HIPAA (Health Insurance Portability and Accountability Act) is the US medical data protection law — mandatory for any organization handling the health information of Americans (PHI). An Israeli Health Tech company wanting to enter the US market must comply with HIPAA. Fines up to $1.9 million per violation. CBE has been guiding Health Tech companies for 30 years — with 100% success and over 4,000 satisfied clients.
CBE specializes in guiding and certifying organizations for the HIPAA standard, tailoring the management system to the organization's needs.
Quick facts – HIPAA
Objective
Protecting personal health information (PHI) in the US
Who needs it
Covered Entities and Business Associates
Relevance in Israel
Mandatory gateway to the US Health Tech market
Complements
ISO 27799, SOC 2, GDPR, Amendment 13
CBE — success rate
100% — hundreds of certified clients
HIPAA defines the rules for handling PHI (Protected Health Information) — any information that can identify a person and relates to their medical condition. It binds Covered Entities (hospitals, health insurers, healthcare providers) and every Business Associate that handles their data.
An Israeli Health Tech company developing an EHR, health app, or any SaaS service for the US medical market is a Business Associate and must sign a BAA and comply with all HIPAA requirements.
CBE doesn't just guide you to HIPAA — we build a framework that combines HIPAA, ISO 27799, SOC 2 and ISO 13485, because the US healthcare market requires more than one standard.
Defines what counts as PHI, when it may be used and how to protect it.
Administrative, physical and technical controls for protecting ePHI.
Mandatory contract between a Covered Entity and every Business Associate.
Mandatory reporting of PHI breaches within 60 days to HHS and affected individuals.
Developing an EHR, telemedicine platform, clinic management? Any SaaS service for the US medical market is a Business Associate and must comply with HIPAA.
To sector pageA device that collects health data and interfaces with US systems must prove HIPAA compliance to suppliers and buyers.
To sector pageA cloud provider storing PHI for US hospitals is a Business Associate — BAA obligation and full compliance.
An AI model analyzing patient data processes PHI. Any organization training models on US patient data must comply with HIPAA.
To sector pageClinical research organizations and labs processing samples from Americans are Business Associates and must comply with HIPAA.
Health insurance companies and third-party payers are Covered Entities in every respect and must fully comply with HIPAA.
To sector pageWithout HIPAA — US hospitals and insurance companies won't sign with you
Fines up to $1.9M per violation + HHS investigations that can disrupt operations
Proven HIPAA compliance increases trust in the medical market and enables collaborations
A comprehensive security framework for protecting PHI from leaks and breaches
Defining the organization's needs, stakeholders and the scope of the quality management system.
Process planning and control, managing customer requirements, external providers and output control.
Management commitment, quality policy and defining roles and responsibilities.
Measurement, analysis, internal audit and management review.
Risk and opportunity management, quality objectives and plans to achieve them.
Managing non-conformities, corrective actions and continuous improvement of the system.
Resources, employee competence, internal communication and documentation.
CBE performs a full Gap Analysis and builds a work plan tailored to your organization.
International Health Tech requires more than HIPAA — here's the full picture
CBE guides you at every step — from Risk Analysis to ongoing compliance and periodic reviews
Mapping ePHI, risk assessment and gap analysis against HIPAA
Privacy Policy, Security Policies, BAA templates, Breach procedures
Workforce Training, implementing technical and physical controls
Preparing for an HHS audit and US client reviews
HIPAA is continuous compliance — CBE guides you through HHS updates
30 years, hundreds of clients, 100% success — here's what sets us apart
Committed to success! No client has ever failed a certification audit. Not certified — you don't pay!
We adapt the timeline to your deadline — tender, supplier, client.
CBE's skilled human team writes your procedures and documentation tailored to your organization.
HIPAA is the foundation. CBE also guides you to ISO 27799, SOC 2, ISO 13485 and more — under one roof.
We don't disappear after the certificate. Annual reviews, standard updates, organizational changes.
From startup to enterprise — experience with every type of organization in every field.
HIPAA covers the US market — but international Health Tech companies also need additional regulations. CBE manages your entire GRC journey under one roof.
About CBE's GRC frameworkCBE specializes in guiding and certifying organizations for the HIPAA standard. The service is provided by CBE's experts, with 30 years of experience in ISO standards, over 4,000 satisfied clients and 100% success in audits.
Tell us about your product and your US client — we'll come back with an exposure assessment