What You Should Know:

• Today, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE).
• ·         The temporary rule will take effect on May 11, 2023, and extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023. For any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, the full set of telemedicine flexibilities regarding the prescription of controlled medications established during the COVID-19 PHE will be extended for one year – through November 11, 2024.

Background

On March 1, 2023, DEA, in concert with HHS, issued notices of proposed rulemakings (NPRM) to allow for prescribing of certain controlled medications via telemedicine without an in-person medical evaluation of the patient under circumstances that are consistent with public health, safety, and effective controls against diversion. The NPRMs received over 38,000 comments from the public and DEA, in collaboration with SAMHSA, is actively reviewing input in order to develop a permanent rule.

Though we seldom see their use in our modern world and, even then, only in fiction, there was a time when it was common for people to actually use things like crystal balls and divining rods to try to uncover unknown yet valuable information. As unbelievable as it may seem, soothsayers peered into crystal balls aiming to help seekers look into the future for guidance, while prospectors would rely earnestly on divining rods as they attempted to locate underground riches of water or oil.

While we may still entertain such images in some of the literature, TV, and movie fantasies we enjoy, in our modern professional world, we tend to entrust industry predictions to those with real, practical knowledge of the business landscape, because they trek, mine, and drill there regularly.

The world of medtech is no different, and for me and my team, connected care is the ground we travel, excavate, and explore on a daily basis. As we venture further into 2023, here’s our perspective on some of the connected care trends we expect to see on the road ahead, from digital therapeutics to remote patient monitoring and clinical trial management.

Precision engagement is an emerging development within digital therapeutics

One of the fast-growing categories within medicine today is digital therapeutics (DTx), which is the delivery of evidence-based treatment through digital solutions that help prevent, manage, or treat a disorder or disease. One recent report valued the global DTx market at $4.2 billion in 2021 and predicted it would expand at a compound annual growth rate of 26.1% between 2022 and 2030, with other estimates projecting even faster growth.

Within DTx, the emergence of precision engagement is a development that holds great promise, especially for chronic conditions where day-to-day choices and behaviors have a significant impact on health outcomes—conditions like diabetes, obesity, and hypertension.

While remote patient monitoring is clearly important for giving care teams visibility into the management of a patient’s condition in order to facilitate vital provider interventions, those living with chronic conditions requiring day-to-day management must also make dozens of additional decisions every day. But initiating provider interventions for all of these would simply not be possible nor even desirable. With diabetes, for example, these can range from food and exercise choices to the need to take medications or interact with a medical device, like a glucose monitor or an insulin pen or pump.

Enter precision engagement. Just as precision medicine can utilize a patient’s genetics or metabolic profile to uniquely fine-tune the dosing of a drug to an individual, precision engagement—with the help of AI and machine learning—can be used by digital health developers and physicians to program connected care platforms to issue electronic interventions or “nudges” that are uniquely tailored and helpful to the individual patient.

These digital nudges prompt a patient to take necessary actions throughout the day that are not only personalized to their needs but delivered in a way that is consistent with their lifestyle and preferences, leading to a better likelihood of engaging the patient and, ultimately, guiding them to better health outcomes. These digital interventions are known in behavioral medicine as just-in-time adaptive interventions or JITAI, and they are helping healthcare professionals use software to precisely engage the right patients with the right interventions at the right time.

With precision engagement, these solutions programmed into connected care platforms are able to digitally “learn” about an individual patient’s preferences from their responses to questions and from the daily decisions they make in their self-management as they engage with the platform’s corresponding app. This learning enables the software to personalize future digital nudges for the patient.

Precision engagement software might be used, then, to help identify the right moment of the day to generate a nudge, like suggesting the patient eat an apple or take a walk at a specific time of day because that’s when the individual is most receptive to such a suggestion.

Or, a digital nudge might involve time- or activity-triggered reminders, such as the need to take medication or to sync the patient’s medical device to the connected-care platform. It might even send the patient an encouraging message prompted by their reaching of a daily target, such as meeting a specific exercise goal.

Precision engagement can even tailor the type of communication used for nudges, from the use of a pop-up message or the suggestion of a video or article to the kind of voice used—maybe through empathy or even humor—to deliver the nudge. 

Precision engagement is one of the most exciting new developments within digital therapeutics, using digital health tools to deliver highly personalized, time-adaptive interventions in ways that lead to positive behavior change, extraordinary patient experiences, and improved health outcomes.

The need for greater RPM awareness is resulting in a measured pace of adoption

While necessity may have forced the issue for care teams during the pandemic regarding the adoption of telemedicine appointments, it turns out that remote patient monitoring (RPM) is still “one component of telehealth that has lagged,” according to the Medical Group Management Association (MGMA). In a Stat poll of 586 healthcare leaders taken by MGMA last year, the association found that 75% of medical practices had yet to offer RPM services.

Despite patients’ positive perspectives of RPM, demonstrated outcomes, payor recognition of RPM’s value, and the establishment of reimbursement mechanisms, the actual pace of RPM adoption has turned out to be more deliberate than these factors had originally led many to predict. In fact, in our work, we’ve found that a large part of preparing providers to make the actual leap to RPM adoption has really been a challenge of growing awareness.

For one thing, we’ve found that in the busy world of providing clinical care, some providers simply haven’t gotten a complete understanding of what RPM reimbursement looks like. So, we continue to chip away at the task of making sure our provider partners have the latest information.

And while some may have caught wind of RPM reimbursement, we’re coming across other providers who have the misconception that only Medicare reimburses for RPM. In reality, there are dozens of private payors covering RPM, with some reimbursing at even higher levels than Medicare. 

Another misconception we encounter among some providers is the mistaken belief that, to get reimbursement for RPM, they must implement every piece of it all at once, from getting patients set up and syncing their data to analyzing the data and providing patient consults. Not only is that not true, but the idea of such a weighty burden is partly why CMS has assigned unique CPT codes for discrete RPM activities. For many providers, implementing RPM is such a significant change management challenge that it actually makes the most sense for them to start small, which they can do by getting patients set up and focusing them on simply sharing their data remotely on a monthly basis. With that, providers can begin submitting for reimbursement, then build from there.

One of the most useful steps for providers unsure of where to begin is to find a reliable partner who specializes in RPM planning and implementation. Resources like AMA’s recently published 12-step RPM Playbook can help, as it covers every stage of establishing a fully operational RPM program.

Pandemic-induced use of decentralized clinical trials provided an up-close view of their efficiencies and is leading to increased adoption

Decentralized clinical trials (DCTs) are trials in which some or all study assessments are conducted at locations other than the investigator site via either tele-visits, mobile or local healthcare providers, local labs and imaging centers, home-delivered investigational products and/or mobile technologies. During the pandemic, when thousands of non-COVID trials—some 80%—were interrupted, virtual trial companies experienced an explosion in demand.

And if market projections are any indicator, demand for DCTs will continue to increase, with an analysis issued earlier this year projecting the global DCT market will grow from $6.1 billion in 2020 to nearly $16.3 billion in 2027.

While the need for social distancing that precipitated the sharp uptick in DCT demand may have subsided from its peak during the pandemic, it’s clear that continued demand for DCTs will be driven primarily by the efficiencies of the model that researchers witnessed first-hand during the pandemic.

One of the biggest advantages of DCTs is how they boost trial enrollment, as they often allow for patients to sign up and participate from home via remote monitoring. Remote participation opens trials and the benefits they provide to those living outside urban centers, which means the trend toward DCTs is also broadening the number and diversity of eligible enrollees.

DCTs can also reduce patient dropout rates and speed up study timelines, two of biggest challenges in life sciences R&D. And they help researchers realize significant cost savings from decreases in the number of physical trial sites and reductions in research staff and travel.

Driven by this wide range of efficiencies benefiting subjects, researchers, and study sponsors, it’s expected the demand for DCTs will continue to ramp this year and in the future.

