Insights

Washington – May 4, 2023: Crowell Health Solutions has launched Trends in Transformation, a new blog that will provide the latest developments in digital health, value-based care, and health equity. The blog offers insights on policy developments and innovative trends to help health care companies keep track of developments and understand fast-moving policy activities to help them achieve their strategic goals in a dynamic health care market.

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 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.