Wednesday, December 28, 2011

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?

Monday, November 21, 2011

A Harmonious HIT Thanksgiving

Since I’m traveling to visit family over Thanksgiving, I’ll take this opportunity to wish everyone a great holiday week. There’s always time to comment on what could be better! But now’s a good time to reflect on things for which I’m thankful in the HIT industry and my professional career. I won’t lengthen this post with all the personal reasons I have to be thankful, but they are many.
    1. I’ve worked in HIT for 34 years at one employer (SMS/Siemens Healthcare). Having a job at all is not to be taken for granted these days, and it’s much more than “a job” because I truly believe HIT, properly applied, can help people.
    2. I’ve had so many opportunities to interact with great people from healthcare providers, other vendors, the federal government, states, payers, pharmacies, labs, consumer advocates, certifying bodies, standards developers, and more, who have greatly enriched my understanding and competence.
    3. I live in a country where people are free to debate and disagree, but still work together, without fear of reprisal from the government. In fact, we have a government that wants to listen, as evidenced by ONC S&I Framework and public hearings and comment processes.
    4. My family and I have received excellent healthcare from many professionals assisted by HIT, and our lives are better (or some are still alive at all) as a result.
    5. My colleagues include many healthcare professionals, some of whom have given me high quality medical care, and who use the EHRs that we and other vendors develop, so they understand firsthand what works and what needs to be improved.
    6. There are increasing opportunities for me to be engaged, as a patient, in HIT.
    7. No one I know is satisfied with the status quo of HIT. We all want it to do more and better in terms of interoperability, usability, efficiency, and promotion of patient safety.
    8. There’s much exciting work ahead, so life in HIT is anything but rote and boring!
Have a wonderful Thanksgiving, filled with harmony among those with whom you spend it.

Monday, November 7, 2011

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.

Friday, October 28, 2011

"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, 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!

Tuesday, October 25, 2011

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.

Wednesday, October 19, 2011

ONC Care TransITions Convocation – What Happened?

I blogged about the meeting that was to be held on October 14th. 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.  

  • 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.

Wednesday, October 12, 2011

Putting the IT in Care TransITions

On Friday, October 14th, 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 14th 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 14th 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.

Monday, October 3, 2011

Forecast Cloudy but Clearing: a Crystal Ball for Meaningful Use

Now that the HIT Standards Committee met on September 28th 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.

Wednesday, July 6, 2011

How Would EHRs Matter to Patients?

In my previous post, I said I’d talk next about patient engagement functions that need EHR data vs. those that don’t.

No doubt, there are some “data-less” functions that can still be useful – you need little or no clinical data to request an appointment, e-mail your doc, or a refill (other than your Rx number). Here’s a list, undoubtedly incomplete, of some functions that I think are Not EHR-dependent vs. those that need (or greatly benefit from) EHR data. Several of the items below are “gray areas.”  

Not EHR-Dependent
  • Personal Health Record (PHR) – untethered, if patient is willing to enter the data or settle for existing PHR data feeds (e.g., PBM med history)
  • Patient self-service functions (e.g., schedule appointment, request drug refill, view clinical data, pay bill)
  • Patient-provider communication and collaboration
  • Tools for providers to improve the patient experience
  • Technologies to make healthcare more accessible for patients, e.g., telemedicine, virtual visits
  • Wellness/lifestyle aids (not just "medical", e.g., diet, exercise, recreation)
  • “Find a doctor”
  • Search for alternatives to provide services (e.g., price comparisons for services not covered by insurance)
  • Patient satisfaction surveys
  • Bedside communication with family & friends (e.g., Skype video chat, web access)
  • Notification/invitation to events (free screenings, symposiums, etc.)
EHR-Dependent (some may also be provided by Health Information Exchanges)
  • Patient access to EHR information (e.g., download)
  • Personal Health Record (PHR) – tethered; or untethered PHR with data feeds from EHR (to greatly increase usability)
  • Patient Portal
  • Patient annotations/amendments to their health information
  • Patient provision of information to providers (e.g., home device measurements)
  • Providers pushing information to patients via patient preference
    • Reminder “app” for taking meds, vaccinations, physical exam, etc.
    • Other apps or notifications that help patients follow through with what was prescribed/planned
  • Tools for patients to act upon their data (trackers, analytics, access to knowledge)
So patients can accomplish quite a bit without EHRs. But you have questions about your lab or imaging tests and their significance, or your many medications, it sure would help to have the actual data and not rely on memory. I doubt that you’d get full benefit from your med list unless you also knew about your problems/conditions and diagnostic results. I, for one, wouldn’t want to take subsets of my data and redundantly enter it into a dozen separate websites.

