You might need to consider interoperability when introducing medical software to your clients. But what is interoperability in medical software? How to achieve it? And why would you need it? Today, we will answer all your questions.
TL;DR
Interoperability means the ability of medical software to exchange information and transfer data to other devices or services. For example, think about sharing information from one doctor (e.g., a neurologist) with another (e.g., an oncologist) without collecting any physical documents.
The most significant benefit of interoperability is improving patients' experience. For example, they don't have to bring records from CT scans, as they are already in their Electronic Health Records. Doctors also benefit from interoperability because they don't waste time creating the patient's documentation from the starting point. They can simply use records provided by other healthcare practitioners.
Interoperability in medical software – definition
There are many definitions of interoperability in documents from different regulatory bodies in Europe and the U.S. For the sake of this article we will use the one stated in the MDR.
Medical Device Regulation (MDR) defines interoperability as “the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data,
communicate with each other,
work together as intended” (source: MDR).
Take notice!
Regulatory bodies might use slightly different (yet overlapping) definitions of interoperability. You can find one by the BfArM (German Federal Institute for Drugs and Medical Devices) and another by the U.S. Federal Drug Administration. Always check the definition applied by the regulatory body whose jurisdiction affects you.
Now, you understand interoperability in theory, but what about the practical aspect?
Interoperability in medical software – examples
To put interoperability in simple terms, it is about the ability of medical software to securely exchange information and transfer data to other devices, services or infrastructures, which may or may not be developed by the same manufacturer.
The objective of interoperability is to empower healthcare practitioners (HCPs), hospitals, and laboratories with easily accessible and readable information, such as patient data, clinical tests, and administrative records. Thanks to interoperability, they can confidently maintain electronic health records (EHRs).
So, what about some real-life examples of interoperability?
The simplest example illustrating interoperability is the following scenario: you have had a CT scan conducted by one doctor and then you consult the results with a second specialist. However, you do not need to bring the results on a CD or other device, as they are posted in your EHR, available to all doctors in the country.
Another example – imagine the following situation: a patient uses a sensor that measures glucose regularly. Such a device can send the collected information directly to the doctor so they can follow episodes of hypoglycaemia (a drop in glucose below 70 mg/dl). Useful, right? Interoperability ensures that the data sent is readable by both the receiving machine (e.g., the web app) and the recipient itself, i.e., the doctor.
So, why is this so crucial? Well, imagine if the sensor recorded the data in one unit, say mg/dl, and then sent it to the doctor's app, which operates in a different unit, mmol/l, without converting the values. The doctor could end up with some pretty alarming and incorrect readings, like 60 mmol/l instead of 60 mg/dl.
Interoperability also enables the collection of patient data in a structured EHR, making it accessible to healthcare practitioners (HCPs) within the country and beyond. This kind of system allows all HCPs to access the results of blood tests, immunisation history, or medication taken by the patient, even if it is the first time they admit this particular person.
What are the four levels of interoperability?
If you read the MDR, you will learn that you need to prove their safety when a combination of two medical devices occurs. But how do you achieve this? Is there any interoperability framework?
HIMSS (Healthcare Information and Management Systems Society) is an American organisation that aims to improve the quality of healthcare through the “power of information and technology”. It divides interoperability into four levels.
Level 1 – Foundational Interoperability
Foundational Interoperability is the easiest one to provide, as it aims to allow simple data communication between the sender and the receiver (e.g., a sensor measuring glucose and a doctor’s app). At this point, the systems don’t need to understand each other; they just need to be able to share and store information.
Level 2 – Structural Interoperability
As part of structural interoperability, you should ensure that both devices use the same data system or are correctly converted when transferring data from one system to another. The data should be readable by all interested parties – patients, HCPs, and machines.
If you're seeking a comprehensive guide to managing interoperability in your medical software, look no further than Health Level Seven International (HL7). This non-profit organisation is a leading authority in the development of standards that are specifically designed to enhance interoperability.
When it comes to structural interoperability, we recommend learning about HL7 FHIR (The Fast Healthcare Interoperability Resources), where you will find information about the standard's five implementation levels. You can read more about that in the article prepared by our Technical Expert, Artur.
Check it out
Check out the HL7 FHIR website to read everything about the medical software interoperability standard you might need.
Level 3 – Semantic Interoperability
This level of interoperability is about providing standardised vocabulary and definitions considering healthcare, for example, using unified medical codes for describing diseases or medical devices (such as LOINC or SNOMED). Thanks to this, everybody can understand concepts shared by the systems.
Level 4 – Organisational Interoperability
This level of interoperability is all about the policies and legal aspects that provide safe and secure data exchange between all the parties involved.
Information about patient health should be protected with the best possible solutions to prevent any data leaks. When your medical software is ought to transfer data to another medical device, you have to make sure that you provide high-level data protection and privacy.
Benefits of interoperability in healthcare software
You might wonder – what will you get from following interoperability standards? How important is interoperability? Let's discuss some benefits of interoperability in medical software.
Improved patients’ care
Patients using devices that measure some parameters (e.g., blood sugar levels) may benefit from a better treatment process because, thanks to interoperability, doctors can receive the results promptly and introduce more suitable treatment. What’s more, patients don’t have to undergo the same test twice as they have lost a CD with CT scan because the results are safe in the EHR.
Time-efficiency
Manual processing of patient data can prolong the process of tailoring treatment to the patient. Thanks to the fast and secure communication between medical devices, doctors can get real-time data and quickly suggest a visit, change a medicine's dosage, or propose alternative treatment. Also, they have insight into the records provided by other doctors and they don’t have to ask multiple questions to the patients.
Reduced number of errors
Manual human data processing can lead to numerous errors – the report by West Health Institute states that medical errors result in three million preventable adverse events each year. Sometimes, results can get lost or can wrongly transfer data from a medical device software to a patient's medical record. Automatic data transfer makes this process more reliable.
Comprehensive data management
Interoperability enables all the elements of the entire national healthcare system to communicate efficiently, making it easier for HCPs to make decisions about proper treatment and allowing the patients to visit different doctors without worrying about lack of documentation.
Less administrative issues
Research conducted in Canada shows that doctors spend millions of hours per year on administrative work. Ensuring interoperability can translate into a more efficient transfer of patient information between healthcare organisations and HCPs. This can reduce the number of documents provided by patients and held by healthcare departments. What’s more, data can be updated regularly without human interference.
Do you need interoperability in your medical software?
Suppose you have developed medical software that needs to be connected to other devices to operate in accordance with its intended use, and you want to market it in Europe. In that case, you need to ensure its interoperability.
Medical Device Regulation (Annex 2, Point 6) states that a manufacturer should prepare a description of such a combination with the proof of its safety as it relates to the “general safety and performance requirements” stated in Annex I.
While you may not currently need to connect your medical software to another system, you may want to do so in the future. Applying the interoperability requirements at the outset of the software development process is a decision that can save you from the complexities of rebuilding the system later on.
As Revolve Healthcare, we are a member of the HL7 International; thus, our solutions meet FHIR standards. Let's discuss how we can help you develop your medical software.
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