A tailored course, built for your situation
Mastering ISO 27701 for Health Economics and Real-World Evidence Practitioners
Build privacy implementation expertise that scales across global evidence programs and compliance landscapes.
$199 one-time
24-hour access provisioning
30-day money-back guarantee
Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Most health economics professionals are sidelined in privacy discussions despite their frontline role in data governance.
The situation this course is for
Even with strong domain expertise, practitioners often lack the structured privacy implementation language to influence beyond their immediate team. This creates dependency on centralized compliance functions and bottlenecks in evidence delivery. The gap isn’t technical, it’s about articulating privacy controls in a way that resonates across audit, legal, and clinical teams. Without a common framework, efforts stay fragmented, and opportunities to lead system-wide improvements are missed.
Who this is for
Senior health economics or real-world evidence consultant operating at the intersection of data privacy, health technology assessment, and compliance. Works across regions, contributes to HTA submissions, and advises on data governance for evidence generation.
Who this is not for
Entry-level data analysts, standalone compliance officers without healthcare domain experience, or professionals focused solely on clinical trial operations without evidence monetization or regulatory reporting.
What you walk away with
- Lead ISO 27701 implementation efforts in evidence generation workflows
- Map privacy controls to real-world data use cases in HEOR and HTA
- Align compliance, legal, and clinical teams around a unified privacy framework
- Accelerate audit readiness for cross-border evidence programs
- Build reusable privacy documentation that scales across submissions and geographies
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 27701 in Healthcare Data
Establish core terminology and structure of ISO 27701 as applied to real-world evidence and pharmacoeconomic data environments.
12 chapters in this module
- Scope and applicability
- Privacy information management systems
- Relationship to GDPR and DPDPA
- Key roles and responsibilities
- Data inventory basics
- Consent lifecycle mapping
- Controller vs processor distinctions
- Data sharing boundaries
- Legal basis alignment
- Documentation hierarchy
- Gap assessment method
- Readiness scoring
Module 2. Integrating ISO 27701 with Health Economics Workflows
Adapt privacy controls to HEOR data pipelines, budget impact models, and evidence generation frameworks.
12 chapters in this module
- Data flow mapping
- Privacy in budget impact models
- Anonymization thresholds
- Data minimization in RWE
- Consent assumptions in modeling
- Third-party data vendors
- HEOR protocol alignment
- Data retention in long-term studies
- Cross-border evidence transfer
- Privacy impact on submission quality
- Stakeholder communication
- Regulatory expectation mapping
Module 3. Mapping Data Flows in Real-World Evidence
Visualize end-to-end data movement across claims, registries, EHRs, and patient-reported outcomes.
12 chapters in this module
- Claims data sources
- Registry integration
- EHR data extraction
- Patient-reported outcome systems
- Data linkage points
- Consent tracking systems
- Data custodianship models
- Jurisdictional boundaries
- Cross-functional handoffs
- Data lineage documentation
- Audit trail requirements
- Data ownership definitions
Module 4. Consent and Legal Basis Mapping
Align consent frameworks with ISO 27701 requirements across EU, India, and North America.
12 chapters in this module
- GDPR Article 6 alignment
- DPDPA the current cycle consent rules
- HIPAA applicability thresholds
- Implied vs explicit consent
- Consent withdrawal mechanisms
- Consent in retrospective studies
- Secondary use justification
- Public interest exemptions
- Consent documentation standards
- Audit evidence preparation
- Multijurisdictional harmonization
- Consent in meta-analyses
Module 5. Privacy by Design in Evidence Programs
Embed privacy controls at protocol design, data sourcing, and model development phases.
12 chapters in this module
- Protocol-level checkpoints
- Data minimization planning
- Pseudonymization methods
- Model input restrictions
- Privacy threat modeling
- Stakeholder privacy training
- Vendor SLA integration
- Data use agreement templates
- Privacy risk scoring
- Ethics board alignment
- Documentation automation
- Compliance workflow triggers
Module 6. Data Subject Rights in HEOR
Implement procedures for data access, rectification, and erasure in long-term evidence programs.
12 chapters in this module
- Right to access protocols
- Data portability in RWE
- Erasure in longitudinal studies
- Rectification workflows
- Data subject verification
- Third-party coordination
- Exemption justifications
- Audit response timelines
- Cross-border enforcement
- Patient-facing communication
- Internal escalation paths
- Documentation retention
Module 7. Vendor Risk and Contracting
Apply ISO 27701 to third-party data processors in real-world evidence research.
