BlitzSafe is the operational discipline we run BlitzClinic on — privacy by design, multi-tenant isolation, audit trails, AI safety. We're now offering the same playbook as a service to teams shipping healthcare AI under HIPAA, GDPR, SOC 2, ISO 27001, ISO 42001 and the EU AI Act.
BlitzSafe is BlitzClinic's internal trust and AI-governance program. It is not a certification body and does not issue legal certificates. Audits and certificates are produced by independent third-party auditors.
Healthcare AI rarely falls under a single regulator. BlitzSafe maps your product to the regimes that actually apply — US, EU, and Romania — and runs the controls in production rather than only writing them down in a policy folder.
Health Insurance Portability and Accountability Act
Safeguards for Protected Health Information across the Privacy, Security, and Breach Notification Rules. We design BAAs, access controls, audit trails and breach workflows around HIPAA's required and addressable specifications.
EU General Data Protection Regulation 2016/679
Lawful basis, data subject rights (access, erasure, portability), DPIA for high-risk processing, records of processing, processor obligations, and 72-hour breach notification.
AICPA Trust Services Criteria (Security, Availability, Confidentiality, Processing Integrity, Privacy)
Security, availability, confidentiality, processing integrity, and privacy controls. We help you reach Type II readiness with auditable evidence collection, change management, and continuous monitoring.
Information Security Management System
An information security management system aligned to Annex A controls. Risk register, statement of applicability, asset inventory, vendor risk, and incident response — all maintained as living documents tied to engineering reality.
Artificial Intelligence Management System
The first international AI management standard. Model lifecycle governance, AI risk assessments, dataset documentation, post-deployment monitoring and human oversight — applied to your models, not just to your policies.
Regulation (EU) 2024/1689 on Artificial Intelligence
Risk-tier classification, prohibited use cases, high-risk obligations (data governance, transparency, human oversight, post-market monitoring) and general-purpose AI provider duties — mapped against your specific medical workflows.
GDPR national implementation in Romania
Romania-specific provisions for processing health data, employment-context personal data, and the role of the DPO. Critical for clinics operating in Romania alongside CNAS reporting obligations.
Regulation (EU) 910/2014 on electronic identification and trust services
Electronic signatures, seals and timestamps with legal effect across the EU. We use qualified trust services for clinical consent, contracts and audit-grade signed records.
Status reflects current alignment, not third-party certification. Independent audit reports are issued by external auditors and shared under NDA on request.
We're a software company with an opinionated compliance program, not a regulator. Here's exactly what you're buying.
We don't ship a 200-page checklist. The program is organised around four operational domains that map cleanly to engineering ownership.
Lawful basis, consent, data minimisation and patient rights — implemented in code, not only in policy.
Identity, authorisation and immutable audit trails across every system that touches patient data.
Encryption, retention, backups and incident response — operated against measurable RTO and RPO targets.
ISO 42001 and EU AI Act controls applied to model lifecycle, evaluations and post-deployment monitoring.
A four-phase engagement that takes a healthcare AI product from "we should probably do compliance" to audit-ready and continuously monitored.
Map your product, data flows, AI systems and target jurisdictions to the frameworks that actually apply. Output: written scope and risk register.
1–2 weeks
Article-by-article assessment against HIPAA, GDPR, SOC 2, ISO 27001/42001 and EU AI Act controls. Output: prioritised remediation plan with named owners.
2–4 weeks
Engineering controls, policy documents, evidence pipelines and AI-governance artefacts (model cards, eval suites, monitoring) delivered alongside your team.
8–16 weeks
Continuous control monitoring, audit-evidence collection, third-party auditor support, and quarterly program reviews after go-live.
Ongoing
Tell us what you're building, who your patients are, and where you're shipping. We'll respond with a written scope and a realistic timeline within two business days.