Overall, we expect 2023 to be a year where our prospecting and development efforts in the connected care landscape will continue producing exciting advancements that will enable us to better support patients living with chronic conditions as well as the physicians and teams who care for them.

About Russ Johannesson

Russ Johannesson is Chief Executive Officer at Glooko, a leading provider of connected care, patient engagement, digital therapeutics, and clinical trial optimization. Deployed in over 30 countries and 8,000 clinical locations, Glooko’s mission is to improve the lives of people with chronic conditions by connecting them with their caregivers and equipping both with digital health technology for improved outcomes.

Hint & Eden Partner to Expand Virtual Direct Primary Care Offering Nationwide

What You Should Know:

• Hint Health, the company powering the Direct Primary Care (DPC) movement, and Eden Health, a leading national virtual and in-person primary care provider, today announced a partnership to expand the Hint Connect footprint with a virtual DPC offering across all 50 states.
• This partnership allows employers to offer a DPC network nationwide for patients who don’t have convenient access to a DPC practice in their communities.

Innovation in Healthcare Via In-Person and Virtual Direct Primary Care Plans

According to a poll, less than half of Americans are satisfied with the quality of U.S. healthcare. Long wait times to see a doctor, short appointments, and lack of coordination between care settings leave patients feeling like no one cares about them or their health. Furthermore, healthcare costs continue to rise despite a worsening patient experience. 

The benefits of Direct Primary Care include:  

1. Access: DPC physicians typically offer same-day or next-day appointments and use technology like telemedicine, e-mail, and text messaging to make themselves more accessible to their patients on demand.
2. Quality: DPC providers are able to spend more time with their patients. Standard primary care providers only have an average of 17 minutes to spend on each patient; with DPC, providers  spend up to an hour with patients to uncover the root cause of complex health issues and offer holistic care.
3. Cost: DPC is proven to sharply decrease costs and utilization in higher cost of care settings, including emergency department, hospital inpatient, and outpatient specialty costs. With DPC, patients pay one transparent, monthly fee and know exactly what is covered. They are able to visit the doctor when needed, instead of waiting until healthcare concerns get worse. 

Hint Connect is a nationally scaled network of Direct Primary Care practices that excels at building trusted clinical relationships locally. When employers or plans offer Hint Connect, members can choose between a fully virtual primary care model or an in-person/virtual hybrid based on their personal preference, geography, and health needs. When members select the in-person/virtual hybrid model, they and their families register with Hint Connect and choose a nearby DPC location. There is no copay or coinsurance for visits. 

When members choose the fully virtual primary care experience with Eden Health, they will be able to  connect with their provider within minutes and at the touch of a button, 24/7/365. Unlike many other telehealth  solutions, patients meet with the same clinician throughout their care journey, allowing them to develop a trusting, longitudinal relationship with their provider. All clinicians are fully-employed by Eden Health and are dedicated to serving their patient panel virtually. Patients receiving virtual care through Eden Health have access to primary care, urgent care, chronic disease management, wellness and care coordination services, all through a single app and free of cost. 

“Eden Health clinicians are more than just someone picking up extra hours after their full-time shift ends,” said Hint Health CEO, Zak Holdsworth. “Eden’s pioneering work to champion a true virtual Direct Primary Care model will allow us to further achieve our mission of making DPC the new standard in U.S. healthcare.”

This partnership means that employers and plans will no longer have to make the tough decision between local options and virtual-only options. Instead, employees will have the opportunity to choose the plan that’s right for them to receive the highest quality, full access, primary care for one flat membership fee built into their health plan. Hint Connect simplifies enrollment and eligibility management, billing, and invoicing for a seamless benefit management experience. 

Together, Hint and Eden offer a uniquely comprehensive solution for organizations looking to solve the national problem of healthcare access and quality.

What You Should Know:

• Patient violence is a top safety concern for healthcare workers, according to recent Motorola Healthcare Worker Safety report.
• Overall, the data shows that healthcare workers feel safe in their respective medical environments, but are grappling with safety issues that have dominated headlines in recent years. Those that have healthcare professionals most concerned include: patients becoming violent (72%), the impacts of burnout/mental health (61%) and active assailants (42%). Healthcare employees also provided insights on their preferred communication methods for when safety issues do arise in facilities or in patients’ homes.

Improving Safety for Healthcare Workers By Understanding Top Concerns

In the aftermath of the COVID-19 pandemic, today’s healthcare professionals are grappling with  safety issues including patient violence, job burnout and active assailants, all while trying to figure out how new home healthcare dynamics may affect their level of personal safety.

To better understand healthcare worker concerns, Motorola Solutions conducted the Healthcare Worker Safety Survey. The study, which was fielded between December 2022-January 2023, features responses from 500 respondents working in the healthcare field, including doctors, nurses, technicians and administrators across the United States. Questions center around issues such as personal safety, mental health, the impact of staffing shortages, home healthcare and workers’ preferred communication methods when emergencies arise.

While the report did find that most healthcare workers generally feel safe going to work each day, personal safety remains a top-of-mind concern for many workers across the country. The key findings from the report are as follows:

1. Patient violence is the top safety concern for healthcare workers: Almost half of all respondents (46%) say that a violent incident has occurred in their hospital/healthcare system over the past year. Some of the biggest safety concerns healthcare workers have include patient(s) becoming violent (72%), the impacts of burnout/mental health (61%) and active assailants (42%).  
2. Personal safety is a top priority for healthcare workers and factors into whether they continue working in the industry: When asked about their top employment priorities during a job search, 26% of respondents said that workplace safety is among their highest priorities. More than half (54%) of healthcare workers noted that they would be at least somewhat likely to quit if a violent incident unfolded in their workplace. Persistent staff attrition and shortages create a vicious cycle that can ultimately cause more staff safety concerns. 
3. Mental health is not getting better—it’s getting worse and compounding safety concerns: Over half of respondents (56%) said that their/their colleagues’ mental health is generally worse now than during the height of the COVID-19 pandemic, with nurses responding that mental health is extremely worse now (24%). 
4. Home healthcare services are throwing a wrench into safety plans: Several years before the pandemic, a healthcare paradigm shift had already begun. Healthcare providers began to utilize technology and expanded care teams so that treatment could be administered outside of the traditional healthcare setting. During COVID, at-home healthcare services and the number of agencies providing treatment in the home or via telemedicine appointments became more commonplace. And today, patients are increasingly choosing to recover or receive care at home. This shift, however, has created additional personal safety vulnerabilities for caregivers entering the home. Nearly half (47%) of respondents to this survey were unsure if their hospital/healthcare system had different safety protocols for at-home care delivery vs. in a traditional hospital setting.
5. Healthcare employees believe the right safety communications and training will help them feel more prepared for workplace safety scenarios: Specifically, respondents shared that they would feel more prepared if their workplace utilized panic button technology or another 9-1-1 alerting system (55%); conducted safety procedure training (51%); used customized text and/or phone alerts (48%); made safety plans digital and easy to access for all staff (46%); and offered a safety app with resources, plans, and emergency contacts (44%).

Providing patients with a positive health outcome is always the priority for their healthcare provider. The journey to accomplishing this goal can often be an uphill challenge with many variables at play. Providers are tasked with not only delivering a positive health outcome but also with the patient experience and level of satisfaction as they make their way through their healthcare journey. Since the Covid-19 pandemic and the emergence of virtual healthcare, the healthcare industry has witnessed dramatic changes in care delivery and the patient experience.

The pandemic brought forth several issues in healthcare provisions and treatments, including staffing shortages, poor delivery of services, and disparities between the health needs of the population and the competencies of health professionals. The National Institutes of Health (NIH) reports that these challenges have halted or reduced treatments for illnesses like cardiovascular emergencies, hypertension, diabetes, and diabetes-related complications. To correct these inefficiencies – and to ensure positive patient experiences and continued satisfaction – the healthcare industry had to embrace change and implement new strategies.

