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

Meaningful Use Seeking Standards!

Update: 10 minutes after I posted below, the ONC NPRM was issued!
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Hello! I, like many of you, are in the midst of reviewing the Medicare and Medicaid Programs; EHR Incentive Program - Stage 2 Proposed Rule (NPRM) on Meaningful Use Stage 2 (MU2), which was published late yesterday afternoon but was probably not seen by most people until today. The reason I titled this post as I did was because MU2 needs to be “married” to the Standards, but we’re all limited by the fact that the ONC NPRM on Standards and Certification Criteria was not published on the same day as the CMS NPRM. We’re still waiting... So for MU 2, we don’t have the actual standards in our hands yet, which we need in order to understand the criteria and assess their effects on providers, vendors, and others. Since I’ve been following the HIT Standards Committee for months, and there were sneak previews given at HIMSS, I know about many standards that ONC supposedly included such as Consolidated CDA, NwHIN Direct, and SNOMED-CT. But I’d sure like to see the details ASAP.

From CMS’ NPRM, many data elements in the “summary of care record,” “clinical summaries,” and “view and download” overlap but aren’t quite the same. As worded they don’t exactly match terms used in standards. Hopefully someone in ONC did the mapping to translate from the HIT Policy Committee’s and CMS’s phrases into the right “data buckets” in Consolidated CDA, for example. If not, I’m available to help through efforts like ONC’s S&I Framework Transitions of Care workgroups.

Margalit Gur-Arie wrote a helpful MU2 summary that helps distinguish what’s the same, what’s slightly new, what’s really new, etc.

As an interoperability champion, I see that ONC really means it when it talks about a big push for interoperability in MU2. MU2 has no more of those “check the box” tests without real exchange that characterized much of MU1! But stage 1 still has a few more years of life in it, for at least some providers, even if it is just a stage setter, Farzad Mostashari spoke of the “massive river flowing” of advances HIT, and I’ll be glad when real information exchanges flow abundantly among providers and patients, as I wrote about in some of my very first blogs.

Unfinished HIT Business

Happy New Year! Typically it’s a time for reflection and looking ahead. But since Keith Boone already blogged about the Top 10 HIT Standards efforts of 2011 and John Halamka predicted the Top 16 HIT Standards Committee Topics for 2012, where does that leave me? I’ll try blending 2011 and 2012, since many things started in 2011 but haven’t yet come to conclusion.

In the hilarious comedy Throw Momma from the Train, Billy Crystal plays a writer who is so obsessed with his ex-wife, that he has serious writer’s block and can’t get past the first sentence of his new novel (“The night was humid…”). He eventually gets his writing groove back (“A writer writes, always”), and doesn’t leave unfinished business. Sometimes I feel like I can’t get a blog started either, so I’m going to just start writing and close out the year!

Here are 11 items of HIT standards unfinished business that I hope reach some closure in ‘12.

1. Meaningful Use Stage 2. More than a hope, it’s a safe bet that this will reach closure in 2012. I predict that items #3, 5, 6, and #8 below will be partially resolved by MU2, but most won’t because they’re complex and/or outside the scope of MU2.
2. Sustainability of federal standards initiatives. HITSP was the previous ONC’s sanctioned standards harmonization effort, but it is gone. Some wheels were reinvented. Now the ONC S&I Framework is here, but an election year and budget cuts loom. What are the chances for national continuity of direction beyond 2012?
3. Sensible certification rules. The HIT SC’s Implementation Workgroup made recommendations based on testimony from the difficult Stage 1 experiences. What practical improvements will be made to certification? 
4. CDA. Just when we thought there was convergence on Consolidated CDA and achievement of a critical mass of CDA-capable products (driven largely by Stage 1 certification), significant CDA changes are being discussed: Detailed Clinical Models (CIMI) and Green CDA standards. What is the path forward that achieves simplification and yet doesn’t send everyone back to the drawing board?
5. Transitions of care. ONC put a lot of effort into the ToC initiative, and some fine clinical recommendations were issued, but they haven’t been fully connected to the Consolidated CDA work yet. How will the MU standards be adjusted so that they truly help clinicians in care coordination?
6. Vocabularies. What appear to be strong recommendations for singular standard vocabularies were made, but seemingly watered down by statements that they are “for quality measures only.” Will converged vocabularies be a reality for interoperability as well as quality measures?
7. Patient-sourced information. Let’s face it, much data in EHRs comes straight from the patient already, yet patient-sourced information seems to be controversial. What HIT standards, will enable patient information (from devices, interviews, messages, PHRs) to have their proper place?
8. Lab reporting and ordering. I hope that the ONC Laboratory Reporting Initiative has achieved widespread consensus.  Will these standards finally result in standardized interfaces in the real world, vs. just on paper?
9. Holistic view of exchange patterns. ONC has focused heavily on the specifications that it commissioned. But will ONC recognize the role of community-based HIEs using standards such as IHE XDS, and not leave a “hole in the middle” by considering only Direct and cross-community NwHIN Exchange?
10. Certificate and/or Provider Directory. Much effort has been poured into supporting only the Direct Project. Will the limited use case of certificate discovery given a Direct address be enough to push Direct into mainstream use? Will there be robust universal certificate directories and provider directories?
11. Query Health. This is not likely to be in MU2, and with so many other priorities, there may not be many organizations geared up to be query responders. What critical mass of industry adoption is necessary in order for population health queries to be statistically significant?

