As the healthcare ecosystem is becoming more interconnected through IoMT devices, digital health platforms, and hospital IT systems, cybersecurity has emerged as the third pillar of patient safety, data security. Cyberattacks on medical systems can compromise clinical workflows, risk patient safety, and damage data privacy and care delivery.
With advancing regulatory frameworks and standards such as FDA’s premarket and post-market cybersecurity guidance, the EU’s Cyber Resilience Act (CRA), HIPAA, and ISO/IEC standards, healthcare companies are expected to embed security controls from the product development stage.
eInfochips helps MedTech and Healthcare companies secure their devices, data, and digital health ecosystems by providing a robust, compliance-focused cybersecurity lifecycle approach from design, development, and testing to deployment and post-market security monitoring.
Capability Area |
Objective |
Key Standards / Frameworks |
Outcome / Approach |
|---|---|---|---|
Healthcare IT Infrastructure Security |
Protect patient data across IT systems, cloud, and connected devices |
• ISO 27001 – ISMS • ISO 27002 – Info Security & Privacy • ISO 27017 – Cloud Security Controls • HIPAA – Health Data Privacy |
• Ensure confidentiality, integrity, availability of health data • Secure IT & cloud environments |
Health Software & IoT Product Security |
Build secure, compliant connected health products |
• IEC 81001-5-1 – Health IT Safety & Security • IEC 60601-4-5 – Safety-Related Security Guidance • IEC/TR 80001-2-2 – Device Security Coordination |
• Implement Security by Design principles • Protect devices and software against cyber threats |
Cybersecurity-Integrated Management Systems |
Align cybersecurity with quality and regulatory processes |
• ISO 13485 – Quality Management System (QMS) • ISO 14971 – Medical Device Risk Management |
• Integrate cybersecurity risk into device QMS • Ensure FDA & EU MDR compliance |
Cybersecurity Risk Management |
Assess and mitigate security risks throughout product lifecycle |
• AAMI TIR 57 – Device Security Risk Management Principles • AAMI TIR 97 – Post-Market Risk Management • NIST SP 800-30 – Risk Assessment Guide |
• Perform threat modeling & vulnerability assessment • Apply defense-in-depth strategies |
Global Compliance & Certification Support |
Validate products for international cybersecurity standards |
• UL 2900-1 – Network-Connectable Product Security • UL 2900-2-1 – Healthcare Product Security • IEC 62443-4-1 – Industrial Automation Security |
• Support product validation & certification • Accelerate regulatory approvals and market readiness |
We invite you to join us for a 30-minute introductory call to explore our Healthcare Cybersecurity Services and hear about our success stories. This call will provide a valuable opportunity to understand how we can meet your needs and demonstrate the impact we deliver. Please fill out the form to secure your spot, and we look forward to connecting with you soon!
eInfochips, an Arrow Electronics company, is a leading provider of digital transformation and product engineering services. eInfochips accelerates time to market for its customers with its expertise in IoT, AI/ML, security, sensors, silicon, wireless, cloud, and power. eInfochips has been recognized as a leader in Engineering R&D services by many top analysts and industry bodies, including Gartner, Zinnov, ISG, IDC, NASSCOM and others.
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