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REMIT: the countdown to full implementation begins as final data reporting rules are published

The REMIT Implementing Acts on data reporting obligations entered into force on 7 January 2015. This document is the final guidance setting out the rules for reporting wholesale energy products and fundamental data in the EU...more

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

OMB and Federal Agencies Publish Final Rule on Grants and Cooperative Agreements

On December 19, 2014, the White House Office of Management and Budget (OMB) and 28 federal agencies published in the Federal Register a consolidated interim final rule to implement OMB’s December 2013 final guidance on...more

EPA Issues Guidance for Developing Data-Derived Extrapolation Factors

The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

Health Care Providers Responding to Ebola: HHS Issues Guidance Reminding Covered Entities that HIPAA Allows the Sharing of PHI in...

The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance to remind HIPAA-covered entities of the ways in which they are permitted under HIPAA to share protected health information...more

CRTC Provides Guidance on CASL Software Provisions – But Some Uncertainty Remains

From November 10 to 12, 2014, the CRTC provided its interpretation of the software provisions in Canada’s anti-spam law (CASL) in several presentations to industry. The CRTC also posted a specific FAQ about their...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

FDA Releases Final Cybersecurity Guidance for Medical Devices

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

GAO Issues Final Report with Recommendations to Improve Large Partnership Audits

The Government Accountability Office (“GAO”) recently issued its final report with recommendations to improve the efficiency and effectiveness of large partnership audits, a copy of which is available here. The GAO issued...more

Department of Education Issues New Guidance on Race and “Resource Comparability”

Yesterday, the US Department of Education’s Office for Civil Rights (“OCR”) issued a 37-page guidance document on “Resource Comparability” and unequal distribution of education resources along racial or ethic lines in...more

The Affordable Care Act—Countdown to Compliance for Employers, Week 14: IRS Notice 2014-55 Gets the Employer Shared Responsibility...

The Treasury Department and the IRS had a busy week issuing no less than five Affordable Care Act guidance items, consisting of...more

OFCCP Joins EEOC in Holding That Gender Identity/Transgender Discrimination is Sex Discrimination Under Title VII

The Office of Federal Contract Compliance Programs (OFCCP) issued a Directive on Gender Identity and Sex Discrimination (DIR 2014-02), announcing that it will follow the EEOC and investigate claims of gender identity...more

CDC Issues Guidance for Colleges and Universities about Ebola Outbreaks

The Center for Disease Control (CDC) has issued guidance to colleges and universities on how to respond to the spread of Ebola in West Africa. The guidance includes suggested precautions with respect to (a) study abroad...more

IRS Finalizes Guidance on Rev. Rul. 81-100 Group Trusts, and Insurance Company Separate Accounts

In Rev. Rul. 2014-24, scheduled for publication on September 8, 2014, the Internal Revenue Service (the Service) substantially completed its pending guidance on Rev. Rul. 81-100 group trusts by permanently authorizing the...more

UK’s Financial Services Regulator Issues Draft Guidance on Social Media – should we Favourite* or #Fail?

On 6 August 2014, the UK’s financial services regulator, the Financial Conduct Authority (FCA), issued long-awaited draft guidance on the use of social media in financial promotions by regulated financial...more

CFPB issues new mortgage servicing guidance

On August 19, 2014, the CFPB issued a compliance bulletin and policy guidance updating and replacing its earlier guidance regarding mortgage servicing transfers. In replacing Bulletin 2013-01 (the “Original Guidance”),...more

OFCCP Issues Directive Addressing Gender Identity and Transgender Bias

Earlier this week the Office of Federal Contract Compliance Programs (OFCCP) issued a directive to “clarify that existing agency guidance on discrimination on the basis of sex... includes discrimination on the bases of gender...more

OFCCP Publishes Directive on Gender Identity and Sex Discrimination

The Office of Federal Contract Compliance Programs (OFCCP) has published a Directive on Gender Identity and Sex Discrimination (DIR 2014-02). The Directive clarifies that agency guidance on discrimination on the basis of sex...more

Airing the USPTO's Naturally Occurring Dirty Laundry — the Subject Matter Eligibility Stain

It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the...more

DOJ and DOE Warning: School Enrollment Practices Must Not Discourage Enrollment of Immigrant Students

According to the U.S. Departments of Justice and Education, U.S. school districts are discouraging student enrollment based on their parents’ illegal immigrant status. The Departments issued guidance, a frequently asked...more

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