Meaningful Use and Consolidated CDA

I invite anyone who is interested in commenting on the ONC Stage 2 Standards and Certification Rule, and/or the HL7 Consolidated CDA standard, to visit this page within the ONC S&I Framework.

http://wiki.siframework.org/ToC+MU+Analysis

As you know Meaningful Use 2 has specified Consolidated CDA and the data to be exchanged with providers (upon transitions of care) and with patients (view, download, and transmit; clinical summaries after visits). But the mapping of the MU2 data to consolidated CDA has been fuzzy, so the work on that page is an attempt to clarify and help "harmonize" ONC's rule with the standard it references. I have a spreadsheet posted that explains this, and Keith Boone does too (and Keith has written extensively about this on his Healthcare IT Standards blog).

The time is short, as comments to ONC are due by early May. We are conducting this analysis via an open process facilitated by ONC S&I, in cooperation with HL7 Structured Documents workgroup.

David

How Will Engaged Patients Get Their Comprehensive Health Information?

As I’ve blogged previously, I believe in the right of patients to access their data. Exercising a right is one thing: deriving benefit is another. The data needs to be usable for the patient or their caregiver/designee. Google Health’s demise, or the fact that patients very rarely ask for an electronic copy of discharge instructions or clinical summary (Stage 1 MU) doesn’t prove that patients don’t want their data: it’s not an “either/or” choice between having convenient functionality vs. having access to the data (see my thoughts here). I’ve made analogies (with caveats) to online banking before. But besides health data being more voluminous and complex than banking data, people usually don’t interact with nearly as many banks as healthcare providers. I as a generally healthy person have visited eight healthcare providers in the last two years, and 12 providers in the last five years. A person with more chronic illnesses would have more providers and far more visits. Will the increasing penetration of EHRs help us as patients? Specifically, how will I get my comprehensive personal health information when it’s scattered in so many different places, electronic or not? Connecting to each one individually doesn’t seem to be the answer.

Here are some ways that might possibly happen (with italicized comments indicating my opinion of feasibility and likelihood):

1. Private or public health information exchanges that connect all my providers (or at least a critical mass), aggregate and perhaps normalize my data, and which have a patient portal with view/download capability for patients.
   A few of these exist, so it may be possible for patients to get somewhat comprehensive information if they stay in the same region or provider network for a while and all those providers share data with the HIE
2. All providers’ EHRs pushing their data to my PHR. This could work with HealthVault, though I don’t know how many other PHRs currently support Direct protocols. The patient can receives separate standardized structured documents (e.g., CCD), but then has the option to merge and reconcile data from those documents into their PHR data fields.
   Unlikely in the near future, though technically possible to the extent that Direct Project becomes adopted and required in Stage 2 MU.
3. All providers’ EHRs making their subset of my data available to me to download, which I then upload into my PHR.
   This is theoretically possible if Stage 2 Meaningful Use continues as proposed by the HIT Policy Committee, but it’s a lot of work for the patient: adds the download + upload steps to the “merge and reconcile” step of #2.
4. Patient Centered Medical Home that aggregates data from multiple providers. Possible in pockets with PCMHs and strong HIE capability
5. All providers having all my data (due to comprehensive information exchange plus EHRs consuming and storing everyone else’s data) so that no matter which one I accessed, I’d have all my personal health info.
   Highly unlikely in the near future, since most EHRs can’t consume and store most of the data. Some EHRs can import some external data, such as medication history.
6. Virtual on-the-fly health record assembled from all sources (similar to the recommendations in the PCAST report).
   Highly unlikely in the near future.

I think #1 and #2 are the most feasible today, though the percent of patients who will actually benefit from them is still low. I’d be interested in your thoughts on what is most likely to gain traction and whether there are other possibilities that are feasible today that I missed.

ONC S&I Framework Face-to-Face "Aha!" Moments

I attended the ONC Standards and Interoperability Framework meeting last week, and found it very helpful, though what I came out with was not what I expected going in. It shows that I need to keep and open and flexible mind! I’m not going to recap the entire meeting, but will focus on three “Aha!” moments that I had. While I had intended to focus on Transitions of Care (ToC), I ended up splitting my time between ToC, Query Health (QH), and Data Segmentation (DS).

The S&I Framework is the place to be to understand where the industry (including Meaningful Use) is headed. It has some of the strengths (open participation) and challenges (difficulty integrating the workgroups) of HITSP, but has more direct buy-in from ONC, and also has the admirable goal of pilot testing standards to prove their viability before incorporating them into regulations. However, not everything done in S&I Framework is connected to Meaningful Use stage 2; some is more futuristic.

