Regulatory Issues


Realizing the Promise of Real-World Evidence

By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.


What’s Happening at the ONC

Supporting the adoption of health IT and the promotion of nationwide health information exchange to improve health care, here is what is happening at the ONC, including the HTI-1 final rule published on the Federal Register with an effective date of February 8, 2024, an HTI-1 webinar, & more.


The ONC HTI-1 Final Rule in a Nutshell

By Jim Tate – The ONC HIT-1 (Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing) Final Rule was published January 9th, 2024. Issued by the ONC, the Rule goes into effect February 8th, 2024.