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Quick Answer

What Is 21st Century Cures Act?

The 21st Century Cures Act is a 2016 federal law that, among many other provisions, established information blocking prohibitions and patient access requirements for electronic health information, enforced under the ONC Cures Act Final Rule.

  • Practices should configure EHRs to release results to the patient portal at the same time they release to the ordering provider unless one of the exceptions applies.
  • Document the basis for any delayed release.
Regulation

21st Century Cures Act

Also known as: Cures Act; Cures Act of 2016

The 21st Century Cures Act is a 2016 federal law that, among many other provisions, established information blocking prohibitions and patient access requirements for electronic health information, enforced under the ONC Cures Act Final Rule.

Definition

Signed into law in December 2016, Cures Act covers FDA drug development, NIH research, and mental health, but its most significant impact on medical billing and practice operations is the Information Blocking Rule (45 CFR Part 171, effective April 5, 2021) prohibiting health care providers, health IT developers, and HIEs/HINs from interfering with the access, exchange, or use of electronic health information (EHI). It also mandated patient access to EHI via standards-based APIs (USCDI v1, expanded to v3+). Penalties apply to health IT developers and HIEs/HINs (up to $1M per violation) under HHS OIG; provider 'appropriate disincentives' include Medicare program penalties.

Example

A practice that refuses to release imaging reports to a patient's app via the FHIR API, or delays releasing test results to the portal until the provider 'reviews' them, may violate the Information Blocking Rule unless an exception applies (e.g., preventing harm, protecting privacy, infeasibility, or content/manner preferences).

Common Misconceptions

The Information Blocking Rule does not override HIPAA — it is layered on top. HIPAA permits patient access; Cures Act requires it without unreasonable delay. The eight regulatory exceptions (Preventing Harm, Privacy, Security, Infeasibility, Health IT Performance, Content & Manner, Fees, and Licensing) define the only legal reasons to limit access.

Practical Application

Practices should configure EHRs to release results to the patient portal at the same time they release to the ordering provider unless one of the exceptions applies. Document the basis for any delayed release.

Where This Applies on MedPrecision

№ 99 The Closing Argument

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