Regulating Connected Health: Pathways, Technology and the Patient

In this paper, we discuss how technology is changing the world around us, particularly focusing on how the introduction of Connected Health solutions can continue providing patient-centered care. We present a definition of Connected Health, which includes five components – Technology, Healthcare Pathways, People, Regulation and Data. Our article focuses on just one of these – that of regulation – presenting the importance of recognizing how Connected Health solutions, given that they are Medical Devices in many cases, must be regulated.  We summarize different regulations, discussing how they should be included as a requirement when designing and developing, implementing, and using a connected health solution. Although not specifically focused on Medical Devices, we include some information on the European Union Accessibility Directive. Our conclusion focuses on the need for developers and end users to understand the importance of regulation when designing and developing health solutions.

By Silvana Togneri MacMahon & Ita Richardson^[1]

I. INTRODUCTION – CONNECTED: A CHANGING WORLD

Through the use of technology, consisting of hardware and software, the world around us is changing dramatically. It is not unusual in many of our everyday environments to use smart phones, internet, mobile technology, integrated software systems and ubiquitous computing.  

How has the advent of technological connectedness changed our everyday lives? A