< + > HTI-1 Final Rule: Implications for Healthcare Providers – Focus on DSI and Algorithmic Transparency

The following is a guest article by Nitin Kunte, Sr. Director at NTT DATA

On February 8, 2024, the Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and Interoperability (HTI-1) Final Rule in the Federal Register, which took effect on March 11, 2024. This comprehensive regulation introduces vital updates to the certification program, promotes algorithm transparency, and establishes critical standards for information sharing among healthcare providers.

The HTI-1 Final Rule has significant implications for all providers who use electronic health records to administer and deliver patient care. This especially relates to how they can use Predictive Decision Support Interventions (DSIs) to improve patient care.

We could dive into and provide insights into the five points mentioned above but we’ll start with the details of the HTI-1 Final Rule, specifically focusing on Decision Support Intervention (DSI) and Algorithmic Transparency. 

HTI-1 Final Rule Synopsis

1. The New Regulatory Approach – “Edition-less” Certification Criteria: discontinue the year-themed editions and establish a single set of certification criteria
2. Certification Standards and Functionality Updates: new and revised standards and certification criteria
3. Emphasis on Decision Support Interventions (DSI) and Algorithmic Transparency: revises existing CDS certification criteria, simplifies and streamlines requirements, and narrows the scope of impacted predictive DSI
4. Insights Condition and Maintenance of Certification Requirements (EHR Reporting Program): provide details on what needs to be reported when (frequency) by whom and how they will be measured. It also provides a reporting timeline 
5. Information Blocking: provides detailed definitions and exceptions

Emphasizing Algorithmic Transparency and the Role of Predictive DSIs

Predictive DSIs are technologies that intend to support decision-making based on algorithms or models that derive relationships from training or sample data and then are used to produce an output or outputs related to, but not limited to, prediction, classification, recommendations, evaluation, or analysis.

The HTI-1 Final Rule particularly focuses on enhancing algorithmic transparency for predictive DSIs defined broadly, encompassing technologies from simple algorithms to advanced machine learning models.

For healthcare providers, the HTI-1 Final Rule mandates access to a new realm of detailed source attribute information for both evidence-based and predictive DSIs. This requirement is crucial for ensuring that healthcare providers can make informed decisions based on transparent and updated information regarding the DSIs they deploy. 

Key Dates and Implementation Timelines

March 11, 2024: The HTI-1 Final Rule takes effect, initiating the transition phase for health IT developers and healthcare providers.

December 31, 2024: Deadline for health IT developers to update their technologies in compliance with the new HTI-1 regulations, specifically regarding the DSI certification criterion and the maintenance of certification requirements as detailed in §170.315(b)(11) and its subparts.

Non-compliance with predictive DSI requirements may result in penalties or loss of certification. Providers not using certified EHR may face downward payment adjustments to their Medicare reimbursements in the affected payment year. 

Predictive DSI: A Closer Look

Predictive DSIs, as defined by the ONC, encompass a broad range of techniques, from simple risk calculators to advanced machine learning models using AI. The finalized configuration nexus, maintenance of certification requirements, and certification criteria outlined in the rule, provide a structured framework for the deployment of these interventions. Importantly, the regulation stresses the need for DSIs to be evidence-based, actively enhancing clinical decision-making processes.

The Goals of New Rules

1. Improve Transparency with respect to how a Predictive DSI is designed, developed, trained, evaluated, and should be used
2. Enhance Trustworthiness through transparency on how certified health IT developers manage potential risks and govern predictive DSIs that are supplied by the health IT developer as part of its Health IT Module
3. Foster an Information Ecosystem necessary to help healthcare organizations and users of these tools better determine whether their Predictive DSIs are fair, appropriate, valid, effective, and safe (FAVES)
4. Advance Health Equity by Design by addressing bias and health disparities, potentially propagated by predictive DSIs, to expand the use of these technologies in safer, more appropriate, and more equitable ways for patients and individuals

Stress on Transparency and Equity

The HTI-1 Final Rule sets clear expectations for health IT modules regarding DSI selection, feedback mechanisms, and source attribute requirements. For example, health IT modules certified to the DSI criterion must enable users of such applications to select, activate, and provide feedback on both evidence-based and predictive DSIs. This inclusivity ensures that healthcare providers can harness the power of predictive analytics while being grounded in evidence-based practices.

The rule also mandates detailed source attribute categories for Predictive DSIs, covering intervention details, development insights, and fairness assessment processes.

Recommendations: To Ensure Compliance by Dec 31st, 2024

Here are our recommendations to healthcare providers to maintain compliance with Decision Support Interventions (DSI) and Algorithmic Transparency under the HTI-1 Final Rule:

1. Audit & Assess Existing DSIs: Conduct a thorough audit of currently utilized Decision Support Interventions. Identify whether they are evidence-based or predictive and assess their compliance with the new rule.
2. Enhance Feedback Loops and Transparency: Establish mechanisms for collecting and analyzing feedback on DSIs. These loops should enable modifications to DSIs based on real-world performance and user feedback, ensuring there are no biases, continuous improvement, and compliance. Ensure that detailed source attribute information for both evidence-based and predictive DSIs is accessible. This includes development details, purpose, intended use, and any limitations or biases addressed.
3. Update Risk Management Plan: Revise and update Intervention Risk Management (IRM) practices in line with the HTI-1 requirements. Focus on algorithmic transparency, fairness, safety, and privacy considerations for each Predictive DSI.
4. Communication and Training: Maintain regular communication and develop comprehensive training programs for medical and technical staff. Focus on understanding the functionalities, limitations, and appropriate uses of DSIs within clinical workflows.
5. Engage with Health IT Developers: Collaborate closely with certified health IT developers to ensure that the DSIs integrated into your systems meet HTI-1 Final Rule standards. Discuss any necessary updates or modifications to maintain compliance.
6. Governance and Monitoring: Set up a governance model to monitor compliance.

Conclusion: Key Takeaways for Healthcare Providers

In a sector facing financial challenges, investing in certified health IT and predictive DSIs is vital. The initial investment in updating technology and training staff is notable. Yet, the benefits in decision-making, patient care, and the avoidance of medical errors are significant. Providers that adopt can offer unique, evidence-based treatments. Compliance with HTI-1 is expected to lead to both improvements in the efficacy of care as well as patient experience.

Following the HTI-1 Final Rule can also protect against penalties from information blocking and non-compliance. This makes the investment in new technology and processes worthwhile. Moreover, using transparent and validated predictive DSIs can lead to more accurate and fair patient care.

Healthcare providers should prepare for these new regulations to take full effect by December 31, 2024. These regulations will affect operational efficiency, financial health, and market position.

About Nitin Kunte

Nitin Kunte is a Sr. Director at NTT DATA, a leading provider of IT and business services with extensive healthcare experience spanning over 50 years. Nitin is the practice lead for NTT’s healthcare technology consulting practice. With his deep expertise in healthcare industry, he has helped healthcare clients with areas such as Integration and Interoperability, predictive AI, developing value propositions that support IT investment and reshaping IT organizations and capabilities to meet their strategic goals. Connect with him on LinkedIn.