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The Tone of Your Voice Holds the Secret to Moving Connected Health to the Next Level

December 11, 2017

Lately, I’ve been thinking quite a bit about what I consider to be an urgent priority — moving from the antiquated, one-to-one model to efficient, time- and place-independent care delivery. I’d like to opine about the topic here, but first need to present three bits of context to set up this post.

Think about your interaction with a doctor.  The process is as old as Galen and Hippocrates. You tell the doctor what is bothering you.  She asks a series of questions.  She gathers information from the physical exam.  Not only the obvious things, like heart and lung sounds, but how you look (comfortable or in distress), your mood, the strength of your voice when you talk, the sound of your cough (if you have one) and your mental state.  Armed with this data, she draws a diagnostic conclusion and (presuming no further testing is needed), recommends a therapy and offers a prognosis.  For the better part of the last quarter century, I’ve been exploring how best to carry out this process with participants separated in space and sometimes in time.  The main reason for this is noted in the next two bits of context, below.

There are two big problems with healthcare delivery as it works today. The first is that, in the US, at least, we spend too much money on care.  The details here are familiar to most…20% of GDP…bankrupting the nation, etc.  The second is that we stubbornly insist that the only way to deliver care is the one-to-one model laid out above.  The fact is, we’re running out of young people to provide care to our older citizens. This is compounded by the additional fact that, as we age, we need more care.  By 2050, 16% of the world’s population will be over 65, double the amount under 5.  More detail is laid out in my latest book, The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan.  We need to move to one-to-many models of care delivery.

Efficiency is a must, and one-to-one care is very inefficient. Essentially, every other service you consume — from banking, shopping and booking a vacation to hailing a taxi — is now provided in an online or mobile format.  It’s not just easier for you to consume it that way, but it’s more efficient for both you and the service provider.

If you can accept my premise that we need to move to efficient, time- and place-independent care delivery, the next logical step would be to ask how are we doing in this quest so far?

We’ve employed three strategies and, other than niche applications, they are all inadequate to get the full job done.  The most loved by today’s clinicians is video interactions. With the exception of mental health and neurological applications, video visits have a very limited repertoire.  We stumble over basic symptoms like sore throat and earache because a video interaction lacks critical information that a conversation alone can’t provide.  The second strategy is to take the interaction into an asynchronous environment, analogous to email.  This is time- and place-independent, so it has the potential to be efficient, but lacks even more nuance than a video conversation.  This modality is also limited in scope to a narrow set of follow up visits.  In some cases, patients can upload additional data such as blood sugar readings, weight or blood pressures, and that increases the utility somewhat.

The third modality is remote monitoring, where patients capture vital signs and sometimes answer questions about how they feel.  The data is automatically uploaded to give a provider a snapshot of that person’s health.  This approach has shown early success with chronic conditions like congestive heart failure and hypertension.  It is efficient and if the system is set up properly, it allows for one-to-many care delivery.

As a Telehealth advocate, I am compelled to remind you that each of these approaches has shown success and gained a small following.  We celebrate our successes.  But overall, the fraction of care delivered virtually is still vanishingly small and each of these methods has more exceptions than rules.

Remote monitoring is the right start to achieving the vision noted above.  It is efficient and allows for one-to-many care delivery.  But currently, all we can collect is vital signs, which represent a really small fraction of the information a doctor collects about you during an office visit.  So while we can collect a pretty good medical history asynchronously (we now have software that uses branching logic so it can be very precise) and we can collect vital signs, for years I’ve been on the lookout for technologies that can fill in some of the other gaps in data collected during the physical exam.  To that end, I want to highlight three companies whose products are giving us the first bit of focus on what that future might look like.  Two of them (Sonde Health and Beyond Verbal) are mentioned in The New Mobile Age, and the third, Res App, is one I just became familiar with.  It is exciting to see this new category developing, but because they are all early stage, we need to apply a good bit of enthusiasm and vision to imagine how they’ll fit in.

