Coronavirus Insights & Updates The information listed below is categorized by topic for your convenience and includes content from the previous week. Bradley is actively monitoring and engaging with relevant federal, state or local entities on issues related to the coronavirus. Please contact one of the authors if you have any questions. Click on a link below to view the full article, alert, blog, webinar recording or interview ...
A new ordinance enacted by SENACON became effective on February 5 bringing changes to the execution of Terms for the Adjustment of Conduct (“TAC”) in administrative proceedings before SENACON, revoking the previous ordinance. The ordinance provides for several phases in the process of execution of a TAC, which will begin with a request, analysis of the feasibility of the negotiation, the negotiation itself, followed by authorization and subsequent decision ...
The Supreme Court has issued Supreme Court Administrative Matter No. 20-12-01-SC (Re: Proposed Guidelines on the Conduct of Videoconferencing) dated December 9, 20201 (Court Videoconferencing Guidelines) to ensure that hearings via videoconferencing are conducted in an orderly manner and that the constitutional rights of the accused are protected ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No ...
On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021 ...
On 4 January 2021, the President of Republic of Indonesia issued Regulation No. 2 of 2021 on the Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents (“PR 2/2021”) (the convention is hereinafter referred to as the “Apostille Convention”). The Apostille Convention was concluded on 5 October 1961 and is intended to simplify a series of formalities for documents signed overseas for the contracting states ...
&The U.S. Court of Appeals for the Federal Circuit, in BGT Holdings LLC v. United States, 1 recently held that the government does not have the discretion to deny a contractor's request for equitable adjustment (REA) under Federal Acquisition Regulation (FAR) 52.245-1 (Government Property) where the conditions specified in that clause are present and the contractor is able to show financial loss ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
The Oil Can published an article by Dinsmore partner Mark Boos this week in its Spring 2021 edition about the importance of indemnification provisions are essential in commercial contracts, an excerpt of which is below. Indemnification provisions are part of virtually every commercial contract. Ironically, they’re also among the contract elements most likely to be overlooked by the parties ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
Aron Beezley of Bradley Arant Boult Cummings LLP enumerates the key impacts of the Federal Acquisition Regulation Council's final rule adopting mandates of the executive order Maximizing Use of American-Made Goods, Products, and Materials. The Federal Acquisition Regulation (FAR) Council recently issued a final rule1 that implements the requirements of the Maximizing Use of American-Made Goods, Products, and Materials Executive Order ...
The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose ...
The introduction of mandatory pre-installation of applications developed by Russian market players, caused by a wave of cases of abuse by global companies of their dominant position in digital markets, is a significant innovation in Russian antitrust and consumer protection law. To reduce the risks of restricting competition and balance the bargaining power of global corporations with small domestic application developers, amendments to the Law dated February 7th 1992 No ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed sweeping changes to the popular “short-form” Proposition 65 warning. On January 8, 2021, OEHHA issued a proposal to amend Article 6 “Clear and Reasonable Warnings” Section 25601. This Article sets forth “safe harbor” warning methods, including warnings for consumer product exposures ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2020 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. Despite the pandemic and the smallest recoveries for the Department of Justice in over a decade, FCA enforcement remains robust. As always, the healthcare industry remains the most frequent subject of FCA cases and investigation ...
Current State of Shopping Centers Our legacy shopping centers are often well-located, near transportation routes, population centers and employment hubs. Post-recession enthusiasm for shopping encouraged the expansion of many retail stores and product lines, and rental rates for prime shopping locations continues to grow ...
Traditionally, Belgian labour law distinguishes between two forms of telework, namely structural telework, regulated by the Collective Labour Agreement n° 85, and occasional telework, regulated by the Act on Workable and Agile Work. Since the start of the Covid-19 pandemic, a third category has been added, namely 'Covid telework', which was, at a certain point, recommended but has now been made compulsory again by the government ...
The Government of the UAE made another milestone announcement on 30 January 2021, announcing a procedure for the granting of citizenship to foreign nationals in a bid to retain talent in critical sectors and to expand and diversify the economy. Nationality and citizenship in the UAE are governed by Federal Law No. 17 of 1972 Concerning Nationality and Passports, as amended by Federal Law No. 10 of 1975 and Federal Decree-Law No ...
