Author(s):

  • Erdmier, Casey
  • Hatcher, Jason
  • Lee, Michael

Abstract:

This manuscript analyses the impact of wearable device technology in the healthcare industry. The authors provide an exploration of the different types of wearable technology that are becoming popular or are emerging into the consumer market and the personal health information and other user data these devices collect. The applications of wearable technology to healthcare and wellness are discussed, along with the impact of these devices on the industry. Finally, an analysis is provided, describing the current regulations in the US and UK that govern wearable devices and the impact of these device regulations on users and healthcare professionals.

Document:

https://doi.org/10.3109/03091902.2016.1153738

References:
  1. PricewaterhouseCoopers Health Research Institute. Health wearables: Early days. [Internet]. New York, NY: PricewaterhouseCoopers; 2014. [cited 2016 Jan 10]. Available from: https://www.pwc.com/us/en/health-industries/top-health-industry-issues/assets/pwc-hri-wearable-devices.pdf[Google Scholar]
  2. Smith A. U.S. Smartphone use in 2015. [Internet]. Washington, DC: Pew Research Center; 2015. [cited 2015 Jun 12]. Available from: http://www.pewinternet.org/files/2015/03/PI_Smartphones_0401151.pdf[Google Scholar]
  3. Sacco A. How wearable tech will change the smartphone as you know it. [Internet]. Framingham, MA: CIO; 2014. [cited 2015 Jun 12]. Available from: http://www.cio.com/article/2379340/consumer-technology/how-wearable-tech-will-change-the-smartphone-as-you-know-it.html[Google Scholar]
  4. Kobielus J. Wearables driving real-time actionable analytics into the modern lifestyle. [Internet]. Armonk, NY: IBM; 2014. [cited 2015 Jun 12]. Available from: http://www.ibmbigdatahub.com/blog/wearables-driving-real-time-actionable-analytics-modern-lifestyle[Google Scholar]
  5. Tilley A. Apple Watch scored an estimated 1 million pre-orders on launch day. [Internet]. Jersey City, NJ: Forbes Media; 2015. [cited 2015 Jun 12]. Available from: http://www.forbes.com/sites/aarontilley/2015/04/13/apple-watch-scored-an-estimated-1-million-pre-orders-on-launch-day/[Google Scholar]
  6. Elmer-DeWitt P. Here’s what Tim Cook said about Apple Watch holiday sales. [Internet]. New York, NY: Fortune; 2016. [cited 2015 Feb 5]. Available from: http://fortune.com/2016/02/05/apple-cook-watch-sales/[Google Scholar]
  7. Whitney L. Apple Watch sales to reach 36 million in first year, analyst predicts. [Internet]. San Francisco, CA: CBS Interactive; 2015. [cited 2015 Jun 12]. Available from: http://www.cnet.com/news/apple-watch-sales-to-reach-36-million-over-first-12-months-predicts-analyst/[Google Scholar]
  8. In the privacy of your own home. Consumer Rep. 2015;80:24–30. [Google Scholar]
  9. PricewaterhouseCoopers. Wearable technology future is ripe for growth – most notably among millennials, says PwC US. [Internet]. New York, NY: Author; 2014. [cited 2015 Jun 12]. Available from: http://www.pwc.com/us/en/press-releases/2014/wearable-technology-future.jhtml[Google Scholar]
  10. Consumer Electronics Association. Record-breaking year ahead: CEA reports industry revenues to reach all-time high of $223.2 billion in 2015. [Internet]. Arlington, VA: Author; 2015. [cited 2015 Jun 12]. Available from: https://www.ce.org/News/News-Releases/Press-Releases/2014/Record-Breaking-Year-Ahead-CEA-Reports-Industry-Re.aspx[Google Scholar]
  11. Hernandez D. Doctors monitor patients remotely via smartphones and fitness trackers. [Internet]. Arlington, VA: PBS Newshour; 2014. [cited 2015 Jun 12]. Available from: http://www.pbs.org/newshour/updates/doctors-monitor-patients-vitals-via-smartphones-fitness-trackers/[Google Scholar]
  12. Padmanabhan P. The Apple Watch: Healthcare data gratification, delayed. [Internet]. Framingham, MA: CIO; 2015. [cited 2015 Jun 26]. Available from: http://www.cio.com/article/2934884/healthcare/the-apple-watch-healthcare-data-gratification-delayed.html[Google Scholar]
  13. US Congress. Health Insurance Portability and Accountability Act of 1996. P.L. No. 104-191, 110 Stat. 1936. [Google Scholar]
  14. Armerding T. Big data collection makes it hard for you to remain anonymous. [Internet]. Framingham, MA: CIO; 2015. [cited 2015 Jun 12]. Available from: http://www.cio.com/article/2903003/big-data/big-data-collection-makes-it-hard-for-you-to-remain-anonymous.html[Google Scholar]
  15. Gibbs S. The future of wearable technology is not wearables – it’s analysing the data. [Internet]. London, UK: The Guardian; 2015. [cited 2015 June 25]. Available from: http://www.theguardian.com/technology/2015/jan/06/future-wearable-technology-analysing-data[Google Scholar]
