Electronic Health Reporter

By Dr. Harietta Eleftherochorinou, vice president 0f innovation ventures, IQVIA.

Patients, health systems and CROs are embracing digital health, as indicated by the number of digital health apps, digital diagnostics, digital biomarkers, digital therapeutics and devices being created. At the same time, over a third of these apps don’t survive longer than a year, devices struggle to get regulatory approval, digital biomarkers are yet to be proven, while digital diagnostics and digital therapeutics are not cheaper alternatives to the standard of care. The question skeptics therefore have is “what is the real value of digital health to patients and the healthcare systems?” Below, there are several tangible value-points of digital health in quantified metrics to give an answer.

The digital health innovation market is experiencing exponential growth. Investments of $24 billion were made globally in digital health in 2020 according to the IQVIA Institute Digital Health Trends 2021 report. And according to CBInsights, in 2021, $39.6 billion were invested on digital health alone, out of the total $100 billion invested globally in healthcare startups. These investments are resulting in greater numbers of mobile apps, wearable devices and other digital tools.

Digital apps are redefining the health experience

Multiple types of digital health tools contributed to mitigating the impact of the pandemic and are now established part of the digital health landscape. Consumer apps remain the most widely available and used digital tool with more than 90,000 new digital health apps added in 2020 — an average of more than 250 apps per day — resulting in over 350,000 apps currently available. Apps are increasingly focused on health condition management rather than wellness management, with the former now accounting for 47% of all apps in 2020, up from 28% in 2015, and with mental health, diabetes and cardiovascular disease-related apps accounting for almost half of disease-specific apps. Downloads and use of apps are heavily skewed with 83% of apps being installed fewer than 5,000 times and collectively accounting for less than 1% of total downloads, while a cohort of 110 apps have each been downloaded more than 10 million times and in aggregate make up almost 50% of total downloads.

Moreover, patients have easy, mobile access to health information and quality healthcare. For example, the Moodpath app allows users to track their mental health through cognitive behavioral therapy. At the same time, mobile apps connect doctors with patients who need assistance in real-time, thus easing the burden on healthcare workers. HealthTap is one such mobile app which offers 24×7 virtual assistance to patients by connecting them to certified doctors through call, text, or video call.  .The value is increased patient engagement, patient education on one’s own condition and patient centricity coming to life rather than talked about.

Positive results from digital therapeutics

With the incorporation of technology to assist with the treating, preventing and managing of specific diseases, innovation amongst digital therapeutics and digital care products is increasing. According to the IQVIA report, Digital Therapeutics (DTx), and Digital Care (DC) products — incorporating software to treat, prevent or manage specific diseases or conditions — have been proliferating. Over 250 such products are now identified, including about 150 products that are commercially available, and the rest in development.

Digital therapeutics, which typically focus on a narrow clinical indication and generate evidence of clinical efficacy, follow a development path that typically requires market authorization by a regulatory body and sometimes a prescription from a provider, though some may be exempt. Neurologic and psychiatric conditions are a key focus of both DTx and DCs, making up over two-thirds of all DTx indications and over 40% of DCs, respectively, with DCs also used by patients suffering from endocrinology, oncology and cardiovascular conditions.

Many of these rely on cognitive behavioral therapy (CBT) as part of their therapy. In fact, a study conducted in the U.K. showed anxiety and depression symptoms in participants were cut in half and remained so even 12 months after the start of Internet-based cognitive behavioral therapy treatment. While there are many ways in how DTx are being defined and outlined for regulatory use, they are all developed with one goal in mind: to deliver new therapeutic interventions and improve the patient experience, thus delivering significant value to those in the healthcare industry.

Wearables, digital diagnostics and digital biomarkers deliver insights

Of the 384 currently marketed consumer wearable devices, activity monitoring devices that measure heart rate, steps taken, distance traveled, and calories burned account for about 55% of these, while the remainder enable data generation and capture across a broad range of health parameters. For those individuals who have embraced wearables, especially where these devices are part of everyday life, there is great value to the data being captured. This data collection incentivizes healthy behaviors and better disease management, while data can also be transmitted to healthcare practitioners and clinical trial study leads. One such example is the NICE England approved wearable tech, which reduces need for finger-prick testing by up to 50%. The wearable is the size of a £2 coin, sits on a patient’s arm and constantly checks their glucose levels. It is accompanied by an app which alerts patients on their sugar levels.

