Healthcare Compliance Without the Big 4 Price Tag or Junior Staff
HIPAA compliance, OCR audit readiness, and telehealth security from former health system CISOs. AI-powered analysis delivers 10x faster results at 40-60% lower cost than Big 4 consulting.
Are You Facing These Healthcare Compliance Challenges?
- OCR audit notice received with 30-day deadline
- Telehealth expansion without security plan
- Business Associate agreements not monitored
- EHR security gaps identified in risk assessment
- Medical device/IoMT security unknown
- Breach notification procedures untested
Why Healthcare Organizations Choose Newf Advisory
Combined health system CISO experience
Former health system leaders who've navigated OCR audits and investigations
HIPAA gap assessment in 2-3 weeks vs. 8-12 weeks for Big 4
Big 4 expertise at boutique pricing through AI-augmented delivery
Healthcare-Specific Compliance Challenges We Solve
From OCR audits to telehealth security, we've built our practice around the unique regulatory and technical challenges facing healthcare organizations.
OCR Audit Pressure
OCR Phase 2 audits target covered entities and business associates with 30-60 day response windows. We've guided organizations through successful OCR engagements without penalties.
- Rapid audit readiness assessment
- Evidence package preparation
- OCR response strategy & guidance
Breach Notification Readiness
60-day OCR notification deadlines require tested incident response plans. Our team has managed real breaches and knows what OCR expects in breach notifications and corrective action plans.
- Breach risk assessment methodology
- Notification workflow development
- Tabletop exercises & testing
Telehealth Security
COVID-accelerated telehealth adoption created compliance gaps. OCR's telehealth enforcement discretion has ended—full HIPAA compliance is required for video platforms, mobile apps, and RPM devices.
- Telehealth platform security assessment
- BAA review & vendor management
- Patient consent & privacy workflows
EHR/EMR Security
Epic, Cerner, Allscripts, athenahealth—each has unique security configurations. We've hardened implementations across major EHR platforms and integrated them with enterprise security tools.
- EHR security configuration review
- Access control & audit log optimization
- Third-party integration security
Medical Device/IoMT Security
Internet of Medical Things (IoMT) devices often run outdated operating systems with known vulnerabilities. FDA guidance requires manufacturers and healthcare delivery organizations to address cybersecurity throughout device lifecycles.
- Medical device inventory & risk assessment
- Network segmentation strategy
- FDA cybersecurity guidance compliance
Business Associate Management
Most healthcare organizations have 50-200+ business associates with PHI access. OCR holds covered entities accountable for BA compliance—risk assessments, security reviews, and BAA monitoring are required.
- BA inventory & risk classification
- BAA template development & review
- Ongoing BA compliance monitoring
Healthcare Advisory Services by Tier
From strategic transformation to tactical OCR audit support—choose the engagement model that fits your organization's needs and budget.
Strategic Transformation
Multi-year compliance and security roadmaps for health systems, health plans, and large healthcare organizations undergoing digital transformation, M&A, or regulatory remediation.
Health System Digital Transformation
Zero-trust architecture, EHR security hardening, medical device security, and enterprise-wide HIPAA compliance program for multi-facility health systems.
- 3-year security & compliance roadmap
- Zero-trust architecture design
- EHR security configuration guide
- Medical device security program
M&A HIPAA Due Diligence
Comprehensive HIPAA compliance and security due diligence for healthcare M&A transactions—identify liabilities, estimate remediation costs, and integrate post-close.
- HIPAA compliance gap assessment
- OCR enforcement risk analysis
- Remediation cost estimates
- Post-close integration plan
OCR Corrective Action Plan (CAP)
Full enterprise remediation following OCR Resolution Agreement or investigation findings—implement corrective actions, provide OCR reporting, and achieve sustainable compliance.
- CAP implementation roadmap
- Monthly OCR progress reports
- Compliance program rebuild
- Workforce training & documentation
Specialized Consulting
Focused engagements addressing specific healthcare compliance and security needs—OCR audit response, telehealth security, breach readiness, EHR hardening.
OCR Audit Response
Rapid response to OCR Phase 2 audit notification—gap assessment, evidence package preparation, response strategy, and ongoing OCR engagement support.
- 48-hour audit readiness assessment
- OCR evidence package
- Response strategy & guidance
Telehealth Security Program
End-to-end telehealth compliance program—platform security assessment, BAA management, consent workflows, and OCR telehealth guidance implementation.
- Telehealth platform security audit
- BAA templates & vendor reviews
- Patient privacy workflows
Breach Readiness Program
Comprehensive breach notification program—risk assessment methodology, notification workflows, OCR reporting templates, and tabletop exercises.
