What's Up With Me?

I'm back on the blog after being M.I.A.

I took an "early retirement" from Siemens, after working there for 35 years. My last day was September 30th. I've communicated that to many people privately, but had not updated my blog to reflect it. This was not an easy decision. I will always appreciate the many wonderful people I worked with at Siemens and also in the healthcare IT industry. It was great to share in the efforts of those who are so dedicated to improving healthcare.

Many have asked me what I'll be doing. I'm taking a few months off to reflect and refresh. Then I hope to have  a "plan for the plan" to tackle the "backlog" of life goals and requirements. (Apparently I haven't retired from business-speak!) I am enjoying spending more time with my family (wife, children, grandchildren whose numbers are growing, siblings, parents); pursuing my musical passions (piano and singing) and hopefully giving recitals/concerts; volunteer and church work; travel while we're still in good health; and possibly "something completely different" as the Monty Pythons would say! 

While I'll take a breather from HIT for the rest of 2012, I expect to remain involved in the HIT industry perhaps as a part-time consultant. I'm currently finalizing some work on the ONC S&I Framework Transitions of Care Initiative, specifically the Companion Guide to HL7 Consolidated CDA For Meaningful Use Stage 2. 

If I continue blogging, it will probably be on different subjects like music, so the "harmonious" will still be there, if not the "HIT." 

David

Patient Engagement as a Two-Way Street Part 3 – Recommendations

In my last post, I spoke of the importance of “getting to know” the patient and asserted that knowing a person can’t be accomplished only by predefined questions. I also referred to the HIT Policy Committee and HIT Standards Committee’s request for comment on Patient-Generated Health Data (PGHD) for Meaningful Use Stage 3 (MU3). Four Siemens employees (including me) submitted comments on that blog last week. Here’s my own summary of the comments, stated as recommendations.

• MU3 should define criteria for EHRs to accept PGHD, initially in either unstructured or structured formats. (Note: “PGHD” should include data not only from patient but from their care givers such as family members)
• Encourage, but don’t mandate, structured data content standards. Define a clear roadmap for standards to come, compatible with data standards for EHRs.
• Clearly define provenance (data source) metadata requirements to inform providers so they can exercise their clinical judgment on how to use the data.
• Focus on relevance, being careful not to overwhelm people with too much data. Allow provider access to additional PGHD where needed.
• While in typical cases the patient is authoritative on many issues, the provider needs to exercise judgment as to trustworthiness in each SPECIFIC patient interaction.
• Avoid being overly prescriptive on which data to gather, but rather let patients say what’s most important to them. We “don’t know what we don’t know.”  
• Strive for wide adoption and low barriers to entry by evaluating and embracing a variety of data entry and viewing technologies most commonly used by patients
• Define clear purposes, expectations and responsibilities for the review and use of PGHD

PGHD is not new: much of today’s healthcare depends on it already. Still, in an increasingly mobile, connected, socially networked culture, there’s a lot more potential for providers to get to know patients better by collaborating with them through the two-way exchange of information. MU1 and MU2 are weighted toward a one-way flow of information from EHRs to patients, but the HIT PC and HIT SC are, commendably, seeking ways to turn this exchange into more of a “two-way street” with PGHD.

Patient Engagement as a Two-Way Street Part 2 – “Getting to Know You”

One of the purposes of patient-generated health data (PGHD) is to help providers know their patients better than they would have otherwise if they relied only on data captured by providers. In my experience, I appreciate doctors who do more physical exams and tests but know more about me that could help them personalize their treatment. As Rodgers and Hammerstein wrote in The King and I, “Getting to know you, getting to know all about you…”

So it is with PGHD. How can it help providers know us better? I worked with colleagues to write a detailed response, which you can find as a comment on the HIT Policy Committee and HIT Standards Committee's blog requesting input on PGHD. I’ll give some highlights in my next installment. The rest of today’s post, while alluding to that response, is my own opinion.

