Is Your Phone a Medical Device?​


How did you celebrate your 11th Anniversary? It just passed…did you observe it? It is likely the last thing you interact with before you sleep, and the first thing you communicate with on waking- not your partner, or your pet- it is your phone, likely your smartphone.

According to Pew Research Center, 77% of people in the USA own a smartphone. It is hard to believe they have only been in existence for eleven years as smartphones have radically altered how we live our lives. You can buy a car, a house, your groceries, or your favorite tacos using your phone via the many apps that live on your home screen. Apps can also be used to improve and manage your health.

At the end of 2017 Statista reported that almost 48,000 health-related apps were available in the app store; that number stabilized in 2017, but as people, employers, and health care systems adopt technology solutions to improve or manage health this number is likely to grow again.

Follow the money

Rock Health recently reported that in Q1 of 2018, funding for digital health reached 1.62 billion dollars across 77 companies. The pace of this funding seems at odds with the statement Dr. James Madara, CEO of the American Medical Association, made in his 2016 address at the general meeting, that some of the early solutions were the equivalent of “digital snake oil of the early 21st Century”. While he was not dismissing the whole industry, he made valid criticisms that these solutions did not consider the health care providers, patients or the workflows in clinical care as part of their deployment. That landscape has shifted in the last two years.

FDA Digital Health Innovation Plan

The FDA is working on standards for digital health as part of its “Digital Health Innovation Plan,” and they have recently rolled out a pilot of their “Software Pre-certification Progam.” This pilot focuses on software as a medical device which is defined “as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Developing a regulatory framework could go some way to allaying fears that digital health solutions are “snake oil”, and those in the health technology space are eager to continue innovating with the freedom they have enjoyed to date.

The Digital Therapeutic Alliance, recently formed, comprises many of the early digital therapeutic companies who now, at maturity, have demonstrated outcomes and leveraged value-based payment models tied to those outcomes. They have also gained experience in deploying digital therapeutics in complex healthcare environments. Their approach has set foundational principles in place for other digital health companies to follow.

Support at your fingertips

All of these developments are good news for consumers. Apps that work with devices to measure blood pressure or blood sugar are getting more sophisticated and user-friendly. They take the user experience as a core component of their engagement journey. Digital Therapeutic companies are also navigating the privacy aspects of health care which continues to be a pivotal aspect for patients and healthcare providers in modern times.

In designing products that look sleek, are intuitive and fun to use the barrier of a steep learning curve disappears. It will be interesting to track how regulation and innovation will navigate this new terrain. There no doubt exists tremendous growth opportunities for companies who deliver outcomes, superior user experience, and optimal integration with the healthcare industry in this new marketplace. There are negative aspects of cell phone use that need addressing as the smartphone enters its tween years, but they are here to stay, or until the next new thing takes over!

Thanks for reading- Trina

(opinions expressed are my own)


Pew Reseach Center


Rock Health

FDA Digital Health Innovation Plan

Digital Therapeutic Alliance

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Close Menu
%d bloggers like this: