Category: Blog Posts

New North Dakota Law Requires Schools to Teach About Fetal Development in Health Class

Azariah Dileo, Class of 2024, Belmont Law 


On April 6, 2023, North Dakota enacted a new law titled “Growth and development and human sexuality curriculum.” The law passed in the state Senate with a vote 37-9 at the end of March and in the House on April 4, with a vote 75-16. Two days later, on April 6, current Governor Doug Burgum, signed the bill into state law. With an overwhelming majority vote in both houses, the North Dakota legislature intends to enhance how school districts educate about fetal human development. 


The new law, on its face, is not explicitly pro- or anti-abortion. State Senator Janne Myrdal drafted the new law after seeing “Baby Olivia,” which is a video showing human (fetal) development in utero. Senator Myrdal, reflecting on the law, stated that “human development in the womb was obviously part of science” and that it was also “what [she] would call a divine concept.” Through the new law, Senator Myrdal hoped to “show[] students the divine journey that every human being experiences.”


The new law requires that a North Dakota school district include discussion and instruction about human growth and development in their health curriculum and human sexuality instruction. School districts’ human biology and pregnancy instruction must include an ultrasound video three minutes long, at minimum, discussing fertilization and showing vital fetal organ formation during the early stages of pregnancy. The brain, heart, sex organs are among the vital organs that the new law specifically requires the ultrasound video to show. In addition to organ formation during early pregnancy, the video must also discuss all stages of fetal cell growth and organ development throughout each week of pregnancy until birth.


The “Baby Olivia” video that inspired Senator Myrdal meets the criteria of the new law. When introducing the, now, law to her fellow senators, Senator Myrdal presented the “Baby Olivia” fetal development animation as a model that school districts could use to meet the proposed law’s requirements. Live Action, the creator of the “Baby Olivia” video, takes a firm pro-life stance. Live Action’s goal, through the “Baby Olivia” video and its other endeavors, is to shift public opinion about ending fetal life by emphasizing the humanity of the fetal, preborn child.


Live Action’s advocacy, which ultimately led to the new North Dakota law, is a microcosm of the influence that people and organizations can have on the legislative process. Legislatures, as democratically elected officials, theoretically represent the opinions of the public. In 2019, Pew Research Center released a study analyzing whether state abortion laws were reflective of public opinion about abortion in each state. The data that Pew Research used came from the 2014 Religious Landscape Study which derived its results from asking 35,000 adults across the United States whether they thought abortion should be legal or illegal in all or most cases. The 2014 data revealed that the people of North Dakota do not have a majority stance pro- or anti-abortion, but rather have more of an equal split in public opinion regarding the topic.


North Dakota’s new law about fetal-human growth and development reveals that North Dakota’s legislative body generally reflects its state’s opinions about abortion. The new law does not specifically advocate for or against abortion. Nonetheless, the law has undertones that respect both pro- and anti-abortion sentiments: it advocates that students, in a K-12 school context, be more fully equipped with scientific knowledge about human development pre-birth. With more knowledge about fetal development, those who passed the law hope to allow North Dakotan youth to make more fully informed reproductive decisions as they mature into adults.



A Bill to Protect Access to Reproductive Technology

Azariah Dileo, Class of 2024, Belmont Law 


Infertility is not uncommon within the United States. Approximately one in five married women who have not previously given birth and are between fifteen years old and forty-nine years old are unable to become pregnant within the first year of trying. While infertility has several causes with various treatment methods, one such method is in vitro fertilization (IVF). IVF is the process of removing an egg from a woman’s ovaries, fertilizing the egg with male sperm, and then returning the now-fertilized egg to the woman’s uterus. IVF is responsible for approximately one million United States births between 1987 and 2015. Today, this statistic amounts to nearly two percent of all United States births annually. 


At the close of 2022, Senator Tammy Duckworth from Illinois, Senator Patty Murray from Washington, and Congresswoman Susan Wild from Pennsylvania introduced a bill called the Right to Build Families Act of 2022 (RBFA). The senators and congresswoman drafted RBFA in the wake of the U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization. RBFA’s purpose, as set out in the bill, is to “prohibit the limitation of access to reproductive technology, and all medically necessary care surrounding such technology.” The assisted reproductive technology (ART) that RBFA aims to protect encompasses “treatments or procedures which include the handling of human oocytes or embryos.”


Although Dobbs does not directly restrict ART, each state’s laws vary regarding how they govern abortion. Some states have laws that implicate fertility treatments because they define “personhood” as beginning at fertilization (i.e., conception). State laws may also have varying definitions for “fertilization” and “embryo.” These definitions, in addition to the state laws themselves, may have the potential to affect individuals and couples who are seeking ART to build their family. Because state laws regarding abortion and related fertility treatments vary greatly, Senators Duckworth and Murray and Congresswoman Wild want a federal safeguard to protect individuals’ ability to grow their families.


RBFA sets out to prohibit state governments from preventing an individual’s access to ART, a healthcare provider from performing ART treatments or procedures, and insurance providers from covering ART treatments and procedures. In the event that RBFA becomes law and is violated, the U.S. Attorney General would be able to bring suit on behalf of the United States against a state, government official, individual, or entity that violates RBFA’s prohibitions. RBFA would also give individuals adversely affected by RBFA violations the ability to sue their state or any government official. Additionally, healthcare providers would be able to commence an action for relief on their own behalf or on behalf of their staff and patients. A court may grant plaintiffs suing under RBFA equitable relief upon proving their case as well as award plaintiffs the costs for the judicial proceedings.


Currently, RBFA is still a bill and has not been enacted into law. While the bill has inspired some political debate, the bill’s outcome remains uncertain.


42 U.S.C. § 263a-7(1),womb%20to%20grow%20and%20develop,to%20term%20(impaired%20fecundity).,births%20annually%20are%20via%20IVF.

Narcan Nasal Spray to Become Available Over-The-Counter Pending FDA Final Approval

Kendall Warden, Belmont Law, Class of 2024

On February 15, 2023, a federal advisory committee voted unanimously in favor of converting Narcan, the overdose reversal drug, from prescription to nonprescription status. The committee consisted of members of the Nonprescription Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, whose advisory opinions, although not binding upon the FDA, are usually followed.


Narcan, otherwise known as naloxone hydrochloride, is a lifesaving drug used to reverse known or suspected overdoses. Narcan injections have been used since 1971 as an opioid reversal agent in both hospitals and under health care provider supervision. Narcan Nasal Spray has been used as a prescription product for community use programs since 2016. Community use programs are typically without a patient-specific prescription requirement and designed for administration by individuals without medical training. However, community use programs are not the same as nonprescription use because they come with additional instructions and patient counseling.


The impact of the opioid crisis has been felt throughout the United States. Both accidental and intentional opioid overdoses have contributed to a major public health crisis and caused more than a million deaths. Between the years of 1999 and 2016 almost 9000 young adults passed away from opioid overdoses. 80,926 deaths occurred from opioid overdoes in 2021, up from more than 69,000 deaths in in 2020. Moving Narcan into nonprescription status would be a huge step forward for opioid overdose prevention efforts. Creating nonprescription options for Narcan will allow for  greater distribution of the life sabing product which in turn will, hopefully, decrease the number of premature deaths stemming from opioid overdoses.


Currently, the prescription status drug is only available through a pharmacy or community distribution program. In order for Narcan Nasal Spray to transition into nonprescription status the FDA must find that the prescription requirement is no longer necessary for public health protection. To do so, the FDA must establish sufficient data to determine the drug can be used safely without the assistance of medical professionals.