Understanding the perception of virtual health care

In a survey conducted by the Cleveland Clinic, results showed patients found virtual health care to be just as impactful as in-person visits. These positive responses from patients are essential to recognize, as the survey, in its fourth iteration by the J.D. Power group, shows that telehealth usage is up nearly 30% now compared to when the study was conducted in 2019. 

Several other studies have shown optimistic statistics related to virtual health care: Perhaps the most important to acknowledge are the ones in which nearly 98% of respondents reported being satisfied with telehealth experiences and 91% satisfied with video consultations. To take that a step further, about 88% agreed that virtual consultations were more convenient than in-person visits, and more than 85% believe telemedicine has the same reliability as in-person visits. These studies all support that trust in doctors ultimately correlated with higher patient satisfaction in remote visits.

These findings are also the key to understanding the patient experience and satisfaction when evaluating virtual care. It’s also apparent when looking at how it has impacted no-show rates. According to an NIH report, the rate of missed in-office appointments is more than 35%, significantly higher than the 7.5% rate of telehealth no-show rates. Convenience seems to have a heavy impact on patients here. And when there is a reduction in missed appointments, it creates better efficiency for providers.

In a 2022 McKinsey and Company survey, respondents reported that telehealth appointments were more convenient and were much more satisfied with their care than in-person care. They also showed interest in broader digital healthcare solutions. The same survey, conducted in 2022, showed that nearly 80% of doctors already offer telehealth and in-person visits. 

Enhancing the patient experience through virtual options

Virtual care options can enhance the patient experience and satisfaction through many different avenues of care. Patients and consumers are similar in a few ways. Both expect products and services to be easy to access and obtain through any device – in a timely and convenient way. When providers can offer patients around-the-clock access to virtual care through a best-in-class platform developed with them in mind, patients are placed on the road to positive health outcomes with benefits that heighten their healthcare experience and journey.

In the 21^st century, with how connected we are, people often take to the internet as soon as they do not feel well to try to understand what their symptoms could mean. Still, while they might get hundreds of immediate “answers,” that doesn’t mean they are receiving the correct ones. Patients should instead have access to a trusted provider who can give them 24/7 consistency with the most accurate and personalized attention. Digital health solutions do this in a way that provides patients with relevant, digestible, reliable information. This gives them the confidence to access their care when they need it long-term, which will bolster their engagement. These kinds of results and level of attention to care will not come with random internet searches. 

Patient data can be accessed across both realms with frictionless movement between the physical and digital worlds within a digital platform. This gives providers instant access to essential patient data, improving their accessibility to review medical history, identify patterns and make informed recommendations. This ensures providers deliver top-notch quality care by more accurately diagnosing illnesses and lessening patient risk levels. With access to all this data and insights, structural complexities are removed, workflows are simplified, and the entire experience is streamlined. The result? The improved overall health and well-being of any patient.

All-encompassing solutions for the long-term

Utilizing digital health platforms to streamline information and processes for providers eliminates mundane administrative tasks that otherwise take hours of interpreting manual data. It frees up providers to dedicate more time to their patients. Virtual healthcare platforms can also reduce patient and provider costs, provide positive health outcomes and ensure higher patient satisfaction. 

There’s no doubt: Virtual care is a means to provide patients with affordability, convenience, and 24/7 access to medical professionals. Enabling this access to patients doesn’t just enhance each encounter; it allows them to have a more significant role in their healthcare journey. Virtual care optimizes the patient experience and satisfaction, which will bolster increased satisfaction now and in the long term.

About Keith Algozzine

Keith Algozzine is the co-founder and CEO of UCM Digital Health. A board-certified Physician Assistant, he was formerly the Chief PA of Emergency Medicine for St. Mary’s Hospital in Troy, NY, where he witnessed firsthand the challenges of the modern healthcare system. Keith was also part of the national ER startup management team for Pegasus Emergency Medicine. He represents UCM Digital Health on the American Telemedicine Association Accreditation Advisory Board and serves as an advisor to the Clinical Practice Guidelines Committees dealing with telemedicine considerations for urgent and emergency care.

Hospitals are increasingly motivated to drive digital transformation in order to improve patient outcomes, reduce costs, meet regulatory requirements and stay competitive. Additionally, digital transformation can support medical research and drive innovation in healthcare, as well as generate new revenue streams. An increasingly important tool as hospitals undergo these transformations is federated learning, a technology that we will expand on later. Federated learning is a machine learning approach that enables the collaboration and sharing of data between multiple institutions while preserving patient privacy and security.

Going back to the general topic of digital transformation of hospitals, we have seen several trends, some of which have been long-standing and some less so:

1. Adopting electronic health records (EHRs) has already been encouraged by the Health Information Technology for Economic and Clinical Health (HITECH) Act’s ‘Meaningful Use’ clause, and EHRs have been used over the last decade to improve communication and coordination among healthcare providers. Additionally, digitized health records have been used to make patient information more easily accessible, first to meet Health Insurance Portability and Accountability Act (HIPAA) and HITECH mandates, and now, increasingly, to meet the 21st Century Cures Act ‘Final Rule’ mandate, requiring timely and standardized access to all patient data.
2. Implementing telemedicine and remote patient monitoring have grown in popularity for years now, and were especially accelerated during the COVID-19 pandemic, in order to increase access to care and reduce the need for in-person visits. They were also enabled by regulatory changes that allowed cross-state patient care and other ways to relax the burden on provider organizations and patients alike.
3. Data analytics and population health management tools are often layered on top of the medical records in order to identify high-risk patients and improve care coordination, as well as adopt value-based care models that focus on outcomes and cost-effectiveness (such as the MACRA-MIPS reforms, encouraging the formation of ‘Accountable Care Organizations’).
4. Increasing the use of technology such as AI and ‘Robotic Automation’ to improve administrative efficiency, diagnostic accuracy and treatment planning. This is the newest trend, reaching broad adoption over the last 2 years (or so), and we will later focus on that as a driving force and component of digital transformation.

As one could assume, the implementation of hospital digital transformation creates significant demands on data availability and interoperability. These demands include:

1. Data Availability: Hospitals need to have access to complete, accurate, and up-to-date patient data in order to provide effective care. This includes both structured data (such as lab results and medications) and unstructured data (such as notes from doctors and nurses).
2. Data Interoperability: Hospitals need to be able to share data with other healthcare providers and organizations in order to coordinate care and avoid duplicate tests and treatments. This requires the use of common data standards and protocols, as well as the ability to securely exchange data across different systems.
3. Data Security: Hospitals need to protect patient data from unauthorized access, use, and disclosure. This requires the use of robust security measures such as encryption, multi-factor authentication, and regular security audits.
4. Data Governance: Hospitals need to have effective policies, procedures, and systems in place to manage and control access to patient data. This includes managing data access controls and permissions, monitoring data usage, and implementing data quality and integrity checks.
5. Data Analytics: Hospitals need to be able to analyze patient data in order to identify trends, patterns, and insights that can inform care decisions and improve patient outcomes. This requires the use of advanced computational and analytics tools and techniques, as well as the ability to integrate data from multiple sources.

These demands are increasingly being met with additional technological innovations entering the conservative hospital world. Despite advances in data interoperability, such as the adoption of FHIR APIs and increasing leverage of Common Data Models (CDMs), the hospital IT world is still highly fragmented, and even the advent of Cloud Compute has not drastically reduced that fragmentation. Moreover, in order to meet these increasing needs, hospital IT must now implement a record number of new technologies in a short period of time, and despite a fairly consolidated EHR market, the rapid cycles of innovation and massive capital investments pouring into the Healthcare IT market have resulted in more vendors than ever before.

How could Federated Learning assist in clinical transformation?