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.

ONC Care TransITions Convocation – What Happened?

I blogged about the meeting that was to be held on October 14^th. Now that it has occurred, with approximately 160 persons attending in person and 300 via webcast, here are first impressions. Some slides from the meeting are posted, with the main conclusions on 13-17 and 24-26.  

KEY POINTS FROM THE MEETING

• ONC's purpose in convening this meeting. Farzad Mostashari (ONC) and Todd Park (HHS CTO) said ONC's role was to "unite the tribes" and "let others help” solve a major problem in today’s health care system.
• Transition between hospitals and post-hospital (PCP, Long-Term Care, Home) was the focus. The consensus was that the current state of affairs is unacceptable. Much of the time there is zero transfer of information from hospital to other providers, particularly public health clinics.
• Plan of Care. Based on findings from four parallel workgroups, there was much mindshare in support of a shared Plan of Care (PoC). "Shared" doesn’t mean just "exchanged" as in passed along from one provider to another. They meant a collaborative mutually-developed Plan of Care that has input from multiple providers (care team) as well as the patient and his caregivers. This comes with challenges of governance and access control, though I didn’t hear those issues discussed.
• Are transitions of care more like a "relay race" (hand off the baton linearly) or like a "football game" which is much more interactive all along the way? Some felt that the best we could expect was to improve the handoffs in a relay (vs. dropping the baton by not exchanging at all), whereas others wanted to move more toward a collaborative care model like a football team. Harmonious collaboration requires much clearer definition of roles and responsibilities across many organizations.
• Some said that the care plan should be approved by the patient, and co-developed, like two people redlining a contract together, rather than thrown over the wall.
• CDA Consolidation Standard. Doug Fridsma and Jitin Asnaani affirmed ONC's support for the new "single standard" CDA Consolidation. This builds upon but also simplifies the standards that many have worked hard to support, and is convergence rather than divergence. I favor this direction, though the standard is still being balloted, and it will take work to migrate to it.
• Dr. Holly Miller of MedAllies gave a good example of the clinical need for standards and information exchange which could not only help care transitions, but change the course of the patient's health. She used the example of repeat visits to the ER involving patient falls treated in isolation, vs. the alternative where the PCP is notified, detects a pattern and underlying cause, and intervenes to prevent future falling incidents.
• Jitin said that 10 HIT/HIE vendors (not named) have committed thus far to the ONC ToC pilots. He said one or two of them would test Consolidated CDA in conjunction with Direct Project. (My editorial comment: Consolidated CDA in its entirety (over 50 sections) is unlikely to be tested in the pilots, but a constrained subset that still needs to be clearly defined should be tested).
• Jitin also announced the coordination of the S&I Framework, Beacon Communities, EHR/HIE Interoperability Workgroup (the multi-state effort led by New York), and the State HIE Programs. The EHR/HIE workgroup is outside of ONC, but is cooperating with them.
• While the focus of much of the discussion was on needs rather than how to do it technically, there was a strong agreement on the need for tight, specific standards.
• Timeliness and Relevance of Information. The theme of "the right information, when I need it, where I need it" was emphasized often. Not just for providers but for patients. Dr. Scott Young of Kaiser Permanente said that typical Discharge Instructions are not given/explained at the right time and place (which should be where the patient spends most of their time, e.g., at home). Similarly, patient education is often deferred until the end of the hospitalization and are generic, whereas it can and should be started while the patient is in the hospital. Several said that PCP and other providers needed to be notified at the time of admission not just at discharge, because they need to be aware of the situation and given the opportunity to contribute to the care process.
• Taking Follow-Up Actions. Others said that Patients should not just be told to do things like make appointments: the hospital should actually make them (or help the patient make them) while the patient is still there. Similarly, don't just tell the patient to get prescriptions filled or buy medical equipment: send them home with them! The highest risk to a patient occurs within the 1st 72 hours after discharge, when the patient is most vulnerable physically but also is distracted by other things needing social support (childcare, finances, cleaning the house, taking care of the yard, etc.).
• Medication Reconciliation. One suggested that the reconciliation process should start with what the patient is actually taking, and then build from there, rather than other people's lists that the patient is asked to verify (because they will tend to say "yes" when asked "Are you taking ____X?" even if they really aren't taking it.
• Feedback loops were often emphasized. While not defined precisely, I gather that it means feedback to the care team and caregiver about how well the care plan is working, whether desired outcomes/goals are being achieved.
• Disintermediation. Dr. Bo-Linn, a physician who has practiced for 50 years, said that there must be "disintermediation" because the system can't afford to be so hierarchical and provider-dependent, but that patients must be able to do more for themselves to remove cost from the system. He pointed to examples like ATMs (no tellers), pumping and paying for gas. Making travel reservations is another example.
• Spread of existing technology rather than new technology. While new technology was encouraged, most felt that the technology exists to do nearly everything that was discussed, and that successes exist in pockets, but are exceptional and seldom replicated. So one of the challenges is disseminating successes and scaling out the solutions that already exist.
• Getting the Word Out. Health Affairs, one of the leading health policy journals, wants to chronicle innovation as its happening, and encourages submissions. ONC is now funding Health 2.0, an innovative group highly focused on patient engagement. It has sponsored an innovation competition, "Ensuring Safe Transitions from Hospital to Home" which ends on November 16th.

