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.

The Department of Health and Human Services (HHS) continues its push on health data interoperability with a proposed rule, HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information Technology.  Specifically, HHS proposes to modify the Health and Human Service Acquisition Regulation (HHSAR) to implement an HHS-wide policy to align requirements related to the procurement of health IT with standards and implementation specifications adopted by the Office of the National Coordinator for Health IT (ONC) or compliance with the voluntary ONC Health IT Certification Program.  This proposed rule was published on August 9, 2024, just 4 days after the ONC proposed HTI-2 rule was published in the Federal Register.

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.