Health Apps and Safety: Views from Recent Sources

October 1, 2012 | Evaluations & Guidance


In our article Judgment Call: Smartphone Use in Hospitals Requires Smart Policies, we discuss the risks of using smartphones in hospitals, including privacy concerns, staff distraction, and electromagnetic interference. Another source of risk, which extends beyond hospital walls, relates to the thousands of mobile health apps that are used by both patients and physicians.

While health apps have the potential to bring about tremendous improvements in healthcare, certain ones—specifically, those used to make critical decisions about a patient’s condition—can put patients at risk if poorly designed or not functioning as intended. And there is currently no guarantee about their quality or performance: The health app world is experiencing what some have called a “Wild West,” with thousands of apps being used despite a lack of regulations to ensure their safety and effectiveness. FDA has attempted to impose some order on this situation, issuing draft guidance for health apps in 2011. But while many observers applaud this initiative, some have also expressed concern that too much regulation could squelch innovation in a field that currently enjoys rapid progress.

Three recent articles have provided...

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