First of all, let’s define federated learning. Federated learning is a powerful machine learning technique that allows for the training of machine learning ‘models’ on multiple disparate datasets. That means that data does not need to be shared/centralized in order to leverage it for creating powerful analytics and algorithms. Thus, federated learning could assist in clinical transformation by allowing hospitals to collaborate and share data in a secure and privacy-preserving way. If provided alongside a comprehensive platform that supports integrating with different infrastructures found in different hospitals, federated learning can assist in, alleviating many risks around data sharing such as compliance risks (e.g., HIPAA, GDPR regulations), data privacy risks (ie, that extend beyond the regulations), reputational risks (e.g., in the case of ‘data leaks’ and malicious use of data by a 3rd party) and financial risks (e.g., the investments required to setup massive repositories and leverage centralized ‘data lakes’). Some specific ways it could be used include:

1. Eliminating the need to create multiple ‘data flows’ to the cloud, and keep all data under the ‘sovereignty’ of the hospital at all times.
2. Reduce the need to integrate multiple technologies one-at-a-time, by having a standard communication method to connect (often) multiple internal ‘data silos’ with external data consumers.
3. Facilitating foundational and clinical research by allowing hospitals to share data insights for research purposes, without driving an ever-growing amount of labor-intensive efforts (e.g., anonymizing, certifying, contracting and governing). This in turn drives translation of ‘better baked’ medical AI models into the clinical workflow, as well as better commercialization of inventions that have been afforded with external data validation (ie, the model works elsewhere) and market validation (users wish to use the model elsewhere).
4. Capture value by increasing the value of data, and enabling hospitals to tap into new revenue streams such as the ones from drug development. Federated learning allows pharmaceutical companies to access sought-after ‘multi-modal’ data from multiple hospitals in order to identify potential drug candidates and evaluate drug safety and efficacy. In addition, this enables hospitals that implement new technologies to ‘leapfrog’ many traditional players that already capture value from such efforts, and ‘take out the middleman’ in the form of data intermediaries that erode the hospital’s value.
5. Enhancing disease surveillance by sharing data insights across multiple jurisdictions to track the spread of diseases in real-time, identify outbreaks quickly and plan interventions accordingly.

A specific area that is mentioned above and is dear to my heart, is supporting the translation of algorithms created by researchers in hospitals. Federated learning supports this, often grueling and difficult, process by reducing the barriers for researchers and clinicians who would like to collaborate, and thus enabling what could often remain as a good publication, turn into a product used to improve patient care, and let hospitals once again take the lead on innovation. The sad reality today is that without being able to translate ‘homegrown’ models into clinical impact, the ability to capture value is reduced, and few models have been licensed to date. Ultimately, I believe ‘Medical AI’ will follow pathology in providing ‘lab developed tests’ as diagnostics. Lab-developed tests (LDT) are tests that are developed, performed and analyzed in-house by a laboratory. One of the key things keeping medical AI behind, is the need for much bigger datasets and need for much broader diversity in order to create and validate a performant model. These needs are not supported by the current paradigm of single-site research and ‘once in a blue moon’ massive collaborations (that usually use redacted data or small amounts of patient data). Federated learning can fix this.

Alongside the many promises, it is important to note that Federated Learning is a complex technology, it requires a well-designed infrastructure and a platform that supports a complex workflow, strong data governance and robust security protocols, a vendor that can take on liability and proper certifications in order to be implemented. FL also requires hospitals and researchers to work closely together to ensure that data is shared in a way that is both secure and compliant with regulations. I am a staunch believer in this approach, and believe that it will lead to (finally) the actual ‘democratization’ of healthcare data and innovation, drive adoption of responsible AI and ultimately lead to improved outcomes for patients and cost savings for the entire industry.

About Ittai Dayan, MD 
Ittai Dayan is the co-founder and CEO of Rhino Health. His background is in developing artificial intelligence and diagnostics, as well as clinical medicine and research. He is a former core member of BCG’s healthcare practice and hospital executive. He is currently focused on contributing to the development of safe, equitable and impactful Artificial Intelligence in healthcare and life sciences industry. At Rhino Health, they are using distributed compute and Federated Learning as a means for maintaining patient privacy and fostering collaboration across the fragmented healthcare landscape.

What You Should Know:

• 2023 started off with the hallmarks of a rebound year. While Q4 2022 signaled the tail end of the digital health funding cycle, January and February funding numbers began to suggest that sector investment was slowly but surely inching back upwards. Inflation was easing ever so slightly. Investors were rediscovering their confidence and launching new projects, signaling optimism in the sector, according to a new Rock Health report.
• However, recent news—the collapse of Silicon Valley Bank, the seizure of Signature Bank, Moody’s downgrading of bank credit ratings, and another Fed rate hike—was a stark reminder that the choppy waters of 2022 aren’t over yet. 

Key Trends and Insights from Q1 2023 – Digital Health Funding

There’s no denying that Q1 2023’s economic conditions, bank scares, and regulatory changes have digital health startups of all sizes nervous, whether they’re trying to raise their next funding round or waiting for the right time to exit.

The following key trends from Rock Health’s report are a review of the venture, banking, and policy waves breaking within digital health, coupled with insights regarding the volatility of the modern-day regulatory landscape, how the financial market seems different for everyone, and how small-scale startups have it the hardest.

Q1 Funding Soars, But 2023 May Struggle to Catch Up to 2019

Q1 2023 U.S. digital health funding closed with $3.4B across 132 deals, with an average deal size of $25.9M. While this quarter exceeded both Q4 2022’s $2.7B and Q3 2022’s $2.2B funding pots, Q1 isn’t enough to signal a new “bull run.” If funding for the next three quarters matches the average funding across the prior three quarters, 2023 is on pace for the lowest level of annual funding since 2019. The truth remains that the founder-friendly market of 2021 and early 2022 has tilted sharply toward investors.

Notably, within its $3.4B raised, Q1 2023 saw heavy representation of mega deals. After only six digital health raises over $100M across Q3 and Q4 2022 combined, Q1 2023 logged six megadeals from Monogram Health ($375M), ShiftKey ($300M), Paradigm ($203M), ShiftMed ($200M), Gravie ($179M) and Vytalize Health ($100M)—accounting for 40% of the quarter’s total digital health funding.

Silicon Valley Bank’s Collapse

SVB’s collapse nearly precipitated a liquidity crisis in the sector, and concerns circulated that startups might need to engage in distressed debt buys or raise emergency bridges—possibly with “lender-friendly” terms or at slashed valuations—in order to secure working capital. It’s worth pointing out that not all digital health startups carried the risk burden equally. Startups with well-established investors were more likely to have the assurances of cash floats and level-headed perspectives from advisors who have been around the block a few times, while those with greener syndicates were left unsure of whether their own funders could even weather the storm.

After seeing their investors operate in crisis mode this March, several digital health founders may feel compelled to re-evaluate their cap tables and possibly move forward with different investors for future raises. Startups were left with another conundrum after SVB’s collapse—which banking institution to choose next. SVB was known to offer startups loans during high-growth periods and took on companies that were too early to demonstrate product-market fit. While late-stage startups likely have the capital and credit requirements to bank with high-street institutions, nascent teams or those based outside of the US will need to turn to more restrictive and expensive alternatives to establish financial operations and secure loans.

The IPO Market and Q1

Q1 2023 logged another quarter with zero digital health IPOs. Digital health stocks started 2023 trading almost 50% lower than they did at the start of 2021, pushing some recently-exited players like Pear Therapeutics to explore going private. No later-stage digital health players felt compelled to venture into IPO territory this quarter, fearing that the market would yield bottom-barrel issue prices.

In December 2022, healthcare data startup Komodo Health raised $200M alongside a restructuring plan that laid off 9% of its workforce. In January, hybrid care provider Carbon Health closed a $100M Series D while also trimming its RPM and chronic care divisions and completing its second round of layoffs.1 That same month, nurse staffing solution Shiftkey announced its $300M raise, accompanied by a quartet of new executives. Connected fitness startup Tonal is rumored to be pursuing private funding at a $200M-$300M valuation, a nearly 90% decline from the $1.9B valuation it floated back in September 2022.

