The 21st Century Cures Act Final Rule: New Standards for Interoperability, Privacy, and Security in EHR Systems

The 21st Century Cures Act Final Rule represents a change in how electronic health information (EHI) is accessed, shared, and secured across the healthcare system in the United States. This regulatory framework is designed to improve interoperability, enabling different healthcare systems to communicate and share patient data efficiently. It also establishes privacy and security measures to protect sensitive health information. This article summarizes the key components of the rule and its implications for medical practice administrators, owners, and IT managers.

Understanding the Cures Act Final Rule

The 21st Century Cures Act, enacted in December 2016, aimed at modernizing the healthcare delivery system. A central feature is the promotion of interoperability among electronic health records (EHR) systems. The ONC’s Cures Act Final Rule, released in March 2020, builds on this foundation by providing specific requirements for a more integrated and efficient healthcare environment.

Key Objectives of the Cures Act Final Rule

The Final Rule has several key objectives:

• Enhancing Patient Access: It requires that patients have electronic access to all their health information without extra fees. This accessibility is intended to promote patient engagement and enable individuals to take an active role in their healthcare decisions.
• Reducing Information Blocking: The rule defines and penalizes information blocking—practices that prevent or interfere with the exchange of health information. Compliance is crucial, as healthcare providers may face monetary penalties or exclusions from Medicare programs.
• Establishing Interoperability Standards: The regulation requires standardized application programming interfaces (APIs) that support the secure exchange of EHI, simplifying access and sharing for patients and providers.
• Ensuring Privacy and Security: Strong privacy and security standards are highlighted, including exceptions to information blocking restrictions to protect sensitive data while enabling necessary access.

Compliance and Penalties

Healthcare organizations must comply with the new regulations to avoid penalties. Violations may lead to exclusion from the Medicare Promoting Interoperability Program or MIPS. As of May 2024, there were over 1,052 complaints about potential information blocking, with 85% from patients, illustrating the importance of compliance.

Changes to EHR Systems

The Cures Act Final Rule has implications for EHR systems, leading healthcare organizations to ensure their technology meets the new standards. Organizations should consider the following changes:

• Implementing Certified EHR Technology (CEHRT): Organizations must use EHRs certified to the 2015 Edition, which includes updated standards for interoperability. Compliance is necessary to avoid payment adjustments and realize the benefits of the regulations.
• Facilitating Seamless Data Exchange: Healthcare providers must encourage interoperability by avoiding practices that lead to information blocking and ensuring their EHRs can exchange data effectively.
• Staff Training and Policy Updates: Ongoing staff training and clear policies regarding EHI access and exchange are vital. Providers must understand the eight exceptions to information blocking to mitigate risks during data transactions.
• Monitoring Practices: Organizations need to set up monitoring systems to confirm compliance with the Cures Act regulations and prepare for audits.

Best Practices for IT Managers

IT managers need a strategic approach to implement the Cures Act Final Rule. Here are some recommendations:

• Integrate APIs: Use standardized APIs for secure, seamless data sharing among systems. This helps comply with regulations and can improve patient care through timely access to health information.
• Establish Data Security Protocols: Implement measures to protect electronic health information from breaches and unauthorized access, ensuring compliance with HIPAA regulations.
• Collaborate with Vendors: Work with EHR vendors to ensure their systems comply with the Cures Act. Regular feedback can help maintain adherence to the latest standards.
• Engage in Continuous Improvement: Regularly review technologies and workflows for improvement in data sharing practices, enhancing patient care and operational efficiency.

Navigating the Regulatory Environment

As healthcare continues to change, administrators and IT professionals face the challenge of compliance while managing patient care demands. Interoperability impacts care delivery and outcomes. The Final Rule addresses several key concerns:

Importance of Interoperability

Interoperability is important for connecting different parts of the healthcare system. When various EHR systems communicate, providers can access comprehensive patient data, enhancing care coordination and informed clinical decision-making.

Furthermore, improved interoperability can lower healthcare costs. Access to patient records reduces the need for repeat tests and delays, leading to better health outcomes.

Emphasis on Privacy and Security

As electronic health information increases, the need for strong privacy and security measures is essential. The Cures Act Final Rule addresses this need with provisions to protect patient data.

Providers must balance access and privacy. The eight exceptions to information blocking regulations offer flexibility but require rigorous policies to protect patient interests.

Failure to comply can result in significant penalties, impacting financial stability and reputation. Organizations should continuously monitor compliance and prepare for inquiries.

AI and Workflow Automation in EHRs

The integration of artificial intelligence (AI) and workflow automation creates opportunities for improving patient care and administrative processes. AI can enhance operations to ensure EHR systems meet interoperability standards effectively.

• Optimizing Workflow: AI can automate tasks like appointment scheduling, allowing practice administrators to use resources more effectively. Less administrative work enables providers to focus on high-quality patient care.
• Enhanced Data Retrieval: AI can speed up data retrieval in EHR systems, helping clinicians access patient information seamlessly during encounters, improving interactions and satisfaction.
• Data Analytics for Improved Decision-Making: AI-driven analytics can reveal patient care patterns, assisting administrators in identifying care gaps and optimizing resources.
• Predictive Analytics: AI helps providers anticipate patient needs based on past data, allowing for proactive interventions that enhance health outcomes.
• Natural Language Processing (NLP): AI applications such as NLP can improve documentation processes by converting spoken information into structured data, saving time while maintaining accuracy.

Healthcare organizations seeking to improve efficiency and compliance with the Cures Act should consider AI and workflow automation technologies that fit their needs and enhance EHR functions.

Closing Remarks

The 21st Century Cures Act Final Rule changes the healthcare system by supporting interoperability, improving patient access to electronic health information, and enforcing privacy and security standards. Medical practice administrators, owners, and IT managers must adapt to these regulations to ensure compliance and enhance patient care.

While implementing these standards may be challenging, the advantages are significant. Embracing these changes can lead to improved patient outcomes, streamlined operations, and a better healthcare delivery system. Understanding the Cures Act Final Rule enables organizations to succeed in an interconnected and patient-focused environment.