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.