GRC Services / GRC for Healthcare
Healthcare · Hospitals · HealthTech · Medical Devices

GRC for Healthcare & Medical Organisations.

Patient data is among the most sensitive data on earth — and the consequences of mishandling it are severe. Savadub helps hospitals, clinics, healthtech companies, and medical device manufacturers build compliant, resilient GRC programs that protect patients and satisfy regulators.

HIPAA / HITECHISO 27001SOC 2FDA 21 CFR Part 11GDPR
$10.9M
Average healthcare data breach cost (2023)
1 in 3
US adults affected by health data breaches
18 mo.
HIPAA audit cycle regulators expect
92%
Of healthtech firms lack mature GRC programs
Industry Challenges

The GRC Challenges You Face

Understanding the unique compliance and risk landscape of your sector is where good GRC begins.

HIPAA Compliance Complexity

HIPAA's Privacy Rule, Security Rule, and Breach Notification Rule create interlocking obligations across administrative, physical, and technical safeguards that require specialist expertise to implement correctly.

Legacy System Risk

Hospitals and clinics often run decades-old clinical systems (EHR, PACS, LIMS) that were never designed for modern security standards — creating persistent risk exposure that cannot simply be patched away.

Third-Party ePHI Exposure

Vendors, cloud providers, billing partners, and insurers all handle protected health information (PHI) as Business Associates — each requiring BAA agreements, security assessments, and ongoing oversight.

Multi-Framework Burden

A healthtech company serving patients in Nigeria, the EU, and the US must simultaneously satisfy NDPR, GDPR, HIPAA, and potentially SOC 2 — creating a complex, overlapping compliance landscape.

How We Help

Our GRC Services for This Sector

Tailored services that map directly to your regulatory obligations, operational risks, and audit requirements.

HIPAA Compliance Program

Complete HIPAA Security Rule and Privacy Rule implementation: risk analysis, sanction policies, workforce training, physical safeguards, technical safeguards, and Business Associate Agreement management.

HITECH & Breach Notification Readiness

Breach detection and notification procedures, incident response playbooks, and the documentation infrastructure to satisfy HHS reporting requirements within statutory timelines.

FDA 21 CFR Part 11 Compliance

Electronic records and electronic signatures compliance for medical device software, clinical trial systems, and pharmaceutical manufacturing — including audit trail validation, access controls, and system validation documentation.

SOC 2 for HealthTech Platforms

SOC 2 readiness and audit support for digital health companies, EHR vendors, and patient engagement platforms — mapping Trust Services Criteria to your specific technical architecture and data flows.

Business Associate Management

Vendor risk assessment program for Business Associates and subcontractors — including BAA template creation, security questionnaires, and periodic review cycles.

Healthcare Data Governance

Patient data lifecycle governance: data classification, retention schedules, de-identification standards, consent management frameworks, and cross-border health data transfer protocols.

Frameworks & Standards

Compliance Frameworks We Cover

Our team holds deep, practitioner-level expertise in every framework relevant to your sector — not just the names, but the controls, audit expectations, and fastest path to certification or attestation.

Ask About Your Framework
HIPAA Privacy Rule HIPAA Security Rule HITECH Act FDA 21 CFR Part 11 SOC 2 Type II ISO/IEC 27001 GDPR NDPR NIST SP 800-66 HITRUST CSF ISO 27799 IEC 62443 (Medical IoT)
Our Methodology

How We Build Your GRC Program

A structured, phased approach that delivers immediate risk reduction and builds long-term compliance maturity.

01
Discovery & Gap Assessment

We audit your current state against your target frameworks, identifying control, documentation, and policy gaps. You receive a prioritised findings report with a clear compliance roadmap.

02
GRC Architecture & Design

We design your governance structure, risk appetite statement, control framework mapping, policy library, and the tooling to support ongoing operations.

03
Implementation & Technical Engineering

We implement controls — technical and administrative. Policies are authored, technical controls configured, and evidence collection workflows established.

04
Audit Readiness & Certification Support

We prepare your evidence package, manage the auditor relationship, respond to findings, and shepherd you through to a successful audit outcome.

05
Continuous Monitoring & Ongoing Management

We set up continuous control monitoring, manage recurring risk reviews, update policies as regulations evolve, and provide monthly GRC reporting to your leadership.

Audit Services

Internal & External GRC Auditing

We provide both embedded internal audit capabilities and independent third-party audit services — including CPA-accredited audit coordination.

Internal GRC Audit (Embedded)
We act as your internal audit function — year-round
Ongoing control testing and evidence collection
Risk register maintenance and treatment tracking
Policy review and update cycles
Management reporting and board-level dashboards
Continuous control monitoring oversight
External / Third-Party Audit Support
Independent audit readiness assessments
CPA-accredited auditor coordination (SOC 1 & 2)
Evidence package preparation and review
Auditor liaison and findings response management
Certification support (ISO 27001, PCI DSS, etc.)
Remediation planning post-audit
Start Your GRC Journey

Ready to Build a Compliant, Resilient Healthcare Organization?

Book a free 60-minute GRC assessment. We review your current compliance posture, identify your highest-priority gaps, and outline a clear path forward — at no cost and no obligation.

No commitment required · Response within 1 business day