Addressing Data Privacy Concerns in the Age of Interoperable Health Systems: Insights from the HTI-1 Implementation

The HTI-1 final rule, issued in December 2023 by the ONC, updates the Health IT Certification Program and changes information blocking regulations under the 21st Century Cures Act. Its aim is to improve interoperability of health IT systems, increase patient access to electronic health information (EHI), and enhance data security and privacy protections. The rule’s compliance deadlines run through January 1, 2026.

One major update in HTI-1 is the expansion of the U.S. Core Data for Interoperability (USCDI) Version 3. This broadens the types of patient data that must be shared, now including more detailed demographics such as sexual orientation, gender identity, and social determinants of health. As a result, healthcare organizations will handle a larger volume and variety of sensitive patient data.

Additionally, HTI-1 introduces an “edition-less” certification model. Instead of releasing periodic edition updates, certification will be maintained as an ongoing, updated framework. This change aims to speed up adoption of new standards by developers and reduce confusion for users and implementers in healthcare settings.

The ONC also now requires an Internet-based method for patients to request restrictions on the use or sharing of their EHI. This aligns with HIPAA regulations and allows patients more control over how their data is shared, making privacy management more dynamic and patient-centered.

Privacy Concerns in the Context of Enhanced Interoperability

While sharing data more freely among providers, payers, and public health agencies can improve care, it also increases exposure to privacy and security risks. Information that moves across organizational lines may be more vulnerable to breaches, misuse, or accidental disclosure.

Healthcare staff like nurses, who handle patient data daily, understand that balancing privacy with interoperability is difficult. Melinda Kidder, a healthcare expert, notes that nurses play an important part in protecting sensitive data as workflows incorporate new IT systems under HTI-1. The key challenge is maintaining strict privacy without blocking timely access to necessary clinical information.

The wider use of APIs and expanded data sharing calls for stronger cybersecurity measures. HTI-1 responds by requiring faster expiration for access tokens and supporting refresh tokens for patient-facing applications, which improves security during electronic health exchanges.

Since many organizations will update or replace health IT modules to meet the new standards, thorough staff training is crucial. Ongoing education helps clinical, administrative, and IT teams understand new workflows, privacy protocols, and technical setups related to interoperability.

The Insights Condition and Increased Transparency Requirements

A new part of the HTI-1 final rule is the Insights Condition within the ONC Health IT Certification Program. This requires annual reporting of interoperability metrics by health IT developers with a significant user base—those serving at least 50 hospital sites or 500 clinicians.

Beginning in 2026, certified health IT vendors must report data on seven key measures across four areas:

• Individual Access to Electronic Health Information (EHI): Counting unique patients who access health data through certified APIs or portals.
• Clinical Care Information Exchange: Tracking volume and reconciliation of Consolidated Clinical Document Architecture (C-CDA) documents, including data on medications, allergies, and health problems.
• Standards Adoption and Conformance: Monitoring use of interoperability standards like HL7® FHIR®, FHIR US Core IG versions, and new vocabulary code sets.
• Public Health Information Exchange: Measuring electronic reporting of immunization data to state or local Immunization Information Systems (IIS) and related query activities.

These aggregated reports will be publicly available on the ONC website to improve transparency and accountability. They will also help developers and healthcare organizations track interoperability performance and privacy compliance.

Healthcare administrators can use this data to assess how their health IT vendors perform and to plan technology upgrades strategically to meet regulatory and patient care goals.

Data Privacy Challenges within Workflow Integration

The interoperability requirements of HTI-1 call for big changes in clinical and administrative workflows. Introducing new health IT systems can strain operations and reveal gaps in privacy procedures.

Healthcare professionals, especially nurses, must adapt to more documentation tasks, new access rules, and extended data sharing while keeping confidentiality intact. Nurses often act as the final protectors of patient information and link technology with patient care.

Hospital and practice administrators should encourage cooperation among clinical teams, IT departments, and health IT vendors. It is important to ensure new technologies fit smoothly into everyday workflows. Getting feedback from end users helps improve system functions and keep patient data safe.

Paul Jeffery Smith, Deputy Director of Certification and Testing Division at ONC, stresses the need for ongoing training and usability improvements to fully benefit from certified health IT while maintaining privacy safeguards.

Patient Empowerment and Privacy in Interoperable Systems

The HTI-1 final rule aims to increase patient involvement by giving individuals easier access and clearer control over their health data. This approach seeks to break down information silos and lets patients be active in their care choices.

The rule requires certified health IT systems to offer patient portals or API-based access where patients can view, download, or send their EHI. Systems must also provide an Internet-based way for patients to limit others’ use or sharing of their data, as mandated by the HIPAA Privacy Rule 45 CFR 154.522(a), effective January 1, 2026.

Greater patient control can add complexities for healthcare providers who must maintain compliance and adapt workflows. When patients request data restrictions, providers need clear policies and teamwork to balance these requests with sharing clinical information.

Medical practice administrators should develop protocols and train staff to recognize and respond to patient restriction requests promptly, all while making sure patient care continues without interruption.

AI and Workflow Automation: Managing Interoperability and Privacy in Practice

Artificial intelligence (AI) and automation tools offer ways to handle the complexity created by interoperability and privacy rules. Under HTI-1, these tools can simplify workflows, support compliance, and reduce administrative work for healthcare staff.

Simbo AI, a company that focuses on front-office phone automation and intelligent answering, demonstrates how AI can improve healthcare administration. Their systems handle patient calls, appointment scheduling, and information requests efficiently, freeing up staff time for patient care.

From the privacy perspective, AI can support enforcement of data access rules. Automated workflows can detect when patients limit use of their EHI and quickly update data-sharing settings in electronic health record (EHR) systems.

Moreover, AI-powered decision support tools, addressed by HTI-1’s Algorithmic Transparency and Decision Support Intervention criteria, must allow feedback and risk management to reduce bias and maintain ethical standards. This oversight is important given AI’s growing role in clinical areas.

Using AI and automation helps healthcare providers manage daily demands of interoperability rules, lower human error, and increase efficiency in patient care delivery.

Solutions like Simbo AI’s show how front-office functions can adjust to new health IT requirements. They also support better provider-patient communication while following privacy rules required by HTI-1.

Strategic Considerations for Medical Practice Administrators and IT Managers

For healthcare providers in the U.S., HTI-1 offers both challenges and opportunities. It is important to take active steps to implement interoperability while handling data privacy rules.

• Invest in Staff Training: Ongoing education for clinical and administrative staff on new workflows, privacy rules, and patient rights under HTI-1 helps reduce risks and improve system use.
• Collaborate with Health IT Developers: Work closely with vendors to learn about upcoming updates, certification requirements, and support for USCDI v3 and FHIR standards.
• Establish Privacy Policies: Review and update privacy policies to address expanded patient data access and restriction requests in line with HIPAA and HTI-1.
• Use AI and Automation Thoughtfully: Assess AI tools for front-office and clinical decision support with attention to transparency, bias reduction, and integration into existing workflows.
• Monitor Provider Performance: Use public interoperability reports from the Insights Condition to compare technology adoption and find areas needing improvement.
• Enhance Cybersecurity: Strengthen security systems to handle faster token expiration and refresh token use, lowering risks from increased API activity.

Careful planning and technology use can help healthcare organizations meet HTI-1 standards and improve both patient involvement and data privacy protections.

As the HTI-1 final rule shapes health information exchange and privacy, medical practice leaders must balance operational demands with regulations. Implementing interoperable systems can be complex, but sound leadership and thoughtful integration—especially with AI and workflow automation—can make the process manageable and aligned with patient care goals.