If I’m a patient who wants a comprehensive and integrated view of my data, how might I get that? More on that next time…

Friday, July 1, 2011

Do Patients Need and Want Data, or Convenience Features?

So it seems that most patients were not “engaged” to, and certainly not “married on” independent PHRs such as Google. Many people including myself have learned more from failures than successes. Sometimes it helps to learn not just from my own failures but from the failures of others. So while the recent announcement of Google Health demise was no surprise, it offers an opportunity to learn. What do patients want? What do they need? Are needs and wants the same?

Mr HISTalk wrote about what Google Health should have done, and asked what actual users (not only HIT pundits) think. Missy Krasner, a founder of Google Health, echoes some of the same observations about people wanting convenience functionality, not a medical archive. She also asks the same question (“to tether or not to tether”) and comments on PHRs not being “social enough” – see my posts about Being Engaged to Multiple EHRs and Social Healthcare and Social HIT).

So, answering Mr. HISTalk’s call, here’s my experience. I was/am a user of both Google Health and Microsoft HealthVault, hoping that one or both would get over the hump of updating my record with providers’ data so I wouldn’t have to enter it myself. Technically, both of them were partially over that hump since they could import medications from my Pharmacy Benefits Manager (Medco), and Lab Results from my main lab provider (Quest), except that I had to get a physician authorization for the labs (why this barrier?), which was an example of the authentication hassle that Missy mentioned. Microsoft was more proactive than Google in allowing HealthVault PHR updated with discrete data extracted from a clinical summary (e.g., CCD) sent by an EHR via SMTP (email) protocol, which I’ve done successfully. While Google was nominally a member of Direct Project, Microsoft was much more involved and visible. Will HealthVault actually be updated by many EHRs, and even so will it still meet Google’s fate? I won’t speculate on that, except to say that Microsoft made it farther over the hump than Google did.

You Don’t Want Only Data, but You DO Need Data!
Nearly everyone intones that a PHR is not useful if it’s just a passive data “filing cabinet.” They say Google Health just didn’t “DO” enough to capture the minds and time of patients, although both HealthVault and Google Health had “ecosystems” of applications that would work with them. A few years ago, I thought “patient engagement” largely meant PHR (including their ecosystems) + patient portals. But I now realize that patient engagement goes way beyond PHR – I’ve got a large and growing list of what it encompasses. Still, just because functionality and convenience are what “sell,” that does not mean that data is unimportant! A physician or hospital won’t want to buy an EHR just for a raw database if the EHR lacks functionality and usability. But an EHR without a solid data foundation probably won’t be very functional or usable either!

Not all patient engagement is data-dependent. For example, I could schedule an appointment without having any of my electronic health information. In my next blog post, I’ll discuss which patient engagement functions clearly need EHR data, which ones don’t, and which ones are in a gray area.

Happy Independence Day!

Tuesday, June 21, 2011

"Social Healthcare" and "Social HIT"

I considered a title of “Socialized Healthcare” as a play on words, just to get some attention. But I’m not talking about socialized medicine and government takeover of healthcare (I won’t touch politics with a 10 foot pole in this blog). Rather, I’m thinking about the implications of social networking and interactive communities. This is a big theme of the Health 2.0 community, of which I’ve attended an innovative and fascinating conference. “Patient engagement” – a key priority in the incentives for Meaningful Use (MU) – isn’t just about patients accessing their electronic health records, but also about interaction among a community of patients, caregivers, care providers, and others. People already “socialize” (talk about) their health quite a lot already, in some cases using IT (e.g., the Internet)!

