During the early stages of digitalization in healthcare, interoperability was not the priority. Today, we must bear the consequences – old IT systems that do not follow standards. How to fix it?
Interoperability dates back 40 years. Since the 1970s, there has been interoperability of data, especially for evaluation, and interoperable solutions for billing between hospitals, practices, and health insurance companies. These datasets – along with grammars and terminologies such as HL7 Version 2 and ICD (International Classification of Diseases and Related Problems) – still exist today and function effectively.
So, interoperability is not the invention of today. Another application was the transfer of laboratory data in hospitals to provide doctors with insights without the need for transcription. These interfaces have been in place for over 25 years and operate globally in hospitals.
However, today’s need for interoperability, particularly concerning patient records, demands precise representations of specialized medical data in a standardized language. The focus is ensuring that modern standards and unique identifiers are employed for medical examinations and diagnoses.
The IT ecosystem and data gathered are changing, so the interoperability standards evolve – numerous standards exist in healthcare, with examples like HL7. In Technical Committee ISO 251, which is dedicated to medical informatics, approximately 300 standards have been developed and coordinated worldwide in recent years, with some already partially implemented.
These standards operate at various levels, necessitating consideration for interoperability at different tiers. Security standards, such as OpenID and OAuth (short for “Open Authorization”) for authentication and technical data transmission, are vital, while syntactic and semantic standards contribute to the diversity.
How are they established?
Standards development is always a result of collaboration between individuals, organizations, and ministries. Organizations, such as the WHO with its classifications, ICH (International Conference of Harmonization) for pharmacovigilance, DICOM for medical images, CDISC for clinical trials, and HL7 as a healthcare standard for processes, work collaboratively to ensure that new standards harmonize effectively.
While each standard has its specific domain and application areas, occasional overlaps occur. The joint effort also facilitates the creation of solutions for those still using older standards and the integration of adapters between different standards.
Implementation guides provide detailed instructions on how standards should be applied in specific projects or products. An example is the implementation guide for rare diseases, specifying the requirements for implementation in a project or product.
You mentioned the changing scope of interoperability. From a physician’s perspective, comprehensive access to all relevant data from various points of care, including those collected at home by smart devices, is critical. Is such data integration from multiple devices, including often non-medical wearables, possible?
The debate on whether this integration makes sense revolves around avoiding overwhelming doctors with an excessive amount of data. In my opinion, it would be meaningful if health data from wearables could be transferred to the patient record and pre-analyzed automatically using artificial intelligence.
To prevent storing vast amounts of data without a clear structure, international standards, also known as patient summaries, have been established. They present the ten essential elements, such as pathological laboratory values, diagnoses, and procedures, at a glance. So, we already have a wide range of standards. The challenge is to implement them across the healthcare ecosystem. However, the speed at which standards are adapted depends on various factors, including policy, industry openness, and technology. Here, political support is crucial, although challenges have arisen in the past with the implementation of laws and deadlines. Responsibilities for standards need clear definitions, and overcoming obstacles, such as difficulties in providing patient records by health insurance companies and data protection concerns, requires continuous progress.
Another challenge lies in the lack of interest in following standards by many software manufacturers, especially smaller ones. What hinders progress are also insufficiently trained professionals for implementing new standards and fear of product interchangeability.
Looking ahead to the future of interoperability, I expect improvements in global agreements and collaborations using standards like FHIR and new data models like the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). However, there will be no definitive end as medicine and technology continue to advance. Interfaces between different systems may be established, making data communication faster and easier, but the need for standards will persist.
In Europe, there is the so-called Patient Summary. Are we ready to exchange data from electronic health records across borders?
Indeed, the so-called International Patient Summary (IPS) is a brief file designed for exchange across national borders, adhering to the specifications of the epSOS Project (European Patient Smart Open Services). A decisive choice has already been made to use the FHIR standard. As you know, Germany is a supporter of FHIR standards, so it’s a right step forward.
