Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
U.S. Senator Bill Cassidy, M.D., the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, has criticized the Food and Drug Administration's (FDA) policy regarding clinical decision support (CDS) software. Cassidy expressed concern over the FDA's decision to expand its oversight over CDS software, which could limit access to crucial technology used to enhance the delivery of healthcare services to Americans.
In a letter addressed to FDA Commissioner Califf, Dr. Cassidy highlighted the importance of CDS software in enabling healthcare providers to analyze patient information effectively and make personalized treatment decisions. He emphasized that CDS software plays a significant role in improving the quality of care and reducing the risks associated with medical procedures.
Dr. Cassidy pointed out that Congress had specifically excluded CDS software from being classified as a medical device in the 21st Century Cures Act. However, the FDA's updated policy now classifies CDS software as a medical device, a move that contradicts congressional intent and imposes unnecessary regulatory burdens on software developers, particularly small healthcare practices.
The Senator raised concerns about the lack of stakeholder input in the FDA's decision-making process, noting that stakeholders were not given the opportunity to provide feedback on the potential negative impacts of the policy change. Dr. Cassidy urged the FDA to explain why it disregarded Congress' directive and expanded its regulatory authority over CDS software without valid safety concerns justifying such action.
In his letter, Dr. Cassidy emphasized, "FDA’s guidance not only runs contrary to an explicit congressional directive but may jeopardize access to advanced tools that improve patient care."
The Senator also posed several questions to Commissioner Califf, seeking clarification on various aspects of the FDA's decision-making process and its implications for CDS software developers and healthcare providers. Dr. Cassidy called for transparency and accountability in the FDA's approach to regulating CDS software to ensure that access to innovative medical technology is not hindered.
The full extent of the impact of the FDA's policy on CDS software and its implications for healthcare delivery remains a subject of ongoing discussion and scrutiny within the Senate HELP Committee and the broader healthcare community.
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