Out of Body Experience - Anatomical Information in Images

Summary: Anatomical information is sometimes hard to come by in images, but it's not as bad as you might expect.

Long Version.

Information about the anatomic region included in a set of images is useful for a number of obvious reasons.

First and foremost, whether the user be an imaging specialist, a clinician who performs their own imaging, a referring practitioner who has requested imaging or is interested in procedures already performed, or a radiographer/technologist about to begin a new procedure, if one is browsing through a patient's record trying to find the "right" images(s) to answer some clinical question, anatomy, together with modality and approximate date are useful.

A related use case, and one which is largely behind the scenes but impacts the quality of the user experience, is to pre-fetch images for any of the first set of use cases, and as we discussed last time, pre-fetching is back in vogue for one reason or another.

Hanging protocols are another application, particularly for longitudinal comparison of complex procedures that involve multiple parts, e.g. skeletal surveys.

So where does the anatomical information come from, in terms of who populates it and in which data elements?

In an ideal world, the anatomy would be implicit in a standard procedure code that was supplied in the request from the order entry system, which might be refined somewhat during the "protocolling" step in the RIS, then fed to the modality via the modality worklist, amended by the operator if they need to perform something other than what was requested, and then recorded in the images and the performed procedure step, and included in the reports. This procedure code, being standard, would have a standard mapping to its related concepts, i.e., what the general anatomic region was, and what the anatomic focus was.

Though such standard procedure codes do exist, in SNOMED, LOINC and more recently in RadLex (which has recently been extended to include CR/DX and NM), they aren't widely used. Indeed, as far as I can tell, they aren't used at all yet. In over a decade of performing international multi-center cancer clinical trials in my last job at RadPharm/CoreLab Partners/BioClinica, I never saw a standard value in the Procedure Code Sequence data element of any image (with the occasional exception of US CPT-4 codes, which though arguably "standard" are billing not ordering codes). Most often there was nothing there, or sometimes illegal empty values or garbage dummy values. If anything was present, it was a private or local code.

That said, there does seem to be reliable standard anatomic information in the image headers a large proportion of the time.

The history of this begins with the original DICOM standard released in 1993. Prior to that time, there were no data elements defined for describing the anatomy in the ACR-NEMA standards (of 1985 and 1988). DICOM introduced the Body Part Examined data element at the Series level, primarily for use with projection radiography (CR at the time). The original list was relatively short, 16 defined terms, ABDOMEN, ANKLE, BREAST, CHEST, CLAVICLE, COCCYX, CSPINE, ELBOW, EXTREMITY, FOOT, HAND, HIP, KNEE, LSPINE, PELVIS, SHOULDER, SKULL, SSPINE, TSPINE. Being defined terms, vendors (and users) are permitted to extend this list, as long as they don't duplicate the meaning of an existing term, and for example Fuji CR describes in its conformance statements also sending HEAD, NECK, LOW_EXM, UP_EXM and TEST.

How did CR modalities obtain a value to populate this data element? Simple, they asked the operator. In the case of Fuji CR, the image processing and parameters applied to make an interpretable image are body part specific, and so the operator selection serves multiple purposes, applying the right processing and populating the DICOM data element. Over time, more general image processing algorithms have evolved that may not require anatomical information, but as X-Ray generators and tubes have become integrated, the body part specific selection of X-Ray technique factors provides another source of this information.

The Digital X-Ray object, introduced in 1998, both to support digital detectors and to improve upon the CR object in DICOM, went one step further and "coded" the anatomy more formally. I.e., rather than using a single string value, a triplet of coding scheme (e.g., SRT for SNOMED), code value (e.g., T-04000) and code meaning (e.g., "Breast") were used in a data element called Anatomic Region Sequence. A list of SNOMED codes for useful anatomic regions was provided, longer this time, 73 if I have counted those listed in Supplement 32 correctly. Included was a mapping from the "older" Body Part Examined string values to to the new SNOMED codes, the list of standard values having grown slightly in the interim.

Some of these new codes remained at the same general level of specificity as the historical Body Part Examined values, e.g., (T-D3000, SRT, "Chest") and CHEST. Others were very specific and for particular uses of radiography, such as to support particular views (e.g., (T-61300, SRT, "Submandibular Gland") to describe submandibular sialograms); others were specialty-specific (i.e., support was added for not only general radiography, but also mammography and dentistry). As an aside, a much more rich description of the projection or view was also added, including codes for epnymous views (such as (R-102AE, SRT, "Waters"), etc.). The approach used at the time was to go through the classic projection radiography textbooks, enumerate all documented techniques, describe their anatomy and other dimensions, and add data elements and coded values for each, and then iterate with radiologists and applications specialists to assure comprehensive coverage. Some implementers expressed skepticism about burdening the console/QC station/plate reader operator, but with education about the possibility of using integrated generator/gantry information to capture the data, and the need to orient the image correctly and document its orientation, progress was made. I used to preach about this in my RSNA Refresher Course on Digital Radiography.

Over the years, all subsequent new DICOM image objects have been defined to use Anatomic Region Sequence, but Body Part Examined remains popular, and has been retrofitted with standard string values for a broad range of purposes, and the list now contains 112 standard values (including the aforementioned examples of GALLBLADDER and SUBMANDIBULAR). This has been done largely in recognition of the fact that the CR object has not gone away (despite the DX object being superior in every way, though I am not biased at all). Sadly, many PACS and viewers are still too dumb to handle coded triplets for display or switching. To be fair, if a PACS or viewer is going to allow the user or site to customize behavior based on some of these values, it is easier to develop a configuration user interface that allows them to enter plain text strings to match, rather than force them to think about codes or choose from a pre-populated drop down list of SNOMED codes (that may not be up to date).

The list of body parts and anatomic region codes has been extended to cover the cross-sectional modalities too. In the early days, there was absolutely no indication of body part in CT and MR images. The standard described the use of Body Part Examined in the General Series module, so it was available, but you may recall that there was nowhere in the user interface on the console to enter it. There was no cutesy little homunculus to point and click to select the protocol, in which the anatomy was implicit. Before the days of modality worklist, there was no place to copy it from (not to say that anatomy is explicit in MWL either, but it can be derived from the Requested Procedure Code, or Scheduled Protocol Code Sequence, or nowadays the Protocol Context Sequence). Indeed, there were no standard protocols and one had to select (or type in) all the technique parameters individually every time. The best one could hope for was something meaningful in Study Description (more on that later).

CT and MR operators nowadays have it pretty easy by comparison, and as vendors have made the user interface more automated and graphical and intelligent, more information has become available for re-use. Many contemporary CT and MR modalities are indeed populating Body Part Examined and/or Anatomic Region Sequence, using values derived from operator protocol selection (and in some cases IHE Assisted Acquisition Protocol Setting).

Ultrasound is a tricky modality, being so operator-dependent in terms of positioning, as well as requiring discipline in terms of selecting from the user interface a description of each captured image. After an abortive attempt in the original DICOM standard to define encoding of ultrasound images, which included stuffing body part information into a value of the Image Type data element, a much cleaner Ultrasound IOD was quickly released, in Supplement 5. It was one of the first to use the Anatomic Region Sequence with codes, as described earlier, thanks to the influence of Dean Bidgood. Unfortunately, it seems that very few, if any, ultrasounds devices actually provide a means for the user to populate this attribute. Nor is Body Part Examined populated in ultrasound as far as I can tell.

Which brings us back to the question of reality. What does one actually see in real world image objects received from various sites? Are these Body Part Examined and/or Anatomic Region Sequence being populated? Do they contain standard values or non-standard strings or codes? Even if they are populated, are they correct and reliable?

The bottom line seems to be that in this day and age, for many modalities, they are often being populated, and if populated they are much more often using standard rather than non-standard values, and appear to be reliable when populated. This may be contrary to some peoples' beliefs or observations, but I can only report my own experience in this respect. As I mentioned before, in my former cancer clinical trials life, I had the opportunity to monitor images from literally thousands of sites around the globe, for most modalities (ultrasound being a major exception), from all vendors and vintages of machine. I can't report exact figures, but on several occasions in the past I examined what we were receiving to ascertain the feasibility of various efforts to improve the workflow of comparing successive time points, for both projection radiography and nuclear medicine bone scans as well as cross-sectional modalities.

In general, for projection radiography with CR, Body Part Examined is populated with a standard value about 75% of the time, is empty or absent about 10%, and contains a non-standard value about 15% of the time. Spot checks on individual images showed that the value sent is rarely incorrect.

