Preview

Medical Doctor and Information Technologies

Advanced search

On the issue of depersonalization and use of real-world data

https://doi.org/10.25881/18110193_2025_2_32

Abstract

   The requirements to anonymized real-world data (RWD), basic methods of anonymization and synthetization of RWD that allow to preserve their clinical informativeness are considered. The description of the procedure of collection, anonymization and use of RWD is given, which provides high stability of anonymized data in relation to threats of breach of confidentiality of information constituting medical confidentiality.

About the Author

A. P. Stolbov
The First Sechenov Moscow State Medical University
Russian Federation

DSc, professor

Moscow



References

1. Rasporyazhenie Pravitel'stva Rossijskoj Federacii ot 17. 04. 2024 № 959-r «Ob utverzhdenii strategicheskogo napravleniya v oblasti tsifrovoy transformatsii zdravookhraneniya na 2024–2030 gody». (In Russ.)

2. Rekomendacii Soveta Evrazijskoj ehkonomicheskoj komissii ot 18. 10. 2024 № 1 «Ob obshchikh podkhodakh k razvitiyu regulirovaniya obrashcheniya lekarstvennykh sredstv v ramkakh Evrazijskogo ehkonomicheskogo soyuza v chasti sbora, analiza i ispol'zovaniya dannykh real'noj klinicheskoj praktiki». (In Russ.)

3. Federal'nyj zakon «O provedenii ehksperimenta po ustanovleniyu special'nogo regulirovaniya v celyakh sozdaniya neobkhodimykh uslovij dlya razrabotki i vnedreniya tekhnologij iskusstvennogo intellekta v sub’ekte Rossijskoj Federacii - gorode federal'nogo znacheniya Moskve – i vnesenii izmenenij v stat'i 6 i 10 Federal'nogo zakona «O personal'nykh dannykh» № 123-FZ ot 24. 04. 2020. (In Russ.)

4. Federal'nyj zakon «Ob ehksperimental'nykh pravovykh rezhimakh v sfere cifrovykh innovacij v Rossijskoj Federacii» № 258-FZ ot 31. 07. 2020. (In Russ.)

5. Federal'nyj zakon «O vnesenii izmenenij v Federal'nyj zakon «O personal'nykh dannykh» i Federal'nyj zakon «O provedenii ehksperimenta po ustanovleniyu special'nogo regulirovaniya v celyakh sozdaniya neobkhodimykh uslovij dlya razrabotki i vnedreniya tekhnologij iskusstvennogo intellekta v sub’ekte Rossijskoj Federacii - gorode federal'nogo znacheniya Moskve – i vnesenii izmenenij v stat'i 6 i 10 Federal'nogo zakona «O personal'nykh dannykh» ot 08. 08. 2024 № 233-FZ. (In Russ.)

6. Proekt Postanovleniya Pravitel'stva Rossijskoj Federacii «O gosudarstvennoj informacionnoj sisteme, prednaznachennoj dlya obrabotki personal'nykh dannykh, poluchennykh v rezul'tate obezlichivaniya personal'nykh dannykh, i vnesenii izmenenij v postanovlenie Pravitel'stva Rossijskoj Federacii ot 14 maya 2021 №733» (ID proekta 01/01/02-25/00154662 ot 14. 02. 2025) (In Russ.)

7. Proekt Postanovleniya Pravitel'stva Rossijskoj Federacii «Ob utverzhdenii pravil proverki sootvetstviya pol'zovatelej gosudarstvennoj informacionnoj sistemy, opredelennoj v sootvetstvii s chast'yu 2 stat'i 13.1 Federal'nogo zakona «O personal'nykh dannykh», trebovaniyam, ukazannym v chasti 7 stat'i 13.1 Federal'nogo zakona «O personal'nykh dannykh», i o vnesenii izmenenij v nekotorye akty Pravitel'stva Rossijskoj Federacii (ID proekta 01/01/02-25/00154667 ot 14. 02. 2025 g.) (In Russ.)

8. Proekt Postanovleniya Pravitel'stva Rossijskoj Federacii «Ob ustanovlenii Pravil vzaimodejstviya federal'nogo organa ispolnitel'noj vlasti, osushchestvlyayushchego funkcii po vyrabotke i realizacii gosudarstvennoj politiki i normativno-pravovomu regulirovaniyu v sfere informacionnykh tekhnologij, s operatorami, obrabatyvayushchimi personal'nye dannye, v celyakh formirovaniya sostavov personal'nykh dannykh, poluchennykh v rezul'tate obezlichivaniya personal'nykh dannykh, sgruppirovannykh po opredelennomu priznaku, pri uslovii, chto posleduyushchaya obrabotka takikh dannykh ne pozvolit opredelit' prinadlezhnost' takikh dannykh konkretnomu sub"ektu personal'nykh dannykh» (ID proekta 01/01/02-25/00154910 ot 21. 02. 2025) (In Russ.)

