Compliance
Meeting the regulatory and contractual requirements that govern how systems and data must be protected. In healthcare, compliance includes HIPAA and FDA requirements for connected medical devices.
What is Compliance?
Meeting the regulatory and contractual requirements that govern how systems and data must be protected. In healthcare, compliance includes HIPAA and FDA requirements for connected medical devices.
Security compliance refers to the process of meeting the regulatory, legal, and contractual requirements that define minimum standards for protecting systems, data, and operations. In healthcare, this means HIPAA, HITECH, and FDA device security requirements. In critical infrastructure, NERC CIP for energy and ISA/IEC 62443 for industrial environments. In finance, PCI DSS, SOX, and FFIEC guidelines. In government contracting, CMMC and FedRAMP.
Compliance is often treated as a minimum bar rather than a security program. This is both practically necessary (organizations must comply with applicable regulations) and strategically limiting (compliance checklists lag behind the actual threat landscape). A compliant organization is not necessarily secure; a secure organization is almost certainly compliant. The most effective programs treat compliance as a byproduct of genuine security rather than as the goal itself.
For IoT and OT environments, compliance is complicated by the scope problem: most compliance frameworks were written with IT environments in mind. HIPAA's technical safeguards reference "electronic PHI systems" in terms that assumed managed IT endpoints. Demonstrating HIPAA compliance for 10,000 networked medical devices requires interpreting and extending the framework's intent to a device category it didn't explicitly anticipate. Regulators are catching up — the FDA's 2023 cybersecurity guidance is a clear signal that IoMT is now in scope for serious regulatory attention.
Key Facts
- HIPAA violations involving unmanaged medical devices have resulted in fines exceeding $5M per incident
- FDA's 2023 cybersecurity guidance created binding device security requirements for medical device submissions
- NERC CIP standards apply to all cyber assets that "affect the reliable operation" of the bulk electric system
- ISA/IEC 62443 is the most widely adopted framework for OT/ICS security compliance globally
How ORDR Addresses Compliance
ORDR accelerates compliance programs by providing the complete asset inventory, vulnerability assessments, and policy documentation that auditors require. ORDR maps its findings to HIPAA, NIST CSF, ISA/IEC 62443, and other frameworks, generating compliance reports that demonstrate security posture across the full connected device estate — not just the managed IT subset.
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See Compliance in practice.
ORDR gives security teams complete visibility into every connected asset—and the intelligence to act on what matters most.