Information Security & Privacy Compliance
Securing Digital Health Innovation
In the era of connected care, patient safety extends beyond physical devices to the data they generate and cybersecurity is now a critical regulatory requirement. We guide medical device and digital health companies through the complex landscape of global cybersecurity and privacy regulations, ensuring your technology remains compliant, secure, and trusted.
We provide end-to-end support for ISO 27001, HIPAA, SOC 2, and GDPR compliance, PPL (Israel) – Privacy Protection & Information Security Law, ISO 42001, Responsible AI Governance for Medical Technologies & EU AI Act. Our team ensures your digital health solutions meet the rigorous security standards demanded by hospitals, regulators, and patients worldwide.
Our main services are listed below.
ISO 27001
Protect Your IP and Patient Data.
We help you establish a robust Information Security Management System (ISMS) tailored to the specific risks of the MedTech sector. From gap analysis to certification readiness, we implement controls that protect your intellectual property and sensitive clinical data, meeting the high expectations of enterprise healthcare customers and global regulators.
HIPAA
US Market Compliance.
For companies targeting the US healthcare market, HIPAA compliance is non-negotiable. We guide you through the Privacy, Security, and Breach Notification Rules, ensuring your software and operational procedures properly safeguard Protected Health Information (PHI) against unauthorized access and cyber threats.
SOC 2
Build Trust with Enterprise Partners.
SOC 2 is increasingly required by hospitals and health systems before adopting new digital tools. We prepare your organization for SOC 2 Type I and Type II audits by defining the necessary controls for security, availability, and confidentiality, streamlining the path to a clean audit report.
GDPR (EU)
Navigating EU Data Rights.
Compliance with the General Data Protection Regulation (GDPR) is critical for any device collecting data in Europe. We assist with Data Protection Impact Assessments (DPIAs), acting as your Data Protection Officer (DPO) support, and ensuring your data processing agreements meet the strictest EU standards for patient privacy.
PPL (Israel)
Israeli Privacy & Data Security Compliance.
We help MedTech and Digital Health companies comply with Israel’s Privacy Protection Law and Data Security Regulations. Our support includes database classification and registration, implementation of information security controls, access management, and incident response—ensuring lawful and secure handling of sensitive medical data in Israel.
ISO 42001
ISO 42001 provides a global framework for managing AI risks, transparency, and accountability. We support the implementation of an AI Management System (AIMS) integrated with your QMS and development processes, enabling safe, compliant, and scalable use of AI in medical devices and digital health solutions
EU AI Act
The EU AI Act introduces new regulatory requirements for AI systems, including many medical applications classified as high-risk. We help you assess applicability, close compliance gaps, and implement the required governance, risk management, and documentation—supporting smooth access to the European market.
Plan · Implement · Maintain
For seamless global compliance in a digital world.