9. Proekt Postanovleniya Pravitel'stva Rossijskoj Federacii «Ob ustanovlenii trebovanij k obezlichivaniyu personal'nykh dannykh, metodov i pravil obezlichivaniya personal'nykh dannykh» (ID proekta 02/07/04-25/00156232 ot 13. 04. 2025). (In Russ.)

10. Postanovlenie Pravitel'stva Rossijskoj Federacii ot 24. 04. 2025 № 538 «Ob utverzhdenii perechnya sluchaev formirovaniya sostavov personal'nykh dannykh, poluchennykh v rezul'tate obezlichivaniya personal'nykh dannykh, sgruppirovannykh po opredelennomu priznaku, pri uslovii, chto posleduyushchaya obrabotka takikh dannykh ne pozvolit opredelit' prinadlezhnost' takikh dannykh konkretnomu sub’ektu personal'nykh dannykh». (In Russ.)

11. Gusev AV, Zingerman BV, Tyufilin DS, Zinchenko VV. Electronic medical records as a source of real-world clinical data. Real-World Data & Evidence. 2022; 2(2): 8-20. (In Russ.) doi: 10.37489/2782-3784-myrwd-13.

12. Ermakova NA, Gusev AV, Rebrova OYu. Errors in real-world data : a review. Medical doctor and information technology. 2024; 1: 28-43. (In Russ.) doi: 10.25881/18110193_2024_1_28.

13. Andreychenko AE, Kaftanov AN, Gusev AV. Methodology for assessing the quality of electronic medical records data. Medical doctor and information technology. 2024; 4: 48-59. (In Russ.) doi: 10.25881/18110193_2024_4_48.

14. Stolbov AP, Kuznetsov PP. Modern models of the organization of the use of personal health data. Health care Standardization Problems. 2010; 1-2: 19-24. (In Russ.)

15. Stolbov AP. De-identification of Personal data in Health care. Medical doctor and information technology. 2017; 3: 76-91 (In Russ.)

16. Goldina TA, Suvorov NI. Real-World Data Studies: from Data to Health Technology Assessment and Decision-Making in Healthcare. Medical Technologies. Assessment and Choice. 2018; 1(31): 21-29. (In Russ.) doi: 10.17116/medtech20234501150.

17. Motrinchuk ASh, Kasimova AR, Novoderezhkina EA. NICE guidance to working with real-world data. Real-World Data & Evidence. 2022; 2(4): 34-44. (In Russ.) doi: 10.37489/2782-3784-myrwd-25.

18. Radaeva KS, Pchelintsev MV. Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making. Real-World Data & Evidence. 2023; 3(3): 28-35. (In Russ.) doi: 10.37489/2782-3784-myrwd-39.

19. GOST R ISO/HL7. Data Exchange Standards . HL7 Clinical Document Architecture, Release 2 // Available at: https://docs.cntd.ru/document/1200135009. Accessed 10. 05. 2025. (In Russ.)

20. GOST R 55036-2012 (ISO/TS 25237:2008). Health informatics. Pseudonymization. Available at: https://docs.cntd.ru/document/1200100339. Accessed 10. 05. 2025. (In Russ.)

21. GOST ISO / IEC 29100-2021. Information technology. Security techniques. Privacy protection fundamentals. Available at: https://docs.cntd.ru/document/1200180230. Accessed 10. 05. 2025. (In Russ.)

22. Shutov DV, Popov AA, Shulkin IM, Akhmetov RN, Drozdov DV, Morozov SP. Technical tests of the hardware and software complex for electrocardiogram recording and processing. Medical doctor and information technology. 2022; 1: 50-61. (In Russ.)

23. Saksonov EA, Sheredin RV. The procedure of depersonalization of personal data. Mechanical engineering and computer technologies. 2011; 3. (In Russ.)

24. Stolbov AP. On standardization of methods of pseudonymization of personal data in Health care. Standartization problems. 2017; 9-10: 19-24 (In Russ.) doi: 10.26347/1607-2502201709-10025-036.

25. Babak NG, Belorybkin LYu, Otsokov ShA, Terenin AA, Shabrova AI. Automatic depersonalization of confidential information. Russ. Technol. J. 2023; 11(5): 7-18. (In Russ.) doi: 10.32362/2500- 316X-2023-11-5-7-18.

26. ISO/IEC 20889:2018. Privacy enhancing data de-identification terminology and classification of techniques. Available at: https://www.iso.org/standard/69373. Accessed 10. 05. 2025.

27. Prikaz Roskomnadzora ot 05. 09. 2013 № 996 «Ob utverzhdenii trebovanij i metodov po obezlichivaniyu personal'nykh dannykh». (In Russ.)

