As Electronic Health Record (EHR) systems have grown in use and sophistication, the issue of interoperability (how computer systems or software exchange and make use of information) has become more and more important.
Although there are currently three leading players in the EHR market, there are estimated to be over 500 vendors in all, offering some level of EHR system. Many healthcare providers will choose to implement elements of systems from a number of different EHR vendors, and patients receive different services from multiple different providers.
Historically, if you wanted to develop a tool that would allow a patient to view their medical records, that tool would need to be designed to be able to work with multiple different EHR systems, used by different hospitals, GP practices and other providers. The tool would need to be able to send a digital request, in the correct format, to each of the systems, and be able to read every single EHR vendor’s unique way of storing data. And, of course, if one of those vendors made a change to the way their data was stored, then your tool would need to be updated immediately to reflect this. Developing such a tool would be highly costly and time-consuming, and it would be prone to errors.
Yet patients, increasingly, expect their health records to travel with them, and to have more access to their data. And the Internet of Things has massively expanded our ability to use smart devices to collect even more health data. With all of this, comes an increased imperative for healthcare systems to be able to ‘talk to each other’. But how do you ensure that different systems, designed by different vendors, can do this?
Luckily, this interoperability conundrum is solved by HL7 FHIR and SMART on FHIR.
What is HL7?
HL7 is an international nonprofit standards-developing organisation (SDO). Launched in 1987, its origins were in the late 70s, when a small working group at University of California San Francisco (UCSF) developed a standard for the exchange of clinical and administrative healthcare data. Health Level Seven International (HL7) was formed to promote this protocol (StatLAN), and went on to develop new standards and protocols.
Since then, they have established themselves as the most well-known SDO for healthcare data. They have produced a number of iterations to the HL7 standards over the years, but the real revelation came in 2014, when HL7 published their next-generation standards framework, HL7 FHIR.
What is HL7 FHIR?
HL7 Fast Healthcare Interoperability Resources (FHIR – pronounced ‘fire’) is a standard that allows software developers to make sure the data held in their system is securely and easily accessible.
It classifies pieces of information as ‘resources’, and provides a standard way of packaging up these resources as individual packets of data. Each resource of the same type is formatted in the same way, and is given its own URL. What this means for the interoperability of healthcare systems is that, if you are looking for a piece of data, not only do you know where to go to look for it, but also how it should look when you get there.
What is SMART on FHIR?
Substitutable Medical Applications and Reusable Technologies (SMART) on FHIR is the final missing link that allows for the transfer of healthcare data from one system to the other. If HL7 FHIR is what tells us where to find our packages of data, and what they will look like, then SMART on FHIR is the courier service that allows us to transport those packages of data.
SMART on FHIR is an Application Programming Interface (API). It provides a conduit that allows us to securely ‘plug in’ one system to another, accessing data on-demand. In everyday terms, every app on your phone relies on an API to allow it to access data, before displaying it to you.
It’s creators, SmartHealthIT.org, describes their goal:
“The goal of the original SMART on FHIR API is audacious and can be expressed concisely: an innovative app developer can write an app once and expect that it will run anywhere in the health care system. Further, that one app should be readily substitutable for another.”
These SMART on FHIR apps essentially work with the security, data and user interfaces of the EHR platforms which support them. For security, they use an industry-standard protocol – OAuth2 – to inherit user rights from the EHR, providing a seamless user experience. For data, they tie into HL7 FHIR servers which have been deployed as an enhanced feature of the EHR, so they can access and query patient information. A SMART on FHIR app can be incorporated in an external system or within the actual EHR itself – so, for a clinician at the hospital, it’s just there, in the software they use every day.
As of May 2016, the 21st Century Cures Act required that all EHR systems developed in the US incorporated a universal API such as this, and the Final Rule from the Office of the National Coordinator for Health Information Technology (ONC) made SMART on FHIR the requirement.
Interoperability and clinical research
From a patient standpoint, the developments with HL7 FHIR and SMART on FHIR open up seemingly limitless possibilities. Not only can a patient’s data from different providers, using different systems, be connected more easily, but a patient can, indeed, now access their own health data through an app on their phone, and the potential for furthering the use of smart devices is clear.
The other major area of healthcare that can benefit massively from this new set of tools is clinical research.
For many years, researchers have been looking for ways to reduce the pain of accessing the data needed for clinical trials. The same challenges that a tool for patients accessing their own data might face, were an issue for the transfer of patient data in clinical trials. One-off, bespoke solutions were attempted to achieve an automated transfer of data from EHR systems to the Electronic Data Capture (EDC) systems used by the pharmaceutical companies sponsoring trials. But these attempts were limited in their effectiveness, and were certainly not scalable to join up the multiple different EHR systems used in hospitals, with the multiple different EDC systems used by pharmaceutical companies.
So, in this absence of a truly effective solution for interoperability of systems in clinical trials, the industry has fallen back on a distinctly low-tech solution: the manual transcription of data from one system to another. This takes up many thousands of hours of effort, and costs many millions of dollars for every trial conducted.
Now, finally, thanks to HL7 FHIR and SMART on FHIR, interoperability of systems in clinical trials is finally a reality. EHR systems that use HL7 FHIR standards and incorporate a SMART on FHIR API (as discussed, now most major EHRs), are primed to be able to ‘plug in’, via a cloud-based application, directly to an EDC system.
This kind of interoperability of systems has huge ramifications for clinical research. The secure, automated transfer of data from EHR to EDC (known as EHR2EDC) has the potential to save those thousands of hours of effort spent on the manual transfer of data. By freeing up time currently spent manually entering data, it can allow hospital research staff to focus on more valuable tasks and, potentially, running more studies at their site. On top of this, the resulting accelerated time to market for drugs has been estimated to be worth possibly billions of dollars to the global pharmaceutical oncology sector alone, but also, of course, will mean that vital cures reach the patients that need them faster.
Are you new to IgniteData?
IgniteData is the company shaping the future of clinical trials. Through our innovative digihealth platform, Archer, we are enhancing interoperability between Electronic Health Records (EHR) and key research applications such as Electronic Data Capture (EDC).
Our solution features turnkey integration with major EHRs, including Epic, Cerner and Allscripts, and EDC solutions, including Castor, Cisiv and Medidata . Find out more about Archer – the world’s first truly agnostic, scalable EHR2EDC solution – here.
Leading healthcare technology expert Steve Tolle joins IgniteData
Guest blog: Joseph Lengfellner on the challenges and solutions for clinical trials – Part 2
Guest blog: Joseph Lengfellner on the challenges and solutions for clinical trials – Part 1
How structured data is used in clinical trials
Evidence from Electronic Health Records-to-Electronic Data Capture live pilot study
IgniteData and Leading New York City Cancer Center Collaborate to Solve the Clinical Trial Data Transfer Challenge
Clinical trial data mapping explained: Mapping EHR data
Quality data and the EHR-to-EDC dream – where and why we need to focus our energies
UK clinical trials landscape: 4 big influencers
ZS’s Qin Ye on trends and driving innovation in life sciences
Meet Archer, the platform transforming EHR-to-EDC data automation