Regulatory Developments and Adapting Digital Health Startups

If circumstances weren’t treacherous enough, digital health startups are bracing for impending regulatory changes. In Q1 2023, an acronym soup of federal agencies (FDA, CMS, DEA, FTC) announced preliminary steps and timelines for refining policies across digital health. These revised guidelines have far-reaching impacts, affecting telehealth reimbursement, controlled substance distribution, healthcare service pricing and rebates, and patient data management. Top of mind is the announcement to end the COVID-19 public health emergency (PHE), which is slated to expire on May 11, 2023.

In the realm of telehealth delivery—perhaps the biggest area of healthcare expansion during the pandemic—telemedicine will officially lose its status as an excepted benefit2 and certain federal penalties for HIPAA non-compliance of telehealth platforms will be reinstated. In alignment with PHE’s conclusion, other government bodies are rolling back pandemic-era measures. State agencies are beginning to unwind expanded Medicaid coverage in conjunction with the expiration of a 2020 federal provision requiring continuous enrollment.

States resume disenrollments, anywhere from 5 to 14 million Americans stand to lose Medicaid coverage and associated benefits, with the hardest-hit populations being low-income youth and working individuals without employer-sponsored plan access. In terms of data privacy and security, Congress introduced the Upholding Protections for Health and Online Location Data (UPHOLD) Privacy Act to regulate companies’ use of health data, the FTC settled investigations into BetterHelp and GoodRx with hefty fines, and the FDA enhanced cybersecurity requirements in regulatory applications for medical devices. Finally, on the billing and coding front, CMS issued its 2024 Medicare Advantage Advance Notice to root out aggressive upcoding practices.

The adoption of virtual health has increased dramatically since March 2020, with 150 million telehealth claims in less than two years. Like other revolutionary innovations throughout history, healthcare innovation is necessitated by time — and unmet needs. So many struggled to create virtual care solutions during the pandemic, and many technology companies jumped into the telehealth space because of the unmet needs of patients. But the pandemic era is soon coming to an end, leaving telehealth to settle into a new normal.

The healthcare industry is changing rapidly. Because numerous moving parts and innovations are at the heart of this transition, the journey hasn’t been entirely linear. The industry has matured; at this stage, the future of virtual care needs less noise and more customer-focused technology to deliver much-needed care.

The telehealth space is witnessing consolidation, acquisitions, and partnerships, enabling a smoother landscape for hybrid care. However, once the public health emergency (known as PHE) funds end, waivers will go away, and many patients will be left without care unless more action is taken in telehealth.

So, What Comes Next?

The new model of care going forward (reimbursements or not) is destined to be a hybrid approach. In some ways, hybrid healthcare could be labeled the “future of telehealth.” A combination of both in-person and virtual appointments, hybrid programs allow providers to care for more patients in myriad ways. A hybrid healthcare system has many benefits. One is the ability to bring in virtual specialists to improve the quality of diagnosis without wasting time or travel.

The hybrid experience allows a primary care doctor to consult with specialists a thousand miles away and provide in-person, cross-care to local patients. As the U.S. continues to move away from fee-for-service models to value-based care, hybrid healthcare will be critical to managing costs and patient loads. Hybrid healthcare combines the best of both worlds: the convenience and accessibility of telehealth and the complete continuum of care for patients who need more care in person. The hybrid model puts the patient at the center of the experience, as it becomes more about convenience, cost, and access.

Hybrid healthcare also gives us better tools to treat patients with chronic illnesses. An estimated 157 million Americans live with chronic conditions, and about 75% of healthcare costs are spent on these patients. With the ability to check in via telehealth in between appointments, providers can see these patients more regularly, keeping them healthier and happier.

Because so many procedures and exams require in-person appointments, physical care delivery will always remain. Healthcare providers who don’t seek additional patient support beyond physical care will fail to accommodate the new normal they find themselves in. Hybrid healthcare is a modern opportunity to reach more patients, keep them engaged in their health, and improve clinical outcomes.

Here’s how your healthcare organization can provide quality hybrid healthcare in the year ahead:

Move to a value-based care model instead of fee-for-service

Value-based care (or VBC) is centered on delivering efficient care that is used wisely and accurately documented. VBC supporters claim that it lowers healthcare costs and improves patient health compared to fee-for-service care. The VBC model compensates medical professionals for their attention to the standard of care they deliver, as opposed to the number of patients seen; this incentivizes quality over quantity. Payment for VBC services is determined by how well these services work to keep patients healthy and avoid sickness.

VBC initiatives encourage better patient care, healthier communities, and long-term cost savings. Notably, they have become more noticeable since the Affordable Care Act shifted the emphasis from counting the care provided without accountability to measuring patient outcomes.

Lobby for reimbursement around telehealth once the PHE ends

Many of the waivers put in place to aid providers during the pandemic expire once the present public health emergency is over. The major exception is telehealth, which has an extra 151 days before losing flexibility and includes allowing patients to get virtual care from home. Medicare does not have distinct payment rates, and reimbursement depends on the facility.

Payment parity between in-person and telehealth appointments is a myth. Many times, for example, because of the way the virtual visit is “covered” or “reimbursed,” patients end up paying more out of pocket to make up for the lack of payment given to the provider. Be involved in your state legislature to ensure waivers are extended and that hybrid healthcare solution are included in new bills.

Continue using telehealth to increase efficiency and ROI

It will be necessary for modern healthcare providers to continuously engage the patient community via telehealth. The goal is to encourage usage and adoption to remain high as more data and clinical outcomes can be tracked and proven successful. Over time, continued research and investment in telehealth will create new innovative healthcare networks that can support patients even more.

As for ROI, workloads that waste time, money, and resources can be streamlined via telehealth, thereby increasing corporate efficiency. According to a 2021 poll by the COVID-19 Healthcare Coalition, almost 80% of telehealth patients were satisfied with their care and felt a sense of access and continuity of care. Happy, healthy patients are the lifeblood of any healthcare organization, and telehealth helps you further those goals. Additionally, those patients are more likely to consider other services or seek inpatient treatment at your facility. Even a 5% retention rate could boost ROI by 95%, according to Bain & Company.

Every industry goes through periods of technological transformation, and healthcare is coming to another pivotal moment: the end of a public health crisis that changed the landscape of the medical field entirely. As hybrid healthcare becomes the new normal in telemedicine, we are seeing health systems work towards streamlining fragmented technology solutions to a more enterprise digital strategy.

About Eric Bacon

Eric Bacon is the President at AMD Global Telemedicine, Inc. He has 20 years of experience designing new medical devices and telemedicine solutions that are deployed in more than 100 countries and used in millions of consults. During his time at AMD, Eric and his team have transformed and expanded the company from a provider of medical devices to a software development and technology company focused on effectuating change and impact across the healthcare industry.

What You Should Know:

– Vivante Health, a provider of digital digestive health solutions for employers and health plans, is expanding its GIThrive platform with enhanced technology that optimizes triage, telemedicine appointments with physicians in every state when needed, and more

– GIThrive’s virtual care model will now be powered by enhanced technology that facilitates triage, including access to all existing GIThrive features plus GI-related test ordering, prescriptions and telemedicine appointments with physicians in every state for members needing such support. 

– Users will now receive AI-driven, personalized care plans guided by an expert team of coordinated care providers including gastroenterologists, internal medicine specialists, dietitians and health coaches, helping increase the speed to diagnosis and treatment in an area where delays can have serious medical and cost consequences. 

GIThrive’s New Capabilities

GIThrive’s new capabilities extend its ability to help members improve their gut health as well as reduce unnecessary medical spend for both members and health plan sponsors. The platform now offers: 

• Individualized care plans that dynamically adjust to reflect updates to members’ symptoms, clinical findings and preferences 
• Accelerated identification of symptom triggers through enhanced data collection 
• Access to a nationwide network of internists and gastroenterologists for diagnosis, treatment, lab test orders and prescriptions
• Test ordering direct from the GIThrive interface when recommended in the member’s care plan
• Colorectal cancer screening kits shipped to eligible users without doctor interaction
• Triage to ensure that members with high acuity issues receive priority for virtual physician visits 
• Referral of members needing in-person care to in-network, brick-and-mortar settings 
• The ability to manage the member’s digestive health care holistically rather than fragmented across different care plans and providers

What You Should Know:

– Love.Life, a health and wellness company leading the convergence of food, medicine, and wellness therapies, is pleased to announce the acquisition of Plant Based TeleHealth Inc., a nationwide telemedicine service focused on the prevention and reversal of chronic disease utilizing lifestyle medicine. 

