Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
On November 5, 2019, the U.S. Department of Justice (DOJ) Antitrust Division announced the establishment of a Procurement Collusion Strike Force (PCSF) to deter, detect, investigate, and prosecute criminal schemes that undermine the integrity of the government procurement process. One of the highlights of the PCSF is to reprioritize prosecutions of cartel conduct after a several-year decline ...
On March 22, 2013, the Department of Homeland Security ("DHS") announced that it will submit to the Office of Management and Budget ("OMB") a new Information Collection Request ("ICR") related to the implementation of the Chemical Facility Anti-Terrorism Standards ("CFATS") Personnel Surety Program ("PSP"). DHS is soliciting comments during a 60-day public comment period (which ends May 21, 2013) prior to the submission of the ICR to OMB ...
Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...
On March 1, 2023, the Department of Education (“DOE”) released guidance related to the instances in which it will require assumption of personal liability for an institution’s continued participation in Title IV programs. Last year, the DOE announced updated signature requirements for institutions’ Program Participation Agreements (“PPA”). Institutions entering into PPAs already agree to comply with regulatory requirements related to financial responsibility ...
On Friday, September 22, 2017, the Department of Education, Office of Civil Rights (OCR) officially withdrew two guidance documents issued under the Obama administration regarding implementation of Title IX on school campuses. In place of these guidance documents, the OCR issued new interim guidance documents regarding how schools should handle sexual assaults. The OCR indicated official guidance and directives will be issued after a formal notice and comment period ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
With inflation in the United States ballooning 8.2% since April of 2022, government contractors with firm fixed price (FFP) contracts are looking for relief. Unfortunately, the Department of Defense (DoD) recently issued a memorandum indicating that requests for equitable adjustments will not mitigate inflation’s impact to existing FFP contracts. On May 25, 2022, DoD issued a memorandum providing “Guidance on Inflation and Economic Price Adjustments ...
Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...
Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...
Delphi has established local task forces at all our offices responsible for gathering knowledge, analyzing and continuously cover legal issues arising as a result of the corona virus and Covid-19. We advise on a number of different issues and also offer backup resources to facilitate businesses continuity planning if key persons who are lawyers are directly affected by the virus ...
On 30 June 2016, Vietnam’s National Assembly voted to delay implementation of Penal Code No. 100/2015/QH13 dated 27 November 2015 (the “Penal Code”), which was to take effect on 1 July 2016. It is not clear at this time when the Penal Code will be implemented and we understand it will undergo significant revisions prior to being approved for implementation by the National Assembly ...
Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...
We have previously reported on the Order that adopted the extraordinary measures under the COVID-19 health emergency declaration, published on March 31, 2020 (the “Order”), and the subsequent Technical Guidelines regarding certain essential activities described in the Order published on April 6, 2020. (These alerts may be found here and here, respectively ...
Defined contribution (DC) pension schemes will soon be required to disclose more information than ever before in a bid to assess and improve value for their members. On 16 September 2021, The Pensions Regulator (TPR) and the Financial Conduct Authority (FCA) published a joint discussion paper on developing a common regulatory framework for measuring value for money (VFM) for DC members. Background VFM has become a key element of DC governance in recent years ...
The CREG granted the possibility to defer the payment obligations of the marketers invoiced by XM S.A. E.S.P in their ASIC and LAC functions ...
On April 16, 2020, by means of Resolution CRA 915 of 2020, the Commission for the Regulation of Water and Basic Sanitation established transitory regulatory measures for the deferred payment of invoices for domestic water and sewerage services and public sanitation services, within the framework of the emergency declared by the National Government due to COVID-19 ...
As concern over cybersecurity continues to grow,[1] defense contractors have been waiting for the Department of Defense (DoD) to roll out its Cybersecurity Maturity Model Certification (CMMC) program. That rollout has occurred, with DoD’s recently published interim rule Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)[2] (“Interim Rule”), effective Nov. 30, 2020, and providing for a five-year phase-in of CMMC ...
The Government of India has been very active in putting in place the necessary framework to implement the objectives of the ‘Atmanirbhar Bharat Abhiyan’. The ‘Atmanirbhar Bharat Abhiyan’ or a program of self-reliance announced by the Government of India intends to focus on the five key pillars of economy, infrastructure, system, vibrant demography, and demand ...
In an opinion issued on June 5, 2023, the Federal Circuit provided a useful framework for overcoming obviousness rejections during patent prosecution, where a proposed modification to a prior art reference renders it unsatisfactory for its intended purpose.[1] Appropriately applying this framework may provide a strong position against a motivation to combine references, or otherwise modify a prior art device in an obviousness rejection. In Medtronic, Inc. v. Teleflex Innovations S.A.R.L ...
