Health Law Advisor

State courts continue to debate whether a state’s constitution recognizes a right to “liberty of privacy” or personal autonomy that would encompass the right to make personal health care decisions, including abortion.

In the post-Dobbs era, state supreme courts have been divided over whether state constitutions offer protections for abortion. Supreme courts in Florida and Iowa have rejected state constitutional protections for abortions, while those in Oklahoma and Montana have found or upheld certain constitutional protections for abortion. Recently, district court judges in Georgia and North Dakota have issued injunctions against their respective state’s abortion bans, finding that each state’s constitution protects a right to abortion.

On September 14, 2024, a district court judge in North Dakota enjoined North Dakota’s total prohibition on abortion, and on September 30, 2024, a superior court judge in Fulton County, Georgia, issued an injunction blocking the state’s six-week abortion ban. While the fate of the North Dakota injunction remains pending, on October 7, the Georgia Supreme Court stayed the lower court’s injunction, allowing Georgia’s six-week ban on abortion to once again take effect. One Georgia Supreme Court justice—Justice John J. Ellington—dissented in part from the decision, opining that “[t]he ‘status quo’ that should be maintained is the state of the law before the challenged law took effect.”

From our Thought Leaders in Health Law video series: The U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country.

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights published a final rule entitled the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009—strengthens privacy protections related to the use and disclosure of reproductive health care information. HIPAA’s Privacy Rule limits the disclosure of protected health information (PHI) and is part of HHS’s efforts to ensure that patients will not be afraid to seek health care from, or share important information with, health care providers.

What are the key takeaways from the Final Rule?

On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law.

On June 13, 2024, a unanimous Supreme Court held that physicians and medical associations opposed to abortion lacked standing to challenge the U.S. Food and Drug Administration’s (FDA’s) approval of the drug mifepristone, which is primarily used in terminating pregnancy. The Court’s decision in FDA v. Alliance for Hippocratic Medicine affirms the status quo—mifepristone will remain available to patients without in-person dispensing requirements and for pregnancies up to 10 weeks.

In April 2023, the U.S. District Court for the Northern District of Texas ruled that the physicians and medical associations in this case did have standing to sue the FDA for approving mifepristone in 2000. Based on that standing, the District Court determined that the FDA’s approval of mifepristone was invalid under the Administrative Procedure Act and enjoined the FDA’s original approval. The District Court delayed its decision for seven days and, as we have previously discussed on this blog, set off a flurry of filings before the Fifth Circuit and Supreme Court, ultimately leading the latter to issue a stay on the District Court’s injunction of the FDA’s original approval of mifepristone. The stay allowed mifepristone to remain on the market under its current approval and remained in effect through the June 13, 2024 decision by the Court.

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance ...

In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al.  that pre-embryos are human children for the purposes of advancing a wrongful death claim, the Alabama legislature enacted a law intended to shield those who “provide or receive goods or services related to in vitro fertilization [(“IVF”)]” from any “action, suit, or criminal prosecution for the damage to or death of an embryo[.]” AL SB ...

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of ...

CMS’s New Actions Related to EMTALA

On January 22, 2024, the Department of Health and Human Services (HHS) announced that, through the Centers for Medicare & Medicaid Services (CMS), it will launch a comprehensive plan related to the Emergency Medical Treatment and Labor Act (EMTALA). The goals of this comprehensive plan are reportedly: (1) to educate the public about their rights related to emergency medical care, and (2) support hospitals that are subject to EMTALA in meeting their obligations. Specifically, this comprehensive plan will:

• Add new informational resources on ...

On November 7, 2023, the citizens of the state of Ohio voted to codify reproductive rights, including the right to abortion, in the state constitution.

In 2019, Ohio banned nearly all abortions once fetal cardiac activity was detected (typically around six weeks’ gestation) through its “Heartbeat Law.” Challenges to Ohio’s Heartbeat Law  under Roe v. Wade and Planned Parenthood v. Casey prevented it from taking effect until the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization repealed those cases. After Dobbs, Ohio’s “Heartbeat ...

The 21st Century digital age has provided women with numerous sexual and reproductive health tools that track periods, ovulation, and pregnancy. By simply plugging certain health data inputs into these apps, women can now accurately track the most intimate moments of their lives. But is this sensitive health information secure?

In this episode of the Diagnosing Health Care Podcast:  The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states.

What has happened since and what is to come?

Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon examine how the Dobbs decision has impacted the legal landscape for patient access to abortion, discuss the challenges facing the health care industry, and explore how industries can manage their compliance efforts moving forward as the legal landscape continues to evolve.

Introduction

Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps to protect reproductive health privacy, some of which we previously discussed here. Specifically, the EO called for agencies to protect “women’s fundamental right to make reproductive health decisions.” Shortly following issuance of the EO, the Biden Administration created its HHS Reproductive Healthcare Access Task Force, requiring all relevant federal agencies to draft measurable actions that they could undertake “to protect and bolster access to sexual and reproductive health care.”  

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.

In this episode of the Diagnosing Health Care Podcast:   The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services.

What additional implications are there for certain aspects of clinical trials and research?

On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.

In this episode of the Diagnosing Health Care Podcast:  In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.

How can health care providers and pharmacies navigate these new restrictions?

In this episode of the Diagnosing Health Care Podcast:  Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, some states have banned abortion in all or most circumstances and many more have enacted new restrictions or enforced old ones.

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how to regulate abortion services.^[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.