Insights

Washington – August 15, 2024: The 2025 edition of The Best Lawyers in America® has recognized 42 Crowell & Moring lawyers as "Best Lawyers" and 29 lawyers as “Ones to Watch.”

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.”

Washington – August 18, 2022: The 2023 edition of The Best Lawyers in America® has recognized 54 firm lawyers as "Best Lawyers" and 32 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 April 26, 2024, the Federal Trade Commission (“FTC”) announced a final rule (“Final Rule”) modifying the Health Breach Notification Rule (“HBNR”). The Final Rule, which largely finalizes changes proposed in a Notice of Proposed Rulemaking published last year (“2023 NPRM”), broadens the scope of entities subject to the HBNR, including many mobile health applications (“apps”) and similar technologies, and clarifies that breaches subject to the HBNR include not only cybersecurity intrusions but also unauthorized disclosures, even those that are voluntary. The Final Rule will take effect 60 days after its publication in the Federal Register.

On April 26, 2024, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) published a final rule entitled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (the “Final Rule”) to address new privacy issues that have resulted in the wake of the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization (“Dobbs”). The Final Rule aims to strengthen reproductive health care privacy under the Health Insurance Portability and Accountability Act and its implementing regulations (collectively, “HIPAA”) by prohibiting covered entities and business associates (collectively, “regulated entities”) from using or disclosing protected health information (“PHI”) to investigate or impose liability on any person for the “mere act” of seeking, obtaining, providing, or facilitating lawful reproductive health care, or to identify any person for such purposes.

Though general rules established by the Health Insurance Portability and Accountability Act and its implementing regulations (collectively known as HIPAA) are relatively well known, fewer people are familiar with some finer details, such as the fact that HIPAA is somewhat limited in scope. It’s also a common misconception that HIPAA applies to all or most individually identifiable health information.

The All-Hands Meeting is a paid admission event and advance registration is essential. If you have any questions, please contact Wendy Smith.

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.