A little-known fact about the Direct Project is that there was a “bake-off” among four exchange protocols: SMTP (e-mail transport***) chosen by consensus as the primary protocol, SOAP (web services as used by IHE) chosen as an option to bridge to many existing EHRs, REST (web services based on Internet HTTP protocol), and XMPP (the protocol used in Facebook). While XMPP wasn’t chosen, its consideration was intriguing. The state of existing technology adoption in healthcare IT, and the fitness to purpose were factors in reaching the decision, but there was recognition that new technologies could play a significant role in the future. So as healthcare itself becomes more interactive and collaborative, new enabling technologies will become more applicable.

***Caveat – I realize that Direct Project is not just “plain old e-mail” like most people are using, but e-mail is the easiest analogy to explain the Direct push pattern of information exchange.

The key question isn’t about protocols, but how persons and systems interact with each other. Generally speaking:
  1. System-system interactions are called interoperability
  2. Person-system interactions are called user interface
  3. Person-person interactions (facilitated by IT) are sometimes called social networking
The first two have received much attention in discussions about MU. The last has not. Even though there are proposed Stage 2 or 3 Meaningful Use requirements such as uploading patient-sourced data, that’s one-way, not really interactive. Secure patient-provider messaging may be the closest MU requirement in the Person-person category.

While e-mail-style of interaction can appear semi-interactive (i.e., long threads), it’s less interactive than chat/instant messaging or Facebook. It matches those use cases that drove it (e.g., pushing referrals, discharge summaries, results, and immunization updates among known recipients). Facebook, in contrast, has push, pull, and publish/subscribe patterns all rolled together. I haven’t seen many use cases that imply more interactivity (though a few were mentioned in the XMPP link above), so I’d be interested if anyone could point out some.

I haven’t researched or pondered this subject enough to write in depth about it it yet, but foresee huge and possibly transformative potential there. My company’s CEO, John Glaser, said as much at the HIMSS HIT X.0 mini-conference. I look forward to learning more about the opportunities (use cases), technologies, and innovations in “Social Healthcare.”

Friday, May 27, 2011

That Harmonious Spring Break Happened

Well, my big piano recital event for which I had been practicing for a year occurred last weekend. I was happy to play, and now I'll be a little less intense for a while, before I start preparing for the MusicAppassionata piano festival in West Chester, PA August 1-6.

I've uploaded most of my recital performances to YouTube. To find them, search in YouTube for David Tao piano recital and they'll show up. The camcorder sound was compressed, meaning that the soft parts were made louder and the loud parts were softened, so there appears to be very little dynamic variation. Trust me, I actually can play soft, sometimes!

I've related music and its performance to interoperability several times in this blog. One thing that a recital teaches you is that things go awry that you totally didn't expect, but you move on. You can't anticipate everything about some keys making unwanted noises, wheel locks not preventing the piano from rolling away, slight movements in the audience causing a brief distraction and memory lapse, etc. Despite avoidance of sugar and caffeine, and conscious intent to stay under control (knowing adrenaline would amp me up anyway), I still played faster than planned. Similarly, implementing interoperability in the real world seldom goes as you envisioned it or as cleanly as what's written in the standards or even developed in a product, because each participant doesn't have control over the other participants' systems or the environment. But every time you do it, you learn and improve the next time.

Happy Memorial Day Holiday Weekend to everyone!


Friday, May 13, 2011

Certification Retrospective Part 4 – Lessons Learned

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

In life in general, and in development of software, standards, and certification criteria, we learn and grow more by trial and error than we do when everything goes smoothly. Frederic Brooks’ classic software engineering book The Mythical Man-Month said “Plan to throw one away; you will anyhow.“ Hence we need prototyping and iterative refinement. The CDA Consolidation Project is fresh on my mind. I voted negative in its HL7 ballot, but that doesn’t mean it won’t succeed, only that it has issues to fix. It would have been a miracle to get that complex task right the first time.

