Kertos and Axipro Partner to Streamline Compliance for European Companies

Risk analysis failures sit behind 76% of HIPAA enforcement actions in 2025, according to The HIPAA Journal’s annual breach report. That single statistic explains why healthcare organizations and their business associates are rethinking how they manage HIPAA. Its no longer enough to conduct an annual policy review, it is now a continuous control problem. Drata fits that shift. It is a security and compliance automation platform that connects to the systems where PHI lives, maps controls to the HIPAA Privacy, Security, and Breach Notification Rules, and keeps evidence current between formal assessments. This guide covers what Drata actually does for HIPAA: which rules it addresses, how the automation works in practice, what it leaves to humans, and how readiness compares to running parallel frameworks like SOC 2. What Is HIPAA and Why Does Compliance Matter? The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is the U.S. federal law governing the protection of protected health information (PHI). It applies to two categories of organizations: covered entities (health plans, healthcare clearinghouses, and most providers) and business associates, a category that captures any vendor, SaaS company, or service provider that creates, receives, maintains, or transmits PHI on behalf of a covered entity. Enforcement is led by the HHS Office for Civil Rights (OCR). Penalties scale with culpability, capped at roughly $2.1 million per violation category per year after inflation adjustments. OCR’s 2025 enforcement priorities were almost entirely focused on the Security Rule, particularly the requirement to conduct a thorough, organization-wide risk analysis. The agency has confirmed that 2026 will follow the same playbook, with risk management evidence (proof that identified risks are being actively reduced) becoming a separate focus area in its own right. Healthcare also remains the most expensive sector for breaches. IBM’s 2024 Cost of a Data Breach Report put the average healthcare breach at $9.48 million, more than double the cross-industry average. The cost is not abstract: in 2025, OCR penalties for risk analysis failures ranged from $25,000 against small practices up to $3 million against a national medical supplier following a phishing-driven breach. What Is Drata and How Does It Support HIPAA Compliance? Drata is a GRC automation platform that integrates with cloud infrastructure, identity providers, HRIS systems, ticketing tools, and endpoint management to continuously collect evidence and test controls against more than 30 compliance frameworks. HIPAA was added in late 2021 as Drata’s third framework, joining SOC 2 and ISO 27001. For HIPAA specifically, Drata does not certify anyone; there is no formal HIPAA certification anyway, but it operationalizes the work that OCR expects to see when an investigation lands. That includes mapped controls for administrative, physical, and technical safeguards; policy templates for HIPAA-specific requirements like the Business Associate Agreement; embedded workforce training; an integrated risk management module; and an evidence library that auditors and counsel can access during a review. Worth Knowing: There is no government-issued HIPAA certification. Any vendor claiming to make you “HIPAA certified” is using marketing language. What auditors and OCR investigators actually look for is documented, ongoing compliance with the three HIPAA Rules. Drata’s value sits in producing that documentation continuously rather than retroactively. For a deeper look at what formal certification actually involves in adjacent frameworks, see our guide to HIPAA certification. Key HIPAA Requirements Drata Helps You Address HIPAA consists of three operative rules, each with distinct compliance obligations. Drata’s control library maps to all three. HIPAA Privacy Rule The Privacy Rule governs the use and disclosure of PHI in any form: electronic, paper, or verbal. It defines 18 specific identifiers that constitute PHI, sets the minimum necessary standard, and gives patients rights of access, amendment, and accounting of disclosures. Drata supports this through policy templates (notice of privacy practices, minimum necessary use, patient rights procedures), access tracking through integrations with identity providers, and workforce training that covers permissible uses and disclosures. HIPAA Security Rule The Security Rule is where most enforcement activity happens. It applies specifically to electronic PHI (ePHI) and requires three categories of safeguards: administrative, physical, and technical. According to HHS, the Security Rule “requires implementation of appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information.” Drata’s control library maps directly to the 45 CFR Part 164 implementation specifications, both required and addressable. HIPAA Breach Notification Rule The Breach Notification Rule requires notification to affected individuals, HHS, and, for breaches affecting 500 or more residents of a state, the media, no later than 60 days after discovery. Drata supports breach response through incident management workflows, policy templates that codify the four-factor risk assessment, and audit trails for breach documentation. The platform does not file your OCR breach report for you; that remains a human task, but it keeps the underlying evidence organized. Important: OCR has explicitly stated that breach notification failures were the second most common reason for a financial penalty in 2025. More than one-fifth of enforcement actions included a breach notification violation. The 60-day clock starts at discovery, not at confirmation, so detection latency directly increases legal exposure. How Drata Automates HIPAA Compliance Automation in Drata operates on four layers: evidence collection, control monitoring, gap detection, and integration with healthcare-relevant tools. The combination is what produces the continuous compliance posture that OCR is now effectively demanding through its risk management initiative. Automated Evidence Collection for HIPAA Audits Drata reports that its platform automates roughly 80% of evidence collection across frameworks. For HIPAA, that means pulling configuration data from AWS, Azure, or GCP; enrollment status from MDM tools like Jamf or Intune; SSO and MFA enforcement from Okta or Entra ID; and onboarding/offboarding records from HRIS platforms. Instead of screenshotting these on demand for an auditor, the platform timestamps and stores them on a continuous basis. Real-Time HIPAA Compliance Monitoring The platform runs automated tests against connected systems daily. If MFA is disabled on an administrator account that has access to a system holding ePHI, the relevant control flips to failing status and the owner

