Health Law Advisor

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At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to determining the eligibility of product codes for the program.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 ...

A major update in cannabis law was announced by the Drug Enforcement Administration (DEA) and Attorney General (AG) this past Tuesday, April 30, 2024 regarding their intent to ease restrictions on cannabis. The DEA plans to recommend that cannabis be rescheduled as a Schedule III substance under the Controlled Substances Act (CSA). This announcement follows mounting federal support over the course of the last few years to reschedule cannabis, which has been listed as a Schedule I substance since 1970.

Although it is possible to change the schedule status of a substance per the CSA via ...

Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers and providers. Our concern is that the final rule,  based on section 1557 of the Affordable Care Act, creates a double standard where more sophisticated organizations are held to a higher level of compliance.  Set to become effective 300 days after publication, health care providers and payers will have a lot of work to do in that time.

In this post, we will lay ...

Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices.

Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as to the provisions the Agency would choose to finalize.

Now, with the wait finally over, EBG joins the rest of industry in our review of the Final Rule, and we will be preparing a more in-depth analysis of the Final Rule and its potential impact on laboratories and the nationwide healthcare system. For now, here are important preliminary takeaways from the Final Rule.

Negative online reviews are a concern for many businesses—but they present a unique challenge for healthcare providers, who are restricted by federal and state privacy laws in how to respond. Is the answer to have patients sign a form agreeing in advance of treatment not to make or post negative comments? According to a recent decision by a federal judge in Washington State, the approach tried by one plastic and cosmetic surgery practice runs afoul of a little-known federal law called the Consumer Review Fairness Act (“CRFA”). The case presents a cautionary tale for doctors and ...

Late last year, the case Shannon MacDonald, MD, et al v. Otto Sabando was filed in the U.S. District Court for the District of New Jersey. The plaintiffs claimed that New Jersey’s licensure restrictions on the use of telehealth were unconstitutional as they infringe on basic civil rights everyone has and therefore should be struck down. However, the defendants argued that the licensure of physicians is within the jurisdiction of states to decide and regulate such that New Jersey’s licensure laws do not violate the U.S. Constitution. EBG discussed the initial arguments in this ...

Aesthetic services and the medical spa industry have continued to grow over the past few years as clients continue to demand the availability of such cosmetic services. In response, many providers and investors in the health care industry are seeing opportunities to open or invest in a medical spa.

Before opening or investing in a medical spa there are several key elements to be considered:

Corporate Structure

One of the first elements to consider when opening a medical spa is the corporate structure and ownership of the medical spa. Many jurisdictions have “Corporate Practice of ...