MedCity Influencers

The Covid-19 pandemic has affected every sector of our society and requires coordinating a broad coalition of assets to contain it. The response includes multiple federal and state government agencies, thousands of hospitals, and a broad swath of commercial manufacturing capabilities and supply chains. We saw this coordination and collaboration early on with personal protective equipment and ventilators, and we see it again as we ramp up vaccine distribution.

To coordinate an effective response, it is critical to integrate disparate data types from multiple domains and sources, something that has been a long-standing challenge in health care. Obstacles include government agency budget structures that don’t incentivize data sharing and legacy databases that create barriers to data integration. The commercial sector also brings the challenges of competition and proprietary systems. Even seemingly simple questions, such as how many ICU beds are available in a community, are maddeningly difficult to answer in near real time. While well-branded and user-friendly websites provide impressive updates on case counts, emergency operation centers have found it challenging to integrate that data with bed availability, hospitalization projections, work force data, supply chain data, mitigation interventions, social determinants of health, and other key data elements that allow for effective planning and response.

In addition to the public health challenges, new care delivery models have underscored the need to better integrate data to deliver care for chronic diseases. The pandemic has accelerated the adoption and use of telehealth. But again, tools, sensors, apps, and devices are often deployed on disparate data platforms that make it cumbersome for patients and providers to integrate data in a meaningful fashion.

The pandemic illustrates the need for better data integration to improve management of this crises as it continues to impede the everyday care of patients.

Lessons learned from defense and intelligence communities
The health industry lags behind other commercial sectors in its adoption of data management and open-source innovations. The health community can learn a great deal about data management from defense and intelligence agencies, which must integrate vast amounts of data from disparate systems to create a common operating picture to support life and death decisions for warfighters.

The 9/11 attacks demonstrated that data gaps can be deadly. The 9/11 Commission Report revealed that information that could have prevented this tragedy was scattered across several different intelligence agencies’ databases. Following the Commission’s critique, the intelligence agencies adopted low schema data “lakes” that could accommodate multiple “streams and rivers” of disparate data and allow for easier integration. Think of these data systems as giant spreadsheets, with each cell containing an entry item. With automated meta-tagging, each cell of information can be correlated with any other item of data to reveal patterns that would otherwise have gone undetected. These data platforms also enabled the accumulation of massive data stores that optimize advanced analytics and artificial intelligence. Intelligence agencies also benefited from security protections at the individual cell level that enhanced data security, an important feature to consider as health information increasingly comes under cyberattack.

The intelligence community also embraced open source tools and open architectures for these data systems. Open source allows the rapid development of new tools at lower cost. Open architectures avoid costly and stagnating vendor lock, and it enables the adoption of new best-in-class tools and capabilities as they are often developed by small niche firms and start-ups

While novel 15 years ago, many of these innovations have been avidly adopted in the commercial sector. However, the same cannot be said for the health domain. That said, there are notable exceptions that are bright spots on the health care landscape.

Advana: Uniting disparate systems and users on a common platform
Advana, a Department of Defense (DoD) data platform, pulls together more than 200 business systems across the DoD and makes data discoverable, understandable, accessible, and usable for advanced analytics for more than 17,000 users across the Army, Navy, and Air Force who need to make decisions about mission readiness, contracts, supply chain logistics and more. The platform has helped the DoD coordinate its Covid-19 response by enabling the easy integration of a wide range of data, including case, bed, supply chain, readiness, and financial data, to inform critical health care decisions. The open architecture platform supports multiple projection models and analytic tools, which allows the DoD to validate findings in a way that would not have been feasible with a single approach.

Advana faced many of the data integration obstacles familiar to health care IT leaders: non-standard interfaces, duplicate data and systems, legacy technologies, and a history of different units pulling their own data for decision making. To integrate disparate data from spreadsheets, application programming interface (APIs), database dumps, and data warehouses from across the enterprise, Advana streams data feeds, automatically categorizing, tagging, and transforming them into a common data model to improve enterprise level analytics.

Preparing for the next health crisis
The value of big data in health care is clear but unless we can integrate and correlate disparate types of data, we can’t realize the benefits. The data challenges of the Covid-19 response illustrate this issue. The seams between government agencies, health systems, and departments within the same organization create chronic barriers to data sharing. Few organizations manage more data than the defense and intelligence agencies, and as with health care, their decisions often have life and death consequences. For critical decisions, they have developed effective strategies to create a common operating picture through robust data integration. As we continue to respond to this pandemic and prepare for the next crisis, the health care community should learn from these mission critical organizations.

Editor’s Note – The author is a Department of Defense consultant.

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3d printing human body. 3d printed implants on white background.

Back in the 1970s, there was a television show called “The Six-Million-Dollar Man” about a fictional astronaut severely injured in a test crash, and then having several body parts replaced by robotics. The show’s opening narration promised that he would be “better than he was before. Better. Faster. Stronger.”

Life is now imitating art, and then some. 3D printers are currently being used to construct not only customized prosthetics for patients in need, but a wide variety of other medical items — foremost among them tissues and organoids, as well as surgical models and tools. It is estimated that 13 percent of 3D printing revenue comes courtesy of the medical field, and that some $3.19 billion will be spent on technology in that sector by 2025. That’s over $2 billion more than in 2018 ($1.13 billion), a compound annual growth rate (CAGR) of 15.89 percent.

There are many reasons for this uptick, not the least of which are that these items can be produced quickly and inexpensively. But there is none bigger than the ever-increasing demand for prosthetics. Some 30 million people around the world, including 1.9 million in the U.S., are in need of such devices, and as of 2018 only 20 percent of them had been provided for.

Factor in other devices and “an aging population with a consequent increase in demand for personalized treatment” — as noted by Tim Deng, Principal Medical Devices Analyst at GlobalData, in a report on the website Express Healthcare — and the overwhelming need becomes that much clearer.

