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HIT Perspectives – December 2024
Reflecting on 2024’s Top 5 Milestones: A Year of Progress in Health IT
By Tony Schueth, CEO
Quick Summary
- CMS-0057 mandates FHIR APIs, driving interoperability and improving patient access.
- Anticipated finalization of the HTI-2 rule promises to enhance FHIR API certification and public health data sharing.
- Federal roadmaps, including ASTP’s FHIR Action Plan and HHS’s Data Strategy, emphasize interoperability and consent management.
- TEFCA becomes operational, connecting stakeholders through qualified health information networks (QHINs).
- FHIR integration into TEFCA SOPs and the FAST Security Implementation Guide improves security and real-time data exchange.
- AI governance advances with the Coalition for Health AI’s framework for responsible use and the Biden administration’s Executive Order on AI Safety.
- Preapproval Information Exchange (PIE) in life sciences enables proactive payer collaboration, expediting patient access to therapies.
- Pharmacy interoperability takes center stage, with policymakers and standards organizations improving data-sharing workflows.
2024 has been a whirlwind year in healthcare information technology (health IT), marked by significant accomplishments and milestones that promise to shape healthcare technology today and, in the future, as well as policies yet to surface. In this year-end issue of HIT Perspectives, we take a closer look at the five key areas where substantial advancements have been made, underscoring the industry’s momentum toward interoperability, enhanced patient access and streamlined data-sharing processes. We also spotlight the year’s landmark achievements in policy, technology and strategic initiatives that are building a more efficient and connected healthcare environment.
1. A Big Year for Health IT Policies and Strategic Initiatives
In 2024, major policy changes and strategic shifts by key federal healthcare policy bodies — most notably the Centers for Medicare & Medicaid Services (CMS) and the restructured & renamed Office of the National Coordinator for Health IT to the Assistant Secretary for Technology Policy (ASTP) — set a new foundation for the future of health IT. Below are some of the critical developments shaping interoperability, data exchange and patient empowerment.
CMS-0057: Mandating FHIR APIs to Foster Interoperability and Streamline Prior Authorization
The CMS-0057 final rule emerged as a pivotal regulation designed to drive healthcare interoperability and improve patient access to health information. This rule mandates the implementation of five Fast Healthcare Interoperability Resources application programming interfaces (FHIR APIs) enabling seamless data exchange among healthcare providers, payers and health IT developers. The APIs will empower patients by giving them greater control over their health data and streamlining prior authorization workflows, setting the stage for expanded digital health initiatives.
Beyond improving immediate data-sharing capabilities, CMS-0057 lays the groundwork for future regulatory developments. These APIs serve as a foundation for more advanced interoperability and are essential for building a healthcare system that is both transparent and efficient. For insights on the strategic advantages of implementing CMS-0057, check out the Point-of-Care Partners (POCP) analysis "Understanding and Leveraging CMS-0057 for Strategic Advantage" and explore our dedicated resource on payer navigation and CMS interoperability.
Drafting and Anticipated Finalization of the HTI-2 Rule
Alongside CMS-0057, the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule made a splash earlier this year. If finalized, it would build on the framework established by Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing final rule (HTI-1). HTI-2 outlines voluntary certification for FHIR APIs, as named in the CMS 0057 final rule, as well as requirements related to strengthening public health data sharing and access, reinforcing the shift toward a more cohesive, interoperable health IT infrastructure. As the industry anticipates HTI-2 finalization, healthcare stakeholders are preparing for a future when certified APIs facilitate standardized data exchange across all facets of the healthcare system. More information on the implications of HTI-2 can be found in our ongoing coverage, HTI-2 Blog Series.
Federal Agency Roadmaps and Action Plans to Accelerate FHIR and Data Strategies
This year, federal agencies released several action plans to accelerate FHIR adoption and enhance data management strategies. ASTP’s 2024 draft FHIR Action Plan outlined strategic steps to embed FHIR standards in public health initiatives and advance interoperability for social determinants of health data. This focus not only enhances real-time data exchange but supports innovations like artificial intelligence (AI), ensuring the health IT infrastructure remains adaptable to evolving healthcare needs. The FHIR Action Plan represents a foundational blueprint for driving future regulatory developments. You can review its priorities and implications in greater detail here and POCP’s analysis here.
Additionally, the 2023-2028 Health and Human Services (HHS) Data Strategy and its focus on consent management underscore the agency’s commitment to bridging health and human services data, fostering a holistic approach to health data governance. For an in-depth look at this strategy’s role in supporting seamless data integration, see our feature on consent management in the HHS Data Strategy here.
Each of these policies and initiatives contributes to a cohesive, patient-centered approach to health IT, making 2024 a landmark year in the journey toward nationwide interoperability and integrated health data governance.
