Control Third-Party Risk. Protect Patient Safety. Secure Health Data.
Neotas delivers intelligence-led, continuous, audit-ready Healthcare TPRM with risk visibility across third parties, Protected Health Information (PHI) access, and subcontractors, n-levels deep into your supply chain.
Use a single platform to ensure third-party regulatory compliance across multiple frameworks, including HIPAA, FDA QMSR, NIS2, CQC, UK GDPR, GDPR, Trade and Sanctions, Anti‑Bribery & Corruption, ESG, and Modern Slavery.
Pre-mapped third-party assessment workflows, qualification checklists, and audit documentation — covering the frameworks that matter to your business. Select your region to see what’s covered from day one.
Third-party risk assessment, vendor cybersecurity monitoring, Business Associate Agreement tracking, patient health data safeguards, breach-coordination workflows.
Foreign Corrupt Practices Act compliance. Corruption-risk screening across your third-party ecosystem. Sanctions and PEP monitoring aligned to FCPA enforcement standards.
Supplier qualification. Clause 7.4 purchasing controls. Medical-device compliance. Warning-letter prevention.
Vendor oversight documentation. CMS Conditions of Participation. Accreditation-ready audit trails.
Human rights, environmental due diligence, and ESG reporting for US-regulated supply chains.
Compliance monitoring aligned to applicable US trade and labour obligations.
Ensure vendors handling NHS data or providing digital health services meet mandatory security, data protection, and interoperability requirements — critical for onboarding and procurement.
Assess and monitor third-party compliance with UK data protection laws, focusing on data processing, storage, and breach management.
Ensure third parties engaged in pharma marketing, communications, or partnerships adhere to strict ethical and promotional standards.
Anti-bribery due diligence and sanctions screening across your third-party ecosystem.
Good governance vendor oversight for Healthcare providers. Inspection-ready evidence.
Human rights and environmental due diligence aligned to UK reporting obligations.
Modern Slavery Act Section 54 statement support. Verified by open source intelligence across 30+ native languages.
Ensure suppliers, manufacturers, and subcontractors meet strict regulatory controls for medical devices and diagnostics, including quality management, traceability, and post-market oversight.
Healthcare classified as "essential entities." Article 21(2)(d) supply-chain security. Penalties up to €10M or 2% of turnover.
Digital Operational Resilience Act. ICT Third-Party Risk Management for financial-sector relationships in your supply chain.
Data protection assessment, processor liability, Data Processing Agreements, inspection-readiness across EU member states.
Strengthen visibility across your supplier ecosystem by enabling collection and validation of ESG and sustainability data required for regulatory reporting.
EU Corporate Sustainability Due Diligence Directive. Mandatory human-rights and environmental due diligence for in-scope organisations.
Supplier verification across 30+ native languages, aligned to LkSG (Germany) and equivalent EU member-state obligations.
Validate that suppliers operate under internationally recognised quality management systems for medical devices, ensuring consistency, safety, and regulatory alignment.
Anti-Bribery & Anti-Corruption. Corruption-risk screening across your Nth-party supply chain. Sanctions and PEP monitoring for organisations operating in multiple jurisdictions.
Human rights and environmental due diligence, powered by open source intelligence across 30+ native languages.
Modern Slavery monitoring across jurisdictions with statutory supplier-disclosure obligations.
Supports compliance with global sanctions and trade controls.
Pre-mapped third-party assessment workflows, qualification checklists, and audit documentation covering the frameworks that matter to your business. Select your region to see what’s covered from day one.
Classify vendor risk, automate supplier qualification, and manage onboarding, monitoring, and renewals in one workflow with continuous intelligence across sanctions, breaches, and PHI exposure, automated reassessments and BAA tracking, and instant escalation when third‑party risk changes.
Most Healthcare organisations stitch together cyber tools, ESG questionnaire platforms, GRC modules, and spreadsheets and still end up with blind spots. Neotas replaces all of them with one platform.
Replace cyber-only tools, prequal questionnaires, GRC suites, workflow-only TPRM, and spreadsheets — all in a single platform with one source of truth.
Real-time intelligence — sanctions, adverse media, breaches, cyber posture, ownership — across 30+ native languages and 200+ jurisdictions. No 11-month blind spots.
Pre-built compliance packages for HIPAA, GDPR, ISO 13485, FDA QMSR, NIS2, CQC, and ABAC. No-code configuration. No consultants. No 12–18 month rollouts.
Neotas continuously verifies whether your third parties meet your standards – across HIPAA, UK GDPR, FDA QMSR, NIS2, CQC, and ABAC. Deployed in days, not months. No consultants. No IT dependency.
Verify your vendors with AI precision & human expertise
Learn from industry experts and gain the insights needed to make data-driven decisions.
Explore how Neotas strengthens Third-Party Risk Management with faster, deeper, and scalable due diligence.
Healthcare risk management software helps health systems, hospitals, pharma, and health tech firms find, assess, and monitor the risks their vendors and suppliers create. It covers cybersecurity, HIPAA compliance, patient safety, and financial crime at once. The better healthcare risk management software does more than send questionnaires. It adds independent intelligence on adverse media, ownership, and financial distress that self-reported data never shows.
Read more: How Neotas approaches healthcare third-party risk →
Vendor risk management covers the vendors you contract with directly. Third-party risk management (TPRM) covers those vendors plus their subcontractors, sub-processors, and the Nth parties who touch your data or supply chain without a contract with you. A lab vendor’s cloud host, or a device maker’s sterilisation supplier, often carries more risk than the vendor itself. Healthcare vendor risk software treats TPRM as the wider discipline and vendor risk management as one part of it.
