00:05
Hello, everyone. This is Steve Gravely. And today I'm going to begin talking about a subject that I've been very heavily involved in for the past three years, at least starting back in 2020, probably even before that. And that's the subject of TEFKa. TEFCA. You've probably heard of TEfka, and if not, then you'll hear about it now. But even if you have heard about TEfra, I'm going to try in this podcast series to help unpack some of the story behind the name and talk about how I think TEfria is going to be really transformational with respect to electronic health information exchange, and supplant perhaps some of the things that are happening now. But first, a little bit of history, because it's really actually pretty interesting. So TEFCA stands for trusted exchange framework and common agreement.
01:32
TEFCA, a name that, not surprisingly, came up through Congress and with input from a variety of different stakeholders. Not exactly a name that rolls off the tone, at least not my tongue. But today, everyone knows it, just as TEFCO. TEFCA is part of the 21st Century Cures act, affectionately known as cures curs. And if you've listened to any of my podcasts about information blocking, I've already provided a bit of a background on cures. But for those of you who may have just dropped in for the TEfra time, as I like to call it, let me just give you a little bit of background on cures. So the 21st Century Cures act is a federal law. It was passed by Congress in the fall of 2016, and it was signed by President Obama in December of 2016 in the waning days of his second term.
02:53
So this is a law that's been around now almost seven years. And Cures was perhaps the last large scale bipartisan legislation passed by Congress. And I'm sure there are some who will point out, oh, well, they did this, they did that. But at least in the healthcare industry, I think that chures was probably the last major piece of bipartisan cooperation. Chores consolidated over 100 separate initiatives related to health information, health technology, the delivery of health care, FDA programs, CMS programs, Indian health Service initiatives, veterans care, and a lot more into a single massive bill. And since 2016, we've really seen almost too many regulatory efforts to even keep track of that, implement different parts of cures. And information blocking is one of those, and TEFCA is another.
04:26
And so what CUREs did was it directed the Secretary of Health and Human Services and specifically the Office of the National Coordinator for Health Information Technology known as ONC, to either develop or adopt a single nationwide on ramp to enhance the exchange of electronic health information. Now, let's unpack that in terms of the CURES Act. So the important actor here is really ONC as the lead department within HHS. And if you're involved in health information technology, anything related to electronic health records, anything related to information blocking, then you already know that ONC, even though it's relatively small compared to other departments of HHS or even other agencies, it may be small, but it's very mighty.
05:54
And it has and continues to play a central role in shaping national policy and actually national implementation of a number of very important federal programs that are related loosely to healthcare information, how that information is created, accessed, shared, used, stored, and exchanged. All right, so ONC was directed by Congress to either implement or adopt a single on ramp for nationwide healthcare data interoperability. Congress found at the time, and we're talking Now, 2016, 2017, that when it came to healthcare electronic information, there was a lot of fragmentation across the country, and there were lots and lots of data silos. Think about it this way, by 2016, we already had the development of very large and very powerful private electronic medical record, or electronic health record companies such as EPIC, CerneR, and literally hundreds of others.
07:46
And that all really came about as a result of the American Reinvestment Recovery act that was passed by Congress after the 2008 recession in the US. So by 2016, we have a vibrant and rapidly growing private sector industry for electronic health records, EHRs that are being implemented and run by hospitals, physicians, and some other sectors of the healthcare industry, but primarily hospitals and physicians back seven years ago. And those vendors, and this is not a criticism, but many of those vendors collected information from their customers and stored that in what we called data repositories. And that was part of the architecture that enabled the users of a particular vendor system to easily and rapidly share information with other users of that same system, and in some cases, with users of other systems.
09:13
By 2017, there were existing national frameworks that were supporting the exchange of electronic health information across different platforms. I was involved in two of those. The e health exchange that started around 2009 and was really the first nationwide information Sharing network, and then CArA quality that began in 2014. But certainly there were other initiatives. I wasn't directly involved in those, but I was involved, and still am, in both e health exchange and care quality. However, Congress found, and I think it was an accurate finding, that we had these data silos that predominated the healthcare landscape. And literally, if you think about grain silos anywhere in the world, certainly in the US, you have a visual image in your head of what a data silo might look like. It's tall and deep, but it stands alone. They're not built to connect to other silos.
