Category: Blog

NAEP, Literacy, and Health Outcomes: Why Health Law and Policy Leaders Must Focus on Literacy as a Vehicle for Patient Welfare and Decision-Making

The National Assessment for Educational Progress (NAEP) is the largest nationally representative and continuous assessment of what students throughout the United States know and can perform in specific subjects. NAEP is one of several tools guiding state and federal lawmakers as they draft legislation and craft strategies for educational improvement. This assessment, delivered every two years, was delayed in 2021 due to the COVID-19 pandemic, meaning this assessment now gives policymakers, education leaders, and other concerned stakeholders a sense of how the COVID-19 pandemic impacted student achievement.

In October, the latest NAEP results were released. Fourth-grade reading averages are lower than all previous assessment years going back to 2005, and the 2022 average mirrors the 1992 average. Eighth-grade reading averages are the lowest the nation has seen since 1998, and not significantly different compared to 1992. Importantly, the years between 1992 and 2022 show little variance in reading proficiency, and inequities in reading proficiency persist. Policymakers and education leaders are responding by investing in research-backed solutions, like diversifying the teacher workforce, implementing the science of reading, and increasing access to high-dosage tutoring. These investments have and will continue to prove effective, but education policy leaders and practitioners should not be the only parties responsible for this task. Health law and policy leaders should also prioritize improving literacy rates as there is a direct relationship between literacy and health outcomes.  

Literacy proficiency is critical to success, both in the classroom and later in life. Additionally, literacy and health are closely connected. Limited literacy is a barrier to accessing health information, proper medication use, and utilization of preventative services. In terms of medication, medication management capacity (MMC) is critical for identifying medications and understanding how they should be taken. MMC is critical for patients dealing with temporary and chronic ailments and diseases. Research confirms the significant association between low literacy and difficulty identifying medications. One example connecting literacy and MMC pertains to the use of asthma treatment. Determining the relationship between literacy and asthma knowledge and self-care, researchers found that eighty-nine percent of patients reading at less than a third-grade level had difficulty using a meter-dosed inhaler (MDI) properly. In contrast, just less than half of patients reading at a high-school level struggled using an MDI. Research also confirms that patients with low literacy skills are more likely to ask fewer questions about their medical care, which may affect their ability to learn about their medical conditions and treatments.

Reading and health outcomes go hand in hand. Investing in literacy is a key strategy for ensuring stronger health outcomes in the long term, and healthcare practitioners are pushing for the healthcare field to increase involvement in literacy. In Ohio, healthcare leaders speak about the continued difficulties patients face in understanding the condition of their health due to limited literacy, and those leaders are making investments to eliminate the barriers low literacy creates in healthcare. Kettering Health, a healthcare non-profit, invested $60,000 to start an Imagination Library Program in Green County, Ohio. Kettering’s involvement in early literacy sets an example for other states to follow and exemplifies the role health law and policy leaders can play in ensuring better patient outcomes.

A patient’s ability to make critical healthcare decisions rests on reading proficiently. Healthcare law and policy leaders should pay close attention to what NAEP reveals about the state of literacy, partner with state and local education leaders to craft early literacy strategies and convince lawmakers to prioritize early literacy investment. Literacy is a key vehicle for health equity. If healthcare leaders do not respond quickly to last month’s NAEP results, barriers to accessing health information and proper care will persist.

America’s Gun Violence Epidemic

Every year in the United States, thousands of people die at the hands of a public health crisis that has plagued the country for decades. Gun violence is responsible for the death of more than 110 Americans every day and firearms are the leading cause of death for children and teens in the United States. It is a detriment to the health, safety, and well-being of people across the country and has continuously infiltrated all our communities. Similar to most public health crises, gun violence also disproportionately impacts poorer communities and communities of color.

Lack of both education and regulation around these weapons continues to create an environment where children are scared to go to school in fear of losing their lives. In the United States, individuals only have to be 18 years old to buy an assault rifle like the one that was used to kill 19 children and two teachers at Robb Elementary School in Uvalde, Texas this past May, making it the deadliest school shooting in almost a decade.

While debates continue over issues related to the Second Amendment, families are stuck grieving the unfair loss of their loved ones. While no parent should have to experience this pain, the reality in the United States is bleak — even during a time monopolized by the COVID-19 pandemic, the country witnessed twenty-seven school shootings that took the lives of hundreds of children just this year.

Congress has responded to this public health crisis by annually allocating $25 million to the Centers for Disease Control (“CDC”) and the National Institutes of Health (“NIH”) to research gun violence. The CDC uses a public health approach in analyzing gun violence by providing data to inform action, applying science to identify effective solutions, and promoting collaboration across multiple sectors to address the problem. Additionally, the CDC’s Division of Violence Prevention is currently funding ten state health departments, up to $225,000 per recipient, as part of an initiative to provide surveillance data on near-real time emergency visits for nonfatal firearm injuries.