Res App has a mobile phone app that uses software to analyze the sound of your cough and predict what respiratory illness you have. This is not as far-fetched as it sounds.  I remember salty, seasoned clinicians who could do this when I was a medical student. They’d listen to a patient with a cough, and predict accurately whether they had pneumonia, asthma, heart failure, etc.  Res App, Australian by birth, says they can do this and have completed a good bit of clinical research on the product in their mother country. They are in the process of doing their US-based trials.  Stay tuned.  If it works as advertised, we can increase the value of that video visit (or the asynchronous data exchange) by a whole step function.  Imagine the doctor chatting with you on video and a reading pops up on her screen that says, ‘According to the analysis of this cough, the patient has a 90% chance of having community-acquired pneumonia and it is likely to be sensitive to a course of X antibiotic.’  Throw in drone delivery of medication on top of e-prescribing and we really could provide quality care to this individual in the confines of their home, avoiding the high cost part of the healthcare system.

Similarly, Israel-based Beyond Verbal has shown — in collaboration the investigators at the Mayo Clinic no less — that the tone of your voice changes in a predictable way when you have coronary heart disease.  Same scenario as above, but substitute heart disease for pneumonia.  And then there is Sonde, whose algorithms are at work detecting mental illness, once again from the tone of recorded voice.  As William Gibson said, “The future is here. It is just not evenly distributed.”

We are a ways away from realizing this vision.  All of these companies (and others) are still working out kinks, dealing with ambient noise and other challenges.  But the fact that they have all shown these interesting findings is pretty exciting.   It seems predictable that companies like this will eventually undergo some consolidation and that, with one smartphone app, we’ll be able to collect all kinds of powerful data.  Combine that with the ability to compile a patient’s branched-logic history and the vital signs we routinely collect and we can start to envision a world where we really can deliver most of our medical care in a time- and place-independent, efficient matter.

Of course, it will never be 100% and it shouldn’t be.  But if we get to a point where we reserve visits to the doctor’s office for really complex stuff, we will certainly be headed in the right direction.

Medicare Reimbursement for Remote Monitoring Should Drive Adoption (What a long, strange trip it’s been….)

November 16, 2017

The Centers for Medicare & Medicaid Services (CMS) released the 2018 Physician Fee Schedule about two weeks ago and there is at least one nugget in there that should speed the adoption of remote patient monitoring.  In fact, the news is even better, but I’m getting ahead of myself.  First, let’s examine the broader context of what adoption of remote monitoring will mean for healthcare delivery and the amazing story of how we got here.

Why it matters

By 2050, 16% of the world’s population will be over 65, more than double the number under five years old.  Inevitably, older people require more healthcare resources and caregiving.  The math is too stark to ignore:  we’re running out of young people to care for our elders if we continue to offer only one-to-one, face-to-face care as an option.  If you want to learn more about this conundrum, it is covered in some detail in my new book, The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan.

Remote monitoring is critical to move us from one-to-one models of care delivery to one-to-many.  Other services have done this, and we need to catch up. At Partners Connected Health, in collaboration with colleagues in our delivery system, we have shown, more than once, that home monitoring of patients with congestive heart failure leads to lower hospitalization rates and improved mortality.  Others have shown this too.  In this type of remote monitoring system, the nurse to patient ratio is about 1:100. That’s what I mean by one-to-many.

Yet, to date, most telehealth has been delivered via videoconferencing between patients and doctors.  These interactions have improved access, but still rely on that one-to-one model.  Stated another way, video communication breaks the ‘place’ barrier but remote monitoring is both time and place independent — a challenge for healthcare providers who are used to thinking that healthcare should be rendered in the doctor’s office.

A survey, published by the American Medical Association (AMA) in 2016,  succinctly outlined the barriers to digital health adoption among physicians:

* Need for evidence
* Reimbursement
* Liability coverage
* Workflow/EMR integration

These insights have driven AMA’s digital health strategy since.  For the last year, I’ve had the privilege of working with them on several aspects of this, including co-chairing their Digital Medicine Payment Advisory Group (DMPAG), which has focused on reimbursement for digital medicine, including remote monitoring.

The specific news

In 2004, I took my kids to the Lemony Snicket movie, “A Series of Unfortunate Events”. The story on Medicare reimbursement for remote monitoring is just the opposite: many dedicated people working, sometimes in coordination and sometimes not, at the right place and right time in history, culminating in a series of fortunate events.

Here are the specifics of what we learned when the 2018 Physician Fee Schedule was released on November 3:

CMS has decided to unbundle and activate CPT code 99091 (collection and interpretation of physiologic data).  CMS has stated that this is an interim step until the Agency considers new CPT codes and valuation recommendations. 

