* Authors Note * This blog is being actively updated as new insights are gleaned from the new proposed rule relating to enforcement.

In the landscape of healthcare regulations, the 21st Century Cures Act (or simply the Cures Act) stands out as a significant piece of legislation that aims to improve interoperability, patient access to health information, and digital health innovation.

Understanding the key aspects of the Cures Act and ensuring compliance are crucial for healthcare providers, digital health companies, and payers.

Let’s explore the key points surrounding the Cures Act, including its scope, impact, key dates, the importance of readiness assessment, and how APIs and FHIR integration are accelerating the transition.


What is the Cures Act?

The 21st Century Cures Act, signed into law in December 2016, is a comprehensive healthcare legislation designed to speed up medical product development and provide patients with faster access to innovative treatments.

The Cures Act was enacted to address the problem of information blocking and ensure patients' seamless and secure access to their healthcare records. 

Information blocking has been a persistent issue, as some health entities unnecessarily restrict or complicate access to electronic health information (EHI), hindering nationwide interoperability efforts. 

By combating information blocking, the Cures Act aims to promote data sharing, enhance care coordination, and facilitate interoperability across the healthcare ecosystem.


Who does the Cures Act impact?

The Cures Act impacts various stakeholders in the healthcare ecosystem. Healthcare providers, including hospitals, physicians, and clinics, are affected by the requirements for electronic health information exchange and patient access to health data.

Digital health companies, such as electronic health record (EHR) vendors, health app developers, as well as the health information networks (HINs) and health information exchanges (HIEs) must comply with the Cures Act's provisions to ensure interoperability and the seamless exchange of health information.

Payers, including health insurance companies and government programs, are also impacted by the Cures Act's requirements for data sharing and patient access.


What are the key dates and enforcement?

The Cures Act establishes specific deadlines for compliance. Effective April 5, 2021, healthcare providers and health IT developers were required to comply with the Cures Act's information blocking provisions. 

By October 6, 2022, payers must implement and maintain secure, standards-based application programming interfaces (APIs) to allow patients to access their health information. It is crucial for organizations to be aware of these key dates and ensure compliance within the specified timelines.

After October 6, any patient data included in Designated Record Sets (DRS) will be subject to the information blocking regulations. However, enforcement by the HHS Office of Inspector General (OIG) will not include penalties and disincentives until rulemaking is finalized.

This means that during this interim period, while the regulations are in effect, enforcement actions may not result in immediate penalties or disincentives. However, it's crucial for healthcare organizations and providers to comply with the information blocking regulations to ensure the seamless exchange of patient data and avoid potential penalties once rulemaking is completed.

On June 27, 2023, the OIG issued its proposed final rule regarding information blocking penalties. The rule establishes penalties for information blocking as mandated by the 21st Century Cures Act. 

If OIG determines that an individual or entity has engaged in information blocking, they may face penalties of up to $1 million per violation

It's important to note that the final rule does not introduce new information blocking requirements but rather incorporates existing regulations from the Office of the National Coordinator for Health Information Technology (ONC) as the foundation for enforcing penalties related to information blocking.

By December 31, 2023, vendors must have certified and made available the EHI Export capability, according to the timeline of the Cures Act. 


Why is it important to assess your readiness?

Assessing readiness for Cures Act compliance is essential to avoid penalties, maintain patient trust, and embrace the benefits of interoperability.

Debi Primaeu headshotDuring a Cures Act webinar last year, Debi Primeau, President of Primeau Consulting Group commented: “the smaller facilities are really struggling to meet some of these interoperability requirements as they lack the necessary resources or expertise.”

Consequently, organizations need to evaluate their current infrastructure, policies, and procedures to identify any gaps or areas that require improvement.

This is especially important considering the prevalence of claims related to information blocking. According to the statistics from ONC, there have been a significant number of claims related to information blocking. 



Source: Office of the National Coordinator for Health Information Technology. 'Information Blocking Claims: By the Numbers,' Health IT Quick-Stat #59 https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers. May 2023.


This information can further support organizations in understanding the importance of complying with the Cures Act and actively working towards interoperability.

Conducting a readiness assessment is crucial for organizations to develop a strategic plan, allocate resources, and implement necessary changes effectively in order to meet the requirements of the 21st Century Cures Act.

checklist-thmbCompliance with the Cures Act necessitates healthcare providers to cultivate a culture of collaboration within their organizations. To assist in achieving interoperability and preventing information blocking, the Cures Act Provider Checklist and Information Blocking Tools of CompliancePro Solutions serves as comprehensive guides. However, it's important to keep in mind that regulations may vary, so it is advisable to consult with the organization's compliance and legal departments for specific details that are relevant to the organization's unique circumstances.


How APIs and FHIR integration are accelerating the transition?

Application Programming Interfaces (APIs) and the Fast Healthcare Interoperability Resources (FHIR) standard play a pivotal role in achieving interoperability and compliance with the Cures Act. APIs enable the secure and standardized exchange of health data between different systems and applications, facilitating seamless information flow.

FHIR, built on modern web standards, provides a flexible framework for exchanging healthcare information electronically. Leveraging APIs and FHIR integration helps organizations accelerate the transition toward interoperability, improve patient access to health data, and comply with the Cures Act's provisions.


Embrace compliance and thrive in the era of healthcare innovation with CompliancePro Solutions

The 21st Century Cures Act has ushered in a new era of healthcare interoperability, patient access, and digital health innovation. Healthcare providers, digital health companies, and payers must navigate its requirements to ensure compliance and stay ahead in the evolving healthcare landscape.

By understanding the scope and impact of the Cures Act, being aware of key dates, assessing readiness, and leveraging APIs and FHIR integration, organizations can successfully transition toward seamless health data exchange, enhanced patient engagement, and improved healthcare outcomes.

Harsh Singh, GM Healthcare of GenzeonHarsh Singh, GM of Healthcare at Genzeon noted, “Let's not seek out the concept of minimum viable compliance, but really, truly go get the business value that's out there.”


Ready to navigate the complexities of the Cures Act and ensure compliance with ease?

CompliancePro Solutions is your trusted partner on this journey. Our team of experts is well-versed in healthcare regulations and can provide tailored solutions to meet your organization's specific needs.

Contact us today and let us guide you towards seamless interoperability, enhanced patient access, and comprehensive compliance. Together, we can thrive in the era of healthcare innovation.


Kelly McLendon