Mobile Healthcare Apps Part 2: To Regulate or Not to Regulate?

In the primary a part of this series, I provided an outline of mobile health applications (apps) which can be available in the marketplace within the areas of general health, wellness, disease management, and hospital workflow. Mobile health apps have many potential advantages, akin to facilitating patient-doctor communication, increasing efficiency, and improving the general quality of patient care. However, there have been recent reports within the news highlighting the hazards of misdiagnosing patients via telemedicine web sites and mobile apps. Serious questions on patient safety arise when mobile health applications are designed to operate as a medical device or enable patients to make a medical diagnosis. Should these apps be regulated by the federal government? Part 2 of this blog series focuses on current regulatory recommendations* regarding using mobile applications in relation to direct patient care.

The Food and Drug Administration (FDA) is the federal government organization liable for protecting public health by ensuring the security of medication, biological products, medical devices, food supplies, cosmetics, and products that emit radiation.¹ In 2015, the FDA published a document describing using health care apps and stating that apps that act as a medical device or accessory to a medical device shall be required to acquire FDA approval. The purpose of a mobile application determines whether it meets the definition of a “device.” If the intended use of a mobile application is for the aim of “diagnosing a disease or other condition, or treating, alleviating, curing or preventing disease, or is intended to affect the structure or any function of the body, the mobile application is considered a device.” ² The intended use is communicated to the patron through the product label, promoting or oral and/or written statements by manufacturers. All products falling inside the definition of a tool are subject to regulations set forth by the FDA before they will be marketed and sold to most people.

The FDA regulations will give attention to mobile applications that turn a mobile platform right into a regulated medical device that might pose a risk to patient safety if it doesn’t function properly. Examples include medical applications that:

• Connect and control medical devices to actively monitor or analyze medical device data. (i.e. an application that controls the delivery of insulin by an insulin pump);
• Turn your mobile platform right into a medical device by utilizing attachments, display screens or sensors, or enabling features just like currently regulated medical devices. (i.e., connecting electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals);
• Perform patient-specific evaluation and supply patient-specific diagnosis or treatment recommendations. (i.e. applications that use patient-specific parameters to calculate a dose or create a dosing plan for radiation therapy).

The following medical applications pose a low risk to patient safety and subsequently FDA will make a discretionary regulatory assessment. Examples are applications that:

• Help patients self-manage their disease or condition without suggesting a selected treatment (i.e., apps that instruct patients with heart problems on easy methods to maintain a healthy weight, eat nutritious food, and exercise);
• Provide patients with easy tools to arrange and track health information without recommending changes to previously prescribed treatments or therapies (i.e., apps that record blood pressure, medication duration, weight loss plan, day by day routine, or emotional state);
• Provide easy accessibility to information related to a patient’s health or treatment (i.e., apps that use a patient’s diagnosis to offer physicians with guidance on best practices for treating common diseases or conditions);
• Help patients document, display potential conditions, or inform their providers (i.e., applications that function video conferencing portals to facilitate communication between patients, healthcare providers, and caregivers);
• Automate easy calculations routinely utilized in clinical practice (e.g., medical calculators for body mass index (BMI), Glascow Coma Scale rating, or APGAR rating);
• Enable patients or providers to interact with electronic health record (EHR) systems to view or retrieve data to facilitate overall patient health management and medical record keeping;
• Transfer, store, convert and display medical device data without controlling or changing the functions of any connected medical device.

Mobile applications that usually are not considered devices as defined by the FDA and don’t have to fulfill regulatory requirements include applications that:

• Provide electronic copies of textbooks or medical literature that usually are not intended to diagnose, treat, cure, or prevent disease to assist a physician evaluate a selected patient;
• They function as educational tools for medical training and could have greater functionality than an electronic copy of text (i.e., videos, interactive diagrams), but usually are not intended to diagnose, treat, cure, or prevent disease by assisting a physician in assessing a selected patient;
• Provide general patient education and access to commonly used reference information;
• Automate general office operations and administrative functions (i.e. coding, invoicing, accounting, scheduling, payment processing);
• Act as general support (i.e., use mobile platform to record audio or send HIPAA-compliant messages between hospital providers).

As more healthcare applications are developed, physicians will play a key role in implementing these applications into routine patient care. We should have basic knowledge concerning the functionality of applications, which ones are purely informative and which ones function as medical devices. More importantly, it’s critical that we fully understand the impact these apps can have on the security of our patients because ultimately we’re liable for protecting them from harm.

In the third a part of this blog series, I’ll review the mobile learning tools available to nurses and description how clinicians should evaluate which information sources are probably the most reliable and appropriate.

Bibliography

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

2. Mobile health applications: guidance for industry and Food and Drug Administration staff (2015). Retrieved June 23, 2016 from
   http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263366.pdf

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