CMS stated in the rule that the Agency “look[s] forward to forthcoming coding changes through the CPT process that [they] anticipate will better describe the role of remote patient monitoring in contemporary practice and potentially mitigate the need for the additional billing requirements associated with these [99091] services.”

This is an amazing announcement since, for decades, Medicare had turned a deaf ear to most forms of telehealth and any discussion of remote monitoring was relegated to the depths of despair.

How we got here

When providers perform a task related to your care, they document the work using a common procedure coding system which includes a number of codesets such as the one maintained by the Current Procedural Terminology (CPT) Editorial Panel.  In most cases, these codes are used to electronically bill your insurer, who then pays the provider according to a contracted fee schedule.  The CPT Editorial Panel has been around for decades and though the members, comprised of a cross-section of healthcare stakeholders including insurers, are appointed by the AMA Board of Trustees, the Panel’s decision-making is independent of the AMA.

The code change application process can occur in a relatively rapid period of time—a matter of months from the date the application is submitted to the date it is considered by the CPT Editorial Panel. However, the Medicare program’s process for considering recommendations for valuation and coverage (through the rulemaking process) can be lengthy because such decisions are made on an annual basis.  Hence, the Medicare process takes years and a code can be derailed at any point.  Medicare can choose not to pay for a code and they can also choose to ‘bundle’ the code, if the work related to that code is already covered in their reimbursement of other services.

The classic example is the code that reimburses doctors for telephone calls with a patient. Insurers don’t pay because Medicare decided that telephone follow up is included in reimbursement for an office visit.  It is important to note that commercial payers can utilize the codes as soon as they are publicly posted by the CPT Editorial Panel and are not required to follow the Medicare process for valuation and coverage.

The importance of the new fee schedule is this: although CPT code 99091 has existed for years, it was bundled.  By simply unbundling this code, CMS opened the door for remote monitoring reimbursement.  And, because the code exists, it already has an assigned monetary value, so as of January 2018, providers can start to provide remote patient monitoring services and actually receive reimbursement.

This breakthrough is not happenstance.  It is the result of two phenomena.  One is the dogged pursuit of a handful of individuals who see the mounting challenges of caring for an aging population, and who are passionate that we have to get there for the sake of better patient care.  These folks have been lobbying the government for years, and despite countless setbacks, have continued the quest.  The second phenomena was the appointment of a new CMS chief, the consequence of a new administration in Washington.  Whatever you think of our current administration, it is a fact that they are more telehealth friendly than any in history.

Now, getting back to the work of the AMA’s DMPAG, we recently put forward three code change applications to the CPT Editorial Panel, including two related to remote monitoring.  This too was not a random event.  The AMA wisely populated this advisory group with half digital health experts/practitioners and half CPT/RUC experts.  We’ve worked well together and the AMA deserves enormous credit for their wisdom and support.

So it was with great thought and preparation – and no guarantee of success – that we presented these proposed new codes in September and the CPT Editorial Panel, which acts independent of the AMA, approved them so our success was not guaranteed.  We felt a sense of victory, but also vulnerability, as we don’t have particular influence over the RUC valuation and even less over whether CMS will reimburse for the new codes. At the time, I reminded our DMPAG team that the apt sports analogy for this success was a first down rather than a touchdown.

This changed significantly with the November 3 announcement and the specific wording that CMS looks forward to new codes from the CPT process.

The wheels could still fall off the wagon. We can’t let up in our quest.

It must also be pointed out that there are other adoption barriers clearly identified in the 2016 AMA survey.  Reimbursement, however, is a big one.  With reimbursement comes enthusiasm from EMR vendors to improve workflows and processes.  As the CPT Editorial Panel only approves codes that have sufficient evidence, and though some will say there is never enough evidence, the case for remote monitoring is a strong one.  And, as we improve workflows, that should also help mitigate liability concerns.

The future is bright for remote monitoring, all of a sudden.  But it has taken us years of work and ‘a series of fortunate events’ to get there.  I’ve been privileged to be part of an amazing team that the AMA gathered, and fortunate to benefit from the hard work of others  to move thinking on this topic at CMS.

