Lab Soft News

Lowe's Offers "Free" Surgical Procedures at Prestigious Hospitals to Its Employees

In previous notes about medical tourism, particularly with regard to Bumrungrad Hospital in Bangkok, I referenced the fact that hospitals abroad were offering pre-priced treatment packages for selected patients for operations such as hip replacement (see: Interview with Bumrungrad Group CEO, Curt Schroeder). I say selected here because patients were required to be examined by a Bumrungrad doctor before being offered any such surgical package. This was obviously a means to identify patients with multi-organ disease who might be not expected to do well post-operatively and for whom pre-payment could result in losses. This approach to care has now arrived in the US with some companies like Lowe's offering "free" surgery to its employees  (see: Some Firms Save Money By Offering Employees Free Surgery). Below is an excerpt with details:

Lowe's home improvement company, like a growing number of large companies nationwide, offers its employees an eye-catching benefit: Certain major surgeries at prestigious hospitals are free....Here's how the program works: Lowe's and other employers pay one flat rate for a particular procedure from any of a number of hospitals they've selected for its quality.....[U]nder the agreement, the hospital handles all the treatment within a certain time frame — the surgery, the physical therapy and any complications that arise — all for that one price....[M]ore than 700 Lowe's employees have taken the company up on its offer....The Pacific Business Group on Health negotiates that [fixed] price for Lowe's, Walmart and a number of other large employers. Associate director Olivia Ross oversees these deals, and says her team is able to negotiate rates that are 20 to 30 percent below what the companies used to pay for the procedures....And, because the hospital is responsible for all that care, the institution has a strong incentive to be careful and thorough....Lowe's initially had trouble wrangling all a patient's medical records from local doctors. And the company found that patients who had questions weeks or months after an operation sometimes had trouble following up with the out-of-town doctor who had performed the surgery."....In addition to cutting the cost of procedures, another chunk of savings to the companies came from avoiding surgeries that probably shouldn't happen in the first place.....What typically happens in these cases, she says, is that employees get a recommendation from a local doctor that they should have surgery, only to have physicians at the selected hospitals deem the operation inappropriate.In some cases that may be because the employee hasn't first tried less invasive treatments, such as physical therapy....

The term "free" in this article needs further explanation. It probably means that the employee undergoing surgery is not responsible for any out-of-pocket expenses such as deductibles, co-pays, or co-insurance. Another major benefit is that the patients are being operated on at well-known hospitals where I will assume that the volume of surgical cases is higher and better postoperative results can be anticipated. One of the reason that these larger hospitals can offer these 20 to 30 percent reductions to Lowe's via Pacific Business Group is that they have refined "the book" on various types of surgical procedures and, in so doing, have been able to squeeze out excess costs. 

In a note almost four years ago about "Big Med," I discuss how super-regional health systems would be offering service like various surgical procedures at a reduced price (see: The Transition to "Big Med": Need for Emphasis on Standardization and Cost). Here's a quote from that note: Large “super-regional” health-care systems will compete aggressively on price and drive smaller hospitals out of business or force them to affiliate with these very large health systems. All of us need to ponder how this will change healthcare delivery as it exists today. Needless to say, a diminishing number of surgeries as smaller hospitals will drive further consolidation. 

One of the most interesting points in the excerpt above is that Lowe's is realizing unexpected savings from the elimination of unnecessary cases that may had been recommended by a local surgeon but called out as unnecessary when the patients were referred to the larger hospitals. The bigger hospitals probably have enough volume that they were wiling to do so and are probably also eager to develop a positive relationship with Lowe's and Pacific Business Group. This is a sad but true commentary on the frequency of unnecessary procedures under our current fee-for-service approach. 

