Other headlinesFDA to revise medical device reporting
White House readies $1.2 billion in HIT grants
Nearly $1.2 billion in grants will be available next year to encourage hospitals and healthcare providers to adopt electronic medical records, according to a Reuters news report today. About $600 million will be set aside to establish 70 healthcare information technology centers to assist in the adoption of EMRs. The remainder will be put toward developing a nationwide system of HIT networks. The grants will be funded through the American Recovery and Reinvestment Act of 2009.
FDA to revise medical device reporting
Proposed changes in an FDA guidance for reporting medical device failures will require the electronic submission of these reports. Comments regarding the proposed changes, publicly released Aug. 20, must be received by the agency within 90 days. The guidance provides general information about how to prepare and send an electronic postmarket medical device report to the FDA’s Center for Devices and Radiological Health. The guidance does not address reports regarding adverse events associated with devices subject to an approved investigational device exemption or reports submitted for postapproval studies.