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
Fees (§171.302)	Procedures	Fees charged are reasonable and based on objective, verifiable criteria
Licensing (§171.303)	Procedures	Licensing terms are reasonable and non-discriminatory

CMS Interoperability and Patient Access Final Rule

• Patient Access API (§431.60): CMS-regulated payers (Medicaid, CHIP, QHP issuers on FFE) must implement a FHIR R4-based Patient Access API allowing patients to access claims, encounter, and clinical data
• Provider Directory API (§431.70): Payers must implement a publicly accessible FHIR-based provider directory
• Payer-to-Payer Data Exchange (CMS-0057-F, effective January 1, 2026): Payers must exchange patient data at the patient's request when they switch plans
• Prior Authorization API (CMS-0057-F): Payers must implement a FHIR-based prior authorization API

TEFCA Exchange Purposes

Exchange Purpose	Description	HIPAA Basis
Treatment	Direct patient care	§164.506(c)(2) — TPO
Payment	Claims, eligibility, coordination of benefits	§164.506(c)(3) — TPO
Healthcare Operations	Quality assessment, care coordination	§164.506(c)(5) — TPO
Public Health	Reporting to public health authorities	§164.512(b)
Benefits Determination	Health plan coverage decisions	§164.506(c)(3)
Individual Access	Patient right of access	§164.524

HIPAA Privacy Safeguards for Interoperability

Patient Access via FHIR API

1. Identity verification: Verify patient identity using multi-factor authentication before granting API access (aligned with NIST IAL2/AAL2)
2. Scope of access: HIPAA right of access (§164.524) — entire designated record set except psychotherapy notes, information compiled for legal proceedings, and certain lab results under CLIA
3. Third-party app authorization: Patient may direct data to third-party apps via SMART on FHIR; once data is shared with a non-covered entity app, HIPAA protections may no longer apply — disclosure notice required
4. Minimum necessary: Does NOT apply to individual access requests (§164.502(b)(2)(v)) or treatment disclosures

HIE/HIN Privacy Requirements

1. Maintain BAAs with all participating providers per §164.502(e)
2. Implement role-based access tied to exchange purpose
3. Apply consent management per state law requirements (particularly for 42 CFR Part 2 substance abuse records and state-specific sensitive categories)
4. Maintain accounting of disclosures per §164.528

Security Requirements for Interoperable Systems

Requirement	Regulation	Implementation
Encryption in transit	§164.312(e)(1)	TLS 1.2+ for all FHIR API and HIE connections
Access controls	§164.312(a)(1)	OAuth 2.0 / SMART on FHIR authorization
Audit controls	§164.312(b)	Log all API requests, queries, and data exchanges with timestamps and actor identity
Integrity controls	§164.312(c)(1)	Digital signatures on exchange payloads; FHIR resource versioning
Authentication	§164.312(d)	Unique user identification for all API consumers; system-level certificates for point-to-point

Enforcement

• Information blocking penalties: Health IT developers, HIEs, and HINs face civil monetary penalties up to $1 million per violation under ONC (final rule effective September 1, 2023). Healthcare providers face appropriate disincentives through CMS (final rule pending).
• HIPAA penalties: Standard HIPAA enforcement under OCR applies to all privacy and security violations in the interoperability context.

Integration Points

• hipaa-privacy-rule: Interoperability must comply with all Privacy Rule requirements for uses and disclosures
• hipaa-security-rule: Technical safeguards for API and exchange security
• hipaa-minimum-necessary: Minimum necessary standard applies to most interoperability disclosures (except individual access and treatment)
• hipaa-baa-management: BAAs required for all HIE/HIN participants and health IT vendors accessing PHI
• hipaa-breach-notification: Breach notification obligations extend to interoperability-related incidents