A freer flow of health information holds promise of achieving ROI
ONC’s National Coordinator Micky Tripathi contends that the ability to share health data and include more information from other sources can aid industry efficiency.
Data sharing across the health ecosystem has the potential to improve industry efficiency and get more bang for the buck invested in information systems.
Micky Tripathi believes that’s one of several important realizations that can help get the industry enthused about new federal regulations. He came to the lead role in the Office of the National Coordinator for Health Information Technology earlier this year, and has worked hard to advance the use of IT to improve healthcare delivery and consumer engagement.
Tripathi heads ONC as the agency looks to implement provisions of the Cures Act Final Rule, widely known as information blocking provisions. He wants to put a positive spin on the rules, preferring to call them information sharing regulations. Improving the flow of information will be important as patients seek more access to their medical information from providers to use as they choose.
In this, the second of a two-part interview with Health Data Management Editor in Chief Fred Bazzoli, Tripathi discusses the promise he sees for data sharing, and gathering and analyzing more data – particularly information on social determinants of health.
HDM: There have been some concerns voiced about information blocking regulations regarding enforcement, the size of fines and how even application will be achieved. What concerns have you personally heard, and how do you expect them to be addressed?
Tripathi: There are three actors that are named in the information blocking rule – providers, certified technology developers (those that develop technologies that are certified by ONC), and health info networks. The law was a little bit curious; it specified that civil monetary penalties can be assessed for those found in violation of the law if they are developers or if they are health information networks. Sot it’s adding up to $1 million per incident, is what the law says. Then you have providers that the law didn’t specify any penalties for.
The law says the secretary of HHS will determine appropriate disincentives. So you have a couple sources of questions and concern from the industry. What does $1 million per incident mean? What is an incident? If an organization gets caught doing the same thing 10 tiimes, is each one of those an incident, or is it one incident? So the answer to that question is that we actually don’t know; it will be a case by case investigation. And to be clear, ONC doesn’t make that determination. ONC defines the policy for what constitutes information blocking, and then the Office of the Inspector General is responsible for doing the investigation and assessing whatever penalties might follow from that.
OIG has a draft rule that’s already out, and they did say earlier in year they thought the final rule would be out in September, but we’ll see whether they’ll be able to make that. And we’re following it closely as well.
Other thing is we get questions on what about providers; those aren’t yet determined, what those appropriate disincentives would be. But we’re working very hard across the department to get a process in place to define those. We think those are really important, because it’s one whole group of actors that don’t have a sense of what penalties might I face? That’s unfair to them as well as unfair to other actors, because the other two actors have very clear penalties associated with them. So it is a top priority to close that enforcement gap.
HDM: What is the role of private industry, particularly, EHR vendors, in facilitating data exchange and preventing data blocking? Enabling technology or more?
Tripathi: The enabling technology is huge. We have a lot of vendors responding to that by moving forward and continuing to move forward with interoperability, so that their customers actually just because of being part of a network that automates the ability to share information, what TEFCA will provide in the future. That helps put the provider in a position where so much of the information sharing is actually automated, with the appropriate protections. A lot depends on their vendor making those connections and making a good workflow.
The other part is providing them with technology enablement that allows them to navigate some of these exceptions that are allowable exceptions. So being able to have better patient engagement, for example, where patients can express their preferences. You can have the ability to have a patient who, for example, may not care about getting lab results right away.
Because of the business vendors are in, they are very close to these rules. They follow the rules very closely. They end up playing a critical role in educating the providers, their customers on what the rules say and what the rules don’t say, making sure understand what’s in the rules and pointing them to resources on our website and other places that help the providers better understand – that’s another really huge role they can play.
HDM: What are critical changes healthcare organizations need to make to successfully transition to a more efficient healthcare system? What are the information technology challenges that ONC expects to tackle to facilitate the transition?
Tripathi: More efficient? That’s always hard. Certainly it’s doing everything you can to take advantage of the technology capabilities that EHR systems have. There is often a big gap between what the technology vendor makes available and how the provider organization implements it – they may not implement it perfectly or they may have implemented these pieces but not these pieces. That gap is part of what allows certain inefficiencies or certain things that providers get frustrated with that they attribute to the technology – it’s actually about the way it was implemented.
I think part of it involves really stepping back and asking, “What’s my real full strategy here? Does this technology vendor have what I need? And how do I make full and the best use of all those capabilities that the technology has?” There is no substitute for more patient engagement in appropriate ways – I would argue that it is a contribution to efficiency because the more engaged patients, are the more they’ll be able to participate in their care. That may feel like an investment, but over the long run, I think it ends up becoming something that is more efficient. That’s because you’ve got the patient being a more active participant in their care, and ultimately, that’s going to delivery higher quality for lower cost.
