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IN BRIEF
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The Department of Health and Human Services (HHS) is taking significant steps to improve the landscape of health information technology (IT) through a proposed regulatory modification aimed at enhancing interoperability. By leveraging procurement policies, HHS seeks to establish a framework that aligns health IT acquisitions with recognized standards established by the Office of the National Coordinator for Health IT (ONC). This initiative not only emphasizes the importance of compliance with interoperability standards but also represents a proactive approach to integrating technology more effectively across health systems. In doing so, HHS aims to foster an environment where the efficient exchange of health information becomes a fundamental aspect of health care delivery.
The Department of Health and Human Services (HHS) is intensifying its efforts towards health data interoperability by proposing a rule designed to align procurement practices with standards and specifications set by the Office of the National Coordinator for Health IT (ONC). This initiative is part of HHS’s broader strategy to enhance health information technology (health IT) practices across various federal entities. By mandating that contractors comply with established standards or certification programs, HHS aims to ensure that health IT systems can effectively exchange data and improve overall healthcare delivery.
Proposed Rule Overview
On August 9, 2024, HHS published a proposed rule that seeks to amend the Health and Human Services Acquisition Regulation (HHSAR). This amendment will implement a policy requiring that all solicitations and contracts involving the “implementing, acquiring, or upgrading health IT” adhere to certain standards. Comments regarding this proposed rule are due by October 8, 2024, presenting stakeholders with an opportunity to weigh in on these crucial developments.
Alignment with ONC Standards
The proposed changes aim to align procurement practices with ONC’s standards and implementation specifications. This is significant because it establishes a consistent framework that all HHS agencies must follow, thereby streamlining health IT investments across the department. The intention behind this alignment is to foster a cohesive health IT environment that prioritizes data interoperability and efficiency.
Historical Context
The push for standardized health IT practices is not a new initiative; in fact, it traces back to the HITECH Act of 2009. This act codified previous directives, including Executive Order 13410 issued in 2006 by the Bush Administration. The executive order required all federal agencies implementing, acquiring, or upgrading health IT systems to use systems that meet recognized interoperability standards. Thus, HHS’s current proposal emerges as a continuation of a long-standing federal commitment to enhancing health IT across the nation.
Contracting Requirements
Under the proposed rule, HHS contracting officers would no longer be able to award contracts involving health IT unless the contractor either meets the ONC standards or is certified under the ONC Health IT Certification Program. This requirement ensures that only those contractors committed to adhering to high standards will be engaged in the procurement process. The proposed regulation stipulates specific procurement language that must be included in relevant contracts.
Defining Health IT and Implementation
The term “health IT” is broadly defined in the proposed regulation, encompassing various technologies that are intended to improve the electronic creation, maintenance, and sharing of health information. It is essential to understand that the proposed rule emphasizes which activities would be classified as “implementing” health IT, focusing on investments necessary for maintenance, data collection, and health information exchange.
Scope of the Proposed Regulation
While the proposed rule establishes clear requirements regarding compliance, the specific scope of its application raises some questions. The rule applies to contracts for health IT procured on behalf of HHS entities and also extends to work performed by contractors classified as health care providers, health plans, or health insurance issuers. This broad application indicates the significance of health IT standards across the healthcare spectrum and the federal landscape.
Implications for Contractors
Entities that enter into contracts with HHS to implement, acquire, or upgrade health IT are urged to thoroughly review the newly proposed requirements. As this regulation may mark the first time comprehensive health IT standards are enforced, organizations must consider the implications of compliance and engage with the ongoing comment period thoughtfully. HHS is particularly interested in clarifying what constitutes “implementing” health IT, indicating an openness to stakeholder input during this important regulatory process.
The Path Forward
The proposed changes align with HHS’s broader Health IT Alignment Policy enacted in 2022, which aims to standardize the language and requirements for contracts, grants, and regulatory actions involving health IT. As the push for interoperability advances, stakeholders should expect additional policy initiatives aimed at fostering adherence to recognized health IT standards.
For more information regarding this proposed rule and to stay updated on comments and discussions surrounding its implications, please check the following resources: HHS Proposed Rule Information, Regulations.gov Document, and Fact Sheet: Biden-Harris Administration.
Comparison of HHS Procurement Policies and their Impacts on Health IT Standards
| Aspect | Description |
| Objective | Enhance interoperability through standardized health IT procurement |
| Proposed Rule Date | August 9, 2024 |
| Comment Deadline | October 8, 2024 |
| Application Scope | Contracts involving implementation, acquisition, or upgrades of health IT |
| Compliance Standards | Requires adherence to ONC standards or certification for health IT |
| Historical Context | Initiatives dating back to 2006 and reinforced by HITECH Act |
| Health IT Definition | Includes hardware, software, integrated technologies related to health information |
| Impact on Entities | Applies to contracts with health care providers, plans, and issuers |
| Future Implications | May lead to additional health IT policy actions and regulations |
The Department of Health and Human Services (HHS) is positioning itself to enhance health data interoperability through an ambitious proposed rule aimed at its acquisition practices. This initiative seeks to embed compliance with existing health information technology (IT) standards into all contracts related to health IT. Published shortly after similar regulatory actions, HHS’s plan underscores its commitment to ensuring that health IT procurement aligns with the standards set forth by the Office of the National Coordinator for Health IT (ONC).
Overview of the Proposed Rule
On August 9, 2024, HHS proposed a modification to the Health and Human Services Acquisition Regulation (HHSAR) to create a unified requirement across the department. This rule mandates that all entities seeking to engage in health IT procurement either adopt ONC standards or obtain certification through the ONC Health IT Certification Program, thereby promoting a consistent approach to health data management.
