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FDA on pace for a Record Number of Breakthrough Devices in 2023
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough device designation prior to requesting market approval regardless of the classification of the device. In order to qualify as a breakthrough device, the…
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Building a Better AI Legal Framework: The EU AI Act and Beyond
Recent discussions surrounding the EU Artificial Intelligence Act have accelerated as the European Parliament took the Act one step closer to becoming effective law. On June 14, 2023, the Parliament voted for negotiations with the Council of the European Union to commence on what the final version of the Act will look like. Since that…
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National Student Clearinghouse and TIAA Notify SUNY Freedonia, CSU, and UB University at Buffalo of MOVEit Data Breach
Over the past few weeks, three large universities posted notices of third-party data breaches after learning that two of the Universities’ vendors, the Teachers Insurance and Annuity Association (“TIAA”) and the National Student Clearinghouse (“NSC”), used MOVEit, a file-transfer software that was recently discovered to contain a vulnerability allowing hackers to access information stored within…
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Multiple Colleges and Universities Notified of National Student Clearinghouse Data Breach Involving MOVEit Vulnerability
Over the past few weeks, multiple colleges and universities have posted notices on their respective websites regarding a National Student Clearinghouse (“NSC”) data breach. Evidently, the NSC data breach involves the organization’s use of MOVEit, a file transfer program that contained a previously unknown vulnerability allowing hackers to access data stored within the program. In…
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United Bank Announces Data Breach Related to “Third-Party Software Tool”
On June 30, 2023, United Bank filed a notice of data breach with the Attorney General of Massachusetts after discovering a vulnerability within a third-party software tool used by the bank. In this notice, United Bank explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information, which includes their…
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Legal Considerations for WHO’s ‘Possibly Carcinogenic’ Aspartame Classification
On July 14, 2023, the World Health Organization (WHO) published a summary of two findings regarding aspartame, an artificial sweetener found in many consumer products. One finding categorized aspartame as “possibly carcinogenic,” which potentially increases businesses’ litigation risk and regulatory scrutiny regarding aspartame-containing products, while the other finding reaffirmed that the current acceptable daily intake…
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Sunflower Bank Confirms MOVEit Vulnerability Resulted in Data Breach
On July 14, 2023, Sunflower Bank filed a notice of data breach with the Securities and Exchange Commission after discovering that MOVEit, a file transfer program used by the bank, contained a critical vulnerability allowing hackers to access confidential customer information. Sunflower Bank is still in the process of investigating the incident; however, if it…
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Russia-Ukraine War: Russian Strikes and Naval Drills Unsettle Black Sea as U.N. Meets
The U.N. Security Council held an emergency meeting on the collapse of a deal that had allowed Ukraine to ship grain despite a Russian blockade. Moscow again struck granaries in the port of Odesa and the Russian Navy practiced destroying a ship in the Black Sea.
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Israel’s Judicial Plan Crisis Grows as Air Reservists Threaten to Stop Serving
In a move that experts say could hurt Israel’s military readiness, pilots and other personnel issued a warning after Benjamin Netanyahu pressed ahead with a plan to limit judicial power.
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How to Fight Canada’s Wildfires in the Era of Climate Change
Canada’s record-breaking wildfire season shows the need to shift from suppressing fires to preventing them as fires become more difficult to combat.
