I sent the following announcement to 10,618 Digital Health LinkedIn Group Members on May 7, 2012:
Mr. Sonnier goes to Washington
Dear Digital Health group members,
I visited Capitol Hill for the first time last week where, much to my delight, I saw that, in spite of our common perceptions and examples to the contrary, our elected representatives and government agencies can be both innovative and focused on accountability. To be clear—and to prevent this from devolving into a political discussion—the scope of my observation is related to governmental efforts in fostering digital health innovation.
My first meeting was with Arnaub Chatterjee, Special Assistant to the Chief Technology Officer (CTO) of the U.S. Dept. of Health and Human Services (HHS). In a very engaging conversation with Arnaub, he told me and my colleague, Dr. Caroline Popper, about the objectives of his team at HHS and some of their key upcoming activities. One initiative that I found fascinating (particularly since it reminded me of Singularity University (SU)) is their Fellows Program. This initiative enlists the assistance of external experts and entrepreneurs (deemed ‘Host Innovation Fellows’) to complement existing talent at HHS to solve some of the most pressing and vexing challenges in healthcare. Along with “rock star” innovation mentors from the startup, venture capital and technology sectors (names to be announced), Host and External Fellows will conceive of and implement rapid iteration solutions addressing specific, high-priority projects over a period of 6-12 months. This actually differs from SU, since the goal here is to both conceive AND implement solutions!
Another big activity being undertaken by HHS is their Health Data Initiative (HDI) Forum and upcoming Health Datapalooza event, which is happening this June 5-6 in D.C. and will bring together upwards of 1,000 stakeholders to discuss ways to utilize the broad and deep databases of health data liberated by the government.
My second meeting on Capitol Hill was with Keith Studdard, Legislative Director for Congressman Marsha Blackburn. Ken Walz (another colleague from Popper and Company) and I had a very enjoyable and candid conversation with Keith about the recent letter sent by Representative Blackburn and five other Congressional Representatives to FDA and FCC. This letter was focused on a memorandum of understanding (MOU) signed by the two agencies back in 2010 and inquired as to progress that has been made in bringing clarity to the regulatory approval process and regulatory purview for wireless connected health solutions like health apps and devices. As we all see in the articles and discussions about digital health innovation posted in the Digital Health group each day, innovation is occurring at a rapid, accelerating rate. As such, our archaic and hidebound regulatory systems are, arguably, limiting the potential for digital health solutions by unnecessarily throttling efforts by entrepreneurs, companies, investors and others seeking to drive this innovation. It’s clear that this also negatively impacts economic activity and job creation.
While I unfortunately didn’t get a chance to meet with the FDA or FCC, I believe they are very aware of the need to streamline approval processes and bring clarity to the digital health regulatory environment. As many of you know, the FDA recently came out with a Draft Guidance on Mobile Medical Apps. From what I gather, there is still debate as to whether a finalized guidance is generally good or bad. I’m still undecided as to the best course of action, but believe that any improvements in reducing ambiguity and streamlining these processes would certainly catalyze innovation.
So, while change in Washington is usually slow, and we don’t usually think of government as being innovative, this is not always the case. My trip was exciting for a variety of reasons, but most of all my spirits were buoyed by the sense of urgency, passion and shared purpose that I observed in Arnaub and Keith. And really, I believe this is shared by all of us since the economic imperatives are simply too great not to act positively and collaboratively. To do things differently, to stick with the status quo, is simply untenable. We have the capability and the technological tools to innovate and do things better, and I remain confident that the digital health revolution that’s just begun will continue to accelerate.
I look forward to hearing your thoughts!
Head of Digital Health Strategy, Popper & Company
Founder, 10,000+ member Digital Health group on LinkedIn
Mentor, Blueprint Health
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