Mid-week questions

Week 6: Mobile Applications

Table of Contents

Mobile Applications

Mobile Health, also known as mHealth, is defined as the use of wireless communication to support efficiency in public health and clinical practice (Yetisen et al., 2014). To facilitate mHealth, mobile applications (apps) have been developed, which can be executed either on a mobile platform or on a web-based software application that is tailored to a mobile platform but is executed on a server. Mobile medical apps are accessories to a regulated medical device or are software that transforms a mobile platform into a regulated medical device. These mobile devices may include, but are not limited to, mobile phones or smartphones, tablet computers, smartwatches, and point-of-care (POC) devices. As growth of mHealth continues, major areas for mHealth growth are:

· Preventive medicine and health promotion can be leveraged through education and awareness applications;

· Portable diagnostic devices that allow monitoring of human conditions in clinical settings or offsite locations;

· Applications for data management, training medical personnel, and mobile payments.

Regulation of Medical Devices

The United States Food and Drug Administration (FDA) oversees medical applications and assesses their potential misuse or malfunction in order to reduce these risks to the public. This growing risk factor prompted the FDA to introduce a guidance in 2011. In 2013, the FDA released its final guidance entitled “Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff”. The guidance offers clear distinction between an unregulated “mobile application” and a “mobile medical application” which are subject to overt FDA regulation. This guidance also focuses on apps that possess a greater risk to patients if they don’t function as they intended.

Medical Device or Mobile Application?

The Food and Drug Administration (FDA) (2013) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms. Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Many mobile apps are not medical devices, meaning such mobile apps do not meet the definition of a device by the Federal Food, Drug, and Cosmetic Act (FD&C Act); therefore, the FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, the FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). One example is a mobile app that makes a light emitting diode (LED) operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific medical device intended use), the mobile app would not be considered a medical device. If, however, through marketing, labeling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for providers to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.

The following activity provides examples that illustrate the distinctions between medical apps and devices, however, this list is not inclusive (FDA, 2013).

Medical Apps and Devices

Medical Apps and Devices (Links to an external site.)

Transcript

The following examples represent mobile apps for which the FDA (2013) intends to exercise enforcement discretion:

Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment –

· Examples include apps that coach patients with conditions such as cardiovascular disease, hypertension, diabetes or obesity, and promote strategies for maintaining a healthy weight, getting optimal nutrition, exercising and staying fit, managing salt intake, or adhering to pre-determined medication dosing schedules by simple prompting.

 Mobile apps that provide patients with simple tools to organize and track their health information –

· Examples include apps that provide simple tools for patients with specific conditions or chronic disease (e.g., obesity, anorexia, arthritis, diabetes, heart disease) to log, track, or trend their events or measurements (e.g., blood pressure measurements, drug intake times, diet, daily routine or emotional state) and share this information with their health care provider as part of a disease-management plan.

Mobile apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference) –

· Examples include apps that use a patient’s diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions such as influenza;

· Apps that are drug-drug interaction or drug-allergy look-up tools.

Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions –

· Examples include apps that serve as videoconferencing portals specifically intended for medical use and to enhance communications between patients, healthcare providers, and caregivers;

· Apps specifically intended for medical uses that utilize the mobile device’s built-in camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient’s skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between healthcare providers or between healthcare providers and patients/caregivers.

Mobile apps that perform simple calculations routinely used in clinical practice-

· Examples of such general purpose tools include medical calculators for Body Mass Index (BMI), Total Body Water / Urea Volume of Distribution, etc.

 Mobile apps that enable individuals to interact with PHR systems or EHR systems-

· Examples include apps that provide patients and providers with mobile access to health record systems or enables them to gain electronic access to health information stored within a PHR system or EHR system.

 Mobile apps that meet the definition of Medical Device Data Systems –

· Examples include apps that are intended to transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device.

Previous
Next

Critical Appraisal of Medical Applications and Implementation to Clinical Practice

Table of Contents

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 Platforms

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

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.)

Transcript

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.

Previous
Next