Lab Soft News

Is Any Hospital Using the "Hybrid" Digital Pathology Business and Workflow Model?

In a previous note, I discussed the hybrid teleradiology business model (see: Hybrid Model of On-Site and Remote Radiology for Enhanced Patient Workflow). In a nutshell, it works in the following way:

• A radiology department at a 370-bed acute-care hospital in Carmichael, California, utilizes both its on-site radiologists and remote radiology ("nighthawk") consultants to improve the quality of care and workflow.
• Cases are turfed to the outside consultants when the local radiology expertise is unavailable (e.g., neuroradiology), when the local number of radiologists is insufficient to handle the current case load, and during the night and weekends when the local radiology department is not fully staffed.

It occurred to me that this model would be ideal for smaller hospitals today who have deployed a digital pathology system or are interested in doing so. When outside consultation is required for a surgical pathology case, it could be scanned after primary review by the local pathologist. The volume of such cases would thus be small and a high-volume, high-throughput, expensive scanner would not be required. Moreover, such a surgical pathology consultation would require only an outside secondary opinion and thus, given my understanding of today's regulatory environment, would be acceptable to the FDA.

The Digital Pathology Association is planning a webinar next month focusing on the various business models that can be used to deploy digital pathology technology. Are there any readers of this blog who have successfully deployed such a hybrid model and wish to be considered as a faculty member for this upcoming webinar?

Hospitals Need to Expand Cloud Services Starting with Radiology Images

I began raising exploring cloud computing in healthcare in early 2008 (see: Cloud Computing in Healthcare: Key Questions to Ask; Finally, A Clear Definition for Cloud Computing). It looks like we are finally seeing some movement toward this technology some five years later (see: Where Do You Keep All Those Images?). Here is an excerpt from an article in the WSJ on the subject:

Health-care providers are starting to embrace the fast-growing area of technology known as cloud services, the model of shared computing in which data is stored on remote servers that hospitals can access via desktop, tablet or smartphone. Instead of big capital investments in their own storage, they are paying a relatively modest upfront charge and monthly usage fees for cloud services. About 15% of health-care systems in the U.S. are using cloud-based storage for images, according to consulting firm Accenture, which estimates that more than half of the country's health systems will use cloud storage for medical imaging in the next three years. The need for storage is immense and growing rapidly. About 600 million imaging procedures are performed each year by health-care providers in the U.S., including CT scans, X-rays, ultrasounds and MRIs....Hospitals generally are required by law to keep images for seven years, but many keep them longer. They also retain backup copies as part of disaster-recovery planning and to comply with the federal health-care privacy law. As a result, image archives are increasing by as much as 40% annually, according to AT&T. Marketers of cloud services say that by allowing health-care providers to store, view and share patient medical images expeditiously over a secure network, they can help doctors make diagnoses faster, reduce the need for duplicate images and protect patients from the extra radiation exposure of having another CT scan because an original can't be found....[An industry expert]....says that despite the advantages of cloud storage, privacy and security concerns have been a barrier to adoption. At present, most providers store recent images in-house, while older images may be shipped to an off-premises data center. In contrast, [he] says, cloud-storage vendors have multiple storage sites, and the provider "doesn't know where the data is sitting and doesn't have direct oversight into who is looking at it. "Vendors have started to provide customers with assurances that they are in compliance with security standards and patient-privacy laws, he says, and the advantages of cloud storage are likely to be increasingly persuasive, especially on the cost side. "With the cloud you have more recurring costs you can finance out of operating funds, as opposed to digging into your capital fund, and you have way less responsibility for maintaining, upgrading and protecting all this hardware every few years,"....

Here's a key quote from the excerpt above: Vendors have started to provide [hospital] customers with assurances that they are in compliance with security standards and patient-privacy laws, he says, and the advantages of cloud storage are likely to be increasingly persuasive, especially on the cost side. Hospital IT personnel have a high level of concern about safety and privacy issues. If they receive proof from cloud vendors and consultants that these concerns can be addressed, they will be more likely to move their data to the cloud. Moreover, hospitals are now under intense pressure to reduce costs and cloud storage is much less expensive than local storage and, for many, operating funds may be easier to acquire than capital funds.

As I noted in a previous note, hospital CIOs will not be using cloud storage for most clinical information without the cooperation and approval of their EHR vendors (see: Google Launches Renewed Effort in Cloud Computing; Reaction in Hospitals). This is unlikely for the following reason, quoting from this note:

There is no possible advantage for these vendors in bringing a third party cloud computing vendor into their relationship with hospitals. If they were to offer a "remote hosting option," they themselves would provide it (Comments about Cerner's Remote Hospital Option (RHO)).

