Case Study: Pharmaceuticals Patrick F. Sullivan, Ph.D. 939 North Graham Avenue, Indianapolis, IN 46219 317-352-1362

Slides:



Advertisements
Similar presentations
Project Quality Plans Gillian Sandilands Director of Quality
Advertisements

HIPAA and Joint Commission Requirements Compared and Contrasted
H OGAN & H ARTSON, L.L.P.
Todd Frech Ocius Medical Informatics 6650 Rivers Ave, Suite 137 North Charleston, SC Health Insurance Portability.
Tips to a Successful Monitoring Visit
29e CONFÉRENCE INTERNATIONALE DES COMMISSAIRES À LA PROTECTION DES DONNÉES ET DE LA VIE PRIVÉE 29 th INTERNATIONAL DATA PROTECTION AND PRIVACY COMMISSIONERS.
Pharmacovigilance by Dr. Notghi Contract Research.
The Law of Privacy Prof. Michael Madison – University of Pittsburgh School of Law – January 22, 2004 [1] What is privacy? [2] What law regulates privacy?
Confidentiality and HIPAA
Increasing public concern about loss of privacy Broad availability of information stored and exchanged in electronic format Concerns about genetic information.
Health Insurance Portability and Accountability Act (HIPAA)HIPAA.
Privacy Laws & Higher Education. Agenda 1.Five Privacy Laws a.FERPA b.HIPAA c.GLB d.FACTA Disposal Rule e.CAN-SPAM 2.Overview of the Laws a.What does.
NCVHS: Privacy and Confidentiality Leslie P. Francis, Ph.D., J.D. Distinguished Professor of Law and Philosophy Alfred C. Emery Professor of Law University.
Clinical QA Data Audits A GCP Point of View Linda Del Paggio GCP Compliance BioBridges, LLC.
IS BIG DATA GIVING YOU A BIG HEADACHE? Risk Reduction - Transactional, International and Liability Issues Oregon State Bar Corporate Counsel Section Fall.
1st Global QA Conference & 21st SQA Annual Meeting Falcon Consulting Group, LLC 1 Phase I Clinical Study Audits “A Deeper Scrutiny” Cheryl J. Priest, R.N.
IS3350 Security Issues in Legal Context
1 PRIVACY ISSUES IN THE U.S. – CANADA CROSS BORDER BUSINESS CONTEXT Presented by: Anneli LeGault ACC Greater New York Chapter Compliance Seminar May 19,
Coping with Electronic Records Setting Standards for Private Sector E-records Retention.
GCP compliance for GenISIS  This presentation is intended for clinical staff involved in recruiting patients to the GenISIS (Genetics of Influenza Susceptibility.
Pharmacists Responsibilities in Clinical Studies Mike R Sather, PhD Crystal L Harris, PharmD February 26, 2004.
On Privacy-aware Information Lifecycle Management (ILM) in Enterprises: Setting the Context Marco Casassa Mont Hewlett-Packard.
Informed Consent and HIPAA Tim Noe Coordinating Center.
Session 6: Data Integrity and Inspection of e-Clinical Computerized Systems May 15, 2011 | Beijing, China Kim Nitahara Principal Consultant and CEO META.
Good Clinical Practice GCP
Overview of Good Clinical Practices (GCPs)
Regulatory Update Ellen Leinfuss SVP, Life Sciences.
Privacy Codes of Conduct as a self- regulatory approach to cope with restrictions on transborder data flow Dr. Anja Miedbrodt Exemplified with the help.
DSDS Quality Assurance Unit State of Alaska, Dept. of Health and Social Services Division of Senior and Disabilities Services (DSDS) Quality Assurance.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin McClure, PhD Department of Psychiatry and Behavioral Sciences.
Confidentiality and Drug Courts Carson Fox Esq. Steve Hanson M.S. Ed.
Computerized Networking of HIV Providers Workshop Data Security, Privacy and HIPAA: Focus on Privacy Joy L. Pritts, J.D. Assistant Research Professor Health.
Advanced HIPAA Issues for Biotech and Life Sciences Companies: Mark E. Schreiber Palmer & Dodge LLP 111 Huntington Avenue Boston, MA
HIT Standards Committee Privacy and Security Workgroup: Initial Reactions Dixie Baker, SAIC Steven Findlay, Consumers Union June 23, 2009.
HIPAA Michigan Cancer Registrars Association 2005 Annual Educational Conference Sandy Routhier.
Privacy Project Framework & Structure HIPAA Summit Brent Saunders
PKI Forum Business Panel March 6, 2000 Dr. Ray Wagner Sr. Director, Technology Research.
LeToia Crozier, Esq., CHC Vice President, Compliance & Regulatory Affairs Corey Wilson Director of Technical Services & Security Officer Interactive Think.
Health Insurance Portability and Accountability Act of 1996 HIPAA Privacy Training for County Employees.
PricewaterhouseCoopers 1 Administrative Simplification: Privacy Audioconference April 14, 2003 William R. Braithwaite, MD, PhD “Doctor HIPAA” HIPAA Today.
1 HIPAA Compliance Strategies for Pharmaceutical Manufacturers, PBMs and Pharmacies Jean-Paul Hepp, Ph.D. Director, Global Privacy HIPAA Colloquium Harvard.
Connecting the Dots A Practical Approach to Integrating Compliance, Risk and Quality Jody Ann Noon RN, JD Partner Health Care Regulatory Practice.
Conducting Clinical Risk Assessments And Implementing Compliance Practices Jane L. Stratton Chiron Corporation VP/Associate General Counsel Chief Compliance.
Policies for Information Sharing April 10, 2006 Mark Frisse, MD, MBA, MSc Marcy Wilder, JD Janlori Goldman, JD Joseph Heyman, MD.
Integrating a Federated Healthcare Data Query Platform With Electronic IRB Information Systems Shan He IPHIE 2010.
Agenda for Session Compliance in Clinical Research
Copyright © 2015 by Saunders, an imprint of Elsevier Inc. All rights reserved. Chapter 3 Privacy, Confidentiality, and Security.
1 Copyright © International Security, Trust & Privacy Alliance -All Rights Reserved Making Privacy Operational International Security, Trust.
HIPAA Security John Parmigiani Director HIPAA Compliance Services CTG HealthCare Solutions, Inc.
ISO CONCEPTS Is a management standard, it is not performance or product standard. The underlying purpose of ISO 1400 is that companies will improve.
Chapter 4: Laws, Regulations, and Compliance
Compliance at the Crossroads: How can the Compliance Profession Move to the Second Generation? A Practical Approach to Integrating Compliance, Risk and.
Lifespan GOOD CLINICAL PRACTICE Record Management GCP May 2005.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin A McClure, PhD Department of Psychiatry and Behavioral Sciences.
All Hands Electronic Information Integrity Call White Paper An Introduction to the Current State of EMR – et.al. R. L. Chamberlain, Ph.D.
GCP (GOOD CLINICAL PRACTISE)
Clinical Trials Validation, 21 CFR Part 11 Compliance
Recent Evolution of New Drug Review and Approval System in Korea
The Information Professional’s Role in Product Safety
Data Protection: EU & International
Current Privacy Issues That May Affect Your Credit Union
Employee Privacy and Privacy of Employee Information
Health Care: Privacy in a Digital Age
Lesson 1  7 Basic Components of an Effective Compliance Plan
Paul T. Smith, Esq. Partner, Davis Wright Tremaine LLP
Making Your IRBs and Clinical Investigators HIPAA-Ready
THE 13TH NATIONAL HIPAA SUMMIT HEALTH INFORMATION PRIVACY & SECURITY IN SHARED HEALTH RECORD SYSTEMS SEPTEMBER 26, 2006 Paul T. Smith, Esq. Partner,
Managing Privacy Risk in Your Commercial Practices
HIPAA Compliance Services CTG HealthCare Solutions, Inc.
HIPAA Privacy and Security Update - 5 Years After Implementation
Presentation transcript:

