Why mHealth App Makers Might be Inadvertently Breaking the Law

Developers of mobile medical apps for European customers are often unaware that their software is subject to CE regulations for medical devices — and that they face legal consequences as a result.


European Medical Device Technology

Under the directive in effect for medical devices, software that offers purported medical benefits is subject to standards and regulations in effect for medical devices. This also applies to mobile app makers that sell apps for medical purposes for the iPhone or Android devices. As long as a vendor sells an app that has purported medical benefits—as opposed to fitness apps — then the software must meet all of the requirements under the CE directive for medical devices.

The main issue is that app makers that sell their software in Europe are unaware that they are breaking the law if their product does not meet the directive’s requirements. “App developers often do not know that their product is considered to be a medical device in Europe,” Tilo Borchardt, head of projects for Getemed, a medtech company for monitoring solutions, said.

For example, an app that uses a smart phone to monitor a patient’s pulse rate, body temperature, and other medical metrics that a doctor could use is subject to regulations for medical devices in Europe, according to Borchardt. “If the app doesn’t have a disclaimer stating it does not offer medical benefits, then the developer is liable,” he added.

Additionally, software developers face legal liability if their devices are linked to death or injury, even indirectly. “If the software sends an instruction to the device that causes a malfunction or injury to the wearer, then the software writer will be at fault and will be legally responsible,” Clive Longbottom, an analyst for Quocirca, said. “As such, it may well be that CE will have to look at the ‘system,’ rather than the device and ensure that everything is seen as a greater whole.”

Much of the confusion stems from the CE directive’s ambiguous wording, according to Borchardt. “The current regulations are too vague,” he said. “App makers simply do not know that they are legally liable until something bad happens or a competitor blows the whistle on them.”

Medical device makers check that software developers meet the requirements of the regulation because they are legally liable for software malfunctions associated with their products. But developers of apps for smart phones are often unaware of the legal guidelines if they do seek legal advice. This is because Apple and Android smart phone vendors are protected by their disclaimers for any legal liability associated with apps sold in their stores and thus have little incentive to warn app makers about the legality of their products in Europe or in other markets. “Medical device makers will inform software developers about the requirements,” Borchardt said. “Smart phone makers do not necessarily have to do that.”

Additionally, smart phones are not considered medical device products, which further protects them from legal liability if software loaded on the devices is used for medical purposes. “Smart phones are not considered medical devices by their manufacturers, but developers are designing apps that use the smart phones as a medical product requiring certification,” Borchardt said.

Different EU member countries will interpret the regulations differently as well, and often have even more stringent mandates in place. “There are often different regulations in EU countries that app makers must follow in addition to the CE requirements,” Borchardt said.

In the United States, FDA requirements for medical mobile apps are clear compared with the CE regulations. “The FDA guidelines are much clearer and complete and the CE regulations are too general,” Borchardt said. “The CE has issued some guidelines for medical devices, but they do no yet cover medical apps. They are working on improving the directive, but the organization is very bureaucratic, so it will take some time.”


Source: Posted in Regulatory and Compliance by Thomas Klein on April 27, 2015



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