This is surprisingly good for CR perhaps, which one might expect to be the least reliable, given the ease with which some vendors allow their sites to customize what can be put in there. If one inspects what non-standard customized values are being sent, they fall into a couple of categories:

• local language equivalents, e.g., BASSIN rather than PELVIS, BRUSTKORB rather than CHEST
• extensions that include the view too, e.g. CHEST_PA
• reasonable values that we should probably add to the standard list, e.g., FOREARM
• incorrectly spelled equivalents, e.g. "L SPINE" with a space or "L_SPINE" with an underscore, instead of the standard "LSPINE"
• incorrectly capitalized equivalents, e.g., "Chest" instead of "CHEST"
• literal copies (sometimes capitalized) of some procedure or billing code, e.g., "CHEST 1 VIEW" or "XR ACUTE ABDOMEN W/PA CXR"

Not infrequently, non-standard values are not only non-standard, they are illegal. The CS (Code String) value representation does not permit lowercase or most special characters or accents, for example, and is limited in length to 16 bytes.

I can see why non-English-speaking sites are tempted to replace all the codes with local language equivalents, since the literally encoded value may be displayed in some modality and PACS user interfaces, or at least in some configuration screens, such as for hanging protocols. But they really shouldn't, since the standard values are supposed to be used regardless of the locale, and the user interface should perform the translation. This is just a bad, though understandable, practice.

One of the strengths of using Anatomic Region Sequence instead of Body Part Examined is that it is local language independent and one can send, and recognize, the same code value, regardless of the code meaning. I.e., one can send (T-D3000, SRT, "Chest") or (T-D3000, SRT, "Thorax") or (T-D3000, SRT, "Tórax") or (T-D3000, SRT, "Brystet") or (T-D3000, SRT, "胸郭") and they all mean the same thing. The idea is that hanging protocols, routers, pre-fetchers or just ordinary human readable browsers should recognize the code (T-D3000, SRT) and render to the user whatever is the locale appropriate string. The code meaning encoded in the message is only there as a fall back in case the code is unrecognized (and indeed it used to be optional in DICOM when coded tuples were first introduced). Theoretically; unfortunately, the lowest common denominator in localization of PACS and viewing applications is probably not up to substituting code meanings yet, probably as a result of user's having higher priorities than localization (or their requirements not being taken seriously by the vendors).

For cross-sectional modalities, given their history, I was expecting a lot worse than I actually observed. For CT, for example, about 60% of the time there is no value sent. No surprise there, but it could be much worse, and this is a sign of improvement. About 35% of the time there is a standard value, and about 5% of the time there is a non-standard value. For MR one sees values much less frequently; roughly 85% of the time there is no value, 10% a standard value, and 5% a non-standard value. For PET though, neither Body Part Examined or Anatomic Region Sequence are ever sent, which is pretty lame (how hard is it to send the code for "whole body" anyway?).

Nuclear medicine is a mess. Like the ultrasound objects, the NM objects were revised early and redefined to include Anatomic Region Sequence. One standard value one sees fairly often is ("T-11000", "SRT", "Skeletal") for whole body bone scans, not surprising in an oncology practice. For historical reasons, the coding scheme may be "99SDM" or "SNM3" rather than "SRT", the price NM pays for being an early adopter of coded tuples. That said, one also sees a lot of private codes from one particular vendor, who sends "99NMG" for the coding scheme, and then sends codes that include not only the anatomy but also the view, which is the wrong thing to do since there is a separate coded data element for that.

Interestingly, I do not see very many combined body parts showing up, apart from TLSPINE. This is probably a consequence of the fact that Body Part Examined is a Series level attribute (and Anatomic Region Sequence is image level). In other words, two different Series in a single Study may have different values for these attributes. This is important to account for if one wants to come up with a single anatomic descriptor of the entire procedure, so a system may need to have the ability to detect and combine these. DICOM defines a bunch of these combined parts, and adds more as they are conceived of (for example, I recently realized we don't have a good value for aortic arch plus carotids plus circle of willis for MRAs). There is a trivial example of how to do this using the available combinations defined in DICOM in com.pixelmed.anatproc.CombinedAnatomicConcepts in my PixelMed toolkit if you are interested; i.e., one doesn't need the complete SNOMED ontology to recognize the relationships, only a tiny subset of it (more on that in a later blog post perhaps).

On the subject of tools as well as limited structured anatomical information, I cannot finish without mentioning Study Description and its ilk, Series Description and maybe even Protocol Name. Worse even than non-standard string values in Body Part Examined, these descriptive data elements can contain anything at all. Indeed that was their intent, to be a human readable description, and not something that was machine recognized. Originally, the modality operator typed in free text values, and often they still have that flexibility, or at least the ability to edit what is pre-populated by protocol selection. Sadly, given that Study Description and Series Description are the most frequently populated data elements in practice, though they are incredibly useful for human browsing, it has become common place to try to match or parse their content to dictate downstream behavior, such as for hanging protocol selection or matching.

Anyhow, given a site-specific set of such description data element values, one can either parse them and try to find anatomic words or phrases, in order to be adaptable to local variations, or one can just do a straight match on the entire string. In order to better support some of my use cases, particularly extracting anatomy for radiation dose extraction projects, I spent a while working on the parsing descriptions problem, with some success. You can find in the com.pixelmed.anatproc package a bunch of attempts to do this, both for cross-sectional and projection radiography, as well as for multiple languages. By comparison, you might want to look at the RadMapps approach, which just does a straight out full string mapping, which requires one to build a mapping once for any sites' list of descriptions, and then maintain it as they evolve. This is the approach being used for the ACR's Dose Index Registry, for example, where they only have to cover a small subset of all possibly procedures. In these approaches, there is some blurring between purely anatomical information and other interesting things one might want to also extract, like why the procedure is being performed or the particular manner in which it is being performed (such as being a CT angiogram or being thin slice, etc.), but the anatomy is a key part of the process. For some use cases it may not even be necessary to extract the anatomy separately, since the goal may be to map to a particular standard procedure code.

Indeed, one might suspect that the primary reason for the popularity of VNAs and the dreaded "dynamic tag morphing" is to deal with the impedance mismatch between the way different vendors and sites have their modalities populating Study and Series Description and the limited configurability of some PACS hanging protocols that depend on these. Of course, I hate to say it, but the "dynamic tag morpher" is probably a good tool to do the extraction or matching of descriptive attributes to populate structured attributes with standard codes for procedures and anatomy, if it has the sophistication required; i.e., use it not just to "clean up" descriptive attributes, but to augment the header with codes extracted from them. Better of course would be to get it right "first", i.e., off the modality or fixed during ingestion, and for everyone to use the same standard codes as the interoperable set, rather than have to "dynamically" coerce the values to match varied expectations of the recipients.

The bottom line is that reliable anatomical information is almost certainly available somewhere, if you want to go to the trouble to extract it, in decreasing order of desirability, increasing order of difficulty, and increasing order of likelihood of availability, from:

• implicit in a standard Procedure Code Sequence value, supplied by the worklist and encoded in the header
• in a standard Body Part Examined value or Anatomic Region Sequence code, extracted from the worklist procedure code, automatically or operator selected protocol, or operator selected dropdown
• extracted by matching or parsing the Study and/or Series Description or Protocol Name data element string values

David

PS. Before someone asks, in DICOM, laterality is conveyed separately, encoded in either Laterality or Image Laterality (or in some cases Frame Laterality), and not pre-coordinated with (built in to)  the Anatomic Region Sequence or Body Part Examined. The opposite is true for Procedure Code Sequence, which has no separate laterality modifier, and for which laterality needs to be pre-coordinated.

Pre-Fetching: Zombie Apocalypse or Nirvana?

Summary: Pre-fetching is back, driven by sluggish access to cloud-based archives and the need for a "local cache".

Long Version.

Like characters in a bad horror movie, or an eighties band, pre-fetching is back, resurrected from the dead (if it ever was truly dead).

For a while, with the concept of "all images spinning all the time for all users" we thought we were on a roll in terms of on-demand access. Assuming all those images were spinning "locally" that is. Tape and optical disk was going the way of the dodo and we didn't have to listen to StorageTek marketing presentations about hierarchical storage masquerading as scientific abstracts at SPIE and SCAR (SIIM) any more. Worst case one could approach image egalitarianism, i.e., all image access equally fast or slow for everyone, if one also made available equal bandwidth.

Not so, it would seem.

When the HIPAA Security rule required everyone in the US to have a means of disaster recovery, and reliable off-site archives came into vogue, it was not expected that these archives would necessarily have on-demand access performance, though it created an obvious opportunity for off-site access. Likewise with the DI-r's in Canada. But nowadays the distinction between the off-site archive and the only archive you have is becoming blurred, as everyone jumps on the "cloud" (aka. Software as a Service (SaaS), or Storage as a Service (STaaS), formerly Application Service Provider (ASP)) bandwagon, based on the naive assumption that if it is good for streaming movies on your smart phone or tablet, the "cloud" must be good for everything else too.

The aggressive marketing of the Vendor Neutral Archive (VNA) concept, often implemented as, or confounded with, cloud storage, has resulted in the introduction of another "layer" between the PACS user and where the images are, in some cases.