– The company has been rebranded as Love.Life Telehealth and will add to the robust suite of medical offerings that Love.Life will feature in its physical locations. 

– As part of the acquisition, co-founder and former CEO of Plant Based TeleHealth, Anthony Masiello, has joined the executive leadership team of Love.Life, which includes Mackey and multiple former Whole Foods Market leaders.

What You Should Know:

– Cosmos Health Inc., a global healthcare group with proprietary lines of nutraceuticals and distributor of pharmaceuticals, branded generics, OTC medications and medical devices, announced today that it has entered into a definitive agreement to acquire ZipDoctor Inc. from American International Holdings Corp (AMIH) for an undisclosed sum.

– ZipDoctor Inc., a wholly owned subsidiary of American International Holdings Corp. (AMIH), is a direct-to-consumer subscription-based telemedicine platform, that expects to provide its customers affordable, unlimited, 24/7 access to board certified physicians and licensed mental and behavioral health counsellors and therapists.

– ZipDoctor’s online telemedicine platform will be available to customers across the United States and shall offer English and Spanish coverage with virtual visits taking place either via the phone or through a secured video chat platform. ZipDoctor customers will be able to subscribe through their website at www.ZipDoctor.co and will be only required to pay a monthly fee, which is determined based on whether they are an individual, a couple, or a family.

What You Should Know:

– Clinical telemedicine company Beam Healthcare has landed a significant investment from Decathlon Capital Partners. Details of the revenue-based funding investment were not disclosed.

– Beam Healthcare plans to utilize the funding toward expanding into new geographic markets and continuing its investment into the development of enhanced patient care programs. Beam Healthcare provides telemedicine services across the country to healthcare organizations and employers of all sizes.

Gone are the days when healthcare information was only available to us at the doctor’s office or through the office’s online portals, and that’s in part due to the rapidly growing popularity of wearable technology devices. It’s estimated that 1 in 5 adults in the U.S. use a fitness or health tracker to monitor things such as heart rate, blood pressure, sleep cycle, and stress. But this information is being used beyond just monitoring specific conditions. Take me, for example; I personally use my wearable tech to track my glucose levels throughout the day. I’m not diabetic, but I do find this information useful when looking at how to modify my diet throughout the day to minimize the impact of glucose spikes.

For someone monitoring a health condition, such as diabetes or high blood pressure, these technologies offer additional peace of mind. Prediabetes, for instance, is plaguing the United States and affecting at least 33% of U.S. adults. Having early insight into abnormal blood sugar activity or body functioning can help individuals prevent health conditions from worsening. We continue to see news about young athletes experiencing complications from undiagnosed conditions and students generally facing increased anxiety due to the stresses of life. The ability to monitor heart rate and blood oxygen levels enables users to identify changes and abnormalities in their vitals, which can serve as an early warning of possible panic attacks or can help determine when a visit to the doctor is needed. 

This shift towards digitally-enabled care has driven consumers to become more engaged in their day-to-day health and has provided better access to care services and leading physicians, regardless of factors that have historically hindered care access, like geographical location or lacking availability and overstretched resources. With the rise in digital health services, we have a wide variety of data at the tip of our fingers – accessible from nearly anywhere on a smartphone or computer. While the benefits of this digital health revolution are undeniable, there are associated risks with tracking health data that digital health companies need to understand to protect themselves. That being said, there is no one-size fits all solution. Every company has unique challenges, concerns, and vulnerabilities and therefore requires a tailored approach to risk management. 

The Evolution of Digital Health-Tracking

Health tracking devices and their capabilities have significantly evolved since the original pedometers and heart monitor straps came to market. Today, health-tracking wearables span a wide range of applications and have become less niche and more commonly adopted. There’s a high demand for health and fitness monitoring devices, and the original models have been replaced by smart devices such as rings, watches, clothing, belts, shoes, and smart sensing technologies that have the capability of tracking blood oxygen saturation and notifying if irregular heart rhythms are detected; some are even capable of taking an ECG reading directly from your wrist and tracking ovulation cycles through temperature sensing. As the population ages globally, monitoring various chronic and acute diseases has become increasingly important, and the medical industry is changing rapidly in order to meet today’s point-of-care (POC) and real-time monitoring needs. 

Outside of the advantages of managing and understanding your own body better, these capabilities come with concerns and challenges regarding access and security of personal health data, as well as prescribing practices. Although users of wearable tech are able to be better in tune with their current health state, the validity of the data analysis and recommendations paired with individual readings are dependent on the digital health companies and healthcare professionals that are evaluating and providing these recommendations. Improper recommendations or guidance can lead to new risks of bodily harm or negligence to the user. 

Risks Associated with Wearables 

Companies need to understand the risks at hand. Data collected by fitness applications are not protected under the law like health information is, making it critical for users to fully understand how best to set up social and location settings, as well as login credentials. Cyber security risks are reportedly on the rise, with an uptick in data breach lawsuits, which are becoming increasingly more common within the healthcare space. The latest data security incident report showed increased duplicative lawsuits, often resulting in steep defense and settlement costs. If a company is dispensing medical advice, providing guidance or therapy, or prescribing or selling products, there are additional risks spanning from medical malpractice to bodily injury claims associated with these services that are often overlooked. 

Despite acknowledging cyber and regulatory concerns as the top risks, a survey of 300 digital health and wellness industry leaders indicated that 76% of those surveyed didn’t have a single insurance policy tailored to the risks they face, despite 99% of surveyors reporting plans to expand and 72% noting growth in demand. Insurance brokerages are able to assist in addressing risk management by gaining an understanding of a company’s inner workings in order to identify how best to protect them. When selecting a partner, it’s important to choose a company that specializes in these specific areas of risk to evaluate best how these risks can be transferred or mitigated. 

Understanding Exposures and Mitigating Risk 

Users of wearable technology rely on doctors and healthcare experts to provide recommendations. Similarly, digital health companies tracking this information and providing these recommendations rely on insurance experts to provide guidance when it comes to identifying and appropriately managing risks. Company leaders must fully understand vulnerabilities and exposures and how best to address them while protecting balance sheets. Cyber liability, errors and omissions, and medical malpractice liability are key exposures. When it comes to cyber insurance, most companies are often grossly underinsured. In my experience, it’s also common for companies to request the wrong information, especially in regard to complex issues such as limit adequacy (i.e., how much insurance is enough?). 

You can’t properly evaluate your own risk by comparing your risk program to others, so taking a benchmarking or comparative approach versus a ground-up analysis of risk often produces suboptimal results. It can be dangerous to rely too much on comparisons, preventing companies from having a holistic view of their individual needs. Just as consumers receive tailored recommendations for how many steps they should take in a day or how much water or calories they should be consuming before they end their day, insurance companies need a customized risk management checklist of sorts unique to their own needs, challenges, and future goals. Focusing internally on a ground-up analysis enables the focus to solely analyze your own risk assessment, avoiding the adoption of unnecessary solutions or lacking areas of coverage. 

Third-party contracts are critical for companies and can help protect balance sheets by working with an experienced team and providing the necessary data to inform proper decision-making. Reviewing contracts can be a difficult task for companies to outsource. Not all attorneys are specialized in insurance, and when it comes to insurance, it’s important to receive the appropriate recommendations for proper protection. Insurance brokerage experts can, in that instance, step in to provide thorough contract reviews focused on their insurance obligations. With the varying level of risk management needs vs. available solutions, partnering with a risk management expert can offer valuable insights and the knowledge necessary to identify solutions best suited to address specific needs.

Why Do Businesses Need a Customized Approach? 

