Published in Volume 16, Number 2 of the DePaul Journal of Health Care Law.
Mobile medical applications are increasingly taking center-stage in the health care industry and more importantly, in the patient-doctor relationship. Yet, as technological prevalence continues its upward trend, regulatory initiatives will also continue their march to the forefront of the discussion. This can lead to only one ultimate conclusion: an impasse between the potential for technological innovation and governmentally enforced restrictions. The first, of what will most likely prove to be many, federal regulations controlling mobile medical applications was recently enacted by the Food and Drug Administration. Overbearing governmental regulations such as these stifle innovation in the health care field and operate to the detriment of the public as a whole by restricting society’s ability to advance in the health care industry. Before implementing any governmental regulation, a cost-benefit analysis should always be performed to ensure that it is truly worth it. In the situation where health care is on one side of the equation, we simply can’t afford to stifle our own future. This can be, quite literally, a matter of life or death.
Presently, the dialogue occurring in health and legal professional circles across the United States of America is centered on health care. A different conversation needs to be had that focuses on the burgeoning field of mobile applications and the role that they will play in the future. With increasing numbers of doctors and medical students using smartphones and associated applications as a source of reference material in daily clinical care, this is not a topic to be overlooked. The federal government has taken notice of this marked increase in use of mobile technology in the health care industry and has responded accordingly by issuing FDA regulations on the topic. While the FDA’s stated purpose is to focus its oversight only on mobile medical apps that transform a mobile platform into a regulated medical device, this is simply another occurrence in a long line of government-imposed regulations that have the impact of stifling creativity and innovation. It is with virtually little dispute that government regulation is a necessary component of a properly functioning society, but when those regulations begin to repress advancement, a cost-benefit analysis must occur.
The purpose of my Journal article, "The Future of Health Care: We Are Our Own Worst Enemies," is to address and perform this necessary cost-benefit analysis. The article first reviews and discusses the regulations disseminated by the Food and Drug Administration, in regards to mobile medical applications, in its most recent guidance. The discussion then pivots to analyze the implications that these regulations will have on future innovation in the health care industry by stifling creativity with overbearing and unnecessary governmental intervention and oversight. After a brief overview of the current state of health technology affairs, the conclusion is reached that overbearing regulations in the health care field do indeed operate to the detriment of the public as a whole because they restrict society’s ability to advance in the field of health care by disincentivizing market entry. While the stated purpose of the article is to merely address the cost-benefit analysis of government regulations on the future, the true spirit of the article is to serve as a cautionary tale. If our society does not make a conscientious effort, in the immediate future, to curtail unnecessary oversight, then we will only be able to blame ourselves for future stagnation in innovation.
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