Lab Soft News

23andMe Moving into Clinical Trial Recruitment, a Potential Source of New Income

I have been blogging about 23andMe for about six years (see: Update on 23andMe; Time for a Review of FDA Definition of Medical Devices). During that time, I have seen the company evolve from the first major consumer genomics enterprise to a clinical laboratory authorized by the FDA to perform testing for ten diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information about an individual’s genetic predisposition to certain medical diseases or conditions (see: FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions). Previous reporting about the company indicates that it is also seeking to become a drug company with 13 drug candidates in its pipeline (see: 23andMe wants to become a drug company, has 13 drugs in its pipeline: 5 notes). Now comes news that it is aggressively pursuing a new goal -- clinical trial recruitments (see: 23andMe, moving beyond consumer DNA tests, is building a clinical trial recruitment business). Below is an excerpt from this latest article: 

Consumer genetics giant 23andMe announced....that it would move deeper into the business of clinical trial recruitment, partnering with a fast-growing startup to help match its customers with nearby study sites based on their diseases, demographics, and DNA. The Silicon Valley company has for months been quietly making inroads into clinical trial recruitment by emailing customers who’ve opted in with recommendations about studies that might be appropriate for them. It has recruited for studies, both interventional and observational, in disease areas including Alzheimer’s, Parkinson’s, attention-deficit hyperactivity disorder, eczema, and liver disease, a spokesperson for the company confirmed. But the new partnership with TrialSpark, which offers a tech-powered alternative to traditional contract research organizations, may help 23andMe address one of the biggest challenges in clinical trial recruitment: geography.

The idea is that patients who want to enroll in a clinical trial centered out of, say, Memorial Sloan Kettering Cancer Center, won’t have to fly to New York and can instead participate by visiting their local doctor’s office....23andMe could make serious money charging drug makers to serve up what are essentially personalized ads for medical research. That could hold significant appeal for some customers. Not only can the company’s spit kits find disease risks lurking in their genes — but they may also be a route to accessing experimental drugs and cutting-edge research that could potentially help them and others with their condition. 

This pursuit of clinical trial recruitment for 23andMe makes a lot of sense. The company has established a good relationship with its customers and also knows their genomic profiles and health histories. With proper permission, it can offer the possibility of such recruitment in collaboration with TrialSpark which advertises its ability to enroll patients in trials with monitoring in local physician offices. Patient recruitment for trials is highly remunerative with payments from the drug companies running them. Here's a quote from the TrialSpark web site:

TrialSpark’s mission is to bring new study treatments to patients faster and more efficiently. We deliver on this mission through partnering with independent and community physicians to transform their practices into high-quality FDA compliant trials sites. TrialSpark also powers sites with a patient-centric digital recruitment approach that focuses on quality, not quantity of leads. This enables us to unlock the 98% of patients not currently participating in clinical trials - resulting in faster, more efficient, and more diverse high-quality trials for our sponsors.

Initially, I am fairly sure that these trial recruitment efforts will not relate to important trials and the reference above to Memorial Sloan Kettering Cancer Center may be fanciful. Nevertheless, I am an avid supporter of the "democratization" of trials and this may be one path in this direction (see: Health care democratization underway, according to 2nd annual Stanford Medicine Health Trends Report). 

VA Pathologist Indicted for Multiple and Continuing Errors, Resulting in Deaths

In what can only be described as a disaster due to organizational failure, a pathologist working at the Veterans Health Care System of the Ozarks has been charged with involuntary manslaughter (see: Former Arkansas VA Doctor Charged With Involuntary Manslaughter In 3 Deaths). Below is an excerpt from the article with the details: 

