THE INTERNET OF BODIES OPPORTUNITIES, RISKS, AND GOVERNANCE MARY LEE | BENJAMIN BOUDREAUX | RITIKA CHATURVEDI SASHA ROMANOSKY | BRYCE DOWNING Cover Design: Peter Soriano Cover Image: Adobe Stock/anttoniart. Limited Print and Electronic Distribution Rights This document and trademark(s) contained herein are protected by law. This representation of RAND intellectual property is provided for noncommercial use only. Unauthorized posting of this publication online is prohibited. Permission is given to duplicate this document for personal use only, as long as it is unaltered and complete. Permission is required from RAND to reproduce, or reuse in another form, any of our research documents for commercial use. For information on reprint and linking permissions, please visit www.rand.org/pubs/permissions.html. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. R® is a registered trademark. For more information on this publication, visit www.rand.org/t/RR3226 Library of Congress Cataloging-in-Publication Data is available for this publication. ISBN: 978-1-9774-0522-7 © Copyright 2020 RAND Corporation What Is the Internet of Bodies? Abbreviations wide variety of internet-connected “smart” AI artificial intelligence devices now promise consumers and Abusinesses improved performance, con- CCPA California Consumer Privacy Act venience, efficiency, and fun. Within this CFIUS Committee on Foreign Investment broader Internet of Things (IoT) lies a growing in the United States industry of devices that monitor the human body, collect health and other personal information, and CGM continuous glucose monitor transmit that data over the internet. We refer to these CPAP continuous positive airway pressure emerging technologies and the data they collect as the Internet of Bodies (IoB) (see, for example, Neal, EHR electronic health record 2014; Lee, 2018), a term first applied to law and policy EU European Union in 2016 by law and engineering professor Andrea M. Matwyshyn (Atlantic Council, 2017; Matwyshyn, EULA end user license agreement 2016; Matwyshyn, 2018; Matawyshyn, 2019). FDA U.S. Food and Drug IoB devices come in many forms. Some are Administration already in wide use, such as wristwatch fitness monitors or pacemakers that transmit data about FTC Federal Trade Commission a patient’s heart directly to a cardiologist. Other GDPR General Data Protection products that are under development or newly on the Regulation market may be less familiar, such as ingestible prod- ucts that collect and send information on a person’s H-ISAC Health Information Sharing gut, microchip implants, brain stimulation devices, Analysis Center and internet-connected toilets. HIPAA Health Insurance Portability and These devices have intimate access to the body Accountability Act and collect vast quantities of personal biometric data. ICS-CERT Industrial Control Systems Cyber IoB device makers promise to deliver substantial Emergency Readiness Team health and other benefits but also pose serious risks, including risks of hacking, privacy infringements, IoB Internet of Bodies or malfunction. Some devices, such as a reliable IoT Internet of Things artificial pancreas for diabetics, could revolutionize the treatment of disease, while others could merely MDIC Medical Device Innovation inflate health-care costs with little positive effect on Consortium outcomes. Access to huge torrents of live-streaming NCD noncommunicable disease biometric data might trigger breakthroughs in medi- cal knowledge or behavioral understanding. It might NFC near-field communication increase health outcome disparities, where only NIST National Institute of Standards and people with financial means have access to any of Technology these benefits. Or it might enable a surveillance state NITRD Networking and Information of unprecedented intrusion and consequence. Technology Research and There is no universally accepted definition of Development the IoB.1 For the purposes of this report, we refer to the IoB, or the IoB ecosystem, as IoB devices (defined PGHD person-generated health data next, with further explanation in the passages that RFID radio frequency identification follow) together with the software they contain and the data they collect.2 3 An IoB device is defined as a device that described in the next section) that are not connected • contains software or computing capabilities to smartphone applications (apps), because although • can communicate with an internet-connected they change the body’s functionality by allowing the device or network user to sense electromagnetic vibrations, the devices do not contain software. Trends in IoB technologies and satisfies one or both of the following: and additional examples are further discussed in the • collects