New Health IT Rule Cuts Red Tape to Boost Innovation
The U.S. Department of Health and Human Services has finalized the HTI-5 rule, slashing administrative burdens for health IT developers in the ONC Certification Program. The move is expected to save over $1.5 billion in regulatory costs and allow developers to focus more on improving tools for patients and clinicians. Officials say the change supports greater interoperability, competition, and innovation in healthcare technology.
On November 2, 2026, the U.S. Department of Health and Human Services (HHS), through its Office of the National Coordinator for Health Information Technology (ONC), finalized the HTI-5 rule—officially titled *Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity*. This rule is designed to reduce administrative burdens on health IT developers participating in the ONC Certification Program, with an estimated savings of over $1.5 billion in regulatory costs. The changes are aligned with two executive orders issued under President Trump’s administration: EO 14192, which promotes deregulation to unleash economic prosperity, and EO 14267, aimed at reducing anti-competitive regulatory barriers. The HTI-5 rule specifically streamlines compliance requirements, allowing developers to redirect resources toward innovation in tools that improve interoperability, automation, and patient and clinician experiences. The ONC has emphasized that these reforms are part of a broader strategy to enhance access to electronic health information (EHI), support market competition, and lower healthcare costs. Key figures involved include HHS Secretary Robert F. Kennedy, Jr., who framed the rule as freeing innovators from bureaucratic obstacles, and Dr. Tom Keane, National Coordinator for Health IT, who highlighted the goal of enabling developers to focus on advancing interoperability. However, comments submitted during the proposed rule phase regarding informatio
The HTI-5 rule could significantly reshape the health IT landscape by reducing barriers to entry for smaller developers and startups, potentially increasing competition and accelerating innovation in digital health tools. By cutting regulatory costs, the rule may enable faster deployment of interoperable systems that improve care coordination and data access—benefits that could extend to patients, especially those managing chronic conditions. However, the long-term impact on data security and quality assurance remains uncertain, as reduced oversight might weaken standards if not balanced with alternative accountability mechanisms. A comparable precedent is the 2015 Cures Act, which mandated interoperability and sought to end information blocking; HTI-5 may be seen as a follow-up effort to further loosen regulatory constraints in that same domain. What remains to watch is whether reduced compliance burdens lead to measurable improvements in clinical workflows or if they risk undermining