The 21st Century Cures Act, Explained: What It Actually Means for Healthcare Builders

If you're building in healthcare, you've probably heard references to the "Cures Act" or "patient access APIs." But most explanations either drown you in legalese or skip the parts that actually matter for your product roadmap.

Here's what the 21st Century Cures Act actually means for healthcare builders in 2026 and why the regulatory landscape just shifted again.

The Core Mandate: Patients Own Their Data

The 21st Century Cures Act, passed in 2016 and enforced starting in 2020, established a simple but revolutionary principle: patients have the right to access their electronic health information without obstruction.

For decades, patient data lived inside hospital systems. Getting records meant faxes, phone calls, and weeks of waiting. The Cures Act changed that by requiring healthcare providers and EHR vendors to make patient data available through standardized APIs.

The key mechanism is ONC's certification requirements. EHR systems that want to participate in federal programs must offer FHIR-based APIs that allow patients (and applications they authorize) to access their health data electronically.

What "Information Blocking" Actually Means

The Act introduced the concept of "information blocking;" practices that interfere with the access, exchange, or use of electronic health information. Since April 2021, information blocking has been illegal, with enforcement handled by the Office of Inspector General.

For healthcare builders, this matters because:

• Providers cannot refuse to share data with patient-authorized applications

• EHR vendors must provide API access without unreasonable fees or barriers

• Health information networks cannot exclude participants without legitimate reasons

The practical effect: if you're building an app that helps patients access their own records, providers and EHRs are legally required to cooperate.

FHIR: The Technical Standard

The Cures Act doesn't specify exactly how data should be shared; it delegates that to ONC's certification criteria. The answer ONC chose was FHIR (Fast Healthcare Interoperability Resources), specifically the US Core Implementation Guide.

FHIR defines standardized formats for health data: patients, conditions, medications, allergies, lab results, and more. In theory, this means a single API integration could work across any certified EHR.

In practice, it's more complicated. Each EHR implements FHIR slightly differently. The resources they expose, the search parameters they support, and the authentication flows they require all vary. This is why integration remains challenging despite standardization.

HTI-5: The Regulatory Landscape Just Shifted

In December 2025, HHS released the HTI-5 proposed rule, one of the most significant updates to health IT policy in years. If you're building in this space, pay attention.

Three changes matter most for healthcare builders:

1. AI Gets Explicit Recognition

HTI-5 proposes updating the definitions of "access" and "use" to explicitly allow autonomous AI systems to retrieve and share health data. The rule states a goal of advancing "AI-enabled interoperability solutions through modernized standards and certification."

This isn't just bureaucratic language. It signals regulatory intent to support AI-powered healthcare applications that need programmatic access to patient data. If you're building AI health tools, this is validation that the regulatory environment is moving in your direction.

2. FHIR Becomes the Foundation

The rule proposes removing over 50% of existing certification criteria to "reset the Certification Program's scope to focus its future on standards-based APIs like FHIR." Legacy document-exchange requirements are being phased out in favor of modern API-first approaches.

3. Information Blocking Gets Teeth

HTI-5 revises several information blocking exceptions to "prevent those participating in health data exchanges from using technical or contractual loopholes to unfairly block data access." Enforcement is ramping up.

What This Means for Your Product

If you're building a healthcare application that needs patient data, the Cures Act and HTI-5 create both opportunity and obligation.

The opportunity: Patients can authorize your app to access their records from any certified EHR. The legal and regulatory framework supports patient-directed data sharing.

The complexity: While the law provides the right, the technical implementation still requires navigating multiple EHR systems, each with their own authentication flows, API quirks, and data formats.

This is exactly the problem we solve at Consolidate Health. We've spent over two years building integrations across Epic, Cerner, athena, eClinicalWorks, NextGen, and other major EHRs so you don't have to. Our API gives you clean, normalized patient data without needing to become a FHIR expert.

The regulatory tailwinds are real. The question is whether you want to spend your engineering resources on EHR integration or on building the features that differentiate your product.