Statements on Introductions of Bills and Joint Resolutions

Floor Speech

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Mr. KING. Mr. President, it is a pleasure to join the Senator from Nebraska. I love the idea of the surf-and-turf caucus reaching across the country to try to find commonsense solutions. I often think about legislation and what we are attempting to do, and there is an attempt to codify common sense, to try to bring to the regulatory process, as it deals with medical devices, a little more thoughtfulness and cautiousness as it affects health information technology.

The first part of the bill actually sets up a process whereby we can examine in a thoughtful kind of way some of these issues to reduce the regulatory burden and at the same time foster innovation and, very importantly, protect patient safety. It sets up a process involving the National Institute of Standards and Technology and other parts of the administration so that the regulatory process in this area can be rationalized across agencies and better coordinated.

The heart of the bill, however, as the Senator just outlined, is our attempt to differentiate between medical software, which has a direct impact upon patient health, and software that is more peripheral and can range from the app I have on my iPhone, which is a pedometer that tells me how much I have walked each day and how much I should walk each day, to the kind of software that is being developed across the country to assist medical practices in their billing and in the operational part of the medical business.

I think one of the most important points, as the Senator pointed out, is that software evolves almost overnight, and if you go through this burdensome regulatory process--whether it is 60 days, 120 days, or 1 year--to get your software approved and then you find there is a bug you have to fix, that could restart the whole regulatory process. So I think we should acknowledge that this is a bit of preemptive legislation because the FDA thus far has not intruded very deeply into this process, and we believe it is important in order to define the areas where regulation and the protection of patient safety is important, but software that manages the billing process of a medical practice should not fall into that category and should not be subject to that level of regulation. That is really what we are talking about.

As the Senator mentioned, this law goes back to 1976. In thinking about 1976, Gerald Ford was President and software was a mink coat. We weren't really thinking about what we are doing today, and of course the legislation did not anticipate the kind of intense innovation and new thinking that is going on that is able to protect people's health just by giving them information about themselves. No doubt the time will come when a smartphone will be able to do blood pressure or temperature or certainly provide one's heart rate, and that is information we should have ourselves, not necessarily regulated by the Federal Government.

I am delighted to join the Senator from Nebraska and the Senator from Florida in introducing this piece of legislation. I think it is important. It is part of a larger project to try to bring our Federal regulatory process into the 21st century where time is of the essence, innovation is at the speed of light, and that we can't burden our people who are creating these innovations with a lengthy and, yes, expensive process that has a tendency to discriminate against smaller entrepreneurs and businesspeople.

I compliment the Senator from Nebraska for bringing this piece of legislation forward. I am absolutely delighted to join her in its sponsorship, and I look forward to moving it through the legislative process. There is a companion piece of legislation in the House, and I think this, as I said at the beginning, is an effort to get as close as we can to legislating common sense in this area, and I believe it will make a difference for businesses, for people, for patients, and for the health care system in America.

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