Four Things to Know About Digital Health
Information is just information until it’s actionable

Adam Istas

Science Writer


he proliferation of digital health applications—and their potential service to clinical and real world research—has led biopharmaceutical companies and device manufacturers to embrace these new technologies in a variety of ways for a variety of purposes. From streamlining clinical trial processes such as patient recruitment and informed consent, to obtaining real world data (RWD) in support of regulatory submissions and value dossiers, a number of innovative applications of digital health tools have emerged over the past decade. While some have been successful (and others less so), their collective experiences and continued advances in technology offer both learnings and warning signs for healthcare product manufacturers looking to address challenges and engage with patients through digital tools. Most encouragingly, these experiences help illuminate the consensus that patient-centered design and usability are critical components for success in any digital health initiative. The following is intended to help promote a better understanding of how patient-centered principles should be at the core of a digital health program.

1 – The solution must address an unmet need

Although engaging with patients digitally may seem like a remedy to multiple challenges, sponsors should start conservatively by identifying one area of concern, then conduct feasibility to determine whether a digital health initiative would be an appropriate solution. With numerous factors contributing to a study’s overall success, a stepwise approach to validate potential solutions independently can provide isolated clarity of their effectiveness and affordability. Pfizer’s REMOTE trial, for example, attempted to replicate a traditional trial by using several web- and smartphone-based technologies concurrently, including a web-based recruiting portal, a web-based informed consent process, and an eDiary for patients to record their health information. Although the trial was terminated early, the video-based informed consent and the electronic data capture tools used in the study were each deemed successful and later adopted for use in other clinical trials. The REMOTE trial may not have succeeded in demonstrating the feasibility of an entirely virtual clinical study, but some of its specific, patient-centered solutions for specific problems were validated and advanced.

2 – Information is just information until it’s actionable

As the market for wearable health technology continues to grow, patients, providers, and industry have seemingly endless opportunities to gather health-related information easily. But unless that information is collected and relayed in a meaningful way, it won’t produce change. “The world doesn’t need more apps,” says Lisa Gualtieri, Director of the Digital Health Communication certificate program at Tufts University School of Medicine. “What the world needs is better apps that encourage and sustain behavior change, and that people can use to support their own goals.” One such tool combining real time information with clinical support is WellDoc’s BlueStar for diabetes self-management. The world’s first app requiring a physician prescription when initially released, BlueStar not only collects health information and provides users with condition-specific information and educational coaching, but it also connects to the patient’s healthcare provider to enable clinical decision support beyond traditional office visits. The BlueStar experience illustrates the potential of digital health to improve patient care considerably, as well as the broader potential to generate much needed real world patient experience data in support of regulatory submissions and formulary negotiations.

3 – One size doesn’t fit all

For biopharmaceutical and medical device companies engaging in digital health activities, ease-of-use should be at the forefront of design objectives as the digital divide is a major issue limiting the more widespread utility of digital health, especially among seniors. “If people have poor digital literacy skills, even configuring a wearable device and app can be challenging,” says Gualtieri. “Setting a step goal that is reasonable for their current level of fitness is important, but it isn’t always obvious that 10,000 is the default,” says Gualtieri. To explore the effectiveness and attitudes of wearable devices among this population, Gualtieri and her colleagues conducted a study investigating the use of fitness trackers by older adults with chronic medical conditions. The results showed improvements in clinical outcomes, but also found that while acceptance and perceptions of tracking devices among participants were ultimately positive, proper training and support are badly needed. “My advice to people now is to go ahead and give your older parent a wearable, but help them set it up—and don’t do it for them but guide them to increase their self-efficacy. And then take a walk together.”

4 – Behavior change is difficult

According to Gualtieri—who also founded RecycleHealth, a non-profit charity providing second-hand fitness trackers to underserved populations—one of the most promising developments in the world of digital health is the greater focus on behavior change. “We’re seeing more emphasis on intrinsic motivation,” she says. “People know what’s healthy for them in so far as diet, exercise, and other choices, but it’s still very hard for people to develop good habits.” Aligned with the philosophy of creating, sustaining, and rewarding healthy behaviors, a recently announced partnership between Aetna and Apple aims to track members’ activity, provide personalized health recommendations, and reward participants for making progress toward their goals. “Digital health developers can learn a lot from gamification,” says Gualtieri, “as it provides a good starting point to help understand the link between information, incentives, and change.”

Despite continued advances in portable, smart technology, digital health can no longer be considered a shiny new object. The potential of digital health tools to improve the delivery of care and contribute to clinical and real world research is unmatched. However, companies entering this space to assist in clinical development or evidence generation must ensure a mindful, patient-centered approach when designing and implementing these initiatives. It is end-user adoption and continued utilization, after all, that will ultimately determine whether the tool is a success or a failure.