ASTP’s HTI-2 Proposes Concerning Changes to Insights Measures

By Greg Thole (Oracle), Chair, EHR Association Certification Workgroup

In the previous installment of our blog series dissecting the EHR Association’s raft of concerns with ASTP’s Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, we focused on the overarching issues. In this blog, we take a deep dive into the complex web of proposed changes to Insights measures that present specific challenges for certified health IT developers and indirect impacts for the providers that use their solutions. (Our full comments to ASTP are available on our website.)

Insights is a Condition and Maintenance of Certification requirement introduced via statutory directive in the 21st Century Cures Act, which tasked ASTP with creating an EHR reporting program for certified health IT developers. By its nature, Insights poses a difficult value proposition for developers, as it requires the commitment of development time and resources to efforts that do not directly benefit providers. 

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Huge Scope, Not Enough Time: Concerns with ASTP’s HTI-2 Proposed Rule

By Stephanie Jamison (Greenway Health), Chair, and Leigh Burchell (Altera Digital Health), Vice Chair, EHR Association Executive Committee

In the months leading up to ASTP’s July 2024 release of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, the EHR Association and other health IT stakeholder organizations braced themselves for what was certain to be a massive policy proposal. Those fears were quickly realized when the overwhelming scope of proposed new and expanded software requirements in the 1067-page HTI-2 NPRM was revealed. 

Following our in-depth analysis of HTI-2 and the process of drafting comments, the Association has identified concerns related to public health, standards, Insights measures, and electronic prior authorization requirements within the proposed rule, all of which will be discussed in greater detail in the subsequent blogs in this HTI-2 series. Additionally, there are several overarching issues we believe need to be addressed – including some previously raised by the EHR Association that have yet to be adequately addressed by ASTP and other regulatory agencies.

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Celebrating World Patient Safety Day 2024

September 17, 2024 has been designated World Patient Safety Day. Promoted by the World Health Organization (WHO), it is a day focused on raising public awareness and fostering collaboration between patients, health workers, policymakers, and healthcare leaders to improve patient safety. The 2024 theme is “Improving diagnosis for patient safety” with the slogan “Get it right, make it safe!” to highlight the critical importance of correct and timely diagnosis in ensuring patient safety and improving health outcomes.

According to the WHO, diagnostic safety can be significantly improved by addressing the systems-based issues and cognitive factors that result in diagnostic errors, which account for 16% of preventable patient harm. Issues include communication failures between health workers or health workers and patients, heavy workloads, and ineffective teamwork. Cognitive factors involve clinician training and experience as well as predisposition to biases, fatigue, and stress.

Timely and accurate diagnoses are essential for positive patient outcomes, and as EHR vendors, we are committed to advancing patient safety through the delivery of safe, clinically relevant health IT.

“Timely and accurate diagnoses are essential for positive patient outcomes, and as EHR vendors, we are committed to advancing patient safety through the delivery of safe, clinically relevant health IT,” share Michael Blackman (Greenway Health), MD, Chair, and Marijo Carnino (MEDITECH), Vice Chair, of the EHR Association Patient Safety Workgroup.

They add: “Information sharing, patient consent considerations, management of sensitive data, and artificial intelligence are just some of the many trending topics on our radar this past year that align with World Patient Safety Day 2024’s focus on advancing initiatives to ‘Get it right, make it safe!’ By fostering collaboration and promoting the use of health information technology in both the solutions our members deliver to the market and the feedback we provide on federal and state regulations, we aim to enhance safety and ultimately improve patient care.”

A Commitment to Patient Safety

Patient safety is a top priority of the EHR Association, which is comprised of 29 companies that supply the vast majority of EHRs to physicians’ practices and hospitals across the U.S. EHR developers have a longstanding commitment to patient safety, which must be considered from the earliest stages of the development process and includes all aspects of EHR use. The goal is to ensure patients get the best possible care with a clinician experience that is free from undue burden. It takes collaboration to share experiences relative to patient safety and the reduction of errors. 

Our commitment to patient safety is reflected in our EHR Developer Code of Conduct. The Patient Safety Workgroup carries out this commitment by actively monitoring, contributing to, and engaging with federal agencies, Patient Safety Organizations, trade associations, professional societies, liability carriers, academics, and other stakeholders to collaborate on efforts to promote a culture of safety in health IT and evolve a non-punitive national learning system. It supports the active involvement of all stakeholders in patient safety initiatives, as providers, patients, healthcare organizations, human factors and usability experts, technology and security experts, and policymakers all bring unique perspectives to the table. Ensuring patient safety in an evolving, complex, data-rich system requires a continuous feedback loop in a non-punitive, collaborative learning environment. 

Part Two: Privacy & Consent Management Landscape and Challenges to Scale

By Hans Buitendijk, Chair, EHR Association Privacy & Consent Task Force

In Part One of this two-part blog series, we introduced the challenges in today’s privacy and consent management landscape and discussed different approaches for rules management. In Part Two, we put forth a proposed roadmap for establishing the necessary framework for privacy and consent management. 

A Roadmap for a Complex Infrastructure

Defining the critical components and standards, and establishing the necessary infrastructure is no small undertaking. It is not sufficient to simply have standards on how to communicate any tags, such as HL7 DS4P for documents, FHIR Security Labels for FHIR resources, and the ARV segment for HL7 v2. Not only that, but more is needed when v2, CDA, or FHIR are used to communicate data that must have tags beyond the data itself to enable evaluation of rules by the receiving system. This is especially true when data can be exchanged in many other formats and ways, including proprietary formats, and when sensitivity is based on the context of multiple data elements that, on their own, would not be considered sensitive, as well as when a patient’s data sharing rules may not involve a well-defined set of data values.

The $64,000 question is, how can we make progress? 

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Part One: Privacy & Consent Management Landscape and Challenges to Scale

By Hans Buitendijk, Chair, EHR Association Privacy & Consent Task Force

As health data flows more widely and automatically across providers, payers, patients, public health, researchers, and others, automated tools to filter for data that is not authorized to be shared have become imperative.  

To date, relatively simple and coarse methods have been deployed where large data sets are excluded from exchange:

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CISA Proposes Practical Guidelines For Reporting Cyber Incidents

EHR Association Privacy & Security Workgroup

The Cybersecurity and Infrastructure Security Agency (CISA), responsible for coordinating cybersecurity programs within the U.S. and improving the government’s cybersecurity protections, proposed new reporting requirements under the Cyber Incident Reporting for Critical Infrastructure Act, or CIRCIA. The proposed rule lays out what incidents must be reported, by whom, and what the reports must contain. While the EHR Association provided comments of support for most areas, suggestions for potential refinement were also offered. 

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