Our patients of all ages will benefit and, importantly, we can achieve a one-to-many delivery model in time to care for the oncoming ‘silver tsunami’ of our aging population.






A Front Row Seat for the Future of Technology-Enabled Health and Wellness

September 28, 2017

The 2017 Connected Health Conference (CHC) is right around the corner, after months of planning, organizing and confirming a terrific lineup of speakers and events. I am delighted that we’ll be gathered at the Seaport World Trade Center in Boston October 25-27.  It is a must-attend event if you are in any way interested in the growing field of digital health.

If you are a veteran of the Partners Connected Health Symposium and missed the news that we merged our event with the Personal Connected Health Alliance’s Conference, let me bring you up to speed.

At last year’s Symposium, we announced the merger, to establish “the singular leadership event focused on the future of technology-enabled health and wellness. ” It’s very clear now that merging the events was a wise decision. We have received very positive feedback from throughout the market, and are attracting an impressive group of sponsors, including: Intel,  Verizon, Philips, IBM and Teva Pharmaceuticals, AARP, Amazon Web Services, Medtronic, Johnson & Johnson, Qualcomm Life, Fitbit, AMA, Validic, TMC Innovation Institute and Conversa Health, with more still signing on.

And, the list of exhibitors is long as well, and we’re very excited to see this growing marketplace. On the exhibit floor, the new Innovation Lounge is bringing together provider, industry and institutional innovation centers and novel collaborations. It is a unique and dynamic area that expands the possibilities and showcases key partnerships that are driving innovation.

I have personally been developing the program with the help of our CHC Advisors and programming team, hand picking the speakers and carefully designing each session to be inspiring, provocative and informative.  Our goal is to bring people together for an experience that gives them a clear view of where the industry is headed.

It is a jam-packed agenda that will deliver forward-looking initiatives, real-world examples, insider perspectives and actionable ideas.  This year’s theme “The Connected Life Journey” brings in cutting-edge developments in aging, chronic care management, consumer and physician adoption, as well as policy, research and the investment community.

To kick off the conference, I have the privilege of delivering the opening keynote on Thursday morning, where I’ll share with you some of the insights, innovations and next steps from my new book that will be hot off the presses, The New Mobile Age: How Technology Can Extend the Healthspan and Optimize the Lifespan. We’ll look at how digital technologies are enabling people to remain vital, engaged and independent through their later years.

But with so much great content and the special events taking place at CHC17, you won’t be able to sit in on every session, so I’ve been thinking about those I’d consider ‘can’t miss’ to share with you.

Our keynote lineup is truly world-class, but I always enjoy hearing from:

Chunka Mui, an expert at fostering innovation.

Adrienne Boissy from Cleveland Clinic, who will share her thoughts on relationship-driven strategies to improve the patient experience.

My friend and colleague, Calum MaCrae, from Brigham and Women’s Hospital in Boston, who will share his vision and progress in building a most exciting future healthcare delivery model.

I’ve always looked to other industries and examples that can be applied to connected health, and one that I often cite is The Truth Initiative. Eric Asche will share their strategy for successfully changing behavior around smoking.

Their experience has wide applicability in our quest to better manage the 70% of healthcare costs that are lifestyle related.

It’s very difficult to just pick a few, but here are some breakout sessions you should also check out:


We’ve also added a new track focusing on Health System innovation, where you’ll hear from the Healthcare Transformation Lab at Massachusetts General Hospital, PULSE@MassChallenge, Healthbox and many more health system leaders.

And at the closing plenary session, Envisioning the Connected Life Journey, I have the privilege of sharing the stage with some insightful and truly visionary colleagues, including Charlotte Yeh from AARP and Rudy Tanzi, a renowned researcher who co-discovered the first Alzheimer’s disease genes and directs the Alzheimer’s Genome Project.

There will be many exhibit floor activities – an important and welcome addition to the Connected Health Symposium, which will add a new dimension for learning and insight.  We have carved out exclusive times for roaming the exhibit floor and for networking, so that attendees and exhibitors will have ample time to interact, without competing with the program.

We still have about four weeks to go until the Connected Health Conference. I hope you are as excited as I am to convene in Boston, share ideas, learn together and move the market forward.

I’m pleased to offer cHealth Blog readers a special $100 discount on your Conference registration. Simply visit the Connected Health Conference website, and register using discount code CHC17100.