The biggest obstacle for full FDA approval is the concerns raised about Narcan’s confusing packaging and instructions. These concerns were raised by participants in past studies by Emergent BioSolutions, the company whose Narcan nasal spray is up for approval. Although the company has pledged to revise the packaging and instructions to address the issues, it is possible the FDA could send the revised product back to the testing stage in order to meet the “sufficient data” standard. However, advocates are pushing for the FDA to quickly implement the advisory committee’s recommendation to align with the FDA’s Prescription Drug User Fee Act goal date of March 29, 2023.




Anxious and Depressed Attorneys: The Need for a Mental Health Reckoning in the Legal Profession

Shane Richards, Class of 2023, Belmont Law 

It’s no secret that the legal profession has a mental health issue, with rates of depression, anxiety, and substance abuse steadily becoming more dire issues. Putting numbers to this phenomenon makes it far more real. A 2016 study by the American Bar Association found that attorneys are 3.6 times more likely to be depressed compared to other careers. The study further found that 28% of licensed, employed attorneys have depression and a further 21% can be characterized as problem drinkers. These stats have only worsened over the past seven years. A mental health survey of attorneys in 2022 showed that 35% of respondents were depressed. About 75% of respondents stated that the legal profession has had a negative impact on their mental health. 19% of respondents reported that they contemplated suicide. The problem with burn out, depression, and suicide is such an issue in the legal profession that every single page on the Tennessee Lawyers Assistance Program website is accompanied by a suicide prevention message. 

These issues seem to start early on as well, before law students even get set foot in their first law office. According to a study by the Dave Nee Foundation, rates of depression among law students spikes drastically after the first semester, going from 10% to 27%. After three years of law school, the study found that 40% of law students experience depression. Another study found that 21% of surveyed law students reported serious thoughts of suicide in their lifetime. A more alarming survey from 2021 reported that nearly 69% of law students said they needed help for emotional or mental health problems in the past year. That number went up from 42% in 2014, which is still a horrific number to consider. 

So, what causes all of these problems? It depends on who you ask. There are countless reasons that are bandied about. Some blame it on COVID-19 and the increased remoteness and isolation, despite these problems being prevalent well before COVID-19. Others believe, almost fatalistically, that this is just what happens when you mix type-A perfectionists with very demanding work—although attorneys are not unique in this regard when compared to other professions. Even others still would lay the blame at the feet of technology, which has doubtlessly increased the pace at which attorneys must practice.  

Perhaps the best people to ask would be the attorneys themselves, and ABA Journal did just that in 2018, incorporating the two cents of various attorneys into its article. Eric J. Trabin, an attorney in Florida, stated plainly that it’s a combination of stress, solving the problems of others, and a toxic bar that deters lawyers from seeking help, saying “It’s why I sadly know numerous attorneys who have committed suicide in the past 11 years of my practice.” James Gray Robinson, a former family law attorney, shed some light on exactly why law students and new attorneys have some of the worst rates of depression: 

Lawyers wear a bullseye on their back. Many Lawyers start their legal careers with crushing debt, zero clients and uncertainty about their future. Law Students face insurmountable odds and can be depressed even before they step foot out of law school. 


Other contributions also indicate how most law students are totally blindsided by the level of debt they will accrue and how long it will take to pay down—the financial prospects not being as good as one might have hoped. So, they have made all of these sacrifices for a better life just to be dropped into a career that is incredibly stressful, is uniquely adverse toward fellow colleagues, takes on the problems of everyone else, requires constantly taking work home, and it may not even pay as well as originally hoped. Even when the financial award may be nice, somehow paying off that debt in a timely fashion, there are so many other burdens that one may not have bargained for. For instance, it could all be lost in an instant because of a momentary lapse in judgment. 

Regardless of the many causes, and the accompanying speculation, what is to be done? The awareness of these issues has been increasing and more law firms are providing mental health programs to help struggling attorneys. Most recently, several law schools have employed an “Early Alert” system which sends out text messages to students which ask them to rate how they feel about certain topics. The system allows for students to report how they feel directly to faculty and then the faculty can refer these students to the appropriate resources. At Pepperdine, 89% of its 1L class use the system and are reportedly more proactive about seeking out the school’s wellness programs. Many law schools have a myriad of wellness resources for its students that have already existed for some time. General calls for the creation of a wellness culture, both in law school and the legal profession, are not new. CLE courses and activities focused on wellness also is not new. As well meaning as these programs might be, they do not fix the core issues, which is evidenced by the statistics only getting worse. 

