Friday, October 31, 2014

McConnell reassures GOP on Obamacare opposition

McConnell reassures GOP on Obamacare opposition-politico: McConnell’s comments Tuesday to Neil Cavuto that a standalone repeal vote would require 60 votes and a presidential signature were taken as a change in position from the Kentucky senator’s frequent references to the goal of repealing the health care law “root and branch.” NPR posted a headline that “McConnell Concedes GOP Senate Will Not Mean Obamacare Repeal” while the Senate Conservatives Fund likened it to a “surrender.”

Wednesday, October 29, 2014

Ten Senate races go down to the wire

Ten Senate races go down to the wire-politico: It’s the largest and most wide-open Senate battlefield in more than a decade: 10 races, all neck-and-neck affairs headed into the final days of the campaign. And it’s not only that there are more competitive races this time around; it’s how close they are that has made the 2014 midterms different from previous cycles. The 10 close contests this year are all separated by 5 percentage points or less, according to RealClearPolitics polling averages as of Tuesday. Fewer races were that close right before recent midterms: eight in 2010 and five in 2006.

Gov't Officials: Industry Should Include Security Elements Early In Device Design

Gov't Officials: Industry Should Include Security Elements Early In Device Design-insidehealthpolicy:  Medical device manufacturers should include security elements in their early product designs to avoid usability tradeoffs and should anticipate new threats such as intentional vulnerabilities inserted into system software, government security experts said, responding to stakeholders' call for a balance between the usability and security of a device. The discussion occurred at an FDA cybersecurity workshop last week on ways to form collaborative approaches for medical device and healthcare cybersecurity, identify areas of vulnerability and outline considerations for manufacturers to develop security measures.

Critics Call FDA Third-Party Social Media Guidance ‘Overbroad’

Critics Call FDA Third-Party Social Media Guidance ‘Overbroad’-thegraysheet: Some stakeholders say a draft guidance released by FDA this summer on how manufacturers should consider interacting with third-parties online when talking about their products is overly broad and goes beyond the agency’s statutory authority. The “Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” states companies are not required to correct potentially misleading information posted by third parties on social media. However, they are responsible for tweets and posts that are owned, controlled, created, influenced or endorsed by them.

Thursday, October 23, 2014

Study: $250K malpractice cap cuts awards

Study: $250K malpractice cap cuts awards-politico: The study says that if the intent of caps is to lower the expected cost of medical liability for the average physician, the findings suggest that more restrictive caps are the only ones likely to have a significant effect. However, if the goal is to reduce extreme verdicts in outlier cases, a less restrictive cap might suffice.


Key Barack Obama aides eye White House exits

Key Barack Obama aides eye White House exits-politico: White House chief of staff Denis McDonough has asked senior aides to tell him if they’re going to stick around for President Barack Obama’s final two years in office, with a West Wing restructuring after the midterms possible. The process, which began in recent weeks, is focused on keeping people at the White House, with the expectation among senior administration officials that whoever’s in place next summer would remain through the end of the presidency.

New EC Leadership Backpedals: EU Device Oversight Will Stay In Health Division

New EC Leadership Backpedals: EU Device Oversight Will Stay In Health Division-thegraysheet: Oversight of medical device and drug policy in the European Union will remain with the European Commission’s health directorate (DG Sanco), and not be switched to the internal markets/industry directorate (DG ENTR) as previously planned. The news was announced just before the European Parliament voted Oct. 22 in favor of the new European Commission, led by President Jean-Claude Juncker, which will officially begin work on Nov. 1. There were 423 votes for the new commission and its new group of commissioners, 209 votes against and 67 abstentions.