Healthcare Required

HIPAA

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

Norvex Assurance's HIPAA compliance programme gives covered entities and business associates a complete, audit-ready compliance posture — documented risk analysis, airtight policies, trained staff, and the BAAs your partners require.

HIPAA Compliance Programme

End-to-end managed service

$1.9M
Max Penalty Per Violation Category
4–8 Wks
Time to Compliance Readiness
200+
Healthcare Clients Served

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

Not sure if you need HIPAA?

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Our HIPAA Process

01

PHI Inventory & Data Mapping

Identify every system, application, workflow, and vendor that creates, receives, maintains, or transmits PHI — including cloud storage, EHR integrations, and communication tools.

02

Mandatory Risk Analysis

Conduct the Security Rule-required risk analysis to identify threats and vulnerabilities to ePHI confidentiality, integrity, and availability. This is the most scrutinised document in an OCR audit.

03

Risk Management Plan

Develop and implement a documented risk management plan to reduce identified risks to a reasonable and appropriate level — with clear ownership and remediation timelines.

04

Policy & Procedure Development

Build your complete HIPAA policy library — Privacy, Security, and Breach Notification — tailored to your organisation's workflows and workforce roles. Never generic boilerplate.

05

BAA Review & Vendor Management

Audit all third-party relationships involving PHI. Review existing Business Associate Agreements and execute new BAAs where none exist — ensuring every vendor relationship is properly documented.

06

Staff Training Programme

Conduct role-appropriate HIPAA training for all workforce members — from clinical staff to developers — with documented completion records that satisfy OCR requirements.

07

Ongoing Monitoring & Annual Review

Implement audit controls, breach detection mechanisms, and structured annual review cycles to maintain continuous compliance and respond to operational changes.

Business Impact

Why Get HIPAA Certified?

OCR Audit-Ready Documentation

Build the documented risk analysis, policies, and BAAs that OCR examiners look for first — before an investigation begins.

Win Healthcare Enterprise Contracts

HIPAA compliance evidence is a prerequisite for contracting with health systems, payers, and government healthcare programmes.

Patient & Partner Trust

Demonstrate your commitment to protecting sensitive health information, building lasting relationships with patients and institutional partners.

Breach Response Confidence

Have a tested, documented breach response plan in place before an incident occurs — so you respond in hours, not days.

Vendor Liability Protection

Properly executed BAAs protect your business from liability exposure when PHI flows through third-party relationships.

Foundation for HITRUST

A strong HIPAA compliance programme is the foundation for HITRUST CSF certification — the gold standard in US healthcare security.

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
Transparent Pricing

SOC 2 Certification Cost — No Surprises

We believe you deserve to know what SOC 2 costs before you commit. All engagements begin with a free scoping call — no obligation.

Startup

Core HIPAA Compliance

$8,000 – $18,000

USD · 4–8 weeks

Ideal forEarly-stage HealthTech and SaaS companies (Seed to Series A) that need HIPAA compliance to sign their first healthcare enterprise contract or BAA.

  • PHI inventory and data flow mapping
  • Mandatory Security Rule risk analysis
  • HIPAA policy and procedure library
  • BAA templates and review
  • Staff training programme
Most Popular

Growth

Comprehensive Programme

$18,000 – $40,000

USD · 6–12 weeks

Ideal forScaling HealthTech companies (Series A–C) with complex PHI environments, multiple integrations, or multiple covered entity relationships.

  • Everything in the Startup tier
  • Hands-on remediation support across engineering and clinical ops
  • Multi-system PHI mapping and vendor BAA management
  • Breach response plan with tabletop exercise
  • Ongoing monitoring setup and annual review support

Enterprise

HIPAA + Multi-Framework

$40,000+

USD · Custom

Ideal forHealth systems, large business associates, or organizations pursuing HIPAA alongside HITRUST CSF or SOC 2 for maximum healthcare market coverage.

  • Everything in the Growth tier
  • HITRUST and/or SOC 2 integrated audit planning
  • Executive-level reporting and board presentations
  • Dedicated senior HIPAA engagement partner
  • Ongoing compliance management retainer

Serving global clients in the US, India, UAE, Singapore, and beyond. All pricing quoted in USD.

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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