Medical Device Integration with EHR: Best Practices, Issues, and Use Cases

Medical device integration with EHR represents a strategic decision for healthcare organizations because it optimizes data flow and improves the accuracy and accessibility of medical information. This approach enables more integrated patient interactions, improves the efficiency of treatment processes, and enhances the quality of care you provide.

But before we dive into the details, let's explore the essence of EHR integration and wearable medical device concepts and how they can improve your clinical practice.

The Electronic Health Records/Electronic Medical Records (EHR/EMR) systems are the digital recording and storage of patients’ PHI (Protected Health Information) and e-PHI (Electronic Protected Health Information). These systems store medical histories, treatment plans, appointment schedules, and other important data on digital health.

Application areas of EHR/EMR integration with medical devices include:

• Real-time patient monitoring. EHR integration with medical devices allows physicians and nurses to monitor the current status of patients' well-being with real-time, actionable data on health indicators.
• Remote Patient Monitoring (RPM). Medical device integration with EHR supports remote monitoring capabilities, allowing healthcare providers to monitor their patients off-site, which is especially relevant in remote care settings.
• Radiology and medical diagnostics. Integrating EHR systems with radiology devices enables health providers to access test results, diagnostics, and images, improving the diagnostic process.
• Medical analytics and reporting. Integration of EHR with medical devices enables in-depth data analysis, leading to improved efficiency and quality of healthcare services.

These are just some of the examples of the use of EHR integration with medical devices in healthcare. In fact, this system is closely linked to all areas of medicine and allows for significantly improved patient data management at all levels.

Wearable medical devices are one of the illustrations of IoT in Healthcare, presenting innovative technologies integrated into wearable items such as watches, bracelets, etc., to track and monitor various vital signs. These devices provide personalized and continuous tracking of patients and provide doctors with valuable data for more accurate diagnosis and treatment.

Examples of wearable medical devices include:

Smart watches with health features. Smart watches provide functions to monitor heart rate and measure blood oxygen levels. They also can perform ECGs and monitor sleeping time and quality. Example: the Apple Watch helps in the early detection of heart abnormalities and provides doctors with everyday health data to analyze.

Smart bracelet. Smart bracelets track physical activity and sleep levels and provide data on heart rate and exercise quality. Example: Fitbit - using physical activity data to assess overall health and make personalized recommendations.

Glucose monitoring device. A wearable device for continuous monitoring of blood glucose levels for diabetic patients. By the way, with the increasing use of diabetic devices, such medical device integration with EHR is being considered most often. Example: Eversense Continuous Glucose Monitoring System - providing real-time glucose level data for diabetes management.

Epileptic seizure monitoring device. A wearable device designed to monitor epileptic seizures and provide alerts. Example: Embrace by Empatica - helping people with epilepsy prevent seizures and providing valuable information to doctors.

Pulse oximeter. A portable device designed for continuous monitoring of pulse rate and blood oxygen levels. Example: Fitbit Charge 4 is a fitness tracker that also provides heart rate and oxygen saturation data, among other features.

Medical device integration with EHRs offers even more global benefits than using them separately, significantly improving healthcare quality and ensuring more accurate and timely care delivery. So let’s find out the advantages your clinic can get if you integrate device with EHR.

Integrating medical devices with EHR provides a means to automatically transfer patient physiologic data into a digital format. In this way, the integration reduces the risk of human error associated with manual entry and ensures the accuracy of the data stored in the electronic health record. Such accuracy becomes a critical factor in diagnosing and developing treatment plans.

Medical device integration with EHR allows physicians to monitor a patient's vital signs continuously in real-time. This is particularly useful for remote patient monitoring, telemedicine, and chronic disease care cases. Physicians gain immediate access to data, facilitating quick and informed decision-making and improving patient experience.

To improve patient monitoring, you can build a separate, specialized solution. Learn more about this in our article about remote patient monitoring software development.

Integrating medical devices with EHRs optimizes operational processes such as surgery, diagnosis, and treatment. Automating data collection reduces the time it takes to analyze information, improving the efficiency of medical procedures and enabling faster interventions.

Integrating medical devices and EHRs provides instant access to up-to-date patient data. This significantly reduces physicians' time searching for information and facilitates faster and more accurate decision-making in urgent medical situations.

