Lab Soft News

Physicians Are Disappearing from the Front Line of Healthcare

A recent, longish article in the New York Times discussed the "disappearing doctor" from the front line of healthcare by which is meant walk-in retail clinics in drug stores and urgent care centers (see: The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care). People are flocking to these facilities because they are readily accessible, user-friendly, and efficient. Patients with the most serious injuries and diseases are triaged to hospital ERs so the patient mix at these walk-in centers is more homogeneous. Below is an excerpt from the article:

...[The] reason big players like CVS Health, the drugstore chain, and most recently Walmart, the giant retailer, are eyeing deals with Aetna and Humana, respectively, to use their stores to deliver medical care. People are flocking to retail clinics and urgent care centers in strip malls or shopping centers, where simple health needs can usually be tended to by health professionals like nurse practitioners or physician assistants much more cheaply than in a doctor’s office. Some 12,000 are already scattered across the country....On the other side, office visits to primary care doctors declined 18 percent from 2012 to 2016, even as visits to specialists increased....There’s little doubt that the front line of medicine — the traditional family or primary care doctor — has been under siege for years. Long hours and low pay have transformed pediatric or family practices into unattractive options for many aspiring physicians....

Apart from true emergency situations, patients’ expectations now reflect the larger 24/7 insta-culture of wanting everything now.....[N]ew deals involving major corporations loom over doctors’ livelihoods, intensifying pressure on small practices and pushing them closer to extinction. The latest involves Walmart and Humana, a large insurer with a sizable business offering private Medicare plans. While their talks are in the early stages, one potential partnership being discussed would center on using the retailer’s stores and expanding its existing 19 clinics for one-stop medical care. Walmart stores already offer pharmacy services and attract older people. In addition, the proposed $69 billion merger between CVS Health, which operates 1,100 MinuteClinics, and Aetna, the giant insurer, would expand the customer bases of both. The deal is viewed as a direct response to moves by a rival insurer, UnitedHealth Group, which employs more than 30,000 physicians and operates one of the country’s largest urgent-care groups, MedExpress, as well as a big chain of free-standing surgery centers.

It's very clear that the former front-line of healthcare, the primary care physician office, is under siege. As noted above, "office visits to primary care doctors declined 18 percent from 2012 to 2016 even as visits to specialists increased." I have previously blogged about how some consumers who visit hospital ERs can be presented with "surprise" bills due to out-of-network services and ER facility fees. Publicity about such bills is causing further erosion of visits to ERs in favor of the alternative first-tier services. Hospitals may be partly to blame for this by trying to generate more revenue from ER visits.

There is another problem for primary care physicians on the horizon. More sophisticated computerized algorithms are being developed for deployment in walk-in clinics and urgent care centers to help diagnose and triage serous disease that might otherwise be missed by the NPs and PAs that staff such facilities. Such algorithms are referred to as CAST tools (see: Computer-aided simple triage). I suspect that CAST software in the hands of skilled PAs or NPs could theoretically rival the skill set of a primary care physician working without such a tool. Here is a list of emergency problems where CAST might be used that I copied from the Wikipedia article just cited:

• Pulmonary embolism (PE)
• Aortic dissection
• Coronary artery disease
• Stroke
• Bone fractures
• Internal bleeding
• Pneumoperitoneum
• Idiopathic intracranial hypertension

Addendum on 6/1/2018

(see: Largest US Nonprofit Healthcare System Shrinks Its Hospital Footprint)

One good marker for this trend is the year-over-year change in hospital admissions. Data given to Congress in the latest MedPac (Medicare Payment Advisory Commission) report on Medicare payment policy show that, between the years 2006 and 2016, the cumulative percent change in the number Medicare inpatient discharges per beneficiary declined by 21.8%. During these same years, the cumulative percent change in the number of outpatient visits per Medicare beneficiary increased by 49%!

More Men Choosing Less Aggressive Treatment for Low-Risk Prostate Cancer

Prostate cancer is the most common form of cancer for men but it often does not present in an aggressive form of the disease. It now appears that more men with this type of prostate cancer are now, appropriately, foregoing aggressive treatment of the disease (see: More men with low-risk prostate cancer are forgoing aggressive treatment). Below is an excerpt from an ariticle on this topic:

American doctors are successfully persuading increasing numbers of men with low-risk prostate cancer to reject immediate surgery and radiation in favor of surveillance, a trend that is sparing men's sexual health without increasing their risk of death. The latest evidence that more men are postponing aggressive therapy unless their symptoms worsen came in a large study...that involved more than 125,000 veterans diagnosed with nonaggressive prostate cancer between 2005 and 2015. Researchers reviewed the former servicemen's medical records and found that in 2005, only 27 percent of men under 65 chose to forgo immediate therapy and instead signed up for “watchful waiting” or “active surveillance” to keep track of their tumors. By 2015, the situation had flipped — 72 percent rejected immediate surgery or radiation in favor of such monitoring. The data for men older than 65 was similar....

The movement away from aggressive early action has gained momentum as doctors, researchers and patients have increasingly recognized the potential harms that can occur in overtreating malignancies that may never pose a threat....[S]tudies from the United States and Europe in recent years have shown that holding off on treatment for nonaggressive prostate cancer does not result in higher death rates....[O]ne reason VA may be adhering to national guidelines at a higher rate is its lack of financial incentives for salaried physicians to recommend expensive fee-for-service procedures. In addition, VA facilities often are affiliated with academic medical centers, which are faster to adopt new approaches....Active surveillance is not for all prostate-cancer patients. It isn't recommended for men with higher-risk prostate cancer or those with genetic defects such as a BRCA mutation, which can increase the chance of having more aggressive cancer. 

For me, two of the most important points being made in this article are that patients with a serious disease like cancer are well advised to seek care in academic centers where it is most likely that the most current forms of treatment will be recommended. Sometimes input from an physician in an academic academic center may be achieved when seeking a second opinion for a serious disease (see: Why One Should Always Solicit a Second Opinion for a Serious Disease). The second point in the article cited above is the observation that less aggressive treatment was commonly recommended in VA hospitals when deemed appropriate. This was because the physicians in these facilities were salaried. They thus had no financial incentive to recommend additional unnecessary treatment because they would derive no benefit from additional procedures performed for a patient. 

The notion of more conservative watchful-waiting for treatment of indolent cases of prostatic has evolved over the years based on clinical observation. We are now entering an era in which genetic profiling of cancers has become commonplace. This is sometimes referred to as cancer gene profiling for response prediction. This is an important path toward better understanding of which cancers behave in a more benign way and and can thus be treated conservatively (see: Genetic Testing as a New Cancer Care Standard; Clinical Trials Also Changing; Cancer Gene Profiling for Response Prediction)

What Is the Significance of the Roche Acquisition of Flatiron?

People are talking about the acquisition of Flatiron Health by Roche. Here is an article from Forbes that discusses the possible rationale for the purchase (see: The Flatiron Health Acquisition Is A Shot In The Arm For Roche's Oncology Real-World Evidence Needs) and below is an excerpt from the article:

...Roche, a global pharmaceutical giant, [has] acquired Flatiron Health, an oncology-focused electronic health records (EHR) company, for $1.9 billion....[Flatiron] has a partnership with a large network of oncology clinics and a few major research facilities to gather patient data. While it was not entirely unexpected for Roche to acquire Flatiron Health, this high-cost deal has surprised many people, as the value proposition of this deal is unclear....But one thing is clear—Roche’s decision was not driven by Flatiron’s healthcare provider-client lists. There are enough regulatory barriers that prohibit a pharmaceutical company from directly collaborating with a provider in the US.....The Flatiron platform captures and normalizes both structured and unstructured oncology data from diverse source systems. It also captures unstructured data from sources such as laboratories, research repositories, payer networks, among others, and its analytics engine pulls out relevant insights from the unstructured data, which, when combined with electronic medical records (EMR) data, generate the real-world evidence. Through its innovative approach, Flatiron addresses a few important issues: how to improve clinical trial results, how to optimize the process of clinical trial eligibility assessment, and how to enable pharmaceutical companies to innovate with groundbreaking research that progresses the human race and pushes the boundary of human capability.

....For Roche, the regulator-worthy, clinical research-grade data, which is being extracted by the Flatiron Health oncology practice network in almost real time, is of immense value and can be used for readout of drug efficacy and utility. In a nutshell, Roche will save money on clinical trials, make quicker decisions, and have a faster time-to-market. A blockbuster drug takes approximately 12 years and $4 billion-$11 billion of investment. Flatiron may help Roche expedite market launch and save R&D cost for its upcoming oncology drugs. Further, Flatiron oncology practice network and patient data can be used by Roche in its digital marketing initiatives, patient assistance programs, and other commercial applications. Considering that this network is highly specialized and focused on oncology, the acquisition provides Roche even greater competitive advantage in the oncology drugs market. 

