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Wearable Medical Devices Give Abundant Data and Risks

0187049001552331169.jpgSince 2013, the number of U.S. consumers tracking their health data with wearables has doubled.1 And that number continues to rise: During the third quarter of 2018, the wearables market saw a nearly 60 percent increase in earnings over the prior year.2

Wearables are electronic devices worn on the body, often like a watch. Wearables can track patient data like heart rate, blood pressure, or blood glucose. They can also track activity level, e.g., counting steps.

Promoters of wearables say that they could provide physicians with abundant data when caring for patients with chronic health issues. They also predict that combining wearables and gamification—e.g., competing with family members to see who can “score” the most steps in a day—may lead to improved health and better health outcomes.

However, skeptics question whether gamification will really lead to healthier behaviors long-term. And questions abound about what to do with wearables’ data and how to protect it. Wearables bring promise, but also real risks for patient safety and physician liability.

Benefits of Wearables

Promoters of wearables believe wearables will drive the transition to intelligent care, whereby physicians have access to more data—in which they can identify actionable components. Florence Comite, MD, a New York endocrinologist who describes wearables as “almost like magic,” uses data from wearables to tailor her interventions for patients with chronic conditions.3

Wearables can help patients take action, too. In one recent study, diabetes patients using a wearable app showed randomized controlled trial results comparable or superior to patients taking diabetes medications.4

Promoters of such digital strategies hope that they will encourage healthy behaviors while requiring fewer office visits purely for monitoring purposes, thereby reducing healthcare costs while improving patient experience and engagement. For instance, David Rhew, MD, chief medical officer for Samsung, hopes that wearables can help patients move to the highest level of patient activation, Level 4.5

The Four Levels of Patient Activation

  • Level 1: Predisposed to be passive. “My doctor is in charge of my health.”
  • Level 2: Building knowledge and confidence. “I could be doing more.”
  • Level 3: Taking action. “I’m part of my healthcare team.”
  • Level 4: Maintaining behaviors, pushing further. “I’m my own advocate.”

Some apps promote healthy behaviors with gamification.6 For instance, a user might compete with family or friends to take the most steps each day, either informally or through an organized group. Harvard professor Ichiro Kawachi, PhD, wrote in JAMA Internal Medicine that this is “an opportunity for clinicians to turn health promotion into an engaging, fulfilling and fun activity.”7 Sponsors hope that such groups can promote accountability, responsibility, and mindfulness about activity and health conditions.

Skepticism about Wearables

It is too soon to say whether wearables will increase healthy behaviors and/or reduce office visits, thus lowering healthcare costs. Some studies have found that wearable devices have no advantage over other forms of goal tracking or social support in helping people meet their health and fitness goals.8 A 2016 study from the University of Pittsburgh, for instance, found that “young adults who used fitness trackers in the study lost less weight than those in a control group who self-reported their exercise and diet.”9

Risks of Wearables

Though each device has its pros and cons, all wearables generate concerns for physicians, including:

  • Poor data quality: Data from wearables may or may not be reliable enough for medical use.10
  • Data fixation: Patients may fixate on one number—steps per day, for instance—at the expense of other health variables, such as their diet, sleep habits, etc.
  • Lack of interoperability with electronic health records (EHRs): If a patient’s wearable cannot stream data to the patient’s EHR, then how can the physician’s practice securely acquire the data?
  • Data saturation: Physicians receiving patient data from wearables risk being soaked by a data fire hose.11 Physicians need a plan and a process to determine what measurements are relevant to a given patient.
  • Unclear physician responsibilities for collecting, monitoring, and protecting data: HIPAA applies to patient data collected by physicians,12 but differing state laws mean that a physician’s specific responsibilities for monitoring and protecting patient data vary by location.
  • Lack of data security—and liability for physicians: Wearables are subject to cyber attack. In addition to presenting obvious risks to patient safety, this may also present liability risks to physicians—who may be expected to notify patients of recalls issued for their wearables.13

Next Steps

As more and more physicians are accepting—or requesting—their patients’ data from wearables, questions include: How can we tell when data from wearables is accurate? When it’s actionable? When it’s secure?

Certainly, physicians interacting with data from wearables should independently confirm that data before changing a patient’s care, and should store data from wearables securely.

For help implementing remote patient monitoring in your practice, see the American Medical Association’s (AMA’s) Digital Health Implementation Playbook.


  1. Donovan F. Despite patient privacy risks, more people use wearables for health. Health IT Security. October 1, 2018. https://healthitsecurity.com/news/despite-patient-privacy-risks-more-people-use-wearables-for-health. Accessed November 28, 2018.
  2. Zaninello L. The wearables market is booming: Fitbit scares Apple and Google. Android Pit. November 26, 2018. https://www.androidpit.com/wearable-market-growth-fitbit-scares-apple-and-google. Accessed November 28, 2018.
  3. Eramo L. Do doctors care about your wearable data? Future Health Index. October 18, 2017. https://www.futurehealthindex.com/2017/10/18/doctors-care-wearable-data/. Accessed November 29, 2018.
  4. Rhew D, panel moderator. Disruptive digital health technology. A4M MMI World Congress 2017. Dec 14; Las Vegas, NV.
  5. Ibid.
  6. Spil T, Sunyaev A, Thiebes S, van Baalen R. The adoption of wearables for a healthy lifestyle: Can gamification help? 50th Hawaii International Conference on System Sciences. 2017 Jan 4-6; Waikoloa, HI. https://pdfs.semanticscholar.org/dacd/744f57cf9551fe012884697e735a2a9cd3a8.pdf. Accessed November 28, 2018.
  7. Berg S. “To boost physical activity in patients, make a game of it.” American Medical Association. February 27, 2018. https://www.ama-assn.org/delivering-care/public-health/boost-physical-activity-patients-make-game-it. Accessed November 20, 2018.
  8. Ross E. Weight loss on your wrist? Fitness trackers may not help. National Public Radio. September 20, 2016. https://www.npr.org/sections/health-shots/2016/09/20/494631423/weight-loss-on-your-wrist-fitness-trackers-may-not-help. Accessed November 28, 2018.
  9. O’Neill S. As insurers offer discounts for fitness trackers, wearers should step with caution. National Public Radio. November 19, 2018. https://www.npr.org/sections/health-shots/2018/11/19/668266197/as-insurers-offer-discounts-for-fitness-trackers-wearers-should-step-with-caution. Accessed November 28, 2018.
  10. Piwek L, Ellis DA, Andrews S, Joinson A. The rise of consumer health wearables: Promises and barriers. PLOS medicine. February 2, 2016. https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001953. Accessed November 28, 2018.
  11. Donovan F. How does HIPAA apply to wearable health technology? Health IT Security. July 24, 2018. https://healthitsecurity.com/news/how-does-hipaa-apply-to-wearable-health-technology. Accessed November 28, 2018.
  12. Ibid.
  13. Carman SL, Umhofer RH. Wearable medical devices can raise issues for healthcare professionals. Healthcare Analytics News. October 30, 2018. https://www.hcanews.com/news/wearable-medical-devices-can-raise-issues-for-healthcare-professionals. Accessed November 28, 2018.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

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