Custom EHR Development: Interoperability, Security & Compliance

Let me tell you an interesting stat, you see, in 2018, a Stanford Medicine Polled doctors about EHRs suggested that 67% of physicians cited problems in solving their interoperability problems. Cut to 2024, the number has surprisingly increased to 69% with critical issues in interoperability disrupting their coordination and care delivery.

Coordination in healthcare has always been a problem. In fact, a study suggests that almost 80% of medical errors are caused by miscommunication, which directly or indirectly implies inefficiencies of their EHR interoperability software.

Upon close inspection of some of the systems of our clients, it was clear that EHR interoperability security is one of the major concerns for them. You see, as instructed by HIPAA, your EHR systems need to be interoperable. And amongst all the healthcare software systems that say they are HIPAA compliant, more than 50% of them are not fully HIPAA compliant, according to Becker’s Hospital Review.

This non-HIPAA compliance is the reason why more than 124-133 million health records were compromised in 2024-2025 alone, according to HIPAA Journal.

And this is why most of the healthcare providers are looking for custom EHR software development, to make their EHR systems more secure, interoperable, and HIPAA-compliant.

Interestingly, all these aspects of interoperability, securit,y and compliance are interconnected, so special attention should be given to these aspects. But achieving this is easier said than done.

On that note, in this blog, let’s explore the different aspects of interoperability, security, and compliance in custom EHR development. So without further ado, let’s get started!

EHR Interoperability Software – The Data Exchange Engine

Interoperability, in a nutshell, is the ability of the computer system to seamlessly connect and exchange information with other disparate systems. Given the collaborative nature of the healthcare industry, achieving interoperability can solve the issue of collaborative care.

With interoperability, every member of the care team is brought on the same page to work together towards the same goal, which is to provide better care. However, achieving interoperability is easier said than done and can be a major challenge in EHR development. That is why many healthcare practices still complain about connectivity in the current healthcare systems.

Moreover, depending on your unique needs and requirements, you need to adopt different levels of interoperability. Here’s a quick overview for understanding interoperability better:

• Foundational Interoperability: This is the basic level of interoperability that allows your system to exchange data with other systems without any errors, seamlessly. Perfectly suited for healthcare systems that just want to transmit and receive data from different healthcare systems.

• Structural Interoperability: This level of interoperability focuses on the format and structure of the exchanged data, since different systems use different formats and structures to store data. Furthermore, it is more suitable for healthcare systems that define the common standards and protocols for data exchange, such as HL7 FHIR, which are a crucial cornerstone of healthcare interoperability.

• Semantic Interoperability: This level of interoperability focuses on the meaning of data that is being exchanged between the systems. In simple terms, with semantic interoperability, your system and connected systems get the ability to understand the data while sending and receiving. Semantic interoperability involves using common vocabularies and ontologies to represent the data in a consistent way.

The role of EHR interoperability software for your practice is that it enables your systems to send, receive, find, and integrate data from other systems into your system and vice versa. For instance, if your EHR software is an EHR interoperability software, then from your system you can easily send, receive, find, and integrate data from other systems like billing, labs, etc.

Moreover, with a basic understanding of the level of interoperability, you can easily choose the one that suits your healthcare system the best. However, the importance of interoperability standards and protocols such as HL7, FHIR or DICOM cannot be ignored. This helps in defining the data structure and can oftentimes be the deciding factor for your system to seamlessly exchange data.

Common Interoperability Standards

Over the years, there have been quite a few interoperability standards that came into practice for healthcare software systems to share information. To give you a nudge in the right direction to choose the interoperability standard that suits your practice the best, here are some standards that you must know:

• HL7 (Health Level Seven): HL7 is basically a set of international standards that are used for exchanging clinical and administrative data between disparate healthcare systems. In simple terms, HL7 standards act as a language that healthcare systems use to communicate with each other. It deals with structured text-based messages to ensure smooth data flow for various clinical and administrative workflows.

• FHIR (Fast Healthcare Interoperability Resources): You can consider FHIR as a next-generation standard for healthcare data exchange, and interestingly, it was developed by HL7 International. It uses modern web technologies like RESTful APIs, JSON, and CML to achieve interoperability, which is much faster, easier, and flexible. It was basically developed to overcome the complexities of older HL7 versions like HL7 v1 or HL7 v2.x.

• DICOM (Digital Imaging and Communications in Medicine): DICOM is another international standard that specifically handles the exchange of medical imaging information. These standards define the format for storing medical images and provide a protocol for systems to transmit and manage them.

Note: Understand your practice needs and requirements for data sharing and collection. This is important because it makes it easier for you to choose the right interoperability standard for your practice. Know the role of interoperability for your custom EHR software system in detail before finalising on the interoperability standard for your software system.

Meeting USCDI Requirements

The USCDI stands for United States Core Data for Interoperability. It basically is a standardized set of health data classes and specific data elements that are required for health information exchange. Some of the core elements in this include demographics, allergies, medication lists, lab results, clinical notes, procedures, etc.

On top of that, you are also required to stay updated with the ONC, which periodically updates to add new data elements and classes for better care delivery, equity, and exchange.

Having said that, the 21st Century Cures Act has also been passed, which aims to improve healthcare interoperability, and it has directed the use of USCDI as a standard for interoperability.

Another aspect that needs to be addressed in the 21st Century Cures Act is information-blocking. It forms a core component of the act and restricts or prohibits practices that unreasonably impede the access, exchange, or use of EHI.

