Legal Loophole of Health Apps by Samra Saleem

Rapid growth in the use of health and healthcare apps has revolutionized the individual users’ involvement with their personal health. For example, MyFitnessPal allows users to track their nutrition and exercise. Calm and Headspace offer meditation and relaxation tools to support users’ mental well-being. MySugr assists in monitoring diabetes and Medisafe assists with adhering to a medication regimen. Teladoc provides virtual medical consultations to make healthcare more accessible.

However, these apps exist in a regulatory gray area. Unlike hospitals and doctors which are covered entities regulated by the Health Insurance Portability and Accountability Act (HIPAA), many health and wellness apps fall outside the regulatory purview of federal health privacy laws. This loophole has enabled a boom in the data brokerage industry, where personal health data is collected, sold and sometimes even used against consumers.

The following aims to explore the legal gaps that allow non-HIPAA-covered entities to monetize sensitive personal health information (PHI), the role of data brokers who take advantage of this regulatory oversight and potential legal solutions to overcome this regulatory gap.

Health Apps and the HIPAA Gap

Health apps are software applications that are designed for smartphones and mobile devices, offering a range of services from medical diagnosis and symptom tracking to medication management and fitness monitoring. By providing tools for telemedicine consultations and mental health support, health apps enhance accessibility and convenience for users. These apps use and assess health information, but they are not covered under HIPAA, which only applies to entities such as hospitals and doctors, health insurers, and business associates that handle data on behalf of covered entities. Since the majority of health apps do not directly provide healthcare services, they successfully evade HIPAA’s privacy and security requirements. Instead, many apps operate under minimal federal oversight, leaving room for unregulated data collection, weak security protocols and monetization of sensitive user information. Apps created by or for covered entities (CEs), such as healthcare providers or insurers, must comply with HIPAA as they handle PHI. However, apps designed for personal use without CE involvement typically fall outside HIPAA’s scope.

The determination ultimately will depend on its specific use case and the relationship between the app developer, the users, and any covered entities or business associates involved. Developers of health-related apps should carefully assess their obligations under HIPAA and ensure that their app is compliant if necessary.

The Data Broker Loophole

Data brokers collect and sell personal information about consumers from various sources, often without the consumers’ knowledge. In the United States, the lack of comprehensive federal privacy legislation allows these brokers to operate with minimal oversight. Health apps, which fall outside the purview of regulations like HIPAA can legally share or sell user data to third parties like advertisers, insurance companies and even law enforcement. This practice creates a significant privacy gap as users’ sensitive health information can be sold without their explicit consent or awareness. For example, a research team at Organization for the Review of Care and Health Apps (ORCHA) reported that “84% of period tracker apps share data with third parties”, but “only one single app demonstrated best practice by explicitly asking users for permission” to share data with data brokers. The ORCHA report exemplifies how entities can sell users’ location data, reproductive health details and mental health history without violating federal law.

The Federal Trade Commission (FTC) has taken steps to regulate data brokers and deceptive health data collection, though FTC enforcement has had limited effect. For example:

  • The Federal Trade Commission (FTC) has taken action against data brokers like Gravy Analytics and Mobilewalla for collecting and selling sensitive location data such as visits to healthcare facilities. Such data sales can lead to unauthorized profiling and potential misuse of personal health information.
  • A 2023 FTC investigation found that BetterHelp shared users’ sensitive mental health data with advertisers despite promising confidentiality. BetterHelp agreed to pay $7.8 million to settle charges brought by the FTC. This case highlighted the lack of enforceable federal regulations that would prevent such practices in the future.
  • In FTC v. Kochava (2023), the FTC sued Kochava, Inc., alleging it sold precise geolocation data that could identify visits to clinics, mental health facilities and addiction treatment centers. As the Verge reported, “Precise location data from advertising IDs and mobile apps can be used for surveillance that, according to the FTC, puts millions of Americans at risk.”

 

At the state level, California has introduced California Consumer Privacy Act (CCPA), Cal. Civ. Code § 1798.100 et seq. However, there is no single comprehensive federal law closing this regulatory loophole for data collection and sharing.