This Forbes article is so good that I really don't have much to add. A key point to understand in terms of the allure of Flatiron Health for Roch is that attention is finally being paid to the value of unstructured EHR data. EHRs were not designed for research purposes but It's very much in vogue these days to discuss the advantages of real-world evidence such as that gathered by EHRs (see: Assessing Drugs Using "Real World Evidence" in Addition to Clinical Trials). This new interest is largely the result of improved computer analytics including natural language processing (NLP). As the article above highlights, companies like Roche are eager to learn how to use such data to improve clinical trial results, drug efficacy, and utility. The value and future of clinical trials are also being discussed with reliance on web applications and real-world data (see: The Future of Clinical Trial Modernization: What’s to Come in 2018; The site-less model allows patients to accomplish study visits from the comfort of their own home).

VA Finalizes Telehealth Initiative; What's the Likelihood of Success?

In various previous blog notes, I have strongly advocated for the expansion of telemedicine across most sectors of the healthcare system. My rationale for this recommendation is that it's one of the only ways to expand healthcare delivery in a cost-effective manner. The approach also avoids the rigidity of a bricks-and-morter strategy with physical facilities becoming quickly outmoded as the style of practice changes. The VA is now finalizing plans for its telehealth program. In order to achieve this goal, the VA is circumventing the various state rules governing the licensing of providers. All of this was described in a recent article (see: VA finalizes telehealth rule to let providers practice across state lines). Below is an excerpt from it:

The U.S. Department of Veterans Affairs finalized its federal rule to allow providers to deliver patient care across state lines and outside of a VA facility using telemedicine. Former VA Secretary David Shulkin, MD, and President Donald Trump first began to push for telemedicine expansion in August through the Anywhere-to-Anywhere initiative....This final rule gives the VA the needed authority to override state restrictions that would inhibit providers from treating patients outside of the agency or their region.....The preemption of state laws was necessary, according to officials, as it would be impractical for VA to lobby each State to remove any restrictions that impair VA’s ability to furnish telehealth services to beneficiaries and then wait for the State to implement appropriate changes. In doing so, the growth of telemedicine usage within the agency would be delayed. And officials are banking on this tool to combat wait times and improve care access to patients. The agency was plagued with scandal in 2014 due to egregious wait times and staff incorrectly recording those numbers. Officials said the rule will also support veterans in rural areas who would have to travel a long distance or cross state lines to see a doctor. The rule will expand access to critical care, like mental health, to provide faster service through the platform. 

I believe that the VA will probably not be successful in this telemedicine venture despite having the handy legal ability to work around state licensure rules. My reasons for such a prediction is that, first of all, the VA has never been strong in a managerial sense (see: Why the Military and the VA Healthcare Systems Are Not Amenable to Change). Superimposed upon the previous history of the VA as bureaucratically and managerially inept is the recent chaos imposed on the VA by Present Trump causing political upheavals (see: V.A. Medical System Staggers as Chaos Engulfs Its Leadership). In other words, the VA medical system is probably incapable of even minor reforms let alone the deployment of a major telemedicine initiative.

I also think that it's possible that VA administrators might perceive that the deployment of telemedicine would be relatively easy because no changes in physical facilities are involved. Not only does telemedicine require a sophisticated IT infrastructure but also a comprehensive retraining of physicians and nurses. Systems like the Cleveland Clinic (see: Details of Cleveland Clinic's MyCare Online Virtual Telemedicine Visits) and Intermountain (see: Intermountain Healthcare Launches Telemedicine Program with Connect Care) have rolled out such programs incrementally, refining the process over time. American Well is the purveyor of the IT platform used by the Cleveland Clinic and other major health systems. I found an interesting article by the company that identified three factors that were responsible for a the successful telehealth program at the Clinic (see: How telehealth has enhanced Cleveland Clinic’s value-based care strategy). They are listed below.

• Staff engagement.
• EMR integration.
• Patient awareness.

