The comment period for the U.S. Department of Health and Human Services Office for Civil Rights (OCR proposed changes to Privacy Rule ended on June 16, 2023, and the first portion of comments have been released to the public. As of June 19, 2023, 25,905 comments were submitted to the U.S. Department of Health and Human Services Office for Civil Rights (OCR), with 65 of those comments being made publicly available for review.

The publicly available comments can be viewed on Regulations.gov under the “Browse Posted Comments” tab. The relevant changes at issue were announced on Monday, April 12, 2023 by the OCR issuing a notice of proposed rulemaking (NPRM) to modify the HIPPA Privacy Rule to address the release of reproductive health care information to third parties for the purposes of civil, administrative, or criminal proceedings for care that is lawfully obtained.

Continue Reading HIPAA Privacy Rule commenters express concerns about privacy, health outcomes, LQBTQIA+ rights, and historical health care disparities

On Monday, April 12, 2023, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the HIPAA Privacy Rule to address the release of reproductive health care information to third parties for the purposes of civil, administrative, or criminal proceedings for care that is lawfully obtained.

OCR has also released a fact sheet on this NPRM. The NPRM included: (1) the addition of new protections with respect to certain information related to reproductive health care; (2) a new obligation for regulated entities to obtain “attestations” (which are different from HIPAA’s traditional authorization) before responding to requests for certain PHI related to reproductive health care; and (3) the modification of the definition of “person,” and the addition of several new definitions.

Continue Reading Proposed changes to HIPAA highlight increased demands for third party access to reproductive health data

On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key medication for women seeking an abortion. Both rulings faulted the FDA’s handling of the approval and its subsequent restrictions on the dispensing of mifepristone, but the two rulings came to very different conclusions as to what the availability of the drug should be.

Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a 67-page opinion ordering that the FDA’s initial approval of the drug, which was approved in 2000, should be stayed pending the court’s full review of the merits of the case. The court then stayed its own order for seven days to allow the FDA to appeal to the U.S. Court of Appeals for the Fifth Circuit.

Just minutes later, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a 31-page opinion ordering FDA and HHS not to make any changes to the availability of mifepristone under the current operative Risk Evaluation and Mitigation Strategy (REMS) program, which requires the drug to be prescribed and dispensed only by certified providers, among other requirements. Unlike Judge Kacsmaryk, whose injunction has nationwide effect, Judge Rice limited the effect of his order to only the 17 states and the District of Columbia who brought the challenge in his court. The 17 plaintiff states in this lawsuit are: Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington and the District of Columbia.

The most difficult-to-reconcile aspect of the two orders is the fact that Judge Kacsmaryk’s order is a nationwide stay of the drug’s approval, while Judge Rice’s order to maintain the status quo availability only applies to the specific plaintiffs.  Notably absent from the Washington order’s applicability would be California, Massachusetts, New Jersey, New York, North Carolina, New Hampshire, and Virginia.

Continue Reading Mifepristone Cases – Our Thoughts

The U.S. Supreme Court on July 26 issued its judgment in the case of Dobbs v. Jackson Women’s Health, officially setting in motion abortion bans in at least four states.

A “judgment” is distinct from the opinion and typically follows issuance of the opinion by about a month. This certified document from the clerk of The Supreme Court is usually simply a formality to allow the Court of Appeals from which the case originated to either close its docket or begin the process of implementing what was ordered on remand.

In the Dobbs case, the Supreme Court issued its opinion (142 S. Ct. 2228) on June 28, but the judgment issued from the clerk’s office to the Fifth Circuit about 30 days later.

Because of the way the trigger bans in at least four states were worded, the issuance of the judgment on July 26 also started the clock on the enforcement of those states’ laws. The trigger laws in Texas, Tennessee, Idaho, and North Dakota will each take effect 30 days after the judgment was issued, i.e., on August 25, 2022.

Continue Reading Supreme Court judgment triggers abortion bans in states, legislative action in others

On June 29, 2022, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) issued two pieces of guidance clarifying the applicability of the Health Insurance Portability and Accountability Act (“HIPAA”) related to privacy of information connected to an individual’s reproductive health. 

Through this guidance, HIPAA addresses both protected health information (“PHI”), which is subject to HIPAA’s rules, as well as general, personal information that is not directly protected by HIPAA.

Continue Reading New Guidance by OCR addresses HIPAA and Disclosures of Information relating to Reproductive Health

As the health care industry as a whole comes to grips with the fallout from the U.S. Supreme Court’s decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health, here at Reed Smith we have formed a Reproductive Health Working Group to bring expertise from the across our many specialty areas to help our clients to prepare for the post-Dobbs reality.

To that end, we have generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog have shared the parts of that series that focused on pharmacieshealth care providers, and fertility practices, and employee benefit plans.

The Working Group has put together two new updates to branch into the employment and privacy areas.

Continue Reading Unanswered Questions on Privacy and Employment from Supreme Court Overturn of Roe v. Wade

Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be felt by employee benefit plans and the companies that offer them. Among those implications are the logistics of how to offer coverage for employees who must travel out of state to obtain a legal abortion.

The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog shared the first three parts of that series that focused on pharmacies, health care providers, and fertility practices, respectively.

In Part IV of the series, Allison Warden Sizemore considers the implications of the reversal on employee benefits plans. Specifically she highlights issues arising from an employer’s offer to cover travel costs for employees who travel for an abortion.

Continue Reading Unanswered Questions for Employee Benefits Plans from Supreme Court overturn of Roe v. Wade

In an opinion authored by Justice Samuel Alito and joined by four of the other conservatives, The Supreme Court in Dobbs v. Jackson Women’s Health Organization held that there is no federal constitutional right to an abortion, and that the decision to regulate abortion should be governed exclusively by state law. In doing so, the decision overruled The Supreme Court’s previous decisions of Roe v. Wade decided in 1973 and Planned Parenthood of Southeastern PA v. Casey decided in 1992.

The Dobbs opinion tracks closely with the previous leaked draft opinion from The Supreme Court and includes concurring opinions from Justice Thomas, Justice Kavanaugh, and Chief Justice Roberts, as well as a dissent by Justices Breyer, Sotomayor and Kagan.

The Chief Justice concurred in the judgment but wrote separately to indicate that he would have only upheld the Mississippi law, and stopped short of overturning the precedents of Roe and Casey.

Decision changes landscape of reproductive health care rights

The Court’s decision, which was effectively 6-3 given the Chief Justice’s concurrence in the judgment, changes the landscape of reproductive health care rights throughout the country.

Continue Reading Supreme Court Overturns Roe and Casey

Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be far reaching both for fertility practices and for health care providers in general.

The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the