Build Healthcare Infrastructure That Patients and Regulators Trust
Konfirmity pairs platform automation with dedicated CISO expertise to implement HIPAA, HITRUST, and ISO 27001 controls that produce audit-ready evidence continuously.
Book A Demo[01] Why It Matters
The Stakes: Why healthcare compliance is a survival issue
Breach Notification Exposure
HIPAA breach notification triggers regulator filings, individual patient notice, and--at scale--media notification. Civil money penalties scale per affected record.
// TODO: confirm OCR penalty band
Health-System Partnership Loss
Failing a hospital or payer security review can end an enterprise contract. Vendor risk teams expect HITRUST certification or SOC 2 + HIPAA equivalence.
Enterprise contract risk
Executive Accountability
Covered entities and business associates carry direct regulatory liability. Senior leaders are increasingly named in OCR settlements and corrective action plans.
Personal accountability
Patient Trust Erosion
Healthcare breaches are public, searchable on the OCR portal, and durable. Patient trust, once lost, is the hardest asset to rebuild in this category.
Long-tail brand damage
[02] Jurisdiction Coverage
Country-by-Country Health-Data Coverage
// Primary Regulators
Office for Civil Rights (OCR) within HHS for HIPAA enforcement; Food and Drug Administration (FDA) for medical-device software; Federal Trade Commission (FTC) for the Health Breach Notification Rule covering non-HIPAA health data.
// Key Frameworks
HIPAA Security Rule, HIPAA Privacy Rule, HITECH Act, HITRUST CSF, NIST SP 800-66 (HIPAA implementation guide), SOC 2 Type II for enterprise vendor reviews.
// Entity Types
Covered Entities (providers, payers, clearinghouses), Business Associates (any vendor processing PHI), and Subcontractors of Business Associates -- all directly liable under HIPAA.
// Enforcement Trend
// TODO: confirm latest OCR enforcement bulletins and HITRUST adoption rates with marketing.
// Key Obligations
Conduct an annual HIPAA Security Risk Analysis, sign Business Associate Agreements with all subprocessors, implement administrative / physical / technical safeguards, notify affected individuals and OCR within 60 days of breach discovery, and train workforce annually.
// Unique Challenges
HIPAA's 'addressable' vs. 'required' specifications leave room for examiner second-guessing. HITRUST is increasingly demanded by hospital systems even though it is not a regulatory mandate. Medical-device software adds FDA premarket and postmarket cybersecurity obligations.
// What Konfirmity Covers
HIPAA Security Rule implementation and Risk Analysis evidence, HITRUST CSF readiness and certification support, BAA registry, breach-notification runbooks aligned to the 60-day window, and SOC 2 + HIPAA combined audit packaging.
[03] Frameworks
One Platform, Every Health-Data Obligation
Framework
What It Covers
How Konfirmity Helps
Regions
HIPAA
Security, Privacy, and Breach Notification Rules for PHI handling
Risk Analysis, safeguard implementation, BAA registry, breach-notification runbooks
USA
HITRUST CSF
Prescriptive control framework adopted by US health systems and payers
Readiness assessment, gap remediation, validated assessor coordination
USA
ISO 27001
Information Security Management System across 114 controls
Full ISMS implementation, risk assessment, certification & surveillance
Global
GDPR (Art. 9)
Lawful processing of special-category health data within the EU/EEA
Article 9 mapping, DPIA templates, transfer-impact assessments, DPO support
EU
NHS DSPT
Annual data-security toolkit for NHS-handling organizations
Annual submission preparation, Cyber Essentials alignment, evidence packaging
UK
MOH Cyber Code
Singapore MOH Cybersecurity Code of Practice for healthcare entities
Code-of-Practice mapping, HCSA license-specific controls, PDPA alignment
Singapore
SOC 2 Type II
Security, availability, confidentiality across 9-12 month periods
Automated evidence collection, auditor-ready packages, continuous monitoring
Global
Custom
Any health-data regulation converted into actionable controls
Line-by-line obligation extraction, control mapping, task assignment
Any
[06] Built By Insiders
Built by healthcare insiders, not compliance consultants
“Healthcare compliance is not a binder of policies -- it is the difference between a hospital saying yes to your platform and your platform never being installed. We have built for both sides of that conversation.”
Amit Gupta
Founder, Konfirmity | Co-Founder, F'inTech | Ex-CTO, NIUM ($2B+)
Amit Gupta
Founder, Konfirmity | Co-Founder, F'inTech | Ex-CTO, NIUM ($2B+)
10+ years leading security and compliance through hypergrowth at fintechs processing millions of daily transactions across 40+ regulated markets. Navigated MAS, RBI, OCC, APRA, BOT, OJK, FCA, and dozens of other regulators.
// FinTech Community
ASEAN's most popular fintech CTO community -- co-founded with Ned Lowe. 100s of fintech CTOs sharing insights on regulatory complexity at scale since 2023.