There isn’t a solution that will adequately cover every business, which is why a customized approach is best. Every company is unique in its own individual needs, so it’s important to partner with a risk analyst who is hyper-focused on your specific areas of need. Within risk management, there are specialized teams equipped with actionable advice within their niche area of expertise. For digital health companies, selecting a partner with a dedicated Digital Health/Telemedicine Practice team would be an optimal fit to ensure their approach to risk management covers their vulnerabilities. 

In the instance of digital health and telemedicine companies, a successful partnership should demonstrate the ability to navigate complex organizational structures – often including professional corporations (PCs), physician owner(s), management services organizations (MSOs), and more operating in various states. Managed Care Errors & Omissions (E&O), coverage provided in the event of allegations of negligence in the administration of managed care contacts, is a prime example of insurance often overlooked since policies cover the services provided by MSOs to the PCs, and if exposure doesn’t fall under traditional Managed Care E&O, then a Miscellaneous Errors & Omissions Policy may need to be obtained. 

Helping clients navigate various state requirements is another factor supporting customization when it comes to risk management solutions. For instance, Pennsylvania has active Patient Compensation Funds (PCF) that include MCARE, a special state fund, which is an additional required filing. Kansas is another state with stringent requirements. Navigating varying regulations and license requirements is critical, and as companies grow rapidly, executives may be unaware that they’re not compliant with regulations. Having regular communication with an insurance broker can help avoid any missteps or growing pains relating to compliance. An experienced insurance broker can also assist with services such as claims advocacy, risk control, and quarterly or semi-annual stewardship reviews, which can inform necessary steps to avoid new exposures. 

Managing Risk in a Consumer-Centric Model 

Health technologies and wearables will continue to push the boundaries on what they can track and how they can improve day-to-day health habits and well-being, and the companies that are best protected have invested in solutions specifically designed to address these challenging areas. While health tracking and digital health companies continue to work to help users navigate data, provide services and products, and offer insights on how to improve, what to change, by how much, and by which methods, so too must the risk analyst ensure precautions and solutions are properly in place. As digital health tools and wearable health technology continues to evolve, risks associated with privacy, cyber security, bodily injury, regulations, and technology will continue to be top of mind. Looking to experts who can not only help assess and analyze current risks but also future risks that could be on the horizon will become the standard for meeting modern-day risk management needs. 

About Cristina Varner

Cristina Varner currently serves as Senior Vice President and National Life Science & Healthcare Practice Leader at Newfront, a modern insurance company transforming the delivery of risk management, employee experience, insurance, and retirement solutions. With 25 years of healthcare and life science industry experience, Cristina is one of the founding members of Newfront and has built practices serving 300+ companies, helping them grow and scale by solving issues around global expansion and new product launches. With expertise in product liability, professional liability and clinical trials insurance, Cristina is a recognized thought leader providing companies with a valuable understanding of how they can accelerate growth and avoid unnecessary risk.

In the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the side effects are tolerable for patients and how these treatments could be improved from the patient’s perspective. Marrying the scientific rigor of clinical research and the human experience captured by patient-reported outcomes (PROs) is essential to the successful development and evaluation of drugs and treatments. 

Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), now expect PROs to be included in study protocols, objectives and even labeling claims. These insights help regulators, payers and providers understand treatments through the eyes of the patient, including how symptoms and adverse events impact study medication adherence and quality of life across patient populations. 

However, stakeholders must bear in mind that oncology patients often have limited time and stamina for extensive surveys. Therefore, a patient-centric electronic clinical outcome assessment (eCOA) strategy will effectively capture the patient voice while minimizing patient burden. eCOAs provide patients with the flexibility to complete assessments on their own time from the comfort of their own homes, via a familiar device. This approach amplifies the patient voice across virtual and hybrid clinical trial models, equipping patients and researchers with a simple way to record and exchange data. 

The FDA has identified 5 core aspects of the patient experience to consider throughout the development of an eCOA:

1. Disease-related symptoms

When collecting patient responses surrounding the severity of common symptoms for oncology-related drugs, the FDA recommends using numeric or verbal (none, mild, moderate, severe) rating scales. If the assessment is intended to quantify occurrence, a frequency scale (never, rarely, daily, etc.) may also be considered. 

2. Symptomatic adverse events

To mitigate patient burden, sponsors should define a concise set of the most relevant symptomatic adverse events likely to occur and capture PRO data in both treatment and control arms. 

3. An overall side effect impact summary

To properly evaluate tolerability, regulators need to understand the overall impact of side effects on a patient’s life. For instance, extreme fatigue preventing a patient from leaving their home is a valuable insight to capture.  

4. Physical function

Regulators, payers and providers alike need the full picture when it comes to how treatment impacts patient mobility and other physical functions. The FDA recommends using a scale to measure levels of ability with clearly defined concepts. 

5. Role function

Perhaps one of the most critical aspects of the patient experience to collect is the overall impact of a treatment on a patient’s ability to work and carry on with daily activities. The European Organisation for Research and Treatment of Cancer QLQ-C30 role function scale is one of the most commonly used assessments to capture this data. 

While each of these categories enriches regulatory submissions, they must be carefully chosen with the patient burden in mind. In a perfect world, sponsors would create assessments that capture many or all of these insights in a single tool to make the most of each patient’s time. 

In addition to these valuable assessment components outlined by the FDA, there are also several overall best practices for a patient-centric eCOA strategy:

1. Think outside the clinic

The pandemic propelled the clinical research industry to dramatically accelerate its approach to decentralization. While many COVID-19 restrictions have since been lifted, sponsors have continued to leverage technology solutions such as eCOAs to support virtual and hybrid clinical trials. 

Whether a trial is conducted remotely or on-site, eCOA data collection eases both the patient and clinician burden. Patients can complete assessments electronically between visits or as part of a remote visit when they are too ill to travel to the site, while clinicians have the flexibility to use an eCOA to collect appropriate Clinician Reported Outcomes via telemedicine. The same eCOA technology can also be leveraged to capture Patient Reported Outcomes and Clinician Reported Outcomes during on-site visits. 

2. Establish a ‘bring your own device’ (BYOD) approach

Another positive outcome of the pandemic was the widespread adoption of the BYOD approach in the clinical research space. This method allows patients to access all trial communications and alerts on their own devices, eliminating the time and cost of securing devices for each patient and ultimately accelerating study startup. 

Research also indicates that patients are highly receptive to using their own personal devices for a clinical trial. Given that trial adherence depends on ease of use for participants, empowering patients to use devices that are familiar to them is a great way to maximize retention. 

3. Prioritize ease of use

Another excellent way to increase trial retention is to cater the solution design itself to patient needs. For example, sick patients suffering from disease symptoms and treatment effects may require breaks while completing their eCOA assessments. Sponsors can proactively address this challenge by creating assessment windows that afford patients ample time for completion. Additionally, the eCOA solution design can be designed to accommodate breaks during and in between assessments as appropriate. 

4. Integrate caregiver assistance options

For oncology patients especially, completing an assessment can quickly become too taxing for a variety of reasons, including disease progression, fatigue and treatment side effects. To alleviate this burden, sponsors can establish caregiver support options to assist the patient with inputting their data into the device. With some solutions, it is even possible to offer a caregiver log-in feature to ensure transparency, security and data attribution upon point of data entry.

5. Patients as research partners 

In recent years, the clinical research industry has experienced a seismic shift toward patient-centricity. Patients are now viewed as collaborative partners in the research process and in their own care journeys. When studies are designed to prioritize both scientific rigor and the patient voice, sponsors maximize retention, enhance the patient experience and ultimately set the stage for the development of breakthrough oncology treatments. 

About Melissa Mooney

Melissa Mooney has over 17 years of experience in the development of IVQIA eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance testing, eCOA data management, and BD support.

Telemedicine has helped improve the quality of life of patients in every corner of the world and has been successfully utilized to provide convenient care to people with limited or no access to health services. Today, worldwide digital interconnectivity is growing, enabling telehealth to advance health equity, bring access to care for underserved regions and meet the urgent, primary and behavioral healthcare needs of an exploding global population.

