| name | hipaa-interoperability |
| title | HIPAA Interoperability — Cures Act, ONC, and CMS Requirements |
| description | Addresses HIPAA privacy and security requirements for health data interoperability under the 21st Century Cures Act, ONC Health IT Certification Program, and CMS Interoperability and Patient Access Final Rule. Covers information blocking prohibitions, FHIR API patient access, TEFCA exchange purposes, and privacy safeguards for health information exchange. Keywords: interoperability, information blocking, FHIR, TEFCA, Cures Act, patient access API, health information exchange. |
| author | mukul975 |
| author_url | https://github.com/mukul975/Privacy-Data-Protection-Skills/tree/main/plugins/privacy-skills-complete/skills/hipaa-interoperability |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | healthcare |
| language | en |
HIPAA Interoperability — Cures Act, ONC, and CMS Requirements
Overview
The 21st Century Cures Act (Public Law 114-255, 2016) fundamentally changed the interoperability landscape by prohibiting information blocking and mandating standardized API-based patient access. The ONC Health IT Certification Program (45 CFR Part 170) and the CMS Interoperability and Patient Access Final Rule (CMS-9115-F, 85 FR 25510, May 1, 2020) together require health IT developers, healthcare providers, health information exchanges (HIEs), and health information networks (HINs) to support seamless data exchange while maintaining HIPAA privacy and security protections. The Trusted Exchange Framework and Common Agreement (TEFCA), launched operationally in December 2023, establishes a nationwide framework for health information exchange with defined exchange purposes and privacy requirements.
Regulatory Framework
21st Century Cures Act — Information Blocking
- Section 4004: Defines information blocking as a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI)
- Actors covered: Health IT developers of certified health IT, HIEs, HINs, and healthcare providers
- EHI definition: As of October 6, 2022, EHI is the electronic protected health information (ePHI) in a designated record set as defined under HIPAA (45 CFR §171.102), plus any other electronic health information identified by the Secretary
Information Blocking Exceptions (45 CFR Part 171)
| Exception | Category | Description |
|---|
| Preventing Harm (§171.201) | Not fulfilling requests | Practice is reasonable and necessary to prevent harm to a patient or another person |
| Privacy (§171.202) | Not fulfilling requests | Practice is required by or consistent with HIPAA Privacy Rule obligations |
| Security (§171.203) | Not fulfilling requests | Practice is directly related to safeguarding the confidentiality, integrity, or availability of EHI |
| Infeasibility (§171.204) | Not fulfilling requests | Fulfilling the request is technically infeasible |
| Health IT Performance (§171.205) | Procedures | Practice is for reasonable maintenance or improvements to health IT |
| Content and Manner (§171.301) | Procedures | Actor fulfills a request in an alternative manner or with alternative content |
