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Medical Device Cybersecurity

Protect patient data and secure your healthcare infrastructure with industry-leading cybersecurity solutions. SD Elements offers tailored protection for medical devices, patient records, and critical healthcare systems, helping you stay compliant with regulations while safeguarding your operations from evolving cyber threats.
Medical Device Cybersecurity

Are your medical devices secure by design?

Medical devices, medical software, and healthcare infrastructure are targets for threat actors.

Product development frameworks must include security by design to safeguard patients.

Medical devices, medical software, and healthcare infrastructure are targets for threat actors. Product development frameworks must include security by design to safeguard patients.

Medical Device Cybersecurity
Increases risk of cyberattack

Medical devices save lives; lacking a Secure Product Development Framework will have harmful ramifications for patients.

Medical Device Cybersecurity
Hinder access to new markets

Post-October 2023, FDA demands more stringent cybersecurity scrutiny in medical device premarket submissions.

Medical Device Cybersecurity
Scarce security resources

Product security teams are stretched thin, which can lead to marketed medical devices being vulnerable to cybersecurity threats.

Decrease risk of cyberattacks

Medical Device Cybersecurity
Ensuring robust cybersecurity in healthcare is essential to protect sensitive patient data and critical medical systems from increasingly sophisticated cyber threats. SD Elements empowers healthcare organizations to build security into every stage of the product development lifecycle. Through our Secure Product Development Framework (SPDF), we offer comprehensive solutions that include threat modeling, risk assessments, and automated compliance checks.
Medical Device Cybersecurity
Medical Device Cybersecurity

Increase Revenue with Healthcare Security Compliance

Medical Device Cybersecurity
Achieving compliance with healthcare regulations like HIPAA is not just about avoiding fines—it’s a strategic advantage that can drive revenue growth. SD Elements enables healthcare organizations and the medical device industry to build security and compliance into every phase of the product development lifecycle. By ensuring that your medical devices and healthcare systems meet rigorous standards, you can access new markets, build trust with patients and partners, and differentiate your offerings.

Scale Medical Device Security

Medical Device Cybersecurity
SD Elements empowers developers in the medical device industry to integrate security at every stage of the development lifecycle. By embedding actionable security guidance directly into existing workflows, our platform helps ensure that medical devices meet rigorous industry standards and regulatory requirements. This approach reduces vulnerabilities and enhances patient safety by ensuring that security is a fundamental aspect of your product design.
Medical Device Cybersecurity

Compliance Regulations in SD Elements

  • HIPAA
  • MDS2-2013
  • NIST SSF
  • PCI-SSF
  • ANSI/ISA 62443
  • AICPA Trust Services Criteria (SOC2)
  • ASD-STIG
  • Brazil Data Protection Law (LGPD)
  • California Consumer Privacy Act (CCPA)
  • California Online Privacy Protection Act
  • CIS Amazon EKS Benchmark
  • CIS AWS Foundations Benchmark
  • CIS AWS Three-Tier Web Architecture Benchmark
  • CIS AWS Three-Tier Web Architecture Benchmark
  • CIS Google Cloud Platform Foundation
  • CMMC 2
  • CNSSI
  • COPPA
  • CWE/SANS Top 25
  • CWE Top 25 2023
  • Cybersecurity Maturity Model Certification (CMMC)
  • DIACAP
  • EBA-Security of Internet Payments
  • EN 303 645 (Consumer IoT)
  • EU Cyber Resilience Act
  • FedRAMP
  • GAPP
  • GDPR
  • GDPR: Agile Development Report
  • GLBA
  • ISASecure CSA 311
  • ISASecure SSA 311
  • ISO 27001
  • ISO/SAE 21434
  • NIST 800-53
  • NIST 800-82
  • NIST 800-171
  • NIST AI RMF
  • NIST Cybersecurity Framework (CSF)
  • NIST-EO-Critical-Software
  • NIST-EO-Software-Verification
  • NIST-SSDF
  • NY SHIELD
  • OWASP Top 10
  • OWASP IoT Attack Surface Areas
  • OWASP IoT Top 10
  • OWASP Top 10 Privacy Risks
  • OWASP Top 10 for Large Language Model Applications
  • PCI-DSS
  • PIPEDA

Resources for Medical Device Industry

Medical Device Cybersecurity
Mapping Security Awareness Training to Regulatory Requirements
Read Whitepaper     
Medical Device Cybersecurity
Ensuring Cybersecurity in Medical Devices: A Guide to FDA’s Latest Guidelines
Read Whitepaper     
getting-started-with-security-by-design-rohit-with-title-medical-industry-thumb
Getting Started With Security by Design
Read Guide     

Additional Benefits

Ensuring Compliance with HIPAA through Automated Security Requirements

SD Elements plays a critical role in helping healthcare organizations ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). HIPAA sets strict standards for the protection of patient health information (PHI), requiring organizations to implement comprehensive administrative, physical, and technical safeguards.

Facilitating Compliance with MDS2-2013 for Medical Device Security

SD Elements helps organizations streamline the process of integrating MDS2-2013 compliance into their product development. The platform generates security requirements that align with the disclosure obligations of MDS2-2013, ensuring that all necessary security controls are considered and implemented during development.

Healthcare Cybersecurity Solutions with SD Elements

SD Healthcare cybersecurity involves protecting sensitive patient data, medical devices, and critical healthcare systems from cyber threats. With the increasing use of connected medical devices and digital health records, securing these assets has become vital. Key regulations like HIPAA in the U.S. and GDPR in the EU mandate strict data protection measures.

SD Elements Solutions

Automated Threat Modeling

SD Elements proactively identifies potential security threats early in the development process, enabling timely implementation of effective controls to safeguard healthcare systems and devices.

Seamless Integration with Security Monitoring Tools

While SD Elements itself does not offer direct security monitoring, it integrates seamlessly with leading monitoring tools to provide real-time insights and vulnerability management, ensuring that healthcare systems remain secure.

Comprehensive Security Control Library

SD Elements provides a robust library of security controls specifically tailored to the healthcare industry, helping organizations achieve and maintain compliance with regulations like HIPAA and GDPR.

Just-in-Time Training (JITT)

Enhance the skills of developers and security teams with targeted training modules delivered precisely when needed, ensuring that teams are equipped to address healthcare-specific security challenges.

Integration with Development Tools

SD Elements embeds security directly into your existing workflows, integrating with tools like JIRA, Jenkins, and GitHub to ensure that security is a seamless part of the development process.

Healthcare Cybersecurity FAQs

Secure Your Medical Devices

Introduce a Secure Product Development Framework (SPDF) to develop your medical device with security
by design to meet new cybersecurity requirements from the FDA and other regulatory agencies.
Introduce a Secure Product Development Framework (SPDF) to develop your medical device with security by design to meet new cybersecurity requirements from the FDA and other regulatory agencies.
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