While a patient-provider relationship is special and not necessarily deeply personal, think about how people get to know each other in general. They talk! In ways that can’t be predefined, prescribed, or pigeonholed. Sure there are facts such as your birthday or address. But the vast majority of emotion, experience, and aspirations are richly expressed through natural language. Would you want to get to know someone by filling out structured forms with multiple-choice questions?! So in response to the blog question “does all PGHD for care management need to be in a structured form?” I’d answer a resounding “no!”  As one working in healthcare standards, I understand and fully support the need for structured data in EHRs, for interoperability, analytics, decision support, quality measures, etc. But even if we could magically get all PGHD structured, standardized, tagged, and automatically imported into EHRs, that wouldn’t necessarily make things great. Structured data has precision, but very little nuance. Very few patients think or communicate via structure, and no amount of standards or government regulation will turn patients into health informaticists.

So I suggest crawling before we walk or run when it comes to PGHD. Let’s lower the barrier to entry by embracing PGHD in whatever formats or devices (PCs, smart phones, basic phones with text messaging, etc.) the patients can create it. Yes, there should be a direction for standards so that appropriate data (such as med lists or glucose levels) can flow from patient-facing systems like PHRs into EHRs and be understood. But let patients express themselves in their own words and preserve this in their health record. And speak to them in plain language that they understand (which won’t be structured XML). Then we’ll have the kind of two-way street that will help my providers “get to know me” and deliver the kind of healthcare relationship that I want for myself and my family.

Patient Engagement Needs to be a Two-Way Street

The “patient and family engagement” objectives within the federal Meaningful Use (MU) incentive program Stages 1 and (proposed) Stage 2 have been well-intended steps forward. But they have mostly regarded patients as receivers of information (education materials, clinical summaries after each visit, view/download/transmit their information, receive patient reminders). This is pretty much a “one way street.”  Sure, there is “secure messaging” where a patient can send essentially an email to a provider. But most requirements assume that providers control the keys to information that they (figuratively) “dispense” to the patient.

I recently read a fascinating book called “Cognitive Surplus: Creativity and Generosity in a Connected Age” by Clay Shirky, whose premise is that the digital age offers “thrilling changes” as society is transformed from a passive consumer culture (e.g., watching TV/movies and reading publications, all controlled by large media companies), to a more networked culture where technology enables people to create, publish, share, connect, and collaborate in innovative ways, without dependence on established authorities. While the “free for all” can produce huge volumes of frivolous or low-quality content, it can also engender truly original and breakthrough ideas, which otherwise would not have happened, by relying on the goodwill and “cognitive surplus” (hitherto untapped creative energies) of millions of people. Examples include Wikipedia, kiva (microfinancing to help individuals start small businesses and alleviate poverty) and Grobanites for Charity fans of a singer who banded together to help charitable causes in places such as Africa. Shirky’s cognitive surplus thesis has strong parallels to the Health 2.0 movement and patient engagement. How can patients be full partners and contributors to their health information and their health, rather than merely passive consumers whose information is controlled by providers? Or, to use a music analogy as I like to do, is the patient just listening to solo performances by each provider, or are they playing harmoniously as an ensemble?

Patients are partial contributors already. After all, didn’t lots of the patient’s history and information about symptoms, contraindications, outcomes, and treatment that’s in paper charts or EHRs come from patients and their families, through interviews, assessments, and clipboards? Who knows better than patients what they are really doing (not what someone else thinks they ought to be doing)? So it’s good that there has been recent testimony and requests for public comment from the HIT Policy and Standards Committees about patient-generated health data (PGHD). If you have any interest in this subject (and, as a patient, you should), you can respond too. There’s no stated deadline, though commenting sooner rather than later you’d be more likely to be heard.