A former pathologist at an Arkansas veterans hospital was charged with three counts of involuntary manslaughter in the deaths of three patients whose records he allegedly falsified to conceal his misdiagnoses. According to federal prosecutors, Dr. Robert Morris Levy, 53, is also charged with four counts of making false statements, 12 counts of wire fraud and 12 counts of mail fraud, stemming from his efforts to conceal his substance abuse while working at the Veterans Health Care System of the Ozarks. Levy was suspended from work twice — in March 2016 and again in October 2017 — for working while impaired, before he was fired in April 2018. A June 2018 review of his work examined 33,902 cases and found more than 3,000 mistakes or misdiagnoses of patients at the veterans hospital dating to 2005. Thirty misdiagnoses were found to have resulted in serious health risks to patients. The three deaths came as a result of incorrect or misleading diagnoses. In one case, according to prosecutors, a patient died of prostate cancer after Levy concluded that a biopsy indicated that he didn't have cancer....Levy used 2-Methyl-2-butanol, a chemical substance that intoxicates a person "but is not detectable in routine drug and alcohol testing methodology," the statement said (see: tert-Amyl alcohol).

When I began writing this note, my mind turned first to the possible absence or inadequacy of a surgical pathology quality control program at this particular VA hospital. Such a program would include periodic peer review of the surgical pathology reports of the accused pathologist (see: Peer (case) review in anatomic pathology can drive improved proficiency). However, I then began to focus more on the facts in the case such as 14 years of what can only be described as overt malpractice on the part of Dr. Levy plus two suspensions for working while impaired.

I came to the conclusion that the major problem at this particular VA was that Dr. Levy's supervisors and colleagues probably watched him stagger to his microscope for many years and kept silent. The fact that he "cleverly" masked his impairment by imbibing a rare form of alcohol is no excuse. Whatever form of alcohol he was drinking, there is no way to disguise the physical impairment associated with excess alcohol consumption. So what lesson should we take away from this case of an impaired pathologist?

I think that indictment of the pathology leadership and hospital executives of this hospital should also be considered -- they are surely accomplices and enablers of this Dr. Levy. The prospects of this happening are highly unlikely. The last thing that senior VA administrators and probably the legal apparatus want to happen is a prolonged media discussion of inadequacies of the VA system. They will willingly "sacrifice" Dr. Levy (now) but don't want the investigation to extend in a wider fashion. It could get out of hand and substantive changes could be demanded by the public of the VA to improve quality and save lives.

In my opinion and, as I have blogged in the past, the military healthcare systems and the VA are not amenable to change (see: Why the Military and the VA Healthcare Systems Are Not Amenable to Change). By the way, Graham Grieve, the FHIR architect, disagreed with this particular blog note posted in 2014 and responded with the following comment.

I think you're wrong to say that this is a feature of the military and not of companies. It's a feature of bad management or workers, and can occur in either, or any other context. What we can say is that the nature of competitive business is more likely to expose the deception quicker, and so it's less tolerated. One consequence of this is that if you replace the existing system with a new one, it will soon come to look like the old one, whoever runs it.

He has a good point but I think that there are unique features of the military healthcare system and the VA that distinguish them from other organizations such as federal oversight/politics and the military chain of command.

Integration of Patient-Generated Test Results with Those from Accredited Laboratories

In response to my note yesterday about direct-access-testing (DAT) (see: New Definition for DTC Lab Testing Prompted by EverlyWell Business Model), Andrea Pitkin, Ph.D., commented in the form of a presentation she had made at the last ASCLS annual meeting. She makes a number of important observations that I hope to comment on in upcoming days. For this note, I will address the following point copied from her comment:

How are consumer testing and Patient Generated Health Data (PGHD) integrated and used within the medical record?

Some apps allow upload to the physician's EHR. They should not be comingled with laboratory performed testing as they are different. The largest issue is one of trust. Does the physician trust from a medical and legal perspective, results performed by consumers (who may have invalidated the home pregnancy test when dropped in the toilet) versus health professional performed testing? How are results kept separate in EHR modules and clinical displays? These new methods and perhaps specimens or transcutaneous analysis should have different LOINC codes so all users can identify these differences in health data.