10:49
At least, that's not their primary purpose. Their primary purpose is to store grain or some other type of product and then dispense that at the bottom to the users of that silo. And they work really well for that purpose. But for the last 1520 years, I know I've been involved in various initiatives to bridge the silos. And so, using that metaphor, Tefka was, and still is, an effort to do that. Now, ONC was directed to either implement or adopt. So Congress recognized that in 2016 and 2017, there were these initiatives that were already in place in the industry to help enhance information sharing and to help promote interoperability across different platforms. In other words, efforts to build bridges between the silos and to make those silos able to share amongst each other with relative ease. And there were a number of these.
12:14
And so Congress said to ONC, well, maybe you do not have to create something entirely new. Perhaps you will be able to simply select one of the existing data sharing networks in the US and appoint that as the trusted exchange framework and common Agreement. In fact, Congress went so far as to say in the cures legislation that whatever ONC did, it should not duplicate existing activity and it should not disrupt the existing level of information sharing that was happening. Okay, so let's fast forward now to 2020, 2021. OweNC decided that there was not any single existing network that would satisfy what it thought Congress intended in the CURES Act. And therefore, selecting one of the existing networks was not an adequate response. And there are many who have questioned that decision, and we should debate that until the cows come home.
13:47
But it doesn't really matter at this point, because ONC made that decision and decided that it would create its own approach to nationwide information exchange and would create what ONC called its nationwide framework. And I would say that almost inevitably, although I'm not sure this was intended, but almost inevitably, by doing that, ONC has duplicated what's happening in the country and has also disrupted efforts that were in place before cures was even passed. Because folks that were already involved in operating their own data sharing networks for health information were required to divert some of their resources, mainly their skilled personnel, to evaluate, provide input for, cooperate, and participate in TEFCO. And since all of us have only 24 hours in a day, it's a zero sum game.
15:17
And so while I'm sure this was not ONC's intention, I think if you talk to people around the country and they are honest, they will say, well, yeah, TEFRA may be great, but it certainly has duplicated some of what was already in place, and it's also disrupted some of those activities moving forward. Really, mainly, it slowed them down because the technical staff and the policy staff can only work so much. They only have so much. Okay, so, but again, we have TEFCA. It's here. It's been here for years. It's not going anywhere. And ONC has consistently reaffirmed this in various industry meetings over the last several years. So now what we have is ONC has published a version 10 of the Common agreement. So let's go back to our acronym, TEFCA, trusted exchange Framework and Common Agreement.
16:36
So the common agreement, some people say, well, the common agreement is the KA part of TEFRA, and the TEF part of TEFRA are policies and the technical architecture that ONC has adopted to support exchange of information through this nationwide onramp. So I'm going to break that down at a high level because those are both really important. So the common agreement is not that hard to understand. Every data exchange network is going to have some type of data use agreement. That's what sort of codifies what the rules are and provides enforcement mechanisms if participants in that network don't follow the rules. So for the e health exchange, it's called the DURSA, the DU RSA, for the care quality framework, it's called the CCA Clara Quality Coordinator Agreement. For TEFRA, it's called the Common Agreement.
17:49
And other networks have their own version of these agreements, and they go by various and sundry names, but they all do basically the same thing. They codify the rules for that network. They identify who can be in the network, they identify what the rules are, they identify how the network will be governed, and they identify the consequences if members of the network don't follow the rules. That should be suspension or even expulsion. So the common agreement is simply the TEFRA iteration of something that's been around for, goodness, 15 plus years, and common agreement version one. I was heavily involved in working on that, and that was published March of 2023. Now, apart from the common agreement, you also have the technical side of the house. In other words, the technical side of how information will be exchanged. Is there a directory?
19:09
Yes, there is, for TEFCA. And what does that directory, how does it operate? What are the technical requirements? What do the data packets look like? Are we talking about CDAs? Are we talking about fire? What are we talking about? This is Steve Gravely, and you have been listening to ehealth legal pulse. You can subscribe to this podcast on our website, Gravelygroup.com, or on Spotify. Follow us on LinkedIn and be sure to share this podcast. Thank you.