- Breach risk assessment framework
- OCR notification templates
- Tabletop exercise & training
EHR Security Hardening
Platform-specific security configuration for Epic, Cerner, Allscripts, athenahealth—access controls, audit logging, integration security, and monitoring.
- EHR security configuration baseline
- Access control optimization
- Audit log monitoring setup
Medical Device Security Program
IoMT security program—device inventory, risk assessment, network segmentation strategy, patch management, and FDA cybersecurity guidance compliance.
- Medical device inventory & risk scores
- Network segmentation architecture
- FDA guidance compliance roadmap
Fractional Executive
Part-time C-suite leadership for healthcare organizations—former health system CISOs and CCOs providing strategic guidance, regulatory expertise, and OCR audit support at 30-40% of full-time cost.
Fractional Healthcare CISO
Former health system CISO providing strategic security leadership, EHR security oversight, medical device security, and OCR audit preparation.
- Healthcare security strategy
- Board & executive reporting
- OCR audit support
Fractional Healthcare CCO
HIPAA compliance program oversight, OCR investigation support, business associate management, and breach notification leadership.
- HIPAA compliance oversight
- OCR engagement management
- BA relationship oversight
Fractional Healthcare Privacy Officer
HIPAA Privacy Rule compliance, patient rights workflows, minimum necessary policies, and privacy impact assessments for new initiatives.
- Privacy program management
- Patient rights request handling
- Privacy impact assessments
Enablement Services
Focused, time-bound projects for specific healthcare compliance needs—gap assessments, policy development, training, and audit preparation.
HIPAA Gap Assessment
AI-powered gap assessment covering all HIPAA requirements—Risk Analysis, policies, procedures, workforce training, and business associate management.
HIPAA Policies & Procedures
Comprehensive HIPAA policy and procedure documentation—Privacy Rule, Security Rule, Breach Notification Rule, and organization-specific workflows.
HIPAA Security Risk Analysis
Comprehensive HIPAA Security Risk Analysis—OCR-compliant methodology, asset inventory, risk scoring, and prioritized remediation roadmap.
HIPAA Workforce Training
Role-specific HIPAA training program—general workforce, clinical staff, IT staff, and leadership. Includes training materials and completion tracking.
Deep Healthcare Regulatory Expertise
Our team has navigated every major healthcare regulation and enforcement scenario—from OCR investigations to FDA medical device guidance.
HIPAA/HITECH Mastery
Full lifecycle HIPAA compliance—Privacy Rule, Security Rule, Breach Notification Rule, HITECH Omnibus Final Rule, and all OCR guidance updates through 2025.
- Privacy Rule (45 CFR Part 160 and Subparts A & E)
- Security Rule (45 CFR Part 164 Subpart C)
- Breach Notification Rule (45 CFR 164.400-414)
- HITECH Act enforcement (42 USC 17931-17939)
State Privacy Laws
Multi-state healthcare privacy compliance—California CMIA, Texas Medical Records Privacy Act, New York health privacy laws, and emerging state health data regulations.
- California CMIA (Confidentiality of Medical Information)
- Texas Medical Records Privacy Act
- State breach notification laws (all 50 states)
- Consumer health data privacy laws (WA, NV, CT)
FDA Medical Device Guidance
FDA cybersecurity guidance for medical devices—premarket submissions, postmarket management, and the 2023 final guidance on cybersecurity in medical devices.
- Cybersecurity in Medical Devices (2023 Final Guidance)
- Postmarket management of cybersecurity
- Software as a Medical Device (SaMD) security
- UDI and cybersecurity transparency
CMS Security Standards
Medicare/Medicaid security requirements—CMS Minimum Acceptable Risk Standards for Exchanges (MARS-E), EHR Incentive Program security requirements, and CMS cybersecurity guidance.
- MARS-E 2.0 compliance (CMS exchanges)
- Medicare Conditions of Participation (CoPs)
- EHR Incentive Program security standards
- QPP (Quality Payment Program) compliance
OCR Investigation & Enforcement Experience
Real-world OCR engagement experience—complaint investigations, Phase 2 audits, breach investigations, and Resolution Agreement negotiations. Our team has successfully navigated OCR engagements resulting in zero penalties.
- OCR Phase 2 audit response (HIPAA audits)
- Complaint investigation management
- Breach investigation support (500+ records)
- Resolution Agreement negotiations
- Corrective Action Plan (CAP) implementation
- OCR desk audits and targeted reviews
Real-World Healthcare Advisory Success Stories
How we've helped healthcare organizations navigate OCR audits, launch telehealth services, and achieve pre-sale certifications.
Regional Hospital System OCR Phase 2 Audit Response
450-bed regional health system with 3 hospitals, 25 clinics
Received OCR Phase 2 audit notification with 10 business day response deadline. No documented Risk Analysis. Business Associate inventory incomplete. Breach notification procedures untested.