Furthermore, Congress introduced and passed the Bipartisan Safer Communities Act (“BSCA”) this session, which will enhance background checks for buyers under 21 years old, disarm domestic abusers, invest in mental health services, and provide federal funding for Red Flag Laws. Though this was a monumental step in curbing the terror of gun violence, barriers still exist to achieving a country free from this crisis. In June 2022, the United States Supreme Court decided New York State Rifle and Pistol Association v. Bruen. This decision struck down a New York state law that restricted individuals from carrying handguns in public by requiring them to “demonstrate a special need for self-protection.” Removing these strict limitations on carrying firearms in public further threatens the health and safety of Americans across the country. Given the Supreme Court’s current conservative majority, it is critical that local, federal, and administrative leaders step up to save the thousands of lives that could be lost to gun violence in the coming years.

In February 2021, Senator Blumenthal of Connecticut introduced Ethan’s Law, which aimed to establish a federal framework to regulate the storage of firearms on residential premises at the federal, state, and tribal levels. Although the bill did not pass federally, it is still possible to replicate these safety measures at the local and state level. So far, 23 states have adopted these laws, forcing gun owners to make a reasonable effort to safely store and lock their firearms so that they cannot be accessed by children. Through this effort, policymakers will reduce the almost 350 deaths annually that result from children unintentionally shooting themselves or others due to improper storage of firearms in their homes.

As demonstrated by the attempts detailed above, gun violence will not be an easy problem to solve. There must be a willingness to do whatever it takes to prevent guns from taking any more of our loved ones. This includes taking steps like securely storing firearms, advocating for bi-partisan legislation, and educating our communities on this public health crisis. It is through these tangible steps that our society can start to curb the terror of gun violence in the United States.

The War on Sugar

Every few decades there is a shift in diet culture. Currently, we are experiencing the war on sugar as consumers become increasingly aware of the growing overconsumption of sugar and the risks associated with it. As a result, high-intensity sweeteners are now a common alternative to ordinary sugar that make up little to no calories when added to food or drink, creating desirability for those attempting a calorie deficit. These sweeteners are frequently used in beverages or foods marketed as “diet” or “sugar-free.” Research from 2019 shows a whopping two-thirds of Americans were attempting to limit their sugar intake. In efforts to keep up with these trends, the food industry had to begin adjusting the contents of their products while adhering to the Food and Drug Administration’s (“FDA”) regulations.

Among the high-intensity sweeteners on the market are saccharin and aspartame. Both are chemical formulas used as food additives to produce an intensely sweet flavor without the calories of sugar; notably, aspartame is 200 times sweeter than sugar. Both saccharin and aspartame are currently approved and regulated by the FDA. High-intensity sweeteners are regulated as a food additive, unless its use is generally recognized as safe (such as stevia leaf). Before a food additive can be used in food and marketed as such, it must undergo premarket review and obtain approval by the FDA. During the premarket review of the current high-intensity sweeteners permitted for use, the FDA established an acceptable daily intake level (“ADI”) for each of the sweeteners. The FDA has included a chart on its website showing the number of tabletop sweetener packets a 132 pound individual would need to consume to reach the ADI: 75 packets of aspartame and 45 packets of saccharin. The FDA also claims that even for consumers whose daily consumption of a sweetener is high, it generally does not present safety concerns if it is still less than the ADI.

Yet, the question remains for consumers conscious about their health but with a persistent sweet tooth: should I be choosing products with sugar or artificial sweetener? This complex question is best answered by comparing Diet Coca-Cola (“Diet Coke”) to regular Coca-Cola (“Coke”). Diet Coke contains artificial high-intensity sweeteners, including aspartame, while regular Coke contains traditional sugar in the form of high fructose corn syrup. However, high consumption of both Diet Coke and regular Coke may be linked to a higher risk of heart disease and other health problems. The question is not “which version of sweetener is better for you,” but “which version of sweetener is less bad for you.” A can of Coke contains 39g of sugar, which amounts to about 7 teaspoons of sugar. The FDA suggests a Daily Value of 50 grams per day for added sugars based on a 2,000 calorie daily diet. Thus, drinking a Coke will make up 78% of one’s suggested daily added sugar intake. Contrary to what many believe, Diet Coke (although containing 0g of sugar) may still present similar health issues as regular coke, such as a spike in blood sugar caused by its artificial sweeteners. Spikes in blood sugar have been linked to heart problems, type-2 diabetes, weight gain and the other various health problems commonly associated with traditional sugar intake.

