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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AI Task Force Tackles the Tangled Regulatory Landscape of AI in Healthcare

By Tina Joros, JD (Veradigm), Chair, and Stephen Speicher, MD, MS (Flatiron Health), Vice Chair, EHR Association AI Task Force

The speed at which artificial intelligence (AI) is becoming deeply embedded into every facet of healthcare has lawmakers, regulators, policymakers, special interest groups, and other stakeholders racing to establish a governance structure to ensure its safe and meaningful use – without hindering innovation and efficacy. Recognizing our unique role in shaping AI’s future in healthcare, the EHR Association established an AI Task Force that will focus on thought leadership, guidance, and advocacy. 

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HHS Establishes ASTP/ONC

On July 25, 2024, HHS announced it had reorganized its technology, cybersecurity, data, and AI strategy and policy functions to “streamline and bolster technology, cybersecurity, data, and artificial intelligence (AI) strategy and policy functions.” Historically, responsibility for policy and operations has been distributed across the ONC, ASA, and ASPR. Now those responsibilities have been consolidated into the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology, or ASTP/ONC.

In response to this announcement, the EHR Association issued the following statement:

“In establishing ASTP/ONC, HHS is acknowledging the increasingly important role of health IT in the care delivery system since the inception of ONC 20 years ago, as well as the critical role electronic patient data plays in the provision of and access to quality care. ONC has collaborated with the health IT industry as we have expanded patient access to their data, the exchange of health information between numerous stakeholders, and now the rapidly growing influence of AI.

“Along with great potential, these changes bring heightened privacy and security risks and the need for a fresh approach to policy, standards, and strategy to address the complex nature of health information technology. The EHR Association believes the new ASTP/ONC can add great value in expanding even further the work they do to coordinate health IT-related policy across the Federal government.

“We look forward to collaborating with ASTP/ONC as we work toward our shared goals of continually improving the quality and efficiency of care through safe, innovative interoperable health IT adoption and use.”

Digital Health Equity: Harnessing Design Systems to Advance EHR Accessibility 

By Jennifer Sagerian (MEDITECH), Member, EHR Association User Experience Workgroup

For many, the pandemic shed light on issues related to web accessibility. Ninety percent of US adults said the internet was “essential” during the pandemic yet many people with disabilities were at a disadvantage; unable to schedule vaccines, communicate with their providers, and schedule appointments. Since then, web accessibility has become a high-priority social determinant of health (SDOH) – and a fundamental human right.  

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