Last week was the deadline for submitting responses to the Office of the National Coordinator for Health IT’s HTI-1 Proposed Rule. Leigh Burchell, vice president for policy and public affairs at Altera Digital Health, and Hans Buitendijk, director of interoperability strategy at Oracle Cerner, both sit on the executive committee of the HIMSS EHR Association. They recently spoke with Healthcare Innovation about the comments submitted by their 30-member group.
HCI: It seems like ONC has to walk a fine line, because they have these mandates to implement, things like the 21st Century Cures Act in a timely fashion, and yet some provider organizations and the EHR Association often say they are going too fast.
Burchell: Even in our comments, we recognize they are under pressure and have statutory obligations that have not yet been fulfilled. There are also policy priorities and needs that they are hearing from the market about and are trying to move rapidly on. I think what we try to do is bring forward a voice — not questioning the priorities that they have identified — but rather, introducing a note of pragmatism or practicality in some areas where we understand they feel a sense of urgency, but we want to do it right. We want to deliver safe software that's user-friendly. And if some of the deadlines in the proposal are not moved, we would be very challenged in doing so. It is about striking the right balance.
HCI: One of the things I read in your comments was that sometimes there's misalignment between the ONC certification timeline and the CMS requirements to use certain technology. What kinds of issues does that raise?
Buitendijk; ONC is not requiring us to support something just on its own. It is enabling programs from CMS to say, in order to be paid, in order to participate, you need to be certified to X, Y or Z. So the timelines by which CMS is aiming to progress their programs and the capabilities that ONC is putting in place need to be consistent, particularly around interoperability to be able to communicate that necessary data in the same way for everybody. It is important that it is in line so that one is not trying to achieve something way ahead of the other. You could say that if some of the ONC capabilities are out there, but CMS is not quite ready for that, that is OK, but that means that there's a lot of effort being spent on things ahead of when CMS needs it. That effort could be spent elsewhere, so that's a balancing act — that the capabilities are there in time, not too late, not too early. It’s important that ONC and the parties that use their prescribed capabilities are all moving along the same path at the same pace so that we don't stretch out too far along the path.
Burchell: I would add that we need a buffer between when our deadline is for deployment, right? They might say you have to be certified by Dec. 31, 2023, for EHI export, for example, but we need time to get that out to our clients. So it can't be called into use by CMS a day later. We have seen examples where there has not been enough time. And we don't always control when our clients will take the upgrade as well.
HCI: ONC is proposing to discontinue year-themed editions and go to just ONC certification criteria for health IT. What would be the pros and cons of that?
Buitendijk: There are pros and cons to treating something like an edition and saying we have a set of work and we now have two or three years to get that done. What they're proposing is to say let's split that up into individual line items, and each one might be able to move at its own pace. If you manage things as a big chunk, you get these peaks and valleys where we work hard to install it, etc., and then we're done.
On the other hand, if I split it up, then I can already start something new before that two to three years are over. It may be very appetizing to do that because it looks like I can start to initiate more. But there's a tendency that if I propose something on its own, to say, hey, it looks good. It's only going to take us six months. But in combination with everything else, is the capacity overall going to be a challenge? There are advantages in that I can focus on advanced things a little bit ahead of time and don't need to wait. On the other hand, I might overload the system with that. It is much more likely that it now becomes a continuous update cycle where every six months, every year, something new comes out. And the kinds of changes that we are increasingly talking about are not necessarily small, focused, behind-the-scenes type of updates. There is a lot of work on the provider side that needs to happen, and now you are doing it every six months or every quarter. That's a lot.
HCI: There was mention in the proposal about electronic case reporting for public health. Did you guys have some different ideas about how they should approach that?
Burchell: Generally, we understand the prioritization of public health as an area of focus. It clearly is something we've all experienced firsthand in the last couple of years and we see the need to invest in that and modernize. We are seeing a bit of a disconnect between the CDC and ONC, where the CDC has been really strongly pushing something called eCR Now that a lot of us have invested a lot of resources in and we've made this available to our clients. But then ONC in its role is taking a different approach. This gets into that larger question about alignment. We spoke about some misalignment with CMS, but it is something that we see with some of the other agencies as well.
HCI: In ONC’s proposal, and in your comments, there was quite a bit of talk about predictive decision support and predictive models. This is a complicated area. Can you talk a little bit about what your concerns are?
Buitendijk: This is a challenging area because it is the question of how big is decision support? We already have decision support capabilities and requirements. We now have these new capabilities that are starting to grow into the AI space where you go beyond the traditionally defined rules. There is a need to be transparent about how it is being used. But the concern we have is how much of that responsibility are you putting on the EHR system using it and referencing it versus the system that actually created it and makes it available? We think there should be more onus on the originators of that decision support to provide that and then we can deliver it when need be.
Burchell: The FDA has put out guidance on CDS and guidance on AI and ML in the last six, nine months. But HHS as a whole is using ONC to get to something that actually seems to be more of an FDA priority and so one of the things that we said in this set of comments is that this could be seen as a misapplication of certification authority, and that it actually would be more straightforward and less burdensome on the industry if the direct authors or creators of decision alerts were the ones who had to do this. Now we can be a delivery mechanism, and there are technological ways for us to do that. That's an easier way to do this. The way that they have put this forward seems to be really unnecessarily work-intensive for us when we are actually not the creator.
HCI: Another interesting issue revolves around a proposal about patients being able to have a right to request a restriction in their records. And I think your letter said you don't support the proposal as it's written. Could you talk about what's problematic about it and what it would take maybe to make something like that workable?
Buitendijk: The patient has the right to ask for restrictions by HIPAA privacy rules that are out there. So that's not the question. On the one hand, we want to make sure that we make a complete set of patient records available to the clinician so that their care decisions can be made. There is the right to not share certain data for one reason or another based on state or federal law. That reduces the amount of data that's available. We could have a policy debate about how you strike that balance. In the end, there will be restrictions that can be placed on the record. And that's where then the next question comes in. How do I manage that? You have your data spread across a number of different providers’ systems. You are defining your restrictions and assuming that they are being accepted. Now I need to record that. How do I share that across those data holders? How do I know what data is being restricted? What are the methods for that? And that's the technology area, the standards area where a fair amount of work still needs to be done to make sure that that actually works.
There are several techniques that can be used, but we have not reached agreement yet on how to do it. So yes, there is the right to have restrictions. It's already there and can be documented on paper. But if you're going to ask us to now put that in technology with the standards that you propose, we are going to get only a sliver of the solution. We will do something and your expectation of what is restricted might not come through. So the crux of our comment was that we really don't have a good solution yet to manage this.
Burchell: I'll just add two really quick points there. Number one, this was an area where universally our membership was really, really concerned about scope of work vs. proposed timeline. They think ONC has underestimated how difficult this would be technologically. And then the second point is that this is an area where we also follow provider organizations. I spent the morning reading a bunch of comments that other people submitted and they had comments about patient safety risks and incomplete record risks.
HCI: Are there any of the comments in your letter to ONC that I haven't asked about that you want to stress?
Burchell: No. 1 for us is the timelines of some of the programs that they've put out. Again, we are not questioning the need for some of the things that they've suggested. But the reality is that this regulation was pretty significantly delayed, right? It was at ONC for a long time, and at OMB for a long time. But they didn't adjust their deadlines that they put on us. They didn't say, ‘Oh, this took us six months to get out, so we're going to push our deadlines for the industry back out by six months or 12 months.’