Case Study: Pharmaceuticals Patrick F. Sullivan, Ph.D. 939 North Graham Avenue, Indianapolis, IN

2 Background Clinical research division of major pharmaceutical Scope of program covers clinical trials and drug safety and surveillance worldwide Program is located in divisional compliance function, under direction of Data Privacy & Security Compliance Area Manager

3 Pharma Research- What’s Different No consumer privacy issues- no research data go outside the division’s databases, no marketing functions in research division, no marketing data comes in Research context changes application of Fair Information Practices  Notice- Consent for participation in protocol; HIPAA authorization to transfer data for research purposes; country-specific consents; general notice  Choice/consent- Everything is consent driven or required by regulation; “opt-out” isn’t a relevant concept  Limitation- Protocol, regulatory requirements determine minimum data; data types may differ- personal data, family history, tissue sample, genetic

4 Pharma Research- What’s Different Access- Difficult to unblind a study; access could expose other’s data; pharma typically gets minimal identifiers- most identifiable data stays with investigator Onward transfer- Disclosures are to regulatory agencies or other investigators, required by regulation (GCPs, Pharmacovigilance)  Data import compliance is a more salient issue Data Integrity- Data accuracy is essential to research; significant SOPs, divisional procedures focused on data accuracy, relevance, currency

5 Pharma Research- What’s different Regulatory environment is more complex  Good Clinical Practices, other protections of human subjects  HIPAA is limited in research context- pharmas are not covered entities; authorizations for transfer from investigator, subsequent research use of data are issues  Part 11- electronic records, digital signature; validation, security, audit trail concerns  International- EU Clinical Trials Directive requires compliance with Data Protection Directive- raises stakes for privacy compliance, transborder data flow compliance

6 Program Organization Fair Information Practices Corporate Compliance Program Requirements Administrative Accountability Policy/Planning Operational Data Subject Rights Data Processing Controls Manage/Maintain Monitoring & due diligence Training Complaints/inquiry Response to non- compliance

7 Our Approach Define core privacy practices, create compliance guidelines- drive through enforceable policy (corporate information, compliance, business practice & security policies) Map data flow Create control objectives for privacy compliance Identify data flow control points, review & index SOPs Revise SOPs as needed Create accountability, maintenance infrastructure and procedure Create updates and continuation/monitoring plans