Privacy and Security Risks

Health apps are vulnerable to privacy and security risks just like any other computer software. Apps collect data that can be used to violate an individual’s privacy. Health apps like mental health trackers and period trackers also pose serious risks to user privacy and security without effective regulation.

Mental Health Apps Sharing Data

A 2022 study found that many mental health apps lacked encryption and transmitted data to third parties without user consent. Another study analyzing mental health applications made similar findings of negligent encryption and data sharing, which not only breaches user trust but also exposes individuals to potential discrimination or exploitation based on their mental health data. As researcher Joanne Kim highlights, “Health insurance providers… could buy mental health data to discriminately charge individuals for care or discriminately target vulnerable populations with advertisements…Scammers could…exploit and steal from individuals living with mental health conditions.”

Period-Tracking Apps and Reproductive Health Data

Period-tracking apps help users monitor their menstrual cycles but also expose sensitive data (PHI) to third parties, including data brokers. Following Dobbs v. Jackson Women’s Health Org. (2022), concerns over reproductive health data escalated. While some states have shield laws to protect reproductive health data, law enforcement and prosecutors can bypass subpoenas and shield laws by simply purchasing user data like location history directly from brokers, creating a direct conflict between state-level privacy protections and permissible activity on the unregulated data market.

The Need for Regulatory Reform

The exploitation of health data through these loopholes has prompted demand for improved regulations. Advocates including Health and Human Rights (HHR) argue for comprehensive privacy laws, suggesting provisions that require apps to obtain informed consent before curating user data and to disclose how PHI will be used. Accordingly, entities that violate privacy standards would be subject to fines and/or sanctions to deter misuse.

Some states have begun to address these issues by following California’s example of the CCPA. For instance, New York’s proposed Health Information Privacy Act aims to limit tech companies’ control over consumer health data and protect individuals. The New York Act can be found here.

Legal Solutions to Protect Health Data Privacy

The unregulated sale of health data collected on health apps presents serious constitutional and consumer protection concerns. While HIPAA was designed for traditional healthcare entities, it fails to regulate the growing health app industry, leaving millions of users vulnerable.

One proposed solution is federal legislation such as the American Data Privacy Protection Act (ADPPA), which proposes restrictions on the sale of consumer health data at the federal level. This would prohibit data brokers from collecting and selling sensitive health information without explicit user consent.

Another approach to addressing this issue involves amending HIPAA to extend its reach to consumer health applications and digital health platforms. This reform would ensure that companies such as fitness trackers, mental health apps and telehealth services, which all collect health-related data, are subject to the same privacy and security requirements as traditional healthcare entities. Expanding HIPAA’s scope in this way would create uniform standards for data protection and require app developers and tech companies to obtain user consent before sharing health data with third parties. Additionally, it would hold these tech entities accountable for breaches and misuse of sensitive information.

At the state level, legislative efforts have attempted to fill the gaps left by federal inaction. [For instance, California’s CCPA and New York’s proposed Health Information Privacy Act aim to limit corporate data sales but without federal backing, enforcement remains inconsistent.] Laws like California’s CCPA and New York’s similar proposed act grant consumers greater control over how their information is collected and shared and provide consumers with the right to request data deletion and opt out of its sale. However, without robust federal backing, enforcement of state laws is inconsistent across state lines, leading to a fragmented national regulatory landscape. While some states have taken proactive measures to safeguard consumer health data, others lack comparable protections, leaving millions of Americans exposed to potential privacy violations.

Until these regulatory gaps are addressed, health tech companies have the right-of-way to continue operating in a legal gray area. While their data remains free to be taken advantage of, consumers remain at risk of harmful privacy breaches. A combination of federal legislation, state enforcement and corporate accountability is needed to bring health data privacy into the modern era.

