Navigate healthcare complexity with confidence
Healthcare innovation never pauses, and neither do the risks that come with it. You need a partner who understands that compliance isn’t just a hurdle—it’s the foundation for patient trust and operational growth.
Coalfire empowers you to navigate complexity, enhance resilience, and safeguard your digital environment, giving you the freedom to prioritize delivering the next generation of care.
Healthcare GRC & Risk Advisory
Build defensible healthcare governance programs that scale with your organization.
Healthcare organizations operate in one of the most complex regulatory environments in the country. Our advisors design and operationalize governance, risk, and privacy programs that align to HIPAA, CMS, HITRUST, applicable state privacy laws, and NIST-based security frameworks—ensuring regulatory defensibility without slowing innovation or care delivery.
We help you move from reactive compliance to structured, continuous risk management across clinical and operational environments.
Healthcare Risk Analysis & Management
NIST‑aligned HIPAA risk analysis ready for OCR review. We support enterprise gap analysis, readiness analysis, M&A due‑diligence, and targeted evaluations to help you identify and manage risk across your environment.
HIPAA & Healthcare Privacy Governance
Integrated privacy and security governance aligned to HIPAA, CMS oversight, and applicable state privacy requirements—including CCPA cybersecurity audit readiness where thresholds apply. We modernize policies, clarify roles and accountability structures, and embed privacy into enterprise risk management programs.
Third‑Party & Vendor Risk Management
Healthcare‑specific third‑party and supply‑chain risk management, including vendor assessments, continuous monitoring, and reporting aligned to HIPAA, HITRUST, and regulatory expectations. We help you build visibility into your vendor ecosystem and sustain it over time.
Supply Chain Risk Program Design & Build
We deliver a structured, workshop-based vendor risk program design built on three pillars—vendor criticality categorization, policy and procedure enhancement, and an SCRM tabletop exercise—resulting in a tailored, defensible program rather than an off‑the‑shelf template.
HITRUST Advisory & Lifecycle Support
Comprehensive HITRUST support across the full lifecycle—gap assessments, policy development, remediation guidance, interim assessments, recertification, and multi‑year compliance planning.
AI, Data & Emerging Risk
Operationalize responsible AI and emerging technology governance with confidence.
We provide NIST AI RMF–aligned risk analysis, ISO 42001 readiness support, bias and fairness validation, and unified HITRUST + AI compliance pathways tailored to the realities of healthcare environments.
AI Risk, Governance & Compliance Advisory
Responsible AI governance for healthcare and regulated organizations. We deliver NIST AI RMF–aligned risk analysis, governance frameworks, bias and fairness readiness, documentation and lineage support, and alignment to emerging healthcare AI regulations.- Unified AI Compliance Pathway (HITRUST + ISO 42001)
A unified approach to AI compliance across HITRUST and ISO 42001. This offering combines readiness assessments, documentation development, remediation support, coordinated assessments, and continuous AI compliance monitoring.
CMS Audit & Advisory
Navigate Center for Medicare and Medicaid (CMS) regulatory complexity with clarity and confidence.
Our services are purpose-built to support the full range of entities operating within the CMS compliance ecosystem — including federal and state health insurance exchanges and marketplaces, state Medicaid agencies, Children's Health Insurance Program (CHIP) agencies, state agencies administering the Basic Health Program (BHP), and their contractors and subcontractors required to comply with CMS Acceptable Risk Controls for ACA, Medicaid, and Partner Entities — Administering Entities (ARC-AMPE-AE) security and privacy requirements.
We also support Direct Enrollment Entities (DEE), including qualified health plan (QHP) issuers and approved web brokers delivering eligibility, enrollment, and year-round customer service experiences across issuer and web broker platforms.
CMS Advisory Services
We offer end-to-end advisory for entities within the CMS environment, including readiness assessments and System Security and Privacy Plan development, and ongoing regulatory change management support to keep your program aligned as requirements evolve.
CMS Audit Services
We provide independent audit support for CMS-regulated entities, helping organizations demonstrate compliance with ARC-AMPE-AE and related federal security and privacy requirements. Our audit engagements are designed to reduce burden, accelerate timelines, and position your organization for successful review.
Privacy Impact Analysis
We conduct Privacy Impact Analyses (PIAs) for CMS entities and their contractors, identifying privacy risks associated with the collection, use, and maintenance of personally identifiable information (PII) in federal healthcare programs — and providing actionable remediation guidance aligned to CMS expectations.
CMS Section 508 Accessibility Testing
We deliver automated and manual accessibility testing that meets federal standards, ensuring your digital tools are accessible to all users — including those with disabilities — and audit-ready for federal review.
Incident Response & Resilience
Strengthen operational resilience across clinical and executive teams.
Our advisors develop healthcare‑specific incident response playbooks, lead executive tabletop exercises, conduct business impact analysis, and build downtime continuity plans that ensure your organization can sustain operations during disruptions.
Incident Response Advisory
We’ll help you prepare, test, and strengthen your incident response program program from the ground up. Our engagements begin with a capabilities gap analysis and targeted remediation to establish a clear baseline — then progress through healthcare-specific playbook development, role-based training, and tabletop exercises designed for clinical and operational environments.- Business impact analysis and resiliency planning
Protect your operations and patient care continuity. We guide you through a structured analysis of the consequences a disruption would have on your organization — identifying critical functions, dependencies, and recovery priorities — then use that intelligence to build customized business continuity and disaster recovery strategies grounded in your organization's risk tolerance and operational realities.
