Medical Writing Editing Anonymisation: A new challenge for medical writers

Volume 27, Issue 3 - Editing

Anonymisation: A new challenge for medical writers

Abstract

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission packages containing anonymised data submitted to the EMA as of March 2018 shows that the most frequent technique to anonymise data is redaction. This is typically performed after reports are submitted to the competent authorities. The study report team, through a strong cross-functional strategy, can reduce the anonymisation required after submission of the document by proactively reducing the use of unnecessary identifiers in the initial report drafts. Therefore, the challenge for medical writers is to become involved in the anonymisation strategy and the creation of a data anonymisation plan for the clinical documents from their initial stages, focusing on the balance between scientific value and risk of re-identification.

Download the full article

References

  1. EMA. EMA policy on access to documents (related to medicinal products for human and veterinary use). Policy/0043 (EMA/110196/2006). 2010 [cited 2018 Jun 13]. Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/Other/2010/11/ WC500099473.pdf.
  2. EMA. EMA policy on publication of clinical data for medicinal products for human use. Policy/0070 (EMA/240810/ 2013). 2014 [cited 2018 Jun 13]. Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/Other/2014/10/ WC500174796.pdf.
  3. EMA. External guidance on the implementation of the EMA policy on the publication of clinical data for medicinal products for human use (EMA/90915/ 2016). 2017 [cited 2018 Jun 13]. Available from: http://www.ema.europa.eu/docs/envGB/ document_library/Regulatory_and_ procedural_guideline/2017/09/WC50023 5371.pdf.
  4. Code of Federal Regulations. Title 45: Public Welfare, Subtitle A §164.514. [cited 2018 Jun 13]. Available from: https://www.gpo.gov/fdsys/pkg/CFR- 2002-title45-vol1/pdf/CFR-2002-title45- vol1-sec164-514.pdf.
  5. Health Insurance Portability and Accountability Act Privacy Rule. [cited 2018 Jun 13]. Available from: https://www.hhs.gov/hipaa/forprofessionals/ privacy/index.html.
  6. Council Regulation (EC) 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data. 2008 [cited 2018 Jun 13]. OJ L193/7. Available from: https://eur-lex. europa.eu/legal-content/EN/TXT/PDF/ ?uri=CELEX:32001R0045&from=EN.
  7. Council Directive (EC) 95/46 of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 1995 [cited 2018 Jun 13]. OJ L281. Available from: https://ec.europa.eu/health/ sites/health/files/files/eudralex/vol-1/ reg_2014_536/reg_2014_536 _en.pdf.
  8. Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 2014 [cited 2018 Jun 13]. OJ L158/1. Available from: https://ec.europa.eu/health/sites/health/ files/files/eudralex/vol-1/reg_2014_536/ reg_2014_536_en.pdf.
  9. 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.
  10. Ferran JM, El Emam K, Nolan S, Grimm B, De Donder N. PhUSE De-Identification Working Group: Providing De- Identification Standards to CDISC Data Models. Presented at the PhUSE Annual Conference, Vienna, October 11-14, 2015 (Paper DH01). Available from: Available from: https://www.phusewiki.org/docs/ Conference%202015%20DH%20Papers/ DH01.pdf.
  11. Kumar P, Sareen R. Evaluation of Reidentification Risk for Anonymized Clinical Documents. Presented at the PhUSE Annual Conference, Edinburgh, October 8-11, 2017 (Paper RG02). Available from: Available from: http://www.phusewiki.org/docs/ Conference%202017%20RG%20Papers/ RG02.pdf.
  12. Data Protection Working Party. Opinion 05/2014 on Anonymisation Techniques. Article 29. WP 216. Available from: Available from: http://www.dataprotection.ro/servlet/ ViewDocument?id=1085.
  13. Data Protection Working Party. Opinion 4/2007 on the Concept of Personal Data. Article 29. WP 136. Available from: Available from: https://www.clinicalstudydatarequest.com /Documents/Privacy-Europeanguidance. pdf.

Search

Articles

Editing
President’s Message
EMWA News
Honing your proofreading skills
How clear is the story?
Editing for writers who have English as an additional language
Microediting – details matter Quality, authority, and reputation: The value of microediting
Revision: Parameters and practices within the translation industry
How to soften the red pen’s blow: Tips for editing a colleague’s work
Go certified – get ready for the BELS exam
Anonymisation: A new challenge for medical writers
Reports from the spring conference in Barcelona: 6th EMWA Symposium
Reports from the spring conference in Barcelona: EMWA social events programme
Reports from the spring EMWA conference. Expert seminar: Use of clinical study reports for Cochrane Reviews
News from the EMA
Profile: An interview with Richard Wheeler
Journal Watch
Medical Devices
In the Bookstores
Lingua Franca and Beyond
Regulatory Public Disclosure
Regulatory Matters
Medical Communication
Good Writing Practice
Manuscript Writing
Getting Your Foot in the Door
My First Medical Writing
Out on Our Own
Upcoming issues of Medical Writing

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

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 Clemens

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