2. TEFCA Goes Operational with Inaugural QHINs
This year marked a milestone for health information exchange as the Trusted Exchange Framework and Common Agreement (TEFCA) became operational, bringing to life the vision of a nationwide data-sharing network. TEFCA’s operational launch, officially in late December 2023, is significant, with several qualified health information networks (QHINs) leading the charge. The inaugural QHINs, including eHealth Exchange, Epic Nexus, KONZA, MedAllies and Health Gorilla, represent early adopters dedicated to building this robust, interoperable data-sharing framework. Currently, this group of QHINs has expanded to include such key players as Commonwell Health Alliance and Kno2, underscoring the growing commitment by many to connect through TEFCA.
For providers, payers, patients and vendors, TEFCA operationalization represents a common mechanism for accessing and sharing patient data across systems, improving patient care coordination, advancing a standards approach to accessing and sharing this information and reducing administrative burdens. However, as TEFCA is still in its early stages, 2025 will be a critical year for advancing the framework. Notably, we expect ASTP to continue spearheading pilot programs to advance the program by addressing adoption barriers and demonstrating TEFCA benefits for a broader range of stakeholders.
One major development for TEFCA this year was the inclusion of FHIR in its standard operating procedures (SOPs). The “FHIR over TEFCA” initiative ensures real-time data exchange capabilities that will be compatible with future advancements, making FHIR a central component in TEFCA’s evolution. Additionally, the SOPs include the FHIR At Scale Taskforce (FAST) Security Implementation Guide, signaling the importance of robust security in health data exchange. This guide, developed by industry experts, provides a foundational framework for safeguarding patient information and aligning TEFCA security protocols with industry standards.
Looking forward to the upcoming release of FAST’s STU 2 Security Implementation Guide, balloting in January 2025, will set further standards for securing FHIR-based exchanges under TEFCA. As TEFCA matures, healthcare organizations and stakeholders are encouraged to familiarize themselves with FAST and incorporate these security practices into their interoperability strategies to fully leverage the TEFCA framework. Luckily, a half-day FHIR over TEFCA Security Education Event is planned for January 13, 2025, to help stakeholders learn more. This event will feature speakers from the FAST Security team, Sequoia project and HL7. Learn more and register.
More on TEFCA's current state and potential can be found in our coverage here.
3. AI in Health IT: Turning Potential into Practice
AI continued to dominate headlines in 2024, but this year also saw concrete action toward establishing a safe and reliable framework for its use in healthcare. In January, the Biden administration expanded the Executive Order on AI Safety and Security issued in late 2023, detailing the steps needed to ensure the trustworthy deployment of AI. Additionally, a bipartisan Task Force on AI led by House Speaker Mike Johnson and Minority Leader Hakeem Jeffries was formed, with specific subcommittees dedicated to exploring AI’s impact on healthcare, privacy and ethical standards.
One notable initiative, the Coalition for Health AI (CHAI), launched guidelines for responsible use of AI in healthcare. POCP has proudly contributed to CHAI’s program management, reinforcing our commitment to ensuring that AI development and implementation in healthcare are both ethical and effective. As AI’s role in healthcare continues to evolve, these initiatives lay the groundwork for responsible AI practices that prioritize patient safety, privacy and data integrity.
4. Life Sciences and Digital Innovation: Prioritizing Patient Access
The life sciences sector made notable strides in 2024, especially in its embrace of digital tools and data-sharing strategies that prioritize timely patient access to new therapies. One standout development is advancement of preapproval information exchange (PIE), allowing life sciences companies to share select clinical and economic data with payers before therapy approval. This approach is a game-changer as it not only expedites patient access post-approval but enables payers to leverage AI to identify prospective patients early, allowing them to begin critical therapies sooner. As digital innovations continue to permeate life sciences, we expect the sector to make even greater headway in patient-centered care through proactive data sharing and advanced analytics. For more information, refer to the POCP article on PIE here.
5. Pharmacy Interoperability Takes Center Stage
Interoperability in healthcare has long focused on connecting providers, patients and payers, yet in 2024 the pharmacy setting became a top priority. With pharmacists increasingly integral to the care team, policy-making bodies and standards organizations like the National Council for Prescription Drug Programs, ASTP/ONC, HL7 and Sequoia Project have initiated efforts to address interoperability within pharmacy workflows. This focus on pharmacy interoperability will lead to new standards, refined workflows and possibly new reimbursement models for pharmacy-based clinical services. In line with these developments, new standards and task forces are emerging to facilitate better integration of primary practice pharmacists offering clinical services as a part of the broader patient care team. POCP dives deeper into these shifts in our recent blog on pharmacy interoperability here.
Looking Ahead: Strategic Guidance for 2025
As we close out a year of tremendous growth, the focus now shifts to how healthcare organizations can leverage these milestones to shape their 2025 strategies. From preparing for TEFCA adoption to implementing FHIR-based APIs for seamless interoperability, the journey ahead requires thoughtful planning and strategic alignment. At POCP, we specialize in helping organizations navigate complex health IT landscapes, prioritize their resources and achieve compliance with emerging regulations. If your organization seeks to capitalize on these 2024 advancements and ensure strategic compliance with evolving health IT policies, contact us to learn how we can support your 2025 goals.