However and as emphasized in the WSJ article above, the major current storage problem in hospitals is located in the radiology departments and their PACSs; these systems are not supplied by the EHR vendors. Therefore, radiology would be a good place to start testing the functionality and value proposition of cloud storage. Accenture, quoted in the excerpt above, is rolling out a new platform to manage hybrid clouds for radiology departments and predicts wide adoption of the technology by the speciality in three years (see: Accenture Rolls Out New Platform To Manage Hybrid Clouds).

Hybrid Model of On-Site and Remote Radiology for Enhanced Patient Workflow

Because teleradiology is so well established and digital pathology (i.e., telepathology) still in its infancy, we need to look carefully at how teleradiology is evolving to order to plan our own future in pathology. I have always held the opinion that digital pathology will not replace pathologists in smaller hospitals but rather support and supplement their work. Currently, pathologists in smaller hospitals select their most challenging surgical pathology cases and send the glass slides, via expedited delivery, to their favorite consultants for an additional opinion. The time interval for the return of the consultant reports will be variable but will usually will be measured in days.

Under a digital pathology model, the same hospital pathologists will instead send the whole slide image (WSI) file for a case to the consultants and ideally receive the reports back in 24-48 hours. National pathology networks are also now evolving that can provide such services (see: PathCentral Debuts Agnostic Global Pathology Network). This model should result in enhanced quality and little disruption to patient throughput and lab workflow. Below is an excerpt from an article discussing a hybrid teleradiology model that has been adopted in a 370-bed California hospital (see: Partnering for Progress: Imaging and the Rapidly Growing Hospital):

Mercy San Juan Medical Center is a 370-bed acute-care hospital in Carmichael, California, that is part of the not-for-profit Dignity Health System. It has experienced significant growth since it opened its doors in 1967....Most patients are affected by imaging, so timeliness, access, and partnership in care of the patient are critical. As the patient load seen by the facility has increased, so have the service lines offered to those patients, according to [the] COO of the hospital. “The case complexity of the patients we are seeing continues to increase over time,” she says. “In addition to being a level II trauma center, we feature neurosciences as a key service line....When patient volume is a key consideration, nothing is more critical than throughput, and the need to get patients through the hospital quickly and appropriately has made imaging a linchpin of care....Without radiologists partnering with us and aligning toward that effort, we will not survive.” Toward that end, Dignity Health System has taken a hybrid approach to its radiology coverage, using a radiology group that is part of the Dignity Health Medical Foundation for daytime and on-site work, in addition to using subspecialty teleradiologists from Virtual Radiologic (vRad).....“This model allows them to access radiology seamlessly. Even at the busiest of times, vRad can help us load balance so that we meet the turnaround times the referring physicians ...need.”....“We have an extensive specialist group of neurologists, neurosurgeons, and interventional neuroradiologists,”...“We’re quickly becoming the center of choice for ambulance and transfer patients from other hospitals for diagnosis and treatment of any type of neurology-related condition.”Without both subspecialty radiologists working remotely and on-site interventional neuroradiologists, this offering would not be possible....

The reason that I like the model described above so much is that improved patient workflow is the most important rationale for deploying teleradiology support in the hospital rather than cost-savings. Mercy San Juan Medical Center has created a hybrid radiology staffing model comprised of its own radiology group for daytime and on-site work and Virtual Radiologic (vRad) for load-balancing and off-hours work. 

Obviously, the key to deploying such a hybrid model is the allocation of work assignments between the two collaborating radiology groups. However, I suspect that this could be a relatively simple matter using computer algorithms based on the orders for various radiology procedures, the complexity of the cases, the degree of urgency of each case, and the available resources at the time from the two professional pools, local radiology and on-line vRad. Obviously, in some hospital settings, such a hybrid model can be controversial in the sense that it takes work away from the local radiology group. Here's a very detailed look from a legal perspective at Alternative Hospital-Radiology Practice Models that was posted on the American College of Radiology web site. 

