Newstead Compares U.S. and U.K. Approaches to Medical Apps

Shook, Hardy & Bacon Partner Alison Newstead has authored an article titled "Healthcare apps: comparing the US and UK approaches" appearing in the April 2014 issue of The In-House Lawyer. According to U.S. Food and Drug Administration (FDA) guidance issued in September 2013, that agency will take a “pragmatic, hands-off, risk-based approach” to regulating medical applications (apps) as medical devices, focusing on functionality and evaluating “whether the app could pose a risk to patient safety if it did not function as intended.” The U.K.’s Medicines and Products Healthcare Regulatory Agency (MHRA), while taking a similar approach to defining what constitutes a medical app in its March 2014 guidance, will focus on the app’s intended purpose. In this regard, MHRA will assess the medical apps’ purpose “in light of all claims made in relation to the app, including claims made in promotional material such as brochures and webpages.” Despite the “striking similarities, between the two sets of guidelines,” Newstead writes, “the U.K. regulator has not gone as far as the U.S. FDA in terms of ‘enforcement discretion.’ . . . U.S. developers should therefore beware as these apps which may not attract attention in the USA may do so in the U.K.”