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 aims to eliminate 34 out of 60 existing certification requirements and revise 7 others, effectively
altering nearly 70% of the current standards. The move is part of an effort to implement President Trump's executive order on deregulation, titled 'Unleashing Prosperity Through Deregulation.' The proposed changes are intended to reduce regulatory burdens on health IT developers, thereby fostering innovation and removing barriers for new entrants in the certified health IT market. A key focus of the proposal is to promote the use of artificial intelligence (AI) through FHIR APIs, establishing a new foundation for AI-enabled interoperability solutions. The proposal also includes changes to information blocking regulations, aiming to redefine 'access' and 'use' to allow autonomous AI to retrieve and share health data.
Why It's Important?
This proposed deregulation could have significant implications for the health IT industry in the United States. By reducing the number of certification requirements, the HHS aims to lower the barriers to entry for new developers and encourage innovation, particularly in AI applications. This could lead to more advanced and efficient health IT solutions, potentially improving patient care and data management. However, the removal of certain requirements, such as those related to clinical decision support algorithms and multi-factor authentication, raises concerns about the potential risks to data security and patient safety. The changes to information blocking regulations could also impact how health data is accessed and shared, potentially enhancing interoperability but also raising privacy concerns.
What's Next?
The proposed rule is open for public comment, allowing stakeholders, including health IT developers, healthcare providers, and patient advocacy groups, to provide feedback. The HHS will review these comments before finalizing the rule. If implemented, the changes could lead to a shift in the health IT landscape, with increased competition and innovation. However, it will be crucial to monitor how these changes affect data security and patient privacy. The healthcare industry will need to adapt to the new regulatory environment, balancing the benefits of innovation with the need to protect sensitive health information.
