Lab Soft News

A Quick Look at Cardiovascular Information and Imaging Systems (CVIS)

Bruce Friedman — 2009-11-20T07:58:55-05:00

I must have been sleeping at the switch. Outside of my lab/LIS world, a new category of integrated clinical information systems has arisen -- the CVIS or cardiovascular imaging and information system. McKesson provides a CVIS web site promoting the McKesson product. Listed below and copied from the "comparing solutions" tab of this web site is a summary of the functionality of their system:

Reporting: (1) Real-time reporting; (2) Remote report creation and signing; and (3) Automated rules-based report distribution
A single, coordinated image display, to view all medical images
Single sign-on for clinicians to access multiple systems
Patient-centric workflow
Robust digital archiving (efficient access to historical images and data, including echocardiograms, and ECGs and hemodynamic waveforms)
Web access for clinicians and referring physicians

Readers of this blog will undoubtedly be familiar with the major "ancillary" information systems: LISs, RISs, and pharmacy information systems. In addition, we now have the PACS variants in both radiology and pathology. They are used for archiving the digital images acquired in both departments. The CVIS is a very interesting variant on this theme of specialty-oriented systems because, it combines workflow, reporting, and digital archiving similar to LISs, RISs, and PACSs. Note the reference above to a "single sign-on for clinicians to access multiple systems." Cardiologists, the major users of CVISs, obviously need access to the hospital EMR to integrate various streams of clinical data such as current medications and nursing progress notes.

I have suggested in previous notes that hospital EMRs are not adequately designed to hold the text and image files generated in diagnostic departments such as the clinical labs, pathology, radiology, and cardiology. Here are two quotes from a previous note discussing the superiority of "ancillary department automation" over EMRs and the goals of EMR vendors (see: EMR Failures and a Recipe for Their Avoidance in the Future):

....Mr. HIStalk's proposed solution [for managing hospital information systems]: stick with ancillary department task automation. I will take his definition of ancillary information systems to primarily involve LISs, RISs, PACs, and pharmacy information systems. Unfortunately, few CIOs and CMIOs have in-depth knowledge about the lab, radiology, or pharmacy systems. They are managed by the knowledge and process domain experts in the specific hospital departments, frequently with hosting by the central IT departments.

For their part, EMR vendors continue to pursue their short-term strategy of selling inadequate and poorly designed systems that that are difficult to install, don't scale up, or perform inadequately. CIOs and CMIOs keep buying inadequate EMRs, despite the long history of failure of these systems, because they are paid to deploy "modern" systems and there are few if any in the market that respond to their wish lists. You have two sets of players that are pursuing a flawed business model in concert.

So what is the take-home lesson from all of this. Pretty simple, really. The "departmental diagnostic systems" continue to evolve, frequently integrating images with reporting information. Moreover, they also manage patient and physician mission-critical workflow for the various specialties. This is in contrast to hospital EMRs that more frequently serve as data repositories relating to clinical care. The LISs, RISs, radiology/pathology PACS, and now CVISs are thus on a different development trajectory than EMRs. I am not exactly sure of the future relationship of the EMRs to these ancillary systems but the "integration" challenges will be formidable.

Reader Suggests Substitutes for the Term "Soft Copy Read" in Digital Pathology

Bruce Friedman — 2009-11-19T08:29:31-05:00

In a blog note posted yesterday, I suggested that the term soft copy read could be used by pathologists to describe the process whereby a scanned image of a tissue lesion is reviewed using a terminal rather than a microscope (see: Digital Pathology, Pathologists, and the "Soft Copy Read"). I am not completely satisfied with this phrase, borrowed from the radiologists, but think that its use, or a similar phrase, could be useful in the digital pathology dialogue. In response, Lance submitted the following comment:

Perhaps a more applicable term would center around the [term]: 'digital diagnosis' or 'z-view diagnosis'. Note, in both terms, inclusion of the term 'diagnosis' implies that the final decision/diagnosis rendered was made using the preceding word's methodology. For the two (off the cuff) terms - 'digital diagnosis' would imply/mean that the diagnosis was made using a digital display, and the latter incorporates the fact that the digital scanner incorporates a z-plane. Granted, with the latter term, a 'z-plane' is technically a component of glass slides as well, though we often don't think of it in such terms. Moreover, this renders an interesting question regarding terminology and nomenclature. One factor not fleshed out in this post is the permanent inclusion of a term (such as 'glass diagnosis' or 'glass review') that details/parallels the 'hard copy', e.g. glass in the world of pathology. Perhaps the term 'tissue diagnosis' remains correct, but it greatly generalizes things and may become akin to saying a clinical diagnosis was made...a term that, in actuality, fails to convey any methodology used, but rather is a generalized 'waste basket' term.

First of all, I agree with Lance that the inclusion of the term diagnosis in the phrase could be misleading. Frequently, there is no lesion present so no diagnosis can be rendered. The use of the term z-view is also misleading because most paraffin sections, but not necessarily cytopathology smears, will be scanned only in one plane. The terms glass view or glass review suggested by Todd above have much to recommend them. I will also suggest the phrase glass read that is quite similar to soft copy read and has a clarity and directness that appeals to me. Given that tissue sections mounted on glass will not disappear in the foreseeable future, any term including the word glass should have a long life.

So, to recap the discussion, we are considering at several terms to describe the review of a scanned image on a terminal screen by a pathologists. The current candidates are the following:

Soft copy read
Soft copy review
Glass read
Glass review
Glass view

Among these, I personally favor glass read or glass view because they are short, descriptive, and to the point. What do you think?

Digital Pathology, Pathologists, and the "Soft Copy Read"

Bruce Friedman — 2009-11-18T07:57:19-05:00

A reader of Lab Soft News has suggested that it would be useful if pathologists were to adopt the phrase soft copy read as part of the ongoing discussion about digital pathology. The term is in common usage among radiologists. Digital pathology, of course, refers to the process by which the images obtained from fixed stained paraffin sections of tissue are converted to digital format, interpreted by pathologists, and then stored. Soft copy read refers specifically to the rendering of a diagnosis from an image displayed on a monitor without the creation of a hardcopy image as an intermediate step. Radiologists, of course, have a history prior to the development of digital radiology of "reading" a hardcopy film copy of the image.

The use of this phrase may be useful because the term digital pathology is often used to describe the entire digital pathology process. I can see the value of teasing out individual steps and assigning them specific names. I personally was initially confused by the use of term soft copy read because pathologists have never made use of a hard copy like radiologists. In other words, this intermediate step has never really existed for pathologists other than in the occasional post-diagnostic step of integrating one or more images of a lesion in the printed report sent to the test-ordering clinician.