U.S. v. Skrmetti: A Landmark Case Regarding Gender-Affirming Care? By Adam Sherman

What types of health care should be available to citizens? Can state or federal governments restrict access to health care based on gender identity? While these questions may seem relatively easy to answer in today’s legal framework, judicial scrutiny recently turned to whether states may restrict or deny access to gender-affirming care for American minors in the United States v. Skrmetti case. After oral arguments in December 2024, a SCOTUS decision is forthcoming and may alter the legal framework around youth access to gender-affirming care.

Gender Dysphoria & Gender-affirmative Care

The World Health Organization defines gender-affirmative care to “include any single or combination of a number of social, psychological, behavioral or medical (including hormonal treatment or surgery) interventions designed to support and affirm an individual’s gender identity.” This care may be deemed medically necessary for an adolescent depending on age and gender classification. According to the Mayo Clinic, a person whose gender identity differs from their sex assigned at birth can experience gender dysphoria, which may be accompanied by other detrimental physical or psychological complications like harassment, anxiety, depression, and even suicidality. A study conducted by Stanford University School of Medicine demonstrated the importance of gender-affirming care for youths who experience gender dysphoria. This 2015 study, exhibiting one of the largest sample sizes of U.S. transgender adults, indicated that “transgender people who began hormone treatment in adolescence had fewer thoughts of suicide, were less likely to experience major mental health disorders and had fewer problems with substance abuse than those who started hormones in adulthood.”

UCLA School of Law’s Williams Institute shed light on concerning statistics regarding this matter, stating “237,500 transgender youth (ages 13-17) live in states that have passed laws banning access to gender-affirming care or where such a law was introduced or pending in the 2024 legislative session.” More than 75% of the transgender youth in the U.S live in states seeking to restrict access to gender-affirming care, indicating the substantial impact the Supreme Court would have with a decision in U.S. v. Skrmetti.

Senate Bill 1 & United States v. Skrmetti

In 2023, the Tennessee legislature enacted Senate Bill 1 (“SB1”), which facially appears to be a blanket ban on gender-affirming care for transgender youth. The ban may encompass medical care, such as administering hormone therapy and puberty blockers to assist youths experiencing the physical and psychological complications mentioned above. Since the enactment of SB1, litigation commenced on US v. Skrmetti, which will have an impact across the nation. The parents of transgender teens initiated the suit against the Tennessee Attorney General on their child’s behalf. The United States later joined as a party, challenging the ban. On December 4, 2024, the Supreme Court heard oral argumentson the case. The arguments addressed the constitutionality of SB1’s ban, which would prevent those of the LGBTQ+ community from accessing care, as well as the requisite standard of review when determining such constitutional compliance.

The Equal Protection Clause and How it Works

Understanding the Supreme Court’s intermediate scrutiny standard of review and the Equal Protection Clause is necessary to grasp this discussion on the Skrmetti oral arguments. Natalie Wexler’s essay supplied by the Supreme Court Historical Society provides a comprehensive background on the Equal Protection Clause and sex discrimination to supplement this discussion.

Intermediate scrutiny, commonly associated with United States v. Virginia, is a more onerous standard of review that commonly applies to issues concerning gender, a “quasi-suspect class.” When legislation draws lines on the basis of sex, as SB1 allegedly does, intermediate scrutiny applies, and the legislation must have a substantial relation to the achievement of an important governmental objective. With this standard of review in mind, one can better understand the arguments discussed below.

An Understanding of Skrmetti’s Oral Arguments

Skrmetti oral arguments began with statements from Elizabeth Prelogar, the Solicitor General from Washington D.C.’s Department of Justice. Her main point: SB1 makes clear that medications and gender-affirmative care may not be prescribed in Tennessee for the purpose of aiding a transgender youth in living or identifying as a different sex than what they were assigned at birth. Prelogar contends this is a facial sex classification which, upon remand to the Sixth Circuit, deserves a heightened level of scrutiny beyond mere rational relation.

Prelogar was met with several questions from the Justices pertaining to evidence gathered abroad that the harms may outweigh the benefits to gender-affirmative care. Nevertheless, Prelogar remained firm that categorical evidence exists, demonstrating the need for this type of care for youths in individualized cases. Other Justices offered questions about the severe complications with gender dysphoria and addressing suicidality. Ultimately, this led to Prelogar’s strength in pointing out the Tennessee legislature’s failure to show the ban served a legitimate state interest when juxtaposed against the severe health consequences suffered by impacted youths.

