Women's Health and Technology

On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off in the United States. On November 13, 2023 the White House announced the Initiative on Women’s Health Research, to be led by First Lady Jill Biden and the Gender Policy Council. The Initiative aims to recognize and address the historic and persisting gaps in women’s health research and, by extension, in our collective knowledge about women’s health as well as how women experience certain conditions or respond to certain treatments differently than men. 

Mintz recently launched a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series highlights women leaders in the health care industry and includes discussions on key issues in the health care industry, women leaders’ reflections on their career, and the impact of mentorship. In our inaugural episode, Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join host Bridgette Keller to share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.

Governor Gavin Newsom recently signed multiple bills into law as part of California’s ongoing efforts to safeguard access to reproductive and gender affirming health care. The new laws are intended to increase protections for health care providers and patients, increase health care provider availability, and improve patient privacy. In a recent press release, California Legislative Women’s Caucus Vice Chair Assemblymember Cecilia Aguiar-Curry noted: “Last year, we enacted 14 bills and budget funding to expand and protect reproductive rights and services in our state. This year, we build on that momentum with legislation that ensures California remains a national leader in the fight for reproductive justice.”

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this activity came just a few days after the FDA approved the first nonprescription daily oral contraceptive for marketing in the U.S. when the agency sent a warning letter to Wise Women’s Choice (WISE) in connection with the marketing and sale of its “birth control cream.” Among other things, this warning letter highlights for consumers the importance of confirming that birth control methods are safe, effective, and FDA-approved for their intended uses.

As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill to over-the-counter (OTC) status. On July 13, 2023, FDA approved the application, based in part on a unanimous advisory committee vote in May that the potential benefits of nonprescription norgestrel daily tablet contraception availability outweighed its potential risks. OTC marketing of the pill will proceed without any innovative regulatory controls or requirements that could have added burdens on consumers’ ability to access the drug at the point of sale. In other words, the agency determined that the Drug Facts Label (DFL), enclosed package leaflet, and other information on the carton (i.e., the Principal Display Panel) provided sufficient mitigation measures for known risks associated with the drug.

The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical devices, has issued a request for public comments on expanding patient access to medical technologies intended for use by patients in their homes.

In response to concerns about the confidentiality of protected health information (PHI) related to reproductive health care less than one year after Dobbs v. Jackson Women’s Health Organization decision, and the prospect of such PHI being weaponized by states and used against patients, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) has proposed amendments to the HIPAA Privacy Rule to protect that information.

On March 9, 2023, the Food and Drug Administration (FDA) published a final rule to update the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements, standardize aspects of mammography reports patients receive. Most notably, the final rule requires informing patients about whether they have "dense" or "not dense" breast tissue and establishes a new mandatory timeframe for facilities to send those reports to the referring health care provider (i.e., within 30 days). The final rule, which takes effect on September 10, 2024, modernizes the MQSA by addressing changes in mammography technology and making improvements that enhance enforcement of quality standards as well as the way mammography results are provided to patients and health care providers.

Member and Chair of Mintz’s ESG practice group, Jennifer B. Rubin and Associate Greer Clem co-authored an article published by Corporate Counsel covering the crime-fraud exception to attorney-client privilege. The authors summarized, "An important and long-standing exception to the attorney-client privilege, the crime-fraud exception, bears examination in the post-Dobbs world. The crime-fraud exception divests attorney-client privilege of confidentiality when a lawyer’s advice facilitates a client’s crime...The crime-fraud exception to attorney-client privilege therefore merits attention for counsel, who should consider the potential areas of risk and some mechanisms to protect the confidentiality of these communications."

In previous posts (available here and here) we reported on some of the legal consequences from Dobbs v. Jackson Women’s Health Organization on employer-sponsored group health plan coverage of abortion-related travel benefits. In this post, Mintz attorneys Alden Bianchi, Greer Clem, and Jen Rubin address the larger concern related to the legality of these benefits in the face of a burgeoning number of states seeking to extend their extra-territorial reach to bar or even criminalize individuals who provide abortion-related travel. 

In this second of our two-part blog series on protecting health information post Roe, we discuss legal and practical strategies that health care providers can take to protect the information of their patients. State laws that restrict or criminalize abortions will require significant amounts of health information to enforce, putting new pressure on health care providers caught in the middle of  competing obligations to their patients and to regulatory and law enforcement authorities making lawful requests for this information.

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts. Those looking ahead have raised concerns about women’s continued access to the wide array of birth control options that have been approved for use in the United States by the Food and Drug Administration (FDA). This post provides a brief historical background on how OTC birth control pills have been regulated under the Federal Food, Drug, and Cosmetic Act and reviews the FDA's Additional Conditions for Nonprescription Use (ACNU) Proposed Rule.

Dobbs impacts employer-sponsored group health plan coverage for abortion services in states where abortion is, or becomes, illegal, and abortion-related travel benefits.  While our earlier post focused on coverage of abortion and abortion-related travel services under a group health plan, and related ERISA preemption considerations, in this post Mintz attorneys Alden Bianchi, Michelle Capezza and Patricia Moran examine other approaches available to employers that seek to make these benefits available, such as HRAs, health FSAs, excepted benefit EAPs and HSAs.

Much has been written about how existing privacy laws such as HIPAA are unhelpful to women in the wake of Dobbs vs. Jackon Women's Health Organization ruling. In the first of this two-part blog post series, the Mintz team breaks down the legal rights and practical strategies that women can use to protect their own information.

With the Supreme Court’s decision reversing Roe v. Wade, employers may find themselves navigating complex benefits and tax-related issues. Our Employment, Labor & Benefits team examines what employers will confront if they seek to amend group health plans, or adopt new plans, programs or arrangements, in an effort to facilitate employee reproductive choice in a post-Roe v. Wade environment.