Use Cases: Patient Verification and Controlled Data Sharing

Actor Profile

Name: Rachel McGill
 Role: Patient Care Coordinator
 Organization: National cancer center
 Responsibilities: Clinical trial enrollment, patient onboarding, health authority coordination
 Focus: Streamlining patient enrollment and improving clinical trial outcomes

Business Context

Healthcare system faces significant inefficiencies in clinical trial enrollment caused by paper-based administrative processes and manual patient verification. Cancer patients seeking treatment in clinical trials experience enrollment delays while facilities verify identities and medical histories, adding stress during critical health periods. Medical records fragmentation across providers creates redundant testing and information errors. Privacy regulations (HIPAA, GDPR) require secure data handling increasing administrative complexity. Researchers depend on accurate, timely patient data for trial recruitment and success. Coordination among health authorities, cancer centers, and research institutions requires secure information sharing. Digital trust and verification systems enable patient-controlled data sharing while reducing administrative burden and improving trial enrollment efficiency.

Challenge Statement

Rachel must enroll cancer patients in clinical trials efficiently while verifying identities, confirming medical histories, and enabling secure data sharing among health authorities and researchers. Manual paper-based enrollment processes delay trial entry adding stress to patients during critical health periods. Patients undergo redundant tests and assessments as different providers independently verify the same medical history information. Medical records fragmentation across multiple healthcare providers creates information silos limiting eligibility assessment accuracy and requiring manual compilation. Paper-based record transmission via fax creates security vulnerabilities and transmission errors. Repeated authorization requests create administrative burden for patients already stressed by health conditions. Rachel needs digital systems enabling patients to control verified personal and medical information sharing while accelerating enrollment and improving data accuracy.

Solution Architecture

Patient-Controlled Digital Health Data Sharing Process

Rachel’s cancer center implements integrated digital trust and identity verification system enabling patient-controlled medical information sharing, streamlined trial eligibility assessment, and secure multi-provider coordination.

Patient Identity Verification & Credential Issuance

  • Patient identity verification using government-issued identification
  • Document verification validating authenticity of patient identification documents
  • Facial recognition confirming identity of patient
  • Digital patient credential issued establishing verified patient identity
  • Patient credential linked to healthcare provider accounts and clinical records
  • Credential authentication required for medical information access

Patient-Controlled Medical Information Repository

  • Centralized secure digital repository storing verified patient medical history and clinical information
  • Patient access controls determining who views specific medical records and clinical data
  • Patients grant time-limited or permanent access to specific healthcare providers and researchers
  • Granular permissions enabling patients to share specific records (labs, imaging, medications) selectively
  • Access logging showing all parties viewing patient information with date and purpose
  • Patient revocation capability enabling immediate withdrawal of access permissions

Medical Record Aggregation & Verification

  • Automated collection of medical records from multiple healthcare providers with patient authorization
  • Verification of record authenticity confirming source from legitimate healthcare institutions
  • Consolidated patient medical history reducing need for redundant testing
  • Unified medication list preventing drug interactions and duplicative prescriptions
  • Laboratory result aggregation preventing unnecessary test repetition
  • Imaging and diagnostic report consolidation enabling comprehensive clinical review

Clinical Trial Eligibility Assessment

  • Pre-populated trial eligibility forms using verified patient medical information
  • Automated eligibility screening reducing manual assessment time
  • Real-time eligibility determination based on verified patient data
  • Elimination of redundant medical assessments and testing
  • Rapid identification of enrollment barriers enabling patient counseling
  • Digital communication of eligibility results to patients and providers

Secure Multi-Provider Coordination

  • Verified information sharing among cancer center, referring physicians, and researchers
  • Encrypted communication channels protecting patient information during transmission
  • Coordinated care planning visible to authorized providers reducing miscommunication
  • Synchronized treatment information preventing conflicting medical decisions
  • Real-time updates to medical records reflecting latest clinical information
  • Audit trails documenting all provider access to patient information

Privacy-Preserving Researcher Data Access

  • De-identified data sharing with researchers protecting patient privacy
  • Patient consent for research participation confirmed through verified authorization
  • Research study protocols reviewed and approved before data access
  • Limited data set access preventing identification of individual patients
  • Royalty or benefit sharing agreements documented for patient information use
  • Patient transparency regarding research participation and data usage

Compliance Documentation & Audit Trail

  • Automated documentation of patient consent and authorization decisions
  • Tamper-proof audit trail recording all data access and information sharing
  • Regulatory compliance verification ensuring adherence to privacy regulations
  • Real-time audit reports supporting institutional compliance monitoring
  • Documentation of data minimization ensuring only necessary information shared
  • Patient transparency reports showing all data access and sharing activities

