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 July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.

On July 4, President Trump signed into law the “One Big Beautiful Bill Act” (“the Act”), or H.R. 1, which makes significant changes to federal healthcare programs, including Medicaid, Medicare, and Health Insurance Marketplaces. As proposed in previous versions of the Act, the Act includes cuts to the Medicaid program and imposes new requirements on beneficiaries, states, and healthcare providers.

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. This update outlines major health policy developments that occurred at the end of 2024 through the first three months of 2025.

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.