Regulating Healthcare Robots in the Hospital and the Home: Considerations for Maximizing Opportunities and Minimizing Risks
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Some of the most dynamic areas of robotics research and development today are healthcare applications. Demand for these robots will likely increase in the coming years due to their effectiveness and efficiency, an ageing population, the rising cost of healthcare, and the trend within the industry toward personalized medicine. But all-purpose “healthcare companions” and robotic “doctors” will not be available for purchase or be deployed in our hospitals any time soon. Rather, robots in healthcare will be an evolution in the coming decades. There are basic, pressing issues that need to be addressed in the nearer future in order to ensure that robots are able to maintain sustainable innovation with the confidence of providers, patients, consumers, and investors. We will only be able to maximize the potential of robots in healthcare through responsible design, deployment, and use, which must include taking into consideration potential issues that could, if overlooked, manifest themselves in ways that harm patients and consumers, diminish the trust of key stakeholders of robots in healthcare, and stifle long-term innovation by resulting in overly restrictive reactionary regulation. In this paper, we focus on the issues of patient and user safety, security, and privacy, and specifically the effect of medical device regulation and data protection laws on robots in healthcare. First, we examine the demand for robots in healthcare and assess the benefits that robots can provide. Second, we look at the types of robots currently being used in healthcare, anticipate future innovation, and identify the key characteristics of these robots that will present regulatory issues, including their increasing number of functions, complex data collection, processing, storing, and use practices, and increasing connectivity and potential for cloud usage, all resulting in an unprecedented expansion and centralization of patient data. Third, we examine 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. We argue the regulation of both must change. In order to maximize robots’ potential and minimize risks to users, we will need to move towards some form of premarket review of robot “safety,” which should include broad considerations of potential harms, including security. Furthermore, current sector-based limitations that lead to gaps between, for example, FTC and HHS-OCR oversight, should be eliminated so that privacy and security interests can be better protected in the “HIPAA-free” zone. A foundational regulatory framework for both medical devices and consumers which is attuned to safety, security, and privacy will help foster innovation and confidence in robotics and ensure that we maximize the potential of robots in healthcare.
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