Having said this and not being sure that the use of the term soft copy read will gain currency among pathologists and digital pathology experts, I do understand the value of its use. In my subsequent notes on this topic, I will try to make it a practice to use this term and we will see if it has staying power.

Some Key Questions in Cytopathology That Rquire Immediate Answers

Bruce Friedman — 2009-11-17T08:18:55-05:00

I recently shared the podium for a lecture with Dr. Liron Pantanowitz. This took place at the annual conference of the American Society of Cytopathology (ASC) in Denver. The two of us discussed innovation and the relevance of information technology (IT) for the field of cytopathology. At the end of his lecture, he presented to the audience the following key questions that are confronting the field and require immediate answers:

Are conventional Pap smears still considered acceptable standard of care?
Is autoverification (no human review) of imaged abnormal Pap tests feasible?
Will future re-screening require morphology review or molecular tests?
Will automated screening be applied to non-GYN specimens and FNA biopsies?
Once [cytopathology] images are [stored] in...computer system[s], [can or] will [their interpretation] be outsourced?
Are new technologies being incorporated into [our training and] educational programs?
Can we do it? i.e. keep cytologists in the center of [the] clinical decision-making [process]?
Can this technology help provide affordable cytology services in unscreened populations without an effective cytology infra-structure? If not, what is the best way to develop this infrastructure?
Will disruptive technology (i.e. new technology that transforms markets) “replace” cytotechnologists &/or pathologists?

I have concluded on the basis of my participation in this conference and other observations that cytopathology professionals have been energized by the availability of vaccines such as Gardasil against human papilloma virus. These vaccines have the potential to eventually eliminate most cervical carcinoma. Much of the energy and professional attention of this group over many decades has been devoted to screening Pap smears for cervical disease. Logically, questions are now being raised within the group about the future of the specialty if and when carcinoma of the cervix is largely eliminated.

From my perspective, it is an urgent matter for pathology groups such as the ASC develop answers to questions such as the ones developed by Dr. Pantanowitz. In fact, I am confident that the ASC leadership is already in the process of addressing many of them. However and for me, these answers are required so quickly that what I regard as the standard approach used by professional societies is no longer adequate. I would recommend instead some variant of the following process:

Set a deadline of, say, six months to a year hence for the delivery of answers to these and related questions from newly empaneled task forces drawn from the members of the society.
Although the members of the society should comprise the bulk of the membership of these task forces, they may need to be supplemented by technical and medical advisers from outside of the society when necessary and appropriate.
It may also be necessary to engage outside consultants to help manage and advise these task forces in order to deliver reports in the aggressive time-frame described above.
Additional financial resources may be required to support these task forces and quickly arrive at the necessary answers. It may thus be necessary to turn to vendors in the cytopathology field to help fund these initiatives with grant support. These vendors, of course, would not be able to influence the deliberations of the task forces but would obviously derive great benefit from their deliberations.
Finally, I believe that it is insufficient to merely provide an informed academic discourse about these questions in reports or white papers. In addition, it will be necessary to develop a set of actionable items such that the talent and expertise of cytopathology professionals can be utilized in diagnosing and treating disease in the face of the new types of "disruptive technology" and social forces that will be confronting them.

Will Posting Calorie Counts in Fast Food Restaurants Help Curb Obesity?

Bruce Friedman — 2009-11-16T08:58:38-05:00

I am a person who thrives on acquiring new information and believe that information can be used to modify one's behavior. In short, I am an informavore (see: Are We Turning into Informavores?). I suspect that many others share this same quality but many in the U.S. population do not. A recent op-ed piece in the New York Times explored the benefits of posting calorie counts in fast food restaurants. Listed below is what I perceive to be the key passage in the article:

Based on the scientific literature, we know that people who seek out and use calorie information are likely to be different from other eaters in many ways, including their motivation to cut calories. Sure, it’s possible that some people who looked at the information were persuaded to consume fewer calories, but it is equally plausible that those who were intending to order lower-calorie meals were more likely to seek out the calorie information. By helping consumers make more informed decisions, calorie posting may be desirable even if it fails to reduce calorie intake. But effective policies to deal with obesity will need to involve much more than posting calories. People eat too much because calorie-dense foods are convenient and cheap, with large portion sizes priced to encourage overeating.

Note the passage above that references "people who seek out and use calorie information." I suspect that they are in the minority in our population. On the other hand, my guess is that the legislators who propose the calorie-posting rules, and the scientists and nutritionists and scientists who advise them, tend to be among those who seek information and are influenced by it. They are also anxious to address the obesity epidemic that we are facing in this country. I personally read calorie counts on labels and would certainly scan them, and be influenced by them, in a fast food restaurant. How many people know that a teaspoon of mustard contains 5% of your daily value for sodium?

However, and as noted above, fast-food-addicts gravitate to these restaurants because of convenience, price, and because the food tastes good to them. These foods taste good because they are loaded with fat, salt, and sugar, all of which have additive qualities (see: Federal Tax on Soda Pop Proposed: Can This Be Justified?). I seriously doubt that posting calorie information in fast-food restaurants goes to the root of the problem that the rules are intended to correct. Our legislative energies should be directed to policies that work rather than those that appeal to information-lovers.

Wal-Mart Launches Co-Branded Walk-In Medical Clinics in Three Cities

Bruce Friedman — 2009-11-13T07:11:47-05:00

Up to this point, walk-in clinics in retail drug stores and big-box stores have not lived up to their expectations. In my opinion, they have enjoyed several key advantages over competing medical offices such as convenience, posted price lists, and relatively low costs for routine procedures. For many of them, however, major liabilities were the absence of a referral network for patients with more complex problems and a lack of integration of their health records with regional physician office and hospital records. This latter problem, of course, is not unique to them. It seems that Wal-Mart has reworked its business model to address at least one of these deficiencies with a co-branding strategy as described in a recent article (see: "The Clinic At Wal-Mart" To Open In Atlanta, Little Rock And Dallas Supercenters). Below is an excerpt from it:

Wal-Mart today announced that its first co-branded in-store clinics will open in Atlanta, Little Rock and Dallas under “The Clinic at Wal-Mart” brand. These clinics – the first of which is expected to open in April – will be connected to their communities via local hospitals that Wal-Mart’s customers already know and respect. Today’s announcement is the first step towards opening 400 co-branded convenient clinics ....Wal-Mart has signed a letter of intent to work with RediClinic...and local hospital systems to open co-branded walk-in clinics in 200 Wal-Mart Supercenters. Wal-Mart has also signed a letter of intent to partner directly with St. Vincent Health System, a part of the Catholic Healthcare Initiatives system, to open four co-branded clinics in Little Rock....“The Clinic at Wal-Mart, owned and operated by St. Vincent Health System” is expected to open in Little Rock by the end of April, as will “The Clinic at Wal-Mart owned and operated by RediClinic” in association with a local hospital system in Atlanta [according to a Wal-Mart executive]. By the summer of 2008, Wal-Mart also expects to open co-branded clinics with RediClinic and a local hospital system in Dallas....The Clinics at Wal-Mart will offer a limited set of affordably-priced Get Well and Stay Well services. Each clinic will operate seven days a week and feature a consistent, innovative design. They will also feature prominent signage in keeping with Wal-Mart’s price transparency promise -- a key aspect that requires operators to post pricing for the services and treatments offered so patients know what their costs will be up front.

