For MedTech companies, EHR interoperability is a major technical challenge, but it’s also a business-critical opportunity. It determines whether your device becomes a trusted tool in a clinician’s workflow or gets lost in the noise of digital health solutions.
In this article, we’ll break down why interoperability is essential for clinical adoption, patient outcomes, and long-term commercial success—and how to make it a core part of your product strategy from day one.
What is EHR Interoperability?
At its core, Electronic Health Record (EHR) interoperability is the ability of different healthcare systems, applications, and devices to exchange, interpret, and use electronic health data seamlessly. For connected medical devices, this means the data they collect—vital signs, biometric readings, real-time alerts—can be shared directly with electronic health records in a format that clinicians can easily access, understand, and act on.
There are three key levels of interoperability to understand:
- Foundational interoperability allows systems to exchange data but doesn’t ensure the receiving system can interpret it.
- Structural interoperability ensures that data exchanged between systems follows a standardized format (such as HL7 or FHIR), making it easier to organize and display consistently.
- Semantic interoperability is the highest level of interoperability. Systems not only exchange data but also interpret and use it meaningfully, enabling clinical decision support, automated workflows, and longitudinal care.
For MedTech companies developing connected devices, true interoperability means going beyond simply exporting data to actively embedding device insights directly into clinical workflows. When your device “speaks the language” of healthcare IT systems, you reduce friction for providers, increase the value of your product, and improve patient care outcomes.
In short, EHR interoperability turns your device from a data generator into a clinical tool.
Turning Integration into a Competitive Advantage
For connected medical devices to gain traction in real-world clinical settings, they must fit seamlessly into existing healthcare ecosystems—starting with EHR.
Integration into electronic health records isn’t just a technical milestone. It’s a strategic lever that can drive adoption, strengthen reimbursement potential, and set your product apart in a competitive market.
Improved Clinical Adoption
Healthcare providers are under constant pressure to do more with less. Any new tool or technology must enhance—not hinder—their workflows. Devices that integrate smoothly with EHR systems offer a frictionless experience for clinicians by embedding critical data directly into the platforms they already use. This eliminates the need to toggle between systems or manually enter data, saving time and reducing the risk of error.
More importantly, integrated devices position themselves as part of the clinical workflow, not as an add-on. This makes it far more likely that your device will be embraced and used consistently by providers. Simply put, if a clinician can access and act on device-generated insights within the EHR, your product becomes an asset, not another complexity.
Stronger Reimbursement Potential
Integration isn’t just about clinical convenience. It has direct implications for your reimbursement strategy. As healthcare systems shift toward value-based care, payers are looking for solutions that can demonstrate improved outcomes, reduced readmissions, and real-time impact on patient health. EHR-integrated devices make it possible to track and report these outcomes with greater accuracy and immediacy.
When your device data flows into the EHR, it becomes part of the patient’s official medical record, contributing to quality metrics and documentation that support billing and reimbursement. This can give providers a stronger case for payer approval and give your device a clearer path to market viability.
Competitive Differentiation
In a market where many digital health products still operate in silos, interoperability is a powerful differentiator. Devices that “play well” with hospital and health system infrastructure are perceived as lower-risk and higher-value by administrators, procurement teams, and IT departments. Integration demonstrates your commitment to meeting industry standards, aligning with regulatory expectations, and supporting clinical outcomes.
Moreover, interoperability can create stickiness. Once your device is embedded into a health system’s workflow and data infrastructure, switching becomes more difficult, which can increase customer retention and lifetime value.
Enhancing Patient Outcomes Through Integrated Data
At the heart of every connected medical device lies a promise: to deliver more timely, personalized, and effective care. But that promise can only be fulfilled when the data generated by these devices is seamlessly integrated into the systems clinicians rely on every day.
EHR interoperability is what transforms raw data into meaningful action—and ultimately, better outcomes for patients. Here’s how integrated data can elevate the impact of your connected device.
Personalized Care Through Longitudinal Records
When device data flows into the EHR in a structured, standardized format, it becomes part of the patient’s comprehensive medical record. This creates a longitudinal view of health that extends far beyond episodic visits or short-term monitoring windows. Clinicians can see trends over time—whether it’s glucose fluctuations, arrhythmias, or respiratory metrics—and use that data to deliver more tailored care.
