07/25/2024

Summer Regulatory & Legal Update

Compliance Reminder:
HIPAA Reproductive Privacy Rule Implementation

As mentioned previously, the HHS Office of Civil Rights finalized a rule this spring stemming from the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. The Biden Administration created this rule out of concern that some reproductive health information held by HIPAA Covered Entities could be used to initiate criminal or civil investigations or proceedings specifically for reproductive health care. The rule comes as some states now have laws that criminalize or penalize abortion services in particular.

Compliance with this new rule will become applicable to HIPAA Covered Entities (including health care providers) on December 23, 2024.

The rule essentially updates HIPAA for providers in three ways:

1) It prohibits the use or disclosure of public health information when it is sought to investigate or impose liability on health care providers obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities.

• The “lawful under the circumstances” is intended to capture circumstances where the protected information is sought and the reproductive health care provided (abortion) is legal. It does not appear that these protections will extend to jurisdictions where the health care information at issue concerns care that is not lawful (states where abortion is restricted).
• Again, this applies in circumstances where the protected reproductive health care information is being requested to conduct an investigation of the care provided (or to identify individuals).

2) Requires a regulated health care provider to obtain a signed attestation that certain requests for protected health information potentially related to reproductive health care are not for these prohibited purposes.

3) Requires regulated health care providers to modify their Notice of Privacy Practices to support reproductive health care privacy.

You can find guidance by HHS here, including a model attestation form. 

Legal Update

Gender-Affirming Care Cases

Over the past few weeks OSMA has been tracking movement on cases concerning prohibitions on gender-affirming care for minors. As previously summarized, a recently passed Ohio law (House Bill 68) has been blocked from enforcement pending the outcome of the case, which challenges the constitutionality of the law. The Supreme Court of the United States has also recently accepted a case out of Tennessee to determine the constitutionality of a similar law in that state. Please see below for a summary and the most recent status of those cases.

United States v. Skrmetti, SCOTUS Docket No. 23-477

On June 24, 2024, the Supreme Court of the United States accepted review of a case challenging a Tennessee law which prohibits all medical treatments intended to allow “a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex” or to treat “purported discomfort or distress from a discordance between the minor’s sex and asserted identity.” This bill prohibits the provision of puberty blockers, gender affirming surgery and hormone therapies—similar to a law currently being challenged in Ohio (Ohio’s law is currently blocked—see below).

The issue before the Court is whether the bill’s provisions violate the equal protection clause of the 14th Amendment.

Briefings and hearings will not be held until next session which begins in October 2024.

Depending on the outcome of Ohio’s case (which will likely be decided earlier) it is yet to be determined what any decision from SCOTUS may have on Ohio physicians.

Moe v. Yost, Franklin County CP No. 24CV2481

In April 2024, a Franklin County judge issued a temporarily injunction for the enforcement of the House Bill 68 legislation, which would prevent transgender youth from receiving gender-affirming care.

This temporary restraining order (TRO) comes as the ACLU of Ohio has filed a lawsuit against the measure on behalf of a two transgender children and their families. The ACLU asked the court to declare the measure unconstitutional and has requested a preliminary injunction.

As a reminder, HB 68 originally passed in the Ohio Legislature in mid-December 2023, and Governor DeWine vetoed the bill on December 29, citing conversations he had with families of transgender youth, along with serious concerns and requests to veto expressed by the medical community. OSMA and a large coalition of several dozen medical organizations and hospitals were among those asking the governor to veto the bill, and had also testified and advocated in opposition to the bill during its journey in the legislature.

On April 22, 2024, Yost petitioned the Supreme Court of Ohio (SCO) to order the trial court judge to alter the TRO in the HB 68 challenge (Yost v. Holbrook, 2024-Ohio-0551). He has filed writs of Mandamus and Prohibition (in which a higher court orders a government entity or lower court to undertake a specific legal or statutory duty) by which he asked that the TRO be only applied to the two plaintiffs in the case, not the entire state. The SCO rejected the petition, protecting the statewide injunction while the case continues.

Trial was held in recently-- July 15 through July 19, 2024. The decision issued by the court will likely be issued sooner than later—followed by an appeal by adverse party.

Thus, HB 68 remains blocked and temporarily unenforceable.

If you have any questions, please contact Sean McCullough at smccullough@osma.org.