An optimist’s view of the FDA’s efforts around digital health

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Why has the FDA been slow at issuing guidance around digital health so that digital health startups can function accordingly?

Remember the time when you called an Uber at the airport and you had to walk across the street to meet your driver on a ramp away from other cabs? It felt like we were a part of a secret society with a secret handshake etc. It was fun, right? Well truly the problem was that Uber had basically steamrolled the entire regulatory process around cab licensing. While the concept, product and services were revolutionary, Uber soon found themselves in a quagmire of legal battles. At one time it was postulated that Uber had a better legal team on their payroll than engineers! 

The question then becomes, is this how disruptive innovation can take place where a few startups offer services that might not fall neatly within existing regulations and they end up dragging the regulatory agencies into new age kicking and crying? Well, my consultant’s answer is, “it depends.” It depends upon the impact or more accurately the negative impact the said innovation can have on our lives. A transportation enabler is essential—when you need it—but there is a limit to how it affects us. Healthcare, that’s another story.

Consider this, there are more than 150,000 apps available in the app store that focus on some element of health, wellness or healthcare. If you are a doctor and your patient asks you to recommend a diabetes management app, what would you choose? Will you choose an evidence-based, the FDA approved app or would you choose an app that you have heard about but don’t understand the science (or lack of it) behind it? I think the answer is easy here.

So then you might ask, why has the FDA been slow at issuing guidance around digital health so that digital health startups can function accordingly? There are many problems as highlighted in a recent article in Wired ( There is in general shortage of talent in this field. The few people that are available would rather work for a tech company than government and the FDA has a huge backlog of submissions and new technologies are adding to that backlog, and finally the legendary congressional budget cuts. 

But all’s not doom and gloom this time around. The FDA has been making concentrated efforts to setup the groups focusing on digital health, they have started interacting with the industry in digital health focused conferences, and they have issued more guidelines in last couple of years than ever. On the other side, companies like Apple and Verily have started recruiting and consulting with FDA veterans. So there is a considerable amount of cross-pollination happening.

You might ask, is it enough and is the pace acceptable? My answer is no. Pace of technology is very fast and unless the FDA figures a way to be nimble, they will find themselves lagging behind the curve again. But all in all, I am hopeful that we will not have to resort to a secret handshake with our doctors to get a disease management app recommendation anytime soon.

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