Senate Brings Bipartisan Attempt to Update Health Privacy Regulations

Posted on March 19, 2022Categories HIPAA & Health Information

On February 9, a group of senators led by Tammy Baldwin of Wisconsin and Bill Cassidy of Louisiana introduced a new bill, the Health Data Use and Privacy Commission Act (the “Act”),  in attempt to revitalize current legislation regarding the protection and use of health data. The bill also has the support of a number of representatives from within the healthcare industry, including Epic, IBM, and Teladoc Health, as well as a number of professional associations like the American College of Cardiology, the Association for Behavioral Health and Wellness, and the Association of Clinical Research Organizations.
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FDA’s Proposed Global Regulatory Harmonization for Medical Devices

Posted on March 18, 2022Categories Drugs & Devices, The Marketplace

On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.
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Why a Culture Change in the Workplace Benefits your Mentoring Program

Posted on March 17, 2022Categories Uncategorized

It’s hard and expensive to find and retain good employees. With this in mind, it’s not a surprise that companies are willing to try all sorts of things to make sure their employees stick around. For example, many companies have attempted to establish corporate mentorship programs where newer employees are paired up with veterans who can show them the way. But is this the right approach? Mentoring programs typically rely on single mentor-mentee matches and formal hierarchical pairings. Even if you can implement the best mentoring program, it is unlikely to achieve its intended result when the surrounding workplace is competitive and individualistic. For mentorship programs to have a real effect on the workplace, it seems that we all must take a step back and realize that real mentorship starts with company culture, not formal programs.
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The Economic War Against Russia: Sanctions, Sanctions and More Sanctions

Posted on March 16, 2022Categories Uncategorized

As the pace of Russia’s incursion into neighboring Ukraine escalated three weeks ago, starting with a massing of troops on Ukraine’s eastern Donbas border and expanding quickly into a full-fledged military invasion, so too did the response of the United States and its Western allies. Initially, the Biden Administration proceeded cautiously, deciding against levying its harshest sanctions over concerns of how they would impact European and global economies and that a stepped approach offered the best chance for de-escalation of tensions. The government began by blacklisting two major state-owned banks that are tied to the country’s defense sector and five Russian nationals with close links to the Kremlin. The U.S. and its European allies also banned the Kremlin from raising new money in the U.S. and Europe and trading new sovereign debt in U.S or European markets. In addition, Germany unilaterally halted certification of the Nord Stream 2 natural gas pipeline which was set to go ahead sometime later this year, an action applauded by the U.S. who had long argued against the project fearing that it would increase Europe’s dependence on Russian fuel.
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Current Status Pending: Title IX, Deliberate Indifference, & Non-Student Offenders

Posted on March 15, 2022Categories Uncategorized

With the Biden administrations new proposed Title IX regulations set to be published in April of this year, attorneys and advocates alike have been left to speculate as to what changes the Department of Education (ED) will propose. Among this speculation, is a narrower question: will ED, in their proposed Title IX regulations, finally state directly that universities can be held liable for deliberate indifference to known sexual harassment perpetrated by a non-student guest? At this point, any answer to this threshold inquiry would be speculative, but there are a few indicators that suggest the answer may be yes. 
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Could Anna Delvey Have Gotten Away with It? Bank Vetting for a $22 million Loan

Posted on March 14, 2022Categories Finance & Banking, The Art of Compliance

Anna Delvey, the alleged scammer who attempted to obtain financial backing of anywhere from $22 million to $40 million in loans, is once again the subject of much debate due to the new Netflix series chronicling her alleged crimes and other actions. The question this article attempts to answer is whether she ever had a chance of realizing her goal of creating an exclusive, members-only, art club much like Soho House. This question hinges on whether she ever had a real chance to secure the funding to make it possible.
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Decriminalization Is Not Enough, Abolition Is a Must

Posted on March 7, 2022Categories The Marketplace, Uncategorized

In the United States, since the 1980s, the federal prison population has increased by roughly 790%. Specifically, presently within Illinois, there are approximately 76,000 citizens who are incarcerated. In 2014, Illinois appropriated and spent nearly $1.3 billion on prison budgets. Where even though cannabis is now legal, in Illinois, roughly 90 inmates are still incarcerated for offenses relating to the use, manufacturing, and selling of cannabis. According to the Last Prisoner Project, inmates remain incarcerated even though House Bill 1438 establishes that persons who have been convicted on an offense are granted a pardon because the Bill provides no resentencing or commutation procedures, and the process to have sentences pardoned is slow.

In examining the injustices of carceral punishment, statistics like these show that these injustices are not an anomaly, but rather the norm. Because prisons are premised on punishment, rather than transformative healing, health, and prevention, prisons are a human rights issue, rather than a criminal justice issue. Prisons are premised on punishment, rather than transformative healing and health, and prevention. As a result, resources and funding which are currently given to our present system of policing and prisons should be reallocated to tools that actually serve the community, rather than on incarceration.
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SEC Proposes New Mandatory Disclosures by Private Equity and Hedge Funds

Posted on March 2, 2022Categories Finance & Banking

Private equity firms and hedge funds, typically utilized by more knowledgeable and sophisticated parties, have not seen much governmental scrutiny in the past. However, the Securities and Exchange Commission (“SEC”) recently passed a proposal that would force these funds to furnish basic disclosures to their investors and guard against conflicts. These changes stem primarily from the 2020 “meme stock” controversy that put a spotlight on vaguely policed private equity and hedge funds.
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What’s the Tea?

Posted on March 1, 2022Categories Uncategorized

When people hear the phrase “regulatory compliance”, they often think about the finance, banking, or tech industry – not the business of loose and pressed leaves. In fact, the tea industry has been on the rise and is projected to reach almost $69 billion by 2027. Within that market, the green tea segment is the highest growth contributor with an estimated $16 billion in 2019 and is projected to reach almost $26 billion by 2027. This leafy market comes with its own set of compliance issues and a potential for growth this year.
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