Historical Context
This initiative is not entirely new; it follows a longstanding commitment to standardizing health IT within federal operations. The push for such regulations traces back to the HITECH Act of 2009, which established foundational requirements for health IT. Moreover, the intention to create standardized procurement language was declared by HHS in 2022, aiming to streamline processes across grants and contracts.
Key Requirements and Implications
The proposed regulations stipulate that no contract involving health IT will be awarded unless the contractor can demonstrate compliance with ONC standards or provide proof of certification. This requirement is significant for healthcare providers and health plans, as it compels them to ensure that their IT systems align with mandated capabilities. The clear linkage between compliance and procurement will likely reshape interactions within the health IT marketplace.
Understanding the Scope of ‘Health IT’
Health IT is broadly defined in the proposed rule to encompass hardware, software, and integrated technologies that facilitate the electronic handling of health information. This extensive definition hints at the potential reach of the new procurement policies. Notably, even activities incidental to contracts, such as data exchange for research purposes, must now be considered within the context of health IT implementation.
Future Directions and Considerations
HHS has explicitly requested feedback on the scope of what constitutes “implementing” health IT, indicating an openness to refine regulations based on stakeholder input. Organizations heavily involved in health IT procurement are encouraged to assess the proposed requirements and consider the implications for their current operational processes. Understanding these regulations will be vital in aligning with federal standards moving forward.
For those interested in further guidance, HHS has provided resources that outline the expectations under the new proposal. Stakeholders can read more about the specific provisions in the official documentation and explore related aspects of the 2024-2030 Federal Health IT Strategic Plan for comprehensive insights.
Key Aspects of HHS’s Procurement Policies for Advancing Health IT Standards
- Interoperability Promotion – Ensuring the use of standardized health IT for effective data sharing.
- Compliance Requirements – All health IT contracts must meet ONC standards or voluntary certification.
- Contract Scope – The policy applies to all HHS contracts involving health IT implementation and upgrades.
- Standard Language Deployment – Establishing consistent terminology across grants and contracts to enhance clarity.
- Historical Context – Building on over a decade of federal efforts to standardize health IT since the HITECH Act.
- Comments Solicitation – Inviting input from stakeholders to refine policies and clarify definitions.
- Broad Definition of Health IT – Includes hardware, software, and integrated technologies for health information exchange.
- Future Policy Actions – Anticipating continued emphasis on health IT standards across various HHS programs.
The Department of Health and Human Services (HHS) has proposed a significant change in its procurement policies aimed at enhancing health information technology (Health IT) interoperability. This initiative is encapsulated in a proposed rule that modifies the Health and Human Services Acquisition Regulation (HHSAR). The central aim is to align the procurement of health IT with standards and specifications set forth by the Office of the National Coordinator for Health IT (ONC). Comments on this proposal are expected by October 8, 2024, marking a crucial step towards the standardization of health IT across federal programs.
Standardization of Health IT Acquisition
One of the foremost recommendations stemming from the proposed rule is the necessity for a standardized procurement language that emphasizes compliance with ONC standards. It is essential for HHS contracting officers to ensure that contracts involving health IT stipulate the requirement for contractors to either meet these standards or utilize certified technology. This approach is vital to create a unified framework that all health care providers, health plans, and IT vendors must follow, ultimately fostering an environment of interoperability that enhances patient care and data sharing.
Implementation of ONC Standards
Entities looking to contract with HHS should not only familiarize themselves with ONC standards but also implement processes for compliance within their operational framework. The proposal indicates that compliance with ONC standards will be essential for any contract involving health IT that pertains to acquiring, implementing, or upgrading such technologies. It is recommended that organizations actively engage in training their staff to understand these standards and how to meet the required specifications as part of their contractual obligations.
Clarification of Scope and Definitions
Another significant aspect of the proposed rule is the necessity for clarity regarding the scope of contracts that are subjected to these new standards. As health IT encompasses a variety of technologies—including hardware and software—it is crucial for all involved parties to understand what qualifies as health IT. Organizations must engage in defining the term “implementing” within the context of their contracts to avoid ambiguity. It is recommended that HHS further elaborates on definitions to ensure that all stakeholders are aligned in their interpretation of contract requirements regarding health IT.
Incidental vs. Required Activities
The proposed rule attempts to delineate between incidental activities related to health IT and those that require compliance with ONC standards. To avoid confusion, it is vital to clarify how data exchange requirements might align with contract stipulations. Organizations should conduct thorough policy analysis to pinpoint exactly when health IT utilization triggers the need for compliance. This level of scrutiny can prevent organizations from facing unintended non-compliance penalties should their contracts inadvertently require the use of health IT technologies, which are not clearly classified.
Engagement and Feedback Mechanism
Given the complexity and potential impact of the proposed procurement policies on health IT, it is essential to establish a robust feedback mechanism for all stakeholders involved. HHS should prioritize engaging healthcare providers, contractors, and technology vendors to understand their concerns and perspectives regarding the proposed changes. Actively seeking and incorporating stakeholder feedback will not only improve the quality of the proposed rule but also enhance its acceptance among those it seeks to regulate.
Future Directions and Policy Development
This proposal marks a pivotal step towards a more cohesive federal approach to health IT procurement. Entities affected by this rule should be proactive in aligning their practices with the anticipated policies. Reviewing internal processes to ensure alignment with HHS Health IT Alignment Policies will be instrumental, as future regulatory actions are expected to push further requirements for using health IT standards. Organizations should prepare for potential forthcoming regulations that may broaden the scope of these requirements to include cooperative agreements and grants, thus necessitating ongoing vigilance and adaptability in their compliance efforts.
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