News Feature | September 26, 2013

FDA Releases Final Medical Apps Guidelines

Source: Health IT Outcomes
Katie Wike

By Katie Wike, contributing writer

HTO FDA

The Food And Drug Administration has issued its final guidance for developers of medical apps and software used on mobile devices

Medical mobile apps - user-friendly software programs that run on mobile communication devices - are now regulated by the Food And Drug Administration’s recent guidelines. According to Medical News Today, FDA “will focus regulation on a small subset of medical apps that present a greater risk and will exercise discretion for the majority that pose minimal risk to consumers.”

Medical News Today explains, “The FDA has powers under the US Federal Drug & Cosmetic Act (FD&C Act) to oversee the safety of drugs, foods, cosmetics and medical devices.” The agency also “recognizes there may be some mobile apps that meet the definition of a medical device, but because they pose a lower risk to consumers, the agency intends to ‘exercise enforcement discretion over these devices,’ meaning it will not enforce requirements under the FD&C Act.”

An FDA press announcement regarding the announcement quotes Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, as saying, “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation.”

The release clarifies the FDA’s stance, noting it is “focusing its oversight 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.”

According to EHR Intelligence, “Although the FDA has emphasized that its list of mobile apps that are and are not medical devices is not exhaustive, it has provided examples of mobile apps that will not be subject to enforcement. These include mobile 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; or
  • Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.”

EHR Intelligence quotes Shuren as saying, “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren, “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

View a pdf of the FDA’s nonbinding recommendations - Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - click HERE.