AACC Speaking Invitation to Elizabeth Holmes for August Largely Irrelevant

I have posted a number of previous notes about Theranos (see: for example, Problems with Theranos' Lab Proficiency Testing; Another Layer of Difficulty?; Why Has Theranos Been Unable Thus Far to Defend Its Science?; Some Fundamental Flaws in the Current Theranos Business Model). None of the latest news about the company is good. Supporters of the company may have been encouraged by the fact that she has been invited to deliver a plenary lecture at the August meeting of the American Association for Clinical Chemistry (AACC). This with the ostensible purpose of finally presenting "data" about the company nanotainers and its Edison analyzer (see: Elizabeth Holmes to finally unveil Theranos data in August — if she lasts). This article struck a somewhat cynical final note by suggesting that she may not necessarily be in place as the Theranos CEO by August. Below is an excerpt from it:

[Theranos's Elizabeth] Holmes plans on finally pulling back the veil on the company’s “nanotainers,” its Edison device and other proprietary research in August at the American Association for Clinical Chemistry‘s annual scientific meeting. Of course, this begs the question: Think Holmes will still be at Theranos this August? This is clearly a damage control play, because Holmes’ reign at Theranos has become all the more tenuous in the past week. The Wall Street Journal reported...that Holmes could be booted from Theranos, citing a letter from regulators that says she hasn’t done enough to fix Theranos’ copious problems....The secretive company has been under fire since October, when the Wall Street Journal wrote a damning exposé about the failings of its single-drop-of-blood diagnostic tools.Looks like pressure from the Journal ...have finally forced Holmes’ hand far enough that she feels the need to speak out.....So let’s see if the Theranos CEO makes it to AACC. If she’s still CEO.

Here's an excerpt from the WSJ article about Theranos linked to above:

The company’s most urgent challenge is to persuade government officials not to impose the crippling penalties detailed in the 45-page [CMS] letter. The agency completed an inspection of the California lab in November and found five major categories of infractions that violate the federal law governing clinical labs.In February, Theranos submitted a correction plan to address the problems, but federal officials concluded it was insufficient, according to the March 18 letter...The letter detailed six proposed sanctions, including revoking the California lab’s federal license and barring it from the Medicare program. License revocation would result in Ms. Holmes and Mr. Balwani being barred from owning or operating any lab for at least two years, according to the copy reviewed by the Journal. CMS also proposed to fine Theranos $10,000 a day and said it wants the company to submit the names and addresses of all doctors and patients who used the lab’s services since January 2014.

In my mind, there's only one real reason why the AACC would offer a speaking invitation to Holmes: to stimulate registration at its annual meeting. However, I am sure that the organization will spin the invitation in some other way. Unfortunately for her, the legal threats to her status as CEO are coming from three different directions: regulatory, financial, and criminal. Here's an interesting quote suggesting that the fact that Theranos is privately held may not provide relief from the SEC for charges of financial malfeasance (see: Theranos, the SEC, and the Enforcement of the Securities Laws Against Private Companies):

...[T]here has long been a belief that there is a sharp distinction between privately held and publicly traded companies. Under this view the liability exposures between the two kinds of companies were perceived to be distinct, with the risk of federal securities law liability exposures limited to publicly traded companies. The D&O [Directors and officers liability] insurance marketplace is built around a basic premise that private and public companies are fundamentally different. The D&O insurance for these two categories of companies are written in entirely different forms, in part based on the assumption that public companies have potential liability exposures under the securities laws, while private companies generally do not. SEC Chair White’s recent speech and the onset of the investigation involving Theranos make it clear that private companies have potential liability exposures under the federal securities laws.

As noted in the first excerpt, there is some doubt whether Holmes will be the Theranos CEO in August in which case the AACC invitation becomes moot. I believe that she is in a very precarious position and will probably be forced out of the company before August. At the very least, her attention will be focused on defending herself and Theranos from a raft of lawsuits. The most interesting question now is whether any of the company assets such as intellectual property will be considered to be of any value by other parties.

