Wednesday, February 26, 2014

Report: U.S. hospitals, medical devices rife with stealthy cybersecurity attacks

Report: U.S. hospitals, medical devices rife with stealthy cybersecurity attacks-massdevice: Unsecured medical devices represent an increasing risk for hospitals, with radiology imaging systems in particular named as a prominent "attack surface" for digital attackers. Cybersecurity researchers at Norse released their report on the "epidemic of compromises at healthcare organizations," flagging radiology equipment, patient monitoring systems, and Internet-facing surgical and anesthesia devices as especially vulnerable elements of hospitals' networked systems.

HHS Pushes To Incorporate UDIs Into Electronic Health Records

HHS Pushes To Incorporate UDIs Into Electronic Health Records-thegraysheet: Developers of electronic health records may be pushed to capture unique device identifiers for implantable medical devices in their systems under a proposed rule issued by the HHS Office of the National Coordinator for Health Information Technology.


Monday, February 24, 2014

Senate to debate bill on veterans’ health care

Senate to debate bill on veterans’ health care-politico: A massive veterans bill the Senate will consider this week would greatly increase their access to health care, through more than two dozen new facilities across the country, greater rehabilitation for men and women who have returned from deployments with traumatic brain injuries and other services.


Specialists Ask Congress To Drop Misvalued Code Provisions In Doc Payment Bill

Specialists Ask Congress To Drop Misvalued Code Provisions In Doc Payment Bill-thegraysheet: Several physician specialty groups that frequently use complex or novel devices in their surgical procedures are asking congressional leaders to remove provisions that require CMS to identify “misvalued” codes and adjust reimbursement accordingly in legislation to repeal the sustainable growth rate formula physician payment formula. The specialist groups also want Congress to consider only “acceptable” offset provisions for the costly bill.

New China Fast-track Review Allows International Devices Accelerated Approval

New China Fast-track Review Allows International Devices Accelerated Approval-thegraysheet: China FDA released the finalized Special Review and Approval Procedure for Innovative Medical Devices Feb. 7, which allows both domestic and international device manufacturers to apply for accelerated approval, at least in theory. According to the regulation, China FDA promises early involvement, dedicated personnel and active communication with applicants, and a science-based review to speed up review time for qualified devices.

Thursday, February 20, 2014

Global View: Talking Harmonization And China With Just-Retired Commerce Official Jeffrey Gren

Global View: Talking Harmonization And China With Just-Retired Commerce Official Jeffrey Gren-thegraysheet: Few have more experience advocating for the U.S. device industry abroad than Jeffrey Gren, a former director at the U.S. Department of Commerce. During his 38-year stint at the department, from which he retired in January, Gren promoted U.S. device and drug exports and regulatory harmonization across countries, among other responsibilities.


Wednesday, February 19, 2014

POLITICO Magazine: The GOP alternative to Obamacare

POLITICO Magazine: The GOP alternative to Obamacare-politico: The Congressional Budget Office’s warning that the Affordable Care Act will cause employment to fall by the equivalent of 2.5 million full-time workers is just the latest of Obamacare’s negative surprises. Unfortunately, House Minority Leader Nancy Pelosi’s statement that “we have to pass the bill so that you can find out what is in it” is proving to be depressingly accurate.