Digital biomarkers to remotely monitor patient health are being validated by feasibility studies with the intent to incorporate them into clinical trials and patient care. In total, 438 studies have examined 933 distinct biomarkers, with more than half of trials in neurology, musculoskeletal disorders and sleep. Among these are digital biomarkers for neuromuscular disease to track muscular dystrophies and motor neuron diseases. Biomarkers advance insights into diseases such as in neurology, musculoskeletal disorders and sleep. Additionally, the extra insight shared directly via remote sensors allows for the collection of real world evidence to drive greater insights and research outcomes by CROs and pharma on the design of treatments. These new and in-depth insights, secured direct from the patient, provide value in advancing clinical research to bring new innovations to market faster while opening up new forms of engagement between patients and providers.

Role of digital devices in clinical trials

Sensors and digital biomarkers are being incorporated into the design of clinical trials for pharmaceuticals and medical devices and are enabling decentralized and hybrid trials with home visits, reducing patient and investigator burdens, and accelerating clinical trial timelines. Since 2016, the percentage of trials using connected medical device technologies doubled and is now 8%, with 10% of Phase II and III trials now including connected devices. Digital biomarkers have gradually gained adoption in clinical trials to track patient outcomes, and more than 193 unique digital biomarkers have been used as endpoints in 96 clinical trials.

The usage of digital biomarkers further accelerated with the start of the epidemic. Pharmaceutical companies embraced remote patient monitoring, and according to the Digital Medicine Society (DiMe), which keeps track of industry-sponsored studies of medical products in its Library of Digital Endpoints, the number of companies conducting such studies have nearly doubled to 69 in the past two years. These innovations drive value by increasing the number of potential participants, those who otherwise would not have been able to travel to a site in-person to participate otherwise.

Healthcare access improves for all

Digital technology can narrow the equity gap in several ways, from streamlining difficult-to-navigate medical bureaucracy processes to eliminating travel and transportation factors from healthcare access. Access is limited by two chief constraints: affordability and availability. High treatment costs and limited insurance coverage are well-known barriers to care. For example, health plans often have poor coverage for fertility treatments, making in vitro fertilization (IVF) prohibitively expensive for many patients. The digital health start-up Univfy is working to lower those costs in two ways: by developing an AI-based platform that predicts a patient’s probability of success and by partnering with clinics to offer refunds if IVF efforts fail.

For many patients, such as those in rural areas, the limited availability of providers and the costs associated with travel and time away from work are barriers to care. The COVID-19 pandemic spurred a rapid and significant increase in telemedicine and improved access for those who were not reliably able to attend in-person consultations. The London-based digital health service provider Babylon offers a transformative example of the power of telemedicine. Developed in collaboration with the Rwandan government in 2016, the company’s Babyl platform is designed to work with the basic phone features available to most Rwandans and, as of December 2021, has more than 2.6 million registered patients. In simplifying access through these innovative solutions, the value of healthcare is increased across the patient population.

Payors and billing struggle to embrace change

There are some areas where digital health innovation continues to struggle to advance, most specifically in the payor or billing departments. Payors are slower to embrace digital health innovation mainly due in part to that interoperability between healthcare systems, especially within the U.S., is not as strong as it could be, creating challenges in how data flows between the patient, provider, researchers, communities and payors. On the billing and patient payment systems, many have not been updated in recent years, as indicated by the lack of patient centric and digital health models. This includes insurance claim processing.

As a result, while digital health apps open the possibility of information exchange, there are challenges in this area. New regulatory guidance and structures are being put in place through FHIR (Fast Healthcare Interoperability Resources) and the Cures Act to improve this flow. Startups that are looking to embrace healthcare innovation should look at how bringing transformation to this aspect of the market could assist in providing real value to practitioners and providers.

Taking all into account on how digital health innovation has advanced the market, the majority of digital health solutions drive an improvement whether it is empowering patients, encouraging greater engagement with healthcare practitioners and driving more detailed research with more real world data. While regulatory frameworks, reimbursement pathways and patient user-centric design are all evolving, the value points of digital health to date are loud and clear.