All of these three points are extremely salient and I think that they all will pose challenges for the VA. For example and given that the VA has only now finalized its EHR contract with Cerner, it will be preoccupied with this EHR installation for years to come (see: VA Signs $10 Billion Health Records Contract With Cerner). 

New At-Home Lab Testing Device Provides CBC Counts for Cancer Patients

I have been closely tracking the development of new at-home lab testing devices because I think, accompanied by expanded telemedicine choices, the face of healthcare will be changed forever. A recent article in Dark Daily announced such a device for complete blood counts (CBC) (see: New At-Home CBC Device Enables Complete Blood Testing for Cancer Treatments and Biological/Viral Monitoring). Below is an excerpt from it:

.....[N]ew devices that enable chronic disease patients to monitor and report findings to care providers continue to be developed and embraced by healthcare consumers. One such device from Athelas, a diagnostic test developer based in Mountain View, Calif., makes it easier and less expensive for patients undergoing cancer therapy to monitor their complete blood counts (CBC) at home without the need to travel to a doctor or medical laboratory to have the blood work performed....The device, which is undergoing the FDA Class 2 clearance process, enables patients to test their complete blood count (CBC) in the privacy of their own homes and report the results to their oncologists....To use the Athelas device, patients perform a simple finger prick and place a drop of blood on a proprietary testing strip. The strip is then inserted into the device where the blood is analyzed. Patients can view their lab-grade blood test results in about a minute. Information gathered by the device can be sent to Android or iOS devices/apps and also to the patient’s doctor....According to Athelas, in about 60 seconds the blood analyzer provides accurate reading for: Neutrophils; Lymphocytes; Platelets; White blood cells; Morphology; and, Cell activation.....The home-testing platform will cost consumers $20 per month, which Athelas hopes will eventually be covered by insurance companies....

In 2017, Sysmex America announced it had received clearance from the FDA for the Sysmex XW-100 hematology analyzer, the first CBC system that allows in-house staff to perform CBC tests at Clinical Laboratory Improvement Amendments (CLIA)-waived locations....The XW-100 device enables physicians to perform in-office blood tests and receive results in as little as three minutes. This allows treatment plans to be initiated without interacting with clinical laboratories, which clearly impacts test ordering and lab revenue. At-home and onsite blood testing devices serve an important role in patient care and provide healthcare professionals with expeditious and convenient test results. However, with the arrival of these new technologies, clinical laboratories will need to find new ways to bring value to physicians who employ them in their offices.

So, as a quick review, we now have devices for home CBC testing as noted above, home hemoglobin testing with the Germaine AimStrip as one example, and home coagulation testing with the Roche CoaguChek as one example. This latter device is relatively expensive at $555.55 but all of these devices are CLIA-waived and thus could also be deployed in walk-in clinics such as CVS's MinuteClinics. Coagulation status monitoring is complex but could reasonably be performed with the oversight of a well-trained pharmacist. I blogged about a similar coagulation monitoring program at Geisinger 12 years ago (see: Pharmacist-Staffed Coagulation Clinics in a Large Health System).

Here's a few observations I have made about the Athelas CBC device described above:

• After a finger prick, a drop of blood is placed on a proprietary testing strip which is then placed in the testing device. Like other home testing devices, information can be sent to a smart phone and subsequently transmitted to a healthcare professional. This is similar to the strategy used for other home testing devices for which smart phones serve a key function (see: AliveCore).
• Athelas has chosen a monthly rental of their pricing strategy. This makes sense for the first entry into the market of such a device where the purchase price may be prohibitively high. Renting allows devices to be reused. Moreover and because the initial use is targeted for cancer patients, demand will be limited to the period when the patient is being intensively treated. 
• Also of interest is that the Athelas web site emphasizes that the company is working hand-in-hand with the FDA ("Working with the FDA from Day One") and also boasts about the fact that its device is clinically validated (Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex 500")
• As I have stated previously, at-home testing coupled with telemedicine visits will inexorably whittle away at the volume of on-site ambulatory care visits in the U.S. In time, this new approach to care will also reduce the test volume of hospital-based clinical laboratories (see: Telemedicine and Home Monitoring Will Promote Healthcare Transformation). 

