The advent of wearable digital medical technology has significantly changed the way we think about healthcare and the practice of medicine. Several factors have converged to enhance the popularity of these devices, including a rapidly advancing technology field minimally encumbered by prohibitive regulations, greatly increased patient and consumer demand, convenience, ease of use and access, potentially decreased health care costs, and physician and health care provider shortages. However, the excitement fueled by the advantages of such technology are tempered by privacy and safety concerns and the legal ramifications of both.

Image: Smart Bandage. National Institutes of Health Image Gallery and Tufts University, Medford, Massachusetts.  CC BY-NC 2.0

Investments and profits from digital healthcare technology exceeded $3 billion last year with more than $4 billion in venture capital funding of areas such as healthcare consumer engagement, digital medical devices, and telemedicine.[1]  Average investment over these three areas alone amounted to over $300 million in 2014.[2] One study demonstrated that over 100,000 medical and health care apps are currently being marketed to consumers.[3] Moreover, a Pew research study of over 1,600 digital experts revealed that 83% of these experts were convinced that the use of electronic devices such as wearable digital medical technology should prove beneficial and will be commonplace in response to patient and consumer demand over the next 10 years.[4]  In fact, increased use of the technology could result in overall reduced health care costs.[5] According to the Health Resources and Services Administration (HRSA), as of last year there were over 6,000 designated Health Professional Shortage Areas (HPSAs) with a total need of an additional 16,000 primary care physicians to adequately care for the medically underserved.[6]

Although the benefits of wearable digital devices are many, including closer monitoring of health conditions (e.g. blood pressure monitoring for hypertension, glucose sampling for diabetes, exercise and weight control), increased patient involvement and compliance with health care regimens, and more frequent and productive interactions with health care providers, some patients and providers are skeptical. Recent problems with hacking, concerns about privacy, patient consent, and compliance with HIPAA have resulted in some healthcare providers proceeding with caution with regard to the use of wearable medical devices are dampening excitement about the digital revolution. [7] The FDA has weighed in, as well, with guidance regarding the use of mobile apps. [8] Additionally, wearable digital technology could have implications for meaningful use with regard to incorporation of data gleaned from these devices in electronic health care records (EHRs). Currently, the Office of Management and Budget (OMB) has proposed a rule that would increase flexibility with regard to the EHR certification program with more frequent updates to accommodate diverse health information applications such wearable medical technology. [9] [10] The legal boundaries are quite unclear in many cases, and new legislative and regulatory developments at both the state and federal level are on the horizon. One promising sign is that legislators in the 114th Congress have proposed making health technology legislation a priority.

This work was originally submitted as an abstract for consideration at the 2015 annual meeting of the American College of Legal Medicine.

Dorkina Myrick, MD, PhD, is a physician-scientist trained at the National Institutes of Health in Bethesda, Maryland. She is a candidate for a Master of Public Policy degree at the University of Oxford in Oxford, England.

[1] Infographic: Inside the $3 Billion Digital Health Care Industry.” HP Matter – The Healthcare Issue. Issue 3. Winter 2015.

[2] Digital Health Funding Year in Review 2014 by @RockHealth

[3] ” mHealth App Developer Economics 2014.” research2guidance. (Strategy advisory and market research company) Fourth Annual Study on mHealth app publishing. www.mHealthEconomics.com.

[4] Anderson, Janna and Raine, Lee. “The Internet of Things Will Thrive by 2025.” Pew Reserach Internet Project. May 14, 2014. http://www.pewinternet.org/2014/05/14/internet-of-things/.

[5] Olson, Parmy. “Wearable Tech Is Plugging into Health Insurance.” Forbes. June 19, 2014. Website: http://www.forbes.com/sites/parmyolson/2014/06/19/wearable-tech-health-insurance/.

[6] “Shortage Designation: Health Professional Shortage Areas & Medically Underserved Areas/Populations.” Health Resources and Services Administration Website. http://www.hrsa.gov/shortage/.

[7] Moon, Tracy. ” Wearable technology and its potential impact on the healthcare industry.” Becker’s Hospital Review. November 14, 2014. Website: http://www.beckershospitalreview.com/hospital-management-administration/wearable-technology-and-its-potential-impact-on-the-healthcare-industry.html.

[8] U.S. Food and Drug Administration, “Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff,” September 23, 2013, pp. 20-22.

[9] Gold, Ashley. “Welcome back! — Meaningful use’s next stage — Digital health reached more than $4 billion in 2014 — Legislative outlook for 2015.” Politico. January 5, 2015. Website: http://www.politico.com/morningehealth/0115/morningehealth16604.html.

[10] “Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements.” Office of the Secretary. Department of Health and Human Services. 45 CFR Part 170. RIN 0991-AB92. ONC-09910AB92-NPRM. Voluntary 2015 Edition.

[11] Image: Smart Bandage. National Institutes of Health Image Gallery and Tufts University, Medford, Massachusetts  CC BY-NC 2.0: Description – “This image features a prototype of a smart bandage equipped with temperature and pH sensors (lower right) printed directly onto the surface of a thin, flexible medical tape. You also see the “brains” of the operation: a microprocessor (upper left). When the sensors prompt the microprocessor, it heats up a hydrogel heating element in the bandage, releasing drugs and/or other healing substances on demand. It can also wirelessly transmit messages directly to a smartphone to keep patients and doctors updated.” Online: https://www.flickr.com/photos/nihgov/42139356290/in/album-72157659401055954/