mHealth Products

mHealth Products. A bewildering array of mHealth products can make it difficult for individual patients or providers to evaluate their quality or utility. The FDA (2013) intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. Incumbent upon each healthcare provider is a clear understanding of the implications of this guidance on clinical practice, specifically when choosing to use a medical app. What influences our decision to use any app? Sometimes the decision is made for us, such as an app that come preloaded on a smartphone. However, it is your decision to use the app or download another. Whether we realize it or not, the process likely involves multiple steps and critical appraisal of a host of factors.

Above all else, mHealth technologies must be safe and effective. Although the vast majority of mHealth products are very low-risk, new evidence emerging through independent evaluations reveals products that do not work as claimed or that make mistakes. Some apps simultaneously promise medical benefits while disclaiming that the app is for entertainment purposes only. Still use of these and other apps place more burden on the user to determine if an app is useful, safe, and appropriate.

Mobile Platformsm (Health Products)

Apps can be run on a number of different devices, or mobile platforms, including smartphones, tablets, and portable computers. The recent FDA guidelines emphasize the importance of analyzing the benefits and risks unique to each mobile platform for a given medical app. The limitations of a platform have the potential not only to compromise the intended use of the app but also to risk patient safety if clinical decisions are made based on the app’s use, such as a radiology app on a mobile phone that is limited by a small screen size and lower contrast ratio. Clinicians assessing the utility and reliability of apps should be aware of whether the platform is appropriate for the app.

Purpose and Risk (Health Products)

The key issue here is whether there is a risk to the patient if the app is not used as intended. The guidelines carefully distinguish higher risk apps—those classified as medical devices—from those that are lower risk. Examples of higher risk apps are those that formulate drug dosing schedules, such as warfarin dosage, based on a patient’s international normalized ratio readings. Lower risk apps include those that simply provide easy access to information for doctors or patients without treatment suggestions, or those that perform simple calculations used in everyday practice, such as a Glasgow coma scale calculator. Whether an app qualifies as a medical device may be difficult to ascertain, especially when diagnosis or management can be informed by the use of lower risk apps. For the creators of apps, a risk assessment can identify the need for safeguards or for the inclusion of a disclaimer. As app users, a similar appreciation of risk in clinical practice may help protect patients and prevent litigation.

Authors, Creators, Developers, and Users

As with the critical appraisal of any clinical tool, it is important to know whether the population for which the tool was designed is representative of the patient group. Is the app designed for use by patients or healthcare professionals? Who created the app? Was a professional body, doctor or other healthcare professional, or a drug company involved? Are there competing interests? It may also be relevant to consider whether the app was designed for use in the United Kingdom, in the United States, or in another country. According to the US guidelines, apps may avoid regulation if they are solely used by the clinician who developed them or are restricted to their immediate clinical practice network. In theory, this allows for entrepreneurial creativity while placing clinical responsibility in the hands of the developer.

Safety, Privacy, and Credibility

Perhaps the most important factor that ensures patient safety is the accuracy and reliability of the information within apps. Although the guidelines put the onus on the app manufacturers to ensure quality and initiate prompt corrections to prevent patient and user harm, ultimately, we as clinicians must judge whether the electronic information we use is reliable, up to date, and does no harm to our patients. Any healthcare provider aspiring to code medical apps should ensure that they are accurate in their coding language and promptly and proficiently debug any errors that may lead to app malfunction or patient harm.

Although there is ongoing debate about whether regulation of medical apps may stifle creativity, the responsibility for good clinical care and patient safety still lies with the clinician, and so clinicians have responsibility for the use of apps in the clinical workplace.

Telehealth and Point-of-Care Technologies

Many mHealth technologies are being used to broaden access to care, either by extending the reach of providers through remote monitoring of patients or by giving advice when users otherwise would not visit a medical professional. Apps like Pocket Doctor and iTriage, which suggest possible diagnoses on the basis of inputs from patients, are proliferating. Making medical advice available beyond traditional settings could broaden access to care for the uninsured, those living in rural areas, immigrants, and perhaps even elderly patients. Tremendous strides have been made in deploying mHealth technologies to expand access to care in less developed countries.

Telehealth is still an evolving technology; while the offsite interventions or contacts often lead to less time being wasted on non-care-oriented tasks because of the efficiencies offered by the technology applications, its use must never be associated with less care. It is also important to note that nursing activity in telehealth still follows the same best practice standards as those espoused in conventional care.

A few clinical uses for telehealth technologies and some sample clinical applications include the following:

Clinical Uses

Clinical Uses (Links to an external site.)


Point -of-care (POC) testing allows for testing and diagnosis at the patient’s side and can be conducted anywhere the patient is, such as the home, physician office, ambulance, or hospital bedside (National Institutes of Health, 2010). This technology allows for quick, on-the-spot testing, with immediately available results. Additionally, these results can be downloaded directly into the EHR through interface engines. This decreases the risk of error in manually entered results, and the results are immediately available to caregivers for making treatment decisions.

There are many innovative devices emerging, particularly those that engage the patient in his or her own care to monitor and maintain health and well-being, including such things as fitness measuring devices, scales, biometric devices, as well as FDA-approved medical devices, such as insulin pumps, pacemakers, defibrillators, and so forth, which can be interfaced with EHRs and patient portals. The potential for advancement in POC devices is one of the most rapidly growing areas in the health care industry with tremendous potential for improvement in patient safety, quality, and population health.


mHealth Products

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