Security in Custom EHR Development – Protecting Data in Motion

As a healthcare professional, you know the importance of sensitive patient data. Furthermore, improving patient care with a custom EHR automatically becomes your responsibility to safeguard patient information and to ensure EHR data security with ethical use.

Moreover, when you exchange this information with disparate healthcare systems, there is a high chance that the data might be breached. This might not only compromise the privacy of the patients but also impact the practice in many ways, such as reputation damage and even hefty fines.

To overcome these common security threats, here are some of the robust security measures that you can take to protect sensitive patient data:

• Encryptions: By implementing robust encryption algorithms, you can easily encrypt data into a new and unreadable format called ciphertext, where even if the data is breached during transmission, it cannot be read unless you have the key. The key is shared between healthcare IT systems, which ensures the integrity of data and adds another layer of protection.

• Access Controls: The threat of unauthorized access is another concern that many healthcare providers face. By implementing role-based access control, you can ensure EHR data security by only allowing authorized personnel to access data.

• Regular Security Audits: While your system deals with patient data, it also generates some data of its own. A sneak peek into it can give you access to deeper insights that might help you in identifying loopholes in your security system. By conducting regular security audits, you can easily identify and address these gaps in system security.

When you connect your EHR with other systems, interoperability is required. However, in the process, it expands the security attack surface with potential entry points for risks if the structure is not designed carefully. Some of the aspects that you need to consider are:

• Unauthorized access and weak authentication
• Data leakage through third-party apps
• API abuse and Denial-of-Service (DoS) risks
• Inconsistent security standards across systems

One of the interoperability and security best practices in EHR systems that you can adopt is to embed them across the entire data exchange lifecycle. Here are some aspects on which you should keenly focus:

• Secure data transmission
• Strong identity and access management
• Data integrity and validation
• Audit trails and monitoring
• Data minimization and contextual sharing
• Vendor and partner security governance

Last but not least, one of the best practices to strengthen the security of your custom EHR software is by adhering to the regulatory requirements, such as HIPAA, GDPR, HITECH Act, etc. With your EMR software developers complying with these guidelines, you can ensure all the security measures are taken and help you seamlessly navigate through the healthcare IT security ecosystem and the legal landscape. Know everything you need to know about the regulatory landscape for your custom EHR software here.

Compliance in Custom EHR Systems – Navigating the 2026 Landscape

As the technological landscape is evolving, it is also changing the healthcare IT landscape. This is one of the major reasons why the regulatory landscape of healthcare IT is complex as well as ever-changing. However, in this transition age of digital healthcare practices, key regulations govern the security and ethical use of healthcare data.

Some of the key regulations that you need to adhere to are:

• HIPAA: It stands for the Health Insurance Portability and Accountability Act. It was passed by the government of the USA, and its purpose is to protect sensitive patient health information (PHI). The key provisions in this involve a privacy rule that sets standards for the ethical use and safeguarding of PHI and a security rule for protecting PHI on physical, technical, and administrative levels. Last but not least, a breach notification rule involves notifying the Department of Health and Human Services of breaches if they take place.

• HITECH Act: HITECH Act stands for Health Information Technology for Economic and Clinical Health Act, and it promotes the adoption and meaningful use of health information technology. It is quite similar to HIPAA and looks after the enforcement of HIPAA, along with breach notification and ethical use of EHR systems.

• GDPR: GDPR stands for General Data Protection Regulation, which is quite similar to HIPAA but is regulated by the European Union. It aims to protect the privacy rights of individuals in the European Union and the European Economic Area.

Furthermore, given that your custom EHR software will mainly deal with sensitive patient health information, your system will need to have robust data privacy, security, and accessibility policies. By adhering to these policies, you can easily ensure the privacy and security of the data and also HIPAA-compliant EHR development.

Last but not least, it is important to comply with the necessary and relevant regulations because non-compliance can lead to penalties, which are hefty fines in most cases. Here’s your quick guide to smoothly navigate through the regulatory landscape of custom EHR software.

TEFCA Participation & Trusted HIE

For better connectivity and network, you can also participate in TEFCA, which stands for Trusted Exchange Framework and Common Agreement. It is a US federal initiative designed to create a nationwide network of trusted health information exchanges. Its major goals is to make healthcare data more accessible to the healthcare organizations and systems for secure and consistent access.

Here are some major things that TEFCA does:

• Establishing a common legal and technical framework for health data exchange.
• Set standard rules for who can exchange data, how it can be shared, and for what purpose.
• A foundation for interoperability beyond one-off integrations.

TEFCA matters because it helps in:

• Reducing fragmented data exchange
• Trust building between participants
• Supporting compliances
• Improved care coordination

The Future of Custom EHR Development

As discussed earlier, the technological landscape is constantly changing, and while the emerging trends like Artificial Intelligence, Machine Learning, and IoT dictate the terms, it is most likely to impact the healthcare IT landscape. Moreover, the application of these technologies in healthcare can be seen in use and has made a significant impact as well. Keeping updated with technological advancements is one of the best ways to future-proof EHR development.

However, the more these technologies take the centre stage, the more likely they will shape the future of EHR development. This will have a direct impact on the regulatory landscape, which makes it even more important for you to stay updated with these latest technologies and the regulatory landscape.

Another important consideration that you must not ignore is the scalability aspect. You see, as your practice grows, your data also grows and to accommodate that data the scalability factor plays a crucial role. Read everything you need to make your custom EHR software scalable here.

Frequently Asked Questions