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Across the healthcare industry, providers are increasingly relying on AI-assisted billing tools to automate medical coding, prior authorization workflows, and the submission of claims to Medicare, Medicaid and other federal payors. The efficiency gains can be substantial, as can the heightened False Claims Act (FCA) exposure these systems can create. As AI continues to develop…

On June 4, 2026, Reps. Jay Obernolte and Lori Trahan released a discussion draft of the Great American Artificial Intelligence Act. The proposal has generated significant attention, but many organizations may be overestimating its practical significance for day-to-day operations. The bill is directed primarily at developers of “frontier” AI models, so its requirements will not…

On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles intended to steer the safe and responsible use of AI across the product lifecycle. While not formal industry guidance, the…

In response to increased cybersecurity threats and significant regulatory enforcement actions, on Dec. 27, 2024, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking seeking to enhance cybersecurity protections under the Security Rule implemented pursuant to the Health Insurance Portability and Accountability Act of 1996. While the proposed rule is…

When dealing with a cybersecurity incident response, nonprofit healthcare systems have different constituents to consider. Patients and staff who risk having personal information exposed or procedures postponed are the most important, but bondholders of a system’s debt also will want to know about the incident. The Securities and Exchange Commission recently updated its Compliance and…

Applicable Provider Types: All

Is Your Entity in Compliance?

The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009 (HIPAA) requires Covered Entities (CEs), Business Associates (BAs) and Business Associate subcontractors to enter into written agreements governing each party’s rights and…

Applicable Provider Types: All

Is Your Entity in Compliance?

The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009 (HIPAA) requires covered entities and their business associates to implement policies and procedures to prevent, detect, contain and correct security violations. Under…

On Feb. 6, 2024, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced a $4.75 million settlement with New York non-profit health system Montefiore Medical Center over alleged malicious insider conduct that caused potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. This settlement follows two other recent investigations that led to OCR’s first-ever settlements stemming from ransomware and phishing attacks. …
Continue Reading OCR Continues Holding Healthcare Entities Accountable for Protected Health Information Breaches

On Nov. 30, the Illinois Supreme Court, in Mosby v. The Ingalls Memorial Hospital et al., held that certain healthcare providers’ biometric data, used for healthcare operational purposes under the Health Insurance Portability and Accountability Act, is not protected under the Illinois Biometric Information Privacy Act. Read on for details about this development and…