Risk
PHI + BA + Vendor Risk
Survey-based risk analysis across PHI flows, BA relationships, vendor cybersecurity posture, and the §164.308(b) cascade.
- PHI inventory captured
- BA register maintained
- Vendor cyber posture scored
For Covered Entities + Business Associates + Multi-Entity Health Systems
HIPAA compliance software that makes your next OCR audit a non-event.
Most health systems run Privacy, Security, and Breach as three separate programs, in three separate spreadsheets, with business associate agreements scattered across departments. When OCR calls, you have weeks to assemble evidence you should have had on hand. RiskWatch runs all of it as one program: assess every facility against one control library, track every business associate in one place, and produce an OCR-ready package on demand, not after a three-week scramble.
Trusted by hospitals, health systems, BAs, and multi-entity covered entities managing the Privacy + Security + Breach Rules, the BA cascade, OCR audits, NIST 800-66 implementation, and HITRUST certification across acute care, ambulatory, lab, payer, and life-sciences environments.
4.7G2 Crowd·120+
4.7Capterra·80+
4.6Gartner Peer Insights·60+
Why Privacy + Security Officers Pick RiskWatch
RiskWatch turns Privacy, Security, and Breach into one program, not four.
RiskWatch gives one team a single program covering every facility, every business associate, and every audit cycle. Run a risk analysis once and it satisfies your Security Rule obligation, your NIST 800-66 implementation, and your HITRUST requirement at the same time, so you stop maintaining three binders that say the same thing. When the auditor shows up, the evidence is already there.
One risk analysis, not three
Run your risk analysis once and it satisfies Privacy, Security, and Breach at the same time, so you stop keeping three binders that say the same thing. (Privacy §164.500, Security §164.300, and Breach §164.400 series, cross-mapped.)
Know your BA liability before a breach does
See which business associate agreements are expiring and which subcontractors never signed one, before a breach makes it OCR's problem. Tracks the full §164.308(b)(2) subcontractor cascade you are held responsible for.
Every facility on one dashboard
Score every facility on its own, then roll the whole system up to one board-ready dashboard. Built for complex setups like multi-hospital systems and joint ventures. Live in 30 days.
The HIPAA Regulatory Landscape
HIPAA enforcement keeps escalating. The numbers prove it.
OCR collected $144.9M+ in HIPAA settlements 2009-2023 with the Right of Access Initiative driving 50+ enforcement actions. The proposed Security Rule update (released Dec 2024) is the first major Security Rule modification since 2013, adding mandatory MFA, encryption, network segmentation, and BA cybersecurity attestation. State laws are layering: Texas HB 300 amendments, NY SHIELD, California CMIA. Each regulator wants its own evidence package, and the BA cascade keeps growing as health systems adopt 100+ SaaS vendors per facility.
$144.9M+
Total OCR HIPAA settlements 2009-2023, Right of Access driving 50+ actions
164(b)(2)
Subcontractor BAA cascade, OCR holds the covered entity responsible
Three Domains, One Platform
HIPAA risk lives in three concrete domains
RiskWatch covers all three. Each domain has a dedicated workflow, scoring model, and remediation queue. They share data so a single risk analysis satisfies §164.308(a)(1), the NIST 800-66 r2 implementation specification, and the HITRUST CSF requirement simultaneously.
Compliance
Privacy + Security + Breach
Privacy Rule (Subpart E), Security Rule (Subpart C), Breach Notification Rule (Subpart D), HITECH Act, 21st Century Cures + ONC, state laws cross-mapped.
- Privacy Rule §164.500 series
- Security Rule §164.300 series
- Breach Rule §164.400 series
Audit
OCR + NIST 800-66 + HITRUST
OCR audit-ready evidence, NIST 800-66 r2 implementation, HITRUST CSF v11 certification, and ISO 27001 + 27799 cross-mapping.
- OCR-ready packages on demand
- NIST 800-66 r2 implementation
- HITRUST CSF v11 mapping
45 CFR §164.308(b) · BAA Cascade Spotlight
Tier-1 BAAs aren't enough. OCR holds you responsible for the cascade.
§164.308(b)(2) makes BA subcontractors directly liable to the covered entity. When a Tier-2 vendor (Stripe via Twilio, AWS via Epic) processes PHI without a BAA, OCR comes back to you. The BAA Cascade tracker maintains the agreement chain through Tier-2 + Tier-3 subcontractors, surfaces expiring renewals 90 days out, and flags missing subcontractor BAAs before the next OCR investigation finds them.