Also with the Interoperability angle of this, it involves being able to really and truly start to take best advantage of the information coming in from other places and automating that as much as possible. The right approach is to say how do you incorporate more of that information to be able to make better decisions –being able to make better decisions as a result is a payoff.
HDM: Federal agencies are supporting more use of standards to enable more efficiency and easier information exchange. How do you assess the standards development progress? What challenges lie ahead in filling the gap between standards development and widespread use of standards?
Tripathi: The standards development process is, by design, very deliberative and very methodical because there are international conventions about how you develop standards; HL7, NCPDP and others are parties to international conventions on how standards are developed so they can be applied industrywide. That imposes a certain degree of governance, a certain degree of process, if they are going to be seen as legitimate standards development organizations – that will always be the case because there is value in having those consensus standards.
That said, we know industry business practices are accelerating, so one of our challenges is how do we have more of a bridge to be able to take advantage of that process but help it move along faster? Is there a way to get better implementer feedback into the standards development process earlier so that it can move faster, to develop consensus faster, so you can get more participation earlier and to have it set some priorities If you have a standards development process, in the absence of any direction from the market, it is just going to keep developing everything, and it will be more broad than it is deep. But if you’re able to say, “What the industry really cares about is this,” SDOs can focus attention a little more and reallocate resources to those things that the industry might find more valuable.
So how does this work in practice? One way is these FHIR accelerators that we’ve worked on, like the Argonaut Project, the Da Vinci Project, the CARIN Alliance, Vulcan, the Gravity project. Those are specific ways that HL7 has been very innovative. And they help us get industry focus, they help us get to participation early, and you see that moving faster at the rapid development of FHIR. I think that’s a testament to the ability to work with standards development organizations.
The other thing I’d point out in Cures Act. There is a little bit of a philosophical change in way we think about standards in connection with interoperability. Up until now, as an industry, we basically said, “We should do this as standards get mature, right?” Well, the reality is that takes too long. And the pace of innovation is faster than pace of standardization. What we’ve done with the Cures Act is we say that the information that needs to be made available is indeed standardized information, the USCDI, which is structured data. That will hold us until October 2022, but after that, it is a much broader set of records that we know that’s electronic health information. It’s really the electronic portion of what HIPAA calls the designated record set.
So the ability for the market to actually develop solutions to make use of that data has also grown tremendously. So that's another important part of the standard discussion, I think, to say we want to keep moving forward with standards, to accelerate the standards development process, but at the same time, we’re saying we're not going to limit ourselves to standardized data as we think about interoperability.
HDM: Could you provide a brief comment about what work is being done around standards for social determinants of health, which are becoming a more important part of care and health for the whole patient.
Tripathi: Data is really important in health equity. As one health equity expert said to us, if you’re not counted, you don’t count. And we don’t have that level of granularity; we don’t have that ability to know where the health inequities are, and then to be able to develop processes and technologies to mitigate those health inequalities.
What we’ve done from an agency perspective is we added SDOH elements and categories to the U.S. Core Data for Interoperability (USCDI). USCDI final version two has five DOH classes and elements. And it also adds sexual origination and gender identity data to what will be the structure required data to be made available for interoperability for information sharing; that’s what you’re required to provide provider of care in transitions of care. That data Is not yet standardized, But what we’ve done with the USCDI process kind of gives an early indication to the industry of the things that the federal government and we believe the industry thinks are important.
This kicks off the process of accelerating the standard development process. So what we’ve done basically is fired the starting gun for the sprint now. That’s a marker to the industry that says USCDI version two is going to be required in regulations most likely, very soon in the future. So let’s get started accelerating those. And what we do now is we work with the industry to say how fast can we get the implementation guides, the standards mature, and the IGs in place to allow that to be structured data capture for those elements. And then the next step of that is how do you turn that into voluntary certification for EHR vendors. We do it that way, because regulation takes a lot of time, and we want to say we have to move faster. And if customers start asking for it, then the vendors will make it available.
Ultimately, It can be a part of a regulation. So we’re expecting the SDOH elements by next summer. We’ve fired the starting gun – by next summer, we believe we will have the implementation guides and we’re working very hard with standards community to be able to get those into a place where they are then able to point to the technical specifications and an implementation guide that tells people exactly how to do it.
Part 1 in this series: Information blocking regs align with healthcare’s new path