Data-Driven, Automated Healthcare

Its Promise, Challenges, and Regulatory Playing Field

Abstract

The future of data-driven, automated healthcare holds both a lot of promise and uncertainty. It is promising because of its ability to make precision medicine and practice-based medicine truly a reality. It is uncertain because the regulatory playing field for this emerging industry has yet to pan out. To date, the US Food and Drug Administration (FDA) still considers health information technology (HIT) software as a medical device. So far the FDA does not subject HIT software to as much regulatory scrutiny as traditional medical devices undergo, but has been criticized for using an outdated regulatory framework to govern modern health technologies. As such technologies become increasingly more prevalent and its capabilities much more salient, potentially affecting the lives of hundreds of millions, will the FDA be able to 1) handle the onslaught of new companies and regulatory burden 2) mitigate risks to public health while promoting innovation?

This paper will first discuss the potential of data-driven, automated healthcare and examples of what it currently is and may become (Section I), followed by an explanation of current regulations and why it has its limitations (Section II), exploration of newly proposed legislations (Section III), and finally recommendations to implementing a smarter regulatory environment for AI-driven healthcare in the future (Section IV).