So it is with certification. The CCHIT Interoperability Workgroup (IOWG) experienced growing pains in its early years. 2006 produced only a roadmap, 2007 produced the first (modest) interoperability criteria. 2008 had stronger criteria and roadmap, and 2009 was poised to make big strides toward semantic interoperability. What were my main lessons learned through these years?

What We Got Right (IMHO):
  • The “methodical march” sequence of building blocks. Putting the horse before the cart sure helps! As described in Method to our Madness?, we proposed a logical sequence for interoperability:
    1. Data Capture
    2. Liquidity
    3. Standardized Content
    4. Data Consumption
Our views crystallized especially in 2008-2009. CCHIT’s criteria included many of the standards that were eventually endorsed by ONC. For example, Lab Results, CCD, e-prescribing, vocabularies (LOINC, RxNorm, SNOMED CT), and leveraging HITSP.
  • The Roadmap (“Glide Path”) Concept. I love maps (online, GPS, paper) and want to know ahead of time where I’m going and the milestones along the way. CCHIT published roadmaps for the next two years beyond each certification year. Roadmaps aimed to provide adequate lead time and to encourage developers to plan and head in the right direction. While the HIT Standards Committee did a great job proposing a “Glide Path” to more robust standards in their proposals in late 2009 (see Jamie Ferguson’s August 20th 2009 Clinical Operations Workgroup presentation), that concept was mostly lost when the ONC regulations were published (see comments on John Halamka’s Feb. 10, 2010 blog). For interoperability, developers need to know the target standards, more than a high-level meaningful use matrix, to move forward.
  • Staying a Course. Once we defined the roadmap, we might adjust timing and provide more detailed criteria in our next development cycle, but overall there was continuity and stability with a minimum of “surprises.”
  • Transparency. CCHIT posted responses to every public comment on its website. Of course not everyone would agree, but we thought everyone deserved to know their comments were considered and our rationale for decisions.
  • Teamwork. The IOWG built relationships and trust among multiple stakeholders within CCHIT, as mentioned in Part 1. That enabled us to work through differences and get things done, despite conflicting opinions. In contrast, it’s harder to capture the “team” element in groups where 50-100 people are nominally on a project but attendance is sporadic, yet I understand the need for openness and transparency. Ultimately, a small group forms a cohesive team within the larger group. For example, the Documentation and Testing workgroup within the Direct Project gradually developed a “team” spirit similar to what the IOWG had.
  • Lack of Opportunity to Finish What We Started. Last week I used football, now here’s my first baseball analogy. CCHIT, as the “starting pitcher” for EHR certification was relieved by ONC in the 6th inning – enough to get a quality start, but not enough to win the game. Our methodical march didn’t reach its goal, but I hope that ONC will be a good “closer” to save the win for interoperable EHRs, coordination of care, and the good of the patient.
  • Lack of End-to-End Coverage. Interoperability involves senders, receivers/requesters, and perhaps intermediaries. To succeed, it must encompass all participants (e.g., EHRs, HIEs, PHRs, labs, pharmacies, public agencies), because so much exchange goes beyond EHRs. We didn’t achieve this in CCHIT, but not for lack of trying! We envisioned covering some end-to-end interoperability through certification programs for HIEs and PHRs in addition to EHRs. Excellent people were in the HIE and PHR workgroups, and the IOWG had good dialogues with both. The HIE program was launched with poor uptake followed by suspension in light of impending ONC program changes. The PHR program was not launched.
  • All-or-Nothing Approach. CCHIT pondered a modular certification approach early on, especially for inpatient EHRs, but didn’t implement it until ONC mandated it in the Certification Final Rule. In hindsight, I wish we had done that sooner. I don’t think we needed an “all or nothing” approach. Truth in labeling would have disclosed each product’s gaps, to help people make informed decisions. Vendors with complete EHR functionality could still differentiate themselves as a “one-stop shop” but others (“little guys”) would not be excluded from certification just because they didn’t provide 100% of all capabilities.
  • A year in limbo. From mid-2009 through mid-2010, the industry was paralyzed by uncertainty and lost momentum on interoperability. It was clear that CCHIT criteria wouldn’t be adopted as is by ONC, but no one knew what would replace them. There was no assurance of staying a course or a clear glide path, and people who had done their best to follow the CCHIT roadmap were concerned and confused. Interoperability features (such as standardized coding and discrete data consumption) that the IOWG expected to be in products in 2010 have been delayed, possibly to MU Stages 2 or 3.

