The Federal Communications Commission (FCC) and Food and Drug Administration (FDA) announced this week in a Public Notice that they will jointly seek comments on regulatory issues arising from healthcare devices that employ radio technology or use commercial wireless communications networks. Comments are due on June 25, 2010. In addition to seeking written comments, the two agencies will hold a joint public meeting to discuss topics related to the convergence between communications and health care devices on July 26-27, 2010, and are accepting requests from parties that wish to make oral presentations at the Public Meeting. The meeting, titled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes,” is designed to gather input from the health care and communications industry regarding the convergence between sophisticated health care devices and systems that employ or rely on communications technology or networks. The agencies will use the information gathered to enhance coordination between the FDA and FCC. The agencies claim such coordination will simplify and expedite the introduction of new health care technology.
In recent years, health care devices and providers have made greater use of devices using communications capabilities. For example, certain devices such as automated insulin pumps and blood glucose monitors employ radio technology to wirelessly transmit critical data to health care providers. These devices are typically regulated by the FDA. Similarly, certain commercially available applications for smartphone and other communications devices transmit medical data over commercial broadband networks to allow physicians to monitor a patient’s health. Such applications and devices come within the ambit of the FCC’s regulatory authority. Some devices will be governed by both the FCC and the FDA. The agencies want to understand the issues and industry perspective to explore whether there are areas where each agency’s jurisdiction can be clarified, or where regulatory approvals can be streamlined.
The Public Notice released on June 15 lays out a number of broad topics on which the agencies plan to focus: data integrity and reliability issues associated with the use of communications technology (including commercial networks); system security issues; use of licensed or unlicensed spectrum for health care devices; risk management; and the relationship between FDA and FCC regulatory approval processes and compliance.
If you have any questions regarding this topic, would like further information about the Public Meeting or would like advice regarding the preparation of comments on this topic please contact the following Bingham Attorneys:
Andrew D. Lipman, Partner
andrew.lipman@bingham.com, 202.373.6033
Joshua M. Bobeck, Of Counsel
josh.bobeck@bingham.com, 202.373.6010
This article was originally published by Bingham McCutchen LLP.