Arien, what is the Direct Project, and what is the problem that Direct is meant to solve?

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1 Moderator: Panelists: Dr. Russell Leftwich, Chief Medical Informatics Officer, State of Tennessee s Office of ehealth Initiatives Dr. Rodney M. Hamilton, Chief Medical Information Officer, Informatics Corporation of America (ICA) Arien Malick, Vice President of Strategy, Relay Health Recorded February 22, 2013 SUMMARY: TRANSCRIPT: This podcast explores the Direct Project, clarifying what it is and is not intended for within the larger health information exchange landscape. Specific topics discussed include the history of the project, benefits over current paper-based methods, general guidance on using the Direct Project, and the use of Direct to achieve Meaningful Use. Russell Leftwich: Welcome to the HIMSS HIE Podcast Series, where today we will discuss what is the Direct Project, and what is the problem that the Direct Project is meant to solve. My name is Dr. Russell Leftwich, I am the Chief Medical Informatics Officer for the State of Tennessee s Office of ehealth Initiatives, and I will serve as the moderator for this podcast. HIMSS is honored to welcome our panelists: Dr. Rodney M. Hamilton, Chief Medical Information Officer for the Informatics Corporation of America, usually known as ICA, and Arien Malick, Vice President of Strategy for Relay Health. Mr. Malick was coordinator of the Direct Project and the S&I Framework for the first 2 years of its existence, and is a member of the ONC HIT Standards Committee. Arien, what is the Direct Project, and what is the problem that Direct is meant to solve? Arien Malick: Thanks Russ. So, in 2009, the HIT Standards Committee heard testimony on the state of health information exchange and standards adoption. And one of the really key anecdotes was from a provider who said something to the effect of, I m trying to get a paper-free practice, but paper keeps pouring in on faxes and by courier. And he also said, You know, I had a patient that was transitioning to another care provider, and I knew that we both had the same EHR system, and we could both send and receive or import and export the summary of care document. But I couldn t get that document to my colleague. I had no secure simple, secure way of doing that. And that s really the kickoff of the Direct Project was to solve that problem. How can we make sure that any provider, across the country, can send and receive both structured and unstructured information to any other provider in the country, or send information to the patient. So, clearly we have a problem that information doesn t need to get where it s needed and when it s needed. What do we do now to try to solve that need? Yeah, that s a great question. So, Direct really fills a niche that, right now, is already filled by, as I mentioned, the fax machine, which is the universal form of information exchange in medical practices, as well as other services that use mail or courier. For example, when a provider refers a patient to a colleague, oftentimes 1

2 the practice will drop the referral information to fax, or will mail a package to their colleague. And that information s coming in, it s coming in unstructured, it s coming in sometimes not very readable. And so, the notion was, can we take that system and give it an upgrade? Give it an electronic upgrade? Thanks Arien, that s a very good analogy for the way things work or don t work. Rodney, Stage 2 of Meaningful Use includes requirements for electronic exchange of health information at transitions of care, and Stage 2 begins not far away in How may hospitals and providers use Direct to meet those requirements? Rodney Hamilton: So Russ, that s a great question. So, because Direct is a method to move information pointto-point, similar to the fax machine, providers in hospitals and ambulatory practices can use their EHR to create a summary of care document, which is a requirements for systems to support in Meaningful Use Stage 2, and then send those documents to whoever needs to receive those on the other end in terms of making sure that the information is to the next place that the patient would be receiving care. So it s actually, you know, fairly simple. The requirement is the EHR must be able to create a document that adequately summarizes the care, and then Direct can be used as the mechanism to transport that. So that document can be a CCD summary that is both human readable and machine readable, then. That is correct, yes. And actually, another part of Meaningful Use Stage 2 at least in the certification requirements for the EHRs is that they must be able to receive that. Not only be able to send it using Direct, but also be able to receive it via Direct, and then be able to incorporate key elements of it (like the medications and problem lists and allergies) into the EHR as structured data. Very good, and what about the requirements to provide patients access to their health information, and the ability to exchange information between patients and providers? So, patients generally will not likely have a Direct address like providers will have. They will usually get their information through some sort of patient portal, or a personal health record such as HealthVault, for instance. And these types of applications can accept, often, a message that s coming from a provider in a Direct format, and then incorporate that into the portal application or into the PHR, and then send a regular to the patient saying, you know, Log into the portal, or, Log into your personal health record, you have information there waiting for you or a message for you to see. So, there are a number of requirements in Meaningful Use in terms of improving the communication between providers and patients, and the requirement to provide visit summaries and transition of care summaries, etc. And so the same way that a provider could use Direct to send that same type of information to another provider, they also can send it to a patient s address that is provided. So, you know, the patient would have to provide some sort of address or mechanism to get it to their personal health record or to a portal application. And it also can be used for secure messaging those are particular document-type transactions that Direct could be used for, but also it could establish communication like you would with regular . Now on the provider side, that may be using Direct in sort of its native format; on the patient side, you know, that conversation may exist within a personal health record or within a portal application. 2

