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.

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 Monday, July 15, New Jersey Attorney General Matthew J. Platkin and the New Jersey Division of Consumer Affairs released proposed rules (the “Proposed Rules”) which require certain New Jersey healthcare providers (i.e., physician assistants, physicians, nurses, and midwives) who provide perinatal treatment and care to pregnant persons to undergo bias training. The training is designed to root out prejudices and stereotypes that may negatively impact the quality of care delivered by these providers to patients during pregnancy, labor, delivery, postpartum, and neonatal periods.  The Proposed Rules were promulgated in an effort “to address pronounced racial disparities in maternal and infant health outcomes in New Jersey.”

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.

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.