Industry Response to Proposed Health IT Certification...

Introduction

The healthcare technology industry is generally in favor of reducing complexities associated with health IT certification. However, experts express concerns regarding certain proposed changes from the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC). These changes aim to eliminate 34 requirements and revise seven others, but industry professionals believe further adjustments are necessary.

Key Aspects of the Proposed Changes

The EHR Association recently discussed critical elements of the proposed rulemaking known as Health Data, Technology, and Interoperability version 5 (HTI-5). This includes modifications to data exchange and security conditions.

Manner Exception Exhausted Policy

Leigh Burchell, chair of the EHR Association and representative from Altera Digital Health, stated, "While the Manner Exception Exhausted policy change appears straightforward on paper, it doesn’t align with how information sharing negotiations and technical decisions actually occur."

Incorporating Autonomous AI

The proposed updates also modify information blocking rules, particularly regarding electronic health information exchange. The draft notice suggests that access should include autonomous AI systems.

ASTP/ONC noted, "We propose to explicitly codify that access means the ability or means necessary to make EHI available for exchange or use, including by automation technologies such as robotic process automation and autonomous artificial intelligence systems."

This inclusion aims to alleviate challenges posed by state data exchange rules, which have long been a concern for software developers in the EHR industry.

Addressing Infeasibility Claims

Another significant update involves the removal of nominal participation in the Trusted Exchange Framework and Common Agreement as a justification for information blocking. Additionally, the proposed changes to the Manner Exception Exhausted condition seek to clarify varying interpretations.

Michael Lipinski, ASTP director, stated, "We're proposing to require all three alternative manners in the exception to be offered, and then eventually, machine-readable format."

Burchell explained that the HTI-5 proposal aims to tighten standards by requiring that all three prescribed 'manner' categories be offered before claiming infeasibility. She emphasized, "The three 'manner' buckets – certified functionality, standards-based exchange, and machine-readable exports – often overlap in practice."

Operational Burdens and Compliance Challenges

Despite the potential benefits, these proposed changes may introduce operational burdens. Burchell noted, "The burden is potentially extensive, based on our member companies' experience to date in complying with ASTP/ONC regulations. We will work over the next several weeks to ensure the agency understands the real impact of the proposed changes."

Privacy and Security Compliance

Proposed alterations to privacy and security measures may also create regulatory challenges for providers. Kate Tipping, deputy director of the ONC Regulatory and Policy Affairs Division, indicated that the agency plans to remove all privacy and security certification criteria and the associated framework.

However, she mentioned an alternative proposal to retain certification criteria related to audits, which could help identify fraud and abuse. Burchell added, "While the proposal could remove criteria and free up resources that more directly support providers and patients, the removal of the 170.315(d) criterion would not change the obligations of health IT developers or providers under the current or proposed HIPAA Security Rules."

The EHR Association advocates for a simplified certification process and urges ASTP/ONC to provide clear proposals for modernized security requirements, allowing the industry to contribute before finalization.

Conclusion

In summary, while the healthcare technology sector supports the proposed simplifications to health IT certification, there are significant concerns regarding operational burdens and compliance challenges that need to be addressed. Comments on the HTI-5 proposal are due by February 27.

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Source: Industry reacts to proposed health IT certification deregulation - HealthcareITNews