Insights

Washington – August 17, 2023: The 2024 edition of The Best Lawyers in America® has recognized 47 firm lawyers as "Best Lawyers" and 41 lawyers as “Ones to Watch.”

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.

On Monday, May 6th, the Office of Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) published a final rule to implement Section 1557 of the Affordable Care Act[1] (“Section 1557”), which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities (the “Final Rule”). Here, we focus on the Final Rule’s application of nondiscrimination principles under Section 1557 to the use of “patient care decision support tools” in clinical care. This Final Rule responds to the President’s Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence and comments received regarding the proposed rule for Section 1557. Other key provisions of the Final Rule, including the restoration of protections for LGBTQI+ and pregnant individuals, are summarized in a companion alert.

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation.

Our health care landscape is rapidly transforming. As the health care space has become more digitized and more reliant on technology than ever before, artificial intelligence (AI), telehealth services, data analysis, and medical devices have become drivers of our health care system. Likewise, value-based care is becoming increasingly popular among delivery systems, leaving accountable care organizations (ACOs) to adhere to changing federal compliance requirements. The burden falls on health care entities to remain up-to-date on how care is evolving as federal and state compliance regulations and privacy concerns continue to develop.

Join us for this year’s Health Care Ounce of Prevention Seminar (HOOPS), a webinar series where our experienced practitioners will provide insight into a number of exciting topics. This year’s seminar will focus on topics such as Remote Health Care and Telemedicine, Mental Health Parity, Health Care Litigation, and Health Care Trends for 2022. 

Please join members of Crowell & Moring’s Health Care Group for a summary and analysis of the Centers for Medicare and Medicaid (CMS) interim final rule modifying the conditions of participation by requiring health care staff at Medicare and Medicaid facilities to be fully vaccinated. 

In this episode, hosts Payal Nanavati and Joe Records talk to Lidia Niecko-Najjum and John Brennan about the legal issues that investors, providers, and innovators should be prepared to navigate when considering offering Ketamine-assisted treatment, including the federal and state laws and regulations related to the practice of medicine, licensure, and many other issues.