I personally think that it's time for one of the various lab standards/accreditation agencies to begin to grapple with what Andrea refers to as Patient Generated Health Data (PGHD). To what extent should it be be integrated, but not comingled, with test results generated in accredited clinical laboratories? This topic is not always straightforward. For example, patient-generated blood pressure readings may be more accurate than those taken in the physician's office due to white coat hypertension (see: White coat hypertension: When blood pressure rises at the doctor's office). 

It's not too early to begin this PGHD discussion because I and others can already view hospital-generated test results in the MyChart app "powered by Epic" which is accessible on my smartphone. I expect this trend to continue in the "opposite direction" (i.e., transfer of data from the consumer to healthcare providers). Consider, for example, AliveCor's six-lead ECG device generates data that is clinically valid and thus transferable to a patient's cardiologist (see: This is your heart × 6). In terms of some ideas that could be incorporated into standards pertaining to PGHD, I would make the following suggestions:

• I have previously blogged what what I referred to as the "diagnostic results package" (DRP) for each lab result or set of lab results which I likened to the provenance of an antique (see: The "Diagnostic Results Package": A New Way to Envision Results Reporting). This idea is relevant for the current discussion. For example, if a patient were to order a set of tests via the web and they were performed by an accredited national reference laboratory, the DRP would include, at the very least, the lab test results, the name of the performing lab, and the reference ranges by test. The results would need to be in an unalterable format like PDF. Interestingly enough and although ordered by a consumer, these results would have a validity comparable to those generated by a hospital lab.
• Alternatively, the DRP for, say, a home pregnancy test would include the name of the consumer performing the test, the manufacturer of the kit test, and the result. Such a result, performed by the health consumer, would need to be confirmed in an accredited lab.
• There now exists what I will call two domains for the storage/access of health information for a consumer/patient: (1) the hospital controlled EHR domain that is accessible by the patient via the patient portal; and (2) the patient-controlled personal health domain using a smartphone as "command central" and linked to various apps and wearables such as an Apple Watch (see: Smartphones Provide a Key Element in Our Personal Health Management Systems).
• As noted above, a consumer can now transmit selected health data like ECG data to a healthcare professional. There is thus perhaps the need now for a third domain for consumers, a general-propose, personal health data repository in the cloud via which a consumer could provide personal health data access to healthcare providers and other relevant hospital personnel.

Should We Integrate "Longevity Medicine" into Mainstream Care

More than 12 years ago, I posted a blog note about the field of anti-aging medicine, longevity and its practitioners (see: Anti-Aging, Longevity Medicine, and Lab Testing) that included the following paragraph:

Just to frame the issue and get your attention, annual revenue from the anti-aging industry is estimated to be $56B  -- this includes products such as anti-aging cream and botox injections. Need to find an anti-aging physician?  No problem. Here is the link to the home page of the American Academy of Anti-Aging Medicine (A4M). It's not too late to attend the 14th Annual International Congress on Anti-Aging Medicine.

Since I posted this first note, there still seems to be a heavy dose of hucksterism in the anti-aging field. A patient visiting a practitioner often is screened with a large panel of lab tests to determine the difference between his or her chronologic and biologic age. Study of telomere length may be one facet of such testing (see: Easing the brakes on the "immortality" enzyme could slow aging). The consequence of testing is often to suggest the need for dietary supplements or anti-aging sera. Here's a typical web page located by a search with the term anti-aging (see: The Best Anti-Aging Secrets). Perhaps even worse for the patient may be the occasional advocacy of the physician for off-label administration of growth hormone as a kind of elixir of youth (see: Growth hormone therapy).

Perhaps the longevity and anti-aging "brands" are now so tarnished that they can't be rehabilitated. However, it did occur to me that it also may be the right time to blend longevity medicine with mainstream medicine. In my mind, preventive medicine overlaps with anti-aging medicine with the suitable goal of pursuing a longer and disease-free life for a patient. This can be accomplished by ameliorating the most common causes of premature death which are sometimes called lifestyle diseases (see: Seeking the Correct Definition for a "Lifestyle Disease"; Relevance of Lifestyle Analytics for Healthcare Organizations). This attention to "lifestyle" problems would involve attention to obesity, diabetes, daily exercise, smoking cessation, drug and alcohol addition/dependence, and adequate sleep habits.