Come join us.  It’s the place to be!

The Next Fountain of Youth? Rethinking Connected Health for Our Aging Population

August 23, 2017

Last month I shared an update on my upcoming book, The New Mobile Age, and am excited to share a bit more about this work.  We continue to hit our editorial milestones for an end of October launch at the Connected Health Conference, and as I’m reading the manuscript for the final time before sending it to the printer, I’m re-learning some important lessons–and enjoying the content! I’ve been honored to gather input from a long list of esteemed colleagues and wanted to share a few ideas I believe are critical in our thinking about the healthspan.   Below is a sneak peek at two fundamental concepts we discuss in-depth in the book.


First some context.  We’ve added 25 years to our lifespan in the last century through various public health innovations, but we haven’t provided tools to help us use those additional years in the most productive, fulfilling way. Instead, we’ve put folks in that demographic (those in the latter 25 years of their life) into a category of ‘old.’  They retire, are perceived as no longer adding value or, even worse, become a burden to their ‘sandwich generation’ adult children.  We must turn aging from being a dreaded inevitability into something to be celebrated. My friend Jody Holtzman, who is quoted in the book, coined the term “Longevity Economy,” and defines it as the 100-plus million people in the United States over age 50 who account for $7.1 trillion in annual economic activity.  He quite accurately notes that only in the eyes of the U.S. government would this population be viewed as a burden. Rather, we need to refocus on this group of older adults as an opportunity!


Now that we’ve extended the lifespan, our first priority should be to enhance the healthspan, by giving people the tools needed to improve their health and inspire them to maintain healthy lifestyle choices.  If we do this right, we will turn this growing cohort of older adults from being seen as a burden to one that is remaining vital, connected and adding value.  And of course, connected health is a big part of the solution.  There are multiple dimensions at play, and I can’t cover it all here, but I want to touch on two areas that became clear to me while researching the book.

The first group of insights comes from another respected friend and colleague who is helping society rethink aging, Charlotte Yeh.  Charlotte has written the Foreword for this book and has taught me several things in the process.  Once I learned of her perspective, I became tuned in to several reproducible findings in patients in my own clinical practice.

We’re used to thinking of predictors of longevity in a very scientific, dry way–measures such as exposure to tobacco, high blood pressure, blood cholesterol level and the like.  Of course, these are valid and important, but Charlotte opened my eyes to a different set of important measures.  One is a sense of purpose.  There is a lot of research on this and we cover it in the book, but anecdotally, as I’ve spoken with my own patients, I’ve seen this come to life.  People who have some purposeful activity they pursue in retirement are healthier.  The second is social connections.  Again, there is a remarkable body of evidence on this, and it turns out that isolation eats away at an individual and has the same effect on health as multiple packs of cigarettes a day!  Finally, physical activity.  This can range from taking the stairs or walking each day to going to the gym or even remaining a competitive athlete.


None of these measures are unique to aging, but to strip away the traditional, clinical science and break it down into these three simple predictors was liberating for me.  Of course, the bonus is that connected health can play a role in all three, whether it is participating in the gig economy to drive purpose, being active on social media or FaceTime to keep up social connections, or tracking your steps on a Fitbit. All of these challenges are made easier by modern technology.


The second important insight driving new, increasing opportunities for personal health technologies has to do with managing chronic illness.  As much as we’d all like to stay healthy all our lives and die peacefully at a ripe old age, the fact is we all suffer from system wear and tear and require more illness management as time goes on.  We are at the breakpoint as a society, to provide the resources needed to do this.  Very soon, we won’t have enough healthcare providers and caregivers to tend to the aging population if we only rely on one-to-one care delivery models. We spend a lot of time in The New Mobile Age talking about how to use technology to create one-to-many care delivery models.  Particularly exciting is the work of some of the early stage companies, paving the way for these new models of care, including:, a platform that features an interactive avatar to engage people in their homes—or in the hospital—to promote medication adherence, detect cognitive changes early on and keep an eye on patients who are prone to falls.

Rendever, an MIT spin-off offering a virtual reality (VR) experience for nursing home patients, as way to connect to the outside world.


OhmniLabs, a startup with a telepresence robot for elder care that enables an older person to stay in touch with his or her family or healthcare provider in real time.