So it was a thought-provoking day that I’m glad I attended. While its intent was to stimulate urgency and innovation, rather than to define standards or regulations, I think it was a preview of priorities that HHS will be focusing on in the future. Speaking of Care Transitions, I’m at the ONC S&I Face-to-Face right now. I plan to blog about the S&I Framework projects that I’m involved in.

Forecast Cloudy but Clearing: a Crystal Ball for Meaningful Use

Now that the HIT Standards Committee met on September 28^th to wrap up their “Standards Summer Camp” and are well along in several of the ONC Standards and Interoperability Framework initiatives, how do we stand in getting a clear weather forecast for Meaningful Use Stage 2? Activity was fluid during the hot summer, but by the chill of winter, much will have “frozen” into the form of ONC’s Notice of Proposed Rulemaking (NPRM) for Stage 2 Standards and Certification Criteria.

I was pleased to see an initial draft of certification criteria produced by the Implementation Workgroup. While it’s very preliminary, I understood it to be the first cut at the criteria that ONC will refine over the next few months as they write the NRPM, expected to be released for public comment perhaps in January. Here are a few highlights of what I found new or surprising. While my main focus is generally on information exchange criteria, there is some noteworthy new information on other objectives too. Numbers refer to the rows in the document.

• 10 Clinical Decision Support. There’s more specificity around the ability to configure the CDS rules based on user role, patient setting, and points in workflow; also display of the evidence/source of each notification or care suggestion
• 15 Lab Results. Lots of work has been done in the ONC S&I Framework and HL7 on the new Lab Results Interface (LRI) implementation guide, in an effort to bridge the gap between competing standards. I applaud efforts to work together to reach consensus, even if it means no one gets everything they want, so I hope that this standards effort is leveraged.
• 18 Electronic Notes. They provide clarity that it must not be a scanned document, but that pretty much every other kind of electronic note is OK. While functionally that is achievable, hopefully there will be careful consideration in how to measure this objective to avoid burdening providers with workflow issues.
• 23 Patient View and Download. A definite shift to patient-initiation via electronic access (a secure web portal for example) to more information than was required in Stage 1, rather than have to request a copy through provider personnel. There’s still much debate about alternative ways to satisfy this (e.g., is an export to a patient-controlled PHR acceptable?), so it will be important for guidance to be clear here. 
• 29 Exchange Clinical Information. In this objective, as well as Patient View and Download, clarity is needed on how many types of clinical documents are required (one-size-fits-all vs. multiple different documents?). For example, the ONC S&I Framework Transitions of Care initiative has recommended specific documents -- Discharge Summary and Discharge Instructions from a hospital and Consultation Request and a Consultation Summary from an EP, but the MU objective is written as if it is just a single clinical summary.
• 33 Syndromic Surveillance. As expected, there is a new implementation guide, though it is only applicable to hospitals. But there is still uncertainty over considering submission of Reportable Cancer Conditions by EPs. If that is to be included, what is the recommended standard?
• 52 Amendments to information. This is a requirement that had not been included in previous presentations of Stage 2 MU. Will it be in the NPRM? If so, it would include replacing a data element while preserving a record of the previous value, and appending patient-supplied information as free text or scanned image/document, for patient engagement (e.g., if the patient disputes something in the record). Note, they use the word "user" but are not clear whether they mean "patient" for the requirement to "Make electronically available, upon a user's request, a historical account of amendment(s).”
• 53 Patient Matching. This is also something not mentioned in the Policy Committee's MU objectives. It is fuzzy at this point. If included in certification, it would impose more validation upon some demographic data.

I encourage you to read these thoroughly and work through the channels available to you (e.g., a provider association, a trade association, an industry consortium, or comments to ONC’s blog) to submit suggestions for clarification. The people on policy and standards committees work very hard, but it’s impossible for them to anticipate every case where someone might have trouble interpreting. The implementation workgroup already has flagged areas that they know need more work. If you can give examples of how interpretations may vary, and offer constructive suggestions for how it could be worded unambiguously and made testable, I think it will help ONC to write the clearest possible regulatory language.

Certification Retrospective Part 2 – Method to our Madness?

Note: this blog post will continue discussing my experiences in CCHIT. The opinions are mine, and do not necessarily reflect the views of CCHIT or Siemens.

In Part 1, I talked about CCHIT giving me the privilege to work with great people over the years. But we didn’t volunteer for CCHIT just to meet people, but to do important work to advance the HIT industry. So what did we accomplish, and what were we thinking as we evolved?

One thing I learned is that no group can please all the people all the time. Sometimes, people wondered why we proposed some criteria and not others, or proposed the timeframes that we did. So we tried to explain these “whys” in a white paper Interoperability, Supplying the Building Blocks for a Patient-centered EHR in mid-2009 which still exists on the website of writer John Morrissey. It described the context for what we were doing and the “methodical march” to increasing levels of information interoperability that we proposed. I don’t think this was well understood by the public, who might have thought some of what we did was arbitrary. But here’s what was in our mind (well, I can only speak for myself – mine at least).

Key principles:

• We aren’t starting with a blank sheet of paper. The existing state of adoption (immature as it might be) must be considered, so we started each year with an “environmental scan” on the state of the HIT industry.
• Adequate time must be provided for EHR products to make the transition to a more desirable state. We aimed for 18 months lead time from our first “signal to the market” (new draft criteria) until certification testing of those criteria.

Given these principles, our methodical march followed the path below.