So too are the benefits of meeting that need. Better, faster, stronger? Well, that part might be a bit of a stretch, at least for now. But certainly it appears that 3D printers are making it possible for patients to be as good, as fast and as strong as they were before illness or injury left them a shell of their former selves.

Serendipity helped galvanize the 3D prosthetics industry. In 2011 an artist named Ivan Owen developed a puppet hand for a steampunk event — i.e., an event where modern technology melds with elements of Victorian-era history and fashion. He circulated a video of his creation, which was seen by Richard Van As, a South African carpenter who, having just lost four fingers in an accident, was looking for a prosthetic hand that would enable him to return to work. The two of them collaborated to construct just such a device, then used a 3D printer to develop another for a five-year-old boy who was born without fingers.

Owen, instead of patenting his invention, elected to open-source it. That led in 2013 to the formation of the nonprofit organization e-NABLE, an online community enabling people to collaborate on the design of 3D prosthetic limbs. Another nonprofit, Limbitless Solutions, came along a year later, with the mission of providing 3D-printed arms for children.

Then there is the startup Unlimited Tomorrow. In 2020, some six years after its founding, the Rhinebeck, N.Y.-based company also rolled out a prosthetic arm courtesy of a 3D printer, while emphasizing its affordability (“as low as $7,995.”) compared to prosthetics produced by other means (over $50,000).

3D printers are getting ever closer to being able to produce organs, and progress is being made on other fronts as well. In 2018, researchers at the University of Utah became the first to produce ligaments and tendons in that fashion, by extracting stem cells from a patient’s body fat, printing them onto a layer of hydrogel, allowing time for the cells to form the required connective tissue outside the body and then implanting it where needed.

This is a particularly important breakthrough, since injuries to tendons and ligaments had in the past proven to be difficult to treat. Most commonly, tissue from cadavers was used, but there was the risk of rejection, or that the connective tissue wouldn’t perform as expected.

In 2019, there was another promising development when a team at Rice University made promising strides toward producing cardiovascular networks and lung-like air sacs through the use of bioprinting technology called “stereolithography apparatus for tissue engineering,” or SLATE. The team hopes to commercialize that technology in the future, which could have obvious benefits for those suffering from heart or lung disease.

Truly there seem to be no bounds to what 3D printers might mean for healthcare. The possibility exists of dental professionals using the technology to create customized dental implants, prosthetics and braces — that printing could be done in-office without long wait times. Once the patient’s teeth have been scanned, their dental treatment will be printed in-office. This allows for a better fit and even time for immediate troubleshooting. Compared to taking a mold and relying on an outside source, this is more convenient for both patients and professionals.

On the other side of the equation, a 3D printer can be used to create customized instruments for use in complex surgeries — and the process can be done far more quickly than is the case by other means. It is also possible to create three-dimensional models of patients’ internal systems before surgical procedures, giving doctors a clear understanding of the challenges they face.

Also of interest is the production of customized medication via 3D printer, a process begun in 2015 to counter the trend toward producing dosages best-suited for white adult men, meaning women and children were receiving more than was necessary. Customizing the dosage, Multiply Labs CEO Fred Paretti told the website 3D Natives, goes a long way toward “highlighting the individuality of each patient, since the error in dosage of certain active ingredients can even lead to the malfunctioning of some treatments.”

The bottom line is that 3D printers will be making an even greater impact on the medical field in the years ahead, as evidenced by the fact that the number of U.S. hospitals featuring the technology grew from three in 2010 to over 100 in 2019. The need is there, and the evolution will certainly only continue. And someday, maybe there really will be a Six-Million-Dollar Man.

Photo: belekekin, Getty Images

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Every year at this time, it feels like the movie Groundhog’s Day for many in the payer community. New members, that can run into the tens of thousands, are onboarded. For those in care management, it’s a mad scramble to obtain patient medical histories. The amount of time, energy, and resources spent on largely manual processes continues to be exasperating.

Take Medicare, for example, where more than 840,000 baby boomers aged into the system and enrolled between 2019 and 2020. When these new members are onboarded, care management teams have a very challenging time attempting to close gaps in care. Common questions such as, “when was the last time a member had a mammogram, and what were those results?” are often difficult to answer because of healthcare’s infamous data silos that ensure patient information remains trapped.

Chronic fatigue syndrome
Payers employ teams of people whose full-time job is calling a doctor’s office, requesting information, and waiting weeks for the data to be mailed in hard copy or other physical media such as CDs —or being required to physically drive to the provider location to pick up records. The onus of collecting patient records doesn’t stop with care management.

During reporting periods for HEDIS/STARS measures or risk adjustment evaluations to set rates for plans, administrative teams must chase down records. This Herculean task often requires extra help from outside firms during the January to April crunch time. Many providers find multiple people from multiple departments from the same payer organization requesting the same type of information over and over again in a single year. The result is extraordinary expense and unnecessary fatigue in a records collection process that repeats itself every year.

Interoperability struggles
2020 was supposed to be The Year that would kick health data interoperability into high gear. The Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid (CMS) issued their highly anticipated rules that are intended to improve data interoperability and to prevent information blocking. The rules specify the interoperable data and technology standards for sharing medical records between patients, doctors and payers. The goals are to give patients greater access and control over their medical information to make better healthcare decisions and to spur the type of consumer innovation that is seen in almost every other industry except healthcare.

Those rules have been delayed twice due to difficulties with payers and providers implementing the standards; and then there was also the pandemic. While it remains to be seen if April 2021 will indeed be the effective date for compliance, and many companies are actively advocating for additional delays, one thing we do know is that neither payers nor providers are completely ready for it.

According to a recent survey by Accenture, fewer than one in five (18%) of the executives surveyed in key leadership positions at U.S. healthcare companies said they are “very familiar” with the new regulations, while 17% said they are completely unaware of it. In another survey by the eHealth Initiative, 64% of payers said their top concern is their ability to implement and maintain the application programming interfaces (APIs) that are required for patient access. This concern dwarfs the results of the next top issue by a large margin which is compliance with the rules where only 14% of payer executives said they were concerned about their ability to adhere to the interoperability laws.

