HIPAA Compliance
HIPAA Compliance for Healthcare and Medical Device Manufacturers
We help medical device manufacturers protect ePHI and meet HIPAA Security Rule requirements, wherever that data flows.
Medysec Deliverables
What HIPAA Deliverables Does Medysec Provide?
We focus on the systems, devices, applications, and data flows that fall within the applicable HIPAA scope.
HIPAA Risk Management Plan
HIPAA Security Policies & Procedures
Administrative Safeguards Assessment
Physical Safeguards Assessment
Technical Safeguards Assessment
PHI/ePHI Data Inventory & Data Flow
Security Incident Response Plan
HIPAA Breach Risk Assessment & Notification Procedures
Contingency & Disaster Recovery Plan
Business Associate Agreement (BAA) Package
HIPAA Compliance Gap Assessment & Remediation Report
Security Testing & Vulnerability Assessment Report
HIPAA Compliance Monitoring & Evaluation Report
Our Compliance Process
Our HIPAA Compliance Process Workflow
We identify the in-scope systems and data flows, assess the safeguards, test agreed surfaces, and document the findings.
Standards & Framework
Standards and Frameworks We Follow
Our HIPAA compliance work is informed by the standards and frameworks relevant to your systems, data, and assessment scope.
- HIPAA Privacy Rule
- HIPAA Security Rule
- HIPAA Breach Notification Rule
- HITECH Act
- HIPAA Administrative Simplification Regulations
- HHS/OCR HIPAA Security Rule Guidance
- HHS/OCR Guidance on Risk Analysis Requirements under the HIPAA Security Rule
- NIST SP 800-66 Rev. 2 Resource Guide
- NIST Cybersecurity Framework (CSF)
- NIST Secure Software Development Framework (SSDF)
- ISO/IEC 27001
- ISO/IEC 27002
- CIS Critical Security Controls
- CIS Benchmarks, where applicable
Step-by-Step Workflow
How to Begin Securing Your MedTech Cybersecurity with Medysec
We analyze your device architecture, build complete cybersecurity evidence, and hand your team an audit-ready submission package.
- 01
Discovery & Artifact Plan
Our senior Medysec expert reads device architecture, intended use, regulatory pathway, and existing cybersecurity evidence then delivers a written artifact plan and fixed-fee quote inside 5 business days.
- 02
Authoring & Testing
Medysec runs hands-on threat modeling, SBOM authoring, security risk assessment, and penetration testing on the named device, using the agreed artifact plan as the work contract.
- 03
Internal Reviewer Simulation
Two named Medysec experts review the package against FDA 2026 guidance check-by-check before handoff. Findings are flagged, retested, and closed.
- 04
Submission Hand-off
You get a one-hour walk-through with your regulatory lead, a Letter of Attestation, and a fixed-fee retest commitment if FDA raises cybersecurity deficiencies.
In Their Words
What Our Clients Say
We work alongside device manufacturers to secure their connected medical devices and clear regulatory review. Here is what those teams have to say about us.
Qualysec Technologies Pvt Ltd's efforts resulted in improved security, risk mitigation, enhanced security controls, and compliance achievement. The team was responsive, flexible, and open to addressing the client's evolving needs. They maintained regular communication via email and virtual meetings.
Billy Sadhu Sharma Kumar
Head-V&V Engineering
HIPAA Case Studies
Security Work That Supports Healthcare Teams
An European MedTech Startup Secures Its Diagnostic Desktop App With Medysec Ahead of FDA 510(k) Submission
A security assessment of a diagnostic desktop application used with the TearView platform, focused on protecting patient diagnostic data, strengthening application controls, and supporting the client’s FDA 510(k) documentation.
Read Case Study
Building a practical threat-modeling process for a healthcare platform
A healthcare platform engagement that clarified security ownership, mapped critical attack paths, and improved evidence for release decisions.
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Securing cloud services behind a patient-facing health application
A practical cloud security review that helped a patient-facing product prioritise its most important configuration and access-control improvements.
Read Case StudyHIPAA FAQ
Frequently Asked Questions
Check where the data goes, who can access it, how it is protected, and whether the cloud provider's role creates additional HIPAA obligations.
Ready to Build HIPAA Compliance for Connected Medical Devices?
Tell us what you are working on and we will give you a straight read on scope, timeline, and cost.