Following Prelogar, statements were heard on behalf of the Plaintiffs by Chase B. Strangio. Strangio, a well-respected lawyer for the ACLU with special expertise in the LGBTQ+ rights field, is the first openly transgender person to present oral arguments before the Supreme Court of the United States, setting the stage and breaking barriers for future LGBTQ+ attorneys to follow.

Strangio’s argument emphasized that regardless of what level of scrutiny the Court applies to SB1, whether it be rational basis, intermediate, or strict, the legislation should fail after a court’s analysis because it is “discontinuous” with the alleged state interest of protecting children SB1 purports to advance.

In response to Strangio’s arguments, the Justices expressed similar concerns to the arguments presented by Prelogar. Justice Barrett noted that it is neither common nor the place for the judiciary to delve deep into medical evidence and research. To this, Strangio countered that when a sex-based classification and the Equal Protection Clause are at play, it may be exactly the place, based on precedent, for the courts to examine a state’s tailoring of legislation allegedly meant to further a legitimate state interest.

Further concern surrounded a topic that often arises when debating gender-affirming care, specifically when minors are involved—regret and reversal. However, the evidence on this matter is conflicting, and for these reasons, it will not be discussed here.

Arguing on behalf of Tennessee’s ban and Attorney General Jonathan Skrmetti was Solicitor General J. Matthew Rice. Rice argued that the Sixth Circuit’s decision to reverse the preliminary injunctions, preventing SB1’s enactment, should be affirmed. Rice contended that SB1’s application hinges on medical purpose and has little to do with sex and sex discrimination requiring intermediate scrutiny. He emphasized the uncertainty and harm associated with the gender-affirming interventions discussed in SB1. Finally, Rice put forth the policy argument that politically elected lawmakers are in the best position to address this issue. This long-debated position may gather support from the Justices who had trepidation that it may be beyond the judiciary’s purview to investigate and assess such medical issues.

Rice bolstered his argument that SB1 turns on medical purpose by using the example of puberty blockers. This led to a major point of contention between Rice and the Justices on the verbiage of SB1, which frames the purpose of the legislation as protecting the youth and encouraging them to appreciate their gender assigned at birth. Of course, this exact language may also further Prelogar and Strangio’s argument that a clear, facially sex-based classification is at hand, implicating intermediate scrutiny.

Final Thoughts and What to Expect

A Supreme Court decision on United States v. Skrmetti is expected around June of 2025. A major concern of the Justices is where the constitutional allocation of authority lies, which will play a large part in the Justices’ decision. Will the decision simply determine the level of scrutiny applicable to SB1, with an order vacating and remanding to the Sixth Circuit? Or will the Court go a step further and strike the ban altogether? Sarah Parshall Perry, a Senior Legal Fellow at the Edwin Meese III Center for Legal and Judicial Studies, titled her commentary, “Oral Arguments Indicate SCOTUS Justices Are Likely To Uphold Tennessee’s Ban on Gender Medicine for Minors.” Thus, indicating her belief that the Justices will be swayed by their suspicions regarding experimental care for minors.

SB1 being upheld would have broad impacts. The 75% of transgender youth living in states where bans have either been imposed or pending would likely lose the access that, in their minds and the minds of their parents and physicians, they desperately need.

Concern with the outcome of the decision spans the political spectrum. If this youth ban is found constitutional, it may lead to analogous decisions upholding similar bans for adults as well. Moreover, it may mean that nothing is stopping other branches of government from crafting similar sweeping declarations, executive orders, or bans on certain gender-related health care procedures, and using Equal Protection arguments to uphold them.

While the Nation waits for the Skrmetti opinion, all we can do is speculate and ponder the ripple effect this may have on the future of the Equal Protection Clause alongside the health care system.