People & Program Extension Services
We deliver vCISO services, embedded healthcare advisors, surge support, targeted role‑based training, and executive reporting frameworks that strengthen your program and accelerate progress.
Extended Cyber Team Services
Strategic cybersecurity leadership and execution without the overhead of a full internal team. Our vCISO services provide program oversight, roadmap development, executive and board reporting, risk leadership, and incident readiness support.
Embedded Healthcare Cyber Expertise
On‑demand healthcare cybersecurity and compliance expertise. We provide interim GRC leaders, embedded advisors, project‑based SMEs, and surge support for audits, remediation, or regulatory deadlines.
Awareness Training & Exercises
Role‑based training that strengthens real‑world readiness. Offerings include incident response training, compliance and privacy training, executive and board tabletop exercises, and CMS, HIPAA, and HITRUST‑focused sessions.
Pre‑Assessment Readiness
Pre‑assessment readiness and mock audits for HITRUST, CMS, HIPAA, and AI governance to help organizations prepare with confidence.
Who we serve
We partner with organizations across the healthcare ecosystem. Whether you’re securing patient data in a hospital system or bringing new digital health solutions to market, our experts deliver the guidance needed to protect your environment and advance your mission.
We have proven expertise across:
• Hospitals & Health Systems
Enterprise, application, and facility-level HIPAA risk analysis, GRC program modernization, and operational resilience
• Payers & Managed Care Organizations
CMS, exchange, and regulatory readiness
• Digital Health & Telehealth Platforms
HITRUST, AI governance, and scalable compliance
Our advisory services also support adjacent healthcare segments, including:
• Medical device manufacturers
• Pharmaceutical and life sciences companies
• Public health agencies
• Cloud and software-as-a-service healthcare technology providers
Why Partner with Coalfire?
We don’t believe in "one-and-done" engagements. You need a partner that’s invested in your long-term success, not just a consultant who leaves after the audit. We combine deep regulatory mastery with a tech-enabled approach to help you scale faster and smarter. When you work with us, you gain more than advice—you gain a competitive advantage.
- Deep regulatory expertise: Expertise across HIPAA, CMS, FDA, and NIST—turning complex requirements into clear action.
- Proven track record: Trusted by leading health systems, payers, and digital health innovators.
- Tech‑enabled acceleration: Proprietary playbooks and accelerators reduce time to compliance.
- Security‑first, practical guidance: Advice grounded in how your systems actually operate.
- Lifecycle partnership: Long‑term advisory support that grows with your organization.
Connect with our Healthcare Experts.
Tell us where you are.
We'll help you get where you need to be.
Start your journey with a Healthcare Risk Strategy Session—plus a complimentary Risk Maturity Snapshot.
Frequently asked questions
What are healthcare advisory services?
Healthcare advisory services are specialized consulting engagements that help healthcare organizations identify, manage, and mitigate security and compliance risks. These services guide organizations through complex regulatory landscapes—such as the Health Insurance Portability and Accountability Act (HIPAA) and the Centers for Medicare & Medicaid Services (CMS) requirements—to protect patient data while supporting operational efficiency and innovation.
Why is third-party advisory important for healthcare compliance?
Healthcare organizations face an evolving threat landscape and rigorous regulatory demands. Third-party advisory provides an objective, expert perspective that helps teams anticipate risks they may have missed internally. It allows organizations to scale security programs faster, reduce time to compliance, and ensure that security measures are not just "check-the-box" tasks, but are practical and grounded in real-world workflows.
What is HITRUST, and how does Coalfire support the certification lifecycle?
HITRUST provides a comprehensive framework for managing healthcare security and compliance. Coalfire supports the full lifecycle—from readiness assessments and gap analysis to remediation, interim assessments, and recertification—helping organizations maintain continuous compliance, not just pass an assessment.
How does Coalfire approach healthcare risk analysis?
Coalfire uses a National Institute of Standards and Technology (NIST)-aligned methodology to conduct risk analysis. Our approach is reality-based: we examine how your systems actually behave to identify threats. Whether you require enterprise-wide HIPAA risk analysis or targeted assessments for mergers and acquisitions, we provide clear, actionable guidance that is ready for submission to the Office for Civil Rights (OCR) and other oversight bodies.
What is the difference between an audit and advisory services?
An audit is a point-in-time verification that your organization meets specific control requirements. Advisory services are consultative and ongoing; they focus on strategy, design, and remediation. While audits confirm your current state, advisory services help you build, test, and improve your programs to ensure you stay compliant and resilient in the long term, rather than just preparing for a single event.
How does Coalfire help with incident response?
We help you move from reactive to proactive. Our incident response advisory includes developing healthcare-specific playbooks, conducting tabletop exercises to test your team's readiness, and providing targeted training. This ensures that when an incident occurs, your team knows exactly how to respond to maintain patient care continuity and protect sensitive data.
What is AI governance, and why does it matter in healthcare?
AI governance ensures that artificial intelligence systems are safe, compliant, and trustworthy. Coalfire helps healthcare organizations implement governance frameworks aligned to the NIST AI Risk Management Framework, validate bias and fairness, and prepare for emerging regulatory expectations.
How does Coalfire support AI governance and compliance?
We deliver NIST AI RMF–aligned risk analysis, ISO 42001 readiness, bias and fairness validation, and unified HITRUST + AI pathways to ensure responsible, compliant AI adoption in healthcare.