Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks

Abstract

Demand for healthcare robots will likely increase in the coming years due to their effectiveness and efficiency, an aging population, the rising cost of healthcare, and the trend within the industry toward personalized medicine. This paper focuses on the issues of patient and user safety, security, and privacy as they relate to healthcare robotics, and specifically the effect of medical device regulation and data protection laws on robots in healthcare.

First, it examines the demand for robots in healthcare and assess the benefits that robots can provide. Second, it looks at the types of robots currently being used in healthcare, anticipates future innovation, and identifies the key characteristics of these robots that will present regulatory issues. Third, it examines the current regulatory framework within which these robots will operate, focusing on medical device regulation and data protection laws. Because we are likely to see health-related robots appearing in both conventional healthcare and consumer spaces, there will be regulatory disruption and the opportunity for regulatory arbitrage. This paper argues that the regulation of both must change.

In order to maximize robots’ potential and minimize risks to users, regulation will need to move towards some form of premarket review of robot “safety.” Such review, likely by the Food and Drug Administration (FDA), should include broad considerations of potential harms, including security. In the data protection sphere, existing sector-based limitations that lead to gaps between, for example, Federal Trade Commission and Department of Health and Human Services’ Office for Civil Rights oversight, should be eliminated so that both patient and consumer privacy and security interests can be better protected. A foundational regulatory framework for both medical devices and consumers that is attuned to safety, security, and privacy will help foster innovation and confidence in robotics and ensure that we maximize robotic potential in healthcare.

Keywords: Health, Healthcare, Robots, Robotics, Safety, Security, Privacy, Medical Devices, HIPAA, FDA, FTC