Sonde Health, another MIT spin-off that uses voice-based technology to analyze health and the user’s emotional state in real life, real time.

Hasbro’s Joy for All Companion Pet, a dog or cat interactive companion pet with built-in sensors and speakers. For ages five and up, it is used for Alzheimer’s patients and as a tool to relieve loneliness, a prime example of intergenerational thinking.


Catalia Health’s Mabu, a kitchen counter robot designed to improve medication adherence that makes eye contact and tracks the emotional state of the user.

Affectiva, a leader in “emotion AI,” the new science of training computers to read and understand human emotion.

Omada Health, which offers a digital curriculum based in part on the National Institutes of Health (NIH) groundbreaking National Diabetes Prevention Program (National DPP).

Iora Health, a “whole new operating system for healthcare” that is focusing on the needs of Medicare patients.

Each of these companies has an innovative approach to helping address the challenges of keeping older adults engaged, vital and independent, and opportunities to provide technology-enabled care for this rapidly growing population.

I’ve enjoyed putting this book together and look forward to sharing it with you, to continue the discussion, gain your feedback and, together, advance our learning and care delivery in this New Mobile Age.

Coming Soon… The New Mobile Age

July 24, 2017

I have fallen behind on blogging over the last few months.  When I started the cHealth Blog, in 2008, I posted every other week, but over the years, the frequency has fluctuated somewhat.  My main excuse is that I’ve had the opportunity to publish in other places, such as NEJM Catalyst, Harvard Business Review, and Nature Biotechnology. This is gratifying personally, but also brings in new audience members and broadens the discussion about connected health.

Given the warm reception The Internet of Healthy Things received, I have also been working on a new book which we’ll release this fall at the Connected Health Conference.  This time around, with the same coauthors, Carol Colman and Gina Cella, we’ve taken a long, hard look at the role technology will play in helping us live longer, healthier, more productive lives.  At this point, the manuscript is almost complete and The New Mobile Age will soon be in the hands of the printers.  This has been an exciting endeavor for me, as we’ve managed to get many of the top minds in aging to lend us their thoughts. Those insights, combined with my own twist, should make for informative, fun reading about this very important topic.  It is no coincidence that the theme of the book marries well with an important initiative that our friends at Personal Connected Health Alliance are leading on Healthy Longevity.

Here’s a quick preview of The New Mobile Age: In the 20th century, we added 25 years to our lifespan. In the 21st century, the challenge is to employ new tools and strategies to enable us to live healthier during those years–adding to our healthspan.  We have already crossed the threshold where the demand for healthcare services is outstripping the supply of providers. And, by 2050, there will be more older adults needing care than younger individuals to provide care for them.

Aging Baby Boomers want control of their health and want to grow old on their own terms. Digital technologies are creating a new kind of old, enabling individuals to remain vital, engaged and independent through their later years. But it has to be the right technology, designed for an aging population, not just what technologists and app developers think people want. Social robots, artificial intelligence, vocal biomarkers and facial decoding will analyze emotion, anticipate health problems, improve quality of life and enable better relationships with healthcare providers. It’s also about using data to better understand the ‘soft science’ of wellbeing and address the neglected crisis of caregiving. It’s a business model but, more so, it’s a new way of life.

The New Mobile Age will explore what needs to be done to bring the healthspan into line with the ever-increasing lifespan. At a time when digital and connected health solutions are needed more than ever to stem this ‘Silver Tsunami,’ health tech innovations will not just improve healthcare for older adults, but will create a better and more responsive healthcare system for everyone.

The time is now to galvanize our efforts on this important topic.  If we continue to insist that the only way to receive healthcare services is one-to-one in a physical location, we will drown in service demand.  Technology, properly designed and implemented, can allow us to live a long, healthy life.

The Path to Scale for Digital Therapeutics

June 16, 2017

Thanks to our friends at Omada and other companies in this space, the term ‘digital therapeutics’ is working its way into our lexicon. There are now many examples of how a digital intervention can have the same or better clinical outcome as a chemical therapeutic, demonstrating the power of connected health, particularly in the realm of lifestyle-related chronic illness.

For the sake of argument during this post, let’s assume that digital interventions can be effective as tools to combat illnesses like type II diabetes, hypertension, asthma and others. With that premise in mind, consider this….

