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DOI: 10.15265/IY-2016-025
Unintended Consequences of Wearable Sensor Use in Healthcare
Contribution of the IMIA Wearable Sensors in Healthcare WGCorrespondence to:
Publication History
10 November 2016
Publication Date:
06 March 2018 (online)
Summary
Objectives: As wearable sensors take the consumer market by storm, and medical device manufacturers move to make their devices wireless and appropriate for ambulatory use, this revolution brings with it some unintended consequences, which we aim to discuss in this paper.
Methods: We discuss some important unintended consequences, both beneficial and unwanted, which relate to: modifications of behavior; creation and use of big data sets; new security vulnerabilities; and unforeseen challenges faced by regulatory authorities, struggling to keep pace with recent innovations.
Where possible, we proposed potential solutions to unwanted consequences.
Results: Intelligent and inclusive design processes may mitigate unintended modifications in behavior. For big data, legislating access to and use of these data will be a legal and political challenge in the years ahead, as we trade the health benefits of wearable sensors against the risk to our privacy. The wireless and personal nature of wearable sensors also exposes them to a number of unique security vulnerabilities. Regulation plays an important role in managing these security risks, but also has the dual responsibility of ensuring that wearable devices are fit for purpose. However, the burden of validating the function and security of medical devices is becoming infeasible for regulators, given the many software apps and wearable sensors entering the market each year, which are only a subset of an even larger ‘internet of things’. Conclusion: Wearable sensors may serve to improve wellbeing, but we must be vigilant against the occurrence of unintended consequences. With collaboration between device manufacturers, regulators, and end-users, we balance the risk of unintended consequences occurring against the incredible benefit that wearable sensors promise to bring to the world.
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References
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- 32 Forensic Focus.. (2013).. Extracting data from damaged mobile devices. Available: https://articles.forensicfocus.com/2013/08/21/extracting-data-from-damaged-mobile-devices.
- 33 Cloud Security Alliance. “The Notorious Nine: Cloud Computing Top Threats in 2013,” February 2013
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- 35 Keil OR. What Do Clinical Engineers Do as Medical Devices Enter New Digital Age?. Journal of Clinical Engineering 2016; 41: 52.
- 36 Torous J, Gipson MT, Chan S. APA Task Force to Develop Guidelines to Assess Apps, Wearable Sensors [Online].. Available: http://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2016.2a10?trendmd-shared=0&=.
- 37 Elenko E, Speier A, Zohar D. A regulatory framework emerges for digital medicine.. Nature Biotechnology 2015; 33: 697-702.
- 38 United States Food and Drug Administration.. Mobile Medical Applications.. Guidance for Industry and Food and Drug Administration Staff [Online]. Available: www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf.
- 39 P. Magazine.. PenTest: Cloud Pentesting [Online]. Available: https://pentestmag.com/download/pentest-open-cloud-pentesting/.
- 40 United States Food and Drug Administration and Center for Devices and Radiological Health.. (November 4, 2009).. Cybersecurity for Networked Medical Devices is a Shared Responsibility: FDA Safety Reminder. Available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm.
- 41 Hayhurst C. Is Your Patient Data Secure?. Biomedical Instrumentation & Technology 2014; 48: 166-73.
- 42 United States Food and Drug Administration.. (January 11, 2002).. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Available: http://www.fda.gov/Regulatory-Information/Guidances/ucm085281.htm.
- 43 United States Food and Drug Administration.. (March 11, 1997).. Design Control Guidance For Medical Device Manufacturers. Available: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm.
- 44 Rakitin SR. Networked Medical Devices: Essential Collaboration for Improved Safety.. Biomedical Instrumentation & Technology 2009; 43: 332-8.
- 45 King-Bailey V. Mastering Regulatory Compliance: Cybersecurity and Green / Lean Validation Strategies. Journal of GXP Compliance 2015; 19: 9-10.
- 46 United States Food and Drug Administration.. Post-market Management of Cybersecurity in Medical Devices.. Draft Guidance for Industry and Food and Drug Administration Staff [Online]. Available: www.fda.gov/downloads/MedicalDevices/Device-RegulationandGuidance/GuidanceDocuments/ UCM4820.
- 47 Steenhuysen J. Beyond Fitbit: The quest to develop medical-grade wearables [Online].. Available: www.reuters.com/article/us-usa-health-wearables-insight-idUSKBN0U10G120151218.
- 48 Heath A. Apple’s Tim Cook declares the end of the PC and hints at new medical product [Online].. Available: http://www.telegraph.co.uk/technology/2016/01/21/apples-tim-cook-declares-the-endof-the-pc-and-hints-at-new-medi.
- 49 Bastani F, Tang T. Improving Security of Wireless Communication in Medical Devices.. Massachusetts Institute of Technology; 2015
- 50 Ransford B, Clark SS, Kune DF, Fu K, Burleson WP. Design Challenges for Secure Implantable Medical Devices.. New York: Springer; 2014
- 51 Finnegan A, McCaffery F, Coleman G. A Security Assurance Framework for Networked Medical Devices.. In: Heidrich J, Oivo M, Jedlitschka A, Baldassarre M. editors. Product-Focused Software Process Improvement, vol.. 7983. Berlin Heidelberg: Springer; 2013. p. 363-6.