The notion of co-branding walk-in clinics with local hospital partners makes perfect sense to me. A previous post discussed how Cleveland Clinic was partnering with Minute Clinic for walk-in facilities in the Cleveland area (see; Cleveland Clinic Partners with Minute Clinic in Retail Health Services). The story above presents two different business models for the Wal-Mart initiative -- direct partnership with the hospital and a three-way relationship including RediClinic and the hospital. I suspect that the latter will appeal to hospitals with little experience or interest in the walk-in model for minor problems but are anxious for the referral of more complex cases. It should not be surprising that one of the first partnerships announced by Wal-Mart was with a hospital system in Little Rock. Regardless of the business model, the idea of posting prices for office visits may have infectious qualities. If it's appropriate for co-branded walk-in clinic facilities, it be also be relevant for those directly owned and managed by a hospital system.

Dr. Jared Schwartz Joins Aperio as CMO

Bruce Friedman — 2009-11-12T10:45:14-05:00

Just after stepping down from his post as president of the CAP, Dr. Jared Schwartz has joined Aperio as the chief medical officer (CMO). Here are are few of the details (see: Jared N. Schwartz, M.D., Ph.D., Joins Aperio as Chief Medical Officer):

Aperio Technologies...has appointed Jared N. Schwartz, M.D., Ph.D, as its Chief Medical Officer (CMO). Dr. Schwartz, former president of the College of American Pathologists, is a leading advocate for improving patient care using technologies such as digital pathology. In his new role as Aperio’s CMO, Dr. Schwartz will continue to interact with the pathology community—including key opinion leaders, professional medical and advocacy societies, and medical directors of major clinical and regulatory organizations—about the benefits of digital pathology. In addition, he will develop and drive execution of Aperio’s clinical strategy in all medical and clinical efforts for scientific publications, product investigations and regulatory submissions. Dr. Schwartz will also provide medical input, perspective and vision to the executive management team and provide senior-level leadership for related functions.

Very interesting pick and surprising in some ways. Dr. Schwartz has been a dynamic leader of CAP and a visionary but with more skills on the clinical lab side than the surgical pathology side. Note the reference above to develop a strategy in "all medical and clinical efforts." Much of Aperio's growth has been in the pharmaceutical industry lately. My guess is that Jared will be able to work in an equally skillful way on both the clinical service and research/pharmaceutical aspects of the digital pathology industry.

Respiragene as a "Not So Useful" Lung Cancer Risk Test Comes to Market

Bruce Friedman — 2009-11-12T09:03:23-05:00

We are entering the golden era of diagnostics ushered in by new biomarkers with greater specificity, measured alone and in also in groups called IVDMIAs. For me, the value of any lab test is whether the integrated result provides key diagnostic or therapeutic information that is otherwise unobtainable. A recent story appropriately questioned the value of a new lab test now being marketed for lung cancer (see: Questioning a Test for Cancer). Below is an excerpt from it:

Christopher Taylor says he never lasted more than a week when he tried to quit smoking in the past. But it has been four weeks and counting this time, since a genetic test indicated he had a much higher risk of developing lung cancer than the average smoker. Of course, said Mr. Taylor, a 45-year-old salesman who has smoked for 25 years, he already knew that cigarettes were dangerous. But he thought, “It’s not going to happen to me.” Then came the gene test....Scaring people into quitting is the marketing rationale for that new genetic test, called Respiragene, which purports to identify which smokers have the highest risk of developing lung cancer. The test, developed by a company called Synergenz BioScience in New Zealand, where Mr. Taylor lives, is now being offered over the Internet in the United States for $700....Respiragene has not been approved by the Food and Drug Administration, which usually does not regulate such tests. Some states do, however, and the test has not been approved for use by residents in New York, California and Maryland....The justification for many of these tests is that knowing one’s risk will prompt people to change their behavior. Such is the premise, for example, of the genome scans offered by 23andMe, costing $400, and one by Navigenics, for $1,000, that are meant to tell one’s propensity for numerous diseases. Navigenics and an organization affiliated with the Scripps Research Institute are now monitoring 4,800 people to see if the Navigenics test results prompt them to eat better, exercise more or get more medical checkups. But smoking could prove the clearest test yet of the behavior modification pitch.

As far as I can determine from this story, Synergenz BioScience developed this test by choosing a list of biomarkers that can purportedly determine whether one is at "high risk" for lung cancer. I take this to mean that one is predisposed to the disease and that this predisposition can be exacerbated by smoking or by being exposed to other risk factors. The company then markets the test based on the premise that it's more "scary" than having your physician say that you are at higher risk. Although not referenced in the story, the picture of the Respiragene report shows the MDL logo, referring to what I assume to be the performing laboratory for the test, Molecular Diagnostic Laboratories. This lab's web page also displays the Respiragene logo.

This notion of using a genetic test to assess whether a current smoker or a previous smoker is at risk for cancer strikes me as sketchy, particularly for a price $700. Here's what I would recommend instead. Stop by one of the local panhandlers on the street, hand him $10, and tell him that you have a 20-pack-year history of smoking. Then, ask him if you have an increased risk of developing cancer. I also suspect that some smokers who don't want to quit smoking are using the test to determine if they are in the lucky minority who have a low cancer risk and can thus continue with their addiction. It's not worth it, pal.

IMS Provides Access to Physician Prescription Information

Bruce Friedman — 2009-11-11T07:50:50-05:00

When a representative of a pharmaceutical company calls on a physician in the office, he or she will generally know how many prescriptions that physician writes per month for the drugs that the rep is promoting. How can this be? Welcome to the world of IMS and PBMs. A recent story in the WSJ and a blog followup below provides the answers (see: What Does IMS Health Do, Anyway?).

