Can we disclose? School Privacy Issues During COVID-19

As COVID-19 continues to spread in the US, teachers, students, and their respective communities face tough privacy issues. Typically, the Health Insurance Portability and Accountability Act (HIPAA) delineates patients’ privacy rights regarding the disclosure of protected health information. However, this is not the case for student health information. The Family Educational Rights and Privacy Act (FERPA), enacted by the US Department of Education, provides guidance to schools handling privacy issues related to COVID-19. The difference between the two health information privacy acts is that FERPA specifically protects health information contained in school records. Similar to HIPAA, FERPA requires consent to disclose protected health information. However, the pandemic has created a “safety emergency exception” to the consent requirement.  

As children across the US slowly return to their classrooms, there are concerns about how and when information about COVID-19 cases will be released to teachers, school staff, students, and their families. USA Today reported inconsistencies in how school districts and health departments coordinate and release information. One reason for the inconsistencies is the lack of clarity at the state level regarding how to approach ongoing risk of COVID-19 in schools. The confusion because of the discrepancy in the application of FERPA compared to HIPAA. Specifically, HIPAA prevents the disclosure of health information, yet while FERPA allows the disclosure of such health information as long as it  as long as it does not include information that could identify the student.

The specific language in FERPA regarding student privacy prohibits the disclosure of the student’s name, ID, or any other information that could indirectly or directly be traced to the affected student.  Moreover, the language in FERPA mandates that the disclosure of health information is examined on a case-by-case basis. This provision ensures that only necessary information is disclosed in consideration of other students’ health during the Pandemic. Additionally, there is a recordkeeping section that requires schools to maintain a record of emergency disclosures that the affected student and parents can examine at any time.

So, what are the legal and public health implications for unconsented disclosure during COVID-19? Containing the spread of the virus, for the time being, has to be the number one priority. There is a real threat to public health and safety when students and parents are unaware of COVID-19 cases that occur within their respective schools. It is understandable that tension may arise when disclosing student health information without clear guidance from state and federal leadership on how to protect those privacy interests. The rationale for withholding such important information during a global pandemic makes no sense. The solution to widespread confusion and inconsistencies is transparency across the board in terms of tracking the spread of the virus. Such transparency in school systems ensures that school districts across the US are doing their jobs and taking the proper precautions to protect the health of our nation’s children.

Please contact Managing Editor for sources.

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Algorithmic Discrimination against Black Americans in Healthcare

As technology continues to advance, hospitals and healthcare providers have gained the ability to utilize artificial intelligence (AI) and algorithms to automate many of the complex decisions that were once only capable of being made by human beings. AI is now used to detect and diagnose diseases, screen patients, and develop various treatment protocols. While the purpose of AI was intended to streamline and simplify decision making and detection processes for hospitals and providers, it has inadvertently created health inequities for Black patients. A study published by Science in 2019 revealed that predictive healthcare algorithmic software discriminates against Black patients by distributing medical resources to white patients over Black ones.

            The study analyzed data from Optum’s algorithmic AI, a health services company, which programmed its AI to predict which patients were most in need of additional care. The color-blind AI system ranked patients solely according to how much they have paid for health care in the past. Because the algorithm did not account for race when predicting which patients were most in need of healthcare services, the fact that Black patients  have less health access to healthcare, and thus pay less for healthcare services, was overlooked. The study revealed that Black patients had substantially worse health despite paying $18,000 less for healthcare services per year compared to their white counterparts. The discrepancy in the amount that Black patients paid for healthcare compared to white patients is the result of Black patients having less access to healthcare services. Of the patients that Optum’s algorithm indicated were in need of additional care, only 17.7% were Black whereas researchers indicated an unbiased proportion would have been 46.5%.

            While Optum’s AI is only one of many algorithmic artificial intelligence products that disproportionally disadvantaged Black patients, finding and acknowledging the present biases is the first step towards correcting them in both AI and human behavior. While excluding race-based criteria may seem like a step towards health equity, racial equality calls for the acknowledgement that there are differences between racial groups. Small changes can be made to ensure that AI software is without bias. Measuring patients’ needs by avoidable costs or higher burdens of chronic conditions eliminates racial biases found in the original AI software as these measurements are more inclusive of Black patients’ struggles. Biases in AI algorithms are not inevitable. By recognizing the biases in AI, we can start to develop new technology that accounts for the different ways in which Black patients are disproportionately treated in healthcare settings.

