Insights

Washington – November 28, 2023: In recent years, rapid developments in digital health technologies has made it easier to collect, transfer, and store electronic data and has expanded the methods in which clinical trial sponsors may conduct research investigations, including through decentralized and hybrid clinical trials.

On January 17, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Interoperability and Prior Authorization Final Rule (Final Rule), which establishes requirements applicable to certain impacted payers which are intended to improve the electronic exchange of health information and prior authorization processes. The application programming interface (API) requirements will take effect January 1, 2027, while the operational provisions will take effect January 1, 2026. CMS has issued a helpful slide deck summarizing the Final Rule.

On December 13, 2023, the U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. The effective date of the HTI-1 Final Rule is updated and is now March 11, 2024.

On November 1, 2023, the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” proposed rule (Proposed Rule). Comments are due by January 2, 2024.

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity.