The United States Food and Drug Administration has issued a press release in regards to its final guidance for developers of mobile medical applications, software programs that run on mobile communication devices and perform the same functions as traditional medical devices.

The agency intends to exercise enforcement discretion for the majority of mobile apps as they do not pose any significant risks to consumers. This means they will not enforce requirements under the Federal Drug & Cosmetic Act. The FDA intends to instead focus its regulatory oversight on subset mobile medical apps that present a greater risk to patients if they do not work as they were intended.

Mobile apps could potentially transform health care by allowing doctors to diagnose patients with potentially life threatening conditions outside of a traditional health care setting, help consumers manage their own health and wellness and also gain access to useful information when and where they need it.

Some current mobile medical apps on the market can diagnose abnormal heart rhythms, transform smart phones into ultrasound devices and even function as the command center for glucose meters used by people with insulin dependent diabetes.

“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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Mobile medical apps that undergo FDA review will be assessed by the same regulatory standards and risk based approach that is applied to other types of medical devices. The agency does not regulate the sale or general consumer use of smartphones or tablets and it does not regulate mobile app distributors.

“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.”

According to Reuters, Shuren told reporters during a conference call that whether the agency regulates a product will depend on its function and its risk. If a heart device used in a hospital is currently regulated, chances are a mobile app will be too.

According to a report published by the market research firm research2guidance in March, the mobile health app market will reach $26 billion by 2017. There are around 97,000 mobile health applications currently in major app stores.