+ HealthTech
HIPAA compliance, FDA clearance, and clinical credibility are prerequisites — not checkboxes. ATA gets you across every one of them.
The Challenge
U.S. healthcare is the most regulated market in the world. Every layer — from data handling to device clearance to reimbursement — requires specific U.S. expertise and relationships that foreign founders rarely have.
Any product that touches protected health information must be HIPAA-compliant before a U.S. hospital or payer will speak to you. HITECH adds breach notification requirements most founders miss.
Software as a Medical Device (SaMD) and AI diagnostic tools require FDA 510(k) clearance or de novo authorization. This process takes 6–24 months and requires a U.S.-based regulatory contact.
Getting covered by Medicare, Medicaid, or private payers is its own multi-year process. Without a reimbursement strategy, enterprise health system sales stall at procurement.
U.S. health systems require peer-reviewed evidence, U.S. clinical references, and local clinical advisors before evaluating a foreign vendor — especially for anything AI-powered.
How ATA Solves It
ATA delivers the full regulatory and commercial infrastructure for HealthTech entry. We work with FDA regulatory consultants, healthcare attorneys, and clinical advisors to get you HIPAA-compliant, FDA-cleared, and in front of the right health system buyers.
From SBIR/STTR grants to VA and CMS contracting, we also open the government health procurement pathway — one of the largest and most accessible markets for innovative health technology.
Regulatory
HIPAA, HITECH, FDA 510(k)/de novo, SaMD, state health regulations
Legal & Entity
C-Corp/LLC, BAA templates, IP protection, data processing agreements
Gov. Procurement
VA, NIH, CMS contracting, SBIR/STTR programs
Credibility
Clinical advisory board placements, health system associations
Insurance & Risk
Medical malpractice, cyber liability, E&O for health products
Go-to-Market
Health system sales strategy, buyer mapping, reimbursement narrative
Regulatory Map
Health Insurance Portability and Accountability Act
The federal standard for protected health information. Any product that creates, receives, maintains, or transmits PHI on behalf of a covered entity requires HIPAA compliance — including Business Associate Agreements (BAAs) with every partner in the data chain.
Health Information Technology for Economic and Clinical Health Act
Extends HIPAA obligations to business associates and subcontractors. Adds mandatory breach notification requirements. Significantly increases civil and criminal penalties. Most foreign founders underestimate its reach.
Premarket Notification
Required for medical devices and Software as a Medical Device (SaMD) that are substantially equivalent to a legally marketed predicate device. Review takes 3–12 months. Missing this classification is a compliance violation, not just a delay.
Software as a Medical Device
International framework adopted by the FDA for classifying clinical decision support and diagnostic software. Determines whether your AI product is regulated as a medical device — and which FDA pathway applies.
System and Organization Controls 2
The standard security and compliance framework required by health system procurement teams. Type II certification signals operational security maturity. Required for enterprise health system sales in most cases.
Centers for Medicare & Medicaid Services
Administers Medicare and Medicaid reimbursement. Getting your product covered requires a reimbursement code (CPT or HCPCS), coverage determination, and payment rate negotiation — a multi-year process that must be started early.
Other Industries
Get Started
HIPAA-compliant. FDA pathway clear. Clinical credibility built. One engagement.
