INSIDE COMPLIANCE

EU says “EW” to Big Tech

April 7, 2022Puja ValeraUncategorized

With new antitrust bills aimed against Big Tech stuck in Congress, across the pond, European Union (EU) lawmakers are close to an agreement on a new and sweeping digital-competition law. This large piece of legislation, known as the Digital Markets Act (DMA), is aimed at Big Tech companies and its stated purpose is to ensure fair competition and open digital markets. DMA, along with its sister act, the Digital Services Act (DSA), are flagship pieces of EU legislation that are currently in the final stages of EU lawmaking procedure.

AntitrustApplebig techeuropean uniongoogleJournal of Regulatory Compliance

New for 2022: Employment Compliance Trends

April 6, 2022Alyssa WolslegelUncategorized

2021 brought on many challenges never faced before for employers, most of which surrounded the central issue of working from home. Employers struggled to keep employees focused with all the distractions of being at home, technology connectivity issues, and making sure employees could still stay connected on a personal level with co-workers. While we may finally be shifting slightly away from the work from home space, 2022 will bring on a whole new variety of employment compliance issues that companies will need to tackle. Now that employees are coming back to the office, the focus will be shifted from managing work from home experiences to minimum wage increases, discrimination protections, and marijuana legalizations just to name a few.

compliance trendsemployee complianceEmploymentemployment compliance trendsJournal of Regulatory Complianceworkforce compliance

Biden Administration Works with the EU to Develop New Data-Sharing Agreement

April 5, 2022Danielle McNamaraUncategorized

After the EU invalidated the previous data transfer agreement between the EU and the US in July of 2020, many big tech companies have been left unsure how to keep business flowing from Europe without the ability to store data within the US. To the relief of these companies, the Biden Administration has reached a preliminary agreement for a new deal with the EU. Coined the Trans-Atlantic Data Privacy Framework, this new agreement works to address concerns raised by the EU.

International AffairsJournal of Regulatory CompliancePrivacy & SecurityRegulation

The Tax Consequences of NFTs

April 1, 2022Daniela RakowskiUncategorized

The popularity of NFTs has been rapidly increasing over the past year, but regulations and guidance relating to the tax consequences of buying and selling NFTs has been slow to keep up. Despite also living on the blockchain, NFTs and cryptocurrencies are not created equally in the eyes of the IRS. The IRS has addressed the rising popularity of cryptocurrencies and published guidance for crypto-investors but has not yet published any specific guidance for NFTs. This leaves many investors in a position of uncertainty regarding the tax consequences of their investments.

cryptoCryptocurrencycryptocurrency regulationNFT RegulationNFT TaxesNFTsRegulationtax

Judge Scrutinizes Wells Fargo and FINRA Over Arbitration Selection Process

March 30, 2022Jeffrey HymenFinance & Banking

Throughout the history of the financial services industry, broker-dealers and investment advisory firms have typically required harmed investors to dispute matters through arbitration rather than the court system. Arbitration disputes between broker-dealers and former clients are generally kept confidential and decided by a purportedly impartial three-person panel; the panels are hand-selected by the parties from a randomly generated list of arbitrators employed by the Financial Industry Regulatory Authority (FINRA). FINRA utilizes a computer algorithm, the Neutral List Selection System (NLSS), which creates a list of potential arbitrators to review the matter based on the type of case. However, a recent court decision overturning a 2019 FINRA arbitration award in favor of Wells Fargo has flooded the financial services industry with widespread allegations of fraud and misconduct. In addition to vacating the arbitration award, Fulton County Superior Court Judge Belinda Edward criticized FINRA’s arbitration selection procedures as well as Wells Fargo for their role in altering the process. Wells Fargo is set to appeal the decision while FINRA now faces immense regulatory pressure to address its failure to facilitate a fair arbitration selection process.

Arbitrationbroker-dealersCongressFINRAInvestorsJournal of Regulatory ComplianceSEC

Is Real ID IDeal?

March 30, 2022Katia Cortes GuzmanUncategorized

By May 3, 2023, U.S travelers must be Real ID compliant to board domestic flights, enter nuclear facilities, visit military bases, and gain access to certain federal facilities. The implementation of the Real ID comes eighteen years after Congress passed the Real ID Act and ten years after the Department of Homeland Security (DHS) issued an enforcement plan for compliance with Real ID standards. Although U.S travelers have a little more than a year to comply with Real ID requirements, compliance may be difficult in light of the Real ID’s history and complications.

DMVJournal of Regulatory Compliancereal ID ActRegulation

FDA-USPTO Collaboration Offers Insight on the Future of Generics

March 29, 2022Andrew ThompsonUncategorized

Following the Biden Administration’s release of the Comprehensive Plan for Addressing High Drug prices in September 2021, the Food and Drug Administration (FDA) responded by opening communication with the United States Patent and Trademark Office (USPTO). On September 10, 2021, the FDA sent a letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO seeking to further develop the FDA-USPTO relationship. The letters point out that while “bringing more drug competition to the market and addressing the high cost of medicines by improving access to affordable medications is a top priority” for HHS and FDA, the FDA is constrained by its inability to regulate the price of drugs it approves. While the FDA’s 505(b)(2) hybrid NDA and 505(j) ANDA pathway decrease the cost and time to market entry for generics, the FDA’s authority is concentrated in the pre-market review stage, with post-market authority focused on actions such as product seizure of adulterated or misbranded articles, phase-4 confirmatory trials, and other actions intended to assess the safety and efficacy of drugs.

Journal of Regulatory Compliance

Innovation in Healthcare: Physician Payment and Automation

March 28, 2022Micaela EngerFraud & Abuse

In the fight against COVID-19, healthcare innovation has been unprecedented. New technology, protocols, and laws have changed the way healthcare functions. However, physician compensation remains complex, burdensome, and often contentious. Physician compensation has always invited compliance risks, operational bottlenecks, and administrative burdens, but now, innovative hospitals are simplifying the process with automation.

automationhealth care fraud and abusehealthcare innovationphysician compensation

What Will it Take to Deter Corporations from Violating Environmental Regulations?

March 26, 2022Giuliano StefanuttiUncategorized

Beverage corporation Diageo has recently been fined £1.2 million for violating environmental regulations. Diageo is a multinational corporation that owns a variety of liquor brands, including Johnnie Walker, Tanqueray, Smirnoff, Captain Morgan, Don Julio, Crown Royal, and several others. Headquartered in England, it operates all over the world, with its North American subsidiary being one of its most profitable. In violation of UK regulations, the beverage company has failed to report the environmental impacts of some of its sites for the past six years and has failed to secure permits for the relevant operations. The corporation alleges that these omissions were the result of an administrative error.

carbon emissionsconsumer productsenvironmentenvironmental regulationenvironmental regulationsGreenhouse Gas EmissionsJournal of Regulatory ComplianceUK

What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic

March 25, 2022Janaki PadmakumarUncategorized

In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.

consumer protectionFDAFood ProcessingRegulation