21st Century Cures Act

The 21st Century Cures Act is federal legislation enacted in December 2016 that mandated significant changes in medical research funding, drug approval timelines, mental health system reform, and — most consequentially for healthcare technology — electronic health information interoperability. The Cures Act's interoperability provisions are what enable modern patient-facing health records, third-party FHIR-based apps, and the price transparency ecosystem that TruePrice and similar tools depend on.

The interoperability rule (finalized by the Office of the National Coordinator for Health IT and CMS in 2020) requires certified EHR vendors to expose patient health information through standardized FHIR APIs, prohibits information blocking by hospitals and providers, and gives patients the right to access their electronic health information at no cost through third-party applications of their choice. This is what allows a member to connect their Epic-based hospital chart to a personal health app, or lets a self-funded employer's care-navigation vendor pull FHIR-based claims data to inform recommendations. Enforcement of the information-blocking provisions has ramped up since 2023, with the HHS Office of Inspector General authorized to impose civil monetary penalties on developers and providers who obstruct information flow. The Cures Act also created the Regenerative Medicine Advanced Therapy designation at the FDA, accelerating approval pathways for cell and gene therapies — which is why we've seen such a burst of high-cost gene-therapy approvals in the past few years.

The takeaway: the Cures Act is why patients now have real portability of their medical records and why third-party FHIR-based tools exist at all. If a hospital or EHR vendor blocks your access to your own records or to a properly authorized third-party app, that's a violation of federal information-blocking rules — reportable to HHS.