Wireless Medical Devices Conference 2014

From December 3-4, the San Jose convention center was transformed into the epicenter of the digital health world, with hundreds of attendees gathering at the MedTechWorld BIOMEDevice "Wireless Medical Devices Conference." The exhibit floor was quaking with both entrepreneurs and more established companies showing off their latest products and services.

Andrew Atwell, of Samsung Open Innovation Center, presented the keynote address on the wireless frontier, and discussed prospects for merging medical and non-medical innovation. Other speakers addressed the Internet of Things, and communications that migrate from the hospital, to the home, and beyond. Mr. Eddy Lee, a Consulting Assistant Professor at Stanford University, surveyed the wide variety of mobile sensor devices that are available, impressing the audience with the scope of the technology.

Bakul Patel, the FDA's Senior Policy Advisor on digital health, provided an address on a range of digital health issues via a remote connection from Washington, D.C. Mr. Patel focused on the need to improve interoperability and security of software-based devices. He also stressed that the international regulatory community is moving away from the term "stand alone software" and instead gravitating towards "software as a medical device," and that the location of the software is not important to its regulatory status.

Fish & Richardson, a sponsor of the event, provided legal insight in two of the many separate educational sessions offered as part of the conference. Our first presentation discussed the evolving FCC and FDA regulation of wireless devices, including medical apps, and the impact of the joint FCC/FDA/ONC report on Health IT. App developers in particular need to be aware of when the FDA considers software to be a regulated medical device, potentially subject to premarket clearance from the FDA, and possibly even clinical trials to prove safety and effectiveness. Our second presentation focused on the challenges that digital health companies face in protecting their intellectual property, particularly in light of recent court decisions on the patentability of software. Other speakers covered wireless infrastructure, wireless product development and design, biocompatibility, data security and privacy, wireless power transfer, and electronic health records.

Whether calling it mHealth, telemedicine, or digital health, there is no doubt that wireless technologies will continue to transform the healthcare industry, including how medical devices are designed, how providers deliver care to patients, and how patients interact with care givers and manage their conditions. Many gray areas and challenges remain, and companies need to stay abreast of this rapidly developing area of law.

For more information about the emerging field of digital health, see:

Fish & Richardson's Digital Health Services

Authors: Keith A. Barritt, Tamara Fraizer, Ph.D.