What's Happening?
The Department of Health and Human Services (HHS) has proposed a significant overhaul of its health information technology certification program. This proposal, released by the Office of the Assistant Secretary for Technology Policy/Office of the National
Coordinator of Health IT (ASTP/ONC), aims to eliminate 34 out of 60 existing certification requirements for electronic health records (EHRs) and revise seven others. The move is part of an effort to implement President Trump's executive order on deregulation, which seeks to reduce regulatory burdens and promote innovation. The proposed changes are intended to remove barriers that hinder health IT developers, thereby fostering a more innovative environment. Key changes include the removal of certification requirements for clinical decision support algorithms and the revision of information blocking regulations to facilitate AI-driven data exchange.
Why It's Important?
This proposed deregulation could have a profound impact on the health IT industry by reducing the compliance burden on developers, potentially accelerating innovation and the adoption of new technologies. By easing certification requirements, the HHS aims to encourage the development of AI-enabled solutions that could enhance interoperability and patient access to health information. However, the removal of certain requirements, such as those related to safety and accessibility, may raise concerns about the potential risks to patient safety and data security. Stakeholders in the healthcare sector, including developers, providers, and patients, could be significantly affected by these changes, with developers gaining more freedom to innovate and patients potentially experiencing improved access to their health data.
What's Next?
The proposed rule is open for public comment, allowing stakeholders to provide feedback on the potential impacts of the changes. The HHS will review these comments before finalizing the rule. If implemented, the changes could lead to a shift in how health IT systems are developed and certified, with a greater emphasis on AI and interoperability. The healthcare industry will need to adapt to these new standards, and developers may need to adjust their strategies to align with the revised requirements. The outcome of this proposal could set a precedent for future regulatory approaches in the health IT sector.