Some Ideas Governing Patient Data Stewardship by Hospitals

A recent kerfuffle at Memorial Sloan Kettering Cancer Center launched a discussion about whether MSK acted judiciously by providing a for-profit, startup company exclusive access to its hospital surgical pathology imaging data as well as associated textual records (see: Controversy at MSK Cancer Center Regarding the Pathology Archive and Database; Controversy Surrounding Memorial Sloan Kettering Cancer Center and Paige.AI Highlights Risks of Data Sharing and Monetization in Anatomic Pathology). The larger issue here is who "owns" or "controls" hospital data. These questions were addressed in a recent article, a passage from which relating to the use of patient data is provided below (see: Who should profit from the sale of patient data?):

With one exception, every U.S. state either recognizes medical providers as the owners of medical data or do not have any laws to confer specific ownership or property right to medical records. Only New Hampshire explicitly grants ownership of data to patients. Regardless of state law, I believe that we must abandon the discussion of data ownership and instead focus on data stewardship. The ownership of data, whether granted to patients or to providers, will have dangerous unintended consequences....

A model of data stewardship alleviates these concerns. Once a party takes the stewardship of data, they have to act according to a set of rules which guarantee the benefits of all other parties. Despite some notable exceptions such as the Apple Health Application in which patients will be in charge of storing and sharing of their medical records, medical providers are designated as de facto stewards of patients’ medical data in the U.S. healthcare system. This aligns with the long term vision of policymakers who authorized billions of dollars to incentives medical providers to adopt Electronic Health Records (EHR) systems so that they could collect, store, and share patients’ medical data in electronic format.

For me, the question of ownership of hospital-based patient data is (or certainly should be) a settled issue along the following lines:

• Medical providers such as hospitals are the owners of patient data according to many state laws but such laws should be construed as requiring them to act as stewards of the data.
• This stewardship by hospitals should be regulated by a set of transparent rules that guarantee benefits to all involved parties including patients, hospitals, and healthcare professionals. 
• The goal of EHRs in hospitals and health systems, the deployment of which has been subsidized with hundreds of millions of dollars of federal funding, should be to collect, store, and share patients’ medical data in electronic format according to such rules.
• As MSK has now come to understand with regard to its pathology database, it would be inappropriate to provide exclusive access to patient data to a single for-profit company, particularly one for which hospital executives and physicians have a fiduciary interest.
• The overarching goal for the sharing of patient data by hospitals in any fashion other than direct patent care should be to improve the overall quality, efficiency, and effectiveness of healthcare so that the patients themselves, the source of such data, derive benefits from this process.

Register Now for the 2018 Pathology Informatics Summit, May 21-24, in Pittsburgh

It's time for all of the readers of Lab Soft News to register for the 2018 Pathology Informatics Summit that will be held in Pittsburgh on May 21-24, 2018. The lineage of this conference dates back to 1983 with an Ann Arbor conference referred to as AIMCL. The PI Summit can thus boast of a 35-year continuous history as the only national conference devoted solely to the field of pathology informatics. It's sponsored by the Association for Pathology Informatics. Browse the conference schedule and you will discover a wide variety of lectures devoted to both applied and research topics. Also pay attention to the workshops on the first day, May 21, that are included in the registration fee of the conference including the HIMA Imaging Science and International Imaging Workshop. On the evening of May 21, there is also a Digital Pathology Association companion meeting from 5:00 to 7:30 p.m. Here are details about only two of the keynote lectures to be offered. Scan the whole schedule to find more like these.

