Substantiating Big Data in Health Care

I/S: A Journal of Law and Policy for the Information Society, vol. 14, 2017

SMU Dedman School of Law Legal Studies Research Paper No. 403

26 Pages Posted: 11 Oct 2018 Last revised: 31 Oct 2018

See all articles by Nathan Cortez

Nathan Cortez

Southern Methodist University - Dedman School of Law

Date Written: September 17, 2018

Abstract

Predictive analytics and "big data" are emerging as important new tools for diagnosing and treating patients. But as data collection becomes more pervasive, and as machine learning and analytical methods become more sophisticated, the companies that traffic in health-related big data will face competitive pressures to make more aggressive claims regarding what their programs can predict. Already, patients, practitioners, and payors are inundated with claims that software programs, "apps," and other forms of predictive analytics can help solve some of the health care system's most pressing problems. This article considers the evidence and substantiation that we should require of these claims, focusing on "health" claims, or claims to diagnose, treat, or manage diseases or other medical conditions. The problem is that three very different paradigms might apply, depending on whether we cast predictive analytics as akin to medical products, medical practice, or merely as medical information. Because big data methods are so opaque, its claims may be uniquely difficult to substantiate, requiring a new paradigm. This article offers a new framework that considers intended users and appropriate evidentiary baselines.

Keywords: big data, predictive analytics, health care, FDA, machine learning, AI, medicine, software, mobile health

Suggested Citation

Cortez, Nathan, Substantiating Big Data in Health Care (September 17, 2018). I/S: A Journal of Law and Policy for the Information Society, vol. 14, 2017; SMU Dedman School of Law Legal Studies Research Paper No. 403. Available at SSRN: https://ssrn.com/abstract=3250968

Nathan Cortez (Contact Author)

Southern Methodist University - Dedman School of Law ( email )

P.O. Box 750116
Dallas, TX 75275
United States
(214) 768-1002 (Phone)

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