The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
On January 19, 2019, federal Magistrate Judge Kandis Westmore of the Northern District of California denied the Government’s application for a search warrant that sought: “all digital devices” present at a California residence; (Order at 3), and “any individual present at the time of the search to press a finger (including thumb) or utilize other biometric features…for the purposes of unlocking the digital devices found in order to permit a search of
The UK data regulator, the Information Commissioner’s Office (“ICO”), has released a statement warning organisations to assess the public risks of using emotion analysis technologies, with those failing to do so risking investigation and enforcement action ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
On May 07th, 2024, the Chilean President of the Republic sent to the Chamber of Deputies a bill (the “bill”) regarding the regulation of Artificial Intelligence (“AI”) systems, being the result of the work carried out on the former bill, the National AI Policy, comparative experience, and several international recommendations regarding AI ethics ...
On April 26th, 2022, the Senate unanimously approved in particular (first constitutional procedure) the Bill that establishes a Framework Law on Cybersecurity and Critical Information Infrastructure. As a result, the legislative proposal passed to the second constitutional procedure waiting to be discussed by the Chamber of Deputies ...
On Monday, April 1st, 2024, the Chilean Government introduced in the Chamber of Deputies a bill which aims, on one hand, to establish regulations to facilitate and promote the transfer of technology and knowledge and, on the other, to enable and stimulate the creation and development of science and technology-based companies (“EBCT”) from higher education institutions ...
On June 2nd, 2014, President Michelle Bachelet entered a bill into Congress which seeks to modify Law N° 19.496 on the Protection of the Rights of Consumers (“CPA”). The message of the bill recognizes that the tools provided by the current legislation to address violations to the rights of consumers are not sufficiently efficient or dissuasive: in several cases it is less expensive for providers to pay a fine for breach of the CPA, than to comply with such regulation ...
Corporations and governments are ferreting out and squirreling away voluminous, detailed and private information about each and every one of us – and they are not afraid to use it. Should we be worried? Singapore’s Health Minister recently revealed that confidential details of 14,200 HIV-positive people, stolen from a government public health database, had been leaked online by a disgruntled US citizen who had been in a romantic relationship with a local doctor ...
How retailers can harness technology to beat e-commerce at its own game. “It's official: Singapore malls are dead, as occupancy reaches its lowest level in 10 years,” screams one headline. “At some suburban malls, retailers confront the sound of silence,” another chimes in. As e-commerce takes hold, shoppers are eschewing brick and mortar in favour of the convenience of point and click ...
Most people probably associate cyber-crime with issues of national security—what with Russia dominating so much space in the headlines, lately. However, cybersecurity breaches can have a palpable and damaging effect on everyday individuals, due to how often they’re tied to corporate security breaches involving highly sensitive personal information like credit card numbers, social security numbers, and contact information ...
With federal privacy legislation stalled and indefinitely delayed, states have moved forward to push an impressive number of privacy laws forward over the last several years. Some of these laws are still relatively obscure, but are being increasingly enforced by state regulators and through litigation ...
What Happened: The US warns victims of ransomware and companies facilitating ransomware payments of potential Office of Foreign Assets Control (“OFAC”) violations in light of rising ransomware attacks. The Bottom Line: Individuals and companies risk potential civil penalties based on strict liability if a ransomware payment involves a person or entity on OFAC’s Specially Designated Nationals and Blocked Persons List (“SDN List”) ...
Two significant events this week raised eyebrows in the lucrative world of live sports broadcasting. Firstly, Facebook agreed an exclusive deal to show La Liga to users in Asian territories including India, Bangladesh, Sri Lanka and Pakistan. It will live stream all 380 matches this season for free to its 348 million users in the region. The move fits with Facebook's ambition to grow use of its social networking platform outside markets that have reached saturation ...
Technology’s dark side may well be the silent threat to democracy. A year ago, Americans installed a reality TV star in the White House who doesn’t seem to let the facts get in the way of a good tweet. Trump’s shambolic management style has given America’s enemies a perceived opportunity to drive their country’s agendas ...
The world is gradually embracing remote working as an alternative way of work – hosting virtual meetings, supporting customers through online communications, and accessing data remotely from outside the office. In the past, working from home (WFH) had not been popular in Hong Kong even though evolving technologies and improved Internet speed made it possible for digital migration ...
Contents Legal and Enforcement Framework Blockchain Markets Cryptocurrencies Smart Contracts Data and Privacy Cybersecurity Intellectual Property Trends and Predictions Tips and Traps Legal and Enforcement Framework What general regulatory regimes and issues should blockchain developers consider when building the governance framework for the operation of blockchain/distributed ledger technology protocols? Bermuda has a digital asset sector specific legal and regulatory re
Contents Government attitude and definition Cryptocurrency regulation Ongoing obligations Sales regulation Taxation Money transmission laws and anti-money laundering requirements Promotion and testing Ownership and licensing requirements Mining Border restrictions and declaration Reporting requirements Estate planning and testamentary succession Government attitude and definition Bermuda has been recognised as a global leader in the regulation of blockchain and cryptocurrency-b
On 22 September 2023, the Royal Decree of 13 September 2023 establishing specific rules on the public procurement of biological medicinal products was published in the Belgian State Gazette (“Royal Decree”) ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
“Belarus will become the first government in the world that opens wide opportunities for the use of blockchain technology”, said in a statement on the official website of the President of Belarus. Alexander Lukashenko, who signed the new law of the land, believes that his county “has every chance of becoming a regional center in this area.” The Presidential Decree of the Republic of Belarus No ...
The value of the car is no longer merely associated with the car body, its engine or other material parts. Substantial value is found in the knowledge that controls the car – knowledge that does not only steer the car, but which may form the basis for maintenance and repairs planning, computing insurance premiums or indicating who is liable in the case of damage ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