In late 2025, Drata became one of a small group of compliance platforms to earn a FedRAMP 20x Low Pilot Authorization, completing the modernized review track that GSA designed to compress federal cloud authorizations from years into weeks. That milestone matters because most “FedRAMP-ready” tools still rely on narrative documentation built for the old process.  Drata’s authorization is proof that its automation pipeline can satisfy the standards the federal program now wants every cloud service provider to meet. This guide explains what Drata actually does for FedRAMP, where it fits in the authorization workflow, what it costs, and where its limits show up, with current context on how FedRAMP 20x is reshaping the entire process. What Is FedRAMP and Why Does It Matter for Cloud Service Providers? FedRAMP is the U.S. government’s standardized program for assessing, authorizing, and continuously monitoring cloud services used by federal agencies. Established in 2011 and codified in law through the FedRAMP Authorization Act of 2022, it operates on a do once, use many principle: a cloud service offering authorized once can be reused across federal agencies without each agency repeating the entire security assessment. The program is administered by GSA through a Program Management Office, with technical baselines drawn from NIST SP 800-53. Three impact baselines define the depth of the controls a cloud provider must implement: Low (156 controls), Moderate (323 controls), and High (410 controls). A separate LI-SaaS baseline streamlines requirements for low-impact SaaS systems. The Moderate baseline is the most commonly pursued path because it covers Controlled Unclassified Information, the threshold most federal contracts demand. What Is Drata and What Does It Do for FedRAMP? Drata Company Overview and Background Drata is a security and compliance automation platform headquartered in San Diego, founded in 2020 by Adam Markowitz, Daniel Marashlian, and Troy Markowitz. The company has grown to roughly 8,000 customers and reached unicorn status with a $2 billion valuation following its Series C round. In February 2025 it acquired SafeBase, folding the trust center product into its core platform. Drata supports more than 30 frameworks including SOC 2 compliance, ISO 27001, HIPAA, PCI DSS, GDPR, NIST 800-53, NIST 800-171, CMMC, and FedRAMP. Does Drata Support FedRAMP as a Framework? Yes. Drata provides pre-built FedRAMP frameworks for LI-SaaS, Low, Moderate, and High baselines, with controls mapped to NIST 800-53 requirements. The platform is built around OSCAL, the open machine-readable format that NIST developed for control catalogs and assessment data, which is now the required submission format under FedRAMP 20x. Drata also offers a dedicated FedRAMP Readiness Framework for organizations earlier in the journey. As of late 2025, Drata holds its own FedRAMP 20x Low Pilot Authorization, meaning federal agencies and contractors can use the platform itself without inheriting a compliance gap from their tooling. How Drata Works for FedRAMP Compliance Step by Step Step 1: Connect Your Cloud and Security Tools The first work in any Drata implementation is wiring up integrations. Drata supports more than 200 connectors covering AWS (including 45+ services), Azure, GCP, GitHub, Okta, identity providers, vulnerability scanners, HRIS, and ticketing platforms. For FedRAMP environments, the AWS GovCloud and Azure Government integrations matter most, since federal workloads typically live in those tenants. The connections feed system data into Drata’s monitoring engine, where it becomes the raw material for automated control tests. Step 2: Map Controls to FedRAMP Requirements Automatically Once integrations are in place, Drata applies its pre-built control mappings against the FedRAMP baseline you have selected. A single control can satisfy requirements across multiple frameworks at once, so an organization that has already implemented SOC 2 compliance or ISO 27001 inherits significant credit when expanding into FedRAMP. For a deeper look at how those frameworks compare, our ISO 27001 vs SOC 2 guide walks through the key differences. The control set is editable, which matters because FedRAMP allows narrowly scoped parameter overrides for some controls. Step 3: Continuously Monitor Your FedRAMP Control Environment Drata runs automated control tests on a continuous basis, validating that the configurations and evidence each control depends on are still in place. When a control drifts, an alert is issued and the gap is logged. For FedRAMP, this is the operational backbone of continuous monitoring for SOC 2, and for FedRAMP alike, the program’s defining requirement and historically the area where authorized providers most often fall out of compliance. Step 4: Collect and Organize FedRAMP Evidence Automatically Evidence is generated as a side effect of monitoring. Configuration data, access logs, and policy acknowledgments flow into Drata and are tagged against the controls they satisfy. The platform replaces manual screenshot collection, which has historically been the most labor-intensive part of FedRAMP audits. Step 5: Prepare Your System Security Plan and Audit-Ready Documentation For Rev 5 authorizations, the System Security Plan remains a written document. Drata centralizes the policy library, control implementation descriptions, and supporting artifacts a 3PAO will need, but it does not write narrative SSP language for you. For FedRAMP 20x submissions, the burden shifts dramatically: the SSP is replaced by structured KSI evidence, and Drata’s OSCAL-native architecture is built specifically to produce the machine-readable packages that path requires. Important: Drata accelerates FedRAMP work, but it does not eliminate the engineering effort. Boundary architecture, encryption-in-transit and at-rest decisions, configuration baselines, and DoD-specific overlays are technical work the platform cannot do for you. Treat Drata as the compliance automation layer on top of a security program, not as a substitute for one. Key Drata Features That Support FedRAMP Authorization Multi-Framework Control Mapping for FedRAMP Baselines Drata pre-maps controls across FedRAMP baselines and cross-maps them to other frameworks. An organization holding SOC 2 Type II that is now pursuing FedRAMP Moderate will see substantial overlap surface automatically, with Drata flagging only the FedRAMP-specific gaps that require new work. If you are already working through the SOC 2 process, the Drata SOC 2 guide covers that workflow in detail. The platform supports custom control parameters for cases where FedRAMP allows tailoring. Continuous Monitoring and Automated Evidence Collection Drata’s continuous