So here are my three “Aha!” moments.

• Transitions of Care. The dots still need to be connected across the many pieces in this initiative. While there’s convergence upon a single standard (CDA Consolidation Guide, which is close to passing its HL7 ballot), that in itself is both too much and yet not enough for ToC. Too much? Many parts of the guide aren’t necessary for ToC. Not enough? The sections that are necessary don’t have the core data element constraints of the Clinical Information Model (CIM) specified clearly enough to know what must be implemented and piloted. I was also surprised to learn that the current reference implementation work in ToC is based on HITSP C32/C83/C80, not yet based on the CIM and CDA Consolidation work because they’re waiting finalization. So they’ll have to flip over quickly to address the emerging standard in order to pilot it. Piloting tools based on C32 would only be nice to have for developers who haven’t already done it, and it wouldn’t make sense to have to pilot them prior to Stage 2 final rulemaking.
• Query Health. I had thought a “query” was something like an SQL query or an IHE document requestry or patient identity query, and assumed it would be synchronous. As Gershwin would say, “it ain’t necessarily so!” While those are indeed queries, QH has a broader definition, and seems to be leaning strongly to asynchronous messages. For example, a query might be composed of two separate (but correlated) push transactions, like a Direct message conveying the “query” (question to be asked, such as “How many diabetic patients with elevated A1C were on X therapy?”). Then the EHR or HIE would run the query and send back the results (again possibly via a push transaction). So it could be like a secure email and a reply to that email. Or it could be like an HL7 Lab Order and a subsequent Result observation message. The QH Technical Workgroup will evaluate the various technical standards to satisfy the use cases. But beyond whatever technical standards are endorsed, I’ll be interested to see how QH defines a mix of predefined query parameters vs totally ad hoc queries, and how the systems are expected to understand what is being requested.
• Data Segmentation (for Privacy?). I was only at about an hour of these discussions, which were moving slowly. But what struck me was the debate about whether this initiative should focus solely on privacy. Clearly, data can be “segmented” for multiple purposes, but given the difficulty up till now of getting a standardized privacy solution deployed even for simpler use cases, I was surprised that broadening the scope was being advocated by some. Other efforts have struggled between “narrow vs broad” use cases. In this particular case, I think the challenge is big enough on privacy that it makes sense to have a narrow focus rather than to “boil the ocean” with other uses of data segmentation. Perhaps a clear definition of phases and scope would help: Phase 1 is solely focused on standards and pilots for privacy data segmentation; later phases can expand the scope. I view this as primarily a problem (granular privacy consent) in search of a solution, rather than a solution (segmentation) in search of many problems. 

So all in all, it was a productive meeting. Much work still remains to be done, and there’s way too much going on for most organizations to stay on top of. Still, I appreciate ONC’s leadership in convening and “uniting the tribes” as Dr. Mostashari said at the Care Transitions meeting.

Would You Like to be Engaged to Multiple EHRs?

There’s strong agreement that for meaningful use of Healthcare IT, patients and families need to be “engaged.” The question is, how? In Stage One, patients are to be given an electronic or paper copy of clinical summary information from office visits and hospitalizations, as well as discharge instructions from hospitals. This is good and a step beyond mere paper. But that raises the question of how this information can be used by the patient, other than viewed as if it were paper. What’s the “Quicken” equivalent of a “killer app” for patients to manage their health? (Oops, maybe “killer” app is not so good for healthcare…). The Stage 2 Meaningful Use Request for Comment proposes that patients be able to view and download their information from a “web based portal” that is a module of an EHR (considering that the incentive program is about “certified EHR technology”).

The best tool for any given patient depends on the individual, so speaking in statistical terms may gloss over some things. But let’s suppose that all EHRs were to offer such a portal. How many of them would a patient need to access? For myself last year, that would have been five (four EP and one hospital). According to an article by Peter Bach of Memorial Sloan Kettering Cancer Center, the typical Medicare patient sees seven doctors in four practices in one year, and those with multiple chronic conditions saw 11 docs in seven practices in one year. If you then throw in a hospital, that means eight healthcare organizations possibly with eight EHRs for one patient in a year. If you’re a family member caring for your children or aging relatives, multiply all that. You might have to interact with more than 20 web portal accounts, ending up with over 40 separate downloaded files (you’d probably need more than one per organization per year). Even if they’re in a standardized format, who or what will reconcile or pull them together? Will you be the one, using copy & paste with a spreadsheet or word processor? I don’t think so… If you use a web-based tool specifically designed to deal with those files, well then you’re probably using a Personal Health Record (PHR).

