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HIT Perspectives – December 2024

Turning up to 11: Playlist for 2025 Health IT Trends

Brian Dwyer By Brian Dwyer, Business Strategy Lead 

Quick Summary

  • Health IT Policy Shifts: Anticipated changes under the new administration could include reversals of Biden-era policies, HIPAA modernization, and evolving TEFCA priorities.
  • Prior Authorization Modernization: CMS-0057 highlights the use of FHIR APIs to reduce inefficiencies, streamline workflows, and improve patient care timelines.
  • Pharmacy Interoperability: Enhanced data sharing among pharmacists, providers, and stakeholders is critical for better medication management and care coordination.
  • Advances in AI: Practical applications of AI are emerging, with a focus on addressing data quality, ethical use, and regulatory oversight.
  • Value-Based Care and Health Equity: Changes in federal priorities may shift equity-focused strategies and influence care delivery models.
  • Digital Health Regulations: Increased scrutiny on data protection and interoperability makes proactive regulation tracking a priority for stakeholders.
  • Patient Consent and Data Sharing: New consent management standards, like those from FAST, aim to balance privacy and interoperability.
  • Personalized Medicine and Precision Health: Genomics integration with EHRs is advancing but requires data standardization and regulatory compliance.
  • Digital Health Integration: Companion apps and digital tools are enhancing patient engagement but face complex regulatory pathways.
  • Real-World Evidence (RWE): Leveraging RWE for clinical decision-making demands robust data infrastructure and partnerships.
  • Remote Patient Monitoring: Wearable technology and RPM tools support proactive care but require secure data management and regulatory compliance.

As we close out a year that includes a historic election, we want to look forward and contemplate what the new year may bring. With all the progress made in 2024, what will the industry build upon? What will the role of new or dismantling policy play? What areas of focus will the industry drive forward because it should and not because it is required? We at Point-of-Care Partners (POCP) are committed to providing strategic guidance by tracking critical industry developments. In 2025, POCP will maintain our focus on the following areas to help our clients recognize and understand opportunities and potential challenges as the ground shifts beneath our feet.

1.    Health IT Policy Shifts

With a new presidential administration, changes in healthcare information technology (health IT) policy are expected. The industry will be watching for potential reversals or modifications to Biden-era policies. These could include shifts in funding priorities, such as possible Centers for Disease Control and Prevention budget cuts affecting public health programs and data collection efforts. Additionally, the progression of regulations like Health Insurance Portability and Accountability Act (HIPAA) modernization and the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule will shape compliance requirements for stakeholders. The future of the Trusted Exchange Framework and Common Agreement could also be uncertain, depending on the administration's focus on data sharing and interoperability.

Why this matters: Regulatory changes can affect compliance obligations, funding allocations, and strategic planning for healthcare organizations and technology vendors.

Implications for industry: Stakeholders will need to closely monitor and analyze changes and quickly adjust their strategies to align with potential regulatory pivots and maintain compliance with evolving standards.

2.    Prior Authorization Modernization

Prior authorization (PA) remains one of the most significant administrative burdens in healthcare, affecting both payers and providers while directly impacting patients’ time to therapy. The CMS-0057 proposed rule is poised to accelerate efforts to modernize the PA process by mandating the use of standardized Fast Healthcare Interoperability Resources application programming interfaces (FHIR APIs) and implementation guides, which are critical to meeting compliance deadlines and achieving meaningful interoperability.

Stakeholders across the industry are actively exploring solutions, with some building in-house tools and others partnering with technology vendors to address the requirements outlined in CMS-0057. These partnerships must be carefully evaluated as the decision to build or buy a solution — and choosing the right partner if outsourcing — can determine the effectiveness of an organization’s compliance strategy and operational efficiency.

Why This Matters: PA processes continue to account for a significant share of administrative overhead, consuming valuable resources of providers and payers. Providers must often navigate time-consuming manual processes to secure approvals, while payers face challenges managing these transactions efficiently. Patient care is directly affected by PA delays prolonging the time to begin critical therapies, ultimately impacting health outcomes. CMS-0057 emphasizes the implementation of FHIR APIs and standardized workflows to streamline communication between stakeholders. Adhering to these standards is not only a compliance issue but also a pathway to reducing inefficiencies and improving coordination.

Implications for Industry: Organizations need to perform realistic assessments of their capabilities to determine whether building an internal solution or partnering with a vendor is the proper path. This decision often hinges on existing infrastructure, resource availability and an organization's long-term strategic goals. Meeting Centers for Medicare and Medicaid Services (CMS) deadlines requires a clear roadmap for implementing FHIR APIs and related standards, which can be complex and resource-intensive. Organizations that delay preparation risk noncompliance penalties and falling behind competitors.

Success in PA modernization often depends on effective collaboration across payers, providers and technology partners to align on solutions that reduce burdens and improve speed of care.

Stakeholders should be vigilant in their progress toward CMS-0057 compliance, checking in early and often to allow for changes in course. We find issues often aren’t discovered until close to the deadline, when mitigating such issues correctly is next to impossible. Sometimes an objective partner can help navigate these challenges, recommend updates to processes to extract maximum value from their compliance efforts, and create plans for building skills and resources that best maintain and foster continuous improvement and efficiencies even after the deadlines have passed.

2025 HITP Turn it up to 11 Playlist Graphic3.    Pharmacy Interoperability

Interoperability across all care settings remains an essential part of seamless healthcare delivery, however, up until recently, pharmacy wasn’t always consistently viewed as a care setting or seen as a priority. Enhanced data exchange supports better patient outcomes through improved coordination among pharmacists, providers, and other stakeholders. Initiatives led by such organizations as the National Council for Prescription Drug Programs and Sequoia Project are laying the groundwork for significant improvements in pharmacy data sharing.