It has been a remarkable journey for the innovators who pioneered telemedicine. Since its inception, digital health services began the transformation from traditional healthcare — a reactive, disease-focused model — to a proactive, holistic system that is now recognized as virtual care. This remarkable approach to care is digitally integrated, patient-centric and focused on personalized health and wellness. 

While market prognosticators forecast fluctuating adoption of telehealth, factoring into their predictions everything from COVID-19 issues and flu outbreaks to worldwide climate change, the impact of this change is palpable regardless of adoption rates. Telemedicine, telehealth and virtual care have essentially become the delivery tools of the future for personalized medicine that results in better health outcomes at lower cost. 

Birth of Telemedicine

The genesis of telemedicine can be traced back to Boston during the late 1960’s with the birth of a fully functioning telemedicine system operating between Mass General Hospital (MGH) and the Logan Airport Medical Station.

Architecting this futuristic configuration was Dr. Kenneth Bird, then Medical Director of the Emergency Department at MGH, his medical resident, Dr. Jay Sanders and Dr. John Knowles, general director of MGH. They garnered a lot of critics and naysayers, and while a team of pioneers pressed forward, it was Sanders who slogged through decades of resistance carrying the torch and becoming recognized as “The Father of Telemedicine.”

Validating the Model, Sparking the Revolution

Dr. Sanders carried forward the concept in academia (University of Miami, Georgia Medical College) and also introduced telemedicine to correctional facilities. Word of this amazing technology traveled globally. While consulting at the University of Texas Medical Branch on telemedicine for inmate care, Dr. Sanders met Dr. G. Byron Brooks, an electrical engineer and medical doctor. 

The Key Turning Point

Dr. Brooks and I enjoyed mountain climbing, loved extreme adventure, and decided to visit the African nation of Tanzania where they would climb Mt. Kilimanjaro. During the ascent, Dr. Brooks and I extensively discussed telemedicine, and that sparked the creation of Teladoc. The concept of commercializing telehealth came to life atop this venerable mountain. 

I this entrepreneurial spirit and experience with building and selling a communications company, Internet Global, and began raising investment dollars for Teladoc. The new telemedicine company was a great idea, but investors did not agree and therefore, in the early years, the majority of the company was built on sweat equity. Nevertheless, the idea did catch hold, and the torch that Dr Sanders’ had been carrying for decades became a rocket engine.  Along the telemedicine journey, the Teladoc team overcame multiple obstacles, including bureaucratic resistance and the absence of a national network of telemedicine doctors amongst many others.

Telehealth Revolution Evolves to Virtual Care, Providing a Solution to Modern Healthcare Challenges

The rest is history.  The adoption of telehealth grew steadily and has greatly expanded over the last two decades. Today, physicians, patients and payers benefit from virtual care options that can be scaled to provide users with access to a wide range of providers, healthcare services and diagnostics that enable remote monitoring and testing which is especially important for chronic condition management. The next generation of Virtual Primary Care (VPC) being introduced by Recuro Health, called Complete Care, expands the model to include virtual urgent care, behavioral health, in-home lab testing, genomics, Artificial Intelligence and more. By removing the strict boundaries of a physician’s office visit or making hybrid virtual/physical arrangements available, all stakeholders can focus their attention on the right quality metrics for improved care.

Successfully Meeting Today’s Healthcare Challenges

As today’s most in-demand telehealth innovation, virtual care solutions are improving quality of life for patients, and successfully meeting today’s medical challenges in complex clinical and financial environments focused on value-based care.

Some of the challenges addressed by virtual care:

– Addressing the healthcare needs of an exploding population coupled with a shortage of primary care physicians and the scarcity of behavioral health clinicians

– Responding to the demand for more affordable and convenient access 

– Resolving patient barriers to accessing care, issues associated with health equity

– Reducing hospital, payer and patient costs

– Improving overall experience of healthcare and outcomes

Virtual Care provides value throughout the healthcare ecosystem and along the patient’s healthcare journey with personalized and proactive digital solutions, connecting patients to providers with on-demand access to in-demand health services for a convenient “virtual first” experience.

Providing a Critical Need for Behavioral Health

With the de-stigmatization of mental and behavioral health issues and the continued surge in COVID-19, there is escalating demand for behavioral health services.  The reservoir of clinicians has not kept pace, and many people at risk are finding it difficult and costly to access behavioral care when needed the most. This challenge severely strains clinical resources and reveals a shortage of providers and other vulnerabilities of the behavioral health system. COVID-19 brought new attention to behavioral health issues, and the pandemic served as a catalyst that spawned a new generation of innovative solutions to meet specific challenges and barriers to care.  Virtual care for behavioral health issues has provided what is widely recognized as a lifesaver.

What’s New, Next and Beyond 

This next generation of virtual care is part of a greater seismic shift toward delivering the full spectrum of care wherever patients are located. It is an objective that is both consumer and payer centric, serving the access needs of all segments of the healthcare ecosystem. 

The goal is to build and operationalize an entirely new engine that improves upon the virtual urgent care model with the next generation of tools specifically designed for preemptive care and able to catch medical issues before they become dangerous and expensive. The best tech-enabled telemedicine engine is founded on the principle to prevent first and treat when necessary. Benjamin Franklin said it best: an ounce of prevention is worth a pound of cure. 

A Tech-Enabled Engine for New Breed of Virtual Care Aligned with Industry Trends

The healthcare industry is uniquely positioned to project trends as they impact all stakeholders, including patients, providers, payers and vendors. It is anticipated that the rapid expansion of virtual care will dramatically reshape how healthcare is delivered and that current approaches, successfully support individuals with chronic conditions, connect caregivers to the best health systems as well as support comprehensive mental and behavioral health challenges. 

There is a greater emphasis on care coordination and diminished focus on siloed, add-on remote monitoring solutions that simply mirror the fragmentation and unreliable care transitions of our existing system. As patients demand more accessible care options, and with healthcare facing a pivotal moment of digital transition, integrated virtual care is poised for higher utilization and significant growth. 

As part of this uptick in adoption, genomics will become a significant disruptive force.  The ability to transform genomic information into effective diagnostics and therapies with greater precision represents the future of personalized medicine as it embraces genomic tools to enable more precise prediction and treatment of disease. The fundamentals of genomics will require the development, standardization and integration of several important tools into health systems and clinical workflows. These genetic tools include health risk assessment, family health history, clinical decision support for complex risk and predictive information. 

Together with in-home diagnostics, genomic information and the efficacious application of Artificial intelligence (AI) tools will enable a paradigm shift to a comprehensive approach.  It will be possible to identify individual risks and guide clinical management and clinical decision-making — all of which form the basis for a more informed and effective approach to patient care. 

It is also expected that as virtual care becomes more accessible, it will generate increased coverage by insurance companies. Health plans and employers place high value on this one-stop resource which integrates all their vendor solutions in one central location to relieve “vendor fatigue” with a “complete care” experience. The most thoughtful and well-architected virtual care solutions provide a seamless, single-point patient experience, delivering health services that are digitally optimized as a benefit of a member’s health plan – whenever care is needed and wherever the patient is located — regardless of time or distance.

Author Michael Gorton

Michael Gorton is a quintessential entrepreneur and company builder. As CEO of Recuro Health he leads a team which includes several leaders from Teladoc, where he served as the founding CEO and pioneered an industry-changing health care model that created a new efficiency paradigm in healthcare. Gorton co-authored and published The Digital Medical Home: a compendium of stories, personal anecdotes and true accounts of how telemedicine was born on the streets of Boston in 1967 and how it slowly grew into the industry we know today. Most importantly, the book shows that as impactful as telemedicine is, in the future it will simply be little more than a delivery tool for the next generation of proactive and preventive medicine. Ernst & Young LLP (EY US) recently named Gorton as one of the 2022 Entrepreneurs Of The Year® based upon his entrepreneurial spirit, purpose, growth and impact, among other core contributions and attributes.