I recently had to complete a clinical research safety training program and the learning module went into some detail about how new drugs and devices get into widespread use. I couldn’t help but compare this to digital therapeutics, and quickly came to the conclusion that we need a better strategy for getting digital therapeutics into the mainstream. Here are some thoughts.

1. Discovery phase: This is where large pharma and/or med device companies work in the lab to create new interventions. This is probably the development phase when digital
therapeutics are most similar to new therapeutics and devices. Innovators and scientists tinker, try new things and publish papers in academic journals. If the research is internal, the path to commercialization is straight forward. If it comes from an academic lab, there is a need to license intellectual property. One way that digital interventions may be different is that the software and/or hardware tested in this early phase is rarely product-ready. There is a commercialization step in software that I believe is not part of the process of pharmaceutical development. It may be part of device development.

2. Preclinical studies: There really isn’t an analogous phase for digital interventions (except perhaps ingestibles or implantables). Since digital interventions are mostly intended to work based on their interaction with our psyche, they have to be tested, from the start, in humans. There is also less worry about safety. Yes, these interventions need validation and patient safety is always important, but this is very different from introducing a new molecule into the bloodstream or a new implanted device.

There are a lot of individuals and organizations weighing in on this issue, including groups like WLSA and others, and I expect that there will be some important debate, and even consensus, building in the near future.

The U.S. Food and Drug Administration (FDA) approach to digital interventions deserves separate attention. For this post, I’ll just mention that, more and more, digital interventions are being approved as class II medical devices, especially if there is a decision support function. The fact that digital interventions can largely leap frog this stage should be attractive to investors, as these products can reach the market that much sooner; and inevitably, these companies are more capital efficient.

3. Clinical validation: Increasingly, companies that wish to have their digital interventions as part of the healthcare delivery armamentarium are spending time and money to do proper clinical validation of their products. As potential consumers of these tools, we should be comforted by this trend. But, from a business perspective, there are challenges here. It takes a long time to do high quality clinical research. Technologies change rapidly and it is common for the software or hardware being studied to go through several upgrades/improvements during the time of the trial.

In addition, there are some research methods that can help move trials faster, but the randomized controlled trial is still industry standard. Because digital interventions can’t be studied in a double-blind manner (the investigator always knows which subjects are in a control group vs the intervention), there is less likelihood that a trial can be stopped early. There is also a fear of investigator bias while looking at data prior to the conclusion of the trial. And while there is a high degree of regulation in the pharma and medical device industries, due to the interactions with the FDA and the need for clinical trials of new interventions, we don’t yet have that for digital therapeutics. I am sure some individuals pray we don’t get to that point, as it adds costs and time to market. I only bring it up because it will be hard to legitimize digital therapeutics without a regulatory framework.

4. Negotiating with payers: Both device manufacturers and pharma companies devote tremendous resources setting prices with pharmacy benefit managers and large insurers. There is nothing like this in the land of digital therapeutics. Each entrepreneur toils in the quicksand of these negotiations, starting with pilots and eventually getting contracts with either employers or health plans. The work is tedious and resource intensive. It is fun to imagine what the world would be like if there were a handful of negotiation points for digital intervention pricing. It seems like this would be necessary to achieve scale.

I asked my friend and colleague, Rob Havasy, HIMSS subject matter expert in connected health, his opinion on this topic. He clearly articulated that, if our goal is to secure reimbursement, our thinking needs to embrace digital therapeutics as a replacement for traditional therapeutics, rather than as an add-on to traditional care, which is often perceived as being an additive cost. In addition, he suggests that we need to focus on comparative effectiveness trials to demonstrate that digital therapeutics can achieve the same or better outcomes as traditional treatments.

5. Distribution: This may be the area where pharma and medical device products have the strongest divergence with digital therapeutics. In both the pharma and device
industries, there are well-worn paths to achieve distribution. In the case of a drug, once the price is set and the drug is in the supply chain, there is a marketing blitz by the manufacturer and folks like me start to write prescriptions. I simply go to the ‘order’ section of my EHR, type in an order for the drug, the software allows me to prescribe it and the patient goes to a pharmacy to pick it up (or has it mailed to their home). In the case of digital therapeutics, there is no pharmacy and no uniform way of prescribing. This may be one reason why so many entrepreneurs are going to employee health plans with these interventions.