Are Current Reforms Adequate to Keep Health Systems Safe from Cyberattacks? By Amna Cehaja

The health care sector is increasingly victimized by targeted cyberattacks. The stakes are uniquely high when a health system finds itself at the center of a cyberattack; the consequences can be severe for both the health system and the patients it treats and serves. The problem is well-known, yet a fix has been elusive. Current laws neither sufficiently protect health systems and patients from these attacks nor adequately compensate those harmed. This analysis explores the deficiencies in both current and proposed legislation and explores what more is required to address the growing risks that accompany cyberattacks on health systems.

Cyberattack Basics.

A cyber incident or cyberattack is “an event occurring through a computer network that actually or imminently jeopardizes the integrity, confidentiality, or availability of computers, information or communications systems [or] physical or virtual infrastructure controlled by computers or information systems…” Cyberattack perpetrators seek health information valuable on the black market; such information “contains details that can be used to access bank accounts or obtain prescriptions for controlled substances.”

Between 2018 and 2022, there was a 107% increase in the number of data breaches reported to the Office for Civil Rights (OCR) that affected 500 or more individuals. The number and size of data breaches steadily rose from 2021 to 2023, with 45.9 million records breached in 2021 and 133 million records breached or otherwise impermissibly obtained in 2023.

It is not surprising that recent years have seen numerous, far-reaching health care cyberattacks. The Kaiser Foundation Health Plan, Inc. suffered a cyberattack in 2024 that resulted in a breach of over 13 million records. In 2023, Welltok, Inc. was the victim of a cyberattack resulting in over 14 million records were impermissibly exposed. The top of the list cyberattack is the attack that targeted Change Healthcare, Inc.; over 100 million records were breached.

Holes within Current Laws and Guidance.

Current laws and guidance have been ineffective in quelling the rise of cyberattacks. The Department of Health and Human Services (HHS) has stressed that “there are measures known to be effective to prevent the introduction of ransomware and to recover from a ransomware attack.”

Under the Health Insurance Portability and Accountability Act’s (HIPAA) Security Rule, covered entities and business associates must implement measures and procedures “that they believe are reasonable and appropriate to respond to malware and other security incidents.” Although HIPAA is a federal law to which covered entities and business associates must follow, the rise in cyberattacks indicates that HIPAA may need strengthening because cyberattacks persist.

The persistence of successful cyberattacks makes clear that guidance, though helpful, is not enough: legislation is necessary if true reform is the ultimate goal. Because “health care and public health sector assets are increasingly the targets of malicious cyberattacks,” the Healthcare Cybersecurity Act (HCA) of 2022 was an effort to mitigate this prevalent problem. The 2022 HCA was meant to introduce reforms that would revitalize the health care sector. It did not pass, but it was reintroduced in 2024 with additions.

Originally known as Senate Bill 3904, the 2022 HCA requires the Cybersecurity and Infrastructure Security Agency (CISA) to coordinate with HHS to improve cybersecurity in the health care sector. The coordination between CISA and HHS would develop products to specifically meet the needs of health care entities, as well as share information that relates to “cyber threat indicators and appropriate defensive measures.” The Secretary of HHS would be required to provide training to health care and public health asset owners and operators, particularly on cybersecurity risks and how to mitigate them.

The 2022 HCA also emphasized that the Secretary of HHS must update the Health Care and Public Health Sector Specific Plan (Plan); the Plan would include an analysis of the impact of cybersecurity risks, an evaluation of the challenges that the health care sector faces, an evaluation regarding best practices, an assessment of relevant cybersecurity workforce shortages, cybersecurity challenges related to the COVID-19 public health emergency, and an evaluation of the most timely ways that CISA and HHS can communicate and establish recommendations to the health care sector.

Proposed Legislation Will Not be Enough to Safeguard Health Systems.

On July 11, 2024, Senators Jacky Rosen (D-NY), Todd Young (R-IN), and Angus King (I-ME) introduced the Healthcare Cybersecurity Act of 2024. When announcing the bipartisan bill, the Senators cited the Change Healthcare cyberattack as motivation behind introduction of the bill, emphasizing that the attack severely interrupted the functionality of hospitals. The 2024 HCA adds a few provisions to supplant the 2022 HCA.