However, there remains uncertainty about terminology, given the associated costs and the lack of an open-source product. Nevertheless, solutions are being devised based on the ISO standard for the international patient file.
Approximately 15 years ago, I had the opportunity to work on this standard, particularly in the field of semantics. The contents, including laboratory values, medication, and diagnoses, are already being standardized and are internationally comparable. But this is a very complex topic, and I expect some challenges that, for example, may arise from differing medication names or differences between countries.
We deal with 27 EU countries with different IT infrastructures, standards, and hundreds of software solutions. But we are progressing, and I’m sure European patients will soon benefit from an interoperable patient summary.
I have an impression that sometimes experts like you have to literally fight for standards to be implemented. How long will it take before interoperability becomes invisibly embedded in digitalized healthcare?
In some cases, it is already widespread, for example, in medical imaging, where standards have gained acceptance. This success was achieved through pressure from professional societies urging manufacturers to implement the same guidelines. The results are enormous – x-rays or MRT results can be exchanged today between different systems and thus faster and easier analyzed.
Unfortunately, similar progress has not been made in the broader medical field, particularly concerning medical specialist data and device data.
Pressure from the EU and other bodies may now compel companies to implement interoperability. However, the current approach of imposing penalties for non-compliance and allowing cross-complaints is less than ideal. While interoperability is already at a high level in certain areas, implementation has not yet occurred in the patient record despite specified standards.
In my opinion, there is a lack of comprehensive education for citizens and even doctors regarding the necessity of interoperability. Interoperability is behind the success of every digital transformation. Let it be finance or aviation. When you make a bank transfer from your bank, it’s possible because the systems are interoperable. In healthcare, the benefits will be revolutionary – think about complete insights into patient data, a better understanding of patient health, and improved decision-making.
Can you please elaborate on the benefits of interoperability for citizens?
Well, imagine being able to access your data from birth to the end of your life.
While data was previously available in the GP’s EHR system, in hospitals, or within health insurance databases, the crucial difference now is that people can directly view their own data. I believe this feature will be a landmark for medicine and healthcare.
In a second scenario, when someone falls ill, doctors must have access to complete medical history in order to make the right decision. It means that all relevant data from different points of care must be consolidated in one place and presented in an understandable and searchable way so that doctors can view it by time, data type, etc. The data that doctors access also includes data gathered by a patient. For instance, a person with diabetes can analyze data from the CGM (Continuous Glucose Monitor) to identify patterns related to their eating habits. This empowers individuals to make targeted adjustments to their behavior, having never seen these effects before.
Another scenario involves seriously ill patients who frequently consult different doctors and must repeatedly narrate their medical history. Access to their own documents helps prevent errors, as doctors require comprehensive information to provide appropriate treatment. Moreover, the available data facilitates the application of precision medicine, a critical aspect, especially when patients receive treatment in various hospitals.
The capability to review personal health data also fosters better self-monitoring. For example, individuals can check lab results and, if necessary, make decisions independently without constantly needing to consult a doctor.
Overall, interoperability assists patients in being better informed, monitoring their health more effectively, and enhancing the quality of medical care. As you see, seamless data flow has the power to shift the paradigm of medicine.
You have been engaged in the interoperability field for a long time and are one of the foremost experts in the domain today. What is so fascinating about this topic?
It’s about technology, people, and a better world. Besides, studies suggest that in societies where people are healthy and age well, there are fewer wars.
I love to work with the international community, where like-minded people from many countries work together to find solutions. Interoperability is an exciting topic on the verge of technology, medicine, and change management, mixed with a political and societal context. That really drives me.
Many young people I cooperate with also realize they can positively impact society and change medicine through seamless data exchange. We are revolutionizing medicine, and it’s such a rewarding feeling.
And the last question: Imagine I know anything about interoperability. How could you explain the word in one sentence?
Interoperability is about computers and people communicating and understanding each other.