It is time we begin to think of digital therapeutics as a legitimate tool in the battle against chronic illness. We need to:

a. Hone the clinical trial process; b. Establish a uniform regulatory process; c. Engage payers in high level negotiations for these products, and; d. Create a distribution network that includes the ability to prescribe and a mechanism for filling prescriptions.

Developers, providers, regulators, payers, consumers. We all have some skin in this game. What’s your take?

Physician Adoption of Connected Health: The Multichannel Paradox

April 19, 2017

One of my advisors has a great perspective on healthcare delivery from the large system perspective.  He served as the chief of staff to our last CEO.  Recently, he posed an incisive question to me.  “Joe, when are we going to take all of these digital health concepts from the 30,000 foot level and get them into that 10 minute window that the doctor has with the patient?”  It is not hyperbole to say that this put the last 20+ years of my career in a whole different perspective.

I remember in the early 1990s, when it seemed we were just getting used to a new tool called voicemail.  Fax machines had become popular in the late 1980s, and we’d all had answering machines that tape recorded messages, but voicemail seemed like a brand new concept with the potential to be a very robust messaging channel.  It seemed like we were just getting used to voicemail when we got another new channel for communication–email.  All the talk in the executive suite was about how we were being inundated with multiple communications channels which, for a while, were overwhelming.

I can’t recall exactly when things changed, but I have to ask: when was the last time you got a meaningful fax?  How about voicemail?  My children chide me, saying nobody uses voicemail any more.  With caller ID, you can quickly decide if you wish to return the call.  Our communications channels have narrowed considerably in the past 20 years, to voice and asynchronous text-based messaging.

There is a parallel with the adoption of connected health into mainstream healthcare delivery.  I visited my own primary care physician the other day and at the end of the appointment had one or two follow up items, so he suggested we do our follow up by evisit.  The evisit is an asynchronous exchange of information for exactly this type of brief follow up encounter.  It is probably more efficient for the doctor and since we’ve already developed an internal payment structure and integrated the workflow into our electronic record, it all goes pretty seamlessly.  I would call this phase one of physician adoption of connected health.  That is, we’ve taken a task that previously required an in-person interaction and transferred it online, making it a bit more efficient for all parties.  Adding an evisit to follow our in-person appointment (which was more like 30 minutes, not 10) was natural and easy, because there was need for some sort of follow up anyway. A perfect example of moving from 30,000 feet to that doctor-patient window!

Phase two will be the integration of tools like remote monitoring of diabetes and blood pressure.  This is more tricky.  The front-end work of monitoring remotely-derived values is done by either a non-physician clinician or, in some cases, a software algorithm.  The doctor gets involved only when there is a complex medical judgment required.  When deployed at scale, this approach extends the doctor across many more patients due to the one-to-many nature of the intervention.

Taking the recent interaction with my PCP as an example, remote monitoring would be considered a whole new channel of work, which doesn’t easily fit in to his workflow like an evisit does.  It is hard to estimate its value, hard to predict how much impact it will have and hard to envision how to integrate it into clinical practice.

Will we see a future where physicians spend hours on end reviewing dashboards of population-level data from myriad of home monitoring devices?  If so, how will we reward them for time spent? How will they find the time to do this work? This is hard to imagine, given today’s crowded schedules and pressure to see more patients face-to-face.  It seems to me, this is analogous to the transition we went through from voice+fax+email+voicemail to voice+email.  There was no guide. It just naturally happened.

How can we smooth this transition?

One way will be to find ways to quantify the work involved in reviewing remote monitoring data sets and taking appropriate action based on high-level clinical judgment.  There is progress on this front and I’m pleased to be co-chairing a panel at the American Medical Association (AMA) that will look carefully at a number of alternative reimbursement models, including remote monitoring.  Of course this is only one component.  Workflow and EMR integration are the others.  A number of creative individuals both at our institution and across the country are working on these important factors.

Phase III is even farther out and includes things like the prescription of mobile apps. Another consortium that includes AMA, called Xcertia, will be attacking that one.  I am watching closely as this develops and hope for a successful launch.

What are your thoughts on taking connected health from 30,000 feet of the theoretical and land it in that well-defined and coveted care delivery window to achieve provider adoption?