Overall, the convoluted truth is that western diet trends heavily influence how products are presented in the media and then marketed to the public. Evidently, there is a surprising lack of concrete scientific evidence to heavily sway individuals in one direction or another in terms of choosing high-intensity sweeteners over classic sugar. Remarkably, the one consensus is that neither of the two are particularly “good” for health as both are addictive and stimulate the brain in a similar fashion. In sum, moderation is key as consuming excess amounts of either sugar or artificial sweeteners can be cause for concern. It is important not to blindly follow the intentional marketing of “diet” or “zero sugar” products without doing further research on what exactly is replacing that sweet flavor. But, to avoid the issue altogether, perhaps opt for a sparkling water sweetened naturally with fruits instead of deciding between a diet or regular Coke.

Accountability for Privacy Violations in Mobile Health Apps: Flo Health and the Health Breach Notification Rule

Digital privacy concerns were raised once again following the overturn of Roe v. Wade in June 2022. These concerns were exacerbated when messages sent via Facebook Messenger discussing a medication-induced abortion were the basis for further search warrants that were used to prosecute a mother and daughter in Nebraska. As exemplified in the Nebraska case, tech companies must comply with search warrants issued by courts, sewing privacy concerns particularly in period tracking app users. Following the overturn of Roe v. Wade, menstruating people were encouraged to delete period tracking apps all together, but data experts warned that deleting the apps alone may not protect users.

Privacy concerns are not new to period tracking apps. Flo Health is a period tracking app, used by more than 100 million users, with a history of privacy concerns. From 2016 to 2019, Flo Health promised users to keep their health data private yet released identifiable health information to third party applications, including Facebook’s analytics division. In 2020, the Federal Trade Commission (FTC) filed a complaint against Flo Health alleging that the app had misled users about how their health information was stored and used. Flo had been sharing user data with third party firms under app event names such as “R_Pregancy_Week_Chosen,” explicitly communicating their health information. Flo Health reached a settlement with the FTC in 2021. Flo Health is just one example of how mobile apps struggle with privacy compliance.

While the Health Insurance Portability and Accountability Act (“HIPAA”) applies to many institutions who store personal health records, its application to mobile health apps, such as Flo Health, can be complicated.  The FTC has released an interactive tool for mobile health app developers to determine if certain regulations apply to their app. One such regulation is the Health Breach Notification Rule (“HBN”). The HBN was enacted in 2009, but, as of 2021, the FTC has never brought  an action to enforce it.  The HBN was enacted to ensure accountability when entities not covered by HIPAA compromise consumers’ sensitive health information.  The regulation requires subjected entities to inform users and the FTC of any breach of security of unsecured personal health records. A breach of security is considered any acquisition of identifiable health records that is not authorized by the consumer.

While the FTC did not charge Flo Health with a violation of HBN, two Commissioners released a joint statement arguing that its application was warranted in the case. Commissioners Rohit Chopra and Rebecca Kelly Slaughter argue that Flo Health shared user data with Facebook and other entitles, without obtaining the user’s authorization to do so. The Commissioners seek enforcement of the HBN as a way to, “induce firms to take greater care in collecting and monetizing our most sensitive information.” The FTC has also published further guidance for mobile health app developers that store sensitive health information. The guidance includes minimizing data collected, storing it in a de-identified form, and limiting operating systems’ access to the data.

Despite this guidance, Flo Health, and apps like it, still store detailed, identifiable information about their users, including personal notes left by the user. However some progress has been made as Flo Health released an “anonymous mode” after the overturn of Roe v. Wade in June, allowing users remove their name, email address, and technical identifiers. However, a user’s privacy and control over their health information should not be an afterthought only brought about by changes in case law, especially when regulations already exist to hold entities accountable for releasing sensitive information without the user’s authorization.

The ACT for ALS: No More Bad Breaks

“For the past two weeks you have been reading about a bad break. Yet today I consider myself the luckiest man on the face of the earth.” Lou Gehrig spoke to a Yankee Stadium crowd of 61, 808 on July 4, 1939 following the publicization of his amyotrophic lateral sclerosis (“ALS”) diagnosis. As a result of Gehrig’s diagnosis and subsequent retirement from baseball, ALS became a well-known disease thanks to the man who considered it to be “a bad break.”

For approximately 20,000 Americans currently living with ALS, the disease is more than “a bad break.” For those with ALS, they must live with the progressive loss of control over their bodies. Voluntary movements such as walking, talking, breathing, and chewing become difficult. The nerve cells that control these voluntary movements are attacked and killed by the disease. As it progresses, ALS weakens and paralyzes the muscles, eventually leading to death. There are currently no cures for ALS.

