Updates From The EMA Technical Anonymization Group & Policy 0070 Cathal Gallagher US Connect 18, Raleigh

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1 Updates From The EMA Technical Anonymization Group & Policy 0070 Cathal Gallagher US Connect 18, Raleigh June 6, 2018 d-wise Technologies, Inc June 6, 2018 Page 1

2 What is Policy 0070 n The European Medicines Agency policy on the publication of clinical data for medicinal products for human use n Phase 1 of Policy 0070 entered into force on 1st January 2015 n Phase 2, which will be implemented at a later stage, pertains to the publishing of individual patient data d-wise Technologies, Inc June 6, 2018 Page 2

3 Anonymization Landscape Secondary Use EMA Policy 0070 Risk Dynamics Clinical data is increasingly being pushed into public domain for transparency and research requests Increasingly, even internal secondary use is subject to scrutiny on appropriateness of use in context of informed consent Submissions to EMA will be in the public domain Personally Identifying Information (PII) has historically been redacted Under Policy 0070, sponsors must anonymize PII in the context of re-identification risk Risk is the likelihood of patient identification Risk should be assessed based on the context of disclosure Risk should be reduced through anonymization of quasiidentifier in shared artifacts Historical manual and code-based approaches are labor intensive, variant, and suboptimal for quality control d-wise Technologies, Inc June 6, 2018 Page 3

4 Context of Risk Large Sphere of Access Small Public External Researcher R&D Staff & Partners Clinical Development Team Health Care Provider Low Ability to Control High Applicants/MAHs should identify possible adversaries and plausible attacks on the data and evaluate the impact on the risk of re-identification. Re-Identification Attack Types 1. Financial Interest 2. Demonstration Attack 3. Acquaintance examines a report 4. Participant is public figure d-wise Technologies, Inc June 6, 2018 Page 4

5 Analysis of CSRs already published (PhUSE review) Lukasz Kniola, Biogen, UK EMA Technical Anonymisation Group (TAG) Meeting November 2017 #PhUSE

6 Publications Over Time * Q Q Q Q Q4-2017* 0 Publications per quarter Publications overall *) As of 31-Oct-2017 #PhUSE

7 Summary of findings cont. #PhUSE

8 What is the TAG n Members from academia, industry, patients and healthcare professionals n Focus to further develop best practices for the anonymisation of clinical reports d-wise Technologies, Inc June 6, 2018 Page 8

9 Who is in the TAG n Khaled El Emam (Privacy Analytics) n Jean-Marc Ferran (Qualiance) n Uwe Fiedler () n Christine Fletcher (Amgen) n Cathal Gallagher (d-wise) n Lukasz Kniola (Biogen) n Bradley Malin (University of ) n Sarah Nevitt n Nicola Orlandi n Lee Parker n Frank Rockhold n Kristian Svendsen n Rafal Swierzewski d-wise Technologies, Inc June 6, 2018 Page 9

10 Who is in the TAG Pharmaceuticals R&D (2) Software (2) Christine Fletcher (Amgen, UK) Lukasz Kniola (Biogen, UK) Khaled El Emam (Privacy Analytics, CA) Cathal Gallagher (d-wise, UK) Academia Research (3) Pharmaceuticals/CRO Legal (3) Sarah Nevitt (University of Liverpool, UK) Frank Rockhold (Duke University, US) Kristian Svendsen (Hospital Pharmacy Tromsø, NO) Nicola Orlandi (Novartis, CH) Lee Parker (Biogen, UK) Uwe Fiedler (PAREXEL, DE) Patients Association (1) Data Protection Agency (1) Rafal Swierzewski (EPPOSI, BE) SME (2) Bradley Malin (Vanderbilt University, US) Jean-Marc Ferran (Qualiance, DK) Giuseppe d'acquisto (Italian DPA, IT) d-wise Technologies, Inc June 6, 2018 Page 10

11 Also members of the TAG: n Monica Dias (chair, EMA) n Ada Adriano (EMA) n Anne-Sophie Henry-Eude (EMA) n Frank Pétavy (EMA) n Karen Quigley (EMA) n Alessandro Spina (EMA) n Giuseppe d'acquisto (Italian data protection authority) n Dina Kampouraki (observer, European data protection supervisor) d-wise Technologies, Inc June 6, 2018 Page 11

12 First meeting of the TAG Highlights n Review of clinical reports published from October 2016 to October 2017 performed by EMA and by PhUSE; n Experience from Pharmaceutical Industry with the anonymisation of clinical reports; n EMA experience with the review of Anonymisation Reports; d-wise Technologies, Inc June 6, 2018 Page 12

13 First meeting of the TAG Highlights n Review of quantitative methods to measure the risk of re-identification; n Data utility in anonymised clinical reports; n Adversary knowledge; n Legal issues with the anonymisation of clinical reports and the impact of the GDPR. d-wise Technologies, Inc June 6, 2018 Page 13

14 Tag Subgroups n Data Utility - EMA Lead - Anne Sophie Henry- Eude n Anonymisation approaches and techniques EMA Lead - Karen Quigley n Plausible attackers EMA Lead - Ada Adriano n Legal issues/gdpr EMA Lead - Alessandro Spina n New technological developments EMA Lead - Frank Petavy d-wise Technologies, Inc June 6, 2018 Page 14

15 Next TAG Meeting n 23 rd 24 th October 2018 n Progress of all Sub groups n The move from Redaction to Anonymisation d-wise Technologies, Inc June 6, 2018 Page 15

16 Latest Development d-wise Technologies, Inc June 6, 2018 Page 16

17 Potential Differences to Consider d-wise Technologies, Inc June 6, 2018 Page 17