3 And I understand that some personal health records are going to actually offer patients a Direct address of their own, so that they may be able to use it to send messages to their providers and meet that secure messaging requirement. So Rodney, Direct will also, I understand, allow providers to meet CPOE requirements, and the requirement to incorporate laboratory results as structured data into their EHR, although the required or the only method of doing that will enable meeting those requirements. Sure, you know, yet again you have a secure method of communicating to another party, so orders can traverse that pathway. And then, in particular, lab results which I think is extraordinarily relevant labs can be sent and used via Direct. And actually a number of labs, the major ones that we would all know who they are, are already capable of supporting this being able to, you know, send a lab report in a human readable format, but also with the associated structured data in that Direct message instead of it being sent via fax or via a PDF document or something of that nature. And then the EHR can incorporate the structured data part of that message into the actual EHR itself. Yes, and I know that, certainly with the providers I talk with, the cost of lab interfaces is certainly a pain point for providers so that a more cost-effective way to do that should be very appealing. Yeah, absolutely. I think, you know, having traditional HL7 interfaces especially for the smaller ambulatory practices, even if they do a reasonable volume with a major lab is pretty cost-prohibitive in many cases. And then, due to insurance requirements or regional requirements or the particularities of a particular lab test that may need to go to a specialty lab, you know, even if the majority is with one of the major labs that even has a program that makes it relatively easy to get an HL7 interface to the system you re still leaving out a fair portion of the labs that are relevant to the patient population. And so Direct obviously, with being a much lower cost infrastructure, it makes a lot of sense to be able to push to have it 100% of what you order in terms of labs and, ultimately, radiology results, etc., to be able to be incorporated in a more structured way inside of the EMR, rather than essentially being an image or, as the case would be most of the time now, or in the case where you would have an HL7 message, you know, having the up-front costs of that implementation, and of course the ongoing costs of those interfaces, as well. And I know that the Standards & Interoperability Framework has initiatives that have worked to develop standards for both laboratory results for the more common tests, for transmission of those results, and for laboratory orders as well. So I think that should further enable that technology. Arien, what is the technology of Direct on a high level, and how does it meet privacy and security requirements? For the technology of Direct, we chose something that was pretty standard and well-adopted and welldescribed. It is secure , and there s a well-defined standard for doing secure , and we in the Direct Project, we specified that down to a common well-defined subset that was highly secure and met all of the key needs for health information exchange, or directed health information exchange. The mechanism uses digital certificates, and what I like to describe it as is kind of like signing something, putting it in a box, and then getting kind of a magic key. You get a magic key from the person you re sending the box to, and that key can only lock the box, it can t unlock the box. They ve got the key that can unlock the box. So you put your content and you put your signature into the box, you use your colleague s magic 3

4 key, and then you send them the box. And then when they get the box, they open it, and they check that signature and go, Yep, that s my colleague. Now the technology involves lots and lots of mathy bits, so it s a little more complicated than I described, but in its essence that s exactly the way it works. And it was designed to satisfy a number of really key privacy and security preconditions. Number one is, we wanted to make sure that if I send it to you, that I know who you are, and that I m sure that only you or your delegate is getting the information. Likewise, if you receive information from me, you should have a high level of assurance that it really did come from me, and only from me. And then finally, you should have a high level of assurance that nobody else that you didn t explicitly authorize has access to that information while it s in transit. And the mechanism that we chose satisfies all three of those preconditions. So it s obviously complicated, but it actually happens without the sender and the receiver having to do anything extra, sort of in the background the computer does it for you. Is that correct? That s exactly right. So in the background, the program, the software that you re using manages all of those requirements for you, makes sure that you are sending to somebody that is well identified, makes sure that you re receiving from someone that s well identified, and you just send and receive information hopefully directly out of your EHR. And so I never have to remember where I put my secret decoder ring. That s good. You never have to remember where you put your secret decoder ring, that s right, your magic key. So, the 2014 certification requirements that align with Stage 2 of Meaningful Use require that certified systems be capable of sending and receiving Direct messages. What does that mean, and how will those requirements be met? Yeah, absolutely. So there s at least 3 requirements that require Direct. One is the transition of care measures that require the ability to transport the transition of care document (which is the consolidated CDA document) via Direct, and the ability to receive it via Direct. And what that means is if you have an EHR that has, for example, integrated its referrals functionality with Direct, that means that hopefully you ll use your EHR, you ll compose your transition of care information, and you ll type in your colleague s Direct address and it ll just go. It also means that you will receive information periodically from hospitals on discharge, from colleagues on consults or, if you re a specialist, from providers that are sending you consultation requests for patients. And you ll receive that information securely, and attached to that information will be the consolidated CDA document that contains their structured information, including the reason for referral, the meds, allergies, problem lists, as well as a number of other data points that are required to be sent on transmission. Also, every patient will have access to what s called a view, download and transmit portal that gives them access to their own health information, and gives them the means to transmit that information to the place of their choice. As was previously mentioned, that could be a PHR that incorporates the Direct specifications. So one of the major obstacles to PHR adoption, which is, How do I get the data from my provider into my PHR?, will be fully integrated into the EHRs and the patient portals that are certified for additional 2014 certification. 4

