The Cures Act has been a transformative milestone in healthcare, establishing the foundation for modern interoperability, data transparency, and patient empowerment. While the healthcare ecosystem continues to evolve with new mandates like HTI-1, the principles introduced by the Cures Act have remained central to driving advancements in health IT and care delivery. Before the Cure’s Act implementation, healthcare systems were hampered by fragmented, siloed operations and inefficient data-sharing practices, leading to higher costs, delayed treatments, and limited patient engagement.
Recognizing the need for urgent reform, the Cures Act was passed in December 2016 introducing measures to enhance interoperability, prevent information blocking, and give patients greater control over their health data. Since then, these initiatives have transformed the healthcare landscape, fostering more connected systems and empowering stakeholders across the industry. As a foundational framework, the Cures Act serves as a key reference point for providers, payers, and health IT developers navigating evolving requirements. With many of ONC’s regulatory updates building upon the Cures Act mandates, the Act remains a critical guide for understanding industry direction and anticipating future compliance requirements.
To offer insight, we’ve outlined the core mandates and principles of the Cures Act, highlighting its regulatory impact on the health IT sector and its role in shaping current critical mandates like HTI-1.
Key Mandates of the ONC Cures Act
Prohibition Against Information Blocking
A cornerstone of the Cures Act is the prohibition against information blocking. Providers, health IT developers, and health information exchanges (HIEs) must ensure they do not unreasonably interfere with the access, exchange, or use of electronic health information (EHI). Exceptions to this rule are narrowly defined, focusing on instances where data sharing poses genuine risks, such as security threats or privacy concerns.
This mandate significantly reshaped the medical sector by eliminating artificial barriers to critical health data. Patients now have greater access to their information, enabling them to make informed decisions about their care and fostering trust in the healthcare system. For providers and developers, compliance has required changes to legacy systems, implementation of modernized data-sharing protocols, and ongoing education to ensure adherence. By prioritizing transparency and collaboration, the prohibition against information blocking has catalyzed a shift toward more patient-centric care and streamlined operations across the healthcare sector.
Standardization of APIs Built on FHIR
The Cures Act mandated the use of standardized APIs, particularly those based on Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®), to promote secure and efficient data exchange. FHIR APIs provide a consistent framework for sharing health data, ensuring that diverse systems and applications can communicate seamlessly. These APIs have powered advancements such as patient portals, telehealth platforms, and mobile health apps, enabling patients and providers to access and exchange health data with unprecedented ease.
For providers, the adoption of FHIR APIs has improved care coordination by enabling real-time data sharing across disparate systems, reducing duplication of tests and improving treatment outcomes. For health IT developers, FHIR represents a market opportunity to innovate and deliver solutions that meet the growing demand for interoperability. As a result, the Cure’s Act has empowered FHIR to become a foundational pillar for interoperability, fostering a more connected and efficient healthcare system.
Enhanced Patient Access Rights
Another advent of the Cures Act was enhanced patient access rights, which helped provide patients legal rights to access their complete EHI in a digital format, fostering greater transparency and empowerment. This mandate has required medical organizations to overhaul legacy systems and workflows to ensure patients can securely and seamlessly access their health data. Importantly, this access extends to third-party applications chosen by patients, giving them the freedom to engage with their information in ways that best suit their needs. However, organizations have also faced challenges in ensuring compliance, particularly around data security and privacy. Moreover, balancing ease of access with robust safeguards has become essential to maintaining both compliance and patient confidence since the Cures Act introduced enhanced patient access rights.
Certification Requirements for Health IT Developers
The Cures Act enforced stricter criteria for electronic health record (EHR) certification, raising the bar for functionality, usability, and interoperability. To meet these requirements, developers had to demonstrate compliance with key standards, including FHIR-based APIs, secure data-sharing protocols, and accessibility guidelines. This certification process not only drove optimization of health IT solutions but also ensured seamless integration across the healthcare ecosystem.
As a result, certified health IT developers can now stand out to providers seeking reliable, interoperable solutions. Certification validates a commitment to innovation, security, and user-centric design while enhancing a developer’s reputation in the marketplace. However, achieving certification demands significant investment in technical development, rigorous testing, and adherence to evolving standards. Organizations like Drummond provide essential support, offering the expertise and tools needed to navigate the certification process efficiently.
Using the Cures Act as a Roadmap for HTI-1 Compliance Success
Successfully navigating HTI-1 requirements demands a strategic understanding of how these mandates build on the foundational goals of the Cures Act. This is because the Cures Act laid the groundwork for advancing interoperability, information-sharing, and patient access, while HTI-1 refined and expanded these principles to address emerging industry challenges and technological advancements.
By treating HTI-1 as a natural extension of the Cures Act, stakeholders can navigate compliance with a clear roadmap that links foundational principles to evolving requirements. For example, HTI-1 builds on the Cures Act’s information blocking regulations by clarifying definitions, expanding enforcement mechanisms, and refining compliance requirements for FHIR API standardization.
By using the core mandates of the Cures Act as a guiding framework, organizations can prioritize long-term initiatives that align with ONC’s evolving regulatory vision. Decisions like investing in scalable API solutions, strengthening information-sharing governance, and preparing for future enforcement actions will ensure continued alignment with federal requirements. By anchoring strategic planning to these foundational principles, stakeholders can not only stay ahead of compliance demands but also drive innovation and efficiency in the years to come.