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 Mobile Applications Mobile Health
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.