The problem with these wellness programs is that they do not address the bigger structural problems. Perhaps they need more time to develop and something like the “Early Alert” system will point aspiring attorneys to these activities. Maybe then a statistical impact will be felt. They certainly are important and should exist to prevent worst case scenarios. At the end of the day, however, a wellness retreat does not take any of the pressure off. An attorney who takes some time off for a wellness retreat is only going to come back to an office with the exact same conditions—it might even be worse because work has stacked up. For a law student transitioning into their legal career, it certainly does little more than distract from reality for a short time. Perhaps a counselor will help one learn how to better deal with the stress, but the source of the stress still exists. The stress remains. The debt, the workload, the hostility between peers, the necessity of tearing others down to elevate oneself, the elevating of only a select few, the pitiful financial compensation awaiting some, the prospect of working every single day to meet required billable hours, the culture of soulless networking to get ahead, all of it still remains. The idea of a firm’s wellness program for a struggling attorney comes down to trying to make them feel better just to throw them back into the meat grinder. The conditions are no better. The pay is no better. The stress is no better. Please, just feel better about these conditions that have driven you to despair and get back to the same work. No, the conditions will not change.  

This attitude and strategy might make people feel better for a while, but it is not a comprehensive solution. Something more than just counseling, prescribing medications, and directing people to other resources needs to be done. Although these things are helpful when it fits the situation, something about the structure and the regular daily conduct of the legal profession needs to change to actually reduce stress among attorneys. Perhaps a more congenial culture between attorneys might help. Maybe more limits could be placed on discovery to reduce one of the most time-consuming aspects of litigation. Another idea may lie is creating a culture of setting boundaries between firms, clients, and attorneys. It could even help if more scholarships, weighted based on need and ability, were created to relieve some of the debt burden that falls on so many law students. There are surely many ideas that could be dreamed up to help, but they also need to be partly focused on relieving the actual sources of stress and not just dedicated to teaching people how to cope with it. Until the actual sources of pressure are relaxed, it is skeptical as to whether the mental health of attorneys and law students will truly improve. 

Works Cited: 


Fraudulent Nursing Degree Scheme Leads to Charges

Kendall Warden, Class of 2024, Belmont Law


Several southern nursing schools are under fire after recent reports disclosed that more than 7,600 fake nursing degrees and transcripts were sold to “aspiring nurses.” During the five-year scheme, purchasers spent a total of $114 million dollars on the fraudulent degrees and transcripts. The average cost of such degrees amounted between $10,000 and $15,000. These fake nursing degrees issued by actual, real nursing schools qualified purchasers to take the National Council Licensure Examination for Registered Nurses (NCLEX). Roughly 2,400 fraudulent degree purchasers successfully passed the NCLEX and were able to obtain employment as registered nurses. These nurses are likely to lose their nursing licenses.


The Department of Justice and Department of Health and Human Services Office of Inspector General have initiated an investigation they dubbed “Operation Nightingale.” Currently, twenty-five individuals affiliated with three Florida nursing schools have been charged in connection to this investigation. The individuals involved face up to twenty years in prison for their participation in the fraud scheme. While the purchases who managed to pass the NCLEX and obtain licensure will likely lose their licenses, it is unlikely they will be federally prosecuted.


However, state licensing boards are calling for action against the nurses who fraudulently obtained their licensure. Licensure annulment and revocation could be the worst punishment received by diploma purchasers in this fraud scheme – criminal charges are not currently being pursued against purchasers. Specifically, Delaware, Georgia, and Texas are initiating disciplinary actions against such individuals. The Delaware Board of Nursing reportedly annulled twenty-six individuals’ nursing licenses. Georgia’s Board of Nursing directly asked twenty-two nurses who obtained their licensure fraudulently to come forward and surrender their licenses voluntarily, but many instead retained counsel to attempt to fight the possibility of licensure revocation. The VA Press Secretary Terrence Hayes told WSB-TV that three of the nurses worked at a Veterans Affairs hospital and have since been removed from the medical center.


