Regulating Healthcare Robots in the Hospital and the Home: Considerations for Maximizing Opportunities and Minimizing Risks
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Authors
Simshaw, Drew
Terry, Nicolas
Hauser, Kris
Cummings, M.L.
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Advisors
Date of Issue
2016
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Abstract
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.
Type
Article
Description
DRAFT
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Naval Postgraduate School (U.S.)
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29 p.
Citation
Drew Simshaw, Nicolas Terry, Kris Hauser & M.L. Cummings, Regulating Healthcare Robots: Maximizing Opportunities While
Minimizing Risks, 22 Rich. J.L. & Tech 3 (2016).
Distribution Statement
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This publication is a work of the U.S. Government as defined in Title 17, United States Code, Section 101. Copyright protection is not available for this work in the United States.