Healthcare Data Security and Compliance

Healthcare data security and compliance protect patient privacy and ensure regulatory adherence across global healthcare regulations. Kesem Solutions provides comprehensive HIPAA compliance services, Australian Privacy Act consulting, GDPR implementation, ISO 27001 information security management, SOC 2 attestation support, and healthcare cybersecurity solutions for medical device manufacturers, digital health companies, and healthcare providers.

Our healthcare data security services include security architecture design with defense-in-depth, penetration testing and vulnerability assessments, security incident response planning, compliance audits and gap assessments, and ongoing security monitoring. Every engagement delivers actionable remediation plans, technical implementation support, and documentation for regulatory audits and certifications.

Healthcare Compliance Services

HIPAA Compliance (United States)

We provide end-to-end HIPAA compliance services covering all rules and regulations. Our HIPAA compliance includes Security Rule implementation with administrative, physical, and technical safeguards, Privacy Rule compliance for protected health information (PHI) use and disclosure, Breach Notification Rule procedures and incident response planning, Omnibus Rule compliance including Business Associate Agreements (BAA), and HITECH Act requirements for electronic health records and breach penalties. We conduct comprehensive Security Risk Assessments (SRA) following NIST and HHS guidelines, identify vulnerabilities in people, processes, and technology, and deliver prioritized remediation roadmaps with implementation timelines.

Australian Privacy Act and My Health Records

Our Australian Privacy Act compliance services ensure healthcare apps and systems meet Australian regulations including 13 Australian Privacy Principles (APPs) covering collection, use, disclosure, and security of personal information, My Health Records system integration with secure authentication and access controls, Notifiable Data Breaches (NDB) scheme compliance with incident assessment and reporting procedures, and TGA regulatory data requirements for medical device software. We assist with privacy impact assessments, privacy policy development, and Office of the Australian Information Commissioner (OAIC) audit preparation.

GDPR Compliance (European Union)

For healthcare organizations serving European patients, we implement GDPR requirements including lawful basis establishment for health data processing (explicit consent, legal obligation, vital interests), data subject rights implementation (access, rectification, erasure, portability, restriction), Data Protection Impact Assessments (DPIA) for high-risk processing, cross-border data transfer mechanisms (Standard Contractual Clauses, adequacy decisions), and Data Protection Officer (DPO) advisory services. Our GDPR compliance includes technical measures like pseudonymization, encryption, and privacy-by-design architectures.

ISO 27001 Information Security Management

We guide healthcare organizations through ISO 27001 certification including Information Security Management System (ISMS) implementation, risk assessment and treatment methodologies, Statement of Applicability (SoA) development selecting relevant controls, security policy and procedure documentation, internal audits and management reviews, and external certification audit preparation. Our ISO 27001 services integrate with healthcare-specific requirements including ISO 27799 (health informatics security management) and ISO 13485 (medical device quality management).

SOC 2 Type II Attestation

For healthcare SaaS platforms and medical device cloud infrastructure, we support SOC 2 Type II attestation including Trust Services Criteria implementation (Security, Availability, Processing Integrity, Confidentiality, Privacy), control design and operating effectiveness evidence collection, audit readiness assessment and mock audits, auditor liaison and technical question response, and continuous compliance monitoring post-attestation. SOC 2 reports demonstrate security posture to healthcare customers, payers, and partners requiring vendor assurance.

Healthcare Cybersecurity Services

Security Architecture and Design

We design healthcare system architectures with security-by-design principles including zero-trust network architecture with micro-segmentation, defense-in-depth with multiple security layers (network, application, data), least privilege access control and role-based permissions, secure API design with OAuth 2.0 and API gateways, and encryption architecture for PHI at rest (AES-256) and in transit (TLS 1.3). Architecture reviews identify security weaknesses in existing systems and provide modernization roadmaps.

Penetration Testing and Vulnerability Assessment

Our offensive security services identify exploitable vulnerabilities including external penetration testing simulating internet-based attacks, internal network penetration testing, web application security testing covering OWASP Top 10 vulnerabilities, mobile app security assessment for iOS and Android, API security testing including authentication bypass and injection attacks, and social engineering assessments including phishing simulations. Testing follows PTES (Penetration Testing Execution Standard) methodology with detailed findings, proof-of-concept exploits, and remediation guidance.