Type 2 Diabetes Reversed by Dieting; Cure Seems to Persist for Some

I don't think that it's common knowledge among patients with Type 2 diabetes that the disease can be reversed by dieting (see: The Changing Face and Diagnostic Challenge of Diabetes; "Curing" Diabetes with Bariatric Surgery; No Nation Has Lowered Its Obesity Rate in 33 Years). Some physicians may prematurely direct their patients to drug treatment of the disease rather than toward the more challenging path of dieting (see: Patients Diagnosed with Type 2 Diabetes Started on Drug Therapy Prematurely; Can You Reverse Type 2 Diabetes?; Few Good Treatment Options for Pre-Diabetes and Metabolic Syndrome). A recent article made reference to a study indicating that Type 2 diabetes can be reversed with a liquid diet and that the disease reversal may persist (see: Hope for Reversing Type 2 Diabetes). Below is an excerpt from the article:

...[N]ew research raises the tantalizing possibility that drastic changes in diet may reverse... [Type 2 diabetes] in some people. Recently, a small clinical trial in England studied the effects of a strict liquid diet on 30 people who had lived with Type 2 diabetes for up to 23 years. Nearly half of those studied had a remission that lasted six months after the diet was over....Studies have also shown that obese individuals who have bariatric surgery frequently see the condition vanish even before they lose very much weight. But the new study... proved the reversal after diet can persist for at least half a year as long as patients keep weight off, and can occur in people who have had the disease for many years. The researchers followed the participants after they had completed an eight-week low-calorie-milkshake diet and returned to normal eating. Six months later, those who had gone into remission immediately after the diet were still diabetes-free. Though most of those who reversed the disease had had it for less than four years, some had been diabetic for more than eight years.....In the United States, some 8.9 percent of adults 20 and older have been found to have diabetes, and health officials estimate that another 3.5 percent have undiagnosed diabetes....Excess fat in the liver can spill into the pancreas, inhibiting insulin secretion and the liver’s response to insulin, resulting in insulin resistance and diabetes. Going on a very-low-calorie diet may allow the body to use up fat from the liver, causing fat levels to drop in the pancreas as well. That “wakes up” the insulin-producing cells in the pancreas, normalizing blood glucose levels. While some previous studies have shown that blood sugars can normalize after significant weight loss, endocrinologists said they were impressed by the persistence of the lower blood sugar levels for months after the diet.

We need a campaign to educate patients that their Type 2 diabetes can be reversed through dieting and exercise. For me, such an option would be the obvious choice. I can't conceive that taking drugs and worrying about my blood glucose level would be perceived as the "easy" way. However, I have blogged extensively about the obesity epidemic in the U.S, (see: The Obesity Epidemic as an Economic Driver for the Clinical Labs; Projected Future Costs of Obesity to "Crush" U.S. and U.K. Healthcare Systems; What's Behind the Obesity Epidemic: Food Too Accessible and Inexpensive). I thus understand that serious dieting may not be an appealing option for the majority of patients.

Readers may may a question what constituted a liquid diet in the study referenced above. Here are the details: The participants in the....trial, who ranged from overweight to extremely obese, were told to stop their diabetes medications and start a 600- to 700-calorie-a-day diet, consisting of three diet milkshakes a day at mealtimes and half a pound of non starchy vegetables a day. I suspect that for many of the subjects, such a diet was not too onerous, at least for a relatively short period. The trick, as always, is to keep the weight off after leaving the liquid diet. Here are some more details about liquid dieting (see: What Are Liquid Diets?):

...[T]he results [of a liquid diet] may not last. When you drastically cut calories, your metabolism slows to save energy. Unless you change your eating habits, you're likely to regain the weight you lost after you go off the liquid diet. Some liquid diets work better over the long term than others. Diets that include both solid food and liquids can help overweight people control the number of calories they eat and help keep the weight off for several years.

