As the public comment period for the Assistant Secretary for Technology Policy’s proposed HTI-2 rule ends, the EHR Association has published a letter raising concerns about the potential impact on IT developers, suppliers and the delivery of patient care.
The 29-member EHRA said the proposed rules – which aim to improve 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 aims to prevent information blocking, improve interoperability and ensure better access to health data across platforms.
The rules also address compliance with privacy laws such as HIPAA and expand the use of the FHIR standard for better data transfer between healthcare providers.
However, the EHRA warns that without changes, these regulations could significantly disrupt the current healthcare IT landscape.
The organization opposed the additional software requirements that HTI-2 would impose on developers.
The letter referenced 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.
“Regulation with this negative market impact for healthcare IT developers also inherently means disruption and stress for providers who currently rely on these solutions to participate in various payment programs,” the EHRA letter said.
Another concern was the financial impact. With an expected 11% decline in the number of healthcare IT developers, the cost of compliance could translate into higher prices for providers as developers pass on the costs.
“Further increased regulatory burden on developers – those who do not go bankrupt – would in many cases translate into higher prices passed on to providers as they keep pace with mandated improved technology, which will trickle down and impact healthcare delivery and operations. “, the letter said.
The EHRA also noted that CMS program planning and ASTP requirements have not been properly aligned, forcing providers to upgrade their systems more often than planned.
“This has led to very frustrated provider organizations as they have been forced to make upgrades much more frequently,” the EHRA statement said.
Despite these concerns, the EHRA expressed support for expanding the program to payers and public health agencies, seeing this as a potential improvement in data sharing if appropriate mandates and incentives are implemented.
For success, they emphasized, agencies like CMS and the CDC would need to play a leading role, and they recommended developing “appropriate incentives or mandates to encourage adoption.”
Nathan Eddy is a healthcare and technology freelancer based in Berlin.
Email the writer: nathaneddy@gmail.com
Twitter: @dropdeaded209