The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers, plans, electronic health record (EHR) vendors and health technology companies.

Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.Continue Reading Healthcare Policy Developments to Watch in 2024

On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).

Background

DCTs include both fully decentralized trials – where all trial activities take place at locations other than trial