JMIR article argues misapplied pharmaceutical model prevents scaling of effective interventions

(Toronto, October 28, 2025) JMIR Publications today released a new article in its growing "News & Perspectives" section, challenging the foundational research model that has shaped the digital health industry for decades. The article, "From Efficacy to Scale: Addressing Digital Health’s Original Sin," argues that treating digital interventions like medication—rather than iterative software—has stymied their ability to achieve mainstream adoption at scale.

The article is the first contribution from JMIR Correspondent Trevor van Mierlo, DBA, a digital health researcher and the Founder of Evolution Health with over 25 years of experience in the field.

The analysis traces the problem back to the industry's inception, where the focus on "disruption" led researchers and investors to apply the Randomized Clinical Trial (RCT) gold standard used for pharmaceuticals. This approach, van Mierlo contends, defined success as users completing a full course of treatment, thus stigmatizing attrition as a research failure rather than recognizing it as a "system signal" about how people actually engage with software.

The article highlights digital Cognitive Behavioral Therapy (CBT) as a key case study: while dozens of trials have proven its efficacy, the pharmaceutical-like trial design overlooked the highly variable nature of real-world therapy—where intensity, progress, and even therapist-patient resonance all affect outcomes.

A New Path to Scale

To move digital health from a proven, yet niche, tool to a scaled, global platform, the article asserts the field must make several shifts:

• Embrace Attrition as a Signal: Dropout data should be normalized and used to map user engagement patterns, not hidden in appendices.

• Shift from Clinical to Controlled Trials: The priority must extend beyond proving efficacy to include optimizing engagement through agile, user-focused experiments common in software development (randomized controlled trials).

• Adopt Software Economics: The traditional pharmaceutical business model, which relies on patents and prescriptions, is misaligned with the realities of software economics, which demand product-led, freemium, and culturally adaptive models to reach hundreds of millions of users.

"Trevor van Mierlo's piece is exactly the kind of critical thinking and evidence-based analysis we aim to deliver in our 'News & Perspectives' section," said Kayleigh-Ann Clegg, PhD, JMIR's Scientific News Editor. "It also moves beyond analysis to action, offering a clear roadmap to help researchers, developers, and investors turn efficacy into real-world impact at scale."

Dr. van Mierlo, who contributed to the original conversation on attrition with research on power law distributions and participation inequality, believes that confronting this "original sin" is a key way to realize the global vision of digital health.

Read the full article here: 

van Mierlo T. From Efficacy to Scale: Addressing Digital Health’s Original Sin. J Med Internet Res 2025;27:e85878

DOI: 10.2196/85878

URL: https://www.jmir.org/2025/1/e85878

About the Author

Dr. Trevor van Mierlo, DBA, JMIR Correspondent, is a digital health researcher, Strategic Advisor, and Founder of Evolution Health. He has over 25 years of experience in the digital health sector and behavioral science.

About JMIR Publications News & Perspectives

JMIR Publications is a leading open access publisher of digital health research. The "News & Perspectives" section is the newest addition to its portfolio, established to bring the rigor and integrity of academic publishing to scientific journalism. The section features well-researched, expert-driven content from the Scientific News Editor, Kayleigh-Ann Clegg, PhD, and a network of specialist JMIR Correspondents, including Dr. van Mierlo, to keep the digital health community informed, inspired, and ahead of the curve.

About JMIR Publications

JMIR Publications is a leading open access publisher of digital health research and a champion of open science. With a focus on author advocacy and research amplification, JMIR Publications partners with researchers to advance their careers and maximize the impact of their work. As a technology organization with publishing at its core, we provide innovative tools and resources that go beyond traditional publishing, supporting researchers at every step of the dissemination process. Our portfolio features a range of peer-reviewed journals, including the renowned Journal of Medical Internet Research. To find out more about JMIR Publications, visit jmirpublications.com or connect with them on Bluesky, X, LinkedIn, YouTube, Facebook, and Instagram.

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