Some disk (arrays) and their interfaces are also cheaper, and potentially slower, than others, so even in the absence of awful media like tape and optical disk, the concept of different "tiers" of storage performance (in terms of either access or in some cases reliability), has not gone away either. Obsession with regulatory and legal issues has led many people to initially purchase far more expensive storage than is perhaps the minimum necessary to do the "caring for the patient" part of the job, and left a nasty (expensive) taste in some customers' mouths. Regardless, it is hard to argue with the economies of scale a provider like Amazon might be able to obtain (as long as it wasn't branded "medical" aka. unnecessarily regulated and excessively expensive and ripe for profit taking).

Anyhow, the buzzword du jour, much bandied about at the last SIIM, was "local cache". I.e., the images that you can access in reasonable time because they live on site and are optimized for performance, and perhaps are already "inside" your PACS and don't need to be retrieved from some other person's product (like a VNA). As opposed to those that are not, for which access performance may suck. Even if you don't have a PACS per se, or access images through it, but perhaps use a (buzzword alert) "universal viewer", the performance difference between images cached in a local server rather than pulled from off-site on demand may be "noticeable", to put it mildly.

I was interested in a comment from someone (can't remember who it was, or what system or architecture they were using), who reported that a colleague genuinely thought that the "A" flag in their study browser stood for "Absent". Apparently it really stands for "Archived", but they drew their own conclusion based on their experience. [Update: Skip Kennedy claims responsibility for telling me this :)]

So, whether you want one or not, it sounds like a "local cache" is in your future, if you don't already have one, whether it be for radiologists' priors or for other users' access to contemporary or older procedures.

How do images get into such a cache in the first place? If the cache is the PACS, the obvious way is to keep the recent stuff, i.e., stuff that was recently acquired, or imported from CD or received from outside for contemporary patient care events (even if they are in the ED or the clinic and have nothing to do with radiology, i.e., are not read again). If the cache is not the PACS, but some pseudo-pod of the off-site archiving allowed to extrude into your local area network (i.e., the on-site box bit of the off-site archiving solution), then likewise, anything recent can be routed to it. But the PACS or local box may fill up, and hence a purging strategy is required (assuming failure and buying more disks are not options, which this discussion presupposes). Not every PACS can do this but let's assume it can. It might even do so intelligently (e.g., purge dead people (assuming Haley Joel Osment doesn't take up radiology), adults, acute not chronic conditions, etc.), but that is a digression.

Sooner or later the priors that are potentially useful for new procedures or for clinical care will be purged and access will be slow or non-existent. Enter the pre-fetcher, which tries to bring some intelligence to bear (?bare) on the problem of what to fetch back and when, and hopefully do it in time. The literature from the 1990's and early 2000's is replete with articles about this (just search the SCAR/SIIM, CARS, SPIE Medical Imaging conference proceedings, journals like JDI and even RadioGraphics, as well as text books like Bernie Huang's). If you are interested, a couple of classics are Levin and Fielding from SPIE MI 1990, Siegel and Reiner JDI 1998, Andriole et al JDI 2000, Bui et al in JAMIA 2001, and the work of Olivia Sheng's group and Okura et al JDI 2002 on artificial intelligence methods. Approaches range from the simple expedient of the age of the study, through using the modality, the body part or the clinical question. The relevance of the body part in particular will be discussed in a follow up post here, and was my motivation for addressing this topic in the first place.

One of the important things to bear in mind is that pre-fetching is relevant not just for radiologists' priors before reporting the current procedure. It is also important for the clinicians, who may well be interested to know, even outside the context of a current radiological procedure, that other procedures have been performed in the past, whether locally or at other facilities, and want to access them without delay at the time of patient consultation, or surgery or some other intervention. Figuring out what is relevant for a clinician maybe considerably more complicated (to optimize) in some of these scenarios than finding priors for radiology reporting, and some of the systems in these users' offices may be much less robust. In particular, local cache sizes and bandwidth may be relatively low, and so not only is fast on-demand access for large studies like whole body CTs, PETs and breast tomosynthesis challenging, but excessive pre-fetching of all images for every scheduled patient encounter may overwhelm resources, and hence need to be selective and optimized. An interesting twist to this pre-fetching scenario, is that there may be no RIS involved and hence no access to the certain events and information; on the other hand the report will likely have been completed and more information may be available from the EMR/EHR/PHR.

Another SIIM theme this year, the decomposition of traditional PACS into its various component parts, archive, display and workflow, for example, seems to be well under way, with new hardware and software technology being brought to bear on classical problems, or having to leverage classical solutions. Hopefully lessons learned in the 1990's will be effectively reapplied, rather than needing to be reinvented. New factors, such as the ability to pre-fetch from central repositories and other facilities, will add interesting challenges, or opportunities if you choose to look at them that way. Likewise, the PACS migration problem potentially overlaps with pre-fetching when the decision is made to migrate patients or studies only on anticipated need, rather than all in advance.

Don't forget though, that "A" should be for "Accessible" not "Absent", and whether it is "Archived" or not should be irrelevant to the users' experience.

It is good to know that accessibility Nirvana (the goal, not the band) is just around the corner, once again.

David

PS. And yes, before you comment about it, I know about "server side rendering", and about Citrix, and why sometimes the images don't have to live locally, if these mechanisms float your boat.

PPS. Just for clarity, I am obviously not talking about the use of the term "cache" in the HTTP protocol sense, by which means, as Jim Philbin regularly reminds us, non-specific "stuff" that has not changed in its content can be served up closer to where it is needed by various caching proxies using technology that has nothing to do with medical imaging applications. This is one of the major justifications for the WADO-RS DICOM stuff that grew out of the MINT project. Though, of course, if it hasn't been pre-fetched, it won't have been seen by the HTTP caches recently either, and even if it has been pre-fetched, it still might not be cached in the intervening proxies on the way to the user.

My PACS has fallen down, and I can't get it upgraded

Summary: Many people have PACS that are not the latest version, and hence cannot use new features; new features are not added to old PACS versions.

Long Version.

In my travels preparing for the Breast Tomo forum that Rita Zuley and I hosted at SIIM (Digital Breast Tomosynthesis & the Informatics Infra-Structure: How DBT Will Kill Your PACS/VNA), I was surprised to discover that the key question was not just "Does your PACS vendor support the DICOM Breast Tomosynthesis SOP Class?", as one might have expected, or even "Do you have the bandwidth/storage/memory/display hardware to handle the large data volume?".

Rather, it was "Do you even have the current version of your PACS?"

This rather surprised me initially, but made sense when I thought of some of the barriers to upgrading, like the need for a fork-lift in some cases (or more seriously, the cost of the necessary server-side hardware). The site that initially exposed me to this dilemma has a problem that may be slightly unusual, extensive customization of additional services added on to a much older version of the PACS, which they cannot do with out.

To try to get a better handle on how widespread this problem was, I did a little survey on a couple of forums, like pacsadmin and comp.protocols.dicom. The response wasn't very great, and in retrospect I should probably not have chosen returning an Acrobat form by email as the survey mechanism, but the online survey tools I checked out first had some limitations too.

Anyhow, since I promised to share the survey results, and did at SIIM, here goes. I ultimately got 23 responses.

Systems were from

• different countries (18 US, 2 Canada, 2 Europe, 1 Asia),
• various settings (13 metropolitan, 2 rural, 8 mixed),
• various scales (5 multi-enterprise, 10 enterprise, 4 multi-departmental, 3 departmental and 1 sub-departmental) and
• multiple vendors (2 Agfa, 2 DR, 3 Fuji, 6 GE, 2 InteleRad, 2 McKesson, 2 Merge, 1 Philips, 2 Sectra, 1 Siemens).

Only 5 (22%) reported that they had the current (i.e., latest) version of their PACS in use, but 14 (61%) did say that they planned to deploy the current version within 3 months to 1 year (2 in 3 months, 4 more in 6 months, 8 more within 1 year).

The structured capture of reasons for not having the latest included:

• cost (5)
• resources for deployment (1)
• resources for validation (4)
• Meaningul Use distraction (3)
• custom RIS interface (1)
• custom reporting/speech interface (0) 
• custom data mining interface (0)
• custom other interface (0)
• awaiting vendor change (2)
• awaiting VNA (0)
• other reasons (13)

Some of the other reasons for delaying that were described in text comments (and which overlapped with some of the structured questions) included the need for validation and user feedback, new features not being "significant enough" (so waiting for next version), server hardware replacement being needed, completing an interim version that needs to be installed first, awaiting a possible vendor change, or the practice of waiting for a while until a release has been generally available (presumably to see what problems it has).

The remainder said they were not going to deploy the current version either for more than 2 years (2 sites) or ever (2 sites). Reasons cited were that the PACS was externally managed & the supplier refuses, or it already "works" so no need for it.

In terms of what they were missing out on by not upgrading:

• media export (2), import (2)
• key images (1)
• annotations (3)
• 3D (4), fusion (4)
• DCE (4), breast DCE (3)
• IHE Mammo Profile (3)
• Breast tomo (3)
• JPEG 2000 (4)
• WADO (2), XDS-I.b (2)

Other stuff mentioned as missing was remote caching, life cycle management and auto-deletion, increased exam capacity, reasonable performance (!), and some new SOP Classes (unspecified).