Admittedly, it’s easier when discussing EHR certification and MU to discuss outputs from the provider’s EHR to patients, because those are easier to understand, quantify, and control (from a provider’s or EHR vendor’s perspective). When accepting information from patients, things are much more unpredictable. The request for comment asks 10 good questions, such as how “structured” PGHD should be, where are patients “the authoritative source,” and what degree of incorporating PGHD into EHRs should be expected of providers.

I have many thoughts on these questions. More to come next week…

Patient-Centeredness: will "Direct-only" get us there?

I read that the HIT Standards Committee recommended that Direct (SMTP, S/MIME secure email) be the only transport protocol for certification. While on the one hand this sounds like a good step toward parsimony (similar to having only one vocabulary for problems or one Consolidated CDA standard for summary of care records), I think it’s different and has some unintended consequences against the patient-centered view that can be advanced with HIEs.

Those of us who worked on Direct recognized its strength for particular “push” use cases. Many also felt strongly that Direct needed a bridge to the HIE world in terms of protocols (hence the XDR and XDM for Direct Messaging specification). The Direct Project Overview made it very clear that Direct “push” is not intended to solve every use case but to coexist with other forms of exchange including “pull” as well explained in this EHRA whitepaper.

This is easy to understand if we look at how businesses are run, and how people manage their personal data. Email push is highly beneficial and essential in my business and personal life. But it’s not all there is. At work, when people collaborate on projects (as providers ought to  collaborate in patient care), they store information in shared resources. They don’t rely upon the project documents existing in every individual’s email or personal folders! That would lead to waste and confusion. Instead, there are repositories that handle version-controlled documents, source code, etc. Wiki pages rather than emails can be used to record the shared project experience. Emails are great for initial notification, but not for the ongoing management of the information. And even individuals don’t email their photos to everyone in their address book: they share them in a single place (like Facebook) from which trusted friends can pull (view and download) them. Information exchange  via Direct should not “push out of the picture” information sharing that benefits the patient and provider community.

HIT SC’s recommendation of a single protocol for certification is fine as a “minimum requirement.” But I’m very concerned that certifying only Direct, if accepted by ONC, could bias providers toward Direct to the detriment of other types of exchange. CMS’ Incentive Program proposes that meaningful use measures only count transmissions to providers using the standards included in certification (page 13708 of the NPRM). This would have the unintended consequence of discouraging sharing through HIEs (at any level), that use IHE profiles such as XDS, XDR, XCA, etc., as most use these instead of Direct. Those profiles require sufficient metadata to support queries against a patient-centered document registry, so that providers can find what they’re looking for. Direct by itself does not provide or require those metadata, so even if Direct were used to push documents to an HIE, the HIE would be hard pressed to correctly index and file the documents.

I’m not criticizing Direct for what it is. I am saying that it was not designed to handle all exchanges, and that overemphasizing it as the only “meaningful use” method that “counts” will have negative impacts on HIEs that provide a patient-centered aggregate view. Point-to-point transmissions don’t provide such a view since each provider’s view from “push alone” is only a “silo” unless everyone copies everyone else on every document (the dreaded “reply to all” email) – not a good idea! While HIEs aren’t required for MU, they should not be discriminated against either. CMS regulations incenting Direct only (implicitly disincenting HIE) could harm progress toward patient-centricity. That would be like a business rewarding people for sending their documents via email but not rewarding them for sharing controlled versions of those documents in a repository. Between ONC and CMS, I hope this problem can be avoided by focusing on the real objective – providers and patients sharing data electronically, without CMS measures counting only Direct SMTP exchanges as qualifying for meaningful use. “Pull” exchanges from an HIE or “push” exchanges using other protocols (e.g., XDR SOAP) should also count toward MU measures. And I hope that HHS goes beyond “permitting” HIEs for MU, but that they will continue to invest in and work with others (e.g., states) on a national healthcare infrastructure (NwHIN Exchange as it evolves) to enable a patient-centered, cross-provider view of data as a public good.

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.