In response to ALS and other neurodegenerative diseases, President Biden signed the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS) into law on December 23, 2021. The ACT for ALS requires that the Food and Drug Administration (“the FDA”) publish and implement a 5-year action to foster drug development and facilitate access to investigational drugs for ALS and other rare neurodegenerative diseases.” Additionally, the ACT for ALS also requires the FDA to award grants or contracts to public and private entities to fund research and developments of interventions meant to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in children and adults.

The action plan that FDA developed per ACT for ALS outlines that FDA will engage in the following: establish the FDA Rare Neurodegenerative Diseases Task Force (FY 22), establish the Public-Private Partnership for Rare Neurodegenerative Diseases (FY 22), develop disease-specific science strategies (FY 22 – FY 26), and leverage ongoing FDA regulatory science efforts. The science strategies FDA developed for ALS addresses current obstacles and challenges to the development of ALS drugs.

On September 29, 2022, FDA approved the new drug Relyvrio (sodium phenylbutyrate/taurursodiol) for treatment of ALS. The drug causes a slower rate of decline and a longer overall survival for patients. It can be taken orally or through a feeding tube alongside a snack or meal. The drug’s efficacy was demonstrated in a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients received either Relyvrio or a placebo, with those receiving the drug experiencing a slower rate of decline than those who received the placebo.

The ACT for ALS appears to be doing its job: spurring more treatment options for patients with ALS and more development for therapies for neurodegenerative diseases. For those experiencing “a bad break,” there is now more hope for the future as more research is incentivized to find treatments for ALS and other rare neurodegenerative diseases.

Hungry for Change: The Biden Administration Takes Steps Toward Ending Hunger by 2030

According to the United States Department of Agriculture (USDA), more than 33 million Americans, including five million children, are considered food insecure. The United States Department of Health and Human Services (HHS) defines food insecurity as a household-level economic and social condition of limited or uncertain access to adequate food. While food insecurity does not necessarily cause hunger, hunger is a possible outcome of food insecurity. Adults who are food insecure may be at an increased risk for a variety of negative health outcomes and health disparities. For example, a study found that food-insecure adults may be at an increased risk for obesity. Another study found higher rates of chronic disease in low-income, food-insecure adults between the ages of 18 and 65. Food-insecure children may also be at an increased risk for a variety of negative health outcomes, including obesity. They also face a higher risk of developmental problems compared with food-secure children. In addition, reduced frequency, quality, variety, and quantity of consumed foods may have a negative effect on children’s mental health.

In an effort to address this issue, President Joe Biden hosted the White House Conference on Hunger, Nutrition, and Health and announced over $8 billion in hunger and nutrition commitments. It was only the second-ever conference of its kind and the first in over fifty years. The last time this conference took place was in 1969, under President Richard Nixon. The Nixon-era conference was a pivotal moment that led to the creation of the big programs underpinning the United States hunger response, such as food stamps and the Women, Infant, and Children program (WIC), which provides child nutrition assistance among other things. The Biden administration used this as an opportunity to lay out its plan to improve the nation’s health. This plan includes pushing for Congress to permanently extend the child tax credit, raise the minimum wage, and expand nutrition assistance programs to help reduce hunger rates. This ties to an ambitious goal the president set in May—ending hunger in the United States by 2030.

The $8 billion in commitments comes from some of the largest corporations in America’s private sector—Google, Tyson Foods, Walgreens—and includes $4 billion that will be dedicated by philanthropies that are focused on expanding access to healthy food. Additionally, there will be a focus on expanding nutrition research and encouraging the food industry to lower sodium and sugar. However, some of the most ambitious proposals require Congressional action. Thus, the partisan split threatens the president’s success.

Furthermore, the conference comes at a time of steep inflation and the end of pandemic benefits that staved off hunger rates. While the expanded child tax credit that was part of the American Rescue Plan of 2021succeeded in reducing poverty and hunger in the United States, Democrats were unable to make that measure permanent in the Inflation Reduction Act that they passed this year. Now, lines at food banks keep getting longer, food prices are rising at their fastest rate in four decades and fears of a recession that could result in higher unemployment rates are growing.

Unfortunately, while the Biden-Harris administration’s strategy includes many great ideas, it also seems to let the food industry off the hook and fails to adequately address the impact that racism, gender inequality, and the climate crisis on food insecurity. Though the conference served as a good first step toward future investments and policy changes around combatting food insecurity, there is still a long road ahead and the administration must do more to achieve its goal of ending hunger by 2030.