Developers of mobile medical apps (MMAs) are increasingly trying to replace existing models for medical diagnostics and treatment. There is an astonishing array of MMAs on the market, many of which are available for free on iTunes. Examples include:
- Heart and blood pressure monitor apps (many of which rely only on an iPhone, and do not require the use of a cuff)
- Prescription refill apps offered by major pharmacies
- Fetal Doppler heart rate monitor apps
- Apps that remind contact lens wearers when to replace their lenses
- CPR instructional apps
- Blood sugar monitor apps that remotely monitor glucose data
Cutting edge technology has suggested the possibility of apps that combine with an outside power source to deliver on the spot heart defibrillation or remote robotic examinations and surgeries.
Recently the Food and Drug Administration (FDA) published a guidance document explaining what apps are “medical devices” that are subject to regulation. Apps that are now regulated by the FDA must be intended “to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated device.” A “medical device” is anything intended to diagnose, cure, mitigate, treat or prevent a disease. In determining whether a developer “intends” the app to be used as a medical device, the FDA looks to advertising, labeling, and written statements by the app company.
Three Classes of Mobile Medical Apps
The first type of app poses a risk to a patient’s safety if it fails to function as intended; for example, an app connected to an accessory such as an insulin infusion pump. The FDA now regulates these apps. The second type of app poses low risk to patients; for example, apps that assist patients manage their health, track and organize health information, or perform simple calculations routinely used by doctors. The FDA does not intend to enforce regulation of these apps. And finally, there are unregulated apps, mainly those intended to provide information, such as medical dictionaries or CPR tutorials.
Dangers of Mobile Medical Apps
According to Iltifat Husain, faculty at the Emergency Medicine department at the Wake Forest University School of Medicine, MMAs, such as those that purport to take blood pressure via one’s iPhone, could land a person in the E.R. or even cause death. One of the fears is that a person might put off life-saving medical treatment in reliance on bad data they receive from the app.
Others, including Nathan Cortez, in his editorial in The New England Journal of Medicine, have expressed concerns that these apps have no validated data compared with accepted reference standards. There is no research available to the public explaining how these apps operate, as developers fiercely guard this information under the guise of patent protection.
Product Liability Litigation Issues
As MMAs are a recent technology, the legal waters are uncharted. Some issues that will be addressed as cases continue to be decided include whether a mobile app is within the class of apps subject to FDA regulation. Another issue is who may be held liable when an MMA malfunctions or causes injury?
In early cases, the manufacturer and the healthcare provider are both being named as defendants. This is a key issue because many states impose caps on non-economic damage awards against healthcare providers, but there is no cap in place for manufacturers. Thus, there is a potential for substantial compensatory damage awards in product liability lawsuits involving these apps.
Although it is too early to determine, these cases may be difficult to win. This is because app companies often use disclaimers with their apps, and an individual may have to explain to the court why they ignored the instructions and relied on the data given by the app. However, many of these apps have little or no disclaimers. Some major apps support pages are known to link to foreign language gaming download sites.
If you or someone you love has been injured as a result of a defective medical device, such as a mobile medical app, the experienced New Jersey product liability lawyers at Shebell & Shebell are poised to hold responsible parties accountable. For a free consultation, call us at 732-532-2011 or contact us online.