Non-US healthcare technology companies entering the American market face one of the most detailed health privacy regimes in the world: the Health Insurance Portability and Accountability Act (HIPAA) and its associated Privacy, Security, and Breach Notification Rules. Global Link Law serves as outside HIPAA counsel for international digital health, medical device, AI, and clinical research companies that need pragmatic, US-ready compliance guidance without building a large in-house legal team.
Who This Page Is For
- EU, UK, Israeli, Canadian, APAC, and LATAM health-tech companies expanding to the US
- International SaMD and AI/ML device manufacturers with US partners
- Global contract research organizations (CROs) handling US clinical data
- Cross-border telehealth platforms offering services to US patients or clinicians
- Vendors serving US hospital systems, payers, or pharma clients
Core HIPAA Issues for International Companies
Are You a Covered Entity or a Business Associate?
Most international technology vendors fall under the Business Associate (BA) definition when they create, receive, maintain, or transmit Protected Health Information (PHI) on behalf of a US Covered Entity. We run the analysis, document it, and build the operating model around it.
Business Associate Agreements (BAAs) and Subcontractor Flowdowns
We draft and negotiate BAAs that are defensible in both US and home-jurisdiction contexts, align with your engineering realities, and avoid dangerous open-ended indemnities. We also build the subcontractor flowdown architecture required by 45 CFR 164.308(b) and 164.314(a).
HIPAA Security Rule Technical and Administrative Safeguards
We translate the Security Rule’s administrative, physical, and technical safeguards into practical policies, procedures, risk analyses, and workforce training materials appropriate for a lean international team. We map existing ISO 27001 and SOC 2 controls to HIPAA requirements to avoid duplicative work.
Breach Notification and Incident Response
We prepare breach notification playbooks that coordinate HIPAA’s 60-day clock with GDPR’s 72-hour clock and other national frameworks, identify the correct reporting paths to HHS and affected individuals, and run tabletop exercises.
Cross-Border Data Transfers and Interaction with GDPR
HIPAA and GDPR overlap and sometimes conflict. We align lawful basis, Standard Contractual Clauses, Transfer Impact Assessments, and data subject rights with HIPAA’s minimum-necessary and authorization standards, so international companies are not caught between two regimes.
State Privacy Laws Layered On Top
HIPAA is not the end of the analysis. We advise on CCPA/CPRA (California), Washington’s My Health My Data Act, Texas medical privacy rules, New York SHIELD Act, and emerging state consumer health data laws that apply alongside or outside of HIPAA.
Typical Engagement Models
- Fixed-scope HIPAA readiness assessment for US market entry
- Outside HIPAA counsel on a monthly retainer for ongoing operations
- Deal support: BAA negotiation for new US hospital or payer contracts
- Incident response retainer with defined response SLAs
- US privacy program build combining HIPAA, CCPA, and state consumer health laws
Related Pages
- Healthcare Technology Law Firm — US & International (pillar page)
- Healthcare Law for EU Market Entry
Talk to HIPAA Counsel That Understands International Companies
If you are an international company scaling into the US and want HIPAA counsel that is commercial, cross-border literate, and responsive to engineering realities, contact Global Link Law to schedule an introductory call.
Strategic Legal Counsel for Healthcare & Health Technology
Your organization faces legal and regulatory complexity that demands more than outside counsel — it demands a partner who has sat on your side of the table.
From government investigations and FCPA matters to healthcare M&A and payer contracting, we’ve handled it from the inside and from the courtroom.
Whether you need fractional leadership, transactional support, or a defensible compliance framework, we deliver counsel built around what the business actually needs. What sets us apart is real-world in-house experience — our partners have served in senior legal roles within large and publicly traded companies, giving them a direct understanding of what business leaders and boards actually need from legal counsel.