The Office of the National Coordinator for Health Information Technology has taken a significant step to reduce friction in the health IT certification process, finalizing the HTI-5 rule with substantial cuts to existing requirements. By eliminating 14 criteria and revising seven others, ONC is signaling a deliberate shift toward a more streamlined certification pathway—a move that will reshape how vendors bring products to market and how health systems evaluate their technology purchases.
For vendors, the streamlined approach represents both opportunity and competitive pressure. Smaller and mid-market health IT companies that previously struggled to meet comprehensive certification requirements may now find pathways to market entry more accessible. However, this democratization of certification could intensify competition among established players, forcing larger vendors to reconsider their compliance strategies and potentially their pricing models. The reduction in criteria suggests ONC recognizes that prescriptive, one-size-fits-all certification standards may inhibit innovation rather than foster it.
Health system leaders, however, face a more complex calculus. While fewer certification criteria could theoretically accelerate the pace at which new solutions reach the market, it also creates an important question: Does less stringent certification mean less reliable products? Organizations will need to implement more rigorous internal vetting processes to compensate for lighter ONC oversight. This places additional burden on IT and procurement teams already stretched thin, requiring them to conduct deeper due diligence on vendor capabilities, security postures, and interoperability performance.
The Information Blocking Elephant in the Room
The most telling aspect of this rulemaking is what ONC deferred: decisions on information blocking enforcement remain in limbo. Information blocking—the practice of deliberately preventing or delaying the sharing of electronic health information—has emerged as a critical concern for health systems seeking to break down data silos. The fact that ONC delayed addressing how information blocking rules will interact with this new certification framework signals that the agency may still be wrestling with enforcement complexity.
For health systems, this creates regulatory uncertainty. Organizations cannot fully understand how vendor obligations around data sharing will be enforced under the new framework, making it difficult to negotiate contracts with confidence or establish accountability measures. For vendors, delayed clarity on information blocking enforcement could mean surprise compliance obligations down the road or retroactive enforcement actions.
The timing also matters. As interoperability increasingly drives competitive advantage and regulatory pressure mounts for data liquidity, vendors need clear guidance on their obligations. A vendor-friendly certification process paired with murky information blocking enforcement could perversely incentivize vendors to achieve certification while skirting data-sharing commitments—the opposite of what ONC intended.
The HTI-5 final rule reflects a philosophical pivot toward lighter-touch regulation in health IT certification. For an industry that has chafed under burdensome compliance regimes, this is welcome. But health system leaders should approach this moment with clear eyes. Lower certification barriers do not eliminate the need for rigorous vendor evaluation. If anything, they amplify it. Organizations should use this transition period to strengthen their internal capability to assess vendor claims independently, rather than relying solely on ONC certification as a proxy for quality or reliability.
Until ONC resolves its information blocking questions, the full implications of HTI-5 remain unclear. Both vendors and health systems should monitor for further guidance and prepare accordingly.
Reporting basis: healthcaredive.com. Analysis by the HTC editorial desk.