Healthcare Compliance

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Your Trusted Partner for Healthcare Compliance

Healthcare organizations face strict regulatory requirements and evolving cyber threats. At BARR Advisory, we help healthcare providers, technology vendors, and other fast-growing businesses in the healthcare space navigate complex compliance obligations with clarity and confidence. Our experts go beyond checklists to help you reduce risk, strengthen your security program, and build trust with patients, partners, and regulators.

Whether you’re establishing a compliance program with HIPAA and HITRUST or maturing your compliance posture with standards like SOC 2, ISO 27001, FedRAMP, or CMMC, our healthcare compliance experts are ready to help.

HIPAA Compliance Services

Ensure your organization meets HIPAA Security, Privacy, and Breach Notification Rule requirements. From risk assessments and ePHI scope discovery to remediation guidance, BARR helps covered entities and business associates safeguard sensitive patient data and demonstrate compliance.

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HITRUST Certification

HITRUST provides a globally recognized framework for healthcare security and risk management. As a HITRUST Authorized External Assessor, BARR guides organizations through readiness and validated assessments to achieve certification and demonstrate robust security controls.

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SOC 2

A SOC 2 examination reports on one or any combination of the AICPA’s trust services criteria—security, availability, processing integrity, confidentiality, and privacy. It demonstrates an organization’s commitment to its consumer requirements and cybersecurity best practices.

While not industry-specific like some other compliance frameworks, SOC 2 is widely recognized and utilized across different sectors, including healthcare. The report can play an important role in oversight of the organization, vendor management programs, and internal corporate governance and risk management processes.

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ISO 27001

ISO/IEC 27001:2022—often simply called ISO 27001—is an international standard that helps organizations establish, implement, and maintain an information security management system (ISMS). Obtaining certification to ISO 27001 is a valuable way to differentiate your organization, as it demonstrates your compliance with industry standards and helps your organization manage the security of your services, data, intellectual property, or any information entrusted to you by a third party.

If your organization has already achieved or is pursuing HITRUST certification, ISO 27001 can be a smart addition to your compliance program. HITRUST can help satisfy the requirements of ISO 27001, since ISO 27001 is part of the foundation that the HITRUST CSF was built upon.

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FedRAMP

FedRAMP standardizes security assessment, authorization, and continuous monitoring for cloud products and services used by federal agencies. It’s built on the security controls defined in NIST 800-53, which sets specific requirements for areas such as access control, vulnerability management, system monitoring, and incident response.

Achieving FedRAMP authorization not only demonstrates that your solution meets rigorous security requirements but also opens doors to the federal marketplace.

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CMMC

CMMC was developed to ensure all contractors and suppliers for the Department of Defense (DoD)—also called the Department of War (DoW)—follow cybersecurity best practices based on the level of risk their work involves. Even if you don’t yet have a government contract, beginning the CMMC readiness process now—including conducting a gap assessment and understanding how your environment aligns with the DoD’s requirements—can help you secure future opportunities.

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FDA Compliance

For organizations operating in the healthcare technology and medical device sectors, compliance with U.S. Food and Drug Administration (FDA) regulations is an essential component of managing risk and protecting patient safety. The FDA establishes requirements for the development, testing, and maintenance of medical devices, including software-based and connected technologies that process sensitive patient data. Establishing strong controls early can help streamline FDA submissions, reduce delays, and support long-term product reliability.

Who We Serve

From foundational compliance to advanced certifications, we offer tailored compliance solutions for every stage of your business growth.

Health Systems

For hospitals, healthcare providers, health insurers, and other health systems, standards like HIPAA, SOC 2, and HITRUST are essential. We can help you verify your compliance with these standards and plan the future of your compliance program, which may also include ISO 27001 for organizations operating in international markets or FedRAMP for companies that work with the U.S. federal government.

Medical Devices

We work with medical device manufacturers and technology solutions firms to assist and attest to your compliance with standards like HIPAA, SOC 2, and HITRUST, as well as FDA regulations. If you produce cloud-connected devices, we can also help you achieve compliance with frameworks like ISO 27001 and its cloud-focused extensions, like ISO 27017 and ISO 27018.

Health Tech

For telehealth companies, digital health startups, and SaaS or AI platforms focused on healthcare, HIPAA compliance is often required. Our expert team can also help guide you on your road to compliance with standards like SOC 2, HITRUST, and ISO 27001 and related frameworks, like ISO 27701 for privacy management and ISO 42001 for AI-powered organizations. We can also assist with FedRAMP or CMMC compliance for organizations that support public-sector or defense healthcare ecosystems.

Proud to Serve Leading Healthcare Organizations

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We’re here to help you! Speak with a BARR specialist about your security and compliance needs.