IMS Health is nearing a deal to sell itself for nearly $4 billion, the WSJ reports. That raises a simple question: What does IMS Health do, anyway? Drug companies pay IMS for information about the prescribing habits of individual doctors. This, of course, is very valuable stuff for the drug company sales reps who make calls at doctors’ offices. IMS buys the raw prescription data — which doesn’t identify patients — from pharmacies. Maine, New Hampshire and Vermont have all passed laws banning the sale of information that identifies individual doctors’ prescribing habits, with proponents arguing that the business interferes with the doctor-patient relationship. IMS and other companies in the business have challenged those laws, arguing that they violate the first amendment. The courts have gone back and forth on the issue. Last year, a federal appeals court upheld the New Hampshire law, overturning a lower court’s ruling. The Supreme Court refused to hear the case. Through the AMA, individual doctors can choose to restrict companies’ access to their prescribing data. IMS’s business isn’t limited to selling prescription information about individual doctors. The company also does consulting work and big-picture analyses of trends in the drug business, among other things.

I have posted a previous note in which I make the case that much of what the public perceives as the confidentiality of medical information is largely a myth (see: Despite HIPAA, the Privacy of Our Health Records Is Largely a Myth, On the Privacy of Health Information: The Horse Is Already Out of the Barn). One of the biggest cracks in the confidentiality wall consists of the pharmaceutical benefit managers (PBMs). IMS Health is a little cagey about the source of its information. Here is a cut-and-paste from its web site listed under market measurement. Note that they "assess" billions of transactions but they don't indicate where they obtain their data.

We don’t just track information at IMS; we evaluate it, test it, understand it. We take a vast array of healthcare data and facts and transform them into actionable intelligence. By assessing billions of transactions involving more than a million products from 3,000+ pharmaceutical manufacturers, we remain the go-to company for clients seeking to make faster, smarter decisions.

The pharmaceutical companies don't have prescription-level information -- it must originate from doctor offices, retail pharmacies, hospital pharmacies, and PBMs. Even if companies like IMS block the names of patients from the drug profile data that they sell, much can be learned from it on the basis of other parameters. Here a quote from Mr. HIStalk from one of the notes referenced above dealing, in this case, with clinical data peddling by HIT vendors (see: Despite HIPAA, the Privacy of Our Health Records Is Largely a Myth). Think joinable fields and loyalty card databases.

I think that [HIT vendors selling hospital clients' ‘de-identified’ clinical data] conveniently [hide] behind the concept of “anonymization” as an absolute; a simple technique of magically rendering highly sensitive personal data untraceable. Sounds good to a lay person, right? It even sounds technically reasonable as long as you’re thinking of someone having only one data element (just your birth date) instead of multiples (your birth date and ZIP code) and one database (a prescription file) instead of multiples containing joinable fields (prescriptions plus driver’s license records plus a grocery store loyalty card database). It’s like security in general: rarely absolute, secure only if there’s not enough incentive for someone to go to the trouble to crack the code.

Geolocation -- A New Solution Emerging from Twitter for the TMI Problem

Bruce Friedman — 2009-11-10T08:14:56-05:00

I am someone who is constantly grappling with a TMI problem -- Too Much Information. I have cobbled together a patchwork of solutions in response. For example, I have commented in the past about how I select people to follow in Twitter who function as filters and present me with new ideas and information that would be difficult to obtain working on my own (see: Extracting Value from Twitter Messages Using Filters). Recently and in order to cope with my TMI problem, I have begun to use my Palm Pre to quickly scan incoming email during my odd downtime intervals. Email browsing is so easy on this device and it is so readily accessible that I can compress this activity into this previously unused time. When I return to my desktop PC, the remaining email in my inbox has been filtered and thus merits more serious attention.

A recent article in the New York Times presents a TMI problem of a different type that is being addressed by Twitter in a clever way (see: Refining the Twitter Explosion). Here's the nub of the Twitter TMI problem. When there is a disaster like the one that recently struck at Fort Hood, there is a rapid influx of Tweets from a large number of putative on-site, real-time observers. Many of these messages are short, written under duress, and do not provide reliable information about their geographic origin. Twitter has come up with a means to group Tweets by their point source using the GPS geolocation feature present on many cellphones. Read more about this below in an extract of the article:

Simply put, there is way too much information on Twitter — lately, it defies navigation. In January, there were 2.4 million tweets a day....Until lately, the main way to make sense of an urgent outpouring of tweets on a particular subject was to use text searches: look for the phrase “Fort Hood,” for example, or maybe an agreed-upon label [tag], “#fthood,” within tweets. Yet during events like the shootings on Thursday at Fort Hood that left 13 people dead, this method is useless. Hundreds of “relevant” tweets pop up every minute, most repeating the same news reports over and over again or expressing concern from far away. Which is why a new feature that Twitter says it could unveil in the next few weeks — “geolocation” — holds such potential to make the Twitter rapids navigable. The idea is to take advantage of global positioning systems on cellphones to allow Twitter users to include a precise location with each tweet. Users would be able, right off the bat, to limit their searches to tweets from a particular location. “Proximity can be this proxy for relevance,” said Ryan Sarver, the director of the Twitter platform, who led a “fairly small team” of programmers who after a few months are close to completing the geolocation project. “We are about delivering the right information to the right people.” After limiting searches to those from within 15 miles of Killeen, Tex., a town near the Army post, you easily find messages sent by soldiers describing what it is like to be on lockdown or worrying about their children at school on the post....Because GPS will provide the ability to become very “granular” with locations, you could mimic through Twitter the banter at the local diner or a barbershop, by limiting a search of tweets to a two-block radius.

The use of geolocation serves a couple of purposes. First of all, it provides reliable information about the location of the reporter even if he or she does not provide it. Secondly, it provides some degree of validation that the reporting party is in the vicinity of the event being referred to in order to differentiate the message from someone who is spoofing. Geolocation of Tweets does not, however, solve the major problem of many short messages generated from disaster sites. Many of them are garbled and may provide misinformation, often because the observer reports rumors or is only observing a limited portion of the event. Information scientists developers are now working on this problem and you can expect some sort of solution in the near future. They are developing software that "ingests" myriad fragmentary real-time Tweets about an event and then develops some semblance of "truth" by parsing multiple messages, analyzing them syntactically, and looking for common themes and scenarios within them.

Continuing Discussion About Citrix as a Critical Component of EMRs and LISs

Bruce Friedman — 2009-11-09T08:02:30-05:00

In response to my recent note about the role of Citrix in prolonging the lifespan of obsolete fat-client EMRs and LISs (see: Citrix Has Become a Barrier to Improvements in Healthcare Software), Dr. Ulysses Balis has responded with a comment. He is Director of the Division of Informatics in the Department of Pathology, University of Michigan Medical School. In this interest of continuing this discussion, I quote it in its entirety below with boldface emphasis mine:

I couldn't agree with you more, Bruce. With the continued insistence of many vendors to push thick client applications, Citrix is often the only effective methodology to purvey support for 100's of concurrent users. As an example, our informatics division looked at the Cellavision product about a month ago. It's a big, bloated thick client app that REQUIRES Open GL. Does that run on Citrix? Nope. Given that our department does not want to support this as a native application on a myriad of hematologist’s PC's that aren't even under our [guidance and control because they are managed by central IT], the answer is simple: Cellavision is a non-starter. There is only one long-term solution to this present slow-burning fiasco, and that is web-based applications, which make use of open architectures whenever possible. Hence, my take is that in the end, Citrix is dead. Epic is dead. Eclipsys is dead. Cerner is dead. I expect a new breed of web-based solutions to replace these Mumps and Cobol-based clunkers within the decade. And when that finally happens, it won't be a minute too soon. So, in summary, I would offer the friendly amendment to your thesis statement that it is not only Citrix that is a barrier to improvement in healthcare software, so too are the myriad of poorly-written thick-client applications that continue to fuel the demand for Citrix. Both need to go.

So here is an interesting question based on Ul's comment. Why are the shares of Cerner, a major vendor of EMRs, at historic highs, reaching about $85 per share in October if their products are dead, to quote Dr. Balis. Let's put aside for the moment some of the bad publicity that Cerner has continued to receive in the U.K. (see: Another Saga of "Blame the Vendor" Leaks Out of the UK). I am sure that most of this tends to be discounted by American investors. Let's also put aside the fact that most of the EMR purchases by major health systems have gone to Epic lately (see: Forbes.com Puts Some Numbers to the Epic Systems Success Story). Everyone agrees that this latter system is the EMR clunker du jour.

Answering my own question, I am sure that the success of the Cerner shares is based on its most recent quarterly financial performance and the infusion of federal money into hospital EMRs (see: CCHIT Certification and "Meaningful Use" of EMRs). I certainly agree that the days of our obsolete EMRs are numbered. "Within the decade" is a rather long span of time, however. The key question at hand is whether the incumbents in the EMR field are investing some of their capital in developing the "next-gen" web-based systems. New EMR market entrants face the formidable task of confronting the computerization of complex healthcare transactions using new tools and with severe penalties for errors. The will also confront very risk averse buyers of their systems who may not be that sophisticated technically.

Citrix Has Become a Barrier to Improvements in Healthcare Software

Bruce Friedman — 2009-11-06T08:38:53-05:00

In my opinion, many EMR and LIS systems have become outdated in terms of their architecture (see: Possible Adverse Consequences of Increased Federal Investment in HIT). I have attributed this in the past to the fact that hospital and lab executives keep purchasing them so there is no rush by the vendors to convert them to a more modern design. A recent note by Mr. HIStalk on the use of Citrix in the healthcare industry provides another view of this problem. Here is his note:

...[S]omeone lists the five companies Dell should take over, all of them in healthcare IT. They are Allscripts, Quality Systems (NextGen), CSC, Cognizant, and Citrix Systems. Citrix isn’t technically a healthcare IT vendor, but [healthcare is] probably [the company's] biggest vertical since the industry is dominated by 1970s time capsule applications that won’t run efficiently and securely without it....Actually I use Citrix a fair amount at work and it’s pretty cool – poorly architected fat client apps run a heck of a lot better over wireless or VPN when you’re only painting screens and not slinging massive data packets back and forth.

His observation is very interesting and hits the mark. I am reminded of a LIS vendor many years ago which was reluctant to admit that the use of Citrix was absolutely essential in order for its product to function adequately. The company did not want current clients to understand its fat-client problem nor potential clients to add the cost of the Citrix software to the total cost of ownership (TCO). This need for Citrix as companion software for many LISs and EMRs also places an additional work burden on the lab and hospital IT support staff. As noted above by Mr HIStalk, the success of Citrix in the vertical healthcare market is a function of the inadequate design of the EMRs and LISs that we continue to buy and operate. Citrix is cool but there is a big price to be paid in order to see it work on a daily basis.

Preventive Medicine Emerging as a New Clinical Practice Opportunity

Bruce Friedman — 2009-11-05T11:10:56-05:00

I have posted a number of previous notes about preventive medicine and also commented about how most physicians tend to focus on the treatment of disease (disease model) rather than health promotion and preventive medicine. Below is an excerpt from an article which suggests that healthcare personnel should place more emphasis on "health" (see: Making health care about health):

As a young cardiologist, Steve Devries noticed a disturbing pattern: His patched-up heart patients kept returning for repairs. It happened so often that Devries decided there must be another way to advance patients' health. Today, his thriving Chicago practice focuses exclusively on preventing disease, and Devries is far more likely to counsel patients about diet, sleep habits and exercise than to prescribe high-tech scans or cholesterol-lowering drugs. Motivated by a growing sense that America's health care system is broken, doctors such as Devries and public health experts are turning to preventive medicine for a potential fix. And lawmakers, eager to curb rising health care costs, are paying close attention. Every serious proposal for health reform includes measures to promote healthier lifestyles and minimize the burden of disease.... Extensive research documents the potential impact. In an April article in PLoS Medicine..., researchers estimated that 191,000 fewer deaths would occur each year in the U.S. if people got more physical activity; 216,000 deaths forestalled if people were a normal weight instead of overweight or obese; and 467,000 deaths averted if people gave up smoking....A recent report in the Archives of Internal Medicine underscores the point by finding that people who live in "healthy" neighborhoods -- areas with plentiful opportunities for physical activity and eating well -- had a 38 percent lower rate of Type 2 diabetes than those in "unhealthy" neighborhoods.

I am very enthused about the idea of increasing the number of physicians specializing exclusively in preventive medicine. I hope that health insurance companies jump on this trend and provide some sort of physician and consumer incentives to enhance the status of preventive medicine. I suspect that the patients who patronize these specialists will fall into two groups: those who already are health and fitness converts and want to pursue even higher level goals and those who have had some health health problem, or even catastrophe, and need help in digging themselves out. As to the "healthy" neighborhoods described above, my guess is that they are populated by individuals with more education who are already predisposed to healthy living. Education has been shown to be the most powerful predictors of good health (see: Education Level A Leading Factor In Good Health, Longevity, According To Health Economists). Researchers have discovered that the correlation between health and education goes beyond a pure understadnding of health maintenance. It may, in fact, have something to do with investing in oneself for the future.

