15+ Compliance Frameworks, One Platform
From HIPAA to the EU AI Act — VertiComply generates compliant healthcare apps across every major regulatory framework in the US, Europe, and globally.
Last updated: March 2026Compliance Frameworks We Support
Every project built on VertiComply benefits from our multi-framework compliance engine. Filter by region or browse the full catalog.
HIPAA
Health Insurance Portability and Accountability Act
The cornerstone of U.S. healthcare data protection. HIPAA establishes national standards to protect sensitive patient health information (PHI) from being disclosed without the patient's consent or knowledge.
What It Covers
Privacy Rule — controls on the use and disclosure of Protected Health Information
Security Rule — administrative, physical, and technical safeguards for electronic PHI
Breach Notification Rule — requirements to notify individuals and HHS after a data breach
Enforcement Rule — compliance investigation and civil monetary penalties
FDA 21 CFR Part 11
Electronic Records & Electronic Signatures
FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. Essential for medical device software and clinical systems.
What It Covers
Electronic record validation — accuracy, reliability, and consistency
Audit trail requirements — computer-generated, time-stamped logs
System access controls — unique user IDs and passwords
Electronic signature standards — legally binding digital signatures
42 CFR Part 2
Confidentiality of Substance Use Disorder Records
42 CFR Part 2 provides additional federal privacy protections for patients receiving treatment for substance use disorders (SUD). It restricts the disclosure and use of SUD patient records beyond what HIPAA requires.
What It Covers
Consent requirements — written patient consent before any disclosure
Re-disclosure prohibitions — recipients cannot further share SUD records
Restrictions on use in legal proceedings without court order
Audit and breach notification requirements specific to SUD data
HITRUST CSF
Health Information Trust Alliance Common Security Framework
HITRUST CSF is a comprehensive, certifiable security framework that harmonizes requirements from HIPAA, NIST, ISO, PCI, and other standards into a single prescriptive framework designed for the healthcare industry.
What It Covers
Risk-based controls mapped to multiple regulatory standards
Information protection program with 19 control domains
Third-party assurance via validated and certified assessments
Continuous improvement through maturity-based scoring
Section 508 / WCAG 2.1
Accessibility Standards for Electronic & Information Technology
Section 508 of the Rehabilitation Act requires federal agencies' electronic and information technology to be accessible to people with disabilities. WCAG 2.1 provides the technical success criteria used to measure compliance.
What It Covers
Perceivable — text alternatives, captions, adaptable layouts, distinguishable content
Operable — keyboard accessible, sufficient time, seizure-safe, navigable
Understandable — readable, predictable, input assistance
Robust — compatible with current and future assistive technologies
NIST CSF 2.0
National Institute of Standards and Technology Cybersecurity Framework
NIST Cybersecurity Framework 2.0 provides a voluntary set of standards, guidelines, and best practices to manage cybersecurity risk. Widely adopted across healthcare organizations as a foundational security posture benchmark.
What It Covers
Govern — establish and communicate cybersecurity risk management strategy
Identify — understand organizational context, assets, and risk
Protect — implement safeguards for critical infrastructure services
Detect — identify cybersecurity events in a timely manner
CCPA / CPRA
California Consumer Privacy Act & Privacy Rights Act
The CCPA and its amendment CPRA grant California residents extensive rights over their personal information. As the strongest state-level privacy law in the U.S., it serves as a benchmark for emerging state privacy legislation.
What It Covers
Right to know what personal information is collected and how it is used
Right to delete personal information held by businesses
Right to opt out of the sale or sharing of personal information
Right to limit use and disclosure of sensitive personal information
U.S. State Privacy Laws
Virginia, Colorado, Connecticut, Texas, Oregon & more
A growing number of U.S. states have enacted comprehensive privacy laws modeled on the CCPA and GDPR. VertiComply proactively supports these emerging regulations to ensure nationwide compliance for our users.
What It Covers
Virginia Consumer Data Protection Act (VCDPA)
Colorado Privacy Act (CPA)
Connecticut Data Privacy Act (CTDPA)
Texas Data Privacy and Security Act (TDPSA)
GDPR
General Data Protection Regulation (EU/UK)
The GDPR is the world's most comprehensive data protection regulation, governing the collection, processing, and storage of personal data for individuals in the European Economic Area and the United Kingdom.
What It Covers
Lawfulness, fairness, and transparency of data processing
Purpose limitation — data collected for specified, explicit, and legitimate purposes
Data minimization — adequate, relevant, and limited to what is necessary
Integrity and confidentiality — appropriate security measures
EU AI Act
Regulation on Artificial Intelligence (EU 2024/1689)
The EU AI Act is the world's first comprehensive AI regulation. It classifies AI systems by risk level and imposes requirements on high-risk AI used in healthcare, including transparency, human oversight, and data governance obligations.
What It Covers
Risk classification — unacceptable, high, limited, and minimal risk tiers
High-risk AI requirements — data governance, documentation, human oversight
Transparency obligations — disclosure when interacting with AI systems
Conformity assessment and CE marking for high-risk AI systems
EU MDR 2017/745
European Medical Device Regulation
The EU Medical Device Regulation (MDR) governs the design, manufacture, and distribution of medical devices in the European Union, including Software as a Medical Device (SaMD). It requires rigorous clinical evaluation and post-market surveillance.
What It Covers
Device classification — risk-based classes I, IIa, IIb, and III
Clinical evaluation and investigation requirements
Post-market surveillance and vigilance reporting
Unique Device Identification (UDI) system compliance
NIS2 Directive
Network and Information Security Directive (EU 2022/2555)
NIS2 is the EU's updated directive on cybersecurity, expanding scope to include healthcare as an essential sector. It mandates risk management measures, incident reporting, and supply chain security for organizations operating in the EU.
What It Covers
Risk management measures — policies on risk analysis and information system security
Incident reporting — 24-hour early warning and 72-hour notification requirements
Supply chain security — assessment of third-party and supplier risks
Business continuity — backup management, disaster recovery, crisis management
SOC 2 Type II
Service Organization Control 2
SOC 2 is a framework developed by the AICPA that defines criteria for managing customer data based on five Trust Services Criteria. Type II certification verifies that controls have been tested and operating effectively over an extended period.
What It Covers
Security — protection against unauthorized access (logical and physical)
Availability — system is accessible for operation and use as committed
Processing Integrity — system processing is complete, valid, accurate, and timely
Confidentiality — information designated as confidential is protected
ISO 27001
Information Security Management System (ISMS)
ISO/IEC 27001 is the international standard for information security management systems (ISMS). It provides a systematic approach to managing sensitive company information so that it remains secure, including people, processes, and IT systems.
What It Covers
Annex A controls — 93 controls across organizational, people, physical, and technological domains
Risk assessment and treatment — systematic identification and mitigation of information security risks
Statement of Applicability — documented justification for control selection
Continuous improvement — internal audits, management reviews, corrective actions
Platform Security Measures
Our defense-in-depth approach ensures your data is protected at every layer.
AES-256 encryption at rest for all stored data
TLS 1.2+ encryption for all data in transit
httpOnly secure cookies with CSRF protection
Role-based access control and least-privilege access
Rate limiting and brute-force protection on all API endpoints
Comprehensive audit logging for all system access
Regular penetration testing and vulnerability scanning
Automated security scanning of generated code
Incident response plan with defined SLAs
Employee security training and background checks
Multi-factor authentication support
Infrastructure on AWS with dedicated VPC isolation
Shared Responsibility Model
Compliance is a shared responsibility between VertiComply and our users. While we provide the tools, infrastructure, and generated code patterns to meet regulatory requirements, you are responsible for:
Review & Validation
Reviewing generated code with qualified professionals before deploying in production healthcare environments.
Risk Assessments
Conducting your own HIPAA risk assessments and maintaining required documentation for your organization.
Access Management
Managing user access, credentials, and permissions within your deployed applications.
Regulatory Updates
Staying current with regulatory changes that may affect your specific use case or jurisdiction.
BAA Execution
Executing a Business Associate Agreement if your use of the platform involves PHI.
Incident Reporting
Reporting any suspected security incidents or breaches related to your applications to the appropriate authorities.
Questions About Compliance?
Our compliance team is here to help. Whether you need a BAA, have questions about a specific regulation, or want to discuss your compliance requirements, reach out.
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SOC 2 Type II | HIPAA | GDPR | FDA | EU AI Act | ISO 27001 Compliant