INSIDE COMPLIANCE

FDA Oops: Two Orphan Drugs Approved for Same Disease or Condition

September 22, 2023Jason VelliganFood and Drug LawLeave a comment

An orphan drug treats a rare disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that the cost of making the drug will ever be recovered by the manufacturer. The Orphan Drug Act of 1983 incentivizes pharmaceutical manufacturers to investigate and develop drugs for rare diseases with a low probability of profitability. Orphan drugs have been approved and used to treat various cancers, Huntington’s disease, Fragile X syndrome, pulmonary fibrosis, myelomas, carcinomas, and other rare and unfortunate ailments that impact people’s lives. According to the National Organization for Rare Disorders, the number of approved drugs for treating rare diseases soared from 38 drugs before the act to 6,583 orphan-drug designations by the Food & Drug Administration (FDA) today. Undoubtedly, the Orphan Drug Act has had a positive impact on both patients suffering from rare conditions and the manufacturers that utilized the law.

New York Non-Competes: Competing to Stay Alive

September 21, 2023Amanda MeyerUncategorizedLeave a comment

There is an ever-growing wave of states banning non-compete agreements (“non-competes”), and New York is likely to join this trend. The New York Legislature just passed one of the broadest non-compete bans in the history of the United States in early June this year, and Governor Kathy Hochul is likely to sign this ban into effect. This broad non-compete ban comes in the form of two bills, both passed by the New York Senate. One bill would ban post-employment non-competes, and the other would prohibit employers from having employees enter into a non-compete, absent a “good faith basis”. If signed by Governor Hochul, these bills will become effective 30 days after signing. These bills will be prospective, meaning they will not invalidate preexisting non-competes signed on or before July 1st, 2023.

From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare

September 21, 2023Katherine OMalleyDrugs & Devices, Healthcare Compliance, HIPAA & Health InformationLeave a comment

The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.

generative AIHealthcare Industry

Ethics for the Supremes

September 21, 2023Kirsten BrueggemannUncategorizedLeave a comment

Shortly before the conclusion of the Supreme Court’s term in June 2023, the Court delivered three blows to President Biden and Democratic party. First, the Court struck down the student debt relief program championed by President Biden. Second, the Court ruled in favor of a Colorado web designer who sought the right to refuse service to a same-sex couple. Lastly, the Court gutted affirmative action by making it unlawful for colleges to consider race as a specific factor in admissions. These high-profile decisions came just over a year after the contentious Dobbs decision, following an extraordinary leak, which overturned abortion rights that had been established under Roe v. Wade and Planned Parenthood v. Casey. These cases are perhaps marred by recent ethics scandals amongst the justices. Consequently, voices from both sides of the political aisle have called for reform of the nation’s highest court.

Ethicsprofessional ethicsSupreme Court

New Rule Proposed by the EPA to Clean Up Coal Waste in the Midwest

September 21, 2023Sarah FritzUncategorizedLeave a comment

On May 18, 2023, the Environmental Protection Agency (EPA) proposed a new rule to address the concern of a previous loophole that allowed pits of coal ash to sit inactive and unmonitored. The new proposed rule was created in response to the August 21, 2018 opinion by the U.S. Court of Appeals for the District of Columbia Circuit in Utility Solid Waste Activities v. EPA.

Environmental LawEnvironmental Protection AgencyEPAJournal of Regulatory CompliancePollution

PGA Tour and LIV Golf Partnership: A Swing and a Miss?

September 21, 2023Jossie WardAntitrust, Athletic Regulation, SportsLeave a comment

The PGA Tour and LIV Golf have agreed to a partnership, ending the rivalry that has divided golf for the past year. While golf fans may be rejoicing, it may be a premature celebration as the Justice Department has already been investigating the golf industry for anticompetitive behavior. The announcement of the PGA Tour and LIV Golf partnership has raised further concerns about monopolistic practices within the golf industry.

AntitrustDOJgolfMonopolypartnershipRegulationSports

Hey U.S. Government, The Romance Scammers Are Eating Americans Dry

September 20, 2023Alexis SlaughterCompliance Spotlight, Finance & BankingLeave a comment

The rise of online dating and social media has brought people closer together but has also given rise to a growing threat: romance scams. These fraudulent schemes prey on individuals seeking love and companionship, resulting in emotional and financial devastation. These scams involve perpetrators who create fake online personas to deceive individuals into forming romantic connections. Once trust is established, scammers exploit emotions to extract money from their victims, often under the pretense of financial emergencies or travel expenses.

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Navigating the AI Frontier: Securing the Future of Financial Services

September 15, 2023Arti SahajpalFinance & BankingLeave a comment

As artificial intelligence becomes more available, apprehension regarding its potential impact on security and data protection grows, especially within the financial services sector. AI technology undoubtedly provides some benefits to the financial sector by offering services that would otherwise be unwieldy, inefficient, time-consuming, and costly when undertaken by humans. The financial services sector is no stranger to security risks and with the increased prevalence of AI, the threat landscape grows larger, especially when considering the financial sector’s increasing dependence on web applications and APIs.

artificial intelligencefinancegenerative AI

Reproductive Health Data Privacy – A Right To Life

May 12, 2023Marisa PolowitzHIPAA & Health Information2 Comments

Following the Supreme Court decision to overturning Roe v. Wade on June 24, 2022, the Dobbs v. Jackson Women’s Health Organization ruling that gutted the long-established right to an abortion has been a constant focus, both inside and outside of the legal and healthcare communities. Notably, the ruling has remained a central focus within both the government, federal and state, and surrounding the tech sector. And these Dobbs-related conversations have a theme – the topic of health data privacy. But more specifically, discussions about data privacy surrounding reproductive healthcare.

Civil Rightsdata securityHIPAAprivacyPrivacy & SecurityRegulation

Legal Risks to Employers when Employees use ChatGPT

April 21, 2023Emily ZhangUncategorized1 Comment

Since ChatGPT became public in November 2022, it has created questions for employers about how to incorporate the tool into workplace policies and best maintain compliance with government regulations. This artificial intelligence language platform, that is trained to interact conversationally and perform tasks, raises issues regarding intellectual property risks, inherent bias, data protection, and misleading content.

AIchatgptEmploymentEthicsintellectual propertyPrivacy & Security