Note that the survey did not include the initial site that prompted my interest, which has too much customized stuff that depends on an obsolete version, and were certainly missing out on Mammo tomo.

This was not a very scientific survey, and the respondents may well have been biased by the context in which the questions were asked, and selectively been more likely to respond if they had an older PACS version perhaps.

The information that Julian Marshall from Hologic presented at the same forum also suggested that there was poor uptake of new SOP Classes (and sufficient hardware performance) to cope with breast tomo.

Hopefully SIIM will post the slides and transcript on their web site soon, but in the interim, here are my slides from the forum, and if you need any images to kill your lame old PACS with, try these tomo ones. If you have any of your own to contribute, let me know and I will provide a place to share them.

David

PS. Interestingly nobody mentioned that a reason was that their PACS vendor had failed and gone out of business, which I guess is a good thing :) Or even mentioned that they had been acquired by another vendor, which is interesting too. Too small a sample, methinks.

PPS. Here is a link to the survey form used, in case you are interested, or want to complete it yourself; I will continue collating results.

Digital Breast Tomosynthesis & the Informatics Infra-Structure
How Digital Breast Tomosynthesis Kills Your PACS/VNA - See more at: http://www.siim2013.org/digital_breast_tomosynthesis_ed_forum.shtml#sthash.O1d6c2cQ.d

IHE Desperation Hypothesis Confirmed

Summary: IHE USA President confirms to Connectathon Monitors that motivation is Meaningful Use.

Long Version.

One of the complaints I have had about the IHE Certification announcements is the poor communication about it, and particularly the Connectathon monitors.

Belatedly, last night a message was sent out to the IHE NA Connectathon Monitors, on behalf of Joyce Sensmeier from HIMSS, President of IHE USA.

Reading beyond the feel-good marketing hype, some phrases stand out like "certification in the US market is already a reality", "this certification program makes IHE a visible part of that process", "highlights the relevance of IHE's profiles" and "provide ... components of meaningful use Stage 3".

Desperation hypothesis confirmed.

I gather, by the way, that ONC folks will be coming to visit the Connectathon for the usual dog-and-pony show, and no doubt their attention will be specifically directed to the ICSA Labs efforts, as a sign that IHE is taking ONC seriously, or something. I bet they will get a laugh in private out of these last minute hand waving attempts to demonstrate relevance (they may not be IHE true believers, but they are certainly not morons). I would also be surprised if it influenced them one iota. I am sure they are well aware that the addition of certification does not magically vindicate the underlying standards or technologies. As enamored as they are of picking and choosing and modifying or reinventing bits and pieces of standards to create their own certification criteria, certification specifically for MU is not going to magically disappear because IHE certifies too.

It is a shame that total obsession with the US EHR Meaningful Use market is triggering an enthusiasm for certification that will contaminate the global market place for all forms of medical technology, raising healthcare costs everywhere.

Still, I have to give Joyce credit for finally having the courtesy to brief the worker bees, so here is the full text of her message:

"Greetings IHE 2013 North American Connectathon monitors,

As you have likely heard, IHE USA has announced a new program <https://www.icsalabs.com/ihe> that will offer certification to complement existing testing of conformance to IHE integration profiles. This new service will be delivered through a strategic partnership between IHE USA and ICSA Labs, and will commence in a pilot program at the 2013 North American Connectathon <http://www.iheusa.org/learnmore.aspx>. IHE USA is pleased to be working with ICSA Labs as we share the goal and experience of accelerating the adoption of usable, secure, and interoperable health information technology, to enable the improvement of patient safety and delivery of higher quality of care. Certification in the US market is already a reality. This certification program makes IHE a visible part of that process. It highlights the relevance of IHE's profiles and their ability to provide substantial interoperability components of meaningful use Stage 3 and any programs that might build on or succeed it.

The IHE North American Connectathon continues to play a pivotal role in allowing the opportunity for HIT vendors to validate their implementation of IHE profiles and help demonstrate compliance with interoperability leading to information exchange. The addition of a certification track will provide a continuum that adds independent third-party assurance that there is a credible, repeatable process that ensures quality, and that these products will exhibit the robust capabilities for optimal data exchange and security that are demanded by our industry today. Certification testing is an elective service and not required for any Connectathon participant. The intent of the certification pilot is to provide a proof of concept for vendors that choose to participate, and lay the groundwork for the ability for products to be certified for interoperability under ISO standards.

We are engaging knowledgeable parties from within IHE to help define the interface between the Connectathon process and certification. This pilot will be conducted separately, but will be convened in the same general location as the 2013 North American Connectathon process that you will be monitoring. The intent is that the pilot activities will not conflict with ongoing Connectathon testing, nor should these activities increase your burden as volunteer monitors during the pilot process over the week. Additionally, IHE USA, as a deployment committee of IHE International, will be providing oversight of the certification program to ensure confidentiality and safeguard any relevant IHE intellectual property. In addition, IHE USA will indemnify its agents (including monitors and contractors) from any liability resulting from testing and certification.

To provide you with a better understanding of this effort we are developing a message to address Frequently Asked Questions. This will be sent by Steve and Lynn in the coming days.

Thank you for your ongoing support of IHE USA as it hosts the 2013 North American Connectathon and have a wonderful holiday!

Regards,

Joyce and the IHE USA and 2013 North American Connectathon team

Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS, FAAN

President, IHE USA"

So there you have it straight from the horse's mouth. Or whatever end you think it is coming from.


Saturnalia optima tibi exopto.

David

PS. I also got a personal response from RSNA staff leadership on the subject, which reiterates many of the same points Joyce made in more detail, but since it wasn't an official announcement to a large group, I won't promulgate it. I mention this because, sadly in my opinion, the imaging leadership that championed much of the development of IHE in the first place seems to have turned its back on its core constituency and seems to be towing the HIMSS-driven party line. If I were a major imaging equipment vendor, I would be supremely pissed, and I am looking forward to seeing what MITA's response on certification is, if any. Though after MITA's pitiful failure to comment on MU2 thanks to GE's veto, they may have already lost both their credibility and relevance.

Will Certification Kill the IHE Connectathon?

Summary: IHE Certification has been announced, is dubious but probably unavoidable; the for-profit ICSA Labs will execute it, possibly gutting the participation in future Connectathons and leading to their demise

Long Version.

With unseemly haste, and little time to go before the IHE North America Connectathon starts at the end of January 2013, IHE USA has announced a new IHE Certification program to be executed by ICSA Labs, a for-profit division of Verizon that has significant experience in security certification and is also a Meaningful Use ONC-Authorized Testing and Certification Body (ONC-ATCB), which competes with the likes of CCHIT.

There is no point in debating whether certification adds any value to the customer of interoperability products; that cat is already out of the bag, for MU at least, since ONC has a hard-on for certification (and asks standards organizations like IHE and DICOM uncomfortable questions when there is no corresponding formal certification program). Compared to all the other ludicrous costs of bring a product to market that do little if anything to improve quality or assure safety or interoperability, this is just yet another check box (and lifetime employment program) for the army of quality, safety and regulatory personnel. I don't have a strong opinion about the merits of certification per se; my anecdotal experience as a vendor and a customer and a worker in regulated industries would lead me to believe that it is neither necessary nor sufficient, unless it is conducted with such thoroughness (by which I mean depth and coverage of testing, rather than volume or rigor of documentation) as to be impractical. But I don't have any real evidence one way or the other.

I have no direct knowledge of the IHE USA Board's discussion of the matter, so can only guess as to their motivation. It isn't likely to be the potential for a significant revenue stream, since the price point precedent established by the ONC-ATCB market isn't very high, and the cost of doing the vast amount of ISO-standard inflicted paperwork isn't trivial. I am not sure whether or not IHE USA is getting a cut from ICSA Labs, or perhaps is even funding them.

The haste smacks of desperation, so another guess would be a desire by IHE USA to try to remain relevant in the US national "discussion" on what standards to adopt (if you can grace the ONC autocratic decision-making process with that term). Since a nice thing about standards is that there are so many of them to choose from, and anyone can make up a new one and call it a standard (as the DIRECT folks have clearly demonstrated), there is no question that choices need to be made. IHE USA's difficulty may be that, much to their chagrin, the ONC does not accept as a no-brainer that IHE's choices are always the best choices.

There is also little point in bemoaning what, as far as I can tell, has been a distinct lack of consultation with the IHE community at large. Almost nobody I have talked to knew anything about this before it was announced, and even those meetings that I am supposed to participate in (being Rad TC co-chair) like the Domain Coordination calls (which discuss such boringly bureaucratic and tedious topics that even I with my love of standards documentation can't stomach), were not, I am told, briefed about this. Nor was there a peep on the Testing and Tools mailing list. Clearly the lowly workers did not merit either the opportunity to comment nor advance warning. Strangely enough, the vendors I have talked to were not aware of it either, and indeed the vendors have a long history of opposing the additional burden of certification and have lobbied against it on the basis that self-certification has a demonstrated successful track record, and certification adds cost without value. Perhaps the IHE Board knew how controversial this would be and did not want their decision second-guessed, or perhaps they just got snowed by a plausible argument by a talented evangelist for the concept.

