Healthcare Cybersecurity Services

Secure Medical Devices, Digital Health Platforms & Healthcare IT Systems

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.

Our Expertise in Cybersecurity Services

Testing

  • Define cybersecurity goals for medical devices, digital health solutions, and healthcare IT systems.
  • Align with FDA cybersecurity guidance, EU CRA, HIPAA, and ISO/IEC cybersecurity standards.
  • Build frameworks for secure product development and cybersecurity governance
  • Conduct gap assessment and cybersecurity compliance readiness review
  • Training for healthcare teams on security best practices

Assessment

  • Threat modeling and risk assessment (TARA) for healthcare systems.
  • Vulnerability assessment and scanning across devices, connectivity, and cloud layers.
  • Data protection and PHI security and risk evaluation.
  • Cybersecurity benchmarking against ISO 14971, AAMI TIR57, and IEC 81001-5-1 standards.
  • Deliver prioritized remediation plan that aligns with regulation requirements.

Design & Development

  • Secure architecture development for medical devices and connected health solutions.
  • Implementation of secure boot, encryption, and authentication protocols.
  • Secure over-the-air (OTA) updates, firmware validation, and integrity check.
  • “Security by Design” and Privacy by Design Framework.
  • Secure coding, validation, and prevention of vulnerabilities.

Testing

  • Penetration testing and vulnerability scanning.
  • Static and dynamic testing and analysis (SAST/DAST) and firmware validation.
  • Fuzz testing and wireless and IoMT protocol testing.
  • Validate and compliance against UL 2900, IEC 62443, FDA cybersecurity requirements.
  • Deliver compliance ready test and verification reports.

Managed Services

  • 24×7 Healthcare Security Operations Center (SOC) for monitoring, detection, and incident response.
  • Vulnerability management and incident handling.
  • Security Information & Event Management (SIEM) and Endpoint Detection and Response (EDR) deployment for connected health environment.
  • Post-market cybersecurity surveillance.
  • Continuous security through DevSecOps and agile processes integration.

Healthcare Cybersecurity Standards

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

Why eInfochips for Healthcare Cybersecurity?

  • Deep industry expertise and hands-on experience with connected digital health, IoMT, MedTech, and healthcare domains. We understand clinical workflows, patient safety, privacy, and regulatory imperatives.
  • End-to-end Security spanning from device firmware & hardware, connectivity, cloud to healthcare applications and users.
  • Implementation and guidance aligned with medical device cybersecurity standards and regulations worldwide, FDA, CE Marking, the EU Cyber Resilience Act (CRA), and HIPAA
  • Dedicated Cybersecurity COE, with certified professionals and labs for penetration testing, vulnerability assessment, continuous monitoring, and incident response.

Case Studies

Smart Surgical Display Platform

Ensured FDA 510(k) cybersecurity compliance with ISO 14971 risk management integration.

  • Threat modeling to identify and mitigate vulnerabilities
  • Secure cloud configurations with regular compliance checks
  • Implemented FDA 510(k) and ISO 14971 cybersecurity standards
  • Proactive monitoring to maintain data integrity and prevent risks

Cybersecurity Testing for Healthcare Mobile App

Conducted STRIDE threat modeling, VAPT, and cryptography verification.

  • User authentication implemented via MUSE APIs
  • Threat modeling with STRIDE and VAPT-based security testing
  • Cryptography verification and MobSF-based SAST/DAST analysis
  • Ensured compliance with OWASP Mobile Security Verification Standard

Blood Analyzer Penetration Testing

Performed firmware analysis, dynamic testing, OWASP compliance, and issue remediation.

  • Conducted threat modeling and static code analysis with secure coding
  • Implemented secure cloud configurations for data confidentiality
  • Integrated FDA 510(k) and ISO 14971 cybersecurity requirements
  • Early detection and mitigation of vulnerabilities pre-deployment

Start a conversation today

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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