Correspondence to:
-
References
- 1 International Data Corporation.. (27 Aug 2015).. Apple Debuts at the Number Two Spot as the Worldwide Wearables Market Grows 223.2% in 2Q15, Says IDC Available: http://www.idc.com/getdoc.jsp?containerId=prUS25872215.
- 2 International Telecommunication Union.. ITU Internet Reports: The Internet of Things.. Geneva; 2005.
- 3 Schreier G. The Internet of Things for Personalized Health.. Stud Health Technol Inform 2014; 200: 22-31.
- 4 Jara AJ, Zamora-Izquierdo MA, Skarmeta AF. Interconnection Framework for mHealth and Remote Monitoring Based on the Internet of Things.. IEEE Journal on Selected Areas in Communications 2013; 31: 47-65.
- 5 Dohr A, Modre-Osprian R, Drobics M, Hayn D, Schreier G. The Internet of Things for Ambient Assisted Living.. Proceedings of the ITNG 2010 - 7th International Conference on Information Technology : New Generations. Las Vegas, Nevada, USA: 2010 p. 804-9.
- 6 Zhang J, Song Y-L, Bai C-X. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.. Int J Chron Obstruct Pulmon Dis 2013; 8: 433-8.
- 7 Hafezi H, Robertson TL, Moon GD, Au-Yeung K-Y, Zdeblick MJ, Savage GM. An Ingestible Sensor for Measuring Medication Adherence.. IEEE Trans Biomed Eng 2015; 62: 99-109.
- 8 Stone M. (2014, accessed 08/01/2016).. Smart-phone Addiction Now Has A Clinical Name. Business Insider Australia. Available: http://www.businessinsider.com.au/what-is-nomophobia-2014-7.
- 9 Deb A. Phantom vibration and phantom ringing among mobile phone users: A systematic review of literature.. Asia Pac Psychiatry 2015; Sep 7 (Suppl. 03) 231-9.
- 10 Smith MW. A Fitbit fanatic’s cry for help: I’m addicted to steps.. Lessons from a year spent fully quantified. Washington Post; 2015. Available: http://www.washingtonpost.com/news/to-your-health/wp/2015/05/11/a-fitbit-fanatics-cry-for-help/.
- 11 Stegemann S, Baeyens JP, Cerreta F, Chanie E, Löfgren A, Maio M. et al. Adherence measurement systems and technology for medications in older patient populations.. European Geriatric Medicine 2012; 3: 254-60.
- 12 Shull PB, Jirattigalachote W, Hunt MA, Cutkosky MR, Delp SL. Quantified self and human movement: A review on the clinical impact of wearable sensing and feedback for gait analysis and intervention.. Gait & Posture 2014; 40: 11-9.
- 13 Redmond SJ, Lovell NH, Yang GZ, Horsch A, Lukowicz P, Murrugarra L. et al. What Does Big Data Mean for Wearable Sensor Systems?. Yearb Med Inform 2014; 9: 135-42.
- 14 Cheek C, Fleming T, Lucassen MFG, Bridgman H, Stasiak K, Shepherd M. et al. Integrating Health Behavior Theory and Design Elements in Serious Games.. JMIR Mental Health 2015; 2: e11.
- 15 Olson P. Wearable Tech Is Plugging Into Health Insurance.. Forbes Tech; 2014. Available: http://www.forbes.com/sites/parmyolson/2014/06/19/wearable-tech-health-insurance/.
- 16 PhysioNet.. (Jan 5, 2016).. Available: http://www.physionet.org.
- 17 HHS Idea Lab.. (Jan 5, 2016).. Available: http://www.hhs.gov/idealab/what-we-do/health-data/.
- 18 Shany T, Wang K, Liu Y, Lovell NH, Redmond SJ. Review: Are we stumbling in our quest to find the best predictor? Over-optimism in sensor-based models for predicting falls in older adults.. Healthc Technol Lett 2015; Aug 3 2 (Suppl. 04) 79-88.
- 19 Kaggle.. (2016, accessed 05/01/2016).. Available: http://www.kaggle.com.
- 20 Atienza AA, Zarcadoolas C, Vaughon W, Hughes P, Patel V, Chou W-YS. et al. Consumer Attitudes and Perceptions on mHealth Privacy and Security: Findings From a Mixed-Methods Study.. J Health Commun 2015; 20 (Suppl. 06) 673-9.
- 21 Deloitte.. Networked medical device cybersecurity and patient safety.. White Paper; 2013
- 22 Kotz D. A threat taxonomy for mHealth privacy.. Presented at the 2011 Third International Conference on Communication Systems and Networks; 2011
- 23 Halperin D, Heydt-Benjamin TS, Fu K, Kohno T, Maisel WH. Security and Privacy for Implantable Medical Devices.. IEEE Pervasive Comput 2008; 7: 30-9.
- 24 Al Ameen M, Liu J, Kwak K. Security and Privacy Issues in Wireless Sensor Networks for Healthcare Applications.. J Med Syst 2010; 36: 93-101.
