Health Law Advisor

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA.  FDA updates that data once a year at the close of its fiscal year.  Clearly the trend is up. But that's a bit backward looking, in the sense that we are only learning after the fact about FDA clearances for therapeutic applications of AI/ML.  I want to look forward.  I want a leading indicator, not a laggard.

I also want to focus on uses of AI/ML that are truly therapeutic or diagnostic, as opposed to the wide variety of lifestyle and wellness AI/ML products and the applications used on the administrative side of healthcare.  As a result, in this post I explore the information on clinicaltrials.gov because not only are those data focused on the truly health related, they are also forward-looking. The more recent clinical trials involve products still under investigation and not yet commercially available or even submitted to FDA.

In April, we shared with you our thoughts on what to consider before opening in or investing in a medical spa, thinking about corporate structure, scope of practice, licenses and registrations, referral restrictions, HIPAA and data privacy, and more. This month, we’re focusing on how states are beginning to regulate in this area, so owners and operators can hit the ground running in terms of compliance—or relax and breathe deep, knowing they are ahead of the plan. 

In March 2024, the state of Rhode Island introduced S 2870, the Medical Spas Safety Act, providing (within the definition of “cosmetic medical procedure”) that:

• The performance of cosmetic medical services is the practice of medicine and surgery; and
• A cosmetic medical service shall be performed by a qualified licensed or certified non-physician only if the services have been delegated by a medical director, supervising physician, supervising physician’s assistant (PA) or supervising advanced practice registered nurse (APRN) who is responsible for onsite supervision of services performed.

On May 25, 2024, Louisiana Governor Jeff Landry signed a bill, SB 276, into law that will classify medications commonly used in pregnancy and to treat stomach ulcers (mifepristone and misoprostol) as controlled substances. The provision classifying mifepristone and misoprostol as controlled substances was added in an amendment to SB 276 to make “coerced” abortions unlawful in the state. The new law is scheduled to take effect on October 1, 2024.

SB 276 represents the first attempt by a state to categorically restrict certain types of medication because they can be used for abortion. Many states have laws restricting the prescription and dispensing of drugs determined to be “abortion-inducing drugs,” but such drugs are only restricted if they are intended to be used to produce an abortion.[1] The laws restricting “abortion-inducing drugs” left open the ability of medical professionals to prescribe these drugs without restriction for non-abortion purposes, such as managing the effects of miscarriage or, in the case of misoprostol, preventing stomach ulcers. Now, due to these drugs’ association with abortion, they will be subject to new restrictions in the state and may impact the treatment of conditions unrelated to abortion.

State governments are increasingly entering the field of health care market oversight and enforcement. In what was once an issue typically left to the federal government, state governments are looking for ways to regulate market activity in the health care industry as a way to stem increases in health care costs. Late May brought yet another example of what the future may offer in this regard.

Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all natural” means—or to hear from experts on the matter.

On May 2, the Second Circuit held that the U.S. District Court for the Southern District of New York did not err in throwing out a class action suit against KIND, LLC based on the use of the term “all natural.”[1] The company, of course, markets, advertises, and distributes snack foods including that Caramel Almond & Sea Salt bar that got you through the afternoon.

The district court granted KIND’s motion for summary judgment in September 2022, holding that the plaintiffs (consumers) had failed to establish how a reasonable consumer would understand the term “all natural.”

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 ...

On May 17, 2024, Colorado Governor Jared Polis signed into law SB 24-205—concerning consumer protections in interactions with artificial intelligence systems—after the Senate passed the bill on May 3. The law adds a new part 17, “Artificial Intelligence,” to Article I, Title 6 of the Colorado Consumer Protection Act, to take effect on February 1, 2026. This makes Colorado “among the first in the country to attempt to regulate the burgeoning artificial intelligence industry on such a scale,” Polis said in a letter to the Colorado General Assembly.

The new law will ...

In this episode of the Diagnosing Health Care Podcast: Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation.

States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access.

What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys Jenny Nelson Carney, Lisa Pierce Reisz, and Erin Sutton dissect gender-affirming care: what it is, what it isn't, and what is at stake for everyone involved.

In our ongoing series of blog posts, we have been examining several key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous blog posts, we considered the importance of negotiating ...

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to determining the eligibility of product codes for the program.  Consistent with the goals outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter, the VMSR Program streamlines reporting of device malfunctions. The program began in 2018 when FDA issued an order granting an alternative reporting approach under 21 CFR 803.19.  The ...