"Six Months of Strategery?"

I read a story in Modern Healthcare about a discussion with HHS CTO Todd Park at a recent conference in Nashville. He talked about unleashing innovation. I applaud Todd for his bravery in giving out his email address publicly seeking input on innovations, and for his goal of “unlocking the mojo” of HHS staff, rather than having good ideas doomed by “six months of strategery.” I liked that!

There has been plenty of recent discussion, and guidance from NIST about improving EHR Usability (for patient safety, efficiency, and many other reasons). There has also been similar discussion in the HIT Standards Committee implementation workgroup about improving the usability of specifications and standards to remove barriers to adoption so the “little guy” isn’t left behind, and so that everyone doesn’t waste time navigating specs that point to other specs that point to other specs (called “the indirection problem”). Some recent standards efforts, such as the HL7 Consolidated CDA implementation guide, are trying to improve usability of specs in this way.

I plan to write Todd speaking as an individual citizen (remember this blog doesn’t speak for my company though my writing is influenced by working in the Health IT industry). Usability is important for both a positive and a negative reason. Lack of usability (of specs, or software, or anything) tends to waste people’s time and “raise their blood pressure” due to frustration. Wasted a few hours per person multiplied by thousands or millions of people, and you have some serious non-productivity! Worse, it can lead to mistakes (like clinical errors jeopardizing patients) or people throwing up their hands and just not doing things that are too complicated (like refusing to use an EHR). On the positive side, when something is usable, like I consider my search engine, Word processing, email, and blog editing software to be, then people can get amazingly more productive, and can do great things.

What about the usability of the specifications that hover over all of us in the EHR industry, Meaningful Use and Certification regulations? Or for that matter, all Federal regulations published in the Federal Register with its three columns and small print, no index and poor searchability? It’s so “1950’s” and paper-oriented. You can’t just scroll down the page like any normal document or web page, because you have to keep backing up for the next column. Try fitting a page on a screen and you can’t read the tiny font. You can’t search it to find a referenced section number, because the numbers are not a sensible scheme like 178.25.3.2.7, where you always know your context: instead section numbers aren’t even contiguous and searchable. For example, the ONC Standards and Certification Final Rule has text like “The standard specified in § 170.207(a)(2)”  OK, if I want to find that paragraph in the document, it’s easily done in the Acrobat search box, right? Nope, can’t be done! It only finds is the references to the paragraph, but not the paragraph itself. The only way to get to § 170.207(b)(2) is by scrolling around and finally locating 170.207 near the end, then finding subparagraph (b) dangling by itself, and finally finding subsubparagraph (2), hopefully still inside of (b) unless I missed a changed letter in between. And when I finally get there, I still can’t see what the standard is, because it says “the code set specified in 45 CFR 162.1002(a)(2)” which isn’t defined in the document. I have to go out to Google. Those like me who have been doing this for a while know some tricks and short cuts and contacts to ask, but a lot of people don’t have that luxury.

So my suggestion to Todd is very low-tech and has nothing to do with HIT, but a lot to do with usability, productivity, and helping folks actually do what the regulations want them to do! First of all, they need to be able to understand the regs in a reasonable amount of time. I’ve spent hundreds of hours reading regulations affecting HIT. I estimate that just their formatting and numbering alone causes me to spend 50-100% more time to digest them than it should. And I probably also miss important information in the process. Multiply that by thousands of others who have the same problem. While it helps that others have created “Readers Digest versions” to simplify and explain the regulations, but why did they have to create them in the first place?

Could this problem be solved by reformatting new regulations for usability, using a few smart people including human factors engineers, armed with common sense and putting themselves in the “consumer’s” shoes? Could this be done without “six months of strategery?” Hopefully yes, if Todd’s right and “mojo gets unlocked” in this area. I admit that I and probably most people and companies have similar entrenched traditions and rules that get in the way of us doing what we ought to do. I just blogged about this today because I read the interview with Todd and connected his ideas with my reading of the regulations. But the Federal Government’s regulations affect thousands of providers, vendors, and others. There’s a real opportunity for a simple low-tech innovation in the government regulation writing and formatting to help many people avoid wasting time, so they can direct more of their energies to creating innovative solutions that will really help people!

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.

Putting the IT in Care TransITions

On Friday, October 14^th, I look forward to attending a meeting in Washington DC called Putting the ‘IT’ in Care Transitions. That will be followed closely by the ONC S&I Framework Face-to-Face meeting in DC on October 18-19, which will also feature a track on Transitions of Care. Meanwhile, Meaningful Use Stage 2 standards definition marches on, as I wrote in my last blog. Many initiatives are converging (I hope).

The October 14^th meeting will consider three specific patient scenarios: an elderly isolated widow with many chronic conditions; a young child with serious asthma and exacerbating home environment; a homeless man with diabetes and schizophrenia. The premise is: “if the system is designed to assist the most complex patients, then the system will function effectively for all.” I agree with the premise as far as capabilities (more complex scenarios often require more robust capabilities), but I don’t think it’s always true from an adoption and usability perspective. How often have you and I felt that a process or a gadget or a computer UI was “over-engineered” because it was designed for a complex but rare scenario, but was cumbersome for the most common scenarios?

The October 14^th meeting also has a premise that “even the most advanced provider and community organizations acknowledge that new innovation is needed to improve the efficiency and effectiveness of delivering transitional care interventions to large numbers of patients, particularly in an environment in which technology adoption is rapidly growing and the state of technology is changing.” Right on, and so I suggest that these are some key areas for “much new innovation:”

1. Innovative and Usable Presentation of a "just right" level of information to clinicians that avoids the extremes of "information overload fatigue" vs. overly aggressive filtering of information, especially when much information exchange occurs. Can HIT be smart enough to anticipate what a clinician needs? Or must HIT be passive and "do no harm" by leaving all decisions up to the clinician?
2. Policies and guidelines for which electronic information a clinician must read, vs. what they do not need to read. While this is often viewed as a bigger problem for HIE/"Pull" models, it’s a concern even for "push" exchanges, especially if a sender sends information to one provider and copies many others on the "care team." 
3. Reconciliation principles for many types of data, not just medications. E.g., lists of problems/diagnoses, allergies, procedures, and immunizations. The risks vs. rewards of merging, aggregation, deduplication, normalizing across multiple information sources whose vocabularies are not fully standardized. Should HIT strive for “a single source of truth” or just accept that “here is what other sources have said?”
4. Who or what makes a care team? The term is used a lot, but is it clear what makes one? Just knowing who other providers are, and even having access to their records, doesn’t necessarily create a team or a care plan. My hometown football team, the Philadelphia Eagles, has so much talent that some dubbed them a “Dream Team” and surely they know each other’s names and roles, but they aren’t an effective team at the moment. And to play off the meeting title, how will putting the T (Technology) into Team result in better patient Care?

I look forward to blogging about the outcome of these next two meetings.

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.