- 25 Symantec.. Networked Medical Devices: Security and Privacy Threats.. White Paper; 2012
- 26 Meingast M, Roosta T, Sastry S. Security and Privacy Issues with Health Care Information Technology.. Presented at the 2006 International Conference of the IEEE Engineering in Medicine and Biology Society; 2006
- 27 Li M, Lou W, Ren K. Data security and privacy in wireless body area networks.. IEEE Wireless Commun 2010; 17: 51-8.
- 28 Maisel WH, Kohno T. Improving the Security and Privacy of Implantable Medical Devices.. N Engl J Med 2010; 362: 1164-6.
- 29 Hei X, Du X, Lin S, Lee I, Sokolsky O. Patient Infusion Pattern based Access Control Schemes for Wireless Insulin Pump System.. IEEE Trans Parallel Distrib Syst 2015; 26: 3108-21.
- 30 Sigholm J, Larsson E. Determining the Utility of Cyber Vulnerability Implantation: The Heartbleed Bug as a Cyber Operation.. Presented at the 2014 IEEE Military Communications Conference, Baltimore USA: 2014
- 31 InGuardians.. (2009).. AMI Attack and Defense Showdown. Available: http://www.willhackforsushi.com/presentations/SGRS%20AMI%20/Attack%20and%20Defense%20Showdown.pdf.
- 32 Forensic Focus.. (2013).. Extracting data from damaged mobile devices. Available: https://articles.forensicfocus.com/2013/08/21/extracting-data-from-damaged-mobile-devices.
- 33 Cloud Security Alliance. “The Notorious Nine: Cloud Computing Top Threats in 2013,” February 2013
- 34 United States Food and Drug Administration.. General Wellness: Policy for Low Risk Devices.. Draft Guidance for Industry and Food and Drug Administration Staff [Online]. Available: www.fda. gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf.
- 35 Keil OR. What Do Clinical Engineers Do as Medical Devices Enter New Digital Age?. Journal of Clinical Engineering 2016; 41: 52.
- 36 Torous J, Gipson MT, Chan S. APA Task Force to Develop Guidelines to Assess Apps, Wearable Sensors [Online].. Available: http://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2016.2a10?trendmd-shared=0&=.
- 37 Elenko E, Speier A, Zohar D. A regulatory framework emerges for digital medicine.. Nature Biotechnology 2015; 33: 697-702.
- 38 United States Food and Drug Administration.. Mobile Medical Applications.. Guidance for Industry and Food and Drug Administration Staff [Online]. Available: www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf.
- 39 P. Magazine.. PenTest: Cloud Pentesting [Online]. Available: https://pentestmag.com/download/pentest-open-cloud-pentesting/.
- 40 United States Food and Drug Administration and Center for Devices and Radiological Health.. (November 4, 2009).. Cybersecurity for Networked Medical Devices is a Shared Responsibility: FDA Safety Reminder. Available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm.
- 41 Hayhurst C. Is Your Patient Data Secure?. Biomedical Instrumentation & Technology 2014; 48: 166-73.
- 42 United States Food and Drug Administration.. (January 11, 2002).. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Available: http://www.fda.gov/Regulatory-Information/Guidances/ucm085281.htm.
- 43 United States Food and Drug Administration.. (March 11, 1997).. Design Control Guidance For Medical Device Manufacturers. Available: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm.
- 44 Rakitin SR. Networked Medical Devices: Essential Collaboration for Improved Safety.. Biomedical Instrumentation & Technology 2009; 43: 332-8.
- 45 King-Bailey V. Mastering Regulatory Compliance: Cybersecurity and Green / Lean Validation Strategies. Journal of GXP Compliance 2015; 19: 9-10.
- 46 United States Food and Drug Administration.. Post-market Management of Cybersecurity in Medical Devices.. Draft Guidance for Industry and Food and Drug Administration Staff [Online]. Available: www.fda.gov/downloads/MedicalDevices/Device-RegulationandGuidance/GuidanceDocuments/ UCM4820.
- 47 Steenhuysen J. Beyond Fitbit: The quest to develop medical-grade wearables [Online].. Available: www.reuters.com/article/us-usa-health-wearables-insight-idUSKBN0U10G120151218.
- 48 Heath A. Apple’s Tim Cook declares the end of the PC and hints at new medical product [Online].. Available: http://www.telegraph.co.uk/technology/2016/01/21/apples-tim-cook-declares-the-endof-the-pc-and-hints-at-new-medi.
- 49 Bastani F, Tang T. Improving Security of Wireless Communication in Medical Devices.. Massachusetts Institute of Technology; 2015
- 50 Ransford B, Clark SS, Kune DF, Fu K, Burleson WP. Design Challenges for Secure Implantable Medical Devices.. New York: Springer; 2014
- 51 Finnegan A, McCaffery F, Coleman G. A Security Assurance Framework for Networked Medical Devices.. In: Heidrich J, Oivo M, Jedlitschka A, Baldassarre M. editors. Product-Focused Software Process Improvement, vol.. 7983. Berlin Heidelberg: Springer; 2013. p. 363-6.