As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading
The January 25, 2015 edition of the Pittsburgh Post-Gazette featured an article in which Reed Smith partner Chris Healy commented on the dramatic rise in popularity of 3D printing technology and the legal issues that have come about – and may arise in the future – as a result of this trend. The article, “3D … Continue Reading
The past few years have seen 3D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few industries have benefitted more from this technology than life sciences and health care. 3D printing has been used to … Continue Reading
The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan's recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices. The meeting is formally entitled: "Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes." The purpose of this meeting is, among other things, to discuss ways to promote investment and innovation in health technology by streamlining government processes.
To help develop an agenda for this important meeting, the FDA and the FCC are seeking input from, among others, the medical and device manufacturing industries, practitioners, and other stakeholders and users of medical technology on a number of questions regarding regulatory challenges and safety of patients and other users of medical devices that include radio elements and of systems that can be tied into broadband communications networks.… Continue Reading