What is the Origin of US Health Data Law?

The cornerstone of this legal structure is HIPAA, enacted in 1996, which was a response to the increasing digitization of medical records and the need for national standards for health data protection. Subsequent laws and state regulations have attempted to address the regulatory gaps created by the rapid growth of non-clinical consumer health technology.

What is the Mechanism of US Health Data Law?

The law operates through a system of defined obligations and enforcement mechanisms, mandating technical and administrative safeguards for PHI. HIPAA establishes the Privacy Rule and the Security Rule, which dictate permissible uses and required security measures. For non-HIPAA-covered wellness data, the mechanism of protection often defaults to consumer protection laws and the Federal Trade Commission's authority over unfair and deceptive practices.

US Health Data Law ∞ Area

US Health Data Law

Meaning

US Health Data Law is the complex, fragmented body of federal and state statutes, regulations, and common law principles that govern the collection, use, and disclosure of personal health information (PHI) within the United States. The primary federal law is the Health Insurance Portability and Accountability Act (HIPAA), which establishes standards for covered entities like hospitals and health plans. However, a significant portion of wellness technology data falls outside of HIPAA’s direct purview, creating a patchwork of regulatory oversight that varies by state and data type.