Why this matters: Pharmacy interoperability enables pharmacists to access and share critical clinical information supporting medication management, preventive care, and chronic disease monitoring while reducing redundant processes and improving workflow efficiency.

Implications for industry: Stakeholders will need to navigate the complexities of system integration, understanding workflow and the needs of not only pharmacists providing clinical services but the data other providers on a patient’s care team may need, all while ensuring compliance with new standards and optimizing the use of pharmacy-based clinical data.

4.    Advances in AI

The health IT sector is moving past the hype phase of artificial intelligence (AI) and toward practical, impactful uses. While AI has shown promise in enhancing diagnostics, decision support, and administrative functions, challenges concerning data quality, bias, and regulatory oversight remain. The industry is currently awaiting the development of standards to govern the ethical and safe use of AI, as well as new legislation that may affect its adoption.

Why this matters: Realistic AI implementation can improve clinical outcomes and operational efficiencies. However, stakeholders must mitigate risks associated with data privacy, bias, and ethical use.

Implications for industry: Stakeholders will need to identify and pilot potential practical applications of AI, ensuring their adoption aligns with best practices and emerging regulations. This will require imagination, creativity, and meticulous methodology for testing.

5.    Value-Based Care and Health Equity

Value-based care models aim to improve patient outcomes while controlling costs, and health equity is an integral part of this approach. However, under a new administration, the level of federal support for health equity initiatives may change. This may influence how organizations align their value-based care strategies with equity-focused objectives.

Why this matters: Addressing disparities in healthcare delivery is not only a moral imperative but a strategic one, as value-based models often depend on holistic and inclusive care.

Implications for industry: Stakeholders should align their strategies with evolving equity-focused policies and adapt data collection and reporting to meet new standards. Language concerning equity may change to focus more on care gaps and underserved populations.

6.    Digital Health Regulations and Compliance

As digital health solutions proliferate, ensuring compliance with evolving regulations becomes more complex. With increased scrutiny on data protection, cybersecurity, and interoperability, stakeholders must keep current with both domestic and global regulations, such as the European Union's Medical Device Regulation.

Why this matters: Noncompliance can result in significant fines, operational disruptions, and damage to reputation, making proactive regulation tracking essential.

Implications for industry: Stakeholder priorities should focus on maintaining compliance, mitigating risks and staying ahead of regulatory changes to avoid costly penalties.

7.    Patient Consent and Data Sharing

As data become more fluid and leveraged for digital health programs, early identification for clinical trials and use across care settings and with payers, managing patient consent becomes more challenging and a more critical problem to solve. Regulations surrounding patient consent and data sharing are becoming stricter as privacy concerns grow. The push for patient-centric data models and interoperability demands robust consent management processes. Emerging standards for consent, such as those highlighted in the FHIR At Scale Taskforce (FAST) consent management project, aim to address these challenges.

Why this matters: Organizations must adjust data governance policies and workflows to meet new compliance requirements, protecting patient rights while facilitating data flow.

Implications for industry: Stakeholders should monitor industry consent management initiatives, like FAST, to provide input and help shape a standardized approach. This should enable comprehensive consent management strategies that leverage standards and align with regulatory and best practices.

8.    Personalized Medicine and Precision Health

The advancement of genomics and the integration of genetic data with electronic health records (EHRs) are making personalized medicine a reality, allowing for treatments tailored to individual patient profiles and enhancing the effectiveness of medical interventions. However, the complexity of data integration and the need for regulatory alignment remain challenges.

Why this matters: Precision Health not only promises better clinical outcomes but requires that data handling practices align with stringent privacy and security standards.

Implications for industry: Payers, life sciences companies, and health IT vendors will need to adapt to data standardization requirements and privacy regulations, enabling effective use of genomic data.

9.    Digital Health Integration and Companion Apps

The integration of digital health tools and companion apps in patient treatment plans is becoming more common. These tools improve patient engagement and adherence, providing real-time data that support clinical decision-making. However, navigating regulatory pathways for these apps remains elusive.

Why this matters: Digital tools can enhance patient care and provide valuable data for personalized treatment but must be compliant with health data regulations.

Implications for industry: Stakeholders will want to monitor the regulatory and standards landscape with a focus on consent, Health Insurance Portability and Accountability Act updates, etc.

10. Real-World Evidence and Data Integration

Real-world evidence (RWE) is increasingly being used for clinical decision-making and regulatory purposes. RWE leverages data from various sources, including electronic health records, patient registries, and wearable devices, to provide insights into treatment effectiveness and patient outcomes.

Why this matters: The ability to integrate and analyze real-world data helps stakeholders make better decisions but requires robust data infrastructure and partnerships with health IT vendors.

Implications for industry: POCP will guide clients in enhancing their data collection and analytics capabilities to use RWE effectively in regulatory submissions and clinical programs.

11. Remote Patient Monitoring and Wearable Technology

The integration of remote patient monitoring (RPM) and wearable technology is a growing trend that supports continuous health monitoring and improved patient engagement. These tools provide real-time health data, enabling proactive intervention and better chronic disease management.

Why this matters: As RPM and wearables become more integrated into healthcare programs, stakeholders must address issues of data security, compliance, and data integration.

Implications for industry: Stakeholders will want to consider how to incorporate RPM and wearables into care plans, ensuring secure data management and compliance with regulatory standards.

Conclusion

Monitoring these 11 key areas will be critical for healthcare stakeholders to remain competitive and compliant in 2025. By staying on top of these developments, POCP aims to provide strategic insight and practical guidance that help organizations navigate the evolving health IT landscape with confidence. Contact us to set up time to discuss your 2025 strategic priorities and how we can help your organization maneuver what is sure to be a rollercoaster of a year.