First, the 2024 HCA calls for the appointment of a liaison with cybersecurity qualifications and expertise. The liaison would be charged with numerous responsibilities, including offering technical assistance on best practices relating to cybersecurity, facilitating cyber threat information sharing, and coordinating with CISA and HHS during cybersecurity incidents, among other related tasks. The liaison must “submit a report that describes the activities undertaken to improve cybersecurity coordination” between CISA and HHS. Ultimately, the liaison is meant to help CISA and HHS coordinate with one another to be able to respond to cyberattacks quickly.

Second, the 2024 HCA would require that the Director of CISA establish criteria to determine what constitutes a high-risk covered asset. A covered asset under the HCA of 2024 is a “healthcare and public health sector asset, including technologies, services, and utilities.” In this context, a high-risk covered asset would be a healthcare asset that may be susceptible to high levels of harm due to its sensitive nature. Further, the Secretary of HHS must develop a list of high-risk covered assets for HHS to use when “prioritiz[ing] resource allocation to high-risk covered assets to bolster cyber resilience.” This section is meant to identify high-risk covered assets so that not only is the federal government aware of their status, but also so that the high-risk covered assets may be prioritized in the event of a cyberattack.

Although some vouch that the 2024 HCA is a “critical step forward in safeguarding our nation’s healthcare infrastructure,” others are unconvinced that the HCA will be as impactful as hoped. Many believe that the 2024 HCA is redundant of actions that are already being undertaken. Steve Cagle, CEO of health care cybersecurity firm, Clearwater, stated that former President Biden’s “National Security Memorandum on Critical Infrastructure, Presidential Policy Directive 41, HHS’s 405d program, and cybersecurity training already offered” all achieve the same initiatives that the 2024 HCA attempts to accomplish. Some argue that what is truly needed is “accountability, email protection, vulnerability management, risk analysis, and experienced security staff to guide programs.”

It seems that those who do not have faith in positive effects of the 2024 HCA argue that, from small-scale organizations to large-scale corporations, basic security controls must be in place first. Without basic controls, federal legislation may not positively contribute to avoiding cyberattacks or even mitigating the risks of cyberattacks.

Conclusion: What Will Work? Will Anything Work?

The health care sector continues to fall victim to the steady rise of cyberattacks that not only disrupt operations, but also affect the patients served. Although the 2024 HCA may be a sign of progress, its impact may be limited without implementation of basic security controls across all sizes of health systems. The Change Healthcare cyberattack illustrates that even a large corporation with seemingly robust resources is vulnerable if it relies on inadequate, reactive security measures.

Although the 2024 HCA strives to curate better strategies in response to cyberattacks, a shift towards proactive security measures within health systems is required to effectuate positive change. Instead of reacting to cyberattacks when they occur, health systems should engage in proactive cybersecurity, where they invest to improve their cybersecurity before an attack occurs. Reactive cybersecurity measures make it more likely that a cyberattack will be successful since adequate security measures are not in place prior to the cyberattack. On the other hand, proactive cybersecurity initiatives anticipate future issues so that an entity is prepared when a cyberattack occurs. Specific examples of proactive cybersecurity measures include workforce training, ongoing risk assessments, third-party risk management, and more. Current law focuses too much on reacting to cyberattacks rather than preventing them. If future law shifts toward a proactive approach, it could better equip health systems to prevent cyberattacks, ultimately improving patient safety and trust. Until foundational measures are addressed, and proactive cybersecurity initiatives are implemented, neither laws nor initiatives, existing or proposed, will be adequate to protect the vulnerable atmosphere that engulfs health systems from the sphere of cyberattacks.

Do No Harm and the Politicization of Equity in Medicine by Emma Lee

Under the banner of anti-discrimination, recently established advocacy group Do No Harm (DNH) seeks to eliminate diversity initiatives in healthcare. DNH believes that diversity, equity, and inclusion (DEI) practices are plain discrimination against certain demographics of patients, medical students, and healthcare workers, which ultimately harms patient health outcomes. This belief contradicts current healthcare and public health goals of utilizing diversity-conscious practices to promote equity and mitigate disparities in healthcare. Legitimization of DNH’s mission would further politicize equity in medicine and frustrate preexisting efforts to eliminate health disparities.