Implementation Considerations

Adoption Barriers

Technology & Process Resistance

  • Patient concerns about online health information security and unauthorized access
  • Distrust of digital systems from patients preferring traditional paper records
  • Healthcare provider concerns about system reliability affecting patient care
  • Administrative staff concerns about technology learning curve and adoption burden
  • Researcher concerns about data access delays or bureaucratic complexity

Infrastructure Requirements

  • Secure patient identity verification platform supporting government document verification
  • HIPAA/GDPR-compliant secure database for sensitive health information storage
  • Encrypted communication channels for inter-provider data transmission
  • Patient portal interface enabling authorization and access management
  • Integration with existing electronic health record (EHR) systems at multiple institutions
  • Real-time audit logging and monitoring infrastructure
  • Backup systems ensuring data availability during emergencies

Resource Constraints

  • Patient education and training on digital consent and authorization processes
  • Healthcare provider and staff training on new enrollment workflow
  • Technical support for patients and providers experiencing system issues
  • Integration work connecting multiple institution EHR systems
  • Ongoing data governance and access management oversight
  • Compliance monitoring and audit preparation support
  • Vendor management and technical support coordination

Cost Considerations

  • Initial investment in secure patient data platform and infrastructure
  • Integration costs connecting with existing EHR systems across multiple institutions
  • Patient portal development and mobile application support
  • Ongoing compliance and regulatory reporting infrastructure
  • Staff training and change management support
  • Ongoing licensing and cloud service fees for secure data storage
  • Technical support and system maintenance

Stakeholder Considerations

  • Rachel & Cancer Center: Require streamlined enrollment processes; value accurate patient data; benefit from reduced administrative burden; need compliance assurance; require patient safety and privacy protection
  • Patients & Caregivers: Value quick trial enrollment with minimal paperwork; need confidence in data security and privacy protection; appreciate transparency about information sharing; prefer convenient digital access
  • Healthcare Providers: Require seamless EHR integration; benefit from coordinated patient information; value reduced redundant testing; need clear data governance and compliance; appreciate efficient referral processes
  • Clinical Researchers: Require timely access to patient data; value data accuracy and completeness; need compliance with research protocols; appreciate reduced enrollment delays; require patient privacy protection
  • Health Authorities & Regulatory Bodies: Require compliance with privacy regulations; need audit capabilities for oversight; value transparent consent documentation; appreciate streamlined data sharing; demand data security assurance
  • Insurance & Financial Partners: Require verified patient information for coverage determination; value accurate medical history; benefit from reduced claim disputes; appreciate transparent data handling; need privacy assurance

Benefits & Value Delivery

Risk Mitigation

  • Patient identity verification preventing unauthorized medical record access
  • Verified consent documentation protecting institutions from privacy violations
  • Audit trails documenting all data access enabling rapid incident investigation
  • Encrypted data transmission preventing interception and unauthorized access
  • Tamper-proof records protecting data integrity and regulatory compliance

Data Protection & Privacy

  • Encrypted storage of sensitive patient health information
  • Patient-controlled access permissions ensuring information shared only with authorization
  • Minimal data sharing ensuring only necessary information accessed
  • Secure deletion of data when patient access revoked
  • Compliance with HIPAA, GDPR, and other privacy regulations
  • Transparent data handling practices building patient trust

Accessibility & Service Expansion

  • Rapid trial enrollment enabling faster patient access to experimental treatments
  • Elimination of redundant testing reducing patient burden and healthcare costs
  • Coordinated care enabling participation in multiple trials or provider coordination
  • Geographic accessibility enabling patients in different regions to participate
  • Language accessibility through digital translation and communication
  • Improved access for patients with mobility or transportation constraints

Operational Efficiency

  • Automated enrollment processes reducing administrative burden and timelines
  • Pre-populated forms eliminating manual data entry and transcription errors
  • Rapid eligibility determination reducing assessment and approval delays
  • Coordinated provider communication reducing miscommunication and delays
  • Reduced redundant testing saving healthcare resources and costs
  • Streamlined compliance documentation reducing audit preparation burden

Competitive Advantage

  • Positions cancer center as modern, patient-focused, and efficient
  • Differentiates through faster enrollment and superior patient experience
  • Attracts patients seeking convenient trial participation options
  • Demonstrates commitment to data security and patient privacy
  • Attracts researchers through efficient trial enrollment processes

Relevant DIACC PCTF Components

  • Authentication: Multi-factor authentication verifying patient identity through government ID verification and facial recognition enabling secure access to medical information and clinical trial enrollment
  • Verified Person: Verification of patient identity establishing eligibility to access healthcare services and participate in clinical trial enrollment
  • Notice & Consent: Clear communication to patients regarding medical information sharing, data access, research participation, and privacy protections; explicit consent required for authorization
  • Privacy: Patient health information protection through encryption, access controls, audit logging, and compliance with healthcare privacy regulations including HIPAA and GDPR
  • Verified Organization: Verification of healthcare providers, research institutions, and health authorities confirming authorization to access patient information and participate in clinical trials