D.C. Report: Patient Matching Discussed in Capital by Stakeholders, Feds

FCC Chair Genachowski Advocates for Mobile Body Area Networks The chairman of the Federal Communications Commission, Julius Genachowski spoke in favor of using mobile body area networks (MBAN) at an event at George Washington University on Thursday.  He detailed the benefits of the devices including their main use – they allow doctors to remotely monitor patients’ vital signs in real-time.  These devices would be an improvement to many tools currently being used because they have wires that are usually attached to monitors or beds and keep the patient from being mobile.

According to the Hill, “The FCC has an agreement with the Food and Drug Administration to help streamline approval processes for medical devices that use wireless spectrum. The two agencies are supposed to collaborate on approving each device, with the FCC handling the technical side and the FDA scrutinizing the medical aspects of the device.”  FCC scheduled a vote to approve a plan for MBANs on May 24.

During the briefing at GWU, chairman Genachowski said MBANs are “a cost effective way to monitor every patient in real time in hospitals,” he said.  A portion of the spectrum under the proposed rule also will be allocated to wireless devices that patients can wear at home.

Bipartisanship Emerging Over FDA User Fee Bill, Strategy on Mobile Medical Apps Questioned  At a time when virtually all meaningful legislation is being held hostage by politics, there is one Ducati motorbike bobbing and weaving through the traffic jam: FDA User Fee legislation.  In what has been described by Hill staffers as the only legislation with “legs” the “Food and Drug Administration Safety and Innovation Act,” has passed both House and Senate committees of jurisdiction.  The full Senate is looking to pass their version of the bill on Monday with House members looking to vote by the end of the month.  While the bulk of the bill is likely to bore segments of the health IT world, there is language in the Senate bill that would be a de facto moratorium on FDA’s mobile medical application guidance.  The Senate bill doesn’t put a direct hold on guidance, first issued as a draft last July, but it would require the FDA to undertake a multi-agency report that would lay out a strategy for “an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology.”  It would have to produce the report with the FCC and the Office of the National Coordinator for Health Information Technology.  This means that “until the report is developed and sent to Congress, all mobile apps that are medical devices will continue to have to meet all applicable FDA requirements,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health wrote in an email to Politico. The resulting report or framework would have eighteen months to be complete – something that provision detractors say will take the full time allotted due to competing agendas and multiple agency involvement. An 18-month moratorium, Mr. Shuren believes, would be a blow to the app industry, forcing FDA to regulate more apps rather than fewer.  But others see it as a chance to bring more stakeholders to the table that would result in a stronger regulatory framework.

Congressional leaders on both sides of the isle are looking to pass legislation before a Supreme Court decision on the Affordable Care Act and have a bill to President Obama by July 4.