A constant refrain in my classes is the fact that much of the history we are living through goes unwritten. That though it is important and significant and causal and the thing to which we will one day refer, the actual happenings of history often go unremarked upon. And I think there’s something to be said about that.
Anyway, such an event is set to occur. Titled. Rethinking the Way FDA Regulates Digital Health Devices: FDA’s Software Precertification Program, a session hosted by the U.S. Food and Drug Administration (the “FDA”) at the annual MedTech Conference will be the place where much of the dialogue about what a modern day regulatory environment should/will/might be to achieve any number of interests represented or spoken to in that room. “In the room where it happens” in today’s parlance.
“The interactive session will discuss how the FDA is looking at new and more efficient ways to regulate software-based medical technologies,” we are told in an invitation to join the session. Fundamental aspects of the agency’s interpretation of the Digital Health Innovation Action Plan and its implementation of the 21st Century Cures Act – you know, important, significant, and causal aspects of medical legislation that need to be done in this country to modernize our healthcare system as it makes increasing use of small-unit, wide-scale, computationally efficiency, electronically based systems that are coming to describe who and what we are with ever greater precision, accuracy, detail, and tedium? you know, that thing your president does not care the least whit about and for which we have seen a precarious rise in “big tech” partnerships that either signal a bright new horizon in regulatory affairs or something suggesting similar partnerships as seen in “big pharma’s” hey-day, you know that thing that will decide how a lot of this stuff ends up happening? – will all be discussed.
And just in case you think I’m spouting on about nothing at all, keep in mind that both Tony Blair and George W. Bush will attend and speak at this same conference. Just in case the Prime Minister of the United Kingdom from 1997 to 2007 and the 43rd President of the United States were just somehow flukes at an otherwise no-name conference, also in attendance?: Chairman and CEO of Johnson & Johnson, another Chairmen for another medical products and services company serving the healthcare industry, a Partner at a high-profile law firm, a Chairwoman of a medical device company which was recently granted FDA Marketing Clearance, and the Directory of the Center for Devices and Radiological Health at that very same U.S. Food and Drug Administration. With over a dozen of the world’s multibillion dollar biomedical corporations sponsoring the event, I imagine a few of the people in a few of those rooms are going to be exchanging words of profound later significance. Could we but crane our necks back enough to take it all in, we might be able to pinpoint the sentence upon which the future hangs.
And it’s about to happen.
Should you wish to attend, are in the area, have some coin to spend on such things (a Standard Non-Manufacturer for Non-Members costing $2,495, you “Academic/Non-Profit/Government” types can get away with $1,495, and perhaps knowing a good whale when they see them, the organizers have decided to let Venture Capitalists, Private Equity, and Angel Investors in at the bargain, low-down price of $1,395), you can do so at the link found here.
Much will be decided. How much will be written?