New Lecture Posted on Integrated Diagnostics

Bruce Friedman — 2009-11-03T13:42:20-05:00

I delivered a lecture/discussion yesterday about integrated diagnostics to a mixed audience of pathologists and radiologists at the University of California San Francisco (UCSF). This is a topic that I have covered in previous notes. Part of the discussion also touched on the development of integrated diagnostic centers and the relationship of the virtopsy/catopsy to these new concepts. The potential patient referral patterns into these integrated diagnostic centers was touched upon, a topic ripe for discussion that I plan to address in subsequent notes.

Flash Drive "Awareness" Bracelets Distributed to Students

Bruce Friedman — 2009-11-02T08:00:00-05:00

Here's a good idea -- flexible "awareness" bracelets are being distributed to public school students in Michigan for storage of their home work, for logging into school computers, and whatever (see: Dexter students sport rubber bracelets as part of technology upgrades). Below is an excerpt from the story:

Using money from a school bond, the Dexter [Michigan] school district recently upgraded its technology, including replacing old PCs with Macs. And giving students a small rubber bracelet was part of those upgrades. Students from fifth through 12th grade each received a bracelet that's a two-gigabyte USB flash drive with two primary functions. It's formatted for both Macs and PCs, so students can take files from one computer to another. But more importantly, the drives will log students in to the computers when they plug them in....However, if students forget their flash drive bracelets at home, it leads to bigger issues [such as not being able to log-on to computers]. If lost, students can replace the drives $7. As with many changes, the school is still taking a wait-and-see approach to see how the bracelets work out. If the flash drives are successful, school administrators will decide whether to buy new ones for incoming students or reuse the ones from departing students.

Logos can be embossed on these flash-drive bracelets, hence the "awareness tag". I don't think that this type of gimmick would have much appeal for adults. most of whom are studiously trying to avoid the various "awareness" campaigns. My need for a flash drive is only sporadic so I keep a pile of them on my desk. I have avoided attaching one to my key chain, which is already too bulky. Still a great idea. One problem is that kids will need to come up with a new excuse when they can't deliver their homework. The "dog ate it" just won't do anymore.

G.E. Jumps into the Hospital Connectivity Space

Bruce Friedman — 2009-10-30T08:02:09-04:00

As someone who spent a lot of time in the past thinking about community health information networks (CHINs), the recent news about G.E. entering the HIE (health information exchange) space made me laugh out loud. The amount of money lost on healthcare connectivity endeavors such as CHINs and regional health information exchanges, a later incarnation of the same concept, has been enormous (see: A Quick Look at CalRHIO). So here we go for one more bite at the apple (see: G.E.’s Bid to Connect Computerized Health Records).

There are all sorts of obstacles to moving the nation’s health care system, choking on paper records, into the computer age. The cost and complexity of making the transition are daunting, though the government’s $19 billion in incentives for doctors and hospitals to adopt electronic health records should help. But the hoped-for benefits of digital health records ...will not really materialize unless information flows seamlessly and securely among labs, clinics, hospitals, doctors’ offices and patients. General Electric’s big health care division is introducing on Thursday a new unit, eHealth, to pursue the business opportunity presented by this challenge. The main target for G.E.’s new business unit is in providing the technology and expertise to build regional and statewide Health Information Exchanges [HIEs], as these planned data-sharing hubs are now being called. An initial $564 million grant from federal government to the states will provide seed money to get things started. Over the last two decades, there have been efforts to set up such health information-sharing networks. They were first called Community Health Information Networks and later Regional Health Information Organizations. Mostly, they failed. Hospitals and physician groups had no incentive to make the investment to share patient information, since they were not paid for doing so. But to qualify for incentive payments from the government, doctors and hospitals need to adopt electronic health records that share information across networks....G.E. said it was investing $90 million to get the new eHealth unit going. Its offerings include software for securely storing and sharing patient information, a Web portal that can pull patient information from various sources and present it to doctor, and a Web-based personal health record, called LifeSensor. It was built by a G.E. partner, InterComponentWare. So is G.E. going head-to-head in the emerging field of personal health records — controlled by individuals, not a doctor, hospital or insurer — with the likes of Google and Microsoft?

I do take issue with the statement above that hospitals lacked an incentive to share patient information and paying them for doing so will provide sufficient motivation. My view has always been that hospital executives view patient information as proprietary and providing some small payment for them to pursue a connectivity goal will be insufficient. The problem is that they will never state their true objection but rather moan about the complexity of medical information and the challenges of clinical data exchange. Incidentally, hospitals have had no problem sharing financial information because this is how they are reimbursed (see: CCHIT Certification and "Meaningful Use" of EMRs).

I have covered both the Microsoft and Google forays into the PHR development and, of late, Google's partial withdrawal from this field. I have come to the personal conclusion that the Google executives have decided either that they have bigger fish to fry (e.g., the cell phone market with Android) and/or the healthcare market poses too many risks and too little profit for a technically innovative and adroit company (see: Google Health Running Out of Steam, According to Experts). For Microsoft, working several years behind the curve and having power lunches with hospital executives probably feels just about right (see: Microsoft's Cell Phone Operating System Lacks Key Functionality). I suspect that G.E. decided to hold its nose and jump into the HIE fray. After all, McKesson, a serious competitor, has had success linking physician offices and office EMRs with its RelayHealth product (see: Developing an Electronic Medical Record Ecosystem (Network).

Another Saga of "Blame the Vendor" Leaks Out of the UK

Bruce Friedman — 2009-10-29T08:25:43-04:00

There are days when I am sure that Neal Patterson, CEO of Cerner, regrets the little pas de deux that his company has been engaged in with the British government and its NHS for years. Mr. HIStalk alerts us to another chapter to this continuing saga with its "blame the EMR vendor" theme:

Speaking of Cerner, St. Bartholomew’s Hospital in London faces fines of $650,000 per month for lengthy patient backlogs that it blames on the “dreadful” Cerner Millennium. I doubt it’s that simple, but blaming the computer is always convenient.

Here's an excerpt from the source (see: Barts faces fine over IT failures):

St Bartholomew’s Hospital in London faces being fined £400,000 a month for missing patient care targets as a result of the troubled NHS IT programme....Tory MP Richard Bacon, a member of the Commons public accounts committee, which scrutinises public spending, said the £12.7bn NHS IT programme had led to Barts developing a backlog of thousands of patients waiting for treatment....He said the Cerner Millennium system had caused “havoc” wherever it had been deployed in the NHS. The hospital was failing to meet a Department of Health target that no one should wait more than 18 weeks to receive hospital treatment from the time they are referred by a GP.