This is not especially surprising given that payers have built compliance capabilities to follow the letter of the law in a heavily regulated health insurance industry. However, interactions with patients are centered around the administration of benefits while they are members. Payers have not traditionally dedicated IT resources to building and maintaining technology to directly engage patients, collect and share health information across their care journey geographically and through time longitudinally. Therefore, it’s also not especially surprising that 79% of payers said they definitely would or probably would use vendor solutions to help meet required deadlines.

Working with a Vendor
If the preferred route is to work with a health IT vendor, and all indications are that payers will need to seek outside help with at least some aspects of interoperability and patient access, here are three important things to consider:

  • Can the vendor handle advanced data? As interoperability increases, more complicated data types will be required as part of the essential health information (EHI) of a patient. Already, the newly defined U.S. Core Data for Interoperability standard expands the criteria for clinical data from its more simplistic forms such as claims data. Patients have the right to ask for and receive more advanced data such as medical imaging and digital pathology. Advanced data contains clinical data of significant value that are crucial to care delivery, chronic and complex disease management, and treatment innovation.
  • Is it a mature solution? Common concerns that I often hear is trepidation in dealing with startups without a track record on reliability, scalability, security and credibility. How do you trust that patient data is being handled with care? That is why it’s important to look for vendors with a mature solution and a track record. As an industry, we need to innovate, but we also need to be measured in our choices and not be fooled or distracted by promises of the next disruptive technology that may never be delivered. With no time to waste, the healthcare industry should rely on proven scale capabilities, even if they are not perfect, and build upon them systematically.
  • Look for “off the shelf” API tools that you can use to access medical networks such as Health Information Exchanges (HIEs) and other data networks that support common standard such as HL7 and FHIR. Payers can then plug and play these API tools to access a broad variety of clinical data such as EHR data, labs and imaging. Vendors providing tools should also provide support services for integration into your enterprise systems. Robust service agreements should provide you with comfort knowing that you have a partner to work with you throughout your data interoperability journey.

We all know the upcoming road is going to be tough and will challenge the healthcare industry to share and collaborate in a way it is unaccustomed to. One of the important lessons from Covid-19 is that, paradoxically, the long-awaited and delayed interoperability rules have proven exactly why we need better data sharing.

Photo: DrAfter123, Getty Images

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Metoprolol (muh•tow•pruh•laal). Eszopiclone (es•zoe•pik•lone). Hydrochlorothiazide (hy•dro•klor•oh•thi•a•zide). Amitriptyline (a•muh•trip•tuh•leen). Canagliflozin (kan•a•gli•floe•zin).

Are you able to recognize or pronounce any of these commonly prescribed medications? If so, you might be a pharmacist, or at least have experience providing patient care. It’s fair to say that most people find it challenging to pronounce drug names, and it may be even more challenging for the elderly.

It’s not uncommon for elderly patients to be prescribed multiple medications to treat multiple chronic conditions, and sometimes these medications come from multiple providers. In my experience, I have seen many patients fail to understand what, why and how to take their prescriptions. Some have the help of family or caregivers while others may not, which makes it even more challenging to manage. Many factors can contribute to these challenges including vision problems, memory loss, swallowing problems and or hearing loss. Medications can be extremely helpful in treating and preventing disease, or they can cause a major health setback if not taken appropriately.

As a pharmacist by training, or “pharmist” as my Grandpa likes to call me, I spend my time reviewing his medications when I’m in town to visit. He loves to sit down with me and tell me all about the medications he’s taking and what he takes them for.  At 87 years old, he’s impressively taking only three (3) medications. Up until last year, he was taking only taking one (1). He’s incredibly sharp and has never needed any extra assistance. My Grandpa is the perfect patient. He’s highly adherent and takes his medications every day, at the same time, right before his morning coffee. I understand the importance of adherence and adherence to the right medications, but I have never personally experienced or witnessed the challenges that come with adherence following discharge from a hospital stay, until now.

Covid-19 hit close to home and affected both of my grandparents this past Thanksgiving. After a few days, it was apparent they were unable to weather this virus alone. It severely affected their cognitive status and caused weakness so severe they were unable to stand or walk on their own. While staying with them during this time, a decision was made to take my Grandpa to the E.R., which led to a six-day hospital stay. Because I know he visits multiple providers and pharmacies, I knew the hospital wouldn’t have a complete record of all the medications he takes….and I was right.  I made sure he went with an updated med-list so that the doctors could give him his regular medications while in the hospital.  I knew this med-list would likely change following his discharge.

Upon discharge, I was provided with a long list of instructions from multiple people on the care team that was difficult to follow along even for me. First came a call from the nurse,  then a call from the provider, then a call from the pharmacist, and lastly a call from the company who would be dropping off his home oxygen. The pharmacist’s call was helpful, but not appropriately timed — I had no discharge papers to reference.  The provider called again, to go over the medications with us. The review was fast. Medications were discontinued. Medications were added. Some medications were named in their brand name while others were listed generically.

Who could possibly follow along? No one expressed to us the duration of these medications. When could they be stopped? Will they ever be stopped? Were refills needed, what doctor would continue to prescribe them? What if I had not been around to help?

Following my Grandpa’s return, I immediately sat down to review and organize all of his medications, new and old. One medication was discontinued, while 4 were added. My Grandpa went from taking 3 medications to 7 overnight, and each medication came with its own set of directions:

  1. Take this tablet with food.
  2. Take this tablet on an empty stomach.
  3. Take this tablet every day and skip on Saturdays.
  4. Take this tablet on Monday, Wednesday, and Friday.
  5. Skip this tablet for two days. Restart on Sunday.
    1. 2 days later* “Actually, take this medication every other day starting Tuesday.”
  6. Take this tablet every day.
  7. Take this tablet three times a day and make sure not to eat too much sugar or salt with this med.

