Sharing Data

Abstract

Implantable medical devices measure and record data about the physiological development in a patient’s body, and communicate the data wirelessly to a monitoring system. In order for the patient to obtain information from the device, however, he or she would typically need to visit a medical provider. Accordingly, patients complain that critical information to a patient’s care is often not available to the patient in real time. This Article aims to begin an important conversation and raise some questions that highlight the tension between intellectual property rights and consumer protection, utilizing medical device software as an illustrative case study. The Article wrestles with the best approaches to addressing this problem, including an exploration of the interests of manufacturers, patients, and researchers. While recognizing that manufacturers must be able to protect their intellectual property rights and their investments in research and development, the Article recommends consideration of data sharing along a more nuanced “disclosure spectrum” rather than the current all-or-nothing narrative. This framework for thinking about how to balance data access rights, might also be useful more generally, as we continue to face similar questions with other interconnected devices in the Internet of Things.

Keywords: implantable medical devices, data, intellectual property, trade secrets, patents, copyright law, internet of things, consumer protection, disclosure, physician, medical device, ownership, access, privacy, FDA, HIPAA, cybersecurity, transmission, property, manufacturers, researchers, patients

JEL Classification: K12, K10, K11, K20, K23, K30, K39