Within the data standards community – and especially among CDISC and HL7, the term “interoperability” is commonly espoused as a vision, mission and goal. For CDISC, the term refers to the ability of clinical studies to reuse data that originate as eSource from electronic health record (EHR) systems by pre-populating study CRFs through its Healthcare Link initiative, most typically for sponsored clinical trials. But the problem goes much deeper than that.
In the world of healthcare informatics, interoperability is a broader term describing the goal of rapid and easy exchange of meaningful, usable information between participants or systems for any relevant health-related purpose. For example, when I visit a new doctor, interoperability should make it possible for both of us to easily get all my medical information from my prior doctors. Instead, I have to complete a new medical history form and list of current medications for each physician or specialist — since there is no comprehensive repository of all my medically-information anywhere except maybe in my head. For a more specific example, as part of a recent medical procedure, I had to visit 5 providers: Primary internist, surgeon, lab, ECG, MRI. Sure, I could get a copy of my record for each visit after the fact by logging into 5 separate portals under separate IDs and passwords, but I couldn’t get one to pass anything on to the next. In fact, in order to get my MRI from the imagist to the surgeon, I had to pick up and deliver the DVD myself. No, that’s not interoperability.
Of course interoperability is difficult, but not impossible – as many have stated, technology is not the problem. Sure we have to ensure security, privacy, and proper authorization – but those challenges can be met. As a matter of fact, I just did so myself for a previously unknown distant relative who shares with me a common great-great-great grandmother from the old country via 23andMe.
For all of us who will know patients or be patients at one time or another, the biggest challenges to interoperability are often between healthcare and research organizations and even within them. There are plenty of excuses for not sharing data (as confessed in a rather controversial recent editorial of the New England Journal of Medicine). But whatever motives may drive or block the sharing of data for individual cases, the representation of data in a syntax and vocabulary that at least has the potential to be consistently expressed and understood by separate authorized parties under the proper circumstances should be a common goal. Indeed it should be possible for patients – and their authorized caregivers – to get the medical information they need when they need it to deliver the best possible care.
So, while data standards development may be a particularly arcane and even tedious task to the vast majority, the need to make it possible for a physician, who may be treating a vacationing patient with a sudden illness, to be able to quickly retrieve his medical records from other providers is something we should all support – it could be, truly, a matter of life or death.
And interoperability is essential to achieve some of the most ambitious and far-reaching of health-related future visions, like the Learning Health System (LHS) and the Precision Medicine Initiative (PMI). While the link from an LHS to clinical research has always seemed tenuous because of the long lag time between processing of pre-marketing clinical studies and delivery of approved new therapies to patient care, the PMI should clearly build on a baseline of knowledge acquired through research. As I’ve espoused in public CDISC presentations many times over the years, a most critical future objective of research is to learn how to tap into the fundamental data flows of digital healthcare as much as possible, rather than trying to operate in a separate, often redundant parallel world.
We’re at a point in time when we have the technology and awareness to finally make real progress toward interoperability. What we need is the courage and will to put the final pieces together and really make it happen. A goal as important as this, which can conceivably affect everyone in the world toward the betterment of health care, is not to be taken lightly. For my part, I’ve decided to go all in.