D.C. Report: Healthcare Innovation Progress Examined, FCC Approves Wireless Medical Monitoring Spectrum

As for the bill’s specifics, there is one piece that should be of interest for the health IT world: a report required to study the intersection of mobile medical applications and how they pertain to device regulation.  The Senate bill doesn’t put a direct hold on FDA 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.

The House is looking to pass its version of the bill before the end of the month and congressional leaders have signaled their wishes to have a bill to President Obama by July 4.

Washington Gathering Discusses Patient Matching At an event held in Washington this week, CHIME members, federal officials and other health IT stakeholders met at the Bipartisan Policy Center to discuss the issue of patient matching.  The briefing was well attended with leading CHIME members, foundation firms and top officials from CMS and ONC looking at various approaches to accurate patient matching.  One of the central issues discussed was the appropriate level of federal involvement.  A unique patient identifier has long-since been taken off the table, government officials indicated, but there remains a need for common standards and methodologies to match data with the correct patient.  The dominant policy question that emerged centered on the fact that if most care is delivered locally, what kind of national policy would reinforce safety, not hinder it.  Examples included forcing more transparency into how false negative / positive error rates are produced and possible standards around how performance data is gathered and presented.  Other conversations focused on the need for uniform and consistent intake / registration procedures, to make sure “dirty” data doesn’t complicate matters further.