FDA Regulations and mHealth
With lightening advances in technology, the medical services landscape
has been intensely impacted. Both the
practitioner and the patient feel these impacts. Practitioners have medical apps available to
them that allow for faster and more accurate diagnosis or calculations, and
patients use apps to check their pulse, calculate insulin levels, or even
diagnose melanoma through a smartphone lens.
The mHealth revolution has put more power into the hands of the
digitally engaged patient (Lupton, 2013).
However, newer studies are reporting that apps and some technology that
patients might be utilizing do not work effectively or sometimes even
correctly. For example, an app utilized
by a large pharmaceutical company found that their technology did not
accurately measure joint swelling for rheumatoid patients by 50% in some
instances (Hamel, Cortez, Cohen, & Kesselheim, 2014). Furthermore, many marketing claims are made
about popular mHealth apps that have no empirical evidence to support
effectiveness of the app (Lewis, & Wyatt 2014; Hamel, Cortez, Cohen, &
Kesselheim, 2014). In addition, critics
point to the potential concerns related to the safety and security of patient
medical data, stating if one small problem arises in the technology, security
of that data could be severely compromised.
Who hasn’t been affected by a virus or a bug in today’s connected world?
Nonetheless, progress can’t be stopped. The FDA in July 2013 made a statement that it
would regulate only apps that were intended as medical devices and the risk to
the patient if the device did not function as intended (Hamel, Cortez, Cohen,
& Kesselheim, 2014). For example, a
device that monitors eye movement to diagnose imbalance disorders. However, the agency stated it would not
regulate apps that pose a lower risk to patients such as tracking asthma
inhaler use or behavioral symptom tracking.
Yet, many professionals point out these apps deemed “low risk” by the
FDA may have significant adverse effects if there was a malfunction. He definition of risk and the definition of
medical device are the key components of this debate.
Other sides of the debate list increased regulation can dampen and
impeded technology progress. Moreover,
with the proliferation of mHealth and medical technology advances the FDA does
not have the resources to effectively monitor every potential risk and device.
References
Hamel, M. B., Cortez, N. G.,
Cohen, I. G., & Kesselheim, A. S. (2014). FDA regulation of mobile health
technologies. New England Journal of Medicine,371(4),
372-379.
Lewis, T. L., & Wyatt, J.
C. (2014). Mhealth and mobile medical apps: A framework to assess risk and
promote safer use. Journal of medical Internet research, 16(9).
Lupton, D. (2013). The
digitally engaged patient: self-monitoring and self-care in the digital health
era. Social Theory & Health, 11(3), 256-270.