person-generated health or biometric next section. data Some IoB devices may fall in and out of • can alter the human body’s function. our definition at different times. For example, a The software or computing capabilities in an Wi-Fi-connected smartphone on its own would IoB device may be as simple as a few lines of code not be part of the IoB; however, once a health app used to configure a radio frequency identifica- is installed that requires connection to the body to tion (RFID) microchip implant, or as complex as a track user information, such as heart rate or number computer that processes artificial intelligence (AI) of steps taken, the phone would be considered IoB. and machine learning algorithms. A connection to Our definition is meant to capture rapidly evolving the internet through cellular or Wi-Fi networks is technologies that have the potential to bring about required but need not be a direct connection. For the various risks and benefits that are discussed in example, a device may be connected via Bluetooth to this report. We focused on analyzing existing and a smartphone or USB device that communicates with emerging IoB technologies that appear to have the an internet-connected computer. Person-generated potential to improve health and medical outcomes, health data (PGHD) refers to health, clinical, or efficiency, and human function or performance, but wellness data collected by technologies to be recorded that could also endanger users’ legal, ethical, and or analyzed by the user or another person. Biometric privacy rights or present personal or national security or behavioral data refers to measurements of unique risks. physical or behavioral properties about a person. For this research, we conducted an extensive Finally, an alteration to the body’s function refers literature review and interviewed security experts, to an augmentation or modification of how the technology developers, and IoB advocates to under- user’s body performs, such as a change in cognitive stand anticipated risks and benefits. We had valu- enhancement and memory improvement provided able discussions with experts at BDYHAX 2019, an by a brain-computer interface, or the ability to record annual convention for bodyhackers, in February whatever the user sees through an intraocular lens 2019, and DEFCON 27, one of the world’s largest with a camera. hacker conferences, in August 2019. In this report, IoB devices generally, but not always, require a we discuss trends in the technology landscape and physical connection to the body (e.g., they are worn, outline the benefits and risks to the user and other ingested, implanted, or otherwise attached to or stakeholders. We present the current state of gover- embedded in the body, temporarily or permanently). nance that applies to IoB devices and the data they Many IoB devices are medical devices regulated by collect and conclude by offering recommendations the U.S. Food and Drug Administration (FDA).3 for improved regulation to best balance those risks Figure 1 depicts examples of technologies in the IoB and rewards. ecosystem that are either already available on the U.S. market or are under development. An Emerging Landscape of Devices Devices that are not connected to the internet, and Ideas such as ordinary heart monitors or medical ID brace- lets, are not included in the definition of IoB. Nor are Internet of Things implanted magnets (a niche consumer product used IoB is closely related to the IoT,4 which also has no by those in the so-called bodyhacker community, universal definition; however, IoT devices do have 4 FIGURE 1 IoB Examples Depression headset Intraocular lens Meditation headset Cochlear Augmented reality with camera implant Bluetooth-connected contact lens Internet-connected hearing aid glasses Wearable UV monitor Smart watch/fitness Pacemaker Tooth-mounted tracker sensor Electronic Temperature bracelet tattoo Electronic pill Artificial pancreas Microchip implant Clothing with temperature monitoring Smartphone with health apps Fertility measurement device Prosthetic Self-lacing shoes Temperature-sensing pacifier Internet-connected Electronic health scale records (EHRs) Antidrowning monitor Sleep-tracking onesie Bluetooth- connected diaper Wearable baby Internet-connected Sleep-sensing monitor toilet mattress several widely agreed-upon characteristics. First, IoT they collect users’ information or alter the body’s func- devices are connected to the internet either directly or tion. However, a hospital’s “smart” refrigerator used through a local network. Second, they have at least one for storing vaccines, which might be connected to a of the following functions: the ability to cause or sense network and alert staff if stock runs low, is not