The emergence of electronic medical devices has facilitated the integration of cybersecurity and privacy practices into the design of medical devices. An essential part of device design is the communication of the device principles to the consumers and providers that will utilize the device. The purpose of this research was to analyze the importance of health information privacy, propose a medical device privacy label and standards that can help fill these gaps for consumers, and evaluate the regulatory framework for which this proposal can be implemented. Privacy, both physical and informational, is a key pillar of American healthcare especially in our connected worlds. The threat to privacy from criminal actors and the impact that those actions of violating privacy can have on an individual’s health are serious. Evaluating previous privacy labels, which lacked in applicability to the healthcare field, this research proposes a unique, standardized consumer privacy label for the FDA to implement, mirroring the design and success of the FDA nutrition label in educating consumers in healthy decision making.

This content is only available via PDF.