• Anil Parwani, MD, PhD, MBA: “Houston: We Have Liftoff— The Initial Experiences with US-based WSI Primary Diagnosis”
• Jeroen Van Der Laak, PhD: "Tackling the Challenges that Still Exist in Computational Pathology"

As one might expect, the 39 faculty members of the PI Summit constitute renown set of pathology informatics experts. No other conference places such a group such as this under one roof. A total of 18 vendors will also participate in the conference with some last minute additions expected. The cover a wide range of products including LISs, digital pathology including quantitative analysis, lab analytics, speech recognition, specimen labeling, and workflow automation. It is commonly understood that the two largest challenges facing pathology and lab medicine in this era of value-based care and hospital consolidation are pathology informatics and molecular/genomic diagnostics. Take advantage of the opportunity to register now for PI Summit 2018 and get up-to-speed in the latest developments in lab automation and analytics. 

Theranos "Demo's" Would Not Have Fooled Competent Lab Professionals

In a recent note I discussed the fraud charges that have been brought against Elizabeth Holmes, founder of Theranos (see: Elizabeth Holmes, Founder of Theranos, Charged by SEC with Massive Fraud). In the final paragraph of this note, I questioned how the executives of Pharmacy A (possibly Walgreens) could have been duped by Holmes and her associates into believing that the Theranos analyzer was market-ready. On this basis, they invested in the company. Walgreens reportedly settled a suit against Theranos for under $30M (see: Theranos, Walgreens reportedly reach a deal to settle suit for under $30 million). Here is the excerpt from my note:

I understand that a number of fraudulent claims were made to Pharmacy A executives by Holmes and she is now being brought to justice for her behavior. However, one does need to ask why the executives of this referenced pharmacy company did not take steps to verify claims about her company's analyzer that could have been easily and quickly verified in a lab setting. She either was one of the world's greatest snake-oil "salesperson" or the pharmacy executives were hopelessly naive or both. 

A recent article in the New York Times about Theranos (see: Elizabeth Holmes, Theranos C.E.O. and Silicon Valley Star, Accused of Fraud) made the following comment about these phoney, staged demo's by Theranos:

Ms. Holmes and the company even went so far as to demonstrate their product on potential investors, the S.E.C. said, drawing their blood through a finger stick and placing it in one of Theranos’s nanotainers. But while investors thought their blood was being tested with the company’s technology, Theranos “often actually tested their blood on third-party analyzers, because Theranos could not conduct all of the tests it offered prospective investors on its proprietary analyzers,” according to the complaint.

I find it difficult to believe that the Pharmacy A executives were advised by a competent lab professional at the time that they were evaluating the Theranos device. It is commonplace in the clinical lab industry for IVD manufacturers to bring new devices to market. Such new devices never gain acceptance without extensive hands-on testing by independent labs and often further testing by the lab considering purchase of the equipment. Homes was famous for not allowing her product to be subjected to such scrutiny in order to "protect her intellectual property." It was announced in 2015 that Theranos would allow Cleveland Clinical lab personnel to test its devices as a possible way to allay the questions in the lab community about the Theranos claims (see: Cleveland Clinic Develops Business Partnership with Theranos) but this never came to pass. In retrospect we now understand that there was really no mature technology to evaluate and the Cleveland Clinic was thus never allowed to play this role. 

FDA Cracks Down on Some Stem Cell Clinics for Unproven Treatments

The FDA is still working to protect the U.S. population from medical chicanery while some of the federal government is wasting money, frittering away time, and trying to harm people. The new target for the agency is stem cell clinics and purveyors of "regenerative medicine" (see: FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients). Below is an excerpt from the article:

The Food and Drug Administration...announced a crackdown on stem-cell clinics offering unproven and potentially dangerous treatments, including an operation in California that the agency said was using the smallpox vaccine on seriously ill cancer patients. U.S. marshals on Friday raided San Diego-based StemImmune and seized the vaccine, which the FDA said had been combined with fat-derived stem cells to create an unapproved product. ....[T]he agency..,[also] posted a warning letter issued...to U.S. Stem Cell of Sunrise, Fla., saying that recent FDA inspections of the clinic found that it was using stem cells derived from fat to purportedly treat illnesses including Parkinson's disease, ALS and heart disease.