Whether right or regret, there are lessons learned that can be applied going forward.
  • Follow the methodical march – a logical sequence of capture, liquidity, standardization, and consumption.
  • Define a roadmap (glide path) with ample lead time.
  • Stay the course.
  • Take an end-to-end perspective.
  • Be transparent.
  • Be flexible, not “all or nothing.”
That’s it! This has been a long blog series, and if you made it to the end, thanks!

Thursday, May 5, 2011

Certification Retrospective Part 3 – Controversies Along the Way

Note: this blog post continues my discussion of experiences in CCHIT. The opinions are mine only and do not necessarily reflect the views of CCHIT or Siemens. Please bear this in mind especially considering that the topic is “Controversies”

From my last Certification Retrospective post, I promised to share lessons learned and some “agonizing controversies” we faced in the CCHIT Interoperability workgroup (IOWG). I thought I could do both in one post, but now realize that I’ll need a “Fourth Movement” after this. Each controversy could easily take up a post of its own, but I’ll try to squeeze them into this post, deferring Lessons Learned to Part 4.
  1. When should HITSP specs be incorporated into certification? Once HITSP was formed, it (not CCHIT) was designated to select standards. CCHIT, however, could decide when/if those standards would be certified, striking a difficult balance between supporting the federal strategy (HITSP was HHS-funded, CCHIT was partially HHS-funded) and yet being pragmatic. It would have been difficult to require EHRs to develop too much at once when certification was “all or nothing” and not modular. From working in both CCHIT and HITSP, CCHIT tended to give more weight to considerations such as market adoption and lead times, not just whether a suitable standard existed. I along with Jamie Ferguson were appointed to co -chair the 10-member HITSP-CCHIT joint working group, whose goal was to coordinate the work of HITSP and CCHIT and address how/when to include HITSP specs in certification. But some HITSP-selected standards were still in “trial implementation” with little adoption, and the approval of a standard (HL7, HITSP, or any other) didn’t mean it should be mandatory within a specific timeframe. And there were just so many of them to digest, let alone certify! Some people weren’t pleased, thinking that CCHIT should be a more aggressive “enforcement arm” of HITSP. In the end, we included more of HITSP in 2008 and 2009 certification criteria than ONC did in its 2011 certification criteria, most notably the HL7 2.5.1 Laboratory results with LOINC vocabulary starting in 2007, C32 CCD starting in 2008 (adding RxNorm, UNII, SNOMED CT vocabularies in 2009) and HITSP TP13 (IHE XDS.b – see point #2 below). But we also roadmapped (2-3 years out) most other HITSP specs when we published our 2009 criteria. I believe this was a sensible middle of the road approach. IMHO, if we had mandated many more HITSP specs in certification, there would be few or zero certified products today!
  2. Should certification require transport standards? Fourth & Ten – we’d better punt! Seriously, we debated this during 2008 and 2009. We recognized this as a glaring gap in interoperability, and wanted to make headway, realizing that lack of secure transport standards would hinder interoperability even if content were standardized. The Direct Project didn’t exist back then. We were aware of diverse ways that HL7 messages were transported, that IHE had defined SOAP-based web services for document transport, and that HITSP had selected many IHE specifications. Many vendors had already tested IHE Cross-Enterprise Document Sharing (XDS.b) at Connectathon. So the IOWG approved XDS.b as 2009 certification criteria (along with PIX/PDQ to support it). But the Board of Commissioners decided to designate these as optional interoperability criteria, not required for certification, because despite the IOWG’s recommendation and strong EHRA support, some commented against it. This was the one case I can recall where my workgroup’s recommendation was overridden by the Board, which I know was a tough decision since the Board usually didn’t do that. This was also a case where we were less aggressive in CCHIT than the EHR Association had proposed. EHRA had sometimes criticized CCHIT for not providing enough lead time, but in this case they were very disappointed that CCHIT had not required this in certification. This one still bothers me as a missed opportunity.
