As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and even their own workplace. More and more, mobile devices are also connecting people with one of the places they least want to go: doctor’s offices.
“Medical companies are looking to leverage mobile platforms to help patients communicate with healthcare providers, capture data about their medical condition and generally improve adherence and access to treatment recommendations,” says Yarmela Pavlovic, a partner in the FDA Medical Devices group at Hogan Lovells. “For example, apps can provide a way to improve adherence for pharmaceutical products by sending reminders, as well important information such as test results, or a new breathing exercise or other therapy that a patient needs—without the hassle of an office visit.”
It sounds simple, but because each new generation of technology brings with it a new set of legal issues, it isn’t. For example, there are privacy regulations that govern how personal information is protected and shared. App developers must be able to prove that they can send confidential information over mobile networks securely, reaching only the intended recipient.
Pavlovic says that for medical device makers, understanding how to navigate the regulatory approval process is key. “They should think of the process as a journey, and work with a team that can find the best path,” she says. “That means assembling the right data and other information to support clearance or approval of their product.”
One of the challenges facing medical app developers is that some regulations were written in a time before mobile apps even existed. “Companies whose products are actively regulated by the FDA have to comply with what the FDA calls a ‘quality system regulation’.,” says Pavlovic. “This is a system of procedures a company has to have in place to describe their product’s manufacturing process. But an app isn’t an implant, so companies have to think creatively about how to develop appropriate procedures without stifling innovation.”
The good news, says Pavlovic, is that the FDA is actively trying to collaborate with companies in order to bring safe, useful products to market in a timely and efficient manner.
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