Exploring the Nature of Medical Device Privacy and Security Legal Regulations

Abstract

Medical devices, from wearable health trackers to pacemakers and telehealth visits, have become increasingly prevalent. Addressing concerns about data privacy and risk management is essential with the amount of personal data collected through these devices rising. While the Health Insurance Portability and Accountability Act (HIPAA) has long been considered the primary regulation for patient personal health information data, the Food and Drug Administration (FDA) and the Healthcare Supply Chain Association (HSCA) have enacted new guidelines that aim to hold medical device manufacturers accountable for data privacy and risk management. The chapter concludes that these legal regulations individually touch upon essential aspects of patient data privacy and medical device safety; however, their combined influence provides a more substantial base to hold medical de-vice manufacturers responsible for risk management and data protection.