I have covered the issue of "blame the vendor" in a previous notes (see: Do Hospital Executives Use Their IT Vendors as Scapegoats?). My guess is that there's plenty of blame to go around with the NHS' EMR program and that their electronic medical record problems are multifactorial (see: NHS Computer Czar "Outed" by his Mum). I also believe that any large-scale IT project mounted by the NHS will inevitably end in chaos, with or without Millennium in the mix. You have a mixture of a creaking government bureaucracy, hospital personnel who may not be motivated to put in a day's work, and a host of grand-standing politicians playing to the crowd. Did you note the name of the Tory MP quoted above -- it's BACON. From what I know about the usual wait for hospital admission in the U.K., 18 weeks seems like good performance. Comparable in some ways to Canada (see: The Fundamental Flaws in the Canadian Healthcare Delivery System). Does everyone understand the irony of the British government fining a hospital $650,000 per month that it itself owns and manages. The government hospital executives will surely ask for a larger operating budget to cover their recurring fines? Another alternative is to withhold payments to Cerner. Blame the vendor.

Are You a Primary Care Pathologist, Asks Dr. Henderson

Bruce Friedman — 2009-10-28T09:03:00-04:00

A new pathology blogger has appeared on the scene -- Dr. Gregory Henderson. He calls himself a primary care pathologist and his first blog note is about this very topic (see: You Might Be A Primary Care Pathologist). Here are the criteria he lists to determine whether one falls into this category:

If you have ever taken phone calls from patients to help explain their diagnosis, you might be a primary care pathologist.
If you have ever scrubbed into a surgical procedure to help the surgeon identify key areas to sample for frozen section, you might be a primary care pathologist.
If you have ever manned a booth at a community health fair that educates women about Pap and HPV testing, you might be a primary care pathologist.
If you have spent an enormous time over the past 3 months helping your hospital prepare for the impending H1N1 epidemic, you might be a primary care pathologist.
If you look around your lunch table most days and see physicians of other specialties and no other pathologists, you might be a primary care pathologist.
If your pattern of practice looks anything like any of the pathologists on this CAP website, you might be a primary care pathologist.

I need to confess that my first reaction, on reading his inaugural note, was to flinch a bit. After all, the notion of "primary-care-anything" seems to be quickly losing its luster in our rush to become uber-specialists, particularly those who can bill for a procedure. However, and after reading his list, I have changed my mind. There is a tendency for one's first blog note to focus on a topic that one really cares about. It goes to the nature of this obsession -- the need to communicate one's ideas on a broader scale. There is the ring of authenticity and sincerity about his list that any pathologist will be proud of. I wish him the best of luck in his future blogging career. I am sure that he will provide us all with better insights into the valuable services that individuals like him provide to their communities. Oh, and the fact that Dr. Henderson refers to Lab Soft News on his home page as one of his favorite blogs had no influence on these remarks.

Microsoft's Cell Phone Operating System Lacks Key Functionality

Bruce Friedman — 2009-10-27T08:10:22-04:00

If I say PC and operating system, some of you will probably respond associatively: Windows and Microsoft. If I say cell phone and operating system, most of you will probably stare at me. That's really not a problem. The critical differentiating feature for cell phone operating systems is not it's name but rather what it can do for you. In previous notes, I have presented the idea that the smartphone is the next PC and will have great relevance for healthcare, pathology, and lab medicine. What users should now be looking for in their cell phones is nearly the same, or better, functionality than their PC.

My Palm Pre browses the web so efficiently that I can read email and search the web without any sense of being inconvenienced. Despite its best efforts and having been in the cell phone OS business for a long time, Microsoft still can't seem to get this right. Some of the details were revealed in a NYT review of a Windows Mobile phone (see: Another Try for a Windows Phone, but It’s Still Clunky). Below is an excerpt from the article:

If you’ve never heard of a Windows Mobile phone, or never particularly cared what kind of software runs on your phone, prepare yourself. In the coming months, Microsoft will release a steady drumbeat of ads intended to make you want a device powered by its software....Windows phones have been around for years, mostly competing with BlackBerrys for the allegiance of business users. But while BlackBerry crossed over into the consumer realm with more user-friendly phones, Windows Mobile remained in its corporate cube, because of devices that could be so frustrating to use that few people would choose one without a corporate mandate....For much of the last year, Microsoft has been saying that its new mobile software upgrade would significantly simplify the user experience. And the upgrade does simplify things, but not much. Instead of poking around with a stylus, Windows now features icons that are big enough to hit with your fingertip. That helps you navigate the phone’s software menu and interact with various programs, but when it comes to the one application smartphone owners use the most — Web browsing — it falls far short....But unlike the iPhone or the Palm Pre, a Windows phone still lacks a multitouch screen, so you can’t pinch and pull the display to a chosen size. Instead, you press buttons and sliders in a scheme that sorely lacks precision....Likewise, instead of simply connecting you to a free Wi-Fi hot spot, Windows forces you into a three-step decision tree that would make a technician’s heart sing, but would strike fear into the heart of just about anyone else who just wants to log on.

There's a lot that's wonderful about the current crop of smartphones. Although I am very fond of my Pre cell phone from Palm, I recently purchased an iPod touch, which is an MP3 player that lacks cell phone capabilities. However, it can connect to the internet effortlessly using W-Fi so I can still place VOIP calls anywhere in the world using a Skype application that I have downloaded and installed. It is quite a remarkable device.

For me, the greatest feature of my Pre is being able to effortlessly surf the web with the essential enabling element being hand-gestures such a "pinch" or "pull" interpreted by the device's touch screen as a zoom-in and zoom-out. Similarly with the Pre, I can change applications, still keeping all of them resident, with a finger-sweeping gesture on the screen to the right or left. The review of Windows Mobile above provides further evidence for me that Microsoft is still wandering in the wilderness. Fortunately for us, there are cell phone OS developers who understand the web and the need on the part of users for a friendly user interface in order to surf it.