Or perhaps ONC just issued one of its edicts and the board had no choice ... conspiracy theories abound given the lack of transparency in the decision making process.

For better or for worse, unless the pilot ICSA Labs project overlaid on top of the IHE NA Connectathon somehow fails spectacularly, IHE Certification, now that it has been "announced" may be here to stay. If few vendors sign up for certification, then it might fail, but given the loss-leader price of $1,500 for each actor (in packs of 5) that they are offering, it seems unlikely that there won't be a sufficient critical mass of product managers who are tempted to get an additional potential marketing advantage over and above their normal Connectathon passing "gold star", or are just scared of being left behind if certification does become a trend. Today's briefing by ICSA Labs was certainly laced with dubious but blatent teasers for marketing folks. Besides, like UK National healthcare IT projects, it may be sufficient to "declare" victory even in the face of obvious failure, if the political motivation to proceed is strong enough.

So, with that background, on to the question of what this means for the upcoming and future Connectathons. One of my initial concerns, that the work product of the army of volunteer monitors who staff the Connectathon would somehow be "re-labeled" as a certification result, was clearly assuaged by ICSA Labs on today's call - their tests will be separate from the Connectathon tests, executed by their own staff (who they are calling "inspectors" to distinguish them from "monitors"), though they may repeat the same test, or add more steps or tests, and will certainly add more documentation. So, the volunteers will not be "exploited" in the sense of their work being reused for someone else's commercial gain. Nor will ICSA Labs interfere with the process; the certification work will be additional, and later in the week, though predicated on a Connectahon pass.

So far, so good, but what about in the long term? If I, as a vendor product manager, feel the need to obtain certification for any or all of my products, why would I bother to participate in the Connectathon at all? If I have to do the same amount of work, gain the same experience, and the additional cost is small related to the real or perceived marketing benefit, why do it twice? Though the certification testing will take place at the Connecthon itself for the pilot, in the long term ICSA Labs plan to do this separately as needed, virtually (over the Internet) if possible. Arguably, the Connectathon serves as dry run, but those can probably be done just as easily at home or informally.

Similarly, why would I ever volunteer to staff a Connectathon, when I could probably charge my hourly rate to ICSA Labs, or get a job with them, to do exactly the same thing (unless of course ICSA Labs treats its employees like parent company Verizon treats its linemen)? There is an educational component to volunteering, but for experienced folks, the supply is small and now there is a competing consumer.

That is why, at this date, I am opposed to IHE Certification process as announced; not because I think it is a waste of time and money (which I sort of do), but because it puts at risk what I think is much more important, the opportunity to gather and learn and test and even experiment at the Connectathon, in a relatively informal manner that encourages iteration, improvement and collegiality between competitors. In my opinion, there will inevitably be a dramatic reduction in Connectathon participation as a consequence of the need to become certified; regardless of how much the engineers might want to test at such an event, their marketing bosses who hold the purse strings just will not have the will or the resources to do both.

If I were one of the IHE decision makers, and felt bound to jump on the certification bandwagon to survive, I might have made a different choice, one which did not put at risk the Connectathon, but instead leveraged it, and found a means to certify Connectathon results, building on the experience and dedication of the existing staff, and added the necessary documentation (preferably automated) to satisfy the ISO processes. This sort of thing has been discussed before, including by the people who do the work. I dare say I would have been skeptical about the feasibility and initial cost of this, and tempted by the offer of an existing organization like ICSA Labs with the ISO infrastructure already in place, but I would have prioritized the future of the Connectathon, and seen the modest revenue stream from certification as a means to (belatedly) beef up the tests and tools that have languished somewhat for lack of resource investment over the years.

Not to mention avoiding the slap in the face to the core Connectathon staff, who, for well over a decade, have been putting on this event with diligence and dedication, and who are now probably destined for unemployment or a future as underpaid mistreated Verizon drones, in addition to seeing their many person-years of work in the form of openly available tests and tools handed off to a for-profit to reap the benefits, as well as being denied the opportunity to turn their vast talent to performing certification themselves. They are obviously not able or willing to speak about this, but observation of their reaction would suggest that they were not consulted or warned about this either; if that is the case, it is shameful treatment by the IHE organization that they have served so loyally.

Given my upcoming New Year's resolution to be more of a glass half full kind of guy though, perhaps I should view this as a precedent and take the opportunity to start a new initiative for DICOM Certification, probably the last thing the world really needs, but hey, there is no point in standing on principle in the face of a tidal wave, and if you can't beat them join them. Give the customer what they think they want, not what they actually need.

I still haven't decided whether or not to withdraw from volunteering as a monitor for the upcoming Connectathon. I would hate to miss it, but given that it is one of the few tangible ways to express my displeasure, I don't think I have much choice other than to boycott the event.

David

PS. An interesting side question, is why IHE USA did not select the non-profit CCHIT organization as a partner in this, particularly since they are doing the certification for Healtheway (formerly the Nationwide Health Information Network NWHIN). Perhaps it is just because Mike Nusbaum, a long time IHE player and expert has joined ICSA Labs as Program Consultant and seems, judging by today's briefing, to be a key player in this effort; they certainly have someone who knows what they are taking about. Not that I have any great love for what CCHIT does either, just wondering.

Patient Empowerment: Real Time Wireless Synchronization of Images and Records to Their Smart Phone

Summary: Your image-enabled personal healthcare records belong on your smart phone, the instant that they have been created.

Long Version.

Imagine you are a patient, and as you climb off the CT table, return to the dressing room and prepare to leave, your smart phone or similar device, which is always turned on, has already authenticated itself on your behalf to the PACS, and proceeded to download the complete set of images just acquired (which come out of the reconstruction pipeline almost instantly nowadays).

Then, whilst sitting in your doctor's waiting room (or perhaps whilst stuck in traffic on the way there; naughty, no reading images whilst driving) you could scroll through the images and decide what questions you wanted to ask about them, perhaps with the benefit of the previous images and reports that you already had, or even with the fresh report that just popped up as the radiologist (finally!) got around to reporting the study half an hour after it was acquired (probably the delay was negotiating for the lowest bidder to report it in India or China).

Technical challenges of bandwidth, storage, compression and so on aside, this is entirely within the realm of possibility right now, much less in a few years, when we will fondly recall how limiting 4G was and how quaint 2GHz quad-core processors were. As applications and services providing seamless synchronization between an individual's myriad devices proliferate, together with remote "backup" (on "cloud" providers), the sort of device-independent availability of information that users already expect for mail, contacts and documents, will become available for healthcare records too.

The imaging use case is more challenging, given the large volume of data, but it is qualitatively if not quantitatively similar.

As for security, authentication and access control, most healthcare facilities seem more than capable of finding ways to identify the patient in order to bill them or or their insurance company. It seems likely that just as one typically enables personal devices like phones to automatically authenticate to commercial service providers for shopping, music and video access, a patient that establishes a relationship with a medical facility ("registers") could at that time (or subsequently) register their device, just as one does with any other online "portal", and the device would cache the credentials (or not, depending on the paranoia and personal policy of its owner).

Subsequently, the "patient health care record app" on the device would take care of automatic synchronization with the most recent record information, at every provider that the patient visited, seamlessly, automatically and silently. It could merrily beep as it received new information, make more arousing noises to notify when more critical information arrived (like an out of range lab test or abnormal radiology result). As the longitudinal record grew it could flush from its cache older information (on a rule driven basis), with the patient secure in the knowledge that the multiple "cloud" servers on which everything was backed up and the entire record stored would allow them to retrieve older stuff on demand as necessary. Geographic proximity to the provider would be unnecessary, and the device would, as they typically do already, even for voice, adapt to the fastest accessible network (Wifi if local, 4G or less if not).

Then, when visiting a new provider and registering with them, the reverse could occur. The patient's own device could synchronize whatever the patient wanted to share with the providers systems immediately on registration, or communicate the unique identifiers of each piece of information to the provider's system so that it could synchronize it from the cloud servers if not locally cached.

With nearly half of all US phone subscribers acquiring a new phone now choosing a smart device, it seems inevitable that the penetration of these devices will asymptotically approach ubiquity.

The single device that a person already carries offers the potential to eliminate the need for paper tokens like airplane boarding passes or entertainment tickets, and for payment, instead of cash and credit cards, and already serves many of us as the primary interface for online information gathering, decision making, navigation and shopping (see it, snap a picture or bar code, buy it online). It seems inevitable that it will also become the primary conduit for all personal information access and storage, so why not healthcare information, including diagnostic images, too?