....[FDA Commissioner] Gottlieb...said that the emerging field of cell-based and so-called regenerative medicine holds “significant promise for transformative and potentially curative treatments” for serious illnesses but that “a small number of unscrupulous actors” is putting the field at risk. He said he is launching a new working group at the FDA "to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health."At the same time, he said, the agency will develop a framework to more clearly describe the “rules of the road” for the field and to allow responsible developers of stem-cell treatments to more easily win FDA approval.

Here's a biosketch for Kristin Comella who is the Chief Science Officer for U.S. Stem Cell copied from the company web site (see: Who We Are):

Ms. Comella is a world renowned expert on regenerative medicine with a focus on adipose derived stem cells....Ms. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose....Ms. Comella is a PhD candidate in Biomedical Engineering at Florida International University and holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.

Take note that the Chief Science Officer of a company that is the self-declared "world leader in of stem cell and regenerative medicine research" is only a candidate for a Ph.D. U.S. Stem Cell also provides "accredited" training programs in regenerative medicine. I can only wonder about the content of these programs. It's also fascinating that the U.S. Stem Cell web site provides a list of ongoing clinical trials in the U.S. and Europe (see: Clinical Trials). Regenerative medicine is definitely an area of high interest for legitimate organizations like the Mayo Clinic (see: CENTER FOR REGENERATIVE MEDICINE). However, it requires a leap of faith to travel from the legitimacy of a large medical research field to the goals and procedures of an organization like U.S. Stem Cell that is now under close scrutiny by the FDA.

Integration and Interoperability Are Essential for Growth of Digital Pathology

Now that digital pathology has been approved for primary diagnosis of surgical pathology specimens (see: FDA Approves the Philips Digital Pathology WSI Solution for Primary Diagnosis), pathology departments will inevitably need to develop plans to integrate this new technology into their existing LISs and automated lines (see: Seamless automation: within reach for AP?). This topic was recently addressed as a blog note by Nathan Buchbinder who is Vice President for Operations at Proscia (see: Integration and Interoperability Are Essential for the Growth of Digital Pathology). It's a longish article so I could not quote all of it. Below is a short passage from it:

There are multiple hurdles that digital pathology must overcome before the widespread adoption of this technology. One key hurdle is that consumers are of digital pathology are rightly wary of staking a lot of money and time on the often frustrating process of installing and adjusting to expensive digital pathology systems. A large portion of this frustration is due to sub-par standards and practices with regards to digital pathology hardware and software implementation and integration. There are two elements that make Implementation and integration particularly crucial to the success of digital pathology. First, digital pathology is just one (albeit crucial) part of the overall pathology and diagnostic workflow. Integration with existing laboratory hardware and software, including the Laboratory Information System (LIS), is vital to ensuring that the full benefits of digital pathology can be achieved. If that doesn’t happen, or if it doesn’t happen smoothly, consumers are justly concerned that the efforts spent on this expensive endeavor won’t pay off. Rather, they will be left with just another tool whose use consumes time and effort that pathology labs simply don’t have.

Secondly, digital pathology technology is evolving quickly. In theory, this rapid evolution provides the consumer with an improved experience, but poor implementation and integration can make it challenging for an existing setup to evolve alongside the technology. As new hardware, software, and accessory tools are developed as part of the pathology workflow, pathologists want to feel assured that their systems will never be outdated and that adopting and integrating new technologies will be straightforward. Digital pathology is not meeting consumer expectations for integration and implementation due to issues concerning interoperability. Closed hardware and software systems leave little room for independent, third party integration. What’s more interesting and troubling is that, to date, even the most open hardware and software providers have yet to successfully establish standards or ensure compatibility between their products. Consumers want a seamless experience from start to finish. 

