For health IT contractors working with federal agencies, compliance is not just a box to check—it’s a critical foundation for securing contracts, protecting sensitive data, and maintaining trust.
With federal health IT compliance requirements tightening and new risks emerging, contractors must stay ahead of the curve to avoid costly penalties and reputational damage.
This blog explores the top 2025 compliance risks for health IT contractors in the United States, offering practical insights into navigating federal contractor regulations, health IT security compliance, and more. Whether you’re a prime contractor or a subcontractor, understanding these challenges will help you thrive in a highly regulated environment.
Cybersecurity: The Heart of Federal Health IT Compliance
Cybersecurity is the backbone of health IT security compliance in 2025, as federal agencies ramp up scrutiny to protect sensitive health data. With cyberattacks growing in sophistication, contractors must meet stringent cybersecurity requirements to safeguard Electronic Protected Health Information (ePHI) and Controlled Unclassified Information (CUI).
Navigating NIST SP 800-171 and CMMC 2.0
For contractors working with the Department of Defense (DoD) or handling CUI, compliance with NIST SP 800-171 remains non-negotiable. This framework outlines 110 security controls, emphasizing:
- Robust access controls, including Multi-Factor Authentication (MFA).
- Continuous monitoring of systems and networks.
- Detailed System Security Plans (SSPs) to document compliance efforts.
Additionally, the Cybersecurity Maturity Model Certification (CMMC) 2.0 is gaining traction across federal contracts. In 2025, higher CMMC levels may become mandatory for certain contracts, requiring:
- Third-party audits to verify compliance.
- Comprehensive supply chain security measures.
- Regular self-assessments to identify vulnerabilities.
Failing to meet these standards could disqualify contractors from bidding or lead to contract termination.
Harmonized Incident Reporting Mandates
The federal government is streamlining incident reporting requirements under regulations like the Federal Acquisition Regulation (FAR), Defense Federal Acquisition Regulation Supplement (DFARS), and the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA). Contractors must be prepared to:
- Report breaches involving CUI within 8 hours of discovery
- Maintain clear incident response plans
- Coordinate with federal agencies to ensure transparency
A well-documented incident response strategy is critical to meeting these government health IT risk requirements and avoiding penalties.
HIPAA Compliance in 2025: Evolving Expectations
HIPAA compliance 2025 is more critical than ever for health IT contractors. The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting patient data, and updates in 2025 are raising the bar.
Stricter Privacy and Access Rules
Anticipated updates to the HIPAA Security Rule may make previously optional measures mandatory. Contractors should prepare for:
- Mandatory MFA for all systems accessing ePHI.
- End-to-end encryption for data at rest and in transit.
- Regular vulnerability scans (biannual) and penetration testing (annual).
- Detailed asset inventories to track devices and systems handling ePHI.
Additionally, patient privacy rights are expanding. Contractors must adapt to:
- Shorter timelines for fulfilling patient requests for PHI access (reduced from 30 to 15 days)
- Allowing patients to inspect PHI in person
- Enhanced workflows to ensure compliance with these access rights
Strengthening Business Associate Agreements (BAAs)
Federal agencies are likely to require annual written attestations from Business Associates to confirm compliance with HIPAA safeguards. This means contractors must:
- Maintain audit-ready documentation
- Implement robust technical and administrative safeguards
- Clearly define accountability for data protection in BAAs
Failure to comply could result in significant fines or loss of federal contracts.
Tracking Technologies and De-Identification
The use of tracking technologies like cookies or analytics tools on health IT platforms is under increasing scrutiny. Contractors must ensure these tools:
- Align with HIPAA de-identification standards.
- Are included in risk assessments.
- Do not inadvertently expose PHI through third-party integrations.
Non-compliance in this area could lead to breaches and regulatory action.
Information Blocking: Ensuring Seamless Data Access
The 21st Century Cures Act emphasizes interoperability and transparency in health IT systems. In 2025, health IT contractors must comply with information blocking rules enforced by the Office of the National Coordinator for Health Information Technology (ONC).
Designing for Interoperability
Contractors must ensure their systems enable seamless access to Electronic Health Information (EHI) without barriers. This includes:
- Building APIs that support third-party integration.
- Avoiding excessive fees or complex processes for data access.
- Designing systems with interoperability as a core feature.
Any practice that could be seen as “blocking” access to EHI—intentionally or not—could result in penalties.
Understanding Exceptions
While exceptions to information blocking (e.g., for privacy or harm prevention) exist, misapplying them can lead to violations. Contractors should:
- Train staff on the nuances of permitted exceptions.
- Document decisions to deny data access transparently.
- Align systems with ONC guidelines to avoid unintentional non-compliance.
System Architecture Overhaul
To meet these requirements, contractors may need to rethink system designs in 2025. This includes ensuring that software supports secure, user-friendly EHI access for patients and providers.
Supply Chain Risks: Accountability Beyond Your Organization
Federal contractor regulations in 2025 place significant emphasis on supply chain security. Prime contractors are responsible for ensuring that subcontractors and vendors comply with the same rigorous standards.
Conducting Vendor Due Diligence
Before partnering with vendors who handle ePHI or CUI, contractors should:
- Evaluate vendors’ cybersecurity maturity and incident history
- Verify certifications like SOC 2, ISO 27001, or FedRAMP
- Review vendors’ incident response and reporting protocols
Implementing Flow-Down Clauses
Contracts with subcontractors must include flow-down clauses to enforce:
- HIPAA compliance 2025 standards.
- NIST and CMMC requirements.
- Timely breach reporting and documentation.
Continuous Monitoring
To maintain compliance, contractors should implement:
- Routine audits of vendor practices.
- Vendor scorecards to track performance.
- Ongoing assessments to ensure alignment with federal standards.
A single weak link in the supply chain could jeopardize an entire contract.
Emerging Risks to Watch in 2025
Beyond the core compliance areas, several emerging trends pose government health IT risks for contractors in 2025.
Ethical AI Governance
As artificial intelligence (AI) becomes integral to health IT systems, federal agencies are focusing on:
- Bias mitigation in AI algorithms.
- Explainability of AI-driven decisions.
- Transparent audit trails for AI processes.
Contractors must establish governance frameworks to ensure ethical AI use and compliance with federal expectations.
Telehealth Compliance
With telehealth becoming a permanent fixture in healthcare, contractors supporting virtual care platforms must address:
- Licensing requirements across state lines.
- Security standards for video consultations.
- HIPAA-compliant integrations for telehealth tools.
Non-compliance in this area could lead to regulatory scrutiny and patient data exposure.
Billing and Coding Accuracy
Health IT systems that support billing must align with 2025 compliance risks related to coding standards. Contractors should ensure their platforms:
- Support updated codes like ICD-11 and CPT.
- Provide clear audit trails for billing processes.
- Prevent errors like upcoding or undercoding that could trigger fraud investigations.
Turning Compliance into a Strategic Advantage
In 2025, federal health IT compliance is not just about avoiding penalties—it’s about building trust and securing a competitive edge.
To stay ahead, health IT contractors should:
- Invest in robust cybersecurity frameworks.
- Align systems with interoperability and information blocking rules.
- Strengthen vendor management and AI governance.
- Stay informed about evolving federal contractor regulations.
By treating compliance as a strategic priority, contractors can protect patient data, maintain federal contracts, and build a reputation for excellence in the dynamic world of health IT.