Medical Writing Artificial intelligence and Digital Health A primer on anonymisation
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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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