PathCentral Debuts Agnostic Global Pathology Network

Various types of pathology networks have evolved over the years and new ones will continue to be created. For now, most of them will probably focus on the exchange of digital pathology files for surgical pathology consultations. Such networks will serve U.S. hospitals and also enable consultations across countries. Diagnostic networks can be agnostic in the sense that they will accommodate all users or proprietary, which is to say reserved for use by a single company. An example of the latter are the networks developed by the teleradiology companies (see: Digital Pathology vs. Digital Radiology: A Broad Divide; Tighter Integration of Nighthawk Reports into Hospital EMRs and RISs). Here's an excerpt from a recent press release about a pathology network launched by an AP-LIS vendor, PathCentral (see: PathCentral Debuts Digital Pathology Network, Online Information Exchange Open to Global Pathology Community):

PathCentral...introduces the PathCentral Pathology Network, ...a comprehensive online information exchange and digital consultation forum. The Network enables physicians to upload case files using digital images for pathologists to review and render critical consulting diagnoses on a global and a domestic real-time basis....[According to the PathCentral CEO], the Pathology Network not only enables us to electronically connect a broad base of users, it helps address the global shortage of highly qualified pathology consultants by bringing their expertise to all corners of the globe. As a truly open network, it will uniquely encourage participation and feedback from everyone who accesses it. In terms of scanning technology and imaging software, the Network is agnostic and designed to be nonexclusive—that is, open to all users regardless of location or consulting institution. The Network seeks to connect the world's pathologists, incorporating tools from social media, making it an ideal forum for pathologists to send and perform consults, create connections, post information, share cases, ask questions, and expand professional relationships....In January, China-based Kindstar Globalgene Technology Inc became the first international organization to sign on to the Network as a sender and a user. Through its participation, Kindstar will be able to access US pathologists and facilitate pathology consultations for more than 3,300 hospitals throughout China. Kindstar and its clients will gain access to hundreds of American pathologists at leading US medical institutions, including many of the top 50 cancer centers, delivering patient diagnoses to physicians in China via the cloud.

Although the main function of the PathCentral digital pathology network will be the exchange of surgical pathology images, I view this as an early stage on the development curve. Such images will soon be packaged with patient biomarker results as well as genomic tumor analyses. The International Genomics Consortium has recently announced the formation of a non-profit company with the University of Michigan Department of Pathology called Paradigm. The goal of this new lab will be to develop tailored treatments for patients based on their genetic makeup as well as that of their tumors. “Paradigm builds on our understanding of the relationship between disease-causing genes and how they affect a patient’s sensitivity to specific treatments,” according to Robert Penny, CEO and co-founder of Paradigm and International Genomics. “In essence, we look for the malfunctions in the cancer and match them with the best therapies.”

The rendering of surgical pathology diagnoses by American pathologists is a component of what is now commonly called reverse medical tourism  but with a twist (see: Reverse Medical Tourism Points Up Pluses and Minuses of U.S. Healthcare). The twist is that the diagnoses are being rendered on the basis of the digital pathology images of tumors transmitted on networks like the one developed by PathCentral. The patients from abroad are not traveling to the U.S. for diagnosis but the images of their tumors are. Such diagnoses will be even more useful when accompanied by genomic analysis and therapeutic recommendations for cancer treatment generated by labs such as Paradigm.

Google Strikes Deal with French Government Regarding Online Content

I have posted previous notes about the question of whether Google is a search engine and news consolidator or a publisher of content (see: When Does Sophisticated Web Search Result in the Creation of New Content?; Google as an Enabler and Protector of Global Information Exchange; Is Google a Publisher or a Search Engine? Can Google Have It Both Ways?; Google's Deal with Publishers; Broad Current Acceptance of E-Books). According to a recent article, this question has been sorted out, for the time being, in France (see: French Publishers Forge Deal With Google, Breaking Ranks With Europe). Below is an excerpt from the article:

Publishers in France say they have struck an innovative agreement with Google on the use of their content online. Their counterparts elsewhere in Europe, however, say the French gave in too easily to the Internet giant.The deal was signed this month by President François Hollande of France and Eric E. Schmidt, the executive chairman of Google, who called it a breakthrough in the tense relationship between publishers and Google, and as a possible model for other countries to follow. Under the deal, Google agreed to set up a fund, worth 60 million euroes, or $80 million, over three years, to help publishers develop their digital units. The two sides also pledged to deepen business ties, using Google’s online tools, in an effort to generate more online revenue for the publishers, who have struggled to counteract dwindling print revenue. But the French group, representing newspaper and magazine publishers with an online presence, as well as a variety of other news-oriented Web sites, yielded on its most important demand: that Google and other search engines and “aggregators” of news should start paying for links to their content. Google, which insists that its links provide a service to publishers by directing traffic to their sites, had fiercely resisted any change in the principle of free linking. The agreement dismayed members of the European Publishers Council, a lobbying group in Brussels, which has been pushing for a fundamental change in the relationship between publishers and Google. The group criticized the French publishers for breaking ranks and striking a separate business agreement that has no statutory standing. The deal “does not address the continuing problem of unauthorized reuse and monetization of content, and so does not provide the online press with the financial certainty or mechanisms for legal redress which it needs to build sustainable business models and ensure its continued investment in high-quality content,” Angela Mills Wade, executive director of the publishers council, said in a statement. German publishers were also scornful, with Anja Pasquay, a spokeswoman for the German Newspaper Publishers’ Association, saying: “Obviously the French position isn’t one that we would favor. This is not the solution for Germany.”

