A Signal of Trust: Breaking Through the ‘Noise’ of Digital Health Products

Digital health applications and therapeutics have exploded over the last 10 years. With over 350,000 health and wellness apps and new wearables promising improved health, happiness, sleep, and recovery, it is becoming increasingly challenging for patients and providers alike to discern what has value and, more importantly, is safe. 
 
Currently, it is up to developers and product leadership to guarantee (or at least market) “good” digital health products. But as this $240 billion digital health market grows, patients and healthcare providers are rightfully starting to demand more, and we developers are struggling to meet the market needs. 
 
An industry built on standards and trust
 
Trust is a cornerstone in our world. Healthcare providers hold their clinical practice to the highest standards of validation and safety. Trust is established through rigorous scientific process, from systematic reviews and meta-analyses of randomized clinical trials to guidelines set by consensus from experts of clinical governing bodies. Conversely, it is lost instantly when new data reveal that the harms may outweigh the benefits. These are the standards that traditional therapeutics are held to and they are increasingly being applied to digital therapeutics. 
 
Further, hospitals and other clinical institutions led by clinicians and clinical informaticists demand markers of trust as well. They aim to uphold the strictest standards around data security, clinical efficacy, and financial value.
 
Most importantly, patients in pain or living with a disease need something they trust, that works as advertised, and is safe. For instance, health literacy might be below an 8th-grade reading level with English as a second language or they’re living with a disability requiring accessibly designed technology. They may also be burdened by both chronic disease and income insecurity, and are therefore unable to afford the solutions they need the most. 
 
In the new age of digital medicine and therapeutics, where it's not necessarily an isolated pill serving one indication, but instead a digital experience intending to guide a vulnerable patient through a journey toward health and health span across one or more disease states, how might developers design quality products to earn the trust of and achieve intended outcomes for highly discerning and skeptical clinicians, institutions and patients in need?
 
Applying this normative practice to digital health products
 
Much like pill-based therapeutics are designed toward and tested against accepted standards of quality and safety, digital therapeutics will increasingly be held to the same level of rigor. To standardize this process, we need a comprehensive framework for digital products that evaluates across multiple domains including, but not limited to, evidence, usability, privacy, security, and equity.
 
One that answers a variety of questions from stakeholders, including:
 
• Is there sufficient evidence to support that the claim that the product developer is making is true?
 
• Will this product cause harm to health systems, clinicians, or patients? 

• Will this product integrate into workflows and meet the needs of diverse patients as end users?
 
To avoid redundancy, the solution must also account for and expand upon existing credentials from third-party audits, certifications, and FDA clearances or acceptances. The recently announced DiMe Seal from the Digital Medicine Society is one such solution; it’s a comprehensive framework to define evidence-based best practices in evidence, usability, privacy, and security with equity woven throughout. 
 
Many organizations – including Curai Health, SimpliFed, and Tidepool – have earned the DiMe Seal for their digital health software products, a symbol indicating quality and trust to providers, clinicians, and patients alike. It establishes something our industry greatly needs – a broadly accepted definition of “good” digital health software.
 
Set the bar before we raise it
 
With digital tools set to grow at an exponential rate and with the potential to improve outcomes, reduce costs, increase engagement or sadly, inflict harm, now is the time to set the standard for what “good” technologies and apps look like throughout healthcare and across the care continuum.
 
Based on these commonly accepted domains and criteria, developers who wish to enter the realm of healthcare must also strive to “do no harm” and build and market products that meet this standard of “good” to instill quality, equity, safety, and trust in digital health technologies.
 
Sameer Sood, D.O., is a family medicine physician and digital health entrepreneur.