  16. Apple Inc. Apple – Press Info – Nike and Apple team up to launch Nike iPod. [Internet]. Cupertino, CA: Author; 2006. [cited 2015 Jun 28]. Available from: https://www.apple.com/pr/library/2006/05/23Nike-and-Apple-Team-Up-to-Launch-Nike-iPod.html[Google Scholar]
  17. Fitbit Inc. Train smarter. Go farther. [Internet]. San Francisco, CA: Author; 2014. [cited 2015 Jun 28]. Available from: https://www.fitbit.com/surge#specs[Google Scholar]
  18. Eadicicco L. Fitbit CEO: Here’s what’s coming next. [Internet]. New York, NY: Time; 2015. [cited 2016 Jan 10]. Available from: http://time.com/4135523/fitbit-fitness-trackers-ceo-interview/[Google Scholar]
  19. Perry T. Apple Watch’s Wristful of Sensors and MEMS. [Internet]. Piscataway, NJ: Institute of Electrical and Electronics Engineers; 2014. [cited 2015 Jun 28]. Available from: http://spectrum.ieee.org/view-from-the-valley/consumer-electronics/portable-devices/apple-watchs-wristful-of-sensors-and-mems[Google Scholar]
  20. Doan D. Vive. [Internet]. Seattle, WA: Author; n.d. [cited 2015 Jun 28]. Available from: http://iamdandoan.com/167224/2666643/my-projects/vive[Google Scholar]
  21. Ambiq Micro. Fitness data heads for the clouds. [Internet]. Westlake Hills, TX: Author; 2015. [cited 2016 Jan 12]. Available from: http://ambiqmicro.com/news/fitness-data-heads-clouds[Google Scholar]
  22. Sametinger J, Rozenblit J, Lysecky R, et al. Security challenges for medical devices. Commun ACM. 2015;58:74–82. [Crossref], [Web of Science ®][Google Scholar]
  23. U.S. Food and Drug Administration. Overview of medical devices and their regulatory pathways. [Internet]. Washington, DC: Author; 2014. [cited 2015 Jun 28]. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm[Google Scholar]
  24. Standen A. Sure you can track your health data, but can your doctor use it? [Internet]. Washington, DC: National Public Radio, Inc.; 2015. [cited 2015 Jun 29]. Available from: http://www.npr.org/sections/health-shots/2015/01/19/377486437/sure-you-can-track-your-health-data-but-can-your-doctor-use-it[Google Scholar]
  25. U.S. Food and Drug Administration. General wellness: policy for low risk devices. Draft guidance for industry and Food and Drug Administration staff. [Internet]. Washington, DC: Author; 2015. [cited 2015 Jun 29]. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery[Google Scholar]
  26. Lynch S. Your Fitbit is safe. FDA won’t regulate fitness apps. Silicon Valley Business Journal. [Internet]. Charlotte, NC: Silicon Valley Business Journal; 2013. [cited 2015 Jun 28]. Available from: http://www.bizjournals.com/sanjose/news/2013/09/23/fda-details-what-health-apps-it-plans.html[Google Scholar]
  27. Sung D. Wearable tech and regulation: Should fitness trackers face the FDA? [Internet]. London, UK: Wareable; 2015. [cited 2016 Jan 10]. Available from: http://www.wareable.com/health-and-wellbeing/wearable-tech-and-regulation-5678[Google Scholar]
  28. U.S. Food and Drug Administration. FDA issues final guidance on mobile medical apps. [Internet]. Washington, DC: Author; 2013. [cited 2015 Jun 28]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm[Google Scholar]
  29. Newman J. FDA wants to regulate some wearables, but Fitbit’s fine. [Internet]. Framingham, MA: PC World; 2015. [cited 2015 Jun 29]. Available from: http://www.pcworld.com/article/2872677/fda-wants-to-regulate-some-wearables-but-fitbits-fine.html[Google Scholar]
  30. Baum S. FDA offers proposed guidance on when a wellness product becomes a medical device. [Internet]. Cleveland, OH: MedCity News; 2015. [cited 2015 Jun 29]. Available from: http://medcitynews.com/2015/01/fda-proposed-guidance-rewards-companies-using-vague-references-improving-health/[Google Scholar]
  31. Sipek S. Missed steps. Workforce. 2015;94:24–27. [Google Scholar]
  32. Cisneros L. UCSF creates center for digital health information, names director to lead it. [Internet]. San Francisco, CA: University of California San Francisco; 2013. [cited 2015 Jun 3]. Available from: http://www.ucsf.edu/news/2013/04/105551/ucsf-creates-center-digital-health-innovation-names-director-lead-it[Google Scholar]
  33. MIT Technology Review Custom. Mobile medical apps: A market on the move. MIT Technology Review. [Internet]. Cambridge, MA: MIT Technology Review; 2014. [cited 2015 Jun 3]. Available from: http://www.technologyreview.com/view/532661/mobile-medical-apps-a-market-on-the-move/#comments[Google Scholar]