The problem with the current MU proposal for downloading from individual EHRs is that it implicitly endorses a “tethered PHR” model – a PHR extension of an EHR. But that PHR is not really patient-centric, because it contains the patient’s data from the organization using the EHR. Over time, the data will broaden as EHRs import and reconcile data from other sources such as EHRs or Healthcare Information Exchanges, but most EHRs aren’t there yet. And “tethered” is only one of several approaches to patient-centric health records. Other flavors include independent personally-controlled PHRs such as Microsoft’s and Google’s; health record banks; payer-based PHRs such as Blue Cross; employer-based PHRs such as Walmart’s using Dossia. They all have their strengths and weaknesses, but the personally controlled PHR has recently made some significant headway, associated in part with the Direct Project announcement re Dr. Paolo Andre’s EHR and Beth Israel’s Direct Push to Healthvault. If independent PHRs can be updated through a standard transport protocol (Direct secure SMTP), that securely pushes standardized content (e.g., CCD or CCR) into the PHR in a way that is structured and codified, as already required in Stage 1 MU, then the potential for a comprehensive, patient-centered record (not tied to any one provider) has increased. Now this isn’t magic – the patient or family member still needs to decide which data from the CCD are relevant and should be added to their master problem list, medication list, etc., as I’ve done with my own PHR. An ecosystem of innovative products (trackers, monitors) can then flourish around the PHR, given the influx of more robust data to operate on.

In preparing comments to the HIT Policy Committee’s Meaningful Use workgroup, I’ve recommended that MU should focus on the goal: getting the information to the patient or caregiver’s hands in a way that they can use, not on inadvertently favoring an EHR-centric “tethered PHR” flavor. Let the EHRs do the behind the scenes work of transmitting the patient’s info into PHRs of the patient’s choice (which might be any of the flavors I mentioned), enabling patients to interact productively with a tool they like, rather than making them “polygamously engaged” to multiple EHRs/portals and encumbered with lots of files to manually import into PHRs. For patients who don’t want to use a PHR, they can still get their electronic copies (as in MU Stage 1). But for those who want the opportunity to have their electronic information together in one place, there’s a great opportunity for MU, defined in a way that allows flexibility and innovation, to leverage the Direct Project and the existing and emerging clinical content standards like harmonized (I like that word) CDA Consolidation Project templates building upon CCD/C32.  

So, patient and family engagement: yes! Let this relationship between patients and HIT be productive, patient-centered, simple-to-use and... engaging, please!

An Aid to Survey the River of Clinical Information

Recently, I’ve had discussions with many people in the HIT industry about the future direction for Meaningful Use (MU), especially about exchanging clinical information. It’s clear that Stage 1 is only the start of a journey, and that increasingly robust sets of clinical information will need to be exchanged. However, such exchanges need to be helpful rather than burdensome, and much work needs to occur to figure out how to display what’s significant, accurate, reconciled, and usable for clinicians and patients (see my recent blog series Part 1, Part 2, Finale).

I’m sharing a spreadsheet (a work in progress) showing a library of standardized reusable data sections and comparing many types of electronic clinical documents/records, including the two most “famous” that are required in Meaningful Use Stage 1, CCD and CCR. This spreadsheet may eventually be published in a more final form from an organization, but even now it may be useful to you if you have any of these questions:

• What must be shared in Stage 1 as a clinical summary with providers and/or patients? (See spreadsheet columns B and D green cells)
• Are certification and MU clinical summaries the same? There are some interesting differences that can be found between the standards for certification and the language for meaningful use (See column A and the CMS FR – Clinical Summary tab).
• What’s the difference between a full C32 and what’s required in Stage 1 certification? Quite a bit, actually! (See column D, white check marks)
• What data are not included in CCR and CCD but might be desirable to share in the future? (See all rows and columns). Stage 1 requires only the most commonly requested clinical summary data (meds, allergies, problems, results, etc.).
• How much reusability exists among today’s electronic clinical documents? (See column Q, which also indicates which sections are most often used). There are worthy efforts afoot to improve commonality and reduce divergence, such as the ONC sponsored CDA Consolidation Project. 

Here’s my compulsory “liquid” or “music” analogy of the day. A mighty rushing river is growing, of clinical information and the standards thereof. I hope my high-level spreadsheet serves as an aid, a “Bridge Over Troubled Water” where you can safely survey the river before you plunge in. Although I created this spreadsheet, with plenty of review from Health Story and EHRA members, I’m far from being the authority on clinical documents. Robin Raiford did wonderful work on a similar spreadsheet in 2009, which was actually more detailed, but was limited to HITSP CDA documents and preceded the ONC Final Rules. I recommend that you read the original specs, and follow Keith Boone’s blog and his upcoming CDA book.