EHR with medical device integration also helps provide a deeper understanding of individual patient needs. This creates the opportunity for personalized treatment, taking into account each patient's unique characteristics, thus improving the overall quality of care provided.

Consider patient portal development to provide the highest quality personalized patient care.

In chronic diseases, medical device integration with EHR enables effective monitoring and management of patients' conditions. This allows timely detection and response to changes, preventing complications and improving the overall effectiveness of treatment. Patients get a more active role in managing their health, enhancing the efficacy of therapy.

Medical device integration with EHR is a major step that requires careful preparation and planning. A thoughtful integration process will allow you to achieve the best results in the shortest time. The Cleveroad expert team compiled the key practices you should consider to integrate device with EHR.

The first and critical step to integrate device with EHR is to define the goals and the expected outcome. It includes identifying the specific problems you want to solve and understanding how this integration can improve patient care. For example, you may want to enhance the efficiency of data exchange between the devices and EHR to improve diagnostic accuracy. Defining your objectives will give you a better understanding of how the medical device integration with EHR should be performed to achieve your integration purposes.

An IT infrastructure assessment is a detailed examination of the device's compatibility with your existing EHR/EMR systems and other health information management systems. This includes analyzing the communication protocols used in your EHR/EMR and ensuring the health devices that need to be integrated can communicate with them. It is also essential to make sure your IT infrastructure can support real-time data transfer to keep your medical information current.

Determining the specific data you need to exchange between your medical devices and the EHR system is integral to a successful integration. This includes establishing the data format, choosing the exchange frequency, and approving standards for information exchange. For example, this may involve the transmission of metrics such as:

• Vital indicators: body temperature, respiratory rate, heart rate, blood pressure
• Laboratory results: date of analysis, patient values, trend.
• Information about medications: list of medications taken, dosage
• Patient history: history of diseases, surgeries, previous appointments, and test results
• Patient information: personal data, contact information

Choosing an experienced IT company becomes a decisive moment in the successful realization of medical device integration with EHR. Partnering with a tech team experienced in healthcare software development services will ensure smoother integration, reduced risk, and increased efficiency. When choosing a software vendor, pay attention to their experience, study customer reviews on platforms like Clutch, and check the portfolio to ensure that they have successful cases in the Healthcare domain.

EHR/EMR systems and medical devices store and transmit sensitive patient data. Ensuring the confidentiality and integrity of the transmitted data is related to implementing healthcare data security measures. For example, our experts use industry-standard data encryption, authentication, and authorization mechanisms, add Role-Based access control (RBAC), and develop security policies that comply with healthcare laws and standards such as HIPAA, PIPEDA, GDPR, FHIR, etc.

Compliance with healthcare regulations and standards, such as HIPAA, GDPR, HL7, PIPEDA, ISO, etc., is integral to medical device integration with EMR. It includes developing a compliance strategy, preparing documents, and building telecare software solutions to meet compliance requirements.

As a proficient healthcare IT provider, we have compiled information for you on some of the critical standards that are important to comply with when integrating devices with EHR/EMR:

Please note that these are not all regulations you healthcare systems must adhere to, as it depends on your region. So it’s recommended to study the regulatory healthcare landscape in your location before integrating medical devices with EHR.

Your software vendor (or your internal tech team) will provide the necessary support once the clinical devices have been successfully integrated into EHR/EMR. The software provider also provides 24/7 technical support ready to address operational issues and creates online resources for easy access to information. Support and maintenance also include regular software updates, implementing new features, and ensuring system security. Security monitoring is also an integral part of the vendor's activities, ensuring the confidentiality of medical data.

Also, to maximize the benefits of medical device integration with EHR, you need to train your staff to use the technology. Training includes regular sessions to familiarize staff with new functionality.

We want to demonstrate our experience integrating IoT devices with telemedicine systems.

For our US client, a manufacturer of IoT devices for ECG heart monitoring and pulse oximeters, we built an IoT-based System for Monitoring EKG and Blood Oxygen Levels. The company approached us to help develop a mobile app allowing users to monitor and check oxygen concentration in blood conveniently from their wearable devices in real time.

Our team built a telecare solution for ECG monitoring and established its connection with the company's pulse oximeters and IoT devices. Our experts also ensured compliance with the 510(k) FDA Medical Device Registration and HIPAA requirements to allow the app to process and store Personal Health Information (PHI).

