In Part 1 of this series, I provided a general overview of mobile medical applications (apps) that are available on the market in the areas of general health, wellness, disease management, and hospital clinical workflow. There are many potential benefits of mobile medical apps, such as facilitating communication between patient and provider, enhancing efficiency, and advancing the overall quality of patient care. There have been recent reports in the news, however, pointing to the dangers of patients being misdiagnosed via telemedicine websites and mobile apps. Serious patient safety questions arise when mobile medical apps are designed to act as a medical device or provide patients with a medical diagnosis. Should these apps be regulated by the government? Part 2 of this blog series focuses on the current regulation recommendations* surrounding the use of mobile apps as it applies to direct patient care.

The Food and Drug Administration (FDA) is the government organization responsible for protecting the public health by assuring the safety of drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation.¹ In 2015, the FDA released a document that outlines the use of health care applications and states that apps that act as either a medical device or an accessory to a medical device will need to obtain FDA approval. The intended use of a mobile app determines whether it meets the definition of a “device.”  When the intended use of a mobile app is for the “diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body, the mobile app is considered a device.” ² Intended use is communicated to the consumer through product labeling, advertising, or verbal and/or written statements made by manufacturers. All products that fall under the definition of device are subject to regulations set forth by the FDA before they can be marketed and sold to the general public.

FDA regulation will focus on mobile apps that turn a mobile platform into a regulated medical device, which could pose a risk to a patient’s safety if it did not function properly. Examples include medical apps that:

• Connect to and control medical device(s) in order to actively monitor or analyze medical device data. (i.e., an app that controls the delivery of insulin on an insulin pump);
• Turn the mobile platform into a medical device by using attachments, display screens, or sensors, or by including functions similar to those of currently regulated medical devices. (i.e., an attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store and display ECG signals);
• Perform patient-specific analysis and provide patient-specific diagnosis, or treatment recommendations. (i.e., apps that use patient-specific parameters to calculate dosage or create a dosage plan for radiation therapy).

The following medical apps pose low risk to patient safety, and therefore, the FDA will exercise discretionary judgment with regard to regulation. Examples include apps that:

• Help patients self-manage their disease or condition without suggesting specific treatments (i.e., apps that coach patients with cardiovascular disease to maintain a healthy weight, eat nutritiously, and exercise);
• Provide patients with simple tools to organize and track their health information, without recommending a change to previously prescribed treatment or therapy (i.e., apps that log blood pressure, drug intake times, diet, daily routine, or emotional state);
• Provide easy access to information related to patients’ health conditions or treatments (i.e., apps that use a patient’s diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions);
• Help patients document, show, or communicate potential medical conditions to their providers (i.e., apps that serve as videoconferencing portals to facilitate communications between patients, health care providers, and caregivers);
• Automate simple calculations routinely used in clinical practice (i.e. medical calculators for Body Mass Index (BMI), Glascow Coma Scale Score, or APGAR score);
• Enable patients or providers to interact with Electronic Health Records (EHR) systems to view or download data to facilitate general patient health management and medical record-keeping;
• Transfer, store, convert format, and display medical device data, without controlling or changing the functions of any connected medical device.

Mobile apps that are not considered devices under the FDA definition and are not required to undergo regulatory requirements include apps that:

• Provide electronic copies of medical textbooks or references not intended to diagnose, treat, or prevent disease by helping a clinician assess a specific patient;
• Act as educational tools for medical training and may have more functionality than an electronic copy of text (i.e., videos, interactive diagrams), but are not intended to diagnose, treat, cure, or prevent disease by helping a clinician assess a specific patient;
• Provide general patient education and patient access to commonly used reference information;
• Automate general office operations and administrative functions (i.e., coding, billing, accounting, scheduling, payment processing);
• Act as generic aids (i.e., using the mobile platform to record audio, or send HIPAA compliant messages between health care providers in a hospital).

As more and more apps are developed in the field of health care, clinicians will play a pivotal role in how these apps are implemented in the routine care of patients. We need to have a basic understanding of app functionality, which ones are purely informational and which ones act as medical devices. More importantly, it is essential that we fully comprehend the impact these apps will have on the safety of our patients, as we are ultimately responsible for protecting them from harm.

In Part 3 of this blog series, I will provide an overview of the medical mobile educational tools available to nurses and how clinicians should evaluate which are the most reliable and relevant sources of information.

*Note: This article is a summary of the FDA guidelines and is not meant to be all-inclusive of the recommendations made by the FDA.

References

1. The U.S. Food and Drug Administration. About FDA. Retrieved on June 27, 2016 from http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

2. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (2015). Retrieved on June 23, 2016 from 
   http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263366.pdf

​Myrna B. Schnur, RN, MSN
 

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