With all of this information, I created a “Fridge Report” for when I’m not around. A Fridge Report is a simple and easy to read medication list. It displays all medications a patient is taking and how to take them in a nice visual display that is easy to follow. I also called and spoke with his primary care provider (PCP) and cardiologist to confirm his active medications and to notify them of the newly added and discontinued medications. I can’t imagine my grandparents, or anyone else’s grandparents, managing this without the help of a pharmacist. The Fridge Report was highly appreciated by my family.

“We need that (Fridge Report). It’s very detailed. No mixing up or second-guessing of medications. Now I know what to give and when to give it.” – Lorraine Armenta, My Aunt

According to the World Health Organization (WHO), care transitions threaten patient safety as they can increase the possibility of losing critical clinical information and require an increased degree of coordination. I believe a multifaceted approach is needed to improve care transitions and is especially needed for vulnerable and high-risk individuals. The transition between inpatient and community settings, in particular, is prone to medication errors related to a lack of communication between health care providers, missed patient follow-up, inadequate patient education, incomplete medication reconciliation, and the absence of patient involvement in medication management. Pharmacists can and should take a more active role in improving medication safety during care transitions; this could lead to a reduction in hospital readmissions and improved quality of care.

Pharmacists serve as quarterbacks of a patient’s at-home-care team, providing essential help to those who are taking multiple medications. We are medication safety experts and have access to sophisticated and innovative tools to better manage the medication-related needs of patients and mitigate adverse drug events (ADEs). Ultimately, engaging with your local pharmacist can reduce the burden placed on a patient’s family and the primary caregiver, while making the transition to at-home care manageable.  

Photo: JohnnyGreig, Getty Images

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Cute 6 years old boy looking through the window

When I remember my first experience with autism spectrum disorder (ASD), it’s the airplane that stands out. I was growing up in Salt Lake City, in the 1980s, and my friend was diagnosed with autism. I’d never heard the word before, but I recognized that it must be important. You see, there weren’t any licensed therapists in the entire state of Utah, so my friend’s parents took the extraordinary measure of flying in a therapist from Boston once a month to work with her.

It made an indelible impression on me, and over the years I’ve come to understand how difficult it is for many families to get access to any therapy, let alone high-quality therapy. Even today, with “autism” and “spectrum” in our common vocabulary (the prevalence of the disorder has grown to one-person-in-fifty-four from one-person-in-one-hundred-fifty 20 years ago) access to qualified, effective, affordable care still falls short of serving the children who need it. ASD can be diagnosed in children as young as two years old, beginning a family’s odyssey of finding the right care. Parents seeking therapy for a child with ASD are too often overwhelmed by the anxiety-inducing demands of keeping so many balls aloft — the waiting lists for quality clinics, the schedules and instructions of independent therapists, their conflicting assessments and goals, the logistics of shuttling from office to office, the crushing bureaucracy of insurance and payment — that it makes something as outrageous as jetting in a therapist seem like a breeze.

There are few parental pressures more staggering than trying to coordinate proper care for a child diagnosed with ASD. On average, autism costs an estimated $60,000 a year through childhood, with the bulk of the costs in special services and lost wages related to increased demands on one or both parents. The inconsistencies of insurance coverage for families with ASD children has further exacerbated the access inequity, with some clinics or individual therapists not accepting insurance, forcing families to pay upfront and submit bills to their carriers for out-of-network reimbursement.

It goes without saying, the cost is prohibitively expensive for most families and presents them with agonizing choices. Mothers of children with ASD, who tend to serve as the child’s case manager and advocate, are less likely to work outside the home. On average, they work fewer hours per week and earn 56 percent less than mothers of children with no health limitations. And while ASD affects all ethnic and socioeconomic groups, children of color tend to be diagnosed later and less often.

Despite the rise of ASD cases in the United States among children ages 2 – 18, it isn’t definitively understood what causes the disorder. Scans show differences in the shape and structure of the brain in children with autism compared to neurotypical children, but causal theories abound, from heredity and genetics to environmental factors such as viral infections and exposure to chemicals. Finding a single trigger has stumped researchers. However, when it comes to therapeutic treatment for ASD, there is consensus: early, integrated, multidisciplinary intervention is the most effective approach for cognitive, behavioral and social development, and delivers lifelong gains.

So, if we can agree on the treatment, if not the cause, why haven’t we succeeded in providing greater access to therapy where a comprehensive, coordinated approach can be best delivered under one roof?

The Demand Supply Imbalance
As is the case with all prevalent medical disorders, the spiraling demand came first. The effort to supply enough quality child development clinics has been playing catch-up ever since.

Applied Behavior Analysis (ABA) therapy is the most commonly used behavioral intervention for autism. It is implemented one-on-one by Board Certified Behavioral Analysts (BCBA) and Behavioral Technicians (BT). Since many children with ASD benefit from speech and occupational therapies, STs and OTs also provide vital care. In other words, when it comes to addressing autism, it takes a team. And because children with autism engage more positively with in-person stimuli, it also takes a building. Trained, caring staff in a warm environment filled with joy is more than a nice thing to provide — it’s a clinical prerequisite.

These imperatives to care have been brought to crisis-level by the Covid-19 pandemic. The forced closure of some clinics has created a therapeutic vacuum that has not been comparably filled by other interventions. Zoom sessions are not a replacement.  Many children with ASD face challenges related to comprehension, connection and communication and have difficulty engaging with therapy behind a screen.

Unfortunately, the response to decades of demand has largely been haphazard and inadequate. Fragmented networks of therapists, and chains of ABA clinics that haven’t made a robust investment in teams and resources, with BCBAs supervising too many inexperienced BTs, result in a lack of consistent, collaborative care. Attempts by private equity to acquire and network small, privately-owned facilities in order to reduce costs of operation and improve service delivery has had little positive impact on client experience and outcomes.