This level of personalized medicine supports more accurate diagnoses, more informed treatment decisions, and earlier interventions. For MedTech companies, enabling this kind of insight through EHR integration can be the difference between a novel device and a truly transformative clinical tool.
Closing the Loop in Chronic Disease Management
Chronic diseases like diabetes, heart failure, and COPD require continuous oversight and coordination between multiple care providers. Devices that integrate with EHRs help close the loop by enabling real-time communication between patients, clinicians, and care teams. When a patient’s blood pressure spike, oxygen level dip, or blood sugar trend is captured by a wearable and sent directly to the EHR, providers can be automatically notified without relying on the patient to initiate contact.
This continuous flow of information allows for more proactive management of chronic conditions, supports care plan adherence, and reduces the risk of complications. It also strengthens the trust and accountability between all parties involved, fostering a more collaborative care environment.
Remote Monitoring and Timely Intervention
Interoperable devices extend the reach of clinical oversight far beyond hospital walls. With real-time or near-real-time integration into the EHR, clinicians can monitor patients remotely and receive alerts when thresholds are crossed or abnormal patterns emerge. This enables rapid response to potential issues before they escalate into emergencies.
Whether it’s detecting early signs of atrial fibrillation, identifying hypoglycemic episodes, or flagging respiratory distress, real-time data integration empowers healthcare teams to act swiftly. This not only improves patient safety but also reduces hospital admissions, emergency department visits, and associated healthcare costs.
Interoperability Challenges for Device Manufacturers
While the benefits of EHR interoperability are clear, achieving it is no small feat, especially for MedTech companies developing connected or wearable devices. The road to seamless integration is often paved with technical, regulatory, and workflow-related obstacles.
Understanding these challenges is essential for building solutions that not only connect to EHRs, but also enhance clinical care without creating new burdens for healthcare teams.
Technical Hurdles
From fragmented EHR ecosystems to patient privacy, there are numerous technical hurdles MedTech companies must overcome in order to build devices with seamless EHR interoperability.
Fragmented EHR Ecosystem
One of the most significant barriers is the sheer diversity of EHR systems in use across healthcare organizations. Each system may have its own integration methods, proprietary APIs, and data models, making it difficult for device manufacturers to build once and deploy universally.
Even within the same health system, multiple EHR platforms or versions may coexist, requiring custom development and testing to ensure compatibility.
Navigating EHR Standards
To bridge these gaps, standards like HL7 (Health Level Seven) and FHIR (Fast Healthcare Interoperability Resources) are used to enable structured data exchange between systems:
- HL7 v2: An older, widely adopted messaging standard that enables basic data exchange but is limited in flexibility and often requires customization.
- FHIR: A modern, web-based standard designed for easier and more scalable interoperability. FHIR uses standardized data models and RESTful APIs, making it more developer-friendly and suited for real-time integration.
Supporting multiple standards—or transitioning from HL7 to FHIR—adds complexity to the software architecture of connected devices and platforms.
Data Normalization and Standardization
Even if devices can export data in compatible formats, that data must be normalized to match the terminology, units, and structure used within the EHR.
Without proper standardization:
- Physiological readings might use inconsistent units.
- Device-generated codes may not align with clinical vocabularies (such as LOINC or SNOMED).
- Historical trends may be misinterpreted due to format discrepancies.
Achieving semantic interoperability requires thoughtful mapping and validation of all device outputs.
Security and Data Privacy Compliance
Interoperability cannot come at the cost of patient privacy. Device manufacturers must ensure that all data transmission and storage is secure and compliant with global data protection laws:
- HIPAA: Requires robust safeguards for health data handled in the U.S.
- GDPR: Applies to any company dealing with data from EU citizens, emphasizing user consent, data minimization, and breach notification.
Encrypting data, securing APIs, managing authentication, and implementing audit trails are just a few of the necessary security practices that must be built into the device’s software infrastructure.
Workflow Integration
Even if technical integration is successful, your device won’t be used if it disrupts how clinicians work. Workflow integration is about embedding device-generated insights into the clinical environment in a way that is intuitive, timely, and relevant.
Avoiding Alert Fatigue
One of the most common pitfalls is contributing to alert fatigue—a state where clinicians become desensitized to constant notifications, potentially missing critical ones.
To avoid this:
- Device alerts should be prioritized and context-aware.
- Notifications should only be sent when they are actionable.
- Customization options should allow clinicians to tune alert thresholds based on patient needs.