Read more: Vendor due diligence services →
A HIPAA Business Associate Agreement is a contract required whenever a vendor creates, receives, stores, or transmits Protected Health Information on a covered entity’s behalf. You need it before data sharing starts, not after. Cloud hosts, billing vendors, transcription services, and most software vendors handling PHI need one. Missing or outdated BAAs show up again and again in OCR enforcement actions.
Read more: HIPAA and BAA requirements explained →
A spreadsheet works for a handful of vendors. Past 50 to 100, it falls apart. Agreements expire unnoticed, subcontractors sign their own BAAs nobody reviews, and audits scramble to find signed copies. Healthcare risk management software swaps the spreadsheet for a central registry tied to each vendor’s PHI access level, with renewal alerts and one-click evidence export. When an OCR or ICO inspector asks, you hand over one audit trail.
Read more: Enhanced due diligence for healthcare vendors →
HIPAA’s Security Rule requires covered entities to manage risk from business associates. It sets no fixed review schedule, so most teams default to annual or biennial questionnaires. A vendor’s risk profile can change the week after a review. A breach. A new subcontractor. A sanctions hit. Continuous assessment, run between scheduled reviews and not only at them, is what catches that change. It’s the main reason health systems move off spreadsheets and onto healthcare risk management software.
Read more: The TPRM lifecycle: continuous monitoring →
Four things. Tiering by PHI or clinical-system access, not just spend. Pre-onboarding qualification mapped to HIPAA, FDA QMSR, and ISO 13485 where they apply. Continuous monitoring instead of point-in-time reviews. And an audit trail that survives an OCR, CQC, or notified-body inspection without weeks of prep. Frameworks built on annual questionnaires alone tend to miss risk between review cycles. That’s the gap healthcare risk management software closes.
A single-source supplier for a sterilisation step or a specialised component means one disruption can halt production with nothing to fall back on. A plant closure. A regional outage. A sanctions designation. Geographic concentration makes it worse. Several vendors that look unrelated can depend on the same regional facility, and neither one tells you. Mapping those dependencies is what surfaces single-source supplier risk before it turns into a shortage.
Read more: Supply chain concentration risk →
FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026. It replaced the QSR and pulled ISO 13485:2016 into 21 CFR Part 820 by reference. For supplier qualification it kept the Clause 7.4 purchasing control requirement: manufacturers have to evaluate and document that suppliers meet quality requirements before onboarding, and keep doing it after. That’s the workflow risk management software for healthcare automates.
Read more: Supply chain risk management →
It should confirm the supplier’s quality certification status, check their own sub-supplier controls, verify traceability records for components used in your devices, and review corrective-action history on past nonconformities. Under QMSR, FDA inspectors can now read supplier quality audit reports directly, so the documentation has to stand up to outside scrutiny, not just internal sign-off.
Read more: Vendor due diligence questionnaire guide →
Medical device cybersecurity risk assessment checks whether a supplier’s software, firmware, and connected systems carry known vulnerabilities, whether they run a coordinated disclosure process, and whether their security posture has shifted since onboarding. FDA’s premarket cybersecurity guidance puts the work on the manufacturer to assess every third party in the device’s software bill of materials, not only the device.
Read more: OSINT tools and techniques in vendor screening →
NIS2 treats healthcare providers as essential entities because a disruption, whether ransomware or a compromised vendor, can hit patient safety, not just data. Article 21(2)(d) requires essential entities to manage supply chain security, including the cybersecurity practices of their direct suppliers. Penalties reach €10 million or 2% of global turnover, whichever is higher. That’s why NIS2 mapping is now standard in healthcare TPRM software.
Read more: Third-party risk management framework →
NIS2 treats healthcare providers as essential entities because a disruption, whether ransomware or a compromised vendor, can hit patient safety, not just data. Article 21(2)(d) requires essential entities to manage supply chain security, including the cybersecurity practices of their direct suppliers. Penalties reach €10 million or 2% of global turnover, whichever is higher. That’s why NIS2 mapping is now standard in healthcare TPRM software.
Read more: Third-party risk management framework →
EU MDR and IVDR hold the manufacturer accountable for the whole supply chain, not only its own facility. Suppliers and subcontractors involved in design, manufacturing, sterilisation, or packaging need documented quality controls, traceability records, and post-market surveillance data the manufacturer can produce on request. A gap at a subcontractor counts as a gap in the manufacturer’s own compliance.
Read more: Supply chain risk assessment template →
CQC Regulation 17 (Good Governance) requires registered providers to keep effective oversight of anyone delivering care or services on their behalf, including outsourced and contracted vendors. Inspectors want documented evidence: vendor qualification records, ongoing monitoring, and a clear line of accountability when a third party’s failure affects patient care.
Read more: How Neotas supports UK healthcare compliance →
Questionnaire-only tools can only report what a vendor is willing and able to disclose. Neotas is intelligence-led healthcare vendor risk software. It checks vendor claims independently using open-source intelligence across 200+ languages: adverse media, beneficial ownership, sanctions proximity, and financial distress signals the vendor cannot or will not report. For Tier 1 vendors like EHR providers, medical device makers, and pharma suppliers, that intelligence layer catches what questionnaires miss.
Read more: Enhanced due diligence services →
Not when they told you they were. When did you independently verify it? Neotas deploys in days – with continuous vendor compliance monitoring built in from day one.
