On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021 ...
On Sept. 15, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on Jan. 14, 2021, and would be effective on Dec. 15, 2021. In June 2021, we reported on CMS’ decision to delay the MCIT Program Final Rule (The Rule) ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
On September 15, 2022, the Wall Street Journal reported Securities and Exchange Commission (SEC) Chairman Gary Gensler told reporters after a Congressional hearing that digital assets and the intermediaries dealing in such assets that allow for staking may shift the “efforts of others” analysis under the Howey test. If so, they would be re-categorized as securities ...
The non-fungible token (NFT) boom among luxury fashion brands recently made headlines again with a highly publicised trial involving the French fashion brand Hermès and its iconic Birkin handbags in New York. The case involved a prominent figure in the world of NFTs, digital artist Mason Rothschild. NFTs are digital assets that are unique, verified, and securely stored on a blockchain (a type of decentralised public digital database) ...
In a circular dated the 15th of November 2022, the Malta Financial Services Authority (“MFSA”) confirmed that electronic signatures which are done with a ‘qualified electronic signature’ shall be accepted by the MFSA ...
The Michigan Economic Development Corporation has announced the Tech Startup Stabilization Fund—a $3 million fund that will provide capital and support for Michigan tech startups impacted by the COVID-19 pandemic. ID Ventures is administering the fund and accepting applications from tech startups across the state at TSSFund.com ...
While public attention focused on the federal and state elections, Michigan voters made an important decision—they adopted Proposal 20-2, which amended Michigan’s Constitution to extend its protection from unreasonable searches and seizures to electronic data and communications ...
The US Second Circuit Court of Appeals, overturning an earlier court ruling from a lower court, has held that the US Government cannot compel Microsoft to hand over emails stored on a server in Dublin in a narcotics case. The decision is a milestone victory for privacy rights and will be greatly welcomed by US technology companies storing data abroad ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
Minnesota Federal Court finds no coverage under technology errors and omissions policy because claims did not arise out of a “Wrongful Act” as defined in the policy ...
As we navigate a rapidly changing digital landscape, upskilling our people continues to be a priority. In response, the innovators at MinterEllison developed Mintcoin, an internal crypto currency designed to reward participation in the firm’s Digital Academy program and innovation initiatives. We’re thrilled to announce that this initiative has secured MinterEllison a spot on the AFRs Most Innovative Companies list for 2023 ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
An application software (app) is a program designed to help customers perform particular activities. These apps, which are usually on our electronic devices, are used to control several things ranging from health & fitness, music, movies, online shopping, gaming to mobile money transfers and even household appliances. In this article, our Davidson Oturu, breaks down the IP considerations app developers should note ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
When the Protection of Personal Information Act, 2013 (“POPIA”) comes into effect fully from 1 July 2021, there are some areas of possible dispute that could arise between employers and employees, including the monitoring of employee emails. In a recent Constitutional Court judgment in Turkey, the personal data protection rights of an employee were considered, and could provide some guidance as to how a similar situation may be handled in a South African context ...
The Supreme Court’s recent decision has seeded another patent protection feather in Monsanto’s increasingly large cap, in addition to providing guidance on application of the patent exhaustion doctrine in the case of self-replicating technology. In Bowman v ...
Yesterday Moscow court of appeal approved the decision of the court of the 1st instance referring to restricting access to LinkedIn website. The main reason for this decision was the fact that LinkedIn did not transfer the databases processing Russian nationals’ personal data in Russia. The Russian Localization Law which is in force as of September 1, 2015, requires that certain types of processing of Russian nationals personal data are performed in the databases located in Russia ...
In a defining moment for the digital economy, Vodafone Germany has recently announced its partnership with Cardano, a public blockchain platform, to launch one of the world’s largest NFT collections. This move by Vodafone demonstrates the growing interest of global telecommunications corporations in embracing blockchain technology and digital assets ...
What will UK data protection look like after Brexit 2.0 on 31 December 2020? Regime 1: the 'UK GDPR': the UK's new bespoke version together with the Data Protection Act 2018 The UK GDPR will be the UK data protection regime based on the 'EU GDPR' (see below) ...
The world is moving at a break neck pace, and a crucial element at the root of these changes are technological developments. As the global business landscape has been irrevocably altered by these developments, it was only a matter of time before each comprising industry would have had to adapt and – to a certain degree – reinvent itself as a consequence ...
Last week, the Norwegian Data Protection Authority announced that they intend to sanction Østre Toten municipality with a fine of NOK 4,000,000 due to the municipality’s non-compliance with the GDPR requirements. The announced sanction follows in the wake of the Data Protection Authority’s investigation of the municipality’s IT systems after it was exposed to a fatal ransomware virus attack in January this year ...
On 17 November 2022, the State Administration Council (“SAC”) enacted the Law Amending the 2022 Union Tax Law (“2022 UTL Amendment”). This law provides tax exemptions for Battery Electric Vehicles (“BEVs”) and increases the corporate income tax rate of companies engaged in the oil and gas exploration and production sector in Myanmar. We highlight below the major changes under this law: 1 ...
Dear valued clients, colleagues and friends, In this article, our partner, Anand Raj, and associate, Jeevitha Thurai Rathnam, discuss the Malaysia Competition Commission’s market review exercise into the transportation sector (port logistics ecosystem and motor vehicle warranty claims) ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