Medical Device Cybersecurity

Medical device cybersecurity requires specialized expertise addressing FDA premarket cybersecurity guidance including Cybersecurity Bill of Materials (CBOM) documentation, Software Bill of Materials (SBOM) for supply chain transparency, secure software development lifecycle (SSDL) implementation, vulnerability management and coordinated disclosure procedures, and security update mechanisms with validation testing. We implement AAMI TIR57 (principles for medical device security risk management) and IEC 81001-5-1 (health software and systems security). Post-market cybersecurity includes continuous monitoring, vulnerability scanning, and security patch deployment.

Security Incident Response and Forensics

We develop and execute incident response capabilities including incident response plan (IRP) development following NIST SP 800-61, incident response team training and tabletop exercises, 24/7 security operations center (SOC) setup or integration, digital forensics for breach investigation and evidence preservation, and breach notification coordination with legal, compliance, and communications teams. For ransomware attacks, we provide containment, eradication, recovery guidance, and root cause analysis.

Cloud Security for Healthcare

Healthcare cloud deployments require enhanced security controls including AWS, Azure, or Google Cloud security baseline configuration, HIPAA-eligible services architecture with Business Associate Agreements, cloud security posture management (CSPM) with automated compliance checks, container security for Docker and Kubernetes workloads, serverless security for Lambda and API Gateway functions, and cloud access security broker (CASB) for SaaS application monitoring. We implement Cloud Security Alliance (CSA) controls and FedRAMP equivalency for high-security requirements.

Technical Security Control Implementation

Identity and Access Management (IAM)

We implement comprehensive IAM for healthcare systems including single sign-on (SSO) with SAML 2.0 or OpenID Connect, multi-factor authentication (MFA) with FIDO2/WebAuthn support, role-based access control (RBAC) with separation of duties, privileged access management (PAM) for administrative accounts, access review and recertification workflows, and directory services integration (Active Directory, Okta, Auth0). For patient-facing apps, we implement patient authentication aligned with NIST 800-63 digital identity guidelines.

Data Loss Prevention (DLP)

DLP solutions prevent unauthorized PHI exfiltration through endpoint DLP agents monitoring file transfers and removable media, email DLP scanning outbound messages for PHI patterns, network DLP inspecting traffic at egress points, cloud DLP for SaaS applications (Office 365, Google Workspace), and automated incident response including blocking, encryption, or admin alerts. DLP policies implement PHI detection using regex patterns, machine learning classifiers, and contextual analysis.

Security Information and Event Management (SIEM)

We deploy SIEM platforms for centralized security monitoring including log aggregation from applications, infrastructure, and security tools, correlation rules detecting suspicious patterns (unusual access, privilege escalation), threat intelligence integration for indicator of compromise (IoC) matching, compliance reporting for HIPAA audit logs and access tracking, and security incident workflow management. SIEM solutions include Splunk, ELK Stack, Sentinel, or Sumo Logic configured for healthcare use cases.

Encryption and Cryptography

We implement cryptographic controls protecting PHI confidentiality including database encryption with Transparent Data Encryption (TDE), file system encryption for servers and endpoints, application-level encryption for highly sensitive fields, key management using Hardware Security Modules (HSM) or cloud KMS, public key infrastructure (PKI) for certificate-based authentication, and encrypted backup storage with separate encryption keys. Encryption implementations meet FIPS 140-2/140-3 validation requirements for regulated healthcare environments.

Compliance Program Development

Risk Assessment and Management

We conduct comprehensive security and privacy risk assessments using NIST Risk Management Framework (RMF), OCTAVE (Operationally Critical Threat, Asset, and Vulnerability Evaluation), or FAIR (Factor Analysis of Information Risk) methodologies. Risk assessments identify threats to PHI confidentiality, integrity, and availability, quantify likelihood and impact, prioritize risks using risk matrices, and develop risk treatment plans with accept, mitigate, transfer, or avoid strategies. Annual risk assessments meet HIPAA Security Rule requirements.

Policy and Procedure Documentation

Our compliance consultants develop healthcare-specific policies including information security policy and standards, acceptable use policy for technology resources, incident response and breach notification procedures, business continuity and disaster recovery plans, vendor risk management and third-party assessment procedures, security awareness training programs, and password and authentication requirements. Policies align with regulatory frameworks and industry best practices (NIST, HITRUST, CIS Controls).

Security Awareness Training

We deliver security awareness training programs for healthcare workforce including HIPAA Privacy and Security Rule training for all employees, phishing awareness with simulated phishing campaigns, mobile device security for BYOD programs, social engineering defense techniques, incident reporting procedures and escalation paths, and role-specific training for developers, IT administrators, and executives. Training meets HIPAA workforce training requirements and includes annual refreshers and new hire onboarding modules.

