Medical Writing Artificial intelligence and Digital Health A primer on anonymisation

Volume 28, Issue 4 - Artificial intelligence and Digital Health

A primer on anonymisation

Abstract

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational readiness to deliver anonymised dossiers. Key steps include understanding the regulatory requirements and anonymisation techniques, assessing internal competencies and/or commercially available software, and establishing infrastructure to deliver anonymised dossiers in a timely manner.

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References

  1. PhUSE. Protection of Personal Data in Clinical Documents – A Model Approach. Available from: Available from: http://www.transceleratebiopharmainc.com /wp-content/uploads/2017/02/ Protection-of-Personal-Data-in-Clinical- Documents.pdf
  2. PhUSE. De-identification and anonymization of individual patient data in clinical studies. A Model Approach. Available from: Available from: http://www.transceleratebiopharmainc.com /wp-content/uploads/2015/04/ TransCelerate-De-identification-and- Anonymization-of-Individual-Patient-Datain- Clinical-Studies-V2.0.pdf
  3. EMA. External Guidance on the Implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. 2018 [cited 30 Oct 2019] Available from: Available from: https://www.ema.europa.eu/en/documents /regulatory-procedural-guideline/externalguidance- implementation-europeanmedicines- agency-policy-publicationclinical- data_en-3.pdf
  4. Health Canada. Guidance Document on Public Release of Clinical Information. 2019 [cited 30 Oct 2019]. Available from: Available from: https://www.canada.ca/en/health-canada/ services/drug-health-product-reviewapproval/ profile-public-release-clinicalinformation- guidance/document.html
  5. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ. 2010;340:c181.
  6. EMA. Data anonymization – A key enabler for clinical data sharing. Workshop report. 2017 [cited 30 Oct 2019]. Available from: Available from: https://www.ema.europa.eu/en/documents /report/report-data-anonymisation-keyenabler- clinical-data-sharing_en.pdf
  7. El Emam K, Dankar FK. Protecting privacy using k-anonymity. J Am Med Inform Assoc. 2008; -15(5):627–7.
  8. Keerie C, Tuck C, Milne G, Eldridge S, Wright N, Lewis SC. Data sharing in clinical trials - practical guidance on anonymising trial datasets. Trials. 2018;19(1):25. Author

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Articles

Table of Contents
Artificial intelligence and digital health
President's Message
EMWA News
Medical writing in the era of artificial intelligence
Blockchain in healthcare, research, and scientific publishing
Embracing a new friendship: Artificial intelligence and medical writers
Drug development and medical writing in the digital world
Intelligent use of artificial intelligence for systematic reviews of medical devices
What medical writers need to know about regulatory approval of mobile health and digital healthcare devices
Digitalisation in long-term care: An issue for medical writers?
An introduction to medical affairs for medical writers
A primer on anonymisation
Sound, microphone, action: Podcasts for medical writers
Regulatory Matters
News from the EMA
Lingua Franca and Beyond
In the Bookstores
Getting Your Foot in the Door
Medical Devices
Veterinary Medical Writing
Teaching Medical Writing
Journal Watch
Medical Communications and Writing for Patients
Good Writing Practice
Out on Our Own
Upcoming issues of Medical Writing

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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk