FCC, FDA Agree to Work Together on Wireless Health Care

The FCC and Food and Drug Administration signed a memorandum of understanding aimed at improving information exchange between the two and streamlining collaboration, the agencies said. The MOU was unveiled at the start of two days of discussions at the commission during a joint meeting with the FDA on mobile health (mhealth) issues. The two agencies also released a joint statement on wireless medical devices. The FCC National Broadband Plan, released in March, dedicated a chapter to healthcare issues. At its July meeting, the FCC began a rulemaking on a program that would provide up to $400 million per year on health connectivity.

"This agreement recognizes that all Americans stand to benefit from broadband-enabled wireless health solutions; that the agencies must unleash innovation while ensuring patient safety; and that they must partner effectively to do so,” the agencies said Monday. “The FCC is responsible for overseeing the efficient use of airwaves, and the FDA is responsible for the safety and efficacy of medical devices."

"Smart spectrum policy is a key enabler to smart health care. … But connectivity and spectrum will only get us so far,” said FCC Chairman Julius Genachowski at the meeting. “We also need to provide more certainty and clarity to the innovators and investors who will develop and launch the next generation of health-related communications technologies."

The need to collaborate “is one of the core reasons the FCC and FDA came together to host this meeting,” Genachowski said. “The FCC is responsible for overseeing the efficient use of the airwaves, and the FDA is responsible for the safety and efficacy of medical devices. It’s vitally important that we work together on issues where wireless meets medical.” The MOU will “promote investment and innovation in health technologies, help realize potential cost savings, and deliver real health benefits to the American people,” he said.

"The benefits that wireless technologies can provide to healthcare are clear, but to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness,” said FDA Commissioner Margaret Hamburg. “Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap."

"Wireless in health care is pervasive and ubiquitous” and “everywhere in all healthcare settings,” said Professor Elliot Sloane of Drexel University. “Deployment of wireless medical systems is outpacing standards, regulation and accreditation programs.” Other speakers said there has been explosive growth in the numbers and kinds of devices being developed for wireless health. They said the industry needs more spectrum and consistent, predictable regulation by the government.

"Some of the current existing planned [spectrum] allocations just aren’t sufficient,” said Dale Wiggins, chief technology officer of Philips Healthcare Patient Care and Clinical Informatics. “We believe that we can really improve patient care and protect safety by encouraging innovation and providing sufficient spectrum. We believe that the case has been made to increase the amount of spectrum.” The reason demand is growing for wireless healthcare devices is clear, Wiggins said. “Patients, when they're moving around, heal better,” he said. “When clinicians can get information at their mobile devices wherever they are at simplifies their work flow.” To “have medical area body networks we need suitable and sufficient wireless spectrum,” said Tim Kottak, director of wireless for GE Healthcare.

Speakers stressed the need for flexible but consistent regulation from the FCC and the FDA. Venture capitalists so far are reluctant to invest in wireless medical devices, said Darren Hite, associate at investment firm Aberdar. “I think clarity around how these technologies are going to be regulated, who’s going to regulate it, at what levels the technologies are going to get reimbursed, these are all open questions for us right now,” he said. “That’s why this meeting is a great idea, but that you should know does tend to scare venture investors away. The worst case scenario is we go into an investment under one set of regulatory assumptions and the goal posts move.”

"Staying flexible is important because envisioning every need for an application going forward is a difficult thing to do,” said Chief Technology Officer Jorge Valdes of DexCom, which manufactures wireless glucose sensors for use by diabetics. Spectrum decisions “have long term consequences” for patients that use wireless devices, he added. “If you take a look at the medical device development cycle compared to the consumer device development cycle the medical device development cycle is much longer,” he said. “In addition, a patient with an implant may have the implant for 10 years or more. If the FDA or the FCC make a decision today it could have consequences 15-20 years in the future.”

"Mobile phone and mobile technology innovation is a global enterprise,” said Hillary Chen of the White House Office of Science and Technology Policy. “In fact, this is a field in which innovation in developing countries is often leading that that’s happening in developed countries,” she said. “You've got people in communities, often rural, around the world who have very limited access to health resources and yet they still have a cellphone. So that phone is becoming a tool with which they seek health services and health technologies.”

Advances in other countries can help lower costs in the U.S., Chen said. “Innovations that are happening abroad don’t have the luxury of being expensive,” she said. “Technologies for those markets must be effective and low cost.” Innovation also can happen first outside the U.S., she said, saying there are 50 million diabetics in India and 90 million in China. “These are massive numbers,” she said. “These 140 million people present an extraordinary testbed for innovation, just because of the sheer quantity of patients. But some proportion of those 140 million people will also come up with new ideas for using mhealth to manage or treat their conditions."

Network overload is becoming a real danger as the number of devices and applications continues to grow, said Bernie Liebler, spokesman for the Advanced Medical Technology Association. “Apparently iPhones are … killing AT&T’s network and there’s some concern that Verizon is next,” he said. “When we discuss cellphone technology and reliability a lot of the focus is on things like dropped calls.”