Andante: What Happens When the Trickle Becomes a Flood?

This is the second part of a “Symphony in Three Movements” blog. The second movement of a symphony is often the slow movement: Andante literally means “a moderately slow tempo (a walking pace).” The first movement (information liquidity) is Allegro (fast, lively) because there’s a national momentum around Meaningful Use (MU). But using/consuming/”drinking” the information has moved slowly for reasons that I’ll discuss now.

All of us have experienced information overload (too much paper mail, e-mail, so many web sites and so little time). Many messages compete for our attention and go unread. So when we advocate health information liquidity, and it comes, we need to be careful what we wish for!

As a patient, father and grandfather, I want clinicians to be helped, not burdened, by availability of my family’s information. So I’d like to know: what do they consider helpful? To starting think through this question, let’s consider a real world scenario rather than abstractions: myself as a patient (I consent to this disclosure of my health information).

Over the past year, as a relatively healthy person who took four sick days from work, I had the following medical encounters:

• one ER visit followed by an additional day of hospital care for a “transient global amnesia” attack, which hopefully won’t recur
• Two PCP visits: one routine annual physical, plus one following up the hospitalization
• One Neurologist office visit following up the hospitalization
• Two dermatology visits with minor procedures performed
• One GI visit, related to a procedure performed in 2008
• I also had dental and chiropractic visits

That’s 7 medical visits. The hospital has an EHR, and my PCP is starting to use one, but I don’t know about the others. Let’s hypothesize that they all are meaningful users of EHRs. Then they would have produced at least 16 electronic clinical documents: 7 clinical summaries and one discharge summary for the next provider, 7 electronic copies of health information and one discharge instructions document for me. I’m not counting other MU information exchanges such as e-prescriptions, immunization registry updates (one flu shot), nor reportable labs or surveillance. Here I’ll just focus on the clinical documents, realizing that much more information can also be exchanged (results for lab, EEG, EKG, CT, Echo; consult notes, etc.). If 2011 and 2012 are like 2010, then by 2013 I’d have 24 or more electronic clinical documents available to other providers. People with serious or chronic illnesses could have far more. So what should my providers in 2013 look at? All 24 documents? How would they decide what’s important and relevant? Most of these documents will be partly duplicative but may not list exactly the same problems, procedures, allergies, etc. To what extent does this additional information (and the effort to digest it) save time or work elsewhere? As far as I know, these aren’t simple questions with simple answers, but I’d be interested in your thoughts.

At a minimum in 2013 I’d expect the hospital to send (push) electronically a discharge summary and/or a CCD to my PCP and the Neurologist, who will then read them. The Direct Project has received a lot of attention because it has clear applicability to common scenarios like discharges, referrals, and consults. But that’s a drop in the bucket compared to all patient’s electronic health information, so there remains a big challenge about what to do with the rest of it.

As reported in the recent PCAST report, p.15, lack of liquidity and interoperability produces this problem: “In effect, the patient has fragmented into disconnected facts and clusters of symptoms. To prevent the most basic medical errors, some facts are elicited over and over again, to the frustration of patients and healthcare providers alike: ‘Do you have any drug allergies? Have you had any surgeries? Are you taking aspirin or blood thinners?’ This frustrating repetition works, albeit inefficiently, if the patient is cognitively intact and well informed, but not all patients fit that description, especially in the event of a serious or acute illness. Health providers need views of the patient that are less fragmented than at present.” And so along comes information liquidity to remedy the fragmentation – or does it? PCAST report p. 23 says: "A first point to convey is that in virtually all of our use cases, the “user” of the data does not need to be, and indeed should not be, scanning through the entire health record. Instead, the user needs to be looking at an application layer that accesses and presents a limited amount of information from a given health record or set of records."

That “application layer” has slowly been emerging in pockets of HIT, perhaps because the information exchange is still a trickle, not a flood yet. Do clinicians trust a layer to limit the information they see? What’s the right balance between too much and too little? Though I’m a standards advocate, I’m not sure we’re ready for standards in this area, but we do need research, innovation, real-world implementation testing, evidence of what works and what doesn’t, sharing of experiences, policies, and guidance. In my third and final movement of this series, I’ll talk about some promising research and projects underway to improve the usability and benefits of the information that flows. Despite what I said about the challenges, I’m optimistic that we (collectively) will figure this out.

In the meantime, while you await the finale of this symphony, Happy Holidays and Merry Christmas to you!