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A License to Discriminate in Health Settings

In a recent federal court case, Religious Sisters of Mercy v. Azar (2021), a coalition of healthcare entities affiliated with the Catholic Church attacked a nondiscrimination provision under Section 1557 of the Patient Protection and Affordable Care Act (PPACA). The U.S. District Court in North Dakota granted a permanent injunction that enjoins the US Department of Health and Human Services (HHS) from enforcing Section 1557 of the PPACA. This injunction also prevents the HHS from withholding federal funding to religiously affiliated providers and insurers who deny transition services. The Plaintiff in this case originally sought an exemption from the anti-discriminatory laws that compelled them to perform and provide coverage for gender transitions and abortions. The Court, however, chose not to rule on the abortion claims. Although this ruling granted protection of religious freedoms under the First Amendment, it also allows healthcare providers impose their religious beliefs onto others and deny essential transgender health services. The implications of this ruling could lead to a broader chipping away of protections for healthcare services that are perceived as “unconscionable” by religiously-affiliated providers and insurers.

Section 1557 of the Patient Protection and Affordable Care Act states that patients shall not, “be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance.” The congressional intent of this provision was to create an all-encompassing healthcare antidiscrimination statute. This was demonstrated through the expansion of existing civil rights laws, specifically the expansion of Title IX, which had only prohibited sex discrimination in federally-funded school activities. Other important civil rights laws that the provision expanded include Title VI (preventing race, color and national origin discrimination), Section 504 (preventing disability discrimination) and the Age Discrimination in Employment Act (preventing age discrimination).

Religiously-affiliated hospitals make up a large portion of the of the hospital’s patients have access to in the United States. In 2016, MergerWatch and Maidson Healthcare Advisors released a report showing that 14.5% of all acute care hospital in the U.S. were Catholic affiliated. The report also found that 46 of these Catholic affiliated hospitals are the sole short-term, acute health care resource for many patients living in specific geographical regions. As a result of this ruling, patients living in these regions who lack access to adequate transportation, have now lost access to transition services.

Should religious protections under the First Amendment extend to health programs at the expense of equitable health care access? While some could argue that those in need of transgender health services can just go to a non-religiously-affiliated hospital, many of these individuals are limited to the hospitals within their geographical region. As other First Amendment lawsuits similar to Religious Sisters v. Mercy are filed, courts will have to determine if granting relief  to religiously-affiliated health entities limits the protections of Section 1557 under the guise of religious freedom.           

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Are Abortion Pill In-Person Requirements During COVID-19 Unduly Burdensome? SCOTUS Says No.

Medication abortion, commonly referred to as the abortion pill, is a safe and effective way to terminate an early pregnancy and has been available in the United States for the past 20 years. The abortion pill is as safe and effective as the surgical procedure, but it can be administered in the comfort of one’s home. Abortion via medication requires the patient take two different drugs: mifepristone and misoprostol. Mifepristone is taken first and blocks the body’s progesterone and stops the pregnancy from progressing. Next, Misoprostol causes the uterus to empty. Individuals can obtain and use the abortion pill up to 77 days or 11 weeks after the date of their last period, although the effectiveness depends on how far along they are into their pregnancy.

The FDA first approved mifepristone in 2000. Mifepristone is a synthetic steroid that is also used to treat hyperglycemia in patients with Cushing’s syndrome. In the United States,  the use of mifepristone for abortion is highly regulated by the FDA through a set of rules known as the risk evaluation and mitigation strategy (REMS), despite evidence of its safety and efficacy. Among other restrictions, the REMS limits the distribution settings of mifepristone, not misoprostol, to clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. This is referred to as the in-person requirement. Mifepristone, when used to end pregnancy, is the only FDA-approved drug required to be dispensed in clinical settings while permitting patients to self-administer at home. Furthermore, the FDA permits patients taking mifepristone for reasons other than abortion to receive the drug through the mail in much higher doses and quantities.

On January 31, 2020, the Secretary of Health and Human services declared a public health emergency pursuant to the Public Health Service Act. Subsequent regulatory guidance focused on allowing patients to access healthcare they need from their home, without worrying about putting themselves or others at risk during the COVID-19 outbreak. This included waivers in recognition of the health risks associated with patient travel to medical facilities, even invoking the use of the “telemedicine exception” in the Controlled Substances Act, which permits practitioners to forgo an in-person evaluation of a patient before prescribing certain controlled substances, including opioids, permitting them instead to rely on telemedicine to assess a patient before issuing a prescription. In response to this flurry of telehealth exceptions, abortion providers challenged the in-person requirement still restricting mifepristone. The US District Court for the District of Maryland granted a preliminary injunction enjoining the FDA from enforcing, threating to enforce, or otherwise applying the in-person requirements for Mifepristone.

