FIRST QUARTER 2016
Interoperability - Even with the Regulators Michael Ibara, CDISC Head of Digital Healthcare
The term "interoperability" is plastered on every meeting, conference, lecture and technical solution you can find these days. And while it's been used for a long time with clear intent, with CMS's Andy Slavitt saying they are "deadly serious about interoperability" we are assured that the term has reached the status of a buzz-word, possibly soon to slide down that slippery slope into a cliché - something that means so many things to so many people that it ends up meaning nothing.
Whatever it's called, the original idea is sound and the goal still makes sense - be able to exchange and share data with those who need it so we can improve healthcare. Sharing data for CMS is focused on consumers and providers, as it should be. But while we understand government's role in driving interoperability, we also need them to be the beneficiaries of it, and in the case of regulated research in the U.S., we need to be "interoperable" with FDA.
This takes the discussion of interoperability beyond technology, into the realm of (gasp) regulatory requirements. But we could do well to remember that in regulated research, the "regulated" part is there to ensure quality and reliability of the data used to make key decisions on drugs and devices which directly impact public health.
From this perspective, reaching interoperability in regulated research means creating a successful path for the data, from the patient and provider all the way through to the regulator. But when you look at the path it takes, you realize that getting all the data, and all the right data, in the right way, to the right people, at the right time, is a tremendously complex and resource-intensive effort, with many stakeholders along the way to make this data- journey possible. One of the goals of interoperability in the context of regulated research is to straighten out this tortured path - to make it easier on sites and researchers, to make it more efficient, improve quality, and make it more timely - all of which lead us to better healthcare decisions.
When we look at things this way we see that to make progress in a multi-stakeholder effort, we should really involve all the stakeholders. This sounds obvious, but in the highly siloed and balkanized world of healthcare (especially here in the States) that actually rarely happens, and when it does, it rarely leads to rapid results.
This is why CDISC is helping to foster interoperability in regulated research by coordinating the first meeting of the eSource Stakeholders Group, this month. The goal is quite modest - to get everyone along the data path together, and to work out the best ways of addressing all the challenges we face along that path. To do this, we need to hear from the stakeholders involved and share information amongst ourselves about which challenges are key to success and how different groups are approaching them. Our motto will be simple - Before we can say how to do it, we must try to do it. This implies a lot of give and take between all stakeholders, and this is what we hope to accomplish. The sites producing the data and the vendors working to free that data usually have no need to think much about a regulator's need to verify the accuracy or provenance of the data, and likewise, an FDA reviewer may or may not have a clear understanding of just what data is collected, and how, in an electronic health record. Nor should either of these groups have to know everything about the other - but the final successful approach does need to know this. The final process or processes need to have been infused with the learnings and understanding of the whole group of stakeholders along the way.
This will be our challenge - to bring together all types of stakeholders involved in regulated research and make it possible for them to share knowledge in such a way that we produce specific deliverables that 1) lay out the key challenges; 2) suggest solutions; 3) share successful demonstrations; and 4) make suggestions on what needs fixing
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