American Academy of Family Physicians Cozies Up to Coke

Bruce Friedman — 2009-10-26T08:40:28-04:00

I sometimes think that many prestigious U.S. organizations have badly lost their way recently. Another possibility is that it's business as usual for all of them and the web provides us with insights into business deals previously gone unnoticed. Here's only one example. A major factor into our obesity epidemic is the sugar-loaded soft drinks. Our politicians are so concerned about this that they want to tax the sugar beverages to restrict usage and, uh, generate new tax revenue (see: Federal Tax on Soda Pop Proposed: Can This Be Justified?). We now learn that one professional physician society has established a tight (i.e., six-figure) relationship with Coke in order to provide "nutritional" information on its web site. Here's the news (see: Looking for health advice? Dr. Coca-Cola will see you now):

When the American Academy of Family Physicians [AAFP] announced it had received a substantial grant to enhance educational information about nutrition on its FamilyDoctor.org site, you’d think health experts would have been happy. But the money was earmarked to focus on the role of beverages and sweeteners in a healthy diet. And it came from the world’s largest beverage maker, the Coca-Cola Co....“We urge the AAFP to regain its credibility by rejecting the deal with Coca-Cola,” [a recent letter from physician critics] stated. “If the AAFP declines to do that, we urge your organization to reassert its support for the public health (and its own independence) by supporting a warning label on caloric sugar-sweetened beverages and a federal tax on soft drinks to support health promotion or health insurance programs.” The letter noted that soda is “the only food or beverage that has been demonstrated to promote overweight and obesity.” ...But the signatories warned that the six-figure grant from Coca-Cola will prevent the doctors group from “criticizing sugar-sweetened beverages in the strongest language.”....In 2003, the American Academy of Pediatric Dentists took a $1 million payment from Coca-Cola. Before the payment, the dentists' group acknowledged the connection between sugary drinks and dental disease. But after the payment, the president of the AAPD told reporters that the ‘scientific evidence is certainly not clear’ on the role soft drinks play.

I think that there is a need to try to explain how a professional physician society could accept a grant from a company such as Coca-Cola. Surely every physician member in the group would immediately understand that this was a big mistake. I suspect that the short answer is money but this response begs for a more in-depth explanation. Here's one for your consideration. Physician professional societies have two major sources of income. The first is membership dues but this does not amount to serious money. Dues are intentionally set low to encourage greater membership. The second source of revenue are the meetings sponsored by the society. Unfortunately, the net revenue generated by medical conferences is headed south. This is a result of the feeble economy and also a more punitive environment regarding conference sponsorship, particularly regarding various types of payments from pharmaceutical companies.

But wait! Why would physician professional societies need a robust revenue stream? The physician leaders of societies work on an unpaid basis. Well, partly to offset the losses from their print medical journals, which are dinosaurs and will soon disappear, and also to develop their web sites devoted to healthy living and good nutrition. Also keep in mind that many such societies, particularly the largest, have hired executive directors who have salaries in the high six figures and a large cadre of well-paid staff members. As a result, the leaders of such societies are increasingly on the hunt for companies that are willing to write big checks for the endorsement of some of their (frequently) unhealthy or unnecessary products. Hence the embarrassing news about the AAFP noted above.

Health Promotion Goes Mainstream at NBC-Universal

Bruce Friedman — 2009-10-23T09:21:18-04:00

I, like many other people, am concerned about the toll that the chronic disease epidemic, including problems such as diabetes, is taking on the U.S. population (see: Seeking Solutions to the Chronic Disease Epidemic). Furthermore, I am convinced that many of the complications and side-effects of these chronic diseases could be avoided if people took better care of themselves. Needless to say, a similar case can be made for the so-called "lifestyle" diseases. So, what is the best way to raise the consciousness of the majority of Americans about these issues? A recent note in the WSJ Health Blog gave me an idea (see: GE Continues Health Push — By Selling Ads). Below is an excerpt from it:

Earlier this year, GE’s CEO made a big speech about how the company planned to expand its health care business. We figured that meant selling more electronic health records systems, CT scanners and the like. Turns out, it also means selling health-themed ads on NBC, the TV network owned by GE. NBC Universal said last week that it was launching something called “Healthy at NBCU” as a companion to GE’s company-wide “healthy imagination initiative.” As part of the program, Campbell Soup will pay to sponsor two health series on the TODAY show, where the company will run ads for its “heart healthy” soups. Ad sales are down for lots of media companies, but advertisers are still willing to pay to tie themselves to a cause, like the environment — or healthy living. Advertiser spending on cause sponsorships in the U.S. is expected to rise slightly to $1.57 billion this year, this morning’s WSJ reports. NBCU has already made similar pushes to bring in marketing from companies who want to tie themselves to environmental causes and women’s issues. Since the end of 2007 the company has brought in incremental revenue “heading toward” $100 million from its health, environment and women’s packages, on top of what it gets from selling regular ads, according to the WSJ.

I now believe that probably the best way to effectively educate the majority of Americans about healthy living is through the main-stream media such as NBC-Universal. If corporations are enthusiastic about sponsoring health-themed TV series, I am all for the idea. If we can educate the population while improving sponsor recognition, so be it. I recently watched one of the celebrity physicians, Mehmet Oz, on his TV show, scrub suit and all. He is both charismatic and a believable spokesperson. His answers to health questions were short, to the point, and accurate. He is also very popular, I am sure, with women, who have much more of an interest in personal health issues than men.

FDA Convenes Advisory Committee to Discuss Whole Slide Imaging

Bruce Friedman — 2009-10-22T08:59:20-04:00

The FDA's Hematology and Pathology Devices Advisory Committee will be convening today and tomorrow to discuss discuss, and make recommendations, about what they describe as "public health issues" related to the use of digital whole slide imaging (WSI) systems that are now being used to replace conventional light microscopy for diagnostic surgical pathology. The meeting will be open to the public. Within the scope of this meeting, digital pathology is defined as the conversion of images that can be observed by conventional light microscopy on histologic glass slides into digital whole slide images via digital scanners. These latter images are then viewed with a computer monitor to render pathologic diagnosis of the lesion of interest. Finally, this process involves digitally archiving and retrieving these images for access at some later time. The committee will not be discussing computer-assisted image analysis or remote real-time microscopy at this time.

The FDA background briefing for this meeting as a PDF file and downloaded from the FDA web site makes interesting reading for those interested in digital pathology. Below is more detail extracted from this briefing paper about what the FDA hopes to achieve by this meeting. Obviously, the major thrust will be the establishment of a set of principles for evaluating the accuracy and reproducibility of pathologists using this tool including both objective and subjective perspectives.

FDA hopes to gather information about how to evaluate and compare the performance characteristics of both the light microscope‐the reference method‐‐and the digital WSI method. As background for the panel discussions, there will be presentations to cover the principles of light microscopy and the possible criteria and studies for analyzing the accuracy and reproducibility of the diagnostic performance of pathologists using the light microscope for examination of human tissue specimens, the principles of digital WSI, and the criteria and studies for the evaluation of the diagnostic accuracy and reproducibility of pathologists using digital WI for examination of human tissue specimens. There will be a discussion of the objective and subjective aspects of reading direct images from a microscope and from a digital screen.