FDA Clears First Blood-Based Colorectal Cancer Screening Test

In the upcoming months, there surely will be an increasing number of blood-based genomic cancer tests approved by the FDA. This specific test market is just too attractive. In a recent note, I discussed some of these testing initiatives from the perspective of companion diagnostics (see: An Expanding Definition for Companion Diagnostics). This form of testing in used in collaboration with cancer therapy to select the right drug or monitor the effectiveness of drug therapy. Obviously and of equal importance are biomarkers intended for cancer screening. A recent article reported that the FDA has cleared the first blood-based screening test for colorectal cancer (see: FDA Clears First Blood-Based Colorectal Cancer Screening Test), Below is an excerpt from it:

The first blood-based colorectal cancer (CRC) screening test, Epi proColon...has been approved by the US Food and Drug Administration (FDA)....The Epi proColon test is a qualitative in vitro diagnostic test for detecting methylated Septin9 DNA, which has been associated with the occurrence of CRC, in plasma obtained from whole-blood specimens. It is indicated for use in average-risk patients who have chosen not to undergo other screening methods, such as colonoscopy or stool-based tests.The test was recommended for FDA approval in 2014 by the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee, but some of the experts were not convinced....The agency approved the Epi proColon test for CRC screening in average-risk patients (as defined by current screening guidelines) who choose not to be screened by colonoscopy or a stool-based FIT [fecal immunochemical test for occult blood in the stool].The Epi proColon blood test for CRC screening can be performed during routine office visits. It requires no dietary restrictions or alterations in medication use. The blood sample is analyzed by a local or regional diagnostic laboratory....The company will initiate a postapproval study to show the long-term benefit of blood-based CRC screening using Epi proColon, as required by the FDA.

Here's more information about Septin9 DNA (see: Plasma methylated septin 9: a colorectal cancer screening marker):

The biomarker septin 9 has been found to be hypermethylated in nearly 100% of tissue neoplasia specimens and detected in circulating DNA fractions of CRC patients. A commercially available assay for septin 9 has been developed with moderate sensitivity (∼70%) and specificity (∼90%) and a second generation assay, Epi proColon 2.0 (Epigenomics AG), shows increased sensitivity (∼92%). The performance of the assay proved to be independent of tumor site and reaches a high sensitivity of 77%, even in early cancer stages (I and II). Furthermore, septin 9 was recently used in follow-up studies for detection of early recurrence of CRC. 

There is clearly a need for a blood-based biomarker for colorectal cancer screening. Patients tend to dislike the home stool collection that is required for fecal immunochemical tests for occult blood in the stool (FIT). Moreover, testing for blood in the stool offers a somewhat crude substitute for the identification of reliable cancer biomarkers in the blood. It must be noted, however, that some of the FDA experts in 2014 were not convinced that the septic 9 biomarker offered advantages over FIT.

I am not sure that septin 9 will be the final and most efficient biomarker for CRC but I am sure of two things. The first is that there will eventually be a high-specificity, high-sensitivity blood test for CRC. The second is that probably tens of billions of dollars would be saved by the elimination of screening colonoscopies for CRC by such a test. I found an article dating way back to 2002 about the number of screening endoscopies performed in the U.S. but the numbers are sill impressive  (see: How many endoscopies are performed for colorectal cancer screening?) Here is a quote from it: "Approximately 2.8 million flexible sigmoidoscopes and 14.2 million colonoscopies were estimated to have been performed in 2002." Needless to say, many gastroenterologists and radiologists may be hoping that such a lab test does not reach the market soon.

Insurance Companies Can Use Telemedicine to Enlarge Their Provider Networks

I have been an enthusiastic supporter of telemedicine as a means for hospitals to provide care to more patients without any bricks-and-mortar investment (see: Details of Cleveland Clinic's MyCare Online Virtual Telemedicine Visits; Hospital Telemedicine Provides Opportunity for Pathologists to Interact with Patients). However, progress in this area has been slow. I attribute this to the fact that hospitals and physicians are usually able to innovate rapidly regarding medical science but act more slowly with organizational changes. A recent article addressed the role of health insurance providers in the adoption of telemedicine as a means to expand their provider networks (see: Could Insurers Use Telemedicine to Widen Provider Networks?):

