The United States health technology sector is poised for its most significant transformation in a decade, prompted by the introduction of the Health Data, Technology, and Interoperability (HTI-5) proposed rule. This sweeping proposal, originating from the Department of Health and Human Services, is driven by a powerful executive order aimed at unleashing prosperity through deregulation and seeks to fundamentally dismantle the existing regulatory framework governing health information technology. By targeting the elimination of nearly 70% of the certification requirements for electronic health records and related systems, HTI-5 signals a decisive pivot away from the prescriptive oversight that has defined the industry for years. The rule’s core objective is to reduce compliance burdens, grant greater flexibility to software developers and healthcare providers, and crucially, foster a new wave of innovation powered by artificial intelligence, setting the stage for a profoundly altered healthcare landscape.
A Radical Overhaul of Certification
At the epicenter of the HTI-5 proposal is a dramatic and ambitious plan to streamline the Health IT Certification Program by eliminating more than half of its 60 existing certification criteria. This far-reaching change is designed to alleviate what the administration has identified as a significant compliance burden on technology developers, thereby freeing up substantial resources that can be redirected from regulatory maintenance to research and development. A key illustration of this deregulatory philosophy is the proposed removal of the “model card” requirements for clinical decision support algorithms—a transparency measure implemented by the preceding administration. This specific action underscores a broader strategic shift, prioritizing the speed of innovation and market-driven progress over prescriptive, government-mandated oversight. By lowering the financial and operational barriers to entry, the rule intends to cultivate a more dynamic and competitive marketplace for health technology solutions.
This new direction creates a fundamental tension with the landmark 21st Century Cures Act, which established a highly detailed and prescriptive framework for health IT. While both legislative efforts share the overarching goals of promoting interoperability and preventing information blocking, their methodologies diverge sharply, revealing a clash between two distinct regulatory philosophies. The Cures Act relied on extensive certification requirements and mandatory technical standards to ensure a baseline of functionality and transparency. In stark contrast, HTI-5 champions a model that favors voluntary standards adoption and trusts the competitive pressures of the marketplace to drive progress and ensure quality. This philosophical pivot is most evident in the context of artificial intelligence, where HTI-5 deliberately removes transparency mandates to reduce barriers to adoption, representing a significant departure from the Cures Act’s emphasis on detailed oversight.
Recalibrating Data Exchange and AI Innovation
While spearheading a deregulatory agenda, the HTI-5 proposed rule does not entirely abandon the foundational principles of data access and exchange. Instead, it aims to refine and clarify the existing regulations surrounding information blocking to address what have been identified as instances of misuse and abuse of the current definitions and exceptions. The proposal seeks to revise key definitions to more effectively promote the access, exchange, and use of electronic health information (EHI), ensuring that the rules are not inadvertently stifling legitimate data sharing among providers and with patients. The ultimate goal of these revisions is to provide clearer, more practical guidance on which activities are permissible, thereby protecting a patient’s fundamental right to their health data while removing ambiguity for healthcare organizations striving for compliance in an increasingly complex digital environment.
A central pillar of the HTI-5 framework is its strategic focus on creating a fertile environment for the proliferation of artificial intelligence within the healthcare ecosystem. The rule strongly advocates for the advancement of Fast Healthcare Interoperability Resources (FHIR) based Application Programming Interfaces (APIs) as the key technological conduit for enabling sophisticated, AI-driven interoperability solutions. In harmony with its overarching deregulatory stance, the proposal seeks to reduce AI transparency requirements that were established in the previous administration’s rulemaking. This approach is part of a larger initiative to modernize standards and certification processes, making them more agile and accommodating to the rapid, iterative development cycles characteristic of AI technologies. By fostering this environment, the rule aims to accelerate the deployment of intelligent tools that can enhance clinical decision-making, streamline workflows, and personalize patient care.
Navigating the New Industry Landscape
The finalization of the HTI-5 rule would trigger a cascade of changes, creating a complex new reality for different segments of the healthcare industry. For health IT developers and vendors, the most immediate impact would be a significantly reduced compliance burden, with projected industry savings exceeding $1 billion. This financial and operational relief would empower developers to reallocate resources from maintaining certifications to investing in research and the creation of new technologies. However, this deregulation would also lower the barrier to entry, likely intensifying competition in the marketplace. Established vendors will need to adapt by enhancing their product offerings and refining their strategies to differentiate themselves in a more crowded field. The new freedom in AI development presents a major opportunity, but it also requires careful navigation of market acceptance and potential liability concerns arising from diminished transparency.
For healthcare providers and health systems, the proposed revisions to information blocking regulations are intended to offer greater clarity on permissible activities, which should assist providers in ensuring their compliance with the refined standards. Moreover, the sweeping changes to the certification program will have a direct impact on vendor selection and the procurement of electronic health record systems. Providers will need to engage with their technology partners proactively to understand how the elimination of certain certifications might affect system capabilities, particularly in critical areas like interoperability and secure patient data access. It is crucial for these organizations to recognize that their obligations under the Cures Act persist; they remain subject to information blocking prohibitions and must continue to provide patients with timely and free access to their EHI, irrespective of the changes in vendor certification requirements.
A Transformed Policy Horizon
The analysis of the HTI-5 proposed rule revealed a fundamental recalibration of federal health IT policy, signaling a definitive transition from the prescriptive regulatory environment of the past toward a new model prioritizing market-driven innovation. This shift promised substantial cost savings and a reduction in administrative burdens for technology developers, which was intended to accelerate the pace of technological advancement, especially in artificial intelligence. However, this approach also introduced significant questions regarding the potential trade-offs between rapid innovation and the established principles of transparency, patient safety, and accountability. The interplay between HTI-5’s deregulatory philosophy and the foundational requirements of the Cures Act created a complex and transformed health IT landscape. Consequently, both healthcare providers and technology developers were required to closely monitor the final stages of the rulemaking process and undertake strategic preparations to navigate a new era defined by both new freedoms and persistent obligations.
