Data Protection and Compliance
Within cell and gene therapy consulting, we are often called upon to help to demonstrate which PHI is processed by which system for PHI management. To assist with PHI management TrakCel consulting services will audit all supply chain systems used (both electronic and paper) to identify and catalogue where and to what extent PHI is processed to produce a data processing diagram for an organisation. These diagrams will inform GDPR/HIPAA compliance strategies for companies processing and sub-processing PHI.
Our cell and gene consultants will also provide information on how PHI/PII may be used as part of the COI strategy and how to address GDPR/HIPAA legislation when using PHI/PII for the purpose of COI management, and how to apply aspects of data management including consent, the right to be forgotten, and data processing limits.