Rep. Collins: Less is more when it comes to mHealth regulations
As chairman of the House Small Business Subcommittee on Health and Technology, Rep. Chris Collins (R-N.Y.) is well positioned to serve as an advocate for mobile medical app entrepreneurs. His leadership of the Health and Technology subcommittee is an ideal platform for railing against what he claims are government regulations stifling small businesses. These businesses account for more than three-quarters of the top app developers, according to a study cited by Collins.
On June 27, Collins' subcommittee held a hearing highlighting the "groundbreaking" apps that entrepreneurs are developing and how the technology is changing the face of healthcare. FierceMobileHealthcare spoke with Collins about the hearing and the business and regulatory environment that entrepreneurs face as they develop their mHealth apps and try to bring them to market.
FMH: What was the purpose of the hearing?
Collins: It wasn't controversial. We were using the hearing to showcase small business entrepreneurs and emerging technology, and having interesting subject matter presented by experts who are entering the new arena of medical data and using smartphones and tablets to assist all of us in how we manage our healthcare--which is the new paradigm now.
FMH: In your opening statement in the hearing, you said that in order for small businesses to bring their mobile health apps to the public, they must navigate a complex web of challenges including product financing, marketing, taxes and regulations. Specifically, how do you see those challenges for entrepreneurs as they relate to taxes and regulations?
Collins: What we heard on the regulation side was everyone is concerned about HIPAA and privacy, as they should be. One gentleman said that anyone using his app has to have their own password into the Medicare database. We also heard about the different platforms and the interoperability issue of how to develop an app in which one platform can talk to another. But, mostly what I heard, and it's what entrepreneurs do, they charge forward. If there's a rule or regulation, they make sure what it is. And, if not, it's the risk-taking that entrepreneurs do, they're going to make their best judgment and move forward. While everyone wants everything well defined, it rarely is. This is certainly a case where it's evolving.
FMH: It's been almost two years since the FDA released its draft guidance for mobile medical applications. The FDA now says it will finalize its guidance by the end of fiscal year 2013. Do you believe two years is too long for software developers and entrepreneurs to wait for the FDA to issue its final guidance, and is the uncertainty of pending regulation from the FDA a major obstacle to innovation and investment in the mHealth industry?
Collins: Clearly, two years is a very long time and certainly too long. On the other hand, entrepreneurs move forward regardless. They take their best guess. Entrepreneurs don't wait for the final regulations before they start. They find a solution to a problem and try to be first to market. They are not dragging their feet waiting for final regs. They just understand that if and when final regulations come out they might have to tweak their product. They're going full bore and well aware that they may have to adapt. That's what entrepreneurs do. They don't know the end as they start their journey. The government moves, in most cases, at a very slow pace. Entrepreneurs will deal with regulations as they come.
FMH: One witness in your hearing testified that in his opinion the FDA should actually include many more mobile medical device apps under its jurisdiction.
Collins: Well, sure. You've got to understand entrepreneurs. He's already paying the tax so he wants everyone else to pay it too. He wants to level the playing field. Look what Amazon is doing. Amazon fought against the Internet sales tax forever. Now, with distribution centers around the country, they have to pay the tax and they want everyone to pay it as well. So, it's not surprising that someone who is paying the medical device tax would want everyone else to do it.
FMH: Another witness in your hearing testified that it's important to remember the impact laws and regulations have on small businesses. As chairman of the Health and Technology Subcommittee, what can be done by Congress to help alleviate those challenges for small businesses in the growing mobile healthcare industry?
Collins: We are over-regulated. It's very difficult for a small business to even know what they are and, to the extent they do, it's money that could be better spent creating jobs instead of adhering to various regulations and reporting requirements. With medical apps, this is an area where I would say less is more. Except as it relates to HIPAA and privacy, we shouldn't attempt in government to tell business exactly what they must do because it shouldn't be one size fits all. I think that stifles competition. I personally am not somebody who believes we need more regulations. Privacy is the one exception.
FMH: In terms of your subcommittee, do you foresee future hearings on this topic?
Collins: We do one hearing each month. I've got technology and healthcare and this was a great example of being able to pull them together. We're going to continue to try to hold hearings that allow small businesses and entrepreneurs to discuss either their problems or, in this case, showcase entrepreneurship at its best.
Editor's note: This interview has been edited for length and clarity.