Many states are tightening their [physician] network adequacy standards, and telemedicine might help insurance companies meet those standards, especially in rural and underserved areas, notes a new report sponsored by the Robert Wood Johnson Foundation. But after discussions with insurance executives, state insurance regulators, and healthcare providers in six states, the researchers concluded that most insurers are not yet using telemedicine for this purpose....However, uncertainty about how regulators would perceive this effort, the lack of infrastructure in most practices, and the concerns of organized medicine about telemedicine have inhibited insurers from using this technology to fill gaps in their networks, the report said....Although "virtual visits" that use videoconferencing can occur between physicians and patients at home, the report focused on telemedicine visits that originate in a clinic with a healthcare professional present. The study noted that insurers increasingly favor narrow physician networks to hold down costs, especially in the state insurance exchanges. In response, both federal and state regulators have proposed more robust network adequacy standards at the state level. These new standards include time, distance, and access measures....Starting January 1, 2017, health plans will be able to use telemedicine to help meet the state's criteria for specialty provider-to-covered-person ratios....Neither payers nor providers have invested in the videoconferencing equipment required to set up remote consults between primary care offices and specialty sites. And while providers are increasingly reimbursed for doing remote consults with patients, "there is insufficient penetration [of telemedicine] to make its use practical," insurers told the researchers.....As a result, insurers may not view telemedicine as an economical or practical method to ensure network adequacy."If and when telemedicine becomes mainstream, the report noted, insurers might use it as a bargaining chip with the specialty groups and healthcare systems that dominate some markets. 

It seems to me that wider adoption of physician e-visists amounts to a chicken-and-egg challenge. In order for telemedicine to move forward, insurers (1) need to reimburse for the service; (2) hospitals and physicians need to be willing and able to offer such services; and (3) the various state medical boards need to support these initiatives on the part of physicians. There seems to be some progress on this last matter to quote from the Robert Wood Johnson report:

In at least two of our study states...,their medical boards have adopted or are considering approaches that would make it easier for physicians to use telemedicine. For example, in Colorado, the medical board required an initial face-to-face interaction to establish a physician-patient relationship inorder to prescribe medication via telemedicine. Insurers in the state noted that this requirement has inhibited telemedicine from expanding. In August 2015, the medical board changed its position and no longer requires face-to-face encounters.

In general, hospitals tend to be slow adopters of modern IT. This should not be an impediment in the case of telemedicine, however because there third-party vendors can supply such solutions (see: Firm Offering "White Label" Service to Enable Virtual Hospital Physician Office Visits). I personally believe that physician interest and willingness to participate in telemedicine programs is one of the major barriers here. 

Cleveland Clinic launched its telemedicine program (Express Care Online) with its family practice physicians who may have been eager to expand their practice and master new ways to interact with patients. As noted above, however, the incentives are for the health insurers is to expand their network of specialty sites.The bottom line here is that health insurance companies need to work in concert with health systems to develop telemedicine initiatives, particularly for medical specialists, coupled with adequate reimbursement for such services.

Pharmaceutical Companies Partner with Flatiron, an Oncology EHR Provider

Hospital EHR databases are a potential treasure trove of clinical information. However, the research value of these assets has not yet been fully explored. It's possible that the current enthusiasm for "big healthcare data" will help to correct this problem (see: Mount Sinai's Icahn School of Medicine Pioneers the Use of Big Data to Study Diabetes). There is one emerging use of EHR databases that I am not enthusiastic about, the details of which were presented in a recent press release (see: Flatiron Health Announces Strategic Relationships with Celgene and Amgen to Further Advance Personalized Medicine for Cancer Patients and Accelerate Clinical Research). Below is an excerpt from the article:

Flatiron Health...announced an expansion of its relationships with Celgene Corporation and Amgen Inc. Through individual agreements, Celgene and Amgen will collaborate with Flatiron Health with the goals of accelerating clinical research, advancing personalized medicine and enhancing treatment options for cancer patients....To help researchers and life science companies answer a broad range of exploratory commercial, medical and research questions, Flatiron Health combines industry-first technology, proprietary data processing capabilities and an extensive understanding of oncology to deliver a continuously aggregating data resource....Flatiron Health will continue supporting Amgen’s customized resource of real-world oncology data: Oncology Services Comprehensive Electronic Records (OSCER). First launched in 2004 and powered by Flatiron Health since January 2015, OSCER allows researchers to conduct observational studies and publish insights on cancer care. OSCER powered by Flatiron Health will further enable Amgen’s oncology teams to optimize data for scientific research, deliver increased value to physicians and patients, and enhance commercialization efforts. In addition, Amgen will leverage Flatiron Health’s products that integrate de-identified clinical treatment and outcomes data with genomic profiling data to accelerate clinical research efforts and inform the development of novel targeted therapies.“....We have experienced first-hand the tremendous value of informing clinical research with real world data,” said Elliott Levy, senior vice president, Global Development at Amgen. “Our collaboration with Flatiron Health will help us take observational research to the next level. Ultimately, we utilize these high-quality oncology data to inform clinical trial design and enhance our understanding of real-world utilization patterns.”

Among other software products, Flatiron provides, to quote its web site, an "industry-leading electronic health record that enables cancer care providers to manage and document the entire treatment process within one cloud-based system" (see: OncoEMR). I am personally worried about the intertwining of pharmaceutical and EHR companies as described in this press release. This process already seems to be quite far advanced as noted in the reference to Amgen and Flatiron's OSCER project which is designed to integrate de-identified clinical treatment and outcomes data with genomic profiling data to accelerate clinical research efforts and inform the development of novel targeted therapies. 

So what exactly is the problem with close collaboration between oncology EHR vendors like Flatiron and major pharmaceutical companies? Aren't all such collaborations useful for the improvement of cancer therapy? What gives me pause is Amgen VP Elliott Levy's reference to the opportunity for observational research in the Flatiron collaboration. I interpreted his phrase to also encompass the opportunity for what I will call observational marketing. The two concepts blend together and, after all, pharmaceutical companies are in business to sell drugs and make money.

To cite only one example of how access to an oncology EHR database could be used in a perverse way, immunotherapy drugs are often sold in packages of a size that exceeds the doses commonly administered to patients. Unused drug is thus paid for but discarded because of packaging constraints. Access to an EHR database would provide easy access to the most commonly used drug dosages in cancer hospitals on an ongoing basis, allowing such "$3B packaging tricks" to continue in an even more sophisticated way (see: This Cancer Drug Trick Is Costing the U.S. Healthcare System Nearly $3 Billion Annually).

Quest Seeking Amateur Athletes as Clients for Its New Biomarker Business

The majority of clinical lab customers are patients with diseases and the purpose of the testing is to evaluate their status. Another component of the lab client base is wellness testing and disease surveillance. A third component that is now emerging is what I will refer to here as fitness monitoring (see: Quest’s Blueprint Lets Athletes Look Deeper Into Their Performances). Below is an excerpt from an article about this topic:

 ...[Richard Schwabacher] runs Quest Diagnostics’ Sports and Human Performance unit, the medical testing giant’s effort to take a product directly to consumers. Not just any consumers, but endurance athletes willing to spend a lot of money to enhance their performance....Training for and participating in an Ironman [competition] isn’t for the frugal[...;] it can run up to $15,000 a year....Quest is in the early stages of bringing a diagnostic tool called Blueprint for Athletes to those free-spenders. It’s recruited what it calls ambassadors—a couple dozen hard-core weekend warriors who regularly win or place in triathlons and ultramarathons—to test the product. It’s also rolled Blueprint out to consumers in endurance athlete havens including Houston, Denver, and Quest’s home base in northern New Jersey. Blueprint was born in part from an effort with the New York Giants football team, for which Quest became a sponsor in 2013....Quest and the [New York Giants] team doctors would analyze dozens of biomarkers...and offer specific advice. The results, Schwabacher says, were powerful as the athletes saw how they could change behavior and quickly improve their performance on the field by altering their workouts or diets.....Quest started honing Blueprint for serious amateur athletes as a way to help its overall business grow.....On Blueprint’s website, athletes can choose test packages designed to boost endurance, recovery, or nutrition. A clinician at a Quest location draws several vials of blood that are then analyzed. After a baseline test at the start of training, an athlete can come for follow-ups. Some get tested monthly; others check in quarterly. Test results are reviewed by a physician, who will flag anything he or she deems critical. The athlete ultimately gets a report that can be dozens of pages long, with details on everything from vitamin D to platelet count.

I partly trace the roots of this biomarker fitness monitoring to the anti-aging movement which I have blogged about for ten years. Here are some of the key links: Anti-Aging, Longevity Medicine, and Lab Testing; Anti-Aging Medicine as a Major Driver of Complex Lab Testing; Cost of Drugs for Aging Ranks Third Compared to Diabetes and High Cholesterol). An important element of an anti-aging workup by a physician has been to perform a large panel of biomarkers to compare the patient's so-called biologic age with his or her chronologic age. The goal of treatment was to lower the former in relationship to the latter with exercise and often various nutrients, the value of some of which were unproved. Some of the biomarkers used in the anti-aging field were also esoteric and sometimes questionable. 

We now see Quest engaging with a new group of biomarker clients. It's probably of little concern from a business perspective that the number of marathoners and "ironmen" is relatively small. More importantly, Quest is now in the process of trying to better understand the use of "standard" labs tests to assess fitness. This knowledge will be useful not only for athletes but also for the the entire population. Monitoring fitness, which can be viewed as synonymous with wellness, will become just as important as monitoring and measuring disease. Blueprint for Athletes is offered directly to consumers so it's a form of direct-access-testing (DAT) which Quest and its main competitor, LabCorp, have only recently embraced (see: LabCorp to Offer Direct Access Lab Testing (DAT) to Consumers; Sonora Quest Competes with Theranos in Arizona with DAT Services).

Hospitals and Ransomware; How Should Hospitals Protect Themselves?

There has been a flurry of stories in recent weeks about hospital computers being attacked by "ransomware." These attacks seems to take place in the following way. Hackers introduce viruses into hospital computers to block access to a broad swath of files including patient records and then demand a ransom to keep the files from being erased. Here is an article discussing one such example (Hospital ransomware: A chilling wake-up call) and here's an excerpt from the article:

Hollywood Presbyterian [Hospital] declared a state of emergency over the ransomware on February 5th....The hospital isn't saying exactly when it paid the ransom, but it looks like they waited at least a week to end the file-hostage situation. Hollywood Presbyterian said its payment was 40 bitcoin, around $17K....During this time, an unnamed doctor told the press the systems responsible for CT scans, documentation, lab work, pharmacy functions and electronic communications were out of commission -- as in, no email. 

The ransomware attacks are continuing in other hospitals (see: Two more hospitals struck by ransomware, in California and Indiana). According to some sources, the culprits behind the attacks use the Locky ransomware virus. Here's a description of it (see: “Locky” ransomware – what you need to know):

..,[Locky ransomware virus is] the nickname of a new strain of ransomware, so-called because it renames all your important files so that they have the extension .locky. Of course, it doesn’t just rename your files, it scrambles them first, and – as you probably know about ransomware – only the crooks have the decryption key.You can buy the decryption key from the crooks via the so-called dark web.