Fixing the Imbalance
We can do a better job. The rising healthcare movement to treat the whole patient must be our movement as well. And though the necessary investment to do so will emphasize people and facilities, there is a role for integrated technology going forward. Remote video training that supports parent coaching, and wraparound technology for family scheduling, as well as support, supervision and quality reviews for therapists collaborating together on a child’s care, can both improve coordination and extend care to the home at the end of the school day.

The need and demand for access to quality, interdisciplinary therapy will only continue to grow. Early intervention, with consistent, qualified care provided under one roof, can generate better outcomes that will help children and their families change what autism means in their lives. With access to well-funded and resourced clinics, where every family from all walks of life are welcome, it will no longer require flying in a therapist on a plane.

Photo: MariaDubova, Getty Images

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aging, senior, old

The pandemic has cast a spotlight on healthcare’s technological shortcomings, accelerating the industry’s historically slow march toward digitization. Confronted with lockdowns and social-distancing mandates, providers have turned to digital communication and data management, e-visits, and telehealth to continue serving patients. In response, enterprising firms of all shapes and sizes—from tech giants to health-app startups—are scrambling to meet this need with secure, efficient, and reliable technology aimed at streamlining remote care.

For those working on the health IT side of things, this demand surge for digital healthcare feels like the dawning of a new era. It’s incredibly exciting to see providers, payers, and patients beginning to embrace digital innovation and experience the positive impact these technologies have on care delivery. Amid all this excitement, however, I find myself feeling leery of how quickly the industry is shifting toward digitization.

I think back to a recent experience my son and I had at a doctor’s office. When we entered the waiting room, we exchanged quick, nervous glances with the other patients in the space before checking in online. Our only human interaction was a brief conversation with the desk attendant—through a plexiglass divider.

While I know that touchless experiences are all the rage (and for good reason), I wonder: if we’re not careful about our migration toward digital care, will human touch and face-to-face interactions become a thing of the past? And will healthcare lose empathy if it swings too far digitally?

There is power in human touch.
Touch is fundamental to the human experience. It forges personal connections, decodes human emotion, and—from a healthcare perspective—promotes trust and healing.

In his book titled, “In the Hands of Doctors: Touch and Trust in Medical Care,” historian Paul Stepansky explores how American medicine has changed since the 19th century, focusing on the role of touch in building trust between doctors and patients. In it he writes, “Medicine then was all about touching, and patients welcomed their touch. It was integral to doctoring, and partly because physicians were part of the community, medicine was about laying hands.”

Using touch as a powerful healing tool is a practice that spans back even further than what Stepansky documented in his book. According to research published in the International Journal of Complementary & Alternative Medicine, the traditional shamans of the North East Australian rainforest have used touch and talk to heal mental and physical disorders for thousands of years. To the aboriginals, touch and human interaction were key to learning secret information about the body, reliably guiding them to the root of the problem.

Modern-day research corroborates these time-tested beliefs. Researchers have published countless studies over the past decade championing the power of touch and empathy in medicine by showing that:

Touch is something we crave on a primal level, and it has proven to be immensely powerful when comforting, diagnosing, and treating patients. But in our rush to digitize every aspect of the healthcare journey, are we leaving this elemental practice behind?

Technology will never replace human interaction
Effective, modern medicine cannot survive without technology. As someone who works for a rehab therapy software company, I fully understand the impact EMRs, mobile apps, telehealth, and general treatment technologies have on improving patient care and outcomes. Regardless of how intuitive the software—or how advanced the technology—patients will always highly value and seek out human touch because:

  1. They remain wary of AI and other nuanced technologies. According to a recent Harvard Business Review report, “patients believe that their medical needs are unique and cannot be adequately addressed by algorithms.” Patient experiences aren’t meant to be 100% digital. And despite the accuracy of computers, humans prefer to seek care from other human beings.
  2. They have emotional needs. And as such, life-altering diagnoses and unforeseen outcomes are best delivered by a living, breathing, feeling individual who can fully understand and address these needs.
  3. Physical examinations are reassuring and restorative. Abraham Verghese, a physician, author, and Professor for the Theory and Practice of Medicine at Stanford University has spoken extensively about the importance of this rudimentary practice, stating that “when [physicians] shortcut the physical exam, when [they] lean towards ordering tests instead of talking to and examining the patient, [they] not only overlook simple diagnoses…[they’re] losing a ritual that I believe is transformative, transcendent, and is at the heart of the patient-physician relationship.”

We must ask ourselves how we can preserve touch in health care

Unfortunately, I don’t think there’s a clear-cut solution to this question yet. At best, technology helps providers reach more patients, reduces administrative burden, and expands access to treatment. At worst, it creates a physical barrier between provider and patient, extinguishing empathy and damaging patient rapport. All things considered, technology’s sole constant is that it will only be as good as the people who created and are using it.

So, from a health technologist’s perspective, I’ll offer up the following considerations for developing digital health tools in the years to come:

  • Focus on the problems rather than the potential solutions
     It’s easy to get distracted by the sheer number of possible solutions your technology can provide. Instead, prioritize your focus by tackling the problems that will deliver the biggest impact once solved. Then, commit your energy to understanding the nuances of those problems. This mindset keeps patient needs front and center, steering you away from feature-rich products that deliver little benefit.
  • Be mindful of unintended consequences. Digital patient intakes and touchless experiences were created for all the right reasons. Yet, however well-intentioned they may be, digital tools always run the risk of producing unintended consequences. As such, physicians and health technologists must work together to understand what problems might occur (e.g., misdiagnoses, overlooked symptoms, missed chances to develop a rapport with patients) if technology is left unchecked.