12 chapters in this module
- Processor vs controller roles
- Data processing agreements
- Sub-processor oversight
- Security level alignment
- Audit rights negotiation
- Breach notification clauses
- Data location constraints
- Compliance validation
- Contract term integration
- Transition planning
- Insurance requirements
- Exit rights
Module 8. Internal Audit and Compliance Monitoring
Develop checklists and review cycles tailored to health economics data environments.
12 chapters in this module
- Audit scope definition
- Control testing methods
- Evidence sampling
- Non-conformance tracking
- Corrective action workflows
- Reporting templates
- Cross-functional review cycles
- Management review inputs
- Regulatory change monitoring
- Compliance dashboarding
- Document retention policies
- Annex A control mapping
Module 9. Cross-Border Data Transfer Mechanisms
Apply international data transfer rules to real-world evidence sharing across EU, US, and India.
12 chapters in this module
- EU-US DPF alignment
- India's DPDPA the current cycle provisions
- SCCs implementation
- Transfer impact assessments
- Data localization requirements
- Adequacy decisions
- Biding corporate rules basics
- Cloud provider responsibilities
- Encryption in transit
- Data residency in analytics
- Legal challenge preparedness
- Documentation for regulators
Module 10. Regulatory Submissions and Privacy Narratives
Strengthen HTA, FDA, and EMA submissions with clear privacy implementation stories.
12 chapters in this module
- Privacy in submission dossiers
- Control evidence integration
- Compliance timelines
- Auditor readiness
- Narrative consistency
- Stakeholder alignment
- Gap disclosure strategy
- Third-party validation
- Cross-border acceptance
- Post-submission updates
- Rejection response planning
- Re-audit preparation
Module 11. Building Repeatable Privacy Implementation Playbooks
Create templates and workflows that compound across multiple evidence programs.
12 chapters in this module
- Playbook structure
- Modular documentation
- Template libraries
- Version control
- Team onboarding
- Stakeholder guides
- Audit-ready assembly
- Automated checklists
- Cross-project reuse
- Knowledge transfer
- Change management
- Continuous improvement
Module 12. Scaling Privacy Leadership Across Teams
Lead privacy adoption in HEOR, market access, and health technology assessment units.
12 chapters in this module
- Champion network development
- Training program design
- Cross-functional alignment
- Leadership communication
- Influence beyond authority
- Metrics for adoption
- Success story documentation
- Resource request justification
- Stakeholder feedback loops
- Lessons learned sharing
- Best practice scaling
- External recognition paths
How this maps to your situation
- Designing a multinational HEOR study with data from EU and India
- Responding to a payer request for evidence with privacy assurance appendix
- Leading vendor selection for RWD analytics with ISO 27701 compliance as criterion
- Preparing a joint submission with partners across three jurisdictions
Before vs. after
Before
Privacy discussions happen without you, even when your data models are in scope. You rely on compliance teams to interpret rules that directly impact evidence design and delivery.
After
You initiate and shape privacy implementation in evidence programs. Teams across regions and functions proactively engage you to align privacy, compliance, and data utility.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters)
- Downloadable templates and worked examples for every module
- Hand-built implementation playbook delivered alongside course access
- 30-day money-back guarantee
Delivery and format
- Course and learning environment access provisioned within 24 hours of purchase
- Hand-built implementation playbook delivered alongside course access
Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.
Time investment: Approximately 3 hours per module, with self-paced access allowing full completion in 6, 8 weeks or faster based on engagement.
If nothing changes
As privacy regulations tighten globally, practitioners who don’t lead in this space risk becoming execution-only resources, missing opportunities to shape strategy and gain recognition across functions.
How this compares to the alternatives
Generic privacy courses focus on IT or legal teams, using abstract examples. This course is built specifically for health economics professionals who need to apply privacy controls in real-world evidence, HTA, and reimbursement contexts, where data utility and compliance must coexist.
Frequently asked
Is this course technical or policy-focused?
It's designed for practitioners in health economics and real-world evidence who need to apply privacy frameworks to data workflows, it balances policy understanding with practical implementation in evidence generation.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Will this help with HTA submissions?
Yes, Module 10 covers how to integrate privacy compliance into HTA, FDA, and EMA dossiers with real examples from cross-border evidence programs.
$199 one-time. Approximately 3 hours per module, with self-paced access allowing full completion in 6, 8 weeks or faster based on engagement..
Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.
30-day money-back guarantee·
144 chapters·
Hand-built playbook included·
Account access within 24 hours