Nov 15
2024
HTI-2’s Sweeping Scope Means Unrealistic Timelines, Costly Compliance Requirements, and Concerning Changes
By Stephanie Jamison (Greenway Health) and Leigh Burchell (Altera Digital Health), Chair and Vice Chair, EHR Association Executive Committee, and Greg Thole (Oracle), Chair, EHR Association Certification Workgroup
In the lead-up to publication by the Assistant Secretary for Technology Policy (ASTP) of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, health IT stakeholders braced 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 an in-depth analysis of HTI-2 and the process of drafting comments (available here), the EHR Association has identified several overarching issues, as well as specific concerns related to Insights measures within the proposed rule.
Highlighting the Positives
Before we delve into the negatives, however, it is important to note that we are highly supportive of several of ASTP’s recommendations. One is the proposal to expand the Certification Program to include criteria focused on the adoption and use of certified health IT by both payers and public health agencies (PHAs) to supplement criteria for healthcare providers. Holding all parties to specific and consistent standards and procedures is critical to achieving real end-to-end interoperability.
Another is the way ASTP has structured the numerous new proposed FHIR API-based required features (e.g., dynamic registration, SMART Health Cards, CDS Hooks, Subscriptions) in a manner that allows developers to re-use the same capability for multiple different use-case-focused criteria. This is a helpful format that allows developers to streamline and avoid duplicating work effort.
Finally, in the context of the Insights requirements, many of ASTP’s proposals demonstrate attentiveness to the questions and concerns raised by the Association and its member companies since the measures were originally finalized in HTI-1 rulemaking. Some of these tweaks to measurement specifications will reduce the burden and make for more consistent and valuable reporting data.
Overarching Concerns
While we do support many elements of HTI-2, there are also several areas of real concern. We’ve raised many of them previously in comments, but they have yet to be adequately addressed by ASTP and other regulatory agencies.
For example, a common refrain in the Association’s comment letters and RFI responses is that compliance timelines and the scope of work in ASTP regulations create significant burdens for all health IT developers, as well as our healthcare provider customers. We delivered this message related to HTI-1, and our members are now devoting extensive resources to compliance—sometimes at the cost of innovation clients have requested.
Yet, as evidenced by the extensive scope of the HTI-2 proposals, ASTP and CMS continue to ignore the significant and serious timeline concerns we’ve voiced for years. CMS programs, such as the Medicare Promoting Interoperability program and Merit-based Incentive Payment System (MIPS), require healthcare providers to use upgraded certified EHR technology effective essentially on the same deadlines set by ASTP for vendors to deliver those updates. This forces developers to deliver compliant solutions significantly earlier than the deadlines officially listed by ASTP and does not allow adequate runway after the deadline for healthcare providers to adopt the updates, potentially compromising a safe and effective implementation process.