As a result, the client received telecare mobile applications connected to IoT devices. The solution is compliant with US health regulations, offering users significant capabilities for monitoring vital signs. Our tailored approach and rigorous quality management ensure a user-friendly solution, reflected in a 95% "4-5 stars" user satisfaction rating. Positive feedback from healthcare professionals further underscores the app's effectiveness.

Our client, a US-based scientific and commercial company, approached us to help build a software solution for a hardware IoT product that tracks the hydration level in a human organism. The IoT-Based System of Human Hydration Monitoring built by our team had to be connected with an IoT hydration sensor to measure real-time metrics for medical and wellness purposes.

Our experts successfully built the telehealth software, ensuring its reliable connection with IoT hydration sensors. Calculation and user advice on the optimal hydration level are based on user data derived from the IoT sensor. We also built the software architecture in compliance with 510(k) FDA Medical Device Registration regulations and integrated it with the customer’s PaaS platform.

As a result, the client received a cross-platform healthcare app successfully integrated with IoT hydration sensors. The solution allowed the customer to expand the audience by half due to the new app. Already, Hydrostasis is running three partner programs while continuing to grow its business.

Medical device integration with EHR has several key challenges that require careful consideration and innovative approaches to overcome successfully. In this section, we look at these challenges in-depth and suggest practical solutions that we at Cleveroad apply to ensure seamless and secure integration of medical devices with EMR systems.

One of the key challenges in medical device data integration with EMR is ensuring continuous real-time synchronization. Changes recorded on devices must be instantly reflected in the EMR, providing accurate and up-to-date data.

Solution: To address this challenge, we at Cleveroad are developing and implementing tools for real-time data synchronization. This includes using modern technology and database optimization for efficient storage and instant access to data.

The variety of data standards and formats in the medical field can lead to compatibility issues between medical devices and equipment and EHR systems. This includes differences in data structure, communication protocols, and information transfer formats.

Solution: The Cleveroad team utilizes medical information exchange standards such as HL7 integration and FHIR to overcome these challenges. Also, if necessary, we can develop middleware solutions that enable interoperability between different healthcare systems and devices.

Due to the sensitivity of medical data, ensuring its security and privacy is a priority. It is important to ensure that data is not only protected during its transfer between devices and EMR/EHR systems but also that it is safely stored in the system.

Solution: Our healthcare software engineers apply robust encryption techniques (e.g., AES-256) to protect medical data. We also actively monitor compliance with regulations such as HIPAA and GDPR and develop solutions to meet these requirements. Among the powerful security methods utilized by Cleveroad's experts:

• MFA, automatic logouts
• RBAC to limit access
• Activity tracking
• Data encryption at rest and on client devices
• Industry-standard data encryption
• HL7 standard
• HTTPS/encrypted WebRTC

Medical device integration with EHR can be complex, requiring specialized knowledge and skills. This can include difficulties understanding communication protocols, data formats, and medical device specifications. Thus, only developers with experience in HealthTech can integrate device with EHR.

Solution: Outsourcing software development is an excellent solution to access the necessary expertise and technology for medical device integration with EHR without being tied to a geographic location. Moreover, by choosing an outsourcing IT provider, you can select the cooperation model that suits your needs best. For example, you can hire dedicated development teams or augment your staff with several specialists.

Cleveroad is a healthcare software development company from the CEE region, notably Estonia. With 11+ years of experience, our team has built a solid expertise in Healthcare software development, medical system/device integration, and consulting. Our tech proficiency encompasses EHR/EMR software development services, building telemedicine and remote patient monitoring solutions, creating doctor appointments, e-prescription apps, healthcare CRM, etc.

Since 2023, Cleveroad has been certified according to two international standards — ISO 9001:2015 and ISO/IEC 27001:2013, covering quality management and information security management systems, respectively. We also received Amazon Web Services (AWS) Select Tier Partner status within the AWS Partner Network (APN).

As an experienced medical software development team, we ensure the software solutions meet healthcare industry standards and regulations like GDPR, HIPAA, PIPEDA, FHIR, ISO, HL7, etc. We pay extra attention to protecting PHI and e-PHI, focusing on Role-Based Access Control (RBAC), secure data storage, and safe transmission.

Our team has practical experience in building healthcare and telemedicine software, including medical device integration with EHR/EMR systems. So, if you are looking for a reliable tech partner to improve caregiving with clinical device integration, we are armed to assist you!