• Data Capture precedes interoperability. You can’t share what you don’t have! When we started CCHIT, not all EHRs even captured all the data that other systems would want, so functionality criteria (ambulatory, inpatient, ED) needed to capture the data elements that could then be shared. Thus in the first certification year, 2006, there were no interoperability criteria required (though several criteria, such as Lab Results and e-prescribing, were roadmapped for later years).
• Information Liquidity (a term we didn’t use, but which implicit in our criteria) is beneficial even prior to semantic interoperability. Thus, the first clinical summaries that CCHIT certified (Continuity of Care Documents, CCDs) in 2008 required human-readable sections for meds, allergies, problems, etc., but not structured data. We were later criticized for this, as if we didn’t care about structured data, but this was always intended as a stepping stone to later stages (as explained in the white paper). Even today (3 years later than the 2008 criteria), many voices espouse liquidity as a more important and realistic for the near-term than semantic interoperability (“don’t let the perfect be the enemy of the good”).  
• Standardized Content (formats and vocabulary). Human-readability is fine for humans, but doesn’t help most EHR systems to “understand” (semantics) and process the information they receive from others. Because of the existing Tower of Babel syndrome most EHRs have been “confounded” in their ability to share information with other EHRs, and to “consume” (not just display) it. So CCHIT supported the goals of ONC and HITSP to progress toward standardization of vocabularies. But it realized that changing an EHR’s vocabulary overnight wasn’t realistic, and that mapping from one vocabulary to another is not simple or foolproof and must be done carefully for patient safety and other reasons. Thus a “glide path” from narrative to standard vocabularies was roadmapped.
• Discrete Data Import (Consumption). When liquidity and standardized content are established, the EHRs that receive or retrieve clinical data can “do something” with the data, more than just file and display it. As early as 2007 criteria, we published certification criteria for ambulatory EHR discrete import of Laboratory Results that referenced the HITSP-endorsed HL7 2.5.1 Lab Results Reporting Implementation Guide, including a common subset of LOINC observation codes. Thus, many of us were disappointed when the ONC Final Rule for certification, published in 2010, lacked a specific HL7 standard and LOINC requirement, not going as far as what CCHIT had been certifying since 2007. There are 127 CCHIT Certified® ambulatory EHRs that already meet this requirement. For CCDs, the challenge of discrete data import is  greater because of the wider variety of data, and multiple applicable vocabularies. Rather than declaring the problem too big to tackle in one shot, we proposed chipping away a few sections at a time, starting in 2010 with discrete import of medications (using RxNorm as specified by HITSP), allergies (using RxNorm and UNII), Immunizations (using CVX) and demographics, then moving on to problems (using SNOMED-CT). These criteria are a matter of public record, and can be found on the CCHIT website: 2008 criteria. See 2008 Criterion IO-AM 11.06 for example, which originally roadmapped discrete data import for 2009, though the date changed to 2010 in the 2009 criteria (published but then withdrawn)***. You can decide based on the facts whether we were too aggressive, or too laggardly, or about right.