The U.S. Attorney for the Southern District of Florida, Markenzy Lapointe, expressed the overarching public policy concern, besides an obvious public safety issue, that this situation “tarnishes the reputation of nurses who actually complete the demanding clinical and course work required to obtain their professional licenses and employment.” She also raised concern for the erosion of public trust in the health care system because of fraud schemes like this one.


It will be interesting to watch this investigation develop, as it is unclear if or in what manner, a route to licensure will be provided to those purchasers who wish to pursue a valid nursing degree.




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The Present Landscape of COVID Vaccine Requirements for Children

Azariah Dileo, Class of 2024, Belmont Law 

State governments have broad discretion when determining vaccine requirements for students. States have historically used mandatory vaccine requirements for students because it has been seen as the most efficient way of achieving herd immunity. Herd immunity is when a high threshold percentage of a community has immunity (natural or through vaccination) against a particular virus or disease. The more contagious a particular virus or disease is, the higher the threshold immunity in the population needs to be in order to achieve herd immunity.  


Since the onset of the COVID pandemic, public health and government officials have unified to achieve herd immunity. Despite this goal, states have not wholly embraced using the most effective tool to achieve these aims: mandatory school vaccinations. Currently, fifty-seven percent of children between six months old infants and seventeen-year-old minors have not received any dosage among the available COVID vaccines. 


California was one of the few states that considered requiring vaccines for public and private school children. Other states have generally seen California as a trendsetter in its pandemic response efforts. For example, California was the first state to issue a statewide stay-at-home order on March 19, 2020. Once California issued the stay-at-home order, many states followed suit shortly thereafter. Despite being a leader among the states in its pandemic response efforts, other states did not take up California’s public health approach to student vaccination requirements.  


There are several reasons that potentially explain why states are not requiring student COVID vaccinations despite their awareness of the benefits that herd immunity promises. Firstly, vaccination requirements typically have the most success when officials are attempting to close a narrow compliance gap. For example, in November 2022, the District of Columbia decided not to enforce its vaccine mandate until the 2023-2024 school year because the current vaccination rate for students remains at forty-four percent. 


Secondly, the public health narrative surrounding COVID vaccines has shifted. Originally, public health officials and vaccine producers equated the vaccine to polio, measles, mumps, etc. vaccines, which require minimal, set doses of the vaccines before the public no longer had to worry about their individual and collective immunity. However, given the rate at which the COVID virus mutates, the COVID vaccination conversation has shifted from minimal, set doses to annual boosters, which mimic the annual flu-shot approach. An annual vaccination approach in combination with a mandatory student COVID vaccine policy would create logistic and administrative difficulties for schools trying to assess and enforce compliance. 


Thirdly, the public does not perceive that children are at risk of contracting COVID. When children do contract COVID, they are less likely to experience serious illness and even less likely to experience death. Nonetheless, some people who support student COVID vaccine requirements argue that the requirements may promote overall immunization against other diseases (i.e. chickenpox, measles, tetanus, etc.), may protect the children as they advance into adulthood, and may prevent the virus from further mutations.  


According to an August 2022 Gallup poll, less than a majority of survey respondents, forty-eight percent, agreed that states should mandate COVID vaccination among students. Perhaps the fifty-two percent who do not support the student vaccination efforts no longer prioritize COVID as a public health issue. In weighing state responses to requiring children’s COVID vaccinations, perhaps another question emerges—is COVID’s recession from the public’s consciousness premature, timely, or is it long overdue? 