Medicine will never progress without technology—there’s no denying that. But for the foreseeable future, human interaction remains an instrumental part of the healthcare experience. So, moving forward, healthcare professionals must find a way to blend the sophistication of technology with the power of touch in order to continue improving patient experiences, care, and outcomes.

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 Cancer care is changing for the better. Advanced cancers that were once considered incurable only seven or eight years ago are now looked upon in a new light thanks to researchers, biotech and pharma companies introducing advanced treatment modalities to the market. Today, clinicians are armed with different treatment options, including targeted therapies and immunotherapies in addition to the more traditional chemotherapy, radiation and surgery approaches.

These new treatments have, in fact, reduced the cancer death rate by 27% over the past 25 years and given the average cancer patient hope for survival. Unfortunately, there are still an estimated 600,000 U.S. citizens who succumb to cancer each year according to the U.S. Cancer Society. This can be attributed to most patients being treated with a ‘one-size-fits-all’ mindset, and a general lack of appropriate predictive biomarkers to guide and personalize cancer treatment.

In recent years, the concept of personalized medicine, or “precision medicine,” has come to the forefront of advanced healthcare systems across the globe. This approach attempts to tailor medical treatment to the individual biologic characteristics of each patient, helping physicians provide optimal care and improve patient outcomes. Within the cancer care community, precision medicine is an integral component of immunotherapy, a new approach that harnesses the power of a patient’s immune system to identify and control diseases such as cancer, boosting the body’s natural defenses to fight the disease. While immunotherapy has made a vital reform in cancer care, the challenge of understanding which patient will benefit from immunotherapy is still an obstacle. In 2019, the American Society of Clinical Oncology (ASCO) defined this challenge as one of the top nine research priorities.

According to research published by JAMA, an estimated 43.63% of U.S. cancer patients are eligible for checkpoint inhibitor immunotherapy, yet only 12.46% (on average) are estimated to respond. This limited response rate can be attributed to the lack of understanding of how patients will react to a given immunotherapy treatment. One of the top questions facing researchers in the field today is “who will respond best to immunotherapy?”

Enter Host Response Profiling
Many studies have focused on tumor-related factors, including driver mutations and cell components in the tumor mass as the basis of resistance. However, in recent years, new studies have indicated that the host (patient) response to almost any type of anti-cancer therapy plays a pivotal role in determining and affecting the response to treatment. Now, if we consider the complexity of the ‘biologic universe’ that is the human body, this understanding of the role of the host should not come as a surprise. In many cases, our own body can even ‘team up’ with the invasive tumor to negate the effects of cancer treatment, resulting in further tumor growth rather than elimination. Shockingly, this phenomenon remained hidden from us for many years.

With advanced AI and machine learning tools, new solutions are now being made available to physicians that allow them to profile patients early in the immunotherapy treatment process to better characterize, analyze and predict host response – or see how the patient will respond to the treatment.

Host response can be identified by proteomic profiling, which involves analyzing a broad range of select proteins in a series of patient blood samples, with the first collected prior to treatment and the next collected after the first dose of treatment. The tracked changes in the select series of proteins between the samples can then be used to serve as a predictive tool to determine the likelihood of the treatment’s success and further guide physicians in tailoring treatment plans for individual patients. With this approach, physicians can better predict which immunotherapy treatment will work for each individual patient, optimizing patient care outcomes while reducing treatment costs and minimizing potential adverse treatment side effects.

Host Response Profiling Waiting In The Wings
I recently came across a patient story of a 62-year-old woman who was admitted into the hospital who had a severe cough and blood in her sputum. The woman, who was a heavy smoker, was diagnosed with non-small-cell lung carcinoma (NSCLC), with the primary cancer located in her lungs and traces of metastasis in her liver and brain. In order to choose the treatment protocol – and as part of the pre-treatment work up – PD-1 levels were measured in the tumor, and the patient’s tumor demonstrated a high expression of PD-1 (a protein that serves as an approved biomarker to guide treatment decision). Usually, this is considered to be good news, since the first line of treatment for tumors with a high expression of PD-1 is a drug that is directed against PD-1, such as Merck’s Keytruda.

As part of a clinical trial, the patient underwent host response analysis to monitor the dynamics of her biological processes in response to her cancer treatment method. Upon receiving the results of the analysis, it was discovered that despite the high PD-1 levels that were measured, the response probability for that specific patient was very low (less than 2%) given the treatment protocol that was chosen for her. Her proteomic analysis also revealed that there were several potential treatment combinations that might have given her a much higher chance of success. The host response analysis tool used for this patient was still in development while this patient was undergoing care, and her physicians were not allowed to implement these added insights. Unfortunately, she passed away three months later.

Putting The Odds In Our Favor
Physicians face incredibly difficult decisions every single day. When patients respond well to treatment, the choice to stay on the course is a relatively simple one. When patients are not responding and cancer growth continues, albeit at a slower rate, physicians need to decide whether to continue with the same treatment modality or attempt an alternate course of care. This decision is made even more problematic as cancer patients are fighting against the clock, not to mention that these treatments can cause uncomfortable and sometimes serious adverse side effects for the patients receiving them.

The more we learn about cancer, the more we understand just how unpredictable, distinct and deadly this disease can be. While cancer is not a one-size-fits-all disease, the treatment currently is, and this needs to change. It is imperative that our physicians be empowered with advanced patient information before and during treatment regimens so that they can provide precise medical treatments for each patient’s specific diagnosis and biological needs. If we can help physicians expedite proper, individualized treatment as quickly as possible, we can help them give their patients a fighting chance.

Photo: mathisworks via Getty Images

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Everyone has a personal list of challenges faced and overcome during the Covid-19 pandemic. At the top of mine is navigating the transition to leading a healthcare IT company as a first-time CEO.

On March 4, 2020, I assumed the CEO role at PatientKeeper, a Massachusetts-based EHR optimization software company. Within two weeks of starting the job, HIMSS20 was canceled, much of the economy shut down, fear had gripped the industry, and financial risk was pervasive.

In a completely unexpected twist of fate, among my first actions upon joining the company was to equip our 200-person workforce to work 100% virtually. Our company’s situation certainly was not unique – nearly every organization that could “go virtual” did so – but mine was. After all, I had barely set foot in the office before I was forced to close it.

Just as significantly, we had to respond quickly to conditions our customers – physicians and other healthcare providers across North America – faced as a result of the pandemic.

As a brand new, first-time CEO, this trial-by-fire experience in leading through a crisis taught me a lot and gave me much to reflect on. Most notably, the responsibility of a healthcare executive (and any leader, for that matter) appears to have fundamentally changed. We may have defined ourselves at one time as decision-makers or problem-solvers or communicators or as those that hire and encourage employees. Going forward, I propose that we must, first and foremost, be activators. We must personally act and execute with a sense of urgency and surround ourselves with others that value velocity and are capable of delivering results at ”Covid speed”, even once the pandemic is history. We must reject old norms such as long, bureaucratic and time-consuming presentations, workshops, and layers of approval required to make decisions. We must drive execution and results based on hypotheses motivated by doing what is right for the patients, providers, and other constituents we serve, without necessarily having the full financial and operational analyses blessed, baked, summarized, and socialized. And we must accept rapid transformation as the norm, and the potential for failure that comes with it.

As we continue to fight the pandemic, I am more convinced than ever that the next decade in medicine will be defined by automation. Our industry will be empowered by technology that will activate data and analytics to both improve clinical care and help reduce the administrative burden on healthcare providers — a huge problem that was exacerbated by Covid-19. Physicians, other providers, nurses, and care teams, who have long been forced to accept monolithic electronic health records (EHR) systems and their usability shortcomings, will require and demand a versatile system of experience that delivers immediately relevant clinical information – think of it as “precision HIT” — to enable higher quality outcomes; and that is available 24×7 on clinicians’ mobile devices, regardless of the physical location of the care team. These ideas are not new, yet it will be the organizations that utilize these products and services and respond at ”Covid speed” to the changing needs of the healthcare community that will be the winners in the future.

Now imagine a world where we attack other pressing problems – poverty, mental health, cancer, obesity, gun violence, climate change, and drug addiction, to name a few – with the same speed, resources, and urgency as we are the current Covid-19 pandemic. I can! And I believe the new post-pandemic responsibility of any leader will be to serve as an activator, driving velocity and a sense of urgency as our pre-eminent responsibility.

Photo: z_wei, Getty Images

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interoperability, rope, braid

Back in 2019, the Proposed Interoperability rules were released from ONC and CMS, and the final version of these rules were published in March 2020. While there were some changes implemented based on comments received, largely the new rules kept a lot of the original requirements along with the timelines for implementation. Some of those timelines have been pushed out due to the coronavirus pandemic, but the first payer deadline will be upon the industry before we know it.

Payers have their work cut out for them, although many have hired consultants and partnered with vendors to help implement the first phase of the rule: Patient Access Application Programming Interface (APIs) and Provider Directory. With a relatively short implementation window of January 2021 (with a 6-month grace period on enforcement), that’s not a lot of time to get ready for compliance.

Based on conversations with customers, prospects and industry organizations, there is still ambiguity in the interpretation of the rules, and operational impacts that payers may not be ready to address.  Here are five bumps on the road ahead to implementing the CMS Rules, effective Jan. 1, and some ways health plans can mitigate those uncertainties.

Implementation Guides – Still in Flight
Although not required by CMS, use of the referenced Implementation Guides on the CMS web site is encouraged. The challenge here is that some of those implementation guides are still not finalized. For example, the CARIN Blue Button and CPCDS Implementation Guide still needs to reconcile comments to Standard for Trial Use ballots (STU1). Additionally, the HL7 Da Vinci Formulary and Provider Directory implementation guides (IGs) are likewise in the process of final updates. Both CARIN and Da Vinci are moving quickly, but it’s hard to implement when the target may still move. As such, it is critical that payers and their vendor partners participate in these workgroups and follow the updates to make sure that they have the latest technical specifications.

Clinical Data – What Counts
CMS finally has provided guidance on this, and the news is good for payers. Only clinical data elements listed in the United States Core Data for Interoperability (USCDI) that are structured data need to be shared for the Patient Access API. So, USCDI clinical data elements embedded in a fax or PDF don’t need to be shared. For payer-to-payer exchange, if data in a PDF sent to a payer contains USCDI, they do need to send it along to the next payer. Here’s the link to answers to some common questions from CMS:

Despite this reprieve,  payers need to be aware they have plenty of structured clinical data that they manage, so locating that data and bringing it all together might be a challenge. Consider sources such as lab data, diagnosis and procedure codes contained in a claim, data entered into a case management system or disease management registry; they will count. Not to mention data that might come in through an Abstract Data Type (ADT) or a Consolidated Clinical Document Architecture (CCDA) directly from a provider. To avoid bumps, payers must ensure they’re working with a vendor that can easily ingest data, no matter what the source format.

Clean Data – Does it Matter What Payers Send to Members?
Not only does it matter what payers share, but also how payers share it. A lot of clinical data captured by a payer is not “clean data”.  This means it might not be in the required coding, there may be multiple copies of the same data (i.e. lab results) stored or data might be in the wrong field when ingested. Cleaning that data before sharing it should be a key consideration. If members don’t understand what they are seeing, and can’t make sense of it, then the member service line might be ringing off the hook. The more payers can curate that clinical data, the easier it will be for third party applications to use and display it to members in a meaningful way. Having aggregated, normalized, and deduplicated data is key to enabling the ability to payers pass clean data to an API vendor.