AI Predicts Which Patients Will Code, Allowing Early Intervention

I will occasionally report in Lab Soft News about examples of artificial intelligence (AI) that are being introduced into healthcare because the use of such tools will radically change the way care is rendered. One such example is a recently developed algorithm that generates warnings about which patients are in imminent danger of "coding" in the hospital (see: Ochsner Health System: Preventing cardiac arrests with AI that predicts which patients will ‘code’). Such a warning enables physicians to intervene earlier for them. Below is an excerpt from the article:

In modern hospitals, doctors and nurses are trained to rush into action when a patient “codes” – suffers a cardiac or respiratory arrest and needs immediate medical help. But what if doctors could see into the future and know who is about to code, so they could prevent a code from happening in the first place? A new artificial intelligence tool launched by Ochsner Health System enables doctors to do just that, by analyzing thousands of data points to predict which patients will deteriorate in the near future.....In a 90-day pilot with the system last fall, Ochsner successfully reduced the hospital’s typical number of codes by 44 percent. It’s now expanding the technology to a 24-hour schedule and to more hospitals in its network, which constitutes Louisiana’s largest not-for-profit system.....Predictive models need massive amounts of data, and the groundwork with Epic’s comprehensive health records software now allows Ochsner to query a large database from 11 hospitals. That data enabled Ochsner to build, train and validate a model to predict patient deterioration....

Building the model was hard work, but integrating it into a human workflow was also tough....Patient statuses constantly change, and the system sends only a handful of alerts a day – six to 10, out of hundreds of patients. Each alert requires attention from a provider trained in quick diagnoses and not just resuscitation..... Alerts provide four-hour warning To reduce false positives, his team trained the model for Ochsner’s population, which has a lot of patients with kidney and heart failure. Lab values worsen before a dialysis patient undergoes treatment, but the patient isn’t at risk of coding.....Too few alerts missed high-risk patients, but too many produced alert fatigue. Alerts sent too soon didn’t convey urgency, while those sent too late didn’t allow for interventions. A four-hour warning turned out to be ideal, giving enough time for a rapid response provider to finish what she’s doing, walk – not run – to a patient’s room and conduct an evaluation. Interventions may be a medication change, transfer to ICU or another form of elevated care. 

Take the time to read this whole article because it goes into detail about how unwise it is to "deploy an algorithm" into a healthcare setting without adequate preparation. Such preparation involves integrating the tool into the normal workflow in order to accommodate to the new processes that it brings with it. For example, the tool needs to be refined to reduce false positives. It also needs to be designed to provide some advance warning when correct, which is to say. when it identifies patients whose clinical status is deteriorating but missed. Attention also needs to be paid to the type of interventions that are required for them. As noted above, such interventions include medication change, transfer to ICU or another form of elevated care. 

All of this remind me of the Apache (Acute Physiology and Chronic Health Evaluation) system that was introduced into critical care units about four decades ago (see: APACHE 1978-2001: The Development of a Quality Assurance System Based on Prognosis). An early decision support tooI, the software was used to assess the prognosis of patients in critical care units based on a panel of lab test results and some clinical observations. One of the initial intended uses for an Apache score for an ICU patient was to identify those near death and for whom continuing monitoring and intervention was useless. Such patients could be discharged from the critical care unit, freeing up a bed for a salvageable patient and reducing healthcare costs. However, the use of Apache for this purpose caused an uproar among some patient family members.

Today such interventions might be deemed useful in order to allow a patient to die at home rather than in a sterile ICU. Again the following lesson bears repeating. Predictive algorithms in healthcare can't be deployed  in a vacuum -- a priori, they need to be integrated into workflow and clinical processes with attention to their efficiency and value. It's important to note that Google has already been able to predict in-hospital mortality using deep learning research based on EHR data (see: Scalable and accurate deep learning with electronic health records).

 

Geisinger to Perform Routine DNA Sequencing for 1,000 Patients in Pilot Study

We are entering an era in which DNA sequencing will become a routine laboratory test for a high percentage of patients. Geisinger, always a leader in innovation, is beginning the validation of this diagnostic approach (see: Geisinger to perform DNA sequencing as routine care). The key question, of course, is what actions hospital personnel will take based on this DNA information. This question is partly answered in the excerpt from the article below:

Geisinger will soon roll out DNA sequencing as part of its preventive care for patients....Over the next six months, the Danville, Pa.-based system will enroll 1,000 patients in a pilot program recommending DNA sequencing as part of routine clinical care. Eventually, Geisinger said will provide clinical DNA sequencing across its Pennsylvania and New Jersey footprint....."This forecasting will allow us to provide truly anticipatory healthcare instead of the responsive sick care that has long been the industry default across the nation [according to the Geisinger CEO]." The health system said in a release DNA sequencing would become a "routine screening" like mammograms, colonoscopies and cholesterol checks for its patients. Physicians will work with their patients to respond to any genomic risk factors found. The pilot will build off of Geisinger's research-focused genomic initiative, known as MyCode Community Health Initiative, that started in 2013 [Should Hospitals Recruit Patients for Drug Company Research Projects?]. So far, Geisinger has alerted more than 500 patients that they have a genomic variant that increases their risk of developing early cancer or heart disease. That amounts to 3% of the more than 200,000 patients enrolled in the DNA sequencing program. But Geisinger executive vice president and chief scientific officer...believes 10% to 15% of patients could benefit from the expanded program as they find more genomic variants. "

So. some key facts now emerge about how routine broad DNA screening may be deployed in the future for patient managment at Geisinger: (1) 1,000 patients will be enrolled in a pilot program for such testing; (2) emphasis will be placed on early warning for cancer and heart disease; and (3) Geisinger personnel predict that perhaps 10-15% of patients could benefit from such DNA screening as the program matures. Obviously, the devil is in the details for such a program but I am confident that Geisinger will get it largely right. All of this boils down to several questions. What genetic abnormalities should a hospital screen for in such a program, how and when should hospitals notify patients of significant DNA results, and what actions should hospital personnel take after a patients has been identified as having one of the key abnormalities being screened for. 

One question pops up in my mind immediately, perhaps because of the litigious nature of our healthcare system. Let's assume that a genetic error is detected for Patient X in this process. What is the health system's obligation legally to that patient in the future? What if he or she changes health systems or drops out of a particular health plan? In short, what obligation is assumed by the hospital detecting a DNA abnormality as opposed to the responsibility of the patient. The answer to these questions and more will soon be understood at least, in part, through this pilot study.

Don't Miss the 2018 Pathology Informatics Summit in Pittsburgh, May 21-24

It's not too late to register for the 2018 Pathology Informatics Summit that will be held in Pittsburgh on May 21-24, 2018. Early bird pricing has been extended. The PI Summit can boast of a 35-year 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. 

As one might expect, the 39 faculty members of the PI Summit constitute a well respected group of pathology informatics experts. No other conference attracts such a group under one roof. A total of 20 vendors will also participate in the conference. They 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. 

Israeli Medical Records Placed On-Line to Promote Research

Electronic medical records are being viewed in some smaller countries like Iceland as a national asset. They are viewed as a means to improve population health and also to stimulate research in the country and elsewhere. Iceland has been pursuing such a strategy for years (see: Centralized Health Databases: Lessons from Iceland; Iceland’s Research Resources: The Health Sector Database, Genealogy Databases, and Biobanks; PDF) and Israel now seems to be pursuing a similar goal (see: Israelis' medical records to be put online for research):

The Israeli Cabinet...[recently] passed a decision launching the "National Digital Health Plan." Approximately...$286,490,000) has been budgeted for the plan which includes technological development, international cooperation, concentrated academic and industrial efforts and regulatory changes to encourage data research...."Israel has a gigantic database that embraces almost the entire population, a large population relative to – let's say – the Baltic countries, one of which has one million people in this database; we have almost nine million people. This is a focused database of the health records of almost each and every one of us over the last two decades," Netanyahu said. "This is a great asset and we want to make it available to researchers, developers and companies in order to receive two things: Preventive medicine and personal medicine, personally calibrated for each person." Netanyahu also said, however, that Israelis would need to agree to share their medical information. "Of course, this depends on the agreement of each person – this right is maintained absolutely," he insisted..... According to Prime Minister's Office Director General Eli Groner, "Every doctor in Israel will be able to see the clinical files of over 98% of the population." The new plan, he said, will "unify the system and create a voluntary data bank that will draw researchers and industry here from around the world." "We are upgrading the quality of the digital medical file so that future doctors will be able to make better diagnoses. We are certain that this decision will be of highest importance." 