5 Excellent. I mean, that s really amazing, that will be the future very soon. That s right. So, how will providers know where to send the Direct message for it to reach another provider? I look at this I usually answer this question in the following way: How do providers know how to send a fax to their colleague? And usually, the answer is, well they ve got a set of frequent colleagues that they do business with, and they know what that fax number is. And their EHR system has the ability to enter that fax number into their address book, and they re off and running. And if they need to send information to a practice or to a hospital whose fax number they don t know, well they pick up the phone and call the practice and ask for their fax number. And if you just replace the Direct address with fax number in that statement, that s exactly the way it will work for Stage 2 Meaningful Use. They ll have a set of colleagues and hospitals that they frequently do business with, and they ll know their Direct address because they ve already gotten it and entered it into their address books. And then if they happen to be sending to a new colleague, they just pick up the phone and say, Hey, what s your Direct address, and their colleague will give them to you. Now, there ll be a little bit of confusion up front because this is a new concept for providers, and it will take a little while for that workflow to be smoothed out, in the same way that, when fax machines were installed in doctors offices it took a little while for providers to get used to that workflow, but that s the way it s gonna work at scale. We may have systems that have richer provider directories, and so your EHR may be connected to one of the richer directories and you ll be able to search for the practice, but even if you don t it ll work the same way it currently does with mailing addresses and fax numbers. You ll have those in your address book, or you ll pick up the phone and ask for the information. And if you re new to this, and you kinda forget and you have your colleague s Gmail address and you try to send something, what happens? Hopefully your EHR should give you a nice error message that says, Hey, we don t trust that address, because that Gmail address is not a secure destination. It doesn t have that magic key associated with it. So you ll need to pick up the phone and talk to your colleague and find out what their Direct address is. Hopefully their EHR vendor will give them all that information so they can give that information to you. And so everything s cool, no protected health information went anywhere- Exactly. -and you know that it didn t go. Likewise, and likewise if you go into Gmail and try to send information to your colleague, it ll fail. You won t be able to get it through, cause again we don t want that information being sourced from an address that anybody could go in and create, um, and we don t want it being sent insecurely. Absolutely. So how is Direct different from HIE, the health information exchange networks that we ve talked about over the past couple years? 5

6 This is a somewhat complicated question, I ll try to simplify it a little but if you think about HIE as a noun, as an organization, you ll have an organization that may offer a range of health information exchange services that would be HIE the verb, the action and one of those services might well be Direct. But there s also the need to, for example, consolidate a patient s health information for unplanned transitions of care. So Direct is a really nice tool if you have a colleague in mind, and you know what information needs to go, and you know where it needs to go. And it s a great tool if you are sending a referral package, or you re receiving information from a hospital discharge back to the referring provider, or you re pushing information to the patient in their chosen EHR. In all those cases, you ve got a well-defined sender and you ve got a welldefined receiver, and you know Direct s a nice tool for that. There are other cases where a patient presents, and you don t know where their health information might be. Those are great cases where you want to be able to search for, huh, where was that patient seen and where might their information be. Direct s not a great tool for that, we need other tools in your HIE toolkit. Likewise, population health management requires accessing and aggregating data across multiple settings of care so that we can better manage the care and health of patients in a longitudinal care team approach, sometimes facilitated by a care navigator, and Direct might be a tool that s used for that. There are some models where people know to push to a central location; there are medical home models where the medical home uses Direct and makes sure that all of their colleagues can push them back information so they can manage the patient longitudinally. But there s also the need for more traditional HIE solutions to take that data and aggregate it, and create an aggregated longitudinal record across the multiple settings of care. So the way I think about this is that, just like other aspects of technology, of the Internet, we have different tools and we use them for different purposes. We ve got , and is a pretty good communication tool, but we ve also got Facebook and Twitter, and we ve got the World Wide Web. The fact that we ve got doesn t make the World Wide Web any less useful, and vice versa. So at scale we re going to have multiple tools in our HIE toolkit, and they ll be used for purpose-specific uses. Great, great explanation. So it s a valuable tool and it will be useful many times every day, but it s not everything. Correct. So Rodney, a number of other use cases have already been proposed that could take advantage of Direct. How might Direct facilitate care coordination? There s a lot of scenarios that Direct could specifically be used to coordinate care, and coordinating care across many entities is often a challenge. One of the particular things is it has been difficult for everyone who has a stake in the care of the patient, being able to communicate to those constituents has not been an easy thing to do. So the fact that you can send a message the same message, actually to multiple end points at once is very useful. So in the case of a hospital discharge, you could send that same information not only to the patient or to the patient s PHR, you could send it to a care coordinator, you could send it to a practice, a generic practice address or to a specific individual position, or even to a specialist physician if the patient was requiring a particular follow-up with a specialist post-discharge. 6

