Qualcomm Life is making news on the mHealth front with a couple of major announcements this week.
The company has unveiled a mobile offering for its well-reviewed 2net Platform, as well as a corresponding 2net Mobile SDK, giving consumers and clinicians the ability to manage home-based telemedicine data from mobile devices and enabling developers to create Android-based apps to plug into the system.
In addition, the company has announced that the U.S. Food and Drug Administration will be providing regulatory support to participants in Qualcomm's XPRIZE competition to create a tricorder device similar to that used in "Star Trek."
XPRIZE assistance
The global XPRIZE competition, launched roughly three years ago, will confer $10 million to a team or teams that develop a "consumer-friendly device capable of diagnosing and interpreting a set of 15 health conditions and capturing key vital signs," according to XPRIZE officials.
A separate XPRIZE competition launched in May of 2012 is offering $2.25 million to create a "new generation of health sensors that can drastically improve the quality, accuracy and ease of monitoring a person's health." That competition is being run in conjunction with the Qualcomm challenge, and officials say they expect those new sensors will be integrated into the tricorder.
The FDA's participation comes as the agency seeks to stake its claim in the rapidly evolving mHealth market, with an initial goal to regulate mobile medical apps. The agency has yet to release a final guidance document on what apps it would regulate, and some advocates have called for the FDA to wait until the Department of Health and Human Services comes up with a master plan for all regulation of health information technology.
Officials said the FDA would help XPRIZE teams on general questions about FDA regulations, as well as offering guidance on what the FDA might need for clearance or approval of such a device. In return, the agency would learn about the new direct-to-consumer technology before it's made public and gain insight on "another platform for testing a unique online communication method for interactions with the stakeholders."
"Part of FDA's mission is to promote public health by helping to bring safe and effective medical devices to U.S. patients," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in a press release. "The FDA is committed to advancing the development of innovative technologies. The input we provide to the Qualcomm Tricorder XPRIZE competitors to meet their future regulatory challenges will help bring these technologies to the U.S. market more quickly. While the winners receive prizes, all the competitors will benefit by having FDA's early input."
"XPRIZE is in a unique position to help incubate the development of a new generation of multi-functional consumer health devices that point toward the future of mobile health," added Mark Winter, senior director of Qualcomm's Tricorder XPRIZE competition. "We greatly value the FDA's willingness to work with us and our teams in this unique context, before they need a full commercial review and clearance process."
Adding mobility to the 2net
The 2net Mobile package, unveiled this week at the Uplinq 2013 developer conference in Qualcomm's home town of San Diego, is billed as "one of the first solutions to enable seamless aggregation of clinical data from multiple medical device sensors into one unified stream on a variety of mobile phones and tablets, and transmission of that data in a system designed to meet HIPAA security requirements."
The 2net Platform was initially launched at the 2011 mHealth Summit in Washington D.C., at which time the telecommunications company also spun off its new Qualcomm Life subsidiary to manage the company's mHealth platform. Since then, the company has forged partnerships with more than 250 mHealth companies and healthcare providers to take part in the network, and is beginning to push that platform to other parts of the world.
"Our objective with the launch of 2net Mobile is to further support our customers' business strategies in remote patient monitoring, while enhancing the ability to innovate on the 2net Platform," said Rick Valencia, Qualcomm Life's vice president and general manager, in a Sept. 4 news release. "Through its open approach to connectivity, transmission and aggregation of data on mobile phones and tablets, 2net Mobile improves the capability of users to monitor their health anytime, anywhere."
Officials say the 2net Mobile software module is comprised of two separate applications: the 2net Mobile Core, which communicates with the biometric sensors attached to the 2net platform, and the 2net Mobile Application, which contains a user interface.