On April 25, 2023, four federal agencies — the Department of Justice (“DOJ”), Federal Trade Commission (“FTC”), Consumer Financial Protection Bureau (“CFPB”), and Equal Employment Opportunity Commission (“EEOC”) — released a joint statement on the agencies’ efforts to address discrimination and bias in automated systems.
EU Pharma Legislation Review Series: Paediatric Medicines
More Obligations for the Same Reward?
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan medicine rules into a single
EU Pharma Legislation Review Series: The Regulatory Sandbox – A Safe Space for Innovators to Grow
As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a “real world environment,” subject to
NYC Artificial Intelligence Rule to Take Effect July 5, 2023: New York City Issues Final Rule Regulating the Use of AI Tools by Employers
The New York City Department of Consumer and Worker Protection (“DCWP”) recently issued a Notice of Adoption of Final Rule (“Final Rule”) relating to the implementation of New York City’s law regulating the use of automated employment decision tools (“AEDT”) by NYC employers and employment agencies.
NYC’s Local Law 144 now takes effect on July
Washington Enacts Update to State Telemarketing Law
On April 20, Governor Jay Inslee signed into law the Robocall Scam Protection Act, which will take effect on July 23, 2023.
As we discuss here, the bill makes a number of updates to the state’s telemarketing law. Notably, the bill prohibits commercial solicitations using an “automatic dialing and announcing device.” It also prohibits
EU Pharma Legislation Review Series: Orphan Medicines
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes up incentives available to the
EU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released today
This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here). It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them.
The proposals have been in development
EU Pharma Legislation Review Series: Regulatory Data Protection
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal products across the EU.” To achieve
Eleventh Circuit Analyzes Article III Standing in Class Action Settlement Context
The Eleventh Circuit recently addressed two aspects of Article III standing relevant to class action settlements: the standing of a class member to object, and the standing of class representatives to seek injunctive relief—and thus whether such injunctive relief should be given any weight as part of the approval process.
DOJ, FTC, CFPB, and EEOC Statement on Discrimination and AI
On April 25, 2023, four federal agencies — the Department of Justice (“DOJ”), Federal Trade Commission (“FTC”), Consumer Financial Protection Bureau (“CFPB”), and Equal Employment Opportunity Commission (“EEOC”) — released a joint statement on the agencies’ efforts to address discrimination and bias in automated systems.
The statement applies to “automated systems,” which are broadly defined