Patient Safety and Health Care Quality of U.S. Laboratory Developed Tests (LDTs) in the AI/ML era of Precision Medicine Provisionally Accepted
- 1Consultant, United States
- 2Precision Policy Solutions, LLC, United States
- 3Georgetown Institute for Women, Peace, Security, Walsh School of Foreign Service, Georgetown University, United States
This policy brief summarizes current U.S. regulatory considerations for ensuring patient safety and health care quality of genetic/genomic test information for precision medicine in the era of artificial intelligence/machine learning (AI/ML). The critical role of innovative and efficient laboratory developed tests (LDTs) in providing accurate diagnostic genetic/genomic information for U.S. patient and family-centered healthcare decision-making is significant. However, many LDTs are not fully vetted for sufficient analytic and clinical validity via current FDA and CMS CLIA regulatory oversight pathways. The U.S. Centers for Disease Control and Prevention's Policy Analytical Framework Tool was used to identify the issue, perform a high-level policy analysis, and develop overview recommendations for a bipartisan healthcare policy reform strategy acceptable to diverse precision and systems medicine stakeholders.
Keywords: Laboratory developed tests (LDTs), FDA proposed rule, CMS Clinical Laboratory Improvement Act (CLIA), genomic tests, return of results (RoR), Regulatory Compliance, Patient Safety, health care quality
Received: 26 Mar 2024;
Accepted: 13 May 2024.
Copyright: © 2024 Kurnat-Thoma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Emma Kurnat-Thoma, Consultant, Bethesda, United States