The Icelandic national database has been developed by a private company called deCODE Genetics. Here is a summary of its business model copied from its web site:

...Iceland, deCODE is a global leader in analyzing and understanding the human genome. A combination of factors provide unprecedented power to uncover the genetic basis of virtually any disease or trait. These include the generous participation of so many Icelanders in our discovery work, our comprehensive genetic and genealogical resources, the relative genetic and social homogeneity of the Icelandic population, and its high quality universal healthcare. Using unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases....The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease.

Unlike Iceland, Israel's population is extremely heterogeneous. Rather than being primarily a database driven by research considerations like the one in Iceland, the National Digital Health Plan seems to have a dual purpose. It is designed to support health care delivery by an amalgamation of health files for 98% of the population of Israel and also to function as an asset for biotech research. The biotech industry in Israel has been highly successful with one expert asserting that Israeli research is present in between 25% and 28% of the world’s successful biotech-based solutions (see: One in four life science innovations has Israeli roots, says expert).

What is the likelihood that a similar "national digital health plan" could be adopted in the U.S. The answer is: pretty slim. For one thing, we don't have a unique patient identifier (see: Has the Time Come for a Unique Patient Identifier for the U.S.?). For another, we don't have a common EHR and EHR vendors have slow-walked interoperability in the past but there may now be a change in this attitude (see: What Epic & Cerner are doing for interoperability: 11 observations). Finally, the warring, tribal political factions in the country that conjure up paranoic ideas like "death panels" would probably view a national digital plan with suspicion (see: Death panel). Even the NIH is faltering in its attempt to build a large biobank, but this may involve bureaucratic blundering or research overreach (see: The Faltering Effort to Develop an NIH Biobank; Time to Pull the Plug?). 

Can Digital Therapeutics Substitute for Drugs or Other Therapies?

The various smart phone apps that are being developed to monitor or help manage diseases like diabetes or insomnia are now being referred generally as digital therapeutics (see: Can “Digital Therapeutics” Be as Good as Drugs?). This article provocatively asks the question whether some of these apps can ultimately substitute for drug therapy. Below is an excerpt from it:

The idea: software that can improve a person’s health as much as a drug can, but without the same cost and side-effects.....[D]efining exactly what a digital therapeutic actually is can be as elusive as finding the famous chalice....[The CEO of a startup] says digital therapies fall into two groups, which he calls “medication augmentation” and “medication replacement.” He says Sleepio is in the latter category because it actually makes sleeping pills unnecessary....The term digital therapeutics began to circulate around 2013, in large part due to Sean Duffy, CEO of Omada Health. He began using it at conferences and in the company’s marketing materials to describe its online coaching software to help pre-diabetics avoid getting sick by exercising more and losing weight.

About a dozen startups now call themselves digital therapeutics providers, and say they’re distinct from the rest of the digital health market of activity monitors, smart scales, and sleep trackers. To distinguish themselves from “wellness” gadgets, digital therapeutics companies tend to carry out clinical tests and sometimes seek regulatory approvals –one company, Welldoc, offers a prescription-only version of its BlueStar phone app for managing diabetes, which it terms the “first FDA-cleared mobile prescription therapy.” But unlike drugs, digital therapeutics don’t usually need approval by the U.S. Food and Drug Administration, since often they promote lifestyle or dietary changes that are deemed to be low-risk. Whether a digital therapeutic involves a tracking sensor or coaching though an app, sothe biggest question is whether they provide a distinct, measureable medical benefit. 

I don't know if the name digital therapeutics will stick but there is clearly something important going on here. As noted above, this is a generic term for the various types of health apps that will evolve over time into software with different functions. The most technically simple type of a health app available today, for example, is designed to achieve mental serenity through meditation. One of them is the well-reviewed Headspace. It is self-contained in the sense that it is used to coach users how to meditate. However, it can also import sleep data from one's Jawbone wearable or Apple Health program running on an iPhone if the goal of meditation is to improve one's sleep.

Much more complex are the health apps that analyze data generated and inputted from a separate device into an iPhone. One example is the Kardiamobile from AliveCore. The device itself has pads for two fingers from both hands to record normal heart rhythm or diagnose atrial fibrillation. Data is transmitted wirelessly to an iPhone for such analysis. It's possible to add a premium membership for Kardiamobile to upgrade to unlimited storage of EKG recordings plus customized monthly reports that can be mailed to the consumer's home to share with a cardiologist. We are only seeing the early and still relatively simple examples of digital therapeutics. There lots of money to be made here with new products hopefully offering the means for consumers to improve their health.