Regulatory & Ethics — HIPAA GDPR and Consent in PGx — Hands-on

Explore the regulatory and ethics landscape around pharmacogenomics programs. This module focuses on core ideas from HIPAA, GDPR and consent frameworks, and how governance, roles and documentation help teams run PGx initiatives in a responsible and compliant way.

Regulatory & Ethics — HIPAA, GDPR & Consent in PGx

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Session Index

Session 1 — Regulatory Landscapes & Data Protection Concepts Session 2 — HIPAA, GDPR & Governance for PGx Data Session 3 — Consent, Reporting & Patient Communication Session 4 — Mini Capstone: PGx Governance Charter & Checklist

Session 1

Fee: Rs 8800

Regulatory Landscapes & Data Protection Concepts

Why pharmacogenomics raises specific regulatory and ethics questions

genomic sensitivity and long term impact family and group level implications clinical vs research use of PGx data

High level view of key regulatory families

health privacy and security themes laboratory and quality regulations idea institutional policies and ethics review

Core data protection concepts used across frameworks

identifiers and de identification thinking purpose limitation and minimisation ideas accountability and documentation themes

Session 2

Fee: Rs 11800

HIPAA, GDPR & Governance for PGx Data

HIPAA style perspectives on health information

protected health information notions role based access control ideas audit trail and breach response themes

GDPR style perspectives on personal and sensitive data

lawful bases and special category data data subject rights at high level data protection impact assessment idea

Designing a simple governance structure for PGx programs

steering group and working groups roles for clinicians labs and IT teams policies standard operating procedures and logs

Session 3

Fee: Rs 14800

Consent, Reporting & Patient Communication

Concepts for informed consent in pharmacogenomics

clarity of purpose and scope future use and data sharing options re contact and withdrawal themes

High level ideas for communicating PGx results

plain language drug and gene summaries avoiding deterministic phrasing supporting shared decision making

Handling secondary findings and family implications conceptually

distinguishing primary and incidental results family communication challenges role of ethics and counselling support

Session 4

Fee: Rs 18800

Mini Capstone: PGx Governance Charter & Checklist

Select a PGx use case and sketch a governance charter

describe scope and clinical context list key roles and responsibilities outline decision and escalation paths

Draft a concise ethics and compliance checklist for PGx teams

data protection and access controls consent documentation and renewal incident response and reporting lines

Deliverables: PGx governance one pager and checklist template

PDF or DOCX summary checklist for local adaptation starting point for ethics discussions

PDF

Regulatory & Ethics in PGx Training | HIPAA, GDPR & Consent Concepts

Regulatory & Ethics — HIPAA GDPR and Consent in PGx — Hands-on