COVID-19 Vaccines: Who will be exempted from a COVID-19 vaccine? by Jessica Kriegsfeld 

Mandatory School Vaccinations: The Role of Tort Law by Anthony Ciolli, JD, MBE 

Herd immunity and COVID-19: What you need to know by Mayo Clinic Staff 

California backs down from requiring COVID-19 vaccine to attend schools by CBS News Bay Area 

Governor Gavin Newsom Issues Stay at Home Order by 

Necessity of 2 Doses of the Pfizer and Moderna COVID-19 Vaccines by Edward H. Livingston, MD 

Ransomware Strikes Again: Health Records for 2,000 Students is Leaked onto the Dark Web

Shane Richards, Class of 2023, Belmont Law

In September of last year, the Los Angeles Unified School District was the target of a ransomware attack that significantly disrupted its information technology systems. Being the second biggest school district in the United States, this attack made national headlines and prompted responses from the FBI and Homeland Security, among other federal agencies. This attack was one of many ransomware attacks targeting school districts across the United States. In the face of this attack, the Los Angeles United School District refused to pay the ransom, the amount of which was not disclosed to the public, stating that paying the ransom “never guarantees the full recovery of data…”

Several months later, it came to light that the group responsible has leaked this information onto the Dark Web, that deep, uncatalogued section of the internet that is only accessible via special tools. Specially, the sensitive health records for “about 2,000 current and former Los Angeles school students.” Included among these records were drivers’ licenses, Social Security numbers, assessment records, and COVID-19 results. The majority of the leaked health information relates to special education students. The information leaked about the special education students includes their academic performance, disciplinary records, and medical histories.

This attack, among many others of a similar nature, shows just how vulnerable the digitalization of sensitive information has become. Hackers are targeting schools, private companies, and hospitals at increasing rates, demanding double ransoms. The first ransom is for unencrypting the information, which could be completely lost otherwise. The second ransom is to keep the information from being published to places like the Dark Web. However, nothing guarantees that paying the ransom will prevent any of the loss of the information nor that the

information won’t be leaked for any nefarious actors to misuse. Although, the specific ransomware gang responsible for the Los Angeles attack is “reasonable” in negotiating their ransoms.

It seems that these ransomware gangs have three initial routes into these public systems. The first is by phishing employee emails, whereby they trick current employees into opening the door. Their second method is to take advantage of dormant account credentials left by former employees. The final way in is by exploiting known vulnerabilities in old software. Once in, these hackers then use techniques “living off the land,” which take piggy back off of legitimate tools to do the hackers’ dirty work, to circumvent detection. It’s unclear exactly which method was utilized in the attack on the Los Angeles United School District; however, the gang responsible has been known to utilize all these methods.

All of these methods used by ransomware hackers are supposedly preventable. However, the number of attacks are increasing year upon year and these attacks are targeted at any institution that has digitized its vital information. It’s not just health care information held by hospitals or medical providers that is at danger, but any third party institution, public or private, need to be prepared to take measures to prevent such attacks. The Los Angeles attack is a good case study in exactly the kind of consequences that can befall an institution and what lays in store for the real victims of such an attack—the patients and students that trust these institutions with their vital information.

Works Cited:

Athena Nursing Homes Under Fire

Kendall Warden, Class of 2024, Belmont Law

In health law section news, the American Bar Association reported that Connecticut-based Athena Health Care Systems is facing major trouble. The organization is facing a myriad of grievances from all sides of the business: complaints from three New England states over nursing home conditions and failure to pay staff, lawsuits from six staffing agencies alleging almost $150,000 in owed wages, a separate suit alleging Athena owes more than $2 million to a different staffing agency, the largest fine ever issued in Massachusetts – $1.75 million – and over 500 complaints in Connecticut alone in less than a year.

Connecticut, Massachusetts, and Rhode Island have placed Athena Health Care Systems under scrutiny after consistently receiving complaints regarding nursing home conditions in each state. Athena runs over forty long-term care facilities in the region, accounts for approximately 70% of nursing home residents in Connecticut alone and may now be running afoul of complying with Medicare or Medicaid compliance standards.

Six temporary staffing agencies sued Athena for allegedly failing to pay almost $150,000 in wages for the employees the staffing agencies provided to offset employee shortages during the pandemic. A separate staffing agency filed suit against Athena claiming over $2 million for temporary employees the company provided to Athena. A further lawsuit has been filed against Athena by an insurance company, “alleging that Athena, a self-insured company, has failed to pay more than $6 million in health insurance claims from its employees.” Such claims caused state officials to contact the U.S Department of Labor to begin an investigation.

The Massachusetts Attorney General’s office saddled Athena with the largest fine ever issued in the state because the organization was caught admitting residents with substance abuse issues without the ability to provide necessary and appropriate treatment. This practice by Athena apparently led to numerous overdoses. Furthermore, several consent orders have been issued to address staffing issues and patient safety concerns such as unsanitary conditions.

Alarmingly, Athena is also facing a wrongful death suit after a resident in one of the organization’s Massachusetts nursing homes was murdered in the facility. The decedent’s roommate slammed his walker against the decedent’s head repeatedly before staff intervened, eventually leading to his death.

Regarding the 518 complaints received by Athena, several report residents being forced to remain in wet undergarments, missing meals, not receiving appropriate medications, and being stuck in bed, among others. Lack of access to care to is the most common complaint received by Athena Health Care Systems. These complaints most definitely stem from the organization being highly understaffed.

In response to complaints, lawsuits, and fines, Athena’s owner, “Lawrence Santilli, acknowledged the company has had financial difficulties that have ‘undermined the quality of care’ in some facilities. ‘For Athena, which serves thousands of patients daily across its 45 facilities with thousands of employees, these unprecedented challenges and expenses and the resulting severe staffing shortages have resulted in significantly higher expenses and have put a strain on resources,’ Santilli said in an emailed statement” to the CT Mirror.

In an attempt to change course, Athena hired a registered nurse to submit reports to the Department of Public Health for a minimum of six months. The organization also halted admissions in an effort to resolve staffing and resource shortages.


Azariah Dileo, Class of 2024, Belmont Law


Until December 29th of this past year, the Federal Food, Drug, and Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA) were the only federal laws that regulated cosmetic manufacturing and distribution processes within the United States. Section 201(i) of the FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Cosmetics, according to the FD&C Act, do not include soaps, dietary supplements, or products that are used for therapy purposes.


Last month, President Biden signed a bill that added one more federal law that would govern the manufacturing and selling of cosmetics within the United States: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—the first update to cosmetics regulations within the United States in eighty years. MoCRA’s purpose is to regulate the manufacturing and processing of cosmetics that are distributed and sold within the country. To meet MoCRA’s initial requirements, every existing cosmetic manufacturing or processing facility must register with the Food and Drug Administration (FDA) no later than December 29, 2023. Any new manufacturing or processing facilities that come into existence after December 29, 2023, must register with the FDA within sixty days after commencing operations.


MoCRA also tasks the FDA with creating regulations for cosmetic production facilities. To minimize any undue economic burdens, MoCRA requires the FDA to formulate its regulations flexibly, keeping in mind that what might be practicable for a larger business may not be practicable for a small business. The FDA has a three-year deadline (2025) by which it must formulate MoCRA regulations for good manufacturing practices.


In addition to enabling the FDA to promulgate regulations, MoCRA sets requirements for cosmetic manufacturers, packers, or distributors who are listed on a product’s label—MoCRA names such an entity a “reasonable person”. A reasonable person must meet several of MoCRA’s requirements, but here are a few. A reasonable person is responsible for providing the FDA with a list of each cosmetic product and corresponding cosmetic ingredient lists. Additionally, a reasonable person must provide an “adequate substantiation of [the] safety” of their cosmetic products. A reasonable person typically meets this requirement by providing the FDA with research or other evidence that the ingredients in their product are safe for the expected use. If a consumer experiences a “serious adverse event” related to using the cosmetic within fifteen days of receiving the cosmetic product, the reasonable person has a duty to report the event to the FDA. 