Background

Retired physician Stanley Goldfarb founded DNH in 2022 to fight for “the elimination of all discrimination in healthcare.” As a national association comprised of like-minded patients, medical professionals, and policymakers, DNH primarily utilizes media, lobbying, and litigation to target pediatric gender-affirming care and DEI practices.

DNH pursues litigation over initiatives like diversity fellowship scholarships, DEI hiring practices, and clinical care practices specialized to meet the needs of racial and ethnic minorities. DNH believes that tailoring healthcare opportunities to racial minorities, women, and other minority groups discriminates against all other “non-minority” groups. DNH grounds its arguments in various combined readings of Title VI of the Civil Rights Act of 1964, Section 1557 of the Affordable Care Act (ACA), and the Equal Protection Clause of the Fourteenth Amendment. These federal provisions prohibit discrimination on the basis of race, color, ethnicity, and sex, and typically resolve cases involving discrimination against a racial, religious, or gender minority. Spurred by changes implemented by the U.S. Supreme Court, DNH wants to use these federal provisions to protect non-minority groups from discrimination.

In the 2023 decision from SFFA v. Harvard, SCOTUS said that “[e]liminating racial discrimination means eliminating all of it”, reinforcing a statement from an 1886 case that the Equal Protection Clause applies “without regard to any difference of race, of color, or of nationality”. The Court held that colleges and universities are now prohibited from considering race as a factor in admissions. After this decision, groups like DNH began filing claims with intent to expand the scope of SFFA v. Harvard to non-university parties, including medical schools and healthcare workplaces.

Like other industries, healthcare evolved over time and gradually implemented diversity-conscious practices to address identified disparities. Medical schools and healthcare employers established policies and opportunities for traditionally underrepresented groups to enter the medical field. Proponents of health equity believed DEI would lead to more accurate, bias-checked medical opinions and treatment decisions, and that a diverse range of physicians caring for a diverse patient population would improve patients’ overall experience and trust in the healthcare system.

DNH discredits diversity initiatives in its own compiled report, which discusses a lack of hard evidence that diversity-conscious practices improve clinical outcomes and “debunks” the methodology of select pro-DEI research. Advocates of diversity initiatives defend the practice by pointing to records of positive subjective patient experiences and a social need to remedy historical inequity in the profession. DNH opposes those exact ideas: first, that diversity in the healthcare workforce results in improved patient health outcomes; and second, that medicine is a practice where equal opportunity matters more than, or as much as, training “the best and the brightest”.

Recent Action by Do No Harm

In March 2024, House Representative Greg Murphy introduced the EDUCATE Act, which proposes a ban on federal funding for medical schools that “force students or faculty to adopt specific beliefs, discriminate based on race or ethnicity, or have diversity, equity, and inclusion (DEI) offices or any functional equivalent.” DNH founder Dr. Goldfarb supported the Act, saying, “If we fail to stop [DEI ideology in medical schools], we risk a generation of physicians ill-equipped to meet the needs of their patients.” Endorsement of the EDUCATE Act reflects DNH’s fear that medical schools are prioritizing diversity and equity over quality medical training, to the detriment of patient health outcomes. The status of the Act has not changed since its referral to the Committee on Health, Education, Labor, and Pensions.

In June 2024, DNH filed a complaint in federal court, challenging a policy of the American Association of University Women (AAUW) that limited eligibility for its fellowship program to women applicants of ethnic minority groups. The court dismissed the case after AAUW agreed to drop race from criteria for consideration of the fellowship. In its August 2024 statement, AAUW acknowledged that “recent Supreme Court decisions have changed how we must fight for equity”, likely referring to SFFA v. Harvard.