The idea of a PHR on a smart phone is incredibly obvious, and already various PHR groups are starting to provide such apps and services with varying degrees of sophistication and integration (see, to name only a few, motionPHR, MyMedicalRecords.com, mobileStorm) and it is inevitable that the sophistication of all aspects of "mHealth", as it is now referred to, will grow at a phenomenal pace. Extending it to include diagnostic imaging beyond the current crop of simple "viewers" (like Mobile MIM) to include seamless synchronization as part of the integrated personal record seems like a no-brainer.

Perhaps by the time we get to Stage 3 of Meaningful Use, the neanderthals who colluded to cripple Stage 2 will have been outpaced by more disruptive innovators, and it will be timely to reimburse specifically for seamless patient-controlled synchronization of images and everything else, not only in a general "download and transmit" sense, but with a specific certification requirement to permit this via their mobile devices.

David

HL7 to Become a Truly Open Standard After All

Summary: HL7 to implement a free IP policy by Q1 2013, and become a truly Open Standard, with both Open Access and Open Use.

Long Version.

I got a whole bunch of emails this morning from HL7 members who had received a special announcement via email from the HL7 CEO, Charles Jaffe.

The long and the short of it seems to be that the HL7 Board of Directors has "committed to licensing its standards and other selected HL7 intellectual property free of charge".

Outstanding!

The details are described in an FAQ at "http://www.hl7.org/about/faqs/FreeIP.cfm", which was only accessible to HL7 members, but as of a few minutes ago, became generally accessible.The CEO's announcement has also just appeared as news on the HL7 home page here.

A few of the highlights of the FAQ include:

• recognition that "charging for standards is a barrier to widespread adoption"
• "increasing government demand for standards that do not require a licensing fee"
• HL7 will retain copyright (i.e., not "public domain") to retain control over change and improvement process (conventional for most standards)

My understanding is that both access to the standards, and the right to use the standards in implementations, will become free, globally, so that any current barriers to open implementation will be removed.

There will be some delay until this policy is in place, and in the interim the current licensing policy applies, but the commitment is to roll this out by Q1 2013, apparently.

I am certain that other open source code developers are as pleased by this as I am, and I am sure that we are all equally grateful to whoever those HL7 stakeholders were who were responsible for this development (like Keith Boone, for example).

David

Diagnostic Quality is Vital; Download and Transmit is Feasible

Summary: ONC could have and should have required CEHRT to include provider viewing of both key review images (fast) and complete sets of diagnostic quality images (slower), and patient viewing, downloading and transmission of both review and DICOM diagnostic images, assuaging the fears of EHR vendors by suggesting the use of links to PACS for the latter, just like for provider viewing. The lack of specificity on diagnostic quality may allow re-emergence of a patient care quality risk and an unsatisfactory standard of care. Deferral to a later stage undermines the progress already being made, due to diversion of all available resources to Meaningful Use.

Long Version.

It may certainly appear from my recent comments about Meaningful Use Stage 2 as if I am a "glass half empty" kind of guy. After all, some might say, one could put a positive spin on the fact that anything to do with imaging at all is included in the certification requirements; John Halamka, for example, sees it as a balance (whilst warning that what remains is still a stretch).

Unfortunately, there is a danger in what has been included, which puts what has been excluded at greater risk than it might otherwise have been. Specifically, there is a risk that the standard of care will be lowered by the suggestion that an incomplete set of non-diagnostic quality images may be sufficient, or will be all that is made available.

There is no question, of course, that there are use cases for which only key images of "review" quality are sufficient; one commenter drew attention to the scenario of reviewing a diagnosis with a patient, perhaps for treatment or prognosis explanation purposes. And that's fine. Certainly, for these scenarios, the manner in which limited review quality images is provided should not be burdensome or slow.

However, as we all know, there are many scenarios in which a complete set of diagnostic quality images are required. It seems that these will not need to be available through the EHR system, whether through a link or direction incorporation, because CEHRT will not be required to provide them, whether to providers or patients, and we all know that all available resources of vendors and providers will be diverted to CEHRT exclusively in order to "cash in" (to use one popular media outlet's tasteless expression) within the required timelines.

Deferring the need to support provision of a complete set of diagnostic quality images unfortunately may undo the good work of the AMA safety panel convened a few years ago to address this very issue, the conclusions of which the AMA reiterated in their CMS comments (not their ONC comments).

One may argue that since the actual final rule itself is silent on the matter of whether diagnostic quality or a complete set are or are not required, that this is not a problem. I am not so sure, since comments were made about the matter, and discussed in the response, and the absence of a requirement seems to establish the lower expectation.

In summary, not only is the "glass half empty", but what remains in it is potentially noxious.

So let me return to the feasibility of the Download and Transmit Images capability that was dropped (and for that matter Viewing by patients, as opposed to providers, which is also not specified), and why I still think both CMS and the ONC could have done better (and for that matter, how I think more commenters could have suggested constructive, non-threatening solutions as opposed to just objecting).

I will address this by discussing how Download and Transmit Images might have been implemented, what the implications are with respect to standards and infrastructure, and how the objections raised by the commenters to either the 170.314(a)(12) – Imaging, and § 170.314(e)(1) - View, download, and transmit to 3rd party could have been addressed, particularly where they overlapped or were addressed in the final rules, either from ONC or CMS.

First of all, let's address the "DICOM images are too big" issue, which is related to both the availability of high bandwidth connections, as well as the impact on the "local" infrastructure (computing resources). Certainly complete sets of diagnostic quality images can indeed be large, very large, even if compressed, and even if irreversibly compressed in a manner that preserves diagnostic information.

Though I have focused on the certification requirements, the means to address the bandwidth concern is apparent from the CMS response to comments, which specifically addresses it in connection with the remaining measure for View, Download and Transmit:

"any EP that conducts 50 percent or more of his or her patient encounters in a county that does not have 50 percent or more of its housing units with 3Mbps broadband availability according to the latest information available from the FCC on the first day of the EHR reporting period may exclude ..."

The CMS response also points out that this is a menu objective.

In other words, there was no need to deny patients the benefit of this capability in those areas where bandwidth is sufficient, since CMS was willing to establish an environment-sensitive exclusion.

What about when there is no digital imaging technology available in the first place (e.g., the chiropractors who commented that they are still using film)? Or when there is no PACS in which what digital images there are can be stored? Again, the CMS response indicates that this can be handled by an exclusion "for providers who have no access to electronic images". Just as this applies to the provider viewing requirement, it could equally have applied to Download and Transmit. Also, though it was not specifically mentioned in the response, it appears that there is no expectation that the images be digitized (which would make them "accessible"), as some commenters had feared.

Then there are "DICOM images are complex", "a complex viewer is needed" and "patients can't be expected to find a DICOM viewer". Well, Word files and PDF files and Flash files and MP3 files are "complex" too and the average consumer seems quite capable of locating the necessary software to do what needs to be done; hunting down extra plugins, codecs and helper applications is second nature to most consumers nowadays, albeit not ideal. The computer literate patients likely to be "engaged" (to use ONC-speak) are also likely to be better able to handle this class of issues than is the typical healthcare provider; what is more, they are not hampered by regulatory requirements or local IS policy; they can download and use what they need to get the job done.

Furthermore, the negative comments in this regard seem to miss a key intention of the View, Download and Transmit to a 3rd party requirement, to enable the patient to get what they need and then pass it on to the next provider, not just to be able to view it themselves. Whilst it is likely true that the vast majority of patients have no interest in any of this electronic stuff at all (i.e., are not "engaged"), and of those, only a further subset will be interested in the images, those who are, can in my opinion, be expected to adapt to whatever is available, more readily than inflexible institutions for whom adaptation is much more challenging (and costly). Nor should patients be treated in the paternalistic manner of some of the commenters, particularly those who assert confidently that "patients do not need diagnostic quality images", without considering why the patients need the images in the first place (such as previously stated, to supplement an inadequate or non-existent provider-to-provider transport network). Even for the patient viewing scenario, adequate free downloadable DICOM viewers that are easy to use are readily available for both Windows and Mac, and likely soon most mobile devices, so I don't think this objection has a leg to stand on. Arguably, the free viewers are better than what the vendors provide in some cases anyway. Frankly, getting the images to the screen may be less of a challenge for many patients than understanding what they are seeing when then get them there, but I would not put it past them to find the subtle or incidental finding that the radiologist may have overlooked.

EHR implementers do indeed have good reason to "fear" the "complexity" of DICOM images though, since actually implementing the software to handle their contents does require expertise and hence consumes scarce development resources. It is not that the DICOM images are much more or less complex than most other formats for images or other structured data, but rather that specific expertise is required, beyond what they are used to. Fair enough, but this is no more or less true (arguably less in fact) than for the provider Viewing requirement, and hence it is clearly reasonable to suggest a way not to burden the EHR implementers, and outsource the solution.

