Alleviating Challenges Related to FDA-Approved Medical Wearables Using Blockchain Technology

Abstract

Medical wearables are an emerging technology that is proceeding its early wellness segment. Medical wearables can provide clinically relevant data and are approved by the Food and Drug Administration (FDA). Some of the FDA-approved medical wearables include the electrocardiogram (EKG) monitor, continuous blood glucose monitor, and smart pill. Wearable technology today simply collects data and stores it in a centralized cloud system. The influx of patient-generated health data (PGHD) and exchange of health data on the network bring challenges around security, privacy, interoperability, and data integrity. In this article, we describe those challenges and propose a conceptual model leveraging blockchain to improve security, privacy, interoperability, and data integrity of FDA-approved medical wearable devices. Our model emphasizes distribution and encryption of data, smart contracts, and permissioned blockchain-based architecture. We then discuss validation and contributions of the proposed model via a case-based scenario.