On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
The end is near. 2018 is fast coming to a close, and it is that time of year when corporate lawyers are counting—not the number of shopping days left until Christmas, but the number weeks, days and hours left before the end of the fiscal year. Admittedly, in the scramble to close deals, insurance requirements and indemnity provisions may not be at the top of the list of critical deal points for clients and counsel ...
Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
In December of 2018, EU Court of Justice Advocate General Campos Sánchez-Bordona concluded that the United Kingdom may unilaterally withdraw its intention to leave the European Union before 29 March 2019 and therefore remain in the EU. This is so long as the revocation notice is made before the formal conclusion of a withdrawal agreement and it respects the UK’s constitutional requirements ...
As in previous years, the California legislature kept busy in 2018. As a result, a number of new and noteworthy employment laws will go into effect on January 1, 2019, and beyond. Much of the legislation stems from the #MeToo movement by strengthening harassment and discrimination protection, imposing broader anti-harassment training obligations, updating lactation accommodations and mandating female presence on boards of public companies ...
In February of this year, the Securities Exchange Commission issued its updated Statement and Guidance on Public Company Cybersecurity Disclosures. In April, the SEC issued an Order that, among other things, levied a $35 million fine against Yahoo! Inc. for failing to properly report a 2014 data breach. These actions support the view that the SEC is consciously committing attention and resources to cybersecurity issues affecting public companies ...
The UAE federal government has recently issued a raft of important legislation. The raft addresses and updates areas of law that are key to businesses in the jurisdiction. Amongst this legislation is Federal Decree-Law 14 of 2018 concerning the central bank and the organisation of financial institutions and activities (the New Banking Law) ...
Since the GDPR has been in force, almost every company has, among other things, dealt with issues of the permissibility of direct marketing and other marketing activities under data protection law. At their data protection conference on Nov. 07-08, 2018, the German data protection supervisory authorities issued a new "orientation guide" on this topic (as of November 2018) ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
The large number of vague terms as well as provisions requiring interpretation in the GDPR create significant application issues for companies. However, it becomes even more of a challenge if companies not established in the EU want to review whether the GDPR is applicable to them. Generally speaking, the European legislator set themselves the goal of creating the most extensive territorial scope of the GDPR possible ...
The new anti-money laundering (AML) law of the UAE took effect at the end of October 2018. Containing features recommended by the Financial Action Task Force (FATF), the new law introduces subtle but important changes to the AML landscape in the UAE. The new law was enacted as Federal Decree-Law 20 of 2018. The previous AML law was Federal Law 4 of 2002, as amended by Federal Law 9 of 2014, and the implementing regulations that were promulgated pursuant to Cabinet Resolution 38 of 2014 ...
The enactment of EU Directive 2018/843 on the prevention of the use of the financial system for money laundering or terrorist financing (the "5th AML Directive") has prompted the Luxembourg government to accelerate the final implementation process of EU Directive 2015/849. This Directive prevents the use of the financial system for the purposes of money laundering or terrorist financing (the “4th AML Directive”) ...
In light of the new EU data protection scheme, shaped by the GDPR, Serbia has enacted a new Data Protection Law earlier this year, with its' applicability postponed for 21 August 2019. The new law was long-awaited: it has been 10 years since the existing law was passed, which was even at that moment already outdated (e.g. it recognized only consent in the written form and almost completely restricted data transfers to non-European countries) ...
On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...
News of a new federal law on foreign direct investment in the UAE has many people asking: “Does this mean I can now form a new company with majority foreign ownership?” The answer is the same as previously, “No, not yet”. Companies incorporated in the UAE require a minimum of 51 percent UAE ownership. As an exception to this rule, 100 percent foreign ownership is permitted in free zones. The new law may lead to further exceptions in the future ...
The introduction of the e-hailing system had changed the landscape of public transport in Malaysia and, at the same time, intensified the competition in the taxi industry. Whilst the taxi industry was subject to specific regulatory requirements there was previously no express law to regulate the operation of the e-hailing system ...
“Tax investigation” entails an examination of a taxpayer’s business books, records, and documents as well as his personal documents to ensure that the correct amount of income is reported and tax is calculated as well as paid by the taxpayer ...
In the last quarter of 2018, the Department of Labor (DOL) issued an opinion letter ending what had become known as the “80/20 rule” for tipped employees. The new rule, which eases restrictions on an employer’s application of the tip credit, is a reissuance of a 2009 opinion letter that had been supplanted by contrary guidance since 2011 ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
On October 31, 2018, the Treasury Department released proposed regulations (“the Proposed Regulations”) providing guidance on the application of Section 956 of the Internal Revenue Code of 1986, as amended (the “Code”) following recent tax law changes under the Tax Cuts and Jobs Act (the “Act”) ...
Earlier this week, the UK Cryptoassets Taskforce published its Final Report on cryptoassets and distributed ledger technology (DLT). The Taskforce – which includes representatives from HM Treasury, the UK Financial Conduct Authority (FCA) and the Bank of England – was established in March 2018 to analyse and assess the risks and potential benefits of cryptoassets and DLT and “set out the path forward with respect to regulation [of these areas] in the UK” ...
"Slavery remains a reality in the modern world. Children, men and children are being exploited in our towns, communities and businesses every day. The victims are hidden from view and many people may never know this cruel practice is taking place on their streets and under their noses". Rt Hon Sajid Javid MP, Home Secretary, October 2018 ...