Digital pathology has been in a kind of limbo state for years, lacking FDA approval for primary diagnosis. This goal has now been achieved, at least for one vendor, and I assume that the other vendors will succeed quickly with the same goal. It's significant that an executive with a digital pathology vendor is now calling for the establishment of standards to ensure compatibility between the various digital pathology products in the market. His company is Proscia and its platform, Pathology Cloud, is describe on the company web site in the following way:

Pathology Cloud helps users get started with digital pathology in minutes. At the core of Pathology Cloud lies an as-a-service infrastructure optimized for scalability, security, and cost-efficiency. With granular access permissions, clients have full control over who can see what, when. This, along with exhaustive access logs available for auditing, make Proscia's cloud infrastructure ideal for sensitive data.

I was active in pathology informatics during the era of standards development for LISs and the associated integration of automated IVD instruments with LISs. All of the same rules apply to digital pathology. These efforts will require a collaborative relationship between pathology departments, digital pathology vendors, LIS vendors, automated AP equipment vendors, and pathology societies. The latter include the Digital Pathology Association (DPA) and the Association for Pathology Informatics (API) and perhaps larger organizations like CAP and ASCP. Among the pathology societies, the one with the largest vested interest in standards development is API with a number of digital pathology vendors as members. Here is a link to the DPA web site showing the logos of its 23 industry members. Omnyx is still listed but its current status is murky (see: Omnyx Shutters Doors in Pittsburgh).

Creating an Effective Consulting and Education Ecosystem for Digital Pathology

Beginning on May 10, 2017, I posted three sequential notes regarding the deployment of digital pathology platforms (see: "Not Yet" a Common Response by Pathologists to Digital Pathology Adoption; Seeking Funding from Hospital Executives for Digital Pathology Platforms; A Potential and Useful Consulting Role for Digital Pathology Vendors). In response to the last one about the need for consulting support when deploying this new technology, Dr. Karim Sirgi, a pathologist, submitted the following comment:

It is true that digital pathology vendors could play a more active role in "educating" their pathology clients about the many operational and financial benefits associated with digital pathology. However, in order to do so, they need to have on their staff, or as part of their own consultants, "real-life" pathologists who work is settings relevant to such digital pathology deployments....[I have discovered] hollowness in my conversations with most digital pathology equipment vendors ... and found myself in the unusual situation where I had to tell THEM about the unadvertised and underdiscovered features of THEIR products ....

In this note and prompted by Dr. Sirgi's comment, I would like to propose a possible means to provide consulting and educational services for digital pathology with emphasis on optimizing the technology. First, though, I want to list what I don't think will be happening regarding consulting and education in this area:

• Digital pathology vendors will not be able to provide sufficient and adequate consulting and education services for their products because this is not the nature of their business and they often lack the "real world" experience to which Dr. Sirgi refers to above.
• Large healthcare consulting firms will not be entering the pathology market. There's not enough business to attract them and they lack the specialized expertise. 

What I envision possibly, and hopefully, happening is the following to facilitate the rapid acceptance and success of digital pathology:

• The creation of a digital pathology education and consulting ecosystem based on a partnership of (1) digital pathology vendors; (2) pathology departments (i.e., pathologists and support personnel in large health systems already using the technology), and (3) pathology informatics societies like the Association for Pathology Informatics (API) and the Digital Pathology Association (DPA). 
• Participants in this ecosystem will begin to organize tutorials and seminars, frequently in hospital settings, to discuss practical issues including the enhancement of workflow to maximize the benefits of digital pathology systems. The teaching materials used for such events will have been largely developed by the pathology departments that are using the technology.
• Ideally, the pathology departments participating in these tutorials and seminars will be the alpha and beta sites for the digital pathology vendors and will be compensated for their participation with access to the vendors' new hardware and software. This creates a virtuous circle -- a self-propagating advantageous situation in which a successful solution leads to more of a desired result or another success which generates still more desired results or successes in a chain. In other words, these pathology departments will always be working with the latest technology and thus pushing the boundaries in real-world environments.