A few comments about this article. First of all, $80 million dollars over three years to keep the French publishers relatively satisfied strikes me as very good news for Google. The amount is trivial for Google and serves to drive a wedge into the European publishing industry on the basis of the French accommodation. I am not surprised that the European Publishers Council and the Germans expressed regret about the deal. So much for European unity. Every country will be trying to strike the best perceived deal for itself.

Secondly, how likely do any of you readers think that Google will be able to help the French publishers in any substantive way to "develop their digital units." I suspect that much of the European book and newspaper industry is either not knowledgeable about the web or resistant to learning any new tricks from the "Silicon Valley" types. Google is buying a temporary hiatus from the French until digital publishing is even more entrenched. Most content publishing will soon be digital. The European newspaper, magazine, and book publishers need to understand this reality and come to view Google as an ally, not an enemy, in the process of monetizing their content going forward. They are swimming upstream.

Healthcare in Developing Countries; Relationship to Smartphone Apps and Devices

I have been blogging a lot lately about various types of health monitoring devices and medical apps that can be attached to, or run on, smart phones (see: "Check Engine Light" for Health Surveillance on Our Smart Phones; Healthcare Consumers as Self-Trackers; Process Enabled by New Apps). Smartphones are fast becoming the "brains" for ECG testing, ultrasound scanners, and lab analyzers such as glucometers and pulse oximeters (see: iHealth adds smartphone-enabled glucometer, pulse ox). This wave of innovation is going to have a major impact on healthcare delivery in both developing countries as well as the more developed ones. Consider the following ideas connected to this prospect:

• There is a long history of developing countries being able to leap over previously essential steps in the  evolution of technology. For example, a number of countries have been able to avoid the installation of fixed telephone land lines, going directly to the construction of cell phone towers.
• One of the most challenging and expensive steps is the diagnosis of complex disease (e.g., malaria, AIDS). Once a diagnosis has been established, some treatments can be as simple as dispensing the appropriate drug at a specified dosage.
• There is a major movement underway to develop low-cost technologies such as medical imaging that are connected to smartphones.  Such technologies can be then deployed in developing countries quickly and inexpensively (see: Using an iPhone as an imaging device in developing countries; LOW-COST X-RAY IMAGING SYSTEMS).
• Test results and imaging study results can be uploaded to "the cloud" from developing countries where they can be interpreted by algorithms or by physicians participating in expert networks. Such an approach will be essential for deployment of some of these new technologies in developing countries with a shortage of diagnostic physicians like pathologists and radiologists.

I believe that all of this will result in a new type of sophisticated healthcare delivery system that is technology-driven but staffed by healthcare practitioners with less training than physicians. Some of the necessary expertise is provided by the point-of-care device, the smartphone, and the cloud. This is analogous to the deployment in the U.S. of physician extenders such as nurse practitioners who will provide the first level of care and diagnosis, supplementing the PCPs (see: A Solution to the PCP Shortage: Nurse Practitioners). These physician extenders will refer the most complex patients to physicians operating at the next care level.

Radiology Patient Portals Gain in Popularity; Patients Help Manage Their Own Images

I posted a recent note about some of the pitfalls associated with patient portals that are used by patients to access lab and pathology reports (see: Publishing Test Results in Patient Portals: Holding a Tiger by the Tail). May major point was that lab professionals have not yet totally mastered the "art" of communicating complex test results to physicians and that we are now presenting some of these same results to patients. This presents a very significant challenge that needs to be attended to. A recent article discussed how radiology departments are now increasingly in the same boat with radiology patient portals (see: Bypassing Doctors, Patients Take Charge of Radiology Images, Reports). Below is an excerpt from it. It's very long so link to the whole thing for more information.

