• Ruth Amos RN JD

Why Digital Health Needs "Reguality"

Updated: Feb 1, 2018

Every year, Webster publishes a new list of Portmanteau words- you know them well- words whose form and meaning are derived from a blending of two or more distinct forms (think smog” from smoke and fog, and the more recent affluenza (affluence/influenza): the guilt or lack of motivation experienced by people who have made or inherited large amounts of money.

For 2018, I submit reguality (regg-yoo-al-it-ee) from the words regulation and reality: the amazingly productive opportunities that present when regulations are written and interpreted while honoring both convenient and inconvenient realities. To my knowledge, reguality has not yet officially been coined- please correct me if it has. When it comes to digital health, we are in desperate need of more reguality!

Recently, I read an article by global Medical Futurist, Dr. Bertalan Mesko, entitled “Digital Health is a Cultural Transformation of Traditional Healthcare.” It correctly outlines how digital health is not at all limited to technology advancements- rather, it is profoundly impacting how care is actually delivered in reality. A quote from the article defining digital health reads, “Physicians are transforming into guides for their patients in the jungle of healthcare information and technologies from being an authority, from being the one who makes all the decisions. As they still have the expertise and a lot of experience, they remain crucial elements in the status quo. However, instead of being the gate keepers to the ivory tower, they become collaborators in the patient’s journey in healthcare.”

Contrast the above statements with the latest US FDA Chief’s definition of digital health. This quote taken from a recent interview with FDA Chief Dr. Scott Gottlieb and CNBC: “The industry has defined the term digital health in different ways. I think of it as software applications, mostly digital tools and medical apps.” Dr. Gottlieb also seemed surprised that it has taken large tech firms like Apple and Alphabet such a long time to take a “concerted interest” in digital health. With all due respect, Dr. Gottlieb…seriously?? How about the massive failures of Google Health a few years back? If we pull back the curtain, this largely had to do with regulatory constraints- namely, the current healthcare reimbursement model. In a 2011 quote from TechCrunch on this subject, “Frankly, Google could have done all the right things, but if the reimbursement model doesn’t change Personal Health Records will remain irrelevant for most healthcare providers. At best, we’re seeing Electronic Health Record vendors release so-called Patient Portals that are often driven more by a marketing objective than a clinical objective.”

There is some light in this tunnel- as the regulatory reimbursement model shifts away from fee-for-service, the folks at Apple (or more likely former Apple execs) may have a fighting chance at real innovation. Maybe that’s why privacy experts from HHS like Deven McGraw just recently joined a startup in Silicon Valley called “Ciitizen,” a venture company created by the former head of Apple’s health team, Anil Sethi. They only see real opportunity when regulations begin to match reality- reguality.

Personally, I believe 2018 will be a fantastic year for digital health, as the regulatory shift in delivery and reimbursement continues toward patient centered care and outcomes, respectively. However, we must be vigilant to insert the concept of reguality into every aspect of these shifts in order to create a sustainable model.

And a gentle nudge to Dr. Gottlieb- as a physician and cancer survivor, you have a powerful position and a real opportunity to influence how digital health, and healthcare overall, is perceived. Please reconsider your definition to include some reguality- it really does go a long way.



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