As the public comment period for the Assistant Secretary for Technology Policy's HTI-2 proposed rule ends, the EHR Association has published a letter raising concerns about the potential impact on IT developers, providers and delivery of patient care.

The 29-member EHRA said the proposed rules – which aim to enhance the accessibility and exchange of electronic health information with new certification criteria for payer and public health IT – could introduce substantial new regulatory challenges.

The regulation is designed to prevent information blocking, enhance interoperability and ensure better access to health data across platforms.

The rules also address compliance with privacy laws like HIPAA and expand the use of the FHIR standard for better data transfers across healthcare providers.

However, the EHRA warns that without changes, these regulations could significantly disrupt the current health IT landscape.

The organization argued against the additional software requirements that HTI-2 would impose on developers.

The letter pointed to ASTP’s projections that HTI-2 compliance obligations could lead to a 12% reduction in the availability of certified solutions, with smaller healthcare organizations particularly affected by this disruption.

“Regulations having this level of negative market impact for health IT developers also inherently mean disruption and stress for providers who currently rely on those solutions to participate in various payment programs,” the EHRA’s letter stated.

The financial implications were another point of concern. With an 11% decrease in the number of health IT developers anticipated, the cost of compliance could translate into higher prices for providers as developers pass on expenses.

“Further increased regulatory burdens on developers – those who are not driven out of business – would, in many cases, translate into higher prices passed along to providers as they keep up with mandated upgraded technology, which will trickle down to impact care delivery and operations,” the letter said.

The EHRA also noted the scheduling misalignment between CMS programs and ASTP requirements, resulting in providers being forced to upgrade their systems more frequently than planned.

“This has led to very frustrated provider organizations as they are forced to make upgrades much more frequently,” EHRA’s statement noted.

Despite these concerns, the EHRA did express support for expanding the program to include payers and public health agencies, seeing this as a potential improvement in data exchange if appropriate mandates and incentives are implemented.

Success, they stressed, would require agencies like CMS and the CDC to take a leading role, and recommended development of "appropriate incentives or mandates to drive adoption."

Nathan Eddy is a healthcare and technology freelancer based in Berlin.
Email the writer: nathaneddy@gmail.com
Twitter: @dropdeaded209