  3. Should we require discrete data import, and who owns that decision anyway? We felt that the main point of requiring standardized content formats and vocabularies, not just human readability/liquidity, was for the discrete data to be consumable. Following our “methodical march” mentioned in part 2, we thought in 2008 that the time had come to propose discrete data import (e.g., update your medication, allergy, or problem lists using data from other providers). But now we were into a “boundary condition.” Where did interoperability’s “turf” end and functionality begin? We had a series of “discrete data import” meetings between the IOWG and the Ambulatory and Inpatient Functionality workgroups. We recognized that data must not only be exchanged, it needs to be reconciled (medication reconciliation being an example), and that you can’t just “slam in” all meds, allergies, problems from many external sources to automatically update the active med/allergy/problem list. The functionality workgroups didn’t think the time was right to require such capability in certification for 2009 or 2010. But how were we going to keep making progress toward semantic interoperability? In the end, we proposed criteria to import very specific discrete data elements for medications, allergies, demographics, and immunizations (with problems to come later), as described in my last post. But we didn’t define the functionality, as long as the discrete data were stored somewhere. And in any case, reconciliation criteria would belong to the functionality workgroups, not the IOWG. I think this would have been a reasonable “baby step” but because of the change in certification that started in 2009, those roadmap criteria never had the chance to be certified. I hope that similar careful thought will go into decisions in ONC certification, whenever it gets to that point. End-to-end interoperability involves content creation, secure standardized transport, and content consumption, all of which should be considered holistically.
  4. Should we push the industry toward a single standard for clinical problems? This was really part of the broader topic of converging on a singular standard vocabulary for each type of data, but SNOMED CT for problems was the lightning rod topic for several reasons: a) the difficulties of getting physicians to create medical problem lists at all; b) ICD-9 diagnosis codes were already required for reimbursement and some physicians systems were built around ICD-9; c) ICD-10 was already complicating things by looming on the horizon; d) anything that imposed more work on physicians could hinder usability and adoption. So though SNOMED CT seemed a clear winner for an interoperable clinical vocabulary and was HITSP-endorsed, we received considerable pushback from some members of the other workgroups as to how fast SNOMED CT could be required. I was pleased that many in the IOWG stepped up to provide statistics and research facts such as analysis of mapping of ICD-9 to SNOMED CT and clarification that standard codes don’t have to be visible in the clinician’s UI. We knew this was a contentious issue, but staked out our positions in the 2009 roadmap and a Q&A document.
The above four were prototypical of the controversies we faced in content, vocabulary, and transport. I could go on with more examples. That’s part of the challenge of interoperability work, as evidenced by the fact that ONC and the HIT Standards Committee still have all of the above issues to ponder for Stages 2 and beyond. I should mention that one more big controversy arose in the very first year, when CCHIT was newly formed and struggling to figure out how to set the interoperability bar. Eyes were upon those first members to resolve the CDA vs. CCR debate. Unlike the four issues above, where we took a stand, we weren’t ready to force a decision in 2006, and then HITSP was formed by ONC to deal with such “standards harmonization” issues. So at least our punt had a receiver (and football wasn’t locked out)!

I promise that Part 4 will really conclude this series with my thoughts on Lessons Learned, proudest accomplishments, regrets, and hopes for the future, stemming from my CCHIT experience. Thanks for listening to my sharing from “inside the trenches” of discussions of which the public was not aware.