CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor software agreements should be carefully reviewed for compliance and […]
For AI Regulation, Look to Data Laws, FDA Action
The legal and regulatory landscape for AI use in clinical labs evolves with the technology
- By Scott Wallask
- > From the Volume XXXII, No. 10 - July 14, 2025 Issue
- Tags: AI, anti kickback statute, artificial intelligence, Charles Dunham IV, data privacy laws, executive war college, FDA, final rule, Food and Drug Administration, G2 Intelligence, Gail Javitt, Greenberg Traurig, HIPAA, Hyman Phelps and McNamara, information blocking, lab intelligence, laboratory-developed test, ldt, machine learning, Medicaid, medical necessity, ML, stark law, the dark report, Today’s Clinical Lab