Vendor Risk Management

Healthcare organizations must assess third-party vendor security. We implement vendor risk management programs including vendor security questionnaire distribution and assessment, Business Associate Agreement (BAA) review and negotiation, on-site security audits for critical vendors, continuous vendor monitoring with external security ratings, and vendor incident response coordination. Vendor assessments cover infrastructure providers (AWS, Azure), SaaS applications (Salesforce, Zoom), and development subcontractors.

Healthcare Security Case Studies

HIPAA Compliance for Digital Health Startup

Challenge: A Series B digital health startup needed to achieve HIPAA compliance before signing enterprise health system customers. The company lacked formal security policies, technical controls documentation, and risk assessment procedures.

Solution: We conducted a comprehensive Security Risk Assessment identifying 47 security gaps across administrative, physical, and technical safeguards. Implemented encryption for PHI at rest and in transit, deployed MFA for all users, established audit logging with 1-year retention, developed 25+ security policies and procedures, conducted workforce security training, and executed BAAs with all cloud providers. Prepared documentation for customer HIPAA compliance audits.

Outcome: HIPAA compliance achieved in 4 months. Passed security audits from 3 health system customers. Zero security findings in external audit. Enabled $15M in enterprise revenue.

Penetration Testing for Medical Device Manufacturer

Challenge: A medical device company needed security testing of their companion app and cloud backend prior to FDA 510(k) submission. FDA premarket cybersecurity documentation required evidence of security testing and vulnerability remediation.

Solution: We performed comprehensive security assessment including mobile app reverse engineering and binary analysis, API security testing with authentication bypass attempts, cloud infrastructure penetration testing, BLE protocol analysis for device communication security, and threat modeling for abuse cases. Identified 12 vulnerabilities including 3 high-severity findings. Provided detailed remediation guidance and re-tested after fixes.

Outcome: All vulnerabilities remediated before FDA submission. Security testing evidence included in 510(k) cybersecurity documentation. FDA clearance obtained with no security-related questions. Ongoing annual security testing established.

SOC 2 Type II for Healthcare SaaS Platform

Challenge: A remote patient monitoring platform needed SOC 2 Type II attestation to meet customer security requirements. The company had basic security controls but lacked formalized processes, evidence collection, and control documentation.

Solution: We implemented SOC 2 Trust Services Criteria across security, availability, and confidentiality. Developed control matrices mapping activities to criteria, implemented evidence collection procedures with screenshots and artifacts, established change management with approval workflows and testing evidence, deployed security monitoring with automated alerts and incident tracking, and conducted internal SOC 2 readiness assessment. Coordinated with external auditor throughout 12-month observation period.

Outcome: Clean SOC 2 Type II report with zero exceptions. Enabled contracts with 8 new enterprise health system customers requiring SOC 2. Annual re-attestation process established with 90% automated evidence collection.

Why Choose Kesem Solutions for Healthcare Security

  • Healthcare Security Expertise: Our team includes Certified Information Systems Security Professionals (CISSP), Certified Ethical Hackers (CEH), and healthcare security specialists with deep knowledge of HIPAA, medical device cybersecurity, and healthcare threat landscape.
  • Multi-Jurisdiction Compliance: We navigate compliance across US (HIPAA), Australia (Privacy Act, TGA), Europe (GDPR), and global frameworks (ISO 27001, SOC 2). Our team understands regional differences and harmonizes controls for efficient multi-region compliance.
  • Technical and Regulatory Balance: We bridge the gap between technical security implementation and regulatory compliance documentation. Our deliverables satisfy both engineering teams and compliance auditors.
  • Medical Device Security Focus: Specialized expertise in FDA cybersecurity guidance, SBOM/CBOM generation, medical device penetration testing, and post-market vulnerability management. We understand unique challenges of connected medical devices.
  • Practical Risk Management: We prioritize security investments based on actual risk to PHI and business operations. Our recommendations consider budget constraints and provide phased implementation roadmaps.
  • Ongoing Security Partnership: Beyond initial compliance, we provide continuous security monitoring, quarterly vulnerability assessments, annual policy reviews, incident response support, and emerging threat briefings. Healthcare security requires ongoing vigilance.

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Strengthen Your Healthcare Security Posture

Ready to achieve comprehensive healthcare data security and compliance? Our team delivers practical security solutions that protect patient privacy, meet regulatory requirements, and enable secure innovation. Whether you need HIPAA compliance, security testing, SOC 2 attestation, or incident response support, we provide expertise across all healthcare security domains.

Typical Engagement: Security Assessment: $15,000-$30,000 | Full Compliance Program: $40,000-$100,000 | Ongoing Security: Custom retainers

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