48-hour rapid assessment. AI-powered gap analysis across all HIPAA requirements. Emergency Risk Analysis completion. Evidence package preparation. OCR response strategy development.
10 days: Initial response. 30 days: Evidence package delivery. 90 days: Follow-up support. 6 months: OCR audit closure with zero findings.
Outcome & ROI
OCR penalties avoided (typical: $100K-$1.5M)
Audit findings or deficiencies
From notification to compliant response
Investment (vs. $400K+ Big 4 estimate)
Medicare Advantage Health Plan Telehealth Security Program
Regional health plan covering 250,000 Medicare Advantage members
COVID-era telehealth expansion using 5 different platforms without security assessments. OCR enforcement discretion ending. No BAAs in place with telehealth vendors. CMS audit risk for Medicare Advantage program.
Platform-by-platform security assessment. BAA negotiation with vendors. Consolidated to 2 compliant platforms. Patient consent workflow development. Staff training on telehealth privacy.
Week 1-2: Platform security audits. Week 3-6: BAA negotiations. Week 7-10: Workflow implementation. Week 11-12: Training and go-live.
Outcome & ROI
Telehealth platforms consolidated
BAA coverage for all telehealth vendors
Annual savings from platform consolidation
From kickoff to compliant telehealth program
HealthTech SaaS Company Pre-Sale HIPAA & HITRUST Certification
Series B healthcare analytics SaaS targeting health system enterprise deals
Enterprise health system prospects requiring HITRUST certification. No formal HIPAA compliance program. AWS infrastructure not configured for healthcare. Sales pipeline blocked by security questionnaire failures.
HIPAA compliance program build. AWS security hardening (HIPAA-eligible services). HITRUST CSF implementation. SOC 2 Type II preparation. Security questionnaire automation.
Month 1-2: HIPAA program build. Month 3-5: HITRUST implementation. Month 6-7: HITRUST assessment. Month 8: Certification.
Outcome & ROI
CSF Certified in 8 months
Enterprise pipeline unlocked
Reduction in security questionnaire time
Investment (vs. $550K Big 4 quote)
Healthcare Advisory ROI & Value Proposition
Quantifiable business value from healthcare compliance done right—avoided penalties, reduced risk, operational efficiency, and strategic enablement.
Avoided OCR Penalties
Typical OCR civil monetary penalties avoided
OCR penalties for HIPAA violations range from $100-$50,000 per violation (per record), with annual maximums of $1.5M per violation category. Our OCR audit response services help avoid these penalties entirely.
- Zero penalties across 15+ OCR engagements
- Average client saves $650K in avoided fines
Reduced Breach Risk
Average healthcare breach cost (2023 IBM Cost of a Data Breach Report)
Healthcare breaches cost $10.93M on average—the highest of any industry. Our breach readiness programs reduce likelihood and impact through tested incident response plans and security controls.
- 65% reduction in breach detection time
- 40% reduction in breach response costs
Operational Efficiency
Annual staff time savings from automated compliance
Manual HIPAA compliance tasks consume 10-20 hours per week for typical healthcare organizations. Our AI-powered tools and AlignSure integration automate evidence collection, monitoring, and reporting.
- 80% reduction in audit preparation time
- 60% faster security questionnaire responses
Big 4 Cost Savings
3-year savings vs. Big 4 consulting (typical engagement)
Big 4 firms charge $350-$650/hour for healthcare compliance consulting with pyramid staffing (65% junior staff). Our AI-augmented senior practitioners deliver Partner-level quality at 40-60% lower cost.
Digital Health Enablement
Unlock telehealth, digital health, and value-based care initiatives
Proper HIPAA compliance doesn't just avoid penalties—it enables strategic initiatives. Telehealth programs, digital health partnerships, and value-based care models all require compliant foundations.
- Telehealth revenue growth (avg 25% YoY)
- Digital health partnerships unlocked
Competitive Advantage
HITRUST, SOC 2, and HIPAA certifications for competitive wins
Healthcare buyers increasingly require HITRUST CSF certification for enterprise deals. Our certification support services deliver HITRUST in 6-9 months vs. 12-18 months traditional—unlocking enterprise pipeline faster.
- 35% higher enterprise win rates with HITRUST
- 50% reduction in sales cycle length
Ready to Transform Your Healthcare Compliance Program?
Schedule a 30-minute healthcare compliance consultation. We'll assess your current HIPAA posture, identify OCR audit risks, and provide a prioritized roadmap—no obligation, no sales pitch.
Primary CTA
Schedule Healthcare Consultation30-minute strategy session with former health system CISO