On January 12, 2021, the Supreme Court issued a brief and unsigned opinion that overturned the District Court’s decision and reinstated the federal requirement that women seeking to end their pregnancies using the abortion pill pick up their medications in person. Chief Justice Roberts, the only member of the majority to write an opinion, explained that this case was decided on judicial deference and allowed the FDA experts to use their statutorily provided discretion. According to Chief Justice Roberts, the issue was not whether the regulation placed an undue burden on women seeking abortions during the COVID-19 pandemic but whether the District Court properly enjoined the FDA from enforcing the in-person requirement. Despite the Court’s insistence that the issue presented did not concern the in-person restriction itself, the effects of this ruling on women seeking abortions is catastrophic.

Due to the vastly limited clinic options and already tight window for obtaining an abortion pill prescription, the FDA’s in-person requirement for Mifepristone places an unnecessary and undue burden on the right to abortion as established in Planned Parenthood v. Casey. In her dissenting opinion, Justice Sotomayor stated that this ruling “singles out abortion for more onerous treatment than other medical procedures that carry similar or greater risks” and “it imposes an unnecessary, irrational and unjustifiable undue burden on women seeking to exercise their right to choose.” The Supreme Court’s ruling brings into question what qualifies as an undue burden under the current judicial framework, and if any obstacle will prevail in arguments before the current majority.

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When a Pandemic Meets an Epidemic: The Opioid Crisis during COVID-19.

In the last year, the COVID-19 pandemic has collided with the opioid epidemic creating an influx of relapses, overdoses, and deaths. Over 20 million people in the United States have a substance use disorder. As of September 2020, thirty states reported an increase in opioid fatalities since the pandemic started in early 2020. While the overwhelming presence of anxiety, grief, and depression caused by or exacerbated by the pandemic significantly contributed to these numbers, the ongoing isolation continues to prevent individuals suffering from addiction from accessing support systems, hospitals, treatment centers, and other sources of help. Whether it is the fear of contracting the virus from a physician’s office or not having anyone nearby to recognize a dangerous situation, the pandemic has become a severe impediment to the opioid crisis. Luckily, American health organizations are increasingly aware of this rise in substance use disorder and are acting.

In July 2020, the FDA took necessary steps to make naloxone, a medication that can help reverse opioid overdose to prevent death, accessible to the community. To do this, the FDA required opioid manufactures to update package inserts to include recommendations about naloxone and its benefits. This recommendation encourages providers to discuss naloxone with all patients when starting or renewing an opioid treatment. It also urges providers to assess each patient’s need for a naloxone prescription. The FDA plans to implement these changes early this year.

Following agency action, in December 2020, the American Medical Association (AMA) provided recommendations to help states and policymakers support patients with opioid use disorder during the pandemic. These recommendations include ensuring access to care for patients with an opioid use disorder, protecting patients with pain, and utilizing harm reduction efforts to better prevent overdose and the spread of infectious disease. As a result, states like Washington, New Jersey, and Ohio are utilizing curbside and doorstep deliveries of methadone and buprenorphine for quarantined or isolated individuals because of COVID-19 and those in the at-risk population. Additionally, organizations like the American Academy of Physical Medical & Rehabilitation provided COVID-19 specific recommendations and considerations for physicians treating patients with chronic pain.

Increased state and agency responses also influenced the federal government to take action for patients suffering from substance use disorder. In January 2021, the Department of Health and Human Services issued a decision to allow physicians to “prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder.” This decision allows physicians to work with patients and provide care without worrying about authorization barriers and a strict regulatory regime. This cancellation of the waiver requirement effectively reduces the detrimental stigma and health disparities in accessing treatment. It nevertheless is important to acknowledge the systemic racial and socioeconomic inequities that still plague America’s health care system.

The repercussions of the collision between the opioid epidemic and the COVID-19 pandemic are only starting to show. The increased need for addiction treatment combined with the decreased access to treatment options presents a detrimental problem in the United States. Policy and lawmakers must continue to analyze and reevaluate how organizations delivery health care to its stakeholders, including adapting to the use of telehealth and continuing the use of regulatory waivers. People with substance use disorder should not have to battle addiction alone during and after the pandemic.

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