Ensuring Clinical Relevance
Device data must show up in the right place, at the right time, and in the right format.
This means:
- Key metrics should be visualized alongside other patient data within the EHR interface.
- Summaries and trends should support decision-making rather than overwhelm providers with raw data.
- Insights must be tailored to specific clinical roles (what a cardiologist needs may differ from what a primary care physician looks for).
Regulatory and Compliance Considerations
Interoperability is now a regulatory priority in both U.S. and global markets. For MedTech companies developing connected devices or SaMD, understanding and aligning with these evolving expectations is essential for approval, adoption, and long-term success.
21st Century Cures Act & Information Blocking
The 21st Century Cures Act prohibits practices that interfere with the access or exchange of electronic health information.
Device manufacturers must ensure:
- No restrictions on data sharing with EHRs or patients
- Transparent documentation of interoperability capabilities
- Use of standards like FHIR for seamless data exchange
Non-compliance can result in penalties and limited provider adoption.
ONC Health IT Certification
While optional for device makers, aligning with ONC Health IT Certification can improve trust and integration prospects.
Key areas include:
- Support for FHIR APIs
- Robust security protocols
- Clear disclosures of interoperability limitations
EU MDR and Interoperability
Under the EU Medical Device Regulation, interoperability is a core component of device safety and performance.
Manufacturers must:
- Document how the device interfaces with other systems
- Validate data exchange functions
- Include clear instructions for safe integration
SaMD Compliance
For Software as a Medical Device, regulators expect:
- Defined and validated interfaces for EHR/data exchange
- Risk management around third-party system dependencies
- Documentation of how interoperability impacts safety and clinical use
This applies across frameworks like FDA SaMD guidance, IMDRF standards, and EU MDR.
Strategic Approaches to Building Interoperable Devices
Building a connected medical device that integrates seamlessly with EHR systems requires more than a plug-in at the end of development. It demands a strategic, intentional approach from the start—one that accounts for standards, workflows, and the evolving needs of healthcare providers.
Here are three key strategies medtech companies should adopt to ensure their devices are built for interoperability and long-term success.
Design for Interoperability Early On
Integrating with EHR systems, especially within complex hospital infrastructures, requires early architectural planning.
From Day 1, device makers should:
- Define integration goals based on the clinical data their device generates.
- Align their software architecture with widely accepted interoperability standards like FHIR, which enables structured, real-time data sharing through RESTful APIs.
- Plan for extensibility, knowing that new standards, requirements, and EHR partners will emerge over time.
Early investment in interoperability simplifies downstream testing, regulatory alignment, and provider adoption.
Leverage Existing Frameworks and Platforms
Rather than building everything from scratch, companies can accelerate development and reduce integration risk by using proven, configurable platforms that already support EHR and device interoperability.
You can do this by:
- Utilizing prebuilt platforms designed for connected medical devices (like Sequenex’s NEX Platform). These often include FHIR/HL7 compatibility, data normalization tools, and secure APIs.
- Partnering with interoperability vendors, especially those certified in HL7 and FHIR. These vendors can streamline connections to major EHRs and ensure compliance with evolving healthcare standards.
These tools help companies avoid common pitfalls and focus on their core innovation, rather than rebuilding interoperability infrastructure.
Iterate with Clinical Stakeholders
No matter how advanced a device’s technology is, it will fall short if it disrupts provider workflows. That’s why clinical input must be embedded in the development process.
You can do this by:
- Involving physicians, nurses, and IT staff early to understand where and how your device fits into care delivery.
- Using iterative feedback loops to ensure alerts, data visualizations, and workflows support real-world clinical decision-making without causing disruption or alert fatigue.
- Conducting pilot integrations with healthcare partners to validate both technical and workflow compatibility.
Collaboration with end users ensures that your integration not only works but works in the way healthcare teams actually practice medicine.
Embracing EHR Interoperability for Future Success
EHR interoperability unlocks the full potential of your device, turning it from a simple data generator into a vital tool for clinicians. It improves clinical adoption, enhances patient outcomes, and provides a clear competitive edge.
By designing for interoperability from the outset, leveraging existing frameworks, and collaborating with clinical stakeholders, MedTech companies can ensure their devices meet the technical, regulatory, and workflow needs of healthcare systems. Embracing these strategies will not only help overcome the challenges of interoperability but will position your product for long-term success in an increasingly interconnected healthcare landscape.
