Alston & Bird has developed the attached checklist tool to assist Covered Entities, Business Associates, and Subcontractor Business Associates to plan their implementation of the January 25, 2013 Omnibus HIPAA Rule. The Omnibus HIPAA Rule significantly amended the HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rules, as discussed in the attached Alston & Bird HIPAA Advisory issued on January 25, 2013.
February 1, 2013
Advisories
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On November 26, 2012, the Departments of Labor, Treasury, and Health and Human Services published proposed regulations (the “Proposed Wellness Rules”) modifying the 2006 HIPAA wellness program regulations in light of the changes made to the statutory provisions by the Affordable Care Act. This advisory discusses key aspects of the Proposed Wellness Rules as applied to group health plans.
January 31, 2013
Advisories
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As noted in our year-end review, there were 308 recalls in 2012 - a little over 25% of these recalls involved children’s products. In addition, the CPSC issued $4,275,000 in civil penalties, the vast majority of which were for failure to timely report a product hazard. In light of these numbers, and democratic majority on the Commission, businesses can expect the CPSC to continue to be very active in 2013.
January 31, 2013
Publications
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This advisory discusses the California Department of Toxic Substances Control’s (DTSC) revised version of its “Safer Consumer Products Regulations,” intended to regulate the contents and design of consumer products sold in California.
January 30, 2013
Advisories
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This advisory discusses the D.C. Circuit Court of Appeals’ holding in Noel Canning v. NLRB that three recess appointments made by President Obama to the National Labor Relations Board (NLRB) were unconstitutional. If the decision stands, it would mean that hundreds of decisions made by the NLRB would be invalidated.
January 30, 2013
Advisories
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This advisory discusses the D.C. Circuit’s ruling on Noel Canning v. NLRB, in which the court invalidated President Barack Obama’s recess appointments to the National Labor Relations Board (NLRB). The Noel Canning decision is significant because if the NLRB recess appointments were invalid, this also calls into question the recess appointment of Richard Cordray as director of the Consumer Finance Protection Bureau (CFPB).
As was the case with the NLRB recess appointments at issue in Noel Canning, Mr. Cordray was appointed as a recess appointment on January 4, 2012, while the Senate was in pro forma session.
The advisory analyzes the impact of the Noel Canning decision on Mr. Cordray’s appointment, as well as the more challenging issue of how an invalidation of Mr. Cordray’s appointment would impact the various settlements, enforcement actions and regulations implemented by the CFPB since the appointment.
January 29, 2013
Advisories
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This advisory discusses Sargon v. University of Southern California, where the California Supreme Court affirmatively recognized that trial courts have a “gatekeeper” function in admitting expert testimony—signaling a small but important step away from California’s Kelly-Frye test and toward the federal Daubert test.
January 29, 2013
Advisories
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As you may be aware, the America Invents Act of 2011 (AIA) will soon bring significant change to U.S. patent law. Notably, any patent application filed on or after March 16, 2013, will be subject to the new First-to-File system. In contrast, any patent application filed prior to March 16, 2013, will still be subject to the old First-to-Invent system.
January 28, 2013
Advisories
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Delaware created its new Secretary of State unclaimed property voluntary disclosure agreement program in 2012. Although it was intended to be a more holder-friendly approach to compliance than either an audit or the old State Escheator VDA program, important details about how the new VDA program would work were unclear, and many holders were reluctant to participate from the outset as a result. Since then, the Secretary of State and the program administrator have issued additional guidance and engaged in productive communications with prospective participants and their advisors regarding the VDA program’s mechanics and logistics. The Delaware General Assembly has also introduced a bill in the 2013 legislative session that would increase the attractiveness of the VDA. It remains the case, however, that time is of the essence in applying for and completing the VDA program. This article by the Alston & Bird LLP Unclaimed Property team summarizes the VDA program and these ongoing developments, providing insightful analysis for holders who are still in the process of determining whether participation would be in their best interests.
Reproduced with permission from Tax Management Multistate Tax, 01/25/2013. Copyright 2013 by the Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com.
January 25, 2013
Publications
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On Friday, January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published the long-awaited final rule, entitled “Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules” (Omnibus Rule). This advisory provides a summary of the significant changes made by the Omnibus Rule in the Privacy, Security, Breach Notification and Enforcement Rules.