Regarding all of this, a recent comment in HIStalk (see Monday Morning Update 4/4/16) raised the issue of the recent ransomeware attack on the MedStar health system (see: Possible ‘ransomware’ attack still crippling some MedStar hospitals’ computers) and suggested that the MedStar health system had outsourced its IT support to Dell with possible offshore support. Here is the HISTalk comment in its entirety:

From Jack: “Re: MedStar Health. Has a major portion of their infrastructure and server management outsourced to Dell, which manages them with offshore IT people. I find myself wondering if Dell is at risk here, and if so, are there others who are vulnerable to ransomware attacks.” 

I don't think that the possibility that MedStar had outsourced its IT support to Dell with possible offshore support has any relevance to this issue. If anything, dealing with a computer virus might be challenging for the IT departments of some hospitals. Outsourcing IT support to a large company like Dell, if anything, could bring more expertise to bear on the problem. The whole issue of ransomware is alerting all health systems about the criticality of the deployment of top quality anti-viral software. Now it boils down to a cat-and-mouse game to see if the attackers or the vendors of anti-viral software stay ahead in the battle.

Mount Sinai's Icahn School of Medicine Pioneers the Use of Big Data to Study Diabetes

Mount Sinai's Icahn School of Medicine is involved with a novel approach to medical research lead by Jeff Hemmerbacher who co-founded the big data company Cloudera (see: In The Hospital Of The Future, Big Data Is One Of Your Doctors). Below is an excerpt from the article:

It’s rare to find a supercomputer in a hospital, even a major research center and medical school like Mount Sinai. But it’s also rare to find people like [Jeff] Hammerbacher...who is best known for launching Facebook’s data science team and, later, co-founding Cloudera, a top Silicon Valley "big data" software company where he is chief scientist today. After moving to New York this year to dive into a new role as a researcher at Sinai’s medical school, he is setting up a second powerful computing cluster based on Cloudera’s software (it’s called Demeter) and building tools to better store, process, mine, and build data models....Combined, the circumstances make for one of the most interesting experiments happening in hospitals right now....What we’re trying to build is a learning health care system. Through real-time data mining on a large scale—on massive computers like Minerva—hospitals could eventually operate in similar ways, both to improve health outcomes for individual patients who enter Mount Sinai’s doors as well as to make new discoveries about how to diagnose, treat, and prevent diseases at a broader, public health scale....[The group is developing a visualization of patients with] Type 2 diabetes. What we're looking at could be an entirely new notion of a highly scrutinized disease....From this map and others like it,...[the researchers] might be able to pinpoint genes that are unique to diabetes patients in the different clusters, giving new ways to understand how our genes and environments are linked to disease, symptoms, and treatments. In another configuration of the map,... [researchers are showing] how racial and ethnic genetic differences may define different patterns of a disease like diabetes—and ultimately, require different treatments.

What I find so interesting about this narrative is that it seems to present a relatively new alternative for medical research that is different from classic bench research. Every medical school with an affiliated  hospital has access to a large EHR clinical database, usually an untapped resource from a research perspective. The Cloudera web site, the company founded by Jeff Hemmerbacher, makes mention of the need for an enterprise data hub (EDH) as a requirement for big data research, which is defined in the following way (see: enterprise data hub).

An enterprise data hub is a big data management model that uses a Hadoop platform as the central data repository. The goal of an enterprise data hub is to provide an organization with a centralized, unified data source that can quickly provide diverse business users with the information they need to do their jobs.  

Also, here is a definition for (see: Hadoop)

Hadoop is a free, Java-based programming framework that supports the processing of large data sets in a distributed computing environment. It is part of the Apache project sponsored by the Apache Software Foundation.

So, in order to get into the "big data research," a medical school like Mount Sinai needs a super computer like Minerva, an enterprise data hub (EDH), and a team of sophisticated IT scientists like Jeff Hammerbacher. No small undertaking. In so doing, however, the school can position itself as a national leader in terms of big data medical research. There is no question that major advances can be made in our understanding of highly prevalent diseases like Type 2 diabetes with such an approach. Big data is extremely important in the for-profit corporate world to better understand, for example, the needs and desires of customers. Why should we not use this same approach for medical research to improve patient care?