Security Technology Solutions
Healthcare Services
The healthcare industry holds vast amounts of Protected Health Information (PHI) and other sensitive data, making it a prime target for cyberattacks. Beyond data breaches, disruptions to critical care systems can have life-threatening consequences. Compliance with strict privacy and security regulations is not just a legal obligation but a moral imperative to safeguard patient trust and well-being.
Key Regulations For Healthcare Sector
Health Insurance Portability and Accountability Act (HIPAA):
The cornerstone of U.S. healthcare privacy law. It establishes national standards for the protection of PHI, encompassing the Privacy Rule (regulating the use and disclosure of PHI), the Security Rule (mandating administrative, physical, and technical safeguards for Electronic PHI), and the Breach Notification Rule (requiring covered entities and business associates to notify affected individuals and HHS of breaches).
State-Specific Data Privacy Laws:
Many states, like California (with CCPA/CPRA, which can apply to certain healthcare entities not fully covered by HIPAA), Massachusetts (201 CMR 17.00), and others, have additional or more stringent requirements for the protection of health and personal data.
Health Information Technology for Economic and Clinical Health (HITECH) Act:
Strengthens HIPAA by increasing penalties for non-compliance, extending HIPAA's reach to business associates, and introducing meaningful use incentives for EHR adoption, all with significant security implications.
Payment Card Industry Data Security Standard (PCI DSS):
Relevant for healthcare providers who process patient payments via credit cards, ensuring the secure handling and storage of cardholder data.
HITRUST CSF (Common Security Framework):
While not a regulation itself, HITRUST CSF is a certifiable framework widely adopted in healthcare. It harmonizes requirements from various regulations (HIPAA, PCI DSS, GDPR, NIST, etc.) into a single, comprehensive security framework, making it a strong benchmark for demonstrating robust security and compliance.
NIST Cybersecurity Framework (CSF) & NIST SP 800-53:
While voluntary for most healthcare organizations, NIST CSF provides a flexible framework for managing cybersecurity risk. NIST SP 800-53 is mandatory for federal agencies and their contractors, including those handling federal healthcare data (e.g., for Veterans Affairs or Medicare/Medicaid), providing a catalog of security and privacy controls.
21 CFR Part 11 (FDA Regulations):
For pharmaceutical and medical device manufacturers, this regulation from the Food and Drug Administration (FDA) sets requirements for electronic records and electronic signatures, ensuring their trustworthiness, reliability, and security, critical for product quality and patient safety.
General Data Protection Regulation (GDPR):
Essential for any healthcare organization that processes the personal data (including health data, which is considered sensitive) of individuals residing in the European Union (EU), regardless of where the healthcare organization is located.
Our Solutions for Healthcare:
Security Technology Solutions understands the unique vulnerabilities and critical compliance needs of healthcare providers and related organizations.
• Security Posture Assessments & Gap Analysis: We conduct in-depth assessments against HIPAA Security Rule requirements and HITRUST CSF to identify gaps in your ePHI protection, clinical systems, and operational technology, providing a roadmap for enhanced patient data security.
• Regulatory Compliance & Governance Consulting: Our experts guide you through HIPAA, HITECH, and relevant state privacy laws, assisting with policy development, Business Associate Agreement (BAA) reviews, and audit readiness to ensure robust PHI protection.
• Enterprise Risk Management (ERM) & Risk Analysis: We help identify and mitigate risks that could impact patient safety, data integrity, and operational continuity, including risks to medical devices and IoT within healthcare environments.
• Incident Response Planning & Advisory: Given the critical nature of healthcare data, we develop and test rapid incident response plans tailored to healthcare environments, ensuring timely breach notification (HITECH Breach Notification Rule) and minimal disruption to patient care.
• Security Strategy & Roadmap Development: We help healthcare organizations develop a security strategy that balances advanced care delivery with stringent security requirements, ensuring resilient IT and OT systems.
• Security Awareness Training & Education Program Design: We create tailored training programs for healthcare professionals, focusing on PHI handling, phishing awareness, and ransomware threats specific to the medical sector, vital for HIPAA compliance.
• Vendor Risk Management (Third-Party Risk Advisory): Essential for managing risks from Electronic Health Record (EHR) providers, medical device manufacturers, and other healthcare business associates, ensuring their compliance strengthens your overall posture.
• Data Privacy Consulting: Our specialized data privacy services ensure your organization adheres to the strictest patient privacy mandates, including data mapping, privacy impact assessments, and managing patient rights concerning their PHI.