It is important that members know the origin of their data. As part of the new USCDI standard, data provenance needs to be part of the data shared. Similarly, knowing the source of that data could help educate members about who to call when the data doesn’t look right. For example, if a medication that a patient is no longer taking appears in the application, knowing the source of that data can help the member follow up with their provider, not their health plan, to make the correction. Health plans need to make sure that they, or their vendor partners, capture and share the provenance data with the third-party apps. There should also be education on the payers’ website and as part of its member portal that provides clear information on what members should do if their information isn’t correct.

API Application Vendor Vetting
The CARIN Alliance is doing a lot of work to create framework and reference documents that help payers assure that the third-party apps are “vetted” prior to connecting to the payer’s infrastructure. Although a payer cannot deny access to an application, they can make sure that the vendor is who they say they are and that they are handing off credentials to a reputable app vendor. [Editor’s note: The author’s employers is a member of the CARIN Alliance.]

CARIN has also created a Code of Conduct, where app vendors can voluntarily attest to the Code. App vendors that have agreed to the code state that they plan to respect patient privacy and only use the data for member benefit. It’s important for payers to let their members know that third-party apps will not be sharing the data in ways the member didn’t intend (often because of language in the app End User Agreement).

While the new regulations come with many challenges, the end result of improved interoperability and providing members greater access to their health data makes it all worth it. For payers, it’s as important to focus on the operational impacts of the CMS rules as it is on the technology used to comply with them. To do this, payers should continue to monitor both feedback from CMS, chatter from the CARIN Alliance and the HL7 Da Vinci project as well as feedback from customers and prospects. By focusing on these non-technical considerations as they move to implementation, the process will become much more seamless.

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If there is any lesson to be drawn from 2020, it’s that making predictions for the year ahead is an act of hubris. Despite that, some clear trends have emerged. The pandemic has permeated every aspect of our lives: health, economics, politics, and beyond. Amid the devastation, the healthcare industry has been at the forefront.

We face more questions than answers. How quickly can vaccines be efficiently distributed across the entire populace, rather than select groups? What strategies will businesses embrace to thrive (or survive) going forward? How will the new administration tackle its inherited challenges and advance its healthcare agenda?

Thus, at the risk of being either foolish or arrogant, here are five of our predictions for healthcare in 2021.

A surge in digital health

Healthcare has often lagged other industries in adopting digital tools, but the pandemic dramatically narrowed the gap. Consumers, either unable or unwilling to leave their homes, quickly transitioned to online services for essential needs. Importantly, this even included the elderly, typically on the digital sidelines, who agreed to connect with caregivers on Zoom or FaceTime. Providers rushed to deploy new remote services to attract, treat, and retain patients, particularly for behavioral health. 

Impact: The sudden shift to digital provided access to care and introduced consumers to a higher level of convenience. For many, there will be no going back. The industry will either deliver enriching online experiences for patients of all ages, or they will find their patients siphoned off by more compelling services. 

Amid progress, this shift to telehealth and electronic communications has exacerbated health inequity. Patients who lack technology or access to affordable internet may be left further behind. It’s a danger that must be addressed at every level of the healthcare industry.

A new focus on agility

Covid-19 hit most institutions like an avalanche, disrupting nearly every aspect of operations. Some services, like intensive care and diagnostic testing, were overrun. Others were shut down as elective procedures were suspended. Employees found themselves without childcare, public transit, or the ability to work from home. Some organizations pivoted, re-assigning or re-training staff, transitioning to remote operations, and deploying tools to enable operational continuity. Others began to collapse, overwhelmed by clinical challenges, administrative failures, and financial losses.

Impact: Traditionally, organizations have prepared for specific incidents – tornados, mass casualties, and the like. The pandemic highlighted the critical value of leadership, capabilities, and culture to adapt to wholesale disruptions of their workforces, supply chains, and even business models. Going forward, planning will be done more holistically, requiring budget, advanced analytics and personal expertise. Of course, this may divert resources away from other initiatives.  

The past as a predictor of the future

If there were a succinct way of describing healthcare following the 2009 financial crisis, it would be that the strong got stronger and the weak got weaker. Organizations that were better prepared heading into the crisis and better managed during it, emerged better positioned afterward. The converse was also true, with many organizations pushed to the brink of bankruptcy.

Impact: As we found a decade ago, high performers will continue to grow, expanding their market share organically and through acquisition. Weaker performers will find themselves under siege not only from stronger players, but also from new entrants – retailers, digital healthcare providers, and others – eager to extend their industry footprint.

New risks and vulnerabilities in the virtual world

Healthcare has always been an attractive target for cyber criminals. The data is valuable, and the stakes are high. Providers face stiff penalties for data breaches and cannot afford to have the safety of their operations compromised. Equally importantly, patients need confidence that their privacy and confidentiality is secure.

However, the rush to virtual environments created new vulnerabilities. Staff began using their own devices and networks, training was postponed, and IT staff were diverted to deploying telehealth, remote monitoring, and work-from-home solutions. Clinical conversations migrated to unsecured email.

Impact: Not surprisingly, healthcare saw a surge of high-profile ransomware attacks. 2021 will be a year of security catch-up as organizations patch holes, retrain, and identify new risks created by their transformed operating environments. Furthermore, the industry will begin to address the challenges that arise as virtual care increases. Organizations may dramatically increase countermeasures to protect IT systems. If they don’t, cyberattacks and data breaches will only intensify. 

The ascension and expansion of public health

What began as a public health emergency quickly morphed into a political battle and an economic crisis, creating a three-pronged disaster. Therefore, any solution that did not address the realities of the other two was destined to fail. 

Impact: The pandemic has shown us that public health is essential to the economic and physical well-being of the country. Smart organizations will onboard this insight by listening and incorporating information, data, and insights from each leg of the healthcare stool. Operating in silos, proposals are a zero-sum game. However, by establishing public-private partnerships and working collaboratively, solutions can be crafted that meet the collective needs of our communities. Hopefully 2021 will be the year of building strong bridges.

Picture: Dmitrii_Guzhanin, Getty Images

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