The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.
SETTING A NATIONAL DATA BREACH REPORTING STANDARD
President Obama is planning on introducing a data breach bill that would standardize the reporting period nationwide at 30 days. The proposed Personal Data Notification and Protection Act would require ...
On January 7, 2015, U.S. Senators Susan Collins (R-ME) and Joe Donnelly (D–IN) along with Lisa Murkowski (R-AK) and Joe Manchin (D-WV) introduced the Forty Hours is Full Time Act, legislation that would amend the definition of a “full-time employee” under the Affordable Care Act to an employee ...
On January 5, 2015, less than one month after the National Labor Relations Board (NLRB) voted to adopt a Final Rule to amend its rules and procedures for representation elections, a lawsuit has been filed in the US District Court for the District of Columbia, asserting that the Board exceeded its authority under the National Labor Relations Act (Act) when it amended its rules for votes on union representation and that the new rule in unconstitutional and violates the First and Fifth Amendments of the US Constitution.
The suit was filed by the Chamber of Commerce of the United ...
As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.
In touch with this trend, FDA has formed an Additive Manufacturing Working Group, and in October 2014, the Agency engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, according to ...
Stakeholders received insight on the Obama administration's expected approach to the certification and oversight of qualified health plans ("QHPs") late Friday, December 19, 2014, with the release by the Centers for Medicare & Medicaid Services ("CMS") of its Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces ("Draft Letter"). This annual release comes more than a month earlier than the release of the 2015 version of this document.
While the Draft Letter largely mirrors the provisions of its 2015 predecessor, or restates earlier proposals, CMS does ...
On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging. FDA's stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available. The proposed rules also go against Senate ...
Earlier today, FDA published guidance, for immediate implementation, effectively delaying the effective date of the product tracing requirements for manufacturers, wholesale distributors or repackagers until May 1, 2015. This guidance appears to be a continuation of FDA's efforts to address industry's concerns about the implementation of the DSCSA product tracing requirements that are effective January 1, 2015.
It is unclear whether the ghosts of FDA past, present or future had anything to do with today's announcement, but this Dickens-esque change of heart should ensure ...
On December 15, 2014, the Supreme Court of the United States decided Dart Cherokee Basin Operating Co. v. Owens, a class action removal case.
In short, the Dart case is welcome news to employers. Standards for removing a case from state to federal court have been an abiding point of concern for employers faced with "home town" class actions. In more recent times, this problem has become a point of interest to employers in health care and other industries that are beset by cybersecurity and data breach cases originating in state courts but calling for the application of federal privacy ...
FDA is the subject of a lot of criticism, some deserved, and some not. However, I don't think FDA gets enough praise when it does something right. Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.
Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA. This clarification likely has the greatest impact on prescription ...
Our colleague Steven Swirsky at Epstein Becker Green wrote an advisory on an NLRB ruling that affects all employers: "NLRB Holds That Employees Have the Right to Use Company Email Systems for Union Organizing - Union and Non-Union Employers Are All Affected." Following is an excerpt:
In its Purple Communications, Inc., decision, the National Labor Relations Board (“NLRB” or “Board”) has ruled that “employee use of email for statutorily protected communications on nonworking time must presumptively be permitted” by employers that provide employees with access to ...
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