It seems obvious, therefore, that the same "link" rather than "duplicate" policy that ONC and CMS accepted for the Viewing objective would have been equally applicable to the Download and Transmit objective, yet few commenters picked up on this and the ONC elected not to take this approach, which surprises me.

This may be a reflection of the limited state of the art in EHR to PACS linkages. It may be common enough right now for EHRs to contain links to pre-rendered individual images (e.g., via WADO or similar) or external image viewers (whether they be PACS or VNA or cloud storage provider or some other system like an XDS-I repository in an HIE), but typically the viewers that are spawned by this mechanism do not then support further handling of what is being viewed. Some may allow download of DICOM images to the local hard drive or CD or USB media, but not all. Probably none currently support forwarding to a third party, other than perhaps to request transmission of the set via local DICOM network services to an analysis workstation.

Furthermore, in many cases the EHR linkage to a PACS viewer may currently only be implemented as a provider-accessible feature, with provisioning mechanisms for security credentials only for staff and a limited set of external providers. The patient-accessible portals are likely implemented in quite a different manner to the provider-accessible portals, and this dichotomy may be the primary source of anxiety about this.

That said, how hard would it be, assuming that one has adequately authenticated the patient who is already using such a portal, and is authorized to view scheduling, billing and electronic record information, to extend that authority to allow them to view their images? This would require that the mechanism used to span the PACS viewer specify the patient's identity, and that the viewer not permit navigation to other patients; not terribly difficult; and likely exactly what has been implemented for the provider portal, since providers are not (or should not be) allowed to just cruise all the patients in the PACS either. In other words, it seems entirely feasible that whatever standard or proprietary mechanism of access control is implemented whilst spawning the provider viewer could be reused for the patient viewer. Yet this was not required by the ONC in the final rule.

What about the burden of shipping a relatively large set of images around in order to be able to Download or Transmit them? Certainly in the case of the Download proposal, the diagnostic quality image set takes a finite amount of time to move across a connection. This is true whether they are encoded in DICOM format or any other, since it is not the fact that they are DICOM per se that makes them large, rather that they are a complete set, and of diagnostic quality. In the case of a patient portal, at a minimum, there is a need to move the entire set from a server location to the patient's desktop, by definition. Ideally, the download would be performed from where the images are already stored, rather than having to first retrieve them to a cache in the portal server, and then provide them to the user. This might be most easily performed by whatever application was spawned to view the images, as discussed above, since such an application would likely already have access to the images in the correct form. Alternatively a specific application on the PACS or archive could be spawned to perform such a function. But in the worst case scenario, the "simplistic" albeit crude approach of just having an application in the portal "pull" (retrieve) the image set from the PACS or archive to its own cache and then download them isn't really that bad; it consumes local resources and it adds a delay that the user might see before the download starts, but if the portal and the archive are co-located at the same site with a high speed connection this may actually not be that bad. EHR implementers might be terrified of the need to learn how to perform a DICOM retrieval, but this is expertise that is easily outsourced and existing free and commercial toolkits have this sort of thing built in; all EHR implementers need to know is how to send via http a bunch of files in a folder, and presumably they are experts in that, and have to do it for other content anyway. Inelegant, but arguably sufficient, and better than nothing at all.

Likewise the Transmit to a 3rd Party requirement isn't really that burdensome either, if one takes a crude approach to it rather than waiting for an ideal solution. If one is willing to retrieve the image set from the archive to a local cache to satisfy the Download requirement, then sending it on to someone else is not hard either, assuming that one has the location and credentials of the recipient available. Since the final rules do indeed still require this feature for non-image data, then the "addressing" capabilities have to be implemented anyway; reusing them for the images would be fairly trivial for the EHR vendor to implement themselves, if they were willing to first retrieve the images and then send them via the ONC specified mechanisms (secure email or XDR, the latter obviously more suitable for large packages than the former).

The Transmit to a 3rd Party requirement would certainly be more challenging to implement in a more sophisticated manner by passing a request to a spawned PACS application. Certainly there are no standards for an EHR to request that a PACS "copy" ("move") a set of images from where they reside to somewhere else, except for the DICOM C-MOVE service, of course, but that only allows copying to a known DICOM network node, and the request has to be made as a DICOM network command, which limits its applicability when one is sending beyond the enterprise's own network. This is actually a bit of a gap in the DICOM Web Services roadmap and the IHE profiles for that matter too; we have defined plenty of services and transactions for actually doing the transfer, but not for requesting the transfer. I.e., there is no DICOM WADO-* or IHE XD* equivalent of the basic DICOM C-MOVE. I need to discuss that gap with both groups, and particularly the need to be able to incorporate in such a hypothetical new standard whatever "address" for the receiving endpoint has been specified by ONC for non-image content.

That said, just as ONC has been willing to accept the proprietary rather than standard mechanisms for linkage of the EHR to the PACS for the provider Viewing requirement, there is no reason that they could not have permitted the same for the Transmit to a 3rd Party requirement, as an alternative to implementing the requirement via the less efficient "retrieve, cache, and transmit" mechanism that I just described. As long as the patient portal in the EHR takes responsibility for access control, i.e., for authenticating the requester and limiting the request to that patient, the spawned application could then "do the work" of transferring a copy to the specified recipient. The PACS application would have to implement the specified transfer protocols though, but it is possible they already support XDR (though unlikely that they support secure email). Of course, for the vendors (and the customers) the proprietary linkage does require the usual n:m integrations between the two sides, with its attendant costs, but if it was good enough for satisfying the provider Viewing requirement, it could have been good enough for the Transmit to a 3rd Party requirement too, had that been considered a high enough priority.

On the subject of priority, it really bothers me that the EHRA insisted that "the images could be provided to the patient on a CD or DVD". Haven't we had enough of the problems associated with physical media? Isn't the goal of the Meaningful Use initiative in the first place to provide better care through electronic access. Sure, once upon a time, physical media was the best we could manage, but the literature and the Internet are filled with a litany of complaints about the problems caused by CDs up to this point, and surely it is a priority to insist that readily available technology be used (just Google "imaging cloud" for instance, not to mention XDS-I). I find the EHRA's comment that "electronic communication of DICOM images, particularly when possibly needing to allow the patient to see the images, is still a new area" to be extremely uninformed at best, if not outright disingenuous.

All in all, as far as I can tell, the final certification requirements boil down to no more or less than this:

"electronically indicate to a user the availability of a patient’s images and narrative interpretations (relating to the radiographic or other diagnostic test(s)) and enable electronic access to such images and narrative interpretations."

No requirement for a complete set, no requirement for diagnostic quality, nothing for images under the category of patient engagement.

Disappointing, since it was entirely feasible, in my opinion, to do better and push the vendors harder.

Farzad tells me that he hopes that the business case is so clear that it will happen regardless, and he may well be right. However, I fear that Meaningful Use seems destined to suck up all available resources and to drag the vast majority down to the lowest common denominator of "no better than Meaningful Use", which is still a pretty high bar and significant progress, apart from imaging. In particular, the dangerous precedent of not requiring diagnostic quality images may directly lead to patient harm. In due course, I dare say we will hear what the plaintiff's attorneys have to say about all this, when someone misses a critical unreported finding when they view an incomplete or low quality EHR image set with the consequence being an unfortunate outcome, since being proactive in this respect seems to be beyond our ability to mandate.

David

PS. I should, by the way, draw attention specifically to the comments of one EHR vendor, who did not follow the crowd of their naysaying peers. Cerner was notable in that it drew attention in a very constructive manner to such things as the need to specify requirements for what the viewer actually should do to be useful (pan/zoom/scroll), for example. In an interview for Radiology Today I had mentioned that this was a factor that we could have addressed in the comments, using something like the IHE Basic Image Review (BIR) Profile perhaps; i.e., provide some functional requirements for the viewer in the certification requirements. Regrettably, I did not think to suggest this when I had an opportunity to contribute to the draft RSNA comments before they were submitted. Not that BIR has had stellar adoption, largely due to the installed base of existing viewers whose implementers are resting on their laurels, and are uninterested in retooling their user interface in the name of consistency; but it does define a baseline for a minimum feature set negotiated with the user community.

PPS. On the matter of the comments related to whether or not this is confined to just radiology images, the CMS responses attempt to clarify that by defining the measure in terms of "tests whose result is one or more images". Perhaps this is clearer, but is the "result" of an echocardiogram or a coronary artery calcium scoring CT the images themselves, or just the numbers (LVEF or Agatston score)? Also, if one is self-referring (e.g., a neurologist with their own MR or a cardiologist with their own CT), is that included in the measure? I guess so, since the measure states "ordered by the EP" and to the extent that an "order" is required to get paid, even if one is fulfilling the order oneself, I suppose it is included. The ONC certification requirement does spell out "radiographic or other diagnostic test(s)".

