Healthcare Required

HIPAA

HIPAA Compliance That Protects Patients — and Your Business From Million-Dollar Penalties

Norvex Assurance builds a complete, defensible HIPAA programme for covered entities and business associates — documented risk analysis, tailored policies, trained workforce, and the Business Associate Agreements your partners and regulators require.

HIPAA Compliance Programme

End-to-end managed service

What Is HIPAA — and Who Does It Apply To?

The Health Insurance Portability and Accountability Act (HIPAA) establishes the national standard for protecting individuals' medical records and other protected health information (PHI). It applies to covered entities — healthcare providers, health plans, and clearinghouses — and to their business associates: any vendor, SaaS platform, cloud provider, or service organisation that creates, receives, maintains, or transmits PHI on their behalf. Non-compliance carries severe consequences. The HHS Office for Civil Rights (OCR) enforces HIPAA with civil monetary penalties ranging from $100 to $50,000 per violation (up to $1.9 million per violation category per year), and criminal penalties for wilful neglect. Beyond fines, a HIPAA breach destroys patient trust and generates the kind of regulatory scrutiny that can shut down a healthcare business.

Key Highlights

  • Applies to covered entities and all business associates handling PHI
  • Three rules: Privacy Rule, Security Rule, and Breach Notification Rule
  • Penalties range from $100 to $1.9M per violation category annually
  • Required for any technology company selling into US healthcare

Who Needs HIPAA?

Healthcare Providers & Clinics
Health Insurance Plans
Healthcare SaaS & EHR Vendors
Medical Device & HealthTech Companies

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Our HIPAA Process

01

PHI Inventory & Data Mapping

We identify every system, application, workflow, and vendor that creates, receives, maintains, or transmits PHI — including cloud storage platforms, EHR integrations, and communication tools. The output is a complete PHI data flow map that underpins every subsequent step in the programme.

02

Mandatory Risk Analysis

We conduct the Security Rule-required risk analysis to identify and document threats and vulnerabilities to ePHI confidentiality, integrity, and availability. This analysis is the most frequently reviewed document in OCR enforcement actions and the foundation of a defensible HIPAA posture.

03

Risk Management Plan

We develop a documented risk management plan that reduces identified threats and vulnerabilities to a reasonable and appropriate level. Each risk item is assigned an owner, a treatment approach, and a resolution timeframe — creating an auditable record of your organization's risk decisions.

04

Policy & Procedure Development

We build your complete HIPAA policy library — covering Privacy Rule obligations, Security Rule safeguards, and Breach Notification requirements — tailored to your organization's workflows and workforce roles. Every policy reflects how your organization actually operates, not a generic template.

05

BAA Review & Vendor Management

We audit all third-party relationships that involve PHI access or processing. We review existing Business Associate Agreements, identify relationships where no BAA is in place, and execute compliant agreements with every applicable vendor — closing a category of exposure that drives significant OCR enforcement activity.

06

Staff Training Programme

We deliver role-appropriate HIPAA training for all workforce members — from clinical staff to software engineers — with documented completion records that satisfy OCR requirements and demonstrate your organization's commitment to a security-aware culture.

07

Ongoing Monitoring & Annual Review

We implement audit controls and breach detection mechanisms, and establish structured annual review cycles to keep your programme current as your systems, vendors, and operations evolve. HIPAA requires periodic review — this step ensures you always have a defensible, up-to-date posture.

Business Impact

Why Get HIPAA Attested?

OCR-Defensible Documentation

We build the risk analysis, policies, and BAAs that OCR examiners request first — structured to demonstrate a thorough, good-faith effort to protect PHI before any investigation begins.

Access to Healthcare Enterprise Contracts

Documented HIPAA posture is a prerequisite for contracting with health systems, payers, and government healthcare programmes. We build the evidence package your sales team needs to pass procurement reviews.

Patient & Partner Confidence

Organizations that can demonstrate structured, documented protection of PHI build deeper trust with patients and institutional partners — particularly in a sector where data incidents receive significant public attention.

Structured Breach Response

A documented breach response plan with clear decision trees and notification procedures means your organization responds correctly when an incident occurs — not after hours of internal confusion.

Vendor Liability Management

Properly executed BAAs with every applicable vendor define responsibilities, limit your exposure, and create an auditable chain of accountability for PHI handling across your entire supply chain.

Foundation for HITRUST

A well-constructed HIPAA programme shares significant overlap with HITRUST CSF requirements. Organizations pursuing HITRUST certification build on the policies, risk analysis, and documentation developed here — avoiding duplicate effort.

ISO 27001:2022 Annex A Controls — What They Cover and Why They Matter

The 93 Annex A controls form the operational backbone of your ISMS. Norvex Assurance helps you select, implement, and document the controls relevant to your scope through your Statement of Applicability (SoA).

HIPAA Privacy Rule

Standards for PHI Use & Disclosure

The Privacy Rule establishes national standards for when and how covered entities may use or disclose protected health information. It gives patients rights over their health data — including the right to access, amend, and receive an accounting of disclosures. Norvex Assurance implements the required notices, policies, and authorization procedures to satisfy every Privacy Rule obligation.

HIPAA Security Rule

Standards for Electronic PHI (ePHI)

The Security Rule requires covered entities and business associates to implement administrative, physical, and technical safeguards to protect ePHI confidentiality, integrity, and availability. The Security Rule risk analysis is mandatory — and it is the most frequently cited element in OCR enforcement actions. Our programme builds and documents this analysis from scratch.

Breach Notification Rule

Mandatory Incident Response

The Breach Notification Rule requires covered entities to notify affected individuals, HHS, and in some cases the media, following the discovery of unsecured PHI. Business associates must notify covered entities within 60 days. Norvex Assurance builds your complete breach response plan — detection, assessment, notification, and documentation — so you respond correctly under pressure.

Everything You Get with Our HIPAA Programme

Our fixed-scope engagement covers every deliverable needed to achieve and maintain your HIPAA certification — no hidden extras.

01
PHI inventory and complete data flow mapping documentation
02
HIPAA Security Rule risk analysis report (OCR-ready)
03
Risk management plan with documented remediation tracking
04
Complete HIPAA policy and procedure library (Privacy, Security, Breach Notification)
05
Business Associate Agreement audit, templates, and executed BAAs
06
Staff HIPAA training programme with role-appropriate content and completion records
07
Incident response and breach notification plan with decision tree
08
Annual review schedule and compliance attestation documentation

What Our Clients Say

"We were losing deals because health system procurement teams couldn't get a satisfactory answer on our HIPAA posture. Norvex Assurance built our entire compliance programme in six weeks — risk analysis, policies, BAAs, training. We've signed four enterprise contracts since."

Chief Compliance Officer

EHR SaaS Platform — Series B

"Our OCR audit came out of nowhere. Norvex Assurance helped us pull together every required document, coached us through the process, and we came through without a single penalty. Having them in our corner was invaluable."

VP of Engineering

Telehealth Company — Series A

"Implementing HIPAA across a hardware-software product was genuinely complex. Norvex Assurance mapped every PHI touchpoint, built a compliance framework that worked across our engineering and clinical teams, and made the entire programme feel manageable rather than overwhelming."

Head of Security

Medical Device Manufacturer

Common Questions About HIPAA

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