In August 2024, DNH filed a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), urging an investigation into the Cleveland Clinic. Since 2019, Cleveland Clinic’s Minority Stroke Program“tailor[ed] treatment and prevention services to Black and Latino patients, including medical referrals and post-stroke care” to address the disparity that “Black men and women are at least two times as likely as white Americans to die from strokes.” DNH alleged that the minority-focused programming violates non-discrimination mandates under Title VI and Section 1557 of the ACA. In September 2024, OCR announced it would investigate the complaint.

Discussion

DNH’s litigation efforts against pro-DEI organizations indicate that any program with DEI initiatives is susceptible to equal protection challenges and discrimination claims. Data, studies, and research in support of one side or the other are frequently met with scrutiny by the opposing side. For example, DNH itself lauded research that “debunked” an influential study on racial concordance and newborn mortality that was often cited by scholars and administrators to justify DEI-conscious admissions at medical schools. The public is adversely affected by apparent discord among medical scholars and health policymakers, with one study attributing a lack of trust in public health agencies to perceptions of political influence within the agency, which risks undermining public health efforts. Further politicization of equity and other healthcare goals frustrates actual progress towards improving health for all.

Updates are slow in this area of health, law, and equity. The ongoing focus and frequency of DNH activity should put organizations on notice to carefully consider existing DEI practices and prepare to either defend or drop diversity-conscious language from any program goals and requirements. Choosing to defend risks the possibility of a court applying the SFFA v. Harvard prohibition on race considerations to this specific healthcare context, or even extending the reach of SFFA v. Harvard to DEI-centered fellowships, research programs, and pipeline programs in every industry, not just healthcare. No court has definitively ruled on the merits of a claim alleging discriminatory diversity-conscious healthcare and medical school programming. Like the AAUW case described above, most cases are dismissed for procedural reasons without judicial comment on discrimination and DEI. However, every lawsuit DNH files against pro-DEI organizations is a step in that direction.

Here in Illinois, DNH has not filed any lawsuits alleging discriminatory practices by healthcare corporations and medical schools. In August 2022, DNH did file an administrative complaint with the Department of Education, Office of Civil Rights (Chicago OCR) against Loyola University Chicago Stritch School of Medicine (Loyola), calling out an internship program that “intended to encourage medical students from racial and ethnic groups that are underrepresented in medicine to consider pursuing a career in academic surgery” in violation of Title VI. Eligibility requirements for the program included the criterion of “African American/Black, Hispanic/Latinx, American Indian/Alaska Native, Native Hawaiian/Pacific Islander”. Chicago OCR dropped its investigation in February 2023 because Loyola removed the contested criterion from its eligibility requirements. Now, the program “invites outstanding students who self-identify as underrepresented in Surgery from a social, economic, or educational perspective” to apply.

In October 2024, DNH Senior Fellow Mark Perry submitted a complaint to Chicago OCR on behalf of DNH against Midwestern University over its dental school scholarship program, which is open to students from “underrepresented minority groups”. According to Perry, the program violates Title VI and is “not legal”. Other than a November 2024 news clip on the DNH site, no further updates are currently available on this matter. Perhaps like Loyola and the AAUW, Midwestern University will eventually rephrase or omit the challenged language from its program requirements.

Other than scholarship programs, minority-focused clinical care and research programs are prime targets for DNH attention. The University of Illinois at Chicago College of Medicine currently runs the Institute for Minority Health Research, which aims to promote research and other interventions to “improve the health of vulnerable minority populations living locally, nationally, and internationally.” DNH could attack the Institute for its apparent catering to “minority populations” over non-minorities, similar to its argument in the Cleveland Clinic investigation.

DNH continues to submit complaints against organizations with DEI practices, condemning claims that minority representation in healthcare contributes to improved patient health outcomes. By pursuing its goal of ending discrimination against non-minorities in healthcare, DNH is polarizing what could be a collaborative discussion on the optimal ways to improve health. “Equity” is now a politicized term rather than a fundamental principle of health and medicine. If any judicial or legislative action legitimizes the goals of DNH and specifically applies SFFA v. Harvard and equal protection to this healthcare context, DEI healthcare and medical programs risk total invalidation —something to keep an eye on in the upcoming years.