaining an EHR certificate is a commendable achievement, it is essential to understand that the journey doesn't end there. Proving and maintaining compliance is an ongoing endeavor, necessitating periodic reviews and updates to ensure the EHR remains in sync with evolving standards and best practices.
4. Submit the Necessary Materials
Upon successful testing, a plethora of materials need to be submitted for certification.
These typically include:
- Documentation demonstrating system functionality
- Evidence of compliance with specified criteria
- Test results from the ONC-Authorized Testing Laboratories
- Details of user roles and permissions
- Data handling and security protocols documentation
- Details of any third-party integrations and their compliance status
5. Get a Result
After submission, the certifying body will evaluate the materials and test results. Generally, within a stipulated time frame, you'll receive a certification status. Achieving certification signifies your EHR system's robustness, compliance, and readiness for real-world deployment.
Certified EHR System Examples
When diving into the realm of certified EHR systems, certain names resonate more profoundly, given their extensive adoption, impressive feature sets, and industry reputation.
Epic is a top-tier EHR solution for large-scale healthcare enterprises, claiming a 39.52% slice of the US national market. The service includes features like scheduling and financial modules seamlessly integrated with avant-garde tools. Functionality like predictive analytics can gauge patient health trends; as well, telemedicine services offer remote consultations and voice recognition, which elevates the user experience to another level.
While Cerner might be perceived as trailing Epic in the popularity race, it holds its unique appeal and stands as a formidable rival to Epic. While Epic dominates larger enterprises, Cerner finds its loyal base among ambulatory care centers and smaller clinical practices. Cerner's distinct edge comes from its embrace of AI-enhanced workflows and robust 24/7 live support.
Meditech has carved its niche with 14.7% of the US market. The system offers top-notch EHR capabilities for smaller healthcare establishments. One finds an intuitive user interface and a plethora of customization options that ensure that healthcare providers can mold the system to enhance efficiency, streamlining their unique workflows.
In sum, these EHR systems are among the industry's crown jewels. They all hold an EHR certificate and serve as great EHR examples, setting a high mark for companies striving to get an electronic health records certification.
Reasons for Developing Software for Healthcare in 2023
In the fast-evolving healthcare domain, 2023 has further underscored the importance of digitization. As we've journeyed through this article, the myriad facets of EHR-certified software have come to light – from intricate certification criteria to the undeniable advantages they bring to patient care, data security, and overall healthcare operations.
The reasons to develop healthcare software this year are more compelling than ever:
- Patient-Centric Care: With certified EHR systems, healthcare providers can offer an unparalleled patient experience, enhancing engagement and care quality.
- Operational Efficiency: Streamlined reporting, easy data exchange, and unified systems ensure smooth operations across healthcare establishments.
- Regulatory Compliance: As healthcare regulations tighten, a certified EHR system keeps providers ahead of the curve, ensuring they adhere to current and emerging mandates.
- Data Security: In a world increasingly concerned with data breaches, certified EHRs offer robust encryption and security protocols, safeguarding sensitive patient information.
- Public Health Initiatives: Beyond individual patient care, these systems are pivotal in strengthening public health trends and surveillance.
In this rapidly progressing digital healthcare landscape, having the right partner for your software development journey is paramount. This is where MLSDev steps in. With our extensive experience and expertise in healthcare mobile app development, we are poised to help you navigate the intricacies of creating EHR-certified software tailored to your needs.
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