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.

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.

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.

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.

Sebelius: ‘Absolutely no evidence’ of job losses under Obamacare

Sebelius: ‘Absolutely no evidence’ of job losses under Obamacare-washingtonpost: Secretary of Health and Human Services Kathleen Sebelius said Monday that there is zero evidence of job losses occurring as a result of the new federal health-care law. "There is absolutely no evidence -- and every economist will tell you this -- that there is any job loss related to the Affordable Care Act," Sebelius said in Orlando, according to video from WESH-TV. Sebelius added: "I know that's a popular myth that continues to be repeated, but it just is not accurate."

Most people say rating sites 'important' when picking doctors

Most people say rating sites 'important' when picking doctors-reuters:  When picking a new doctor, most people factor the reviews left on rating websites into their decision, according to a new study. Researchers found 59 percent of people said those physician-rating sites were at least "somewhat important" when choosing a doctor

Lee calls Obamacare delays a 'shameless power grab'

Lee calls Obamacare delays a 'shameless power grab'-politico: Sen. Mike Lee says President Barack Obama’s executive actions delaying portions of Obamacare are “shameless” acts done purely for political reasons.“This is a shameless act, a shameless power grab that is designed to help the president and his political party achieve a particular outcome in a partisan election,” the Utah Republican said on "Fox News Sunday."

Last call for state parties?

Last call for state parties?-politico: For many state parties, the party may soon be over. State party officials across the country say the explosion of money into super PACs, nonprofit groups and presidential campaigns has made fundraising more difficult. And some of those outside groups are starting to take over the traditional local roles state parties play, spending big on voter contact and outreach operations.

GOP: Obamacare hitting seniors hard

GOP: Obamacare hitting seniors hard-politico: Republican Rep. Tom Rooney of Florida took aim today at Obamacare’s impact on older Americans, saying that seniors across the country are paying “more money for fewer choices, less access and far less peace of mind.” In the GOP’s weekly address, Rooney castigated President Barack Obama’s very public pledge that Americans of all ages would be able to keep their doctors under the health law. Since the fall, the president has had to backtrack on that statement, acknowledging that the law was forcing changes in insurance plans that meant some people were losing their physicians.

Lawmakers Urge RAC Changes As Watchdogs Seek Reversal Of Program Limits

Lawmakers Urge RAC Changes As Watchdogs Seek Reversal Of Program Limits-insidehealthpolicy: A bipartisan group of over a hundred lawmakers, led by Reps. Sam Graves (R-MO) and Adam Schiff (D-CA), is urging HHS to reform its Recovery Audit Contractor program – including changing payment methods – and pointing to the two-year backlog at the third level of the appeals system as consequence of current problems with the program. The lawmakers' request comes shortly after Citizens Against Government Waste pushed lawmakers to reinstate the RAC audits that CMS limited when instituting the two-midnights inpatient admission policy.

FDA Requires Electronic Submission Of Adverse Event Reports By August 2015

FDA Requires Electronic Submission Of Adverse Event Reports By August 2015-thegraysheet: Beginning 18 months from now, medical device manufacturers will be required to submit their adverse event reports to FDA electronically, instead of on paper. The new requirement applies to all device manufacturers and importers, regardless of their size. It goes into effect on Aug. 14, 2015. The details are spelled out in a final rule (PDF) issued by the agency Feb. 13.

Summer Sunshine: CMS Pushes Open Payments Deadline To June Or Later

Summer Sunshine: CMS Pushes Open Payments Deadline To June Or Later-thegraysheet: Device makers will have until at least June to register in CMS’ Open Payments system and submit detailed 2013 physician payment data, but they will need to submit aggregate payment data by March 31. CMS announced the new timeline Feb. 7 amid questions and confusion from stakeholders about whether CMS expected companies to submit data for the 2013 program year by March 31, as it states in the final rule released last February, or per other communications from the agency that suggests firms would have 90 days from when CMS opened the registration process. 

U.S. medical device regulator to improve PMA, IDE processes

U.S. medical device regulator to improve PMA, IDE processes-massdevice: The US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.

Device Center Moves To Better Prioritize Its Scientific Work

Device Center Moves To Better Prioritize Its Scientific Work-thegraysheet: FDA’s device center has created a Regulatory Science Subcommittee to identify and prioritize scientific needs, and the Office of Science and Engineering Laboratories is considering restructuring to enhance its responsiveness to regulatory science issues. These are just two changes afoot at CDRH in response to recommendations in a report written by the FDA Science Board’s CDRH Research Review Subcommittee and approved by the full Science Board last June.

To work or not to work? Hearing looks at Obamacare’s influence

To work or not to work? Hearing looks at Obamacare’s influence-politico: Is it always bad to discourage people from working? That was the hotly debated question Wednesday morning at the House Budget Committee, where members quizzed Congressional Budget Office Director Doug Elmendorf on his agency’s latest economic report. The report, which projected that Obamacare will cause Americans to work fewer hours, sparked intense partisan debate over whether the health care law will deprive people of jobs they need — or whether it’s simply freeing them from jobs in which they wouldn’t have otherwise stayed but for health benefits.