7 The other thing, I think, that s really interesting is that our typical communication methods being predominantly mail or fax, and not really having a good electronic means of communicating except where we have well-established interfaces, which is just a small fraction of the places where you may need to communicate to is that is a black and white world. Fax machines are a black and white world. And so there are a lot of scenarios, especially in terms of consultations or referrals, where it could be very useful to send an image. So if I were referring someone to a dermatologist, and I have a particular lesion that I ve taken a picture of for my own record, wouldn t it also be useful to send that to the dermatologist that I m referring to? Or let s say that I m in a rural area, and I m a pediatrician who s seeing a child who has some degree of dysmorphic features, and I just can t put my finger on exactly what this looks like but they may have some sort of condition and I want to send an image of that patient to a geneticist. The patient may not actually need to see that geneticist that consultation could be facilitated, maybe almost completely, especially if you re a ways away from a tertiary medical center which may have those resources. So, I think there are a lot of situations where just the richness of the information, even if it s not in a direct computable form, can be facilitated, but also the fact that structured information can accompany a lot of this information as well, will make the process more efficient on the receiving end as it s not just processing the image or image of a document or an actual image, but also be able to have associated structured metadata that actually travels along with it. So those are great points, that in terms of care coordination which is a very complex and often broken process that copies can go to the whole care team so everybody knows what the game plan is, or that there s a new development. And also that important pieces of information, images in particular, can go to care team members where that will help with care coordination. Some implementations are already being built around public health and clinical quality measure reporting. Tell us briefly about those type of use cases. Sure. I mean, syndromic surveillance data is one of the examples where data is being collected in an emergency department or in a hospital, sort of all across an area, that actually needs to be aggregated in a central place to be able to look for particular patterns. Direct is a great mechanism to do that, especially compared to having to have dedicated interfaces, notifiable diseases and conditions that hospitals and ambulatory practices are required to report. So the ability to get rid of paper process and fax processes, etc., and in many cases, many of those, there wouldn t necessarily oftentimes be an interface established for those, especially for smaller practices or it may not exist at all. But it could go to a common secured inbox that could be processed at the level of a public health agency. Being able to report cancer diagnoses to cancer registries at a community or state level; immunization data, which most states have some sort of mechanism to send immunization data. Today it s often through more traditional methodologies, or, you know, in many cases it s still a fairly manual process OR one that requires you to log into a state system to be able to submit or to be able to get information. And yet again, this is a simpler method of being able to send and being able to receive that kind of information. So those are just a few examples on the public health side, the ease of the implementation of Direct and the ability, especially to be able to collect across a wide area in a low-cost manner. And getting rid of so many of the manual processes will actually improve our public health information rather 7

8 dramatically in this country as that is further proliferated with the adoption of EHRs and the support of this type of delivery mechanism. The same kind of thing for quality reporting or sending information to government entities for whatever reason, or even for ultimately to payers, etc.. This certainly smooths that process as well, and we would replace mechanisms with secure FTP or other sort-of mechanisms to send in a secure manner that are just more difficult, or more one-off for those particular cases, as opposed to having a more universal mechanism of having a secure method to send that kind of information from one place to the other. So that sounds fantastic. So you just send your syndromic surveillance report that your EHR generates to or your quality measure to That s fantastic. I could certainly foresee a time when you have a configuration in an EHR with a lot of different addresses, and a lot of this stuff gets automatically sent without a lot of involvement. Fantastic. Well, thank you gentlemen. I think that has been a great overview of Direct and the possibilities, and I m sure all of our audience will be hearing more soon, and more details about the many use cases. HIMSS would like to thank our panelists for this important and informative presentation today. Thanks so much, and thanks for inviting us. 8

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