January 25, 2013
Advisories
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On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP) requirements for combination products, which will take effect on July 22, 2013. FDA promulgated the rule in response to comments the agency received on its CGMP Guidance for Combination Products that described the need to develop a clear regulatory framework to account for the variety of combination products that can contain drug, device and/or biologic components.
January 24, 2013
Publications
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This advisory discusses the SEC’s approval of the amended listing standard of the NYSE and Nasdaq pertaining to compensation committee independence and compensation advisers. The exchanges proposed the listing standards in accordance with Section 952 of the Dodd-Frank Act and the requirements of Rule 10C-1 of the Securities Exchange Act of 1934.
January 23, 2013
Advisories
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New changes to Basel III expand the types of assets eligible for LCR and extend the deadline for 100 percent compliance by four years, but what is the effect for CMBS lenders and servicers?
January 22, 2013
Advisories
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“Consumer-Fraud Class Action Challenging ‘Natural’ Claim Is Dismissed,” Section of Litigation, Products Liability, News & Developments, American Bar Association Website, January 18, 2013.
January 18, 2013
Publications
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As we reported last month, the CPSC recently filed a suit against the makers of Nap Nanny infant recliners after the manufacturer would not agree to conduct a voluntary recall of the product. Earlier this month, the manufacturer of Nap Nanny filed a motion alleging that the CPSC’s press release incorrectly stated that it was illegal under federal law to sell the product. Although the CPSC had filed suit to stop the sale of the Nap Nanny, the manufacturer noted that the representation that it was illegal to sell the product was false because a court had not yet issued an order recalling the product. In response, the CPSC corrected the press release, but not until after 6:30, after the press release had been up for several hours and long after most media outlets had done their reporting for the day. Even though there has not been a ruling on the recall, several major retailers have voluntarily recalled the product.
January 2013
Publications
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This advisory discusses generic legal advice released in November 2012 (AM 2012-009), in which the Chief Counsel’s Office, applying the economic substance doctrine, disregarded a typical securities lending transaction entered into before May 20, 2010, to avoid U.S. withholding tax. The IRS stated that it was aware of cases where financial institutions promoted such securities lending transactions to foreign customers as a way to avoid U.S. withholding tax based on Notice 97-66, despite the fact that no prior withholding tax was paid within the chain of transactions. AM 2012- 009 concludes that, if the IRS determines that such a transaction lacked economic substance, (i) the lender may be treated as retaining ownership of the securities, and thus receiving a U.S.-source dividend subject to U.S. withholding tax under Code Section 871 or 881; and (ii) the borrower may be treated as the withholding agent with respect to the dividend and thus subject to U.S. withholding tax under Code Section 1441 or 1442 and 1461.
January 15, 2013
Advisories
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This advisory discusses the Federal Trade Commission’s (FTC) annual adjustment of the jurisdictional thresholds for pre-merger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) and for interlocking directorates under Section 8 of the Clayton Act. The revisions account for changes in the level of the U.S. gross national product and constitute an increase of approximately four percent.
January 15, 2013
Advisories
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The advisory discusses the Supreme Court’s holding that a sufficiently broad covenant not to sue can divest a federal court’s jurisdiction to hear trademark invalidity counterclaims. In Already, LLC v. Nike, Inc., No. 11-982, slip op. (U.S. Jan. 9, 2013), the Court held that a covenant not to sue issued by the plaintiff, Nike, Inc., after it filed suit against the defendant, Already, LLC, mooted Already’s counterclaim to cancel Nike’s mark. We believe the Supreme Court’s holding will have relatively limited significance in trademark or patent litigation because of the unique fact pattern of the case. Nevertheless, the decision provides some guidance to intellectual property owners on how to terminate litigation, including invalidity counterclaims, if discovery reveals that the facts of a case are not what the IP owner understood them to be at the time of filing.
January 15, 2013
Advisories
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January 15, 2013
Publications
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On December 31, 2012, FDA issued two guidance documents detailing the agency’s approach to reviewing the completeness of medical device applications reviewed by the Center for Devices and Radiological Health (CDRH). The two guidance documents cover PMA submissions, Acceptance and Filing Reviews for Premarket Approval PMAs) (“PMA Guidance”), and 510(k) submissions, Refuse to Accept Policy for 510(k)s (“510(k) Guidance”). Both of these documents superseded previous FDA guidance on evaluating whether medical device applications were complete for filing.
January 14, 2013
Publications
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