PPPS. Surprisingly, I could find little mention of some key issues that commenters could have objected to that are real infrastructural challenges, For example, nobody mentioned (as far as I could find) the matter of patient identification, which would have been an issue for Download and Transmit, since during importation at the other end, one often has to do this manually (though the IHE IRWF Profile provides ways to automate this). The focus seems to be more on getting stuff out rather than back in again, so I suppose that is fair enough, and having a national patient identifier seems to be a dead duck in the US for now.

PPPPS. All this talk of "links" to other systems, whether via WADO or similar proprietary mechanisms, spawning of external viewers, or even synchronized applications in a CCOW-like manner, reminds me that this is not a new topic and that there is a lot of experience, favorable and unfavorable, in this respect, which might lead one to the conclusion that links are an interim step and that a monolithic system will one day be needed (e.g., real images really stored in the EHR, and advanced visualization built in). You might want to read "Radiology IT: Applications Integration vs. Consolidation" by Peter Kijewski about the MSKCC experience, as well as Wang et al "Five Levels of PACS Modularity: Integrating 3D and Other Advanced Visualization Tools".

Also, now that I think of it, there is a reason that the VA has, for a very long time, had Vista Imaging as part of their EHR system, rather than depending on accessing images through the various locally deployed PACS. You might want to track down old articles by Peter Kuzmak or Ruth Dayhoff on the subject; there are too many to enumerate here, but this 1999 (!) symposium paper on "Providing a complete online multimedia patient record" is a classic. It is amazing to consider how fearful contemporary EHR vendors are of images, yet well over a decade ago the VA just got on with the job and took care of the needs of their users. "Electronic communication of DICOM images ...  is still a new area" (says the EHRA); yeah, right; Luddites.

By the way, the VA's Consolidated Health Informatics Standards Adoption Recommendation Multimedia Information in Patient Records is good read too.

Influencing the ONC - Collusion or just reasonable lobbying?

Summary: The EHR vendors amongst themselves and/or through their EHR Association appear to have colluded to ensure that imaging download and transmit was excluded, and Epic in particular lobbied their customers to comment; this was presumably obvious to the ONC; regardless of the merits of the argument, is it fair?

Long Version.

This post is not going to discuss the merits of including Download and Transmission of images, which I will save for another post, but rather the appropriateness of the comments and the manner in which they are submitted.

I wasn't going to bother addressing this issue further, but the topic of the commonality of certain aspects of the comments was picked up from my summary on the Healthcare Renewal blog in "Health IT Vendor EPIC Caught Red-Handed Using Customers as Stealth Lobbyists; Did ONC Ignore This?", so I suppose I should.

Also, an anonymous commenter on my blog entry responded last night:

"But that doesn't mean that there is a conspiracy - or that one organization (as you blogged earlier in the week) has deeper influence than any other .. and if you think that Epic's redundant comments parroted by their many customers counted as anything more than one opinion - you underestimate the aptitude of our friends at ONC and CMS. They weren't born yesterday, ya know."

I do agree that it is likely that similarity of the comments was completely obvious to the government folks, who no doubt did a very thorough analysis, and that they took this into account. It seems likely that they were sensitive to the intensity of the strident opposition of the entire EHR industry, and considered the merits of the arguments independent of the manner in which they were submitted.

I can't say that I agree, however, that there might not have been a "conspiracy", although I don't think there was anything particularly clandestine about it (particularly since many of the comments from the customer sites were prefaced in their covering material with "I agree with Epic", etc.).

I took a look with Google and on the HIMSS EHR Association web site to see if I could find minutes or other records of EHRA meetings, where perhaps they might have discussed a consistent response in order to discourage the inclusion of View, Download and Transmit images, but I couldn't find anything.

I don't know what anti-trust protection procedures these EHR vendors follow when they meet in their association, and there was no mention of that on the association's site or on the parent organization HIMSS web site either (in their bylaws or any where else). I found this a bit surprising, since in my experience, NEMA (the DICOM parent organization), as one example, is obsessive about this issue, and has all minutes both reviewed by counsel and posted publicly to assure transparency and appropriate conduct.

Since the public comment process for a proposed rule-making is not a procurement or grant award, I dare say that the "Red Flags of Collusion" described on the DOJ web site are not directly relevant here, even though the Final Rule specifies certification criteria that products will have to meet to be viable in the marketplace, and hence the conduct of the public comment process directly shapes that market. Certainly if they were applicable, the "similarities between vendor applications or proposals" criterion would be met! I am not sure to what extent this does or does not fit within the concept of conduct to "encourage uniform action" (as distinct from "voluntary parallel action").

I guess there is a fine line between trying to develop or adopt standards to promote interoperability, a goal that is clearly in the public interest, and trying to manipulate the market to satisfy the shared objectives of a group of vendors. Others have expressed general concerns (in a context that has nothing to do with imaging) about the MU certification process distorting the marketplace and leading to increased prices for certain functions (e.g., see the comments by the Kansas Hospital Association).

Likewise, making public comments may or may not constitute "lobbying". I couldn't easily find online any documentation of whether the EHRA or HIMSS does or does not formally engage in lobbying or have a separate PAC, or how this is related to their non-profit status (insubstantial portion), or whether they report this. By contrast, in NEMA, as I understand it, the standards development and other activities are separated from lobbying activities, and there is a separate NEMA PAC, and it makes the required reports to the Senate about how much it spends, etc. I mention NEMA only because I have some familiarity with them, not to imply that they are pure as the driven snow.

What about the distinction between comments from vendors and customers? Why, for instance are so many Epic customers apparently willing to relay the EHRA's message that single sign-on is not wanted? Why on earth would a user want to log in separately to the PACS every time they wanted to look at an image, even though they were already logged in to the EHR application (and the operating system for that matter)?

I suspect the answer is the obvious one, the responses aren't from actual "users" at all, but rather from the IS folks who deploy the systems, and who are on the hook for providing the service and paying for the infrastructure, which in many cases may not be supported by their existing software choices (and in some cases obsolete versions). It is clear from the Epic template, as well as explicit comments from other vendors, that customers were left in little doubt that the single sign on feature was going to either cost them money or divert resources from other developments that they might perceive to be a higher priority, as well as require engagement from other vendors. This almost suggests "intimidation" but I suppose can be construed as simply laying the facts on the table (resources are limited; choose what to focus on).

Amongst those other vendors making similar comments were the PACS vendors, some of whom may be equally lame when it comes to infrastructure friendliness features like single sign on, and may well be equally opposed to being forced to deal with this, as would their "customers" (as opposed to "users") too; in theory the PACS vendors might be happy to have the infrastructure manage security and access control, but in practice, how many customers want to be forced to upgrade their PACS just to support meaningful use, and how much would it cost them? Bottom line is that many folks may well want to do this, but in their own time, with as little extra cost as possible, and not be regulated into doing it.

And, with respect to the single sign on feature in particular, it may simply be that the technology and the standards are not ready for prime time; the fact that ONC has a Challenge to study this currently in progress would seem to substantiate that. But I am digressing into the "merits" rather than the "appropriateness", so I will defer that for another occasion.

The same goes for downloading and transmitting images on the network, which is largely a security integration question too, since the EHR "portal" would likely just be acting as a proxy to the PACS where the images reside; this is perhaps not as technically difficult as some have construed (a later discussion), but it is one more thing that involves two vendors talking, and that, as we all know, despite standards, costs money. Contrast the position of the vendors and the customers, with that expressed by the "real" users, the physicians in this case, as expressed by the support, for example, by the American College of Physicians.

So, as the line from the movie goes, "follow the money", not in the sense that any bribery or corruption is involved, of course, but rather in terms of commenters' motivation. The cynical view is that everyone wants to receive the incentives (or benefit from the market created by them) yet spend the least in the process.

The lesson for me, of course, is that those of us who wanted this done "right" should have worked harder to assure that ONC was swamped with supportive comments (and sufficient technical detail to clarify feasibility) and then they might have felt more comfortable sticking to their guns; in failing to do so, "we" were outmaneuvered by the naysayers.

Presuming it is indeed legal and ethical to engage in such conduct, next time "we" need to call in the super-PACs (and not in the imaging sense of the word).

By "we" in this context, I mean those of us who believe that ready access to a full set of diagnostic quality images encoded in DICOM is a critically important and entirely feasible part of any comprehensive electronic healthcare "system", and hence equally deserving of incentives, lack of penalties and certification criteria.

David

PS. My Anonymous commenter also made the point that "doesn't mean ... that one organization (as you blogged earlier in the week) has deeper influence than any other", presumably referring to my initially singling out as GE Healthcare as the prime evildoer in this respect. And he/she is probably right to some extent, since, as it turns out, GE's comments parrot those of their other EHR "fellow travelers"; I would though, be very interested to know how much influence GE individual contributors had in terms of developing the EHRA position in the first place (I have no inside knowledge in that respect). That said, comments that come from companies like GE, which have a reputation as both imaging and EHR vendors, might well, in my opinion, have held greater sway, given their presumed experience in both fields. Hence I suggest that GE and their ilk deserve extra vilification as a consequence of their disloyalty to the imaging cause.