The health sector is under siege with cybersecurity threats. Some of the largest announced cyber attacks in U.S. history have targeted organizations in the health industry. Regulators have...02 May 2016
FCC and FDA to Hold Public Forum Regarding Wireless Medical Technology; Public Comments Sought
The Federal Communications Commission and the Food and Drug Administration jointly announced this week an upcoming public forum to discuss the review process for “Life-Saving Wireless Medical Technology.” The joint public forum is scheduled for July 26-27, 2010 and written comments in advance of the meeting are due June 25, 2010.
The FCC and FDA share joint regulatory authority over wireless-enabled medical devices, most notably those relying upon commercial broadband wireless networks to relay patient information back to providers. As described in the FCC news release, “[t]he joint public meeting . . . reflects a commitment by the two agencies to work even more closely to ensure the safety and reliability of [these] devices while increasing their availability to consumers and health care providers. This collaboration is a critical step in the development and approval of new wireless medical devices . . . .” The two agencies expressed a desire to develop a collaborative, streamlined process for review of new devices.
The accompanying Public Notice included a list of questions on which the agencies are seeking written comments in advance of the public forum. These topics include:
- Data integrity and reliability issues arising from the use of allocated spectrum, the use of unlicensed devices, and the use of commercial networks and applications, and needs, uses, and risks for ‘medical-grade’ wireless technology and communications.
- Medical device and system security issues including inadvertent and intentional intrusion.
- View on current FDA and FCC regulatory requirements, including the relationship between FDA approval/clearance and FCC certification of applications, and post market and compliance requirements
The request also solicited comments on additional topics appropriate for inclusion in the forum.