Healthcare GRC automated. From HIPAA Security Rule compliance to HITRUST CSF certification and 405(d) HICP readiness, Uno protects patient data while streamlining the complex regulatory landscape that healthcare and life sciences organizations navigate every day.
Healthcare organizations operate in one of the most heavily regulated environments in the world. The stakes are uniquely high: patient safety, data privacy, and organizational survival all hang in the balance.
The healthcare compliance landscape is a web of overlapping regulations that grows more complex each year. HIPAA remains the foundation, but organizations must also navigate HITRUST CSF for demonstrable security maturity, 405(d) HICP guidelines to show "recognized security practices," FDA requirements for medical devices and life sciences data, and an expanding patchwork of state privacy and breach notification laws.
Adding to the challenge: OCR enforcement actions reached record levels, with penalties now routinely exceeding $1 million per violation. The 2021 HITECH Act amendment recognized that organizations implementing "recognized security practices" -- including 405(d) HICP -- may receive reduced penalties and more favorable audit treatment. This has made 405(d) compliance a strategic imperative, not just a best practice.
Healthcare organizations also face unique third-party risk challenges. Business associates, cloud providers, EHR vendors, medical device manufacturers, and telehealth platforms all handle PHI and must be assessed, monitored, and managed under BAA requirements. The average health system works with hundreds of business associates, each representing a potential breach vector.
Manual approaches to healthcare compliance simply cannot keep pace. Spreadsheets, email-based evidence collection, and point-in-time assessments leave dangerous gaps between audits. Uno's AI-native platform brings continuous, automated compliance management to healthcare -- covering every HIPAA safeguard, every HITRUST control, and every 405(d) practice with the depth and accuracy that healthcare demands.
For life sciences organizations, the regulatory landscape extends further: FDA 21 CFR Part 11 governs electronic records and signatures, GxP requirements ensure product quality and patient safety, and medical device regulations (EU MDR/IVDR) demand ongoing post-market surveillance. Uno covers all of these within a unified platform, eliminating the fragmented tooling that creates compliance blind spots.
The result: healthcare organizations achieve HIPAA and HITRUST readiness in weeks instead of months, maintain continuous compliance posture between audits, demonstrate 405(d) recognized security practices to reduce OCR exposure, and free their security teams to focus on actual risk reduction rather than manual evidence gathering.
From HIPAA compliance to HITRUST certification, Uno autonomously manages the complex regulatory landscape of healthcare and life sciences organizations.
AI agents continuously monitor your PHI protection posture across all systems, users, and business associates. Automated data flow mapping, access reviews, and encryption verification ensure your patient data is protected at every touchpoint.
Stay ahead of regulatory changes. Uno monitors OCR guidance, HITRUST updates, state privacy law changes, and FDA requirements -- automatically assessing the impact on your compliance posture and flagging actions needed.
Implement a control once, satisfy multiple frameworks. Uno automatically maps controls and evidence across HIPAA, HITRUST, SOC 2, ISO 27001, NIST CSF, and 405(d) -- eliminating 85% of redundant compliance work.
Stop chasing evidence. AI agents automatically collect, organize, and validate compliance evidence from your EHR, cloud infrastructure, HR systems, and security tools -- building an always-current evidence package.
Healthcare's third-party risk challenge is unique. Every vendor that touches PHI is a business associate, subject to HIPAA obligations and requiring ongoing assessment, BAA management, and breach notification readiness.
Uno's autonomous AI agents assess your business associate ecosystem with the same rigor and depth as your internal compliance program. From initial vendor intake through ongoing monitoring, every BA is evaluated against HIPAA requirements, HITRUST controls, and your organization's specific security standards.
BAA tracking ensures you always know the status of every agreement -- expiration dates, amendment requirements, and compliance obligations. When a business associate experiences a breach, Uno's notification workflow ensures you meet HIPAA's 60-day reporting requirement with proper documentation.
Concentration risk analysis identifies where multiple business associates create single points of failure -- a cloud provider hosting three critical systems, a clearinghouse processing all your claims, or a managed services provider with access to multiple PHI repositories.
The result is a comprehensive, always-current view of your third-party risk posture that satisfies OCR expectations and protects your patients' data across your entire extended enterprise.
“Our HIPAA risk analysis used to take three months of manual effort. With Uno, we completed it in under two weeks with better coverage and documentation than we have ever produced. The 405(d) alignment alone saved us from significant OCR exposure.”