New State Laws Requiring Notice of Health Care Transactions Will Uniquely Impact Distressed Transactions
Health Law Advisor
by Ryan K. Cochran
1w ago
Distressed businesses are often compared to melting ice cubes or an aircraft in rapid descent. The goal for a distressed business is to get to a transaction before the ice cube melts or the aircraft and ground meet at an unsurvivable speed. New state laws modeled after the federal Hart-Scott-Rodino (HSR) Act now require, or will soon require, parties to provide notice of certain health care transactions to state regulators creating additional hurdles for distressed healthcare businesses ..read more
Visit website
Unpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials
Health Law Advisor
by Bradley Merrill Thompson
1w ago
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 A ..read more
Visit website
Louisiana Becomes First State to Classify Mifepristone and Misoprostol as Controlled Substances
Health Law Advisor
by Erin Sutton
1w ago
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 state ..read more
Visit website
Interested in Opening a Medical Spa? (Part II): Here’s (More) That You Need to Know
Health Law Advisor
by John W. Eriksen, Nivedita B. Patel, Ashley A. Creech
1w ago
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 ..read more
Visit website
California’s Office of Health Care Affordability Kicks into Action: Are Organizations Ready for Increased Scrutiny in Health Care Transactions?
Health Law Advisor
by Paul R. DeMuro, Ph.D., Jeremy A. Avila
1w ago
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 ..read more
Visit website
Nuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading
Health Law Advisor
by Jack Wenik, Theodora McCormick, Robert Lufrano, Zachary (Zach) Taylor
2w ago
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 b ..read more
Visit website
HHS Publishes Final Rule to Support Reproductive Health Care Privacy
Health Law Advisor
by Karen Mandelbaum, Allen R. Killworth, Lisa Pierce Reisz, Nivedita B. Patel, Laura J. DePonio
3w ago
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  ..read more
Visit website
Colorado SB 24-205: On the Verge of Addressing AI Risk with Sweeping Consumer Protection Law
Health Law Advisor
by Adam S. Forman, Nathaniel M. Glasser, Alaap B. Shah
3w ago
On May 8, 2024, Colorado’s House of Representatives passed SB 24-205—concerning consumer protections in interactions with artificial intelligence systems—after the Senate passed the bill on May 3. If enacted, the law would add a new part 17, “Artificial Intelligence,” to Article I, Title 6 of the Colorado Consumer Protection Act. The legislation now awaits the signature of Governor Jared Polis, who has a June 7, 2024 deadline to sign or veto the legislation or to let it become law without his signature. Colorado’s 2024 Regular Session also ended on May 8. If Polis allows  ..read more
Visit website
Podcast: Unveiling Gender-Affirming Care: Why It Matters and What’s at Stake – Diagnosing Health Care
Health Law Advisor
by
3w ago
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 ev ..read more
Visit website
Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases
Health Law Advisor
by Allison S. Zangrilli, Zlata Fayer
1M ago
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  ..read more
Visit website

Follow Health Law Advisor on FeedSpot

Continue with Google
Continue with Apple
OR