Murphy Letter to FDA Commissioner on Artificial Intelligence Regulation
Washington, D.C. — Today, Congressman Greg Murphy, M.D. sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. regarding regulatory frameworks for artificial intelligence in health care.
"Artificial intelligence is set to transform health care dramatically, and its emergence in the field of medicine is happening rapidly," said Congressman Greg Murphy, M.D. "As a physician of over 30 years, I am thrilled by the potential of AI to improve the efficiency and quality of patient care in more ways than we could have imagined just ten years ago. We must be judicious in cultivating a regulatory environment that both protects consumers and encourages innovation."
"The U.S. Food and Drug Administration carries great responsibility for approving new technologies and devices. The agency must be prepared for explosive growth in artificial intelligence in the health care industry which is set to grow tenfold by 2030. Collaborating with policymakers, federal agencies, and industry stakeholders will yield tremendous benefits for patients, physicians and the economy, but it is paramount we have consensus and guardrails laid out first."
Background
Artificial intelligence in health care reached a market value of roughly $11 billion in 2021 and is estimated to grow at a compounded annual growth rate of 37% to $188 billion in 2030. Additionally, the technology could eliminate up to $360 billion in health care spending in the United States alone.
In late 2023, the European Parliament and Council reached a provisional agreement on the proposal of the Artificial Intelligence Act. Congress has yet to consider comprehensive legislation to establish artificial intelligence regulatory framework.
The FDA is responsible for machine learning and AI-enabled device approval. To date, it has already cleared over 500 such devices utilizing current 510(k) clearance/premarket approval (PMA) frameworks.
Read the letter here
Read Politico's coverage here