“Just Scanning Around” with Diagnostic Medical Ultrasound: Should States Regulate the Non-Diagnostic Uses of this Technology?


Recent advances in medical imaging have provided physicians with more accurate diagnostic information, which has allowed them to tailor their therapies to reduce health care costs. These recent advances have caused the New England Journal of Medicine to hail diagnostic medical imaging as one of the greatest contributions to medicine in last thousand years. Yes, modern diagnostic imaging plays a major role in medicine, especially in the case of diagnostic imaging technology. One reason this technology has assumed such a prominent position worldwide is the usage of higher sound intensities by its manufacturers for better image quality. A recent survey shows diagnostic medical ultrasound is responsible for nearly one-quarter of all the worlds imaging studies. Unfortunately, all of their success has led some entrepreneurs to seek an economic advantage by offering consumers increased access to this relative inexpensive technology. Although the FDA classifies ultrasound systems as devices, which require physician involvement, some entrepreneurs have chosen to offer access to these systems and their services without involving physicians. Tom Cruise brought the issues related to the nondiagnostic uses of this technology to national attention when announced his purchase of one of these systems for home use. Because such practices may violate the prudent use of this technology, as intended by its manufacturers, state-based legislative efforts may be needed to protect consumers from abuse. This article identifies the current nondiagnostic services that may pose a potential health risks to consumers, and it explains the science underlying those risks. It also reviews the existing federal and state regulations, and shows why all stake holders have a vested interest increased legislation that mandate increased control of this technology.


Health Law and Policy

Date of this Version

July 2006