45 CFR §164.308(b) · BAA cascade
BAA + subcontractor BAA · all tiers visible
OCR enforcement: missing subcontractor BAA = Tier 3 violation
Covered Entity
Regional Health System
Business Associate
Epic · EHR vendor
Active · 2024 · renews 2026-08-15
Business Associate
Datadog · monitoring
Active · 2025 · renews 2027-03-20
Business Associate
Twilio · patient SMS
Expires 2026-06-01 · renews 2026-06-01
Subcontractor BAA
AWS (via Epic) · §164.308(b)(2)
Confirmed · renews Cascaded
Subcontractor BAA
Stripe (via Twilio) · missing
Not on file · renews Action required
47 BAAs current · 2 expiring · 1 missing subcontractor§164.308(b)(2) covered.
The Coverage Gap
Most HIPAA software covers one rule
Privacy compliance vendors handle Privacy. Security platforms cover the Security Rule. Breach notification tools handle incidents. Vendor management handles BAs. Each does one job. Privacy + Security Officers still operate four parallel programs.
| Platform Category | Privacy | Security | Breach | BA cascade | HITRUST | Multi-entity |
|---|---|---|---|---|---|---|
| Privacy Compliance VendorsCompliancy Group, Accountable | Yes | Partial | Partial | Partial | · | · |
| Healthcare Security PlatformsClearwater, Censinet | Partial | Yes | Partial | Partial | Partial | Partial |
| Generic GRCServiceNow GRC, Archer | Partial | Partial | Partial | Partial | · | Partial |
| BAA Management ToolsOnspring, Whistic | · | · | · | Yes | · | Partial |
| HITRUST SpecialtyHITRUST MyCSF | Partial | Partial | · | · | Yes | · |
| Spreadsheets & Email | · | · | · | · | · | · |
| RiskWatchThe unified OCR-ready platform | Yes | Yes | Yes | Yes | Yes | Yes |
RiskWatch is the only platform covering all six HIPAA compliance domains: Privacy Rule, Security Rule, Breach Notification, the BA cascade, HITRUST CSF, and multi-entity coordination. Privacy vendors handle Privacy. Security platforms cover the Security Rule. BAA tools handle vendors. Each does one job. RiskWatch unifies all six in one survey-based assessment workflow.
How It Works
One platform. Continuous compliance across every rule.
RiskWatch is a survey-based assessment platform. The work is structured around questionnaires that capture Privacy, Security, and Breach posture in a consistent format, then scored against every framework you align to.
For HIPAA, that workflow runs continuously across the Privacy Rule, Security Rule, Breach Notification Rule, the BA cascade under §164.308(b), HITECH expansions, NIST 800-66 r2, HITRUST CSF v11, and state-specific overlays. A single risk analysis scores against §164.308(a)(1), the corresponding NIST 800-66 r2 implementation specification, and the HITRUST CSF requirement simultaneously.
The same platform runs all of it, surfaces gaps before OCR arrival, assigns remediation owners, and tracks completion. Replace the Privacy tool, the Security platform, the BAA spreadsheet, and the breach-notification binder between them.
The Workflow
- 01AssessSurvey-based questionnaires capture Privacy, Security, and Breach posture across every facility, BA relationship, and PHI flow.
- 02ScoreResponses score against your chosen framework: Privacy Rule, Security Rule, Breach Notification Rule, NIST 800-66 r2, HITRUST CSF v11, ISO 27001:2022 + 27799:2016, or custom.
- 03RemediateGaps become assigned tasks. Owners get deadlines. BA + subcontractor + 3rd-party tasks cascade to the supplier portal automatically.
- 04AuditEvidence trails export to PDF, OCR investigation format, NIST 800-66 r2 implementation map, HITRUST submission, or breach-notification packet. OCR-ready in minutes.
PrivacySecurityBreachBA CascadeHITRUST
Built For Your Role
Who uses RiskWatch in a healthcare organization
Chief Privacy Officer
Owns enterprise Privacy Rule compliance, Notice of Privacy Practices, Right of Access requests, and OCR-facing privacy posture.
Privacy Rule §164.500 series scoring continuous. Right of Access SLA tracked. Disclosures accounting live. OCR investigation response ready in hours.HIPAA Security Officer
Owns the Security Rule (45 CFR 164 Subpart C), NIST 800-66 r2 implementation, and the technical safeguards across every facility.
All Security Rule standards scored. NIST 800-66 r2 implementation map live. Risk analysis §164.308(a)(1) refreshed annually. Encryption + MFA evidence captured.Compliance + Audit Lead
Owns OCR audits, internal compliance audits, HITRUST certification, and multi-state regulatory reporting (Texas HB 300, NY SHIELD).
OCR audit-ready packages on demand. HITRUST CSF v11 mapped. State-law overlays tracked. Multi-entity rollup to consolidated dashboard.BA + Vendor Risk Lead
Owns the BA register, BAA cascade under §164.308(b), and the vendor cybersecurity posture for 100+ SaaS + clinical-system vendors.
BA register live. Subcontractor BAA cascade tracked. Renewal calendar surfaces 90 days out. Vendor cyber posture scored continuously.Risk Manager
Owns the §164.308(a)(1) risk analysis, enterprise risk register, and the cross-functional Privacy + Security risk reviews.
