In recent years, with the continuous improvement of science and technology standards in China, the country’s cryptography technical capabilities have also begun to enter the global forefront. In turn, China has promulgated various policies and measures to fulfill its non-proliferation obligations, which have promoted the gradual implementation of control measures for the export of cryptographic technologies ...
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 ...
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 ...
Early last year the Prime Minister dropped the “E-bomb” on British motorists, announcing a ban on cars powered wholly by petrol and diesel from 2030, and on the sale of new hybrid vehicles with the capability to drive a significant distance with zero emissions (such as plug-in or full hybrids) from 2035. Since then, the COVID-19 pandemic has impacted the world in an unprecedented manner ...
In December 2020, the National Institute of Industrial Property (INPI) published on its portal the Examination Guidelines for Inventions Implemented by Computer Program ...
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 ...
On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015 ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
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 ...
We would like to inform you that several laws, that will have a significant impact on IT and data protection regulation, were adopted at the end of 2020 (“Amendments”). Further rules for blacklisting Internet resources The first amendment to Russian law is aimed at securing guarantees, for citizens’ rights, to freely search, access and disseminate information ...
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 ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
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 ...
A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus ...
In recent years, Russia has focused on regulating its IT area. In particular, this has been needed due to the increasing number of cases, when prohibited information has been distributed on various large Internet resources, such as a social network. However, according to Russian government agencies, despite the risks of possible sanctions, many foreign companies still do not respond quickly enough to government requests, or ignore the demands to remove prohibited information ...
For the time being, there are no specific laws governing the use of artificial intelligence in Canada. Certainly, the laws on the use of personal information and those that prohibit discrimination still apply, no matter if the technologies involved are so-called artificial intelligence technologies or conventional ones ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
All indications are that the evolution of privacy laws and their impact will continue to evolve, perhaps even at a greater pace, in 2021. In celebrating Privacy Day, January 28, 2021, we would like to share four things businesses should be keeping their eyes on, and planning for, in 2021. 1. Significant changes to privacy legislation in Canada. Canadian federal and provincial governments have tabled and proposed sweeping changes to privacy laws in Canada ...
CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
Over the last several years, banks of all sizes have successfully partnered with emerging fintech companies to offer innovative loan products to a broader range of customers. Under a typical form of this partnership, a fintech, which is subject to the policies of the partner bank, will market loan products, take and process loan applications, and will service those loans once they are funded ...