So what’s the point of this retrospective? I’ll sum up lessons learned in the next post. I’ll also speak more about how CCHIT’s interoperability criteria compared to ONC’s criteria.

I’ll also discuss some of the agonizing controversies that we faced, particularly in 2008 and 2009 over issues like standardized transport, discrete data import, data reconciliation turf (is it interoperability or functionality or both?) and the feasibility of requiring SNOMED-CT. We wrestled with each of these, and did our best. We might not have succeeded perfectly in all of them, and our criteria development work was superseded by ONC before we could resolve them all, but we learned much in the methodical march!

David

*** (Long Footnote)

The 2009 Ambulatory Certification criteria, along with the CCHIT 2009 certification program, were not launched, since they were in limbo awaiting decisions on ONC-ATCB certification. But eventually most of these criteria (without the roadmap) were relabeled and launched as the 2011 CCHIT Certified® ambulatory criteria. If the 2009 program had proceeded, Criterion IO-AM 11.06 would have required the following in 2010, adding much specificity beyond what had been proposed in the same criterion in 2008:

The system shall provide the ability to display CCD documents, using a subset of the HITSP C32 specification for the Medication and Immunization History module, file them as intact documents in the EHR, and import the discrete data from one or more of the entries in a structured form into the patient record. The system shall provide the ability to import as discrete data the following data elements from the C32 Medications Module: Free text SIG, free text product name, free text brand name, coded product name, coded brand name, product concentration, status of medication, quantity ordered, order date/time, order expiration date/time, prescription number, quantity dispensed, and fill number. (Note: fill number means the number of fills dispensed, not the number of fills prescribed). The “required if known” (R2) data elements will not always be known, and therefore will not be present in every instance of a C32 document, but if present, the system shall be able to import them

More was explained in the Comments column:

Medication and Immunization History-Coded Subset includes the following content modules of the HITSP C32: Person Information, Healthcare Provider, Medications-Prescriptions and Non-Prescription, Information Source, Comments

The intent for 10 Certification is not to require specific capability to use the imported data but only to show the system is capable of processing discrete data elements from a CCD. In future certification years, more functionality criteria to “use” the data may be added. Fulfillment of the 10 Certification criteria may be demonstrated in a variety of ways, including but not limited to any one of the following:

- Reconciliation functionality that allows CCD data to be compared with existing data, and selectively imported into a list

- A display of data captured from external sources, including the imported discrete data. The physical storage location (database table, file, etc.) is at the vendor’s discretion and does not need to be the same location as the active allergies.

- Creation of an CCD that includes the elements previously imported as discrete data

Vendors may innovate and differentiate their products by how well such data are used, but 10 Certification will not limit vendors to any particular approach

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.