Once the exclusive province of doctor-to-doctor communications, radiology images and reports are migrating into the hands of patients, a trend that may soon exert extraordinary influence over the specialty. Using new technologies called "patient portals," patients can now access their medical images and the diagnostic reports on which they are based and decide who will see them. A project involving some of the top medical institutions in the United States is sowing the seeds of patient online access to this information, just as vendors experiment with low-cost means to provide it. Preliminary research has documented that patients overwhelmingly want this access. And the benefits of obtaining it may go far beyond patient empowerment and include immediate and long-term savings to radiology operations in time and money, as well as the streamlining of medical practice overall, potentially laying the foundation for better emergency care and broadly based clinical studies.

Since 2009, the University of California, San Francisco; University of Chicago; Mayo Clinic in Rochester, Minnesota; the University of Maryland in Baltimore; and Mount Sinai Medical Center in New York, New York, have collaborated on Image Share, a project that allows patients to pull their medical images from the Internet cloud. As part of Image Share, these institutions developed Web-based personal health records for participating patients, who arrange with radiology practices to file image and diagnostic reports in those patient records. ....

This is the next revolution in digital imaging," said David Mendelson, MD, Chief of Clinical Informatics at Mount Sinai Medical Center and lead investigator of the Image Share project. "It gives the patient ownership over their records and makes the information more accessible to physicians. Plus, it decreases unnecessary radiation exposure that can be caused by physicians ordering duplicate examinations owing to records not being easily available." At Houston Medical Imaging (HMI), a private imaging provider that operates in 3 sites in Houston, Texas, patients can access their images and reports using software developed by Carestream Health. Patients can register to use the software, called MyVue, after completing an imaging examination at HMI. Accessing their MyVue account as they might an online banking account, these patients can view -- and distribute -- their images and radiology reports to anyone they choose.

Think about the long-term implications of radiology patient portals and, perhaps, some of the future implications for lab/pathology patient portals. Radiology is now providing patient access to the same images that are being used to generate diagnoses as well as narrative radiology reports. As digital pathology matures and surgical pathology images are more commonly posted on pathology PACS servers, I believe that patients will soon have access to these images as well.

The key sentence in the excerpt above is the following: [patients are] accessing their MyVue account as they might an online banking account, these patients can view -- and distribute -- their images and radiology reports to anyone they choose. Some patients will thus now be in a position to participate in discussions/decisions such as whether proposed duplicative imaging studies should be ordered for them or whether to request an additional opinion about a study. Here's the good news in all of this. I suspect that not many patients will assert that they are more skilled in interpreting imaging studies than radiologists as was the case when neurosurgeons and orthopedic surgeons got rapid electronic access to them via PACS servers.

The Internet as the New Industrial Revolution: Implications for Healthcare

Pathology Informatics 2012, the most important pathology conference of the year, was held on October 9-12 in Chicago at the Hyatt Regency. All of the PowerPoint slides for the lectures synched with audio have been posted and are available online (see: Full Schedule). Click on any of the lecture titles to launch the presentation. In this and subsequent notes, I will frequently link to this rich set of lectures to support some of the new ideas that have been germinating in my mind post-conference. --BAF

I had to turn to the Wikipedia for a concise definition of the industrial revolution that was referred to in a recent article describing the Internet as the modern analogue of it (see: Industrial Revolution). Here it is:

The Industrial Revolution was a period from 1750 to 1850 where changes in agriculture, manufacturing, mining, transportation, and technology had a profound effect on the social, economic and cultural conditions of the times. It began in the United Kingdom, then subsequently spread throughout Western Europe, North America, Japan, and eventually the rest of the world. The Industrial Revolution marks a major turning point in history; almost every aspect of daily life was influenced in some way. Most notably, average income and population began to exhibit unprecedented sustained growth...."For the first time in history, the living standards of the masses of ordinary people have begun to undergo sustained growth ... Nothing remotely like this economic behavior has happened before".

Here's the link to the article that caught my eye and below is an excerpt from that it (see: The Internet Revolution is the New Industrial Revolution):

In the mid-90s, ARPANet was transformed from a military safety net to the civilian Internet that has become such an integral part of our lives, bringing with it change not only technological, but societal and epic in scope....The Internet is bringing a revolution along with it. Access to information combined with global supply and demand is reshaping established conventions and destroying old world definitions....The very definition of ‘success’ is now drastically changing. It once meant a “keeping up with the Joneses” lifestyle your neighbors would be envious of; now it’s about making personal, intimate choices about how to live your life....Anyone now has the opportunity to monetize their skills, from the full-time worker looking for additional income to the once hobbyist building their very own business....As we engage in a century where everyone is not only a global citizen, but a valuable “Brand in Waiting,” we begin to understand that the Internet Revolution IS in fact the Industrial Revolution of our time....It’s the return of personal choice and personal definitions of value, as we increasingly define ourselves by the work we produce rather than being defined only by the work available.