Risk analysis refreshed annually. Risk register live. Treatment plans tracked. PHI flow mapped. Threat-source + likelihood scoring continuous.Breach + Incident Response Lead
Owns the §164.402 breach assessment, OCR notification timelines, individual notifications, and media notifications when applicable.
Breach assessment workflow live. OCR notification timelines tracked. Individual + media + HHS notifications generated. Post-breach corrective action tracked.Built For Your Segment
Healthcare segments we serve
Hospitals + Health Systems
Acute care + multi-facility health systems running Privacy + Security + Breach across hospitals, clinics, ambulatory surgery centers, and home health.
Health Plans + Payers
Commercial, Medicare Advantage, Medicaid, and self-funded health plans running Privacy + Security + Breach plus state-specific insurance regulator overlays.
Diagnostic + Reference Labs
Clinical labs, reference labs, pathology + diagnostic imaging running CLIA-aware Privacy + Security + Breach with 21st Century Cures + ONC information-blocking.
Business Associates
EHR vendors, RCM companies, billing services, IT/MSP providers, and SaaS vendors running BA-side Privacy + Security + Breach with subcontractor cascade visibility.
Pharmacies + PBMs
Retail pharmacies, mail-order, specialty pharmacy, and PBMs running HIPAA + state board + DEA + 340B overlays.
Pharma + Life Sciences
Pharma manufacturers, biotechs, CROs running HIPAA-relevant patient-data flows + FDA + ICH-GCP + multi-jurisdiction overlays.
Frameworks We Cover
HIPAA frameworks built into the library
RiskWatch ships with pre-built libraries for every major US health-data regulation + recommended practice + industry standard. Map controls once. Score against the framework that matters this audit cycle.
Regulatory Frameworks
- HIPAA Privacy Rule
- 45 CFR 164 Subpart E, uses + disclosures, Notice of Privacy Practices, Right of Access, accounting of disclosures.
- HIPAA Security Rule
- 45 CFR 164 Subpart C, administrative, physical, technical safeguards for ePHI. Proposed Dec 2024 update mandates MFA + encryption + segmentation.
- HIPAA Breach Notification
- 45 CFR 164 Subpart D, breach assessment, individual + HHS + media notifications, BA-to-CE notification timelines.
- HITECH Act
- Health Information Technology for Economic and Clinical Health Act, expanded HIPAA enforcement, BA direct liability, breach notification.
- 21st Century Cures + ONC
- ONC information-blocking rule (45 CFR 171) and 21st Century Cures interoperability requirements, distinct from HIPAA but cross-affecting Privacy.
- State Health-Data Laws
- Texas HB 300 (broader than HIPAA), NY SHIELD Act, California CMIA + AB 352, Massachusetts 201 CMR 17, state-specific overlays tracked per facility.
Industry + Implementation Frameworks
- NIST 800-66 Rev 2
- Implementing the HIPAA Security Rule: A Cybersecurity Resource Guide (Feb 2024), the federal implementation playbook integrated into the library.
- HITRUST CSF v11
- Health-industry common-security framework cross-mapping HIPAA, ISO 27001, NIST 800-53, PCI DSS, certification-grade evidence shared.
- NIST CSF 2.0
- Cybersecurity Framework 2.0 (Feb 2024), outcome-based mapping of HIPAA Security Rule to Govern / Identify / Protect / Detect / Respond / Recover.
- NIST 800-30 Rev 1
- Guide for Conducting Risk Assessments, the methodology behind §164.308(a)(1)(ii)(A) risk analysis.
- ISO 27001:2022 + 27799:2016
- ISMS standard with the 2022 Annex A plus ISO 27799 health-informatics extension, international hospital networks running both.
- AHIMA / HIMSS
- American Health Information Management Association + Healthcare Information and Management Systems Society, health-info-management leading practices.
Trusted by 500+ risk and compliance teams
We had Privacy in one binder, Security in a SharePoint site, BAAs in an Excel spreadsheet, and breach response in a PDF runbook. Now it's one platform. Privacy + Security + Breach scoring, BAA cascade tracking, NIST 800-66 r2 implementation, and HITRUST CSF cross-mapping all run from the same evidence vault. Our last OCR investigation produced two compliance recommendations instead of nine, and we cleared HITRUST i1 in 11 weeks.
D. Esposito
Chief Privacy Officer + HIPAA Security Officer, Regional health system · 5,800 employees · 11 facilities · 140 Business Associates
4 → 1tools consolidated to one platform
9 → 2OCR investigation findings on most recent review
11 weeksfrom kickoff to HITRUST i1 cleared
Resources
Practical playbooks for Privacy + Security Officers
FAQ
Frequently asked questions
Privacy · Security · Breach · BA Cascade
See RiskWatch run a Privacy + Security + Breach cycle live
30-minute walkthrough of the HIPAA library, your facility + BA inputs, and the OCR-ready evidence-trail output. No slideware, no consulting upsell.
Or call US: +1 941-500-4525