Patients now more than ever want immediate answers to their health questions. What they have discovered is that typically there’s an app for that—or there is a provider with plans to develop one.
The U.S. Food and Drug Administration (FDA) recently issued final guidance for providers and developers of mobile medical applications (apps), which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.
The variety and availability of smartphone apps have exploded in recent years as multi-tasking consumers increasingly use their phones to keep up with the latest on news, finance and health. Apple says its iPhone App Store has more than 350,000 apps, and Android, BlackBerry, Windows, and other smartphones account for tens of thousands more. With so many apps on the market, it’s no wonder the number of health care related apps has also spiraled.
As a consequence, the FDA intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers, as long as they comply with all of the other rules imposed by the Federal Trade Commission for mobile apps including containing appropriate privacy policies and disclosures. This list includes mobile medical apps that:
- Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to patients’ health conditions or treatments;
- Help patients document, show, or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers;
- Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.
The FDA has also already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allow physicians to view medical images and X-rays. These mobile medical apps are included in the category of apps that the FDA does not consider to be a device or require additional regulation as follows:
- Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities;
- Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received;
- Mobile apps that are intended for general patient education and facilitate patient access to commonly used reference information;
- Mobile apps that automate general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; and
- Mobile apps that are generic aids or general purpose products.
Rather, the FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended. Specifically, the FDA is focusing on mobile medical apps that:
- Are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- Transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.