We all understand that the effects of the Internet/Web are ubiquitous. The technology affects nearly everyone and everything in very fundamental ways. It's inescapable. I personally spend perhaps four hours per day working on web-enabled email, writing these blog notes, and searching for information with Google. But let's turn our attention to a physician working in a large, complex hospital. On the one hand, such physicians are now demanding that they be allowed to access the hospital EHR with their smart phones or tablets. On the other hand, we have hospitals today spending hundreds of millions of dollars installing EHRs running on local servers that are the rough equivalent of "mainframe computers" in a former era. Dr. Paul Chang commented in his lecture at PI-2012 that healthcare is the only industry in the U.S. that "solves" its computer problems by using a single, monolithic, inflexible EHR system rather than a set of specialized servers connected on a network (see: Digital Revolution in Radiology). With this more advanced computer architecture, the user submits a query to the network and the response is assembled using information from the most appropriate, specialized systems.

Hospital executives are also passively resisting the exchange of clinical information with HIEs because they view it as proprietary to their hospital. They resist cloud computing on the basis that it is too risky and because their favored EHR vendors are committed to older technology (see: Relevance of the Cloud for Lab Computing). Hospital executives are providing patients access to their own medical information via patient portals primarily because it is required by Phase II of the HITECH act with financial penalties for not cooperating rather than because it's a key element in customer service (see: Relevance of Meaningful Use Rules for Lab Professionals; Patient Portals For Laboratory Results: Conundrums and Care).

Simply put, the Internet "Industrial Revolution" will swamp much of the outdated IT that is being deployed and healthcare will be no exception. One person quipped to me during PI-2012 conference that the Epic EHR will be "gone" in ten years. This is clearly impossible but there is no question in my mind that the company will be seriously challenged in upcoming years by more innovative HIT choices. Companies will spring up that offer better EHR services for much less money based on modern technologies and processes. This has always been the modus operandi in healthcare IT.

Last Chance to Register for Pathology Informatics 2012; October 9-12; Chicago

The largest pathology informatics conference in the country, Pathology Informatics 2012, will take place on October 9-12, 2012, at the Hyatt Regency Hotel in Chicago. Here is a link to entire conference schedule. On-line registration is available as well as walk-in registration. Make plans to attend as soon as possible.

The first day of the conference will be devoted to three workshops: (1) Pathology Informatics Overview (2) Histology Image Analysis, and (3) LIS Strategies in the Era of the EMR. The main conference will consist of three tracks: (1) Clinical Information Management (2) System Support and Connectivity, and (3) Digital Imaging. A total of 11 plenary lectures will also be offered.  

More than 50 faculty members will participate in the event. Thirty-one exhibitors will display their products in the vendor ballroom. A small number of exhibitor tables are still available. Companies that are interested in participating should contact the conference manager, Barbara Karnbauer, at 412-648-9184 or email her at bjk37@pitt.edu.

Digital Pathology Misconceptions Debunked by Amanda Lowe

Amanda Lowe, president of Digital Pathology Consultants, posted a very illuminating blog note recently in Keith Kaplan's Digital Pathology Blog (see: Digital Pathology Misconceptions Debunked by Digital Pathology Consultants). It's definitely worth a look. Misconception #1 caught my attention and I reproduce it below:

Misconception #1: The FDA has not approved digital pathology; therefore, it must not be safe.

The FDA does not regulate laboratories and it does not issue blanket approvals for specific applications like digital pathology. The reality is that the FDA approves the digital pathology hardware and software produced by a manufacturer for a specific intended use (e.g., primary diagnosis of H&E slides). Digital pathology manufacturers are required to go through a premarket approval (PMA) process to have their systems approved as a Class III medical device; this process takes time and is very costly for manufacturers. These hurdles have made it difficult for manufacturers to apply for FDA approval, but they are working on it. However, several digital pathology manufacturers have received FDA 510(k) clearances for specific manual and semi-quantitative analysis of specific IHC assays including HER2, ER/PR, Ki-67, and p53.