Client Background
Our Client Enables Pharma Innovation with RWD Solutions
Our client is a US-based healthcare company offering data subscriptions and on-demand collaborations to pharma clients. Their focus is on leveraging real-world data sources, including imaging, genomics, and free-text notes, to drive innovation in Neurology, Cardiology, Oncology, and Rare Diseases. By integrating seamlessly with existing health system technologies, they reduce IT overhead and accelerate secure data collaborations. Their data applications support machine learning model development, biomarker research, clinical trial recruitment, and patient identification.
Challenge
Growing Cybersecurity Risks & Compliance Gaps
The aim was to strengthen its cybersecurity framework while managing large volumes of sensitive patient data, including clinical trial information. Ensuring compliance with regulations such as HIPAA, HITECH, and GDPR was a key priority, but they required additional expertise to navigate complex security requirements effectively. Recognizing the need for a structured approach to risk mitigation and compliance, they sought a strategic partnership with Healthark to enhance their security posture and regulatory readiness.
Healthark’s role
Strengthening Security & Compliance
Healthark implemented a two-pronged approach to enhance cybersecurity and ensure compliance with HIPAA and GDPR regulations.
- Enhancing Cybersecurity Posture
1. Secure Software Development & Proactive Risk Management
We have embedded security at every stage of the software development lifecycle by implementing secure coding practices, static code analysis (SAST), and dependency scanning to identify vulnerabilities early. Regular secure code reviews and automated security testing (DAST, SCA) in our CI/CD pipelines ensure continuous compliance. Our DevSecOps framework integrates security seamlessly into development workflows, leveraging container security tools, runtime protection, and infrastructure-as-code (IaC) scanning to prevent misconfigurations. Additionally, we have established clear data governance policies, encrypting data at rest (AES-256) and in transit (TLS 1.3) while enforcing least privilege access across all systems.
2. Robust Access Control, SaaS Security & API Protection
To strengthen identity and access management (IAM), we have enforced Multi-Factor Authentication (MFA) for all users, implemented Role-Based Access Control (RBAC), Just-in-Time (JIT) access, and adaptive authentication to mitigate unauthorized access risks. Our Continuous SaaS Discovery & Risk Management program provides real-time visibility into third-party applications, ensuring compliance through Cloud Access Security Brokers (CASB) and SaaS Security Posture Management (SSPM) tools. Additionally, we have hardened API security with OAuth 2.0, OpenID Connect (OIDC), API gateways, rate limiting, and JWT expiration policies, reducing attack vectors and ensuring secure communication between applications.
- Achieving HIPAA & GDPR Compliance
1. Data Protection and Access Control To safeguard patient health data, we have implemented strong encryption (AES-256 at rest, TLS 1.2/1.3 in transit), alongside firewalls, endpoint security, and intrusion detection systems (IDS/IPS) to prevent breaches. Access is strictly controlled through Role-Based Access Control (RBAC) and Privileged Access Management (PAM), ensuring that only authorized personnel can handle sensitive data. Multi-Factor Authentication (MFA) has been enforced across all access points, and Zero Trust Architecture (ZTA) principles have been embedded to verify and validate every request before granting access.2. Compliance Monitoring, Transparency, and Risk Management
To ensure compliance with HIPAA and GDPR, we have established transparent data handling policies, clearly outlining data collection, processing, and retention practices. We leverage Consent Management Platforms (CMPs) to track user consent, enabling individuals to exercise their rights, such as data access, rectification, and erasure. Regular compliance audits using automated tools like OneTrust and TrustArc validate our adherence, and vendor risk assessments ensure that third-party service providers meet the required security and privacy standards. We also conduct Data Protection Impact Assessments (DPIA) before implementing new processing activities.
3. Incident Readiness, Continuous Improvement, and Security Adaptation
A comprehensive Data Breach Response Plan is in place, integrating SIEM solutions for real-time threat detection and ensuring that breaches are reported within 72 hours, as mandated by GDPR. Our incident response framework includes predefined playbooks, forensic investigation protocols, and cyber insurance measures to mitigate risks. Additionally, we maintain a continuous improvement approach, regularly updating our security frameworks, privacy policies, and compliance training to align with evolving regulatory landscapes. Ongoing penetration testing, security simulations, and machine learning-based anomaly detection enhance our proactive defense mechanisms.
Empowering Tomorrow's Healthcare
This case study highlights how Healthark Insights helped a SaaS-based healthcare firm fortify its security and compliance framework. Through advanced cybersecurity strategies and regulatory adherence measures, we enabled secure data collaboration for life sciences innovation.
Want to learn more about Healthark’s expertise in data security and compliance? [Explore our website] or [Contact us today]!