With MoCRA being the first update in federal laws governing cosmetic production in eighty years, its impact is vast. In addition to the changes that MoCRA brings, described above, it has additional implications for the FDA, preemption of state laws, and other production practices.

Works Cited:

Reckoning with Ransoms: The Dangers of Relying on Electronic Patient Data Increases

Shane Richards, Class of 2023, Belmont Law

The issues with using paper forms and records instead of electronic versions are numerous and numerous to anyone who has ever worked in an office. Even in my limited experience of working at a law firm, I have learned that paper files have their downsides. They can be difficult to manage. The document you need can easily be lost amidst thousands of other paper documents and hundreds of other file folders being tossed around, shared among a busy office. “Who has the Johnson file?” and similar questions can often be heard, sending all nearby attorneys rummaging around their desks to figure out if they were the ones to misplace the file. Physical files also take up a lot of space and it is generally more time consuming to comb through a paper file to find just that one document you need. These questions of ease make using electronic records alluring enough, and that still leaves out the security questions. Is it not relatively easy for a nefarious actor to take a peek at a sensitive, misplaced file?

Many of these issues are solved by creating electronic files. Even doing something as simple as putting documents on a program like Google Docs cuts down on paper, makes locating them easier, and improves security. Other systems can put further password protections on sensitive records and take it however many steps further a company may desire. Only one who is supposed to look at it can look at it—that is the logic. One does not need to look far to this same reasoning being used to move medical records from cumbersome paper form to a sleek electronic manifestation. Another bonus unique to the context of electronic medical records is the added shareability. The possibility of easily sharing medical records from one healthcare provider to another is theoretically invaluable. Several pieces of legislation in this new electronic age, like the 21st Century Cures Act, has been pushing the health care industry in the direction of relying on electronic databases for the storage and access of medical records.

However, it may not be more secure at all. New data being published in Journal of American Medical Association Health Forum and cited by Westlaw Today, show that health care providers are being faced by a grave new threat: ransomware attacks. In the days of old, a nefarious actor had to physically walk into a hospital and look at sensitive documents to retrieve personal information. There are many obvious things a hospital can do to combat such an issue. Now, however, with most records being made electronic, a nefarious actor can force a hospital to pay an exorbitant ransom from the comfort of their own homes—and hospitals are struggling to deal with this new paradigm.

As described by Westlaw Today, a ransomware attack is a type of computer malware that “attempts to deny access to data, usually encrypting the data with a key known only to the hacker, until a ransom is paid.” These types of attacks have doubled from 2016 to 2021, totaling 374 ransomware attacks. These attacked impacted almost 42 million people—that’s about 13% of the US population. The ransom being paid or unpaid, only 20% of organization reported that they were able to restore that data, meaning that 80% of data was lost. It can be confirmed that in 16% of these attacks, the stolen information was made public. Those numbers may seem sufficiently worrisome on their own. However, there are reasons to believe the number of attacks are significantly underreported due to regulatory penalties and potential class action lawsuits.

Despite what some would think, it appears that more tech might mean more problems. These developments have created a new frontier of security concerns and threats, with both sides—hacker and hospital—crafting new and unique ways to protect data and to phish for that data. As noted by Westlaw, employee training and education is vital to prevent such attacks. Yet, no one is perfect and even the best trained staff can fall victim to such an attack. The operations of hackers continue to get more sophisticated and someone will be caught off guard eventually. The question then becomes what does a hospital do when all of its data is lost? Should a protocol be in place to

regather and reenter that information? Should the data be regularly backed up to a completely different data base? Is it worth keeping a paper backup of the most important information? Wouldn’t paper versions kept at the hospital bring us back to the paper problems we all know? These are the questions faced health care institutions in the electronic age. Is it worth having these great electronic systems of communicating medical records between institutions if more than 10% of patient information is ransomed and lost, causing treatment delays?

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