By Stephanie Jamison (Greenway Health), Chair, EHR Association

Last year ended with a bang as ONC issued the HTI-1 final rule and officially opened the doors to TEFCA by designating the first five QHINs. It was a small taste of what’s to come in 2024, and the EHR Association will be busy ensuring our members’ voices are heard at the state and federal levels as the regulatory wheel continues to spin.

Even as EHR developers and providers begin work on HTI-1 compliance, ONC is already moving forward with plans for the HTI-2 proposed rule, which is expected to focus on public health, patient engagement, and information sharing. The EHR Association will work closely with ONC and other stakeholders to voice concerns, provide recommendations, and educate on issues impacting our membership.

Additionally, as the 21^st Century Cures Act transitions from policy to practice, individual states have been looking at their own interoperability and privacy regulations and priorities that will impact healthcare and health IT utilization. We will continue our efforts to ensure the voices of EHR and other health IT developers are heard as states work to enact laws and regulations that impact our industry. Among the priority areas of focus are conflicts with federal mandates and the need to balance patient privacy and consent management concerns with effective interoperability.

Other 2024 areas of focus include:

• TEFCA: Along with new QHIN designations, TEFCA is expected to expand use cases/exchange purposes in 2024 to include public health and payment/healthcare operations. This will require additional Standard Operating Procedures and reference of standards for these use cases, both of which we’ll focus on in the new year.
• Disability Inclusion: We’ll continue efforts to raise awareness of how disability exclusion impacts health IT users and create resources and tools, including scenarios, to support accessibility in EHR workflows.
• USCDI and USCDI+: Ambiguities within USCDI and USCDI+ data definitions are creating significant challenges for EHR and other health IT developers. We will continue working to raise awareness about these ambiguities and the multiple risks this lack of clarity creates, including decreased effectiveness of standards-based interoperability.  
• Information Blocking and Patient Privacy: With patient privacy and information blocking regulations in place, we’ll focus on the implications for developers and providers, as well as the user experience when it comes to striking a balance between when it’s required to share information and when it should be held back.
• Electronic Prior Authorization (ePA): CMS has released its Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule, and we are standing by for the ONC regulation known as HTI-2 which is expected to contain ePA technical provisions. We’ll analyze the impact of these rules on developers and the providers who use their technologies.

Not to be overlooked is artificial intelligence (AI). The regulatory landscape is rapidly evolving as Congress – including the Senate HELP committee – continues to explore broad AI legislation and federal agencies and departments carry out President Biden’s Executive Order to create standards and regulations for the safe and responsible creation and use of AI systems. We will offer our expertise and work to ensure our members’ concerns are heard. 

In particular, we will monitor efforts underway by HHS to establish an AI safety program focused on harmful or unsafe healthcare practices, a common framework for its responsible use, and methods for tracking incidents of bias, discrimination, or other harm. The EHR Association is establishing an AI Task Force to ensure our members are informed and current on the latest AI policy and technical discussions.

The health IT regulatory landscape is continuously evolving. The EHR Association is committed to ensuring our member companies’ concerns are heard and offering our expertise to support legislative and other efforts to advance interoperability and improve healthcare.