28. Metodicheskie rekomendacii po primeneniyu prikaza Roskomnadzora № 996 ot 05. 09. 2013. Utverzhdeny 13. 12. 2013. (In Russ.)

29. Proekt prikaza Roskomnadzora «Ob utverzhdenii trebovanij k obezlichivaniyu personal'nykh dannykh i metodov obezlichivaniya personal'nykh dannykh» (ID proekta 02/08/03-25/00155867 ot 27. 03. 2025) (In Russ.)

30. Prikaz Minzdrava Rossii ot 14. 06. 2018 № 341n «Ob utverzhdenii Poryadka obezlichivaniya svedenij o licakh, kotorym okazyvaetsya medicinskaya pomoshch', a takzhe o licakh, v otnoshenii kotorykh provodyatsya medicinskie ehkspertizy, medicinskie osmotry i medicinskie osvidetel'stvovaniya». (In Russ.)

31. Postanovlenie Pravitel'stva Rossijskoj Federacii ot 09. 02. 2022 №140 «O edinoj gosudarstvennoj informacionnoj sisteme v sfere zdravookhraneniya». (In Russ.)

32. Prikaz Minzdrava Rossii ot 20. 03. 2025 № 139n «Ob utverzhdenii Poryadka obezlichivaniya svedenij o licakh, kotorym okazyvaetsya medicinskaya pomoshch', a takzhe o licakh, v otnoshenii kotorykh provodyatsya medicinskie ehkspertizy, medicinskie osmotry i medicinskie osvidetel'stvovaniya». (In Russ.)

33. Borisov SA, Bosov AA, Ivanov DE. Application of Simulated Computer Modeling to the Problem of Depersonalization of Personal Data. Condition Assessment and Key Poins. Programming. 2023; 4: 58-74 (In Russ.) doi: 10.31857/s0132347423040040.

34. Mishchenko EYu, Sokolov AN. Quantitative analysis of the Depersonalization Procedure. Method of Identifiers. Bulletin of the South Ural State University. Ser. Computer Technologies, Automatic Control, Radio Electronics. 2015; 15(3): 18-25. (In Russ.) doi: 10.14529/ctcr150303.

35. GOST R 34.11-2012. Information technology. Cryptographic data security. Hash-function. Available at: https://docs.cntd.ru/document/1200095035. Accessed 10. 05. 2025. (In Russ.)

36. Federal'nyj zakon «O edinom federal'nom informacionnom registre, soderzhashchem svedeniya o naselenii Rossijskoj Federacii» ot 08. 06. 2020 № 168-FZ. (In Russ.)

37. Postanovlenie Pravitel'stva Rossijskoj Federacii ot 09. 10. 2021 № 1723 «Ob utverzhdenii Pravil predostavleniya svedenij, soderzhashchikhsya v edinom federal'nom informacionnom registre, soderzhashchem svedeniya o naselenii Rossijskoj Federacii, v tom chisle perechnya ukazannykh svedenij i srokov ikh predostavleniya, i perechnya obezlichennykh personal'nykh dannykh, soderzhashchikhsya v edinom federal'nom informacionnom registre, soderzhashchem svedeniya o naselenii Rossijskoj Federacii». (In Russ.)

38. Postanovlenie Pravitel'stva Rossijskoj Federacii ot 05. 02. 2022 № 116 «Ob utverzhdenii Pravil vedeniya Federal'nogo reestra medicinskikh dokumentov o rozhdenii». (In Russ.)

39. Prikaz Minzdrava Rossii ot 13. 10. 2021 № 987n «Ob utverzhdenii formy dokumenta o rozhdenii i poryadka ego vydachi». (In Russ.)

40. Martsevich SYu, Kutishenko NP, Lukina YuV, Lukyanov MM, Drapkina OM. Observational studies and registers. Their quality and role in modern evidencebased medicine. Cardiovascular Therapy and Prevention. 2021; 20(2): 2786. (In Russ.) doi: 10.15829/1728-8800-2021-2786.

41. Ivanov AV. Registers as a basis for data collection and evidence building. Real-World Data & Evidence. 2021; 1(1): 10-15. (In Russ.) doi: 10.37489/2782-3784-myrwd-3.

42. Martsevich SYu, Lukina YuV, Kutishenko NP, Tolpygina SN, Lukyanov MM, Drapkina OM. Medical registers. Role in evidence-based medicine. Recommendations for creation. Methodological recommendations. М.: FGBU «NMIC TPM» of the Ministry of Health of Russia. 2023. 44 рр. (In Russ.) doi: 10.15829/ROPNIZ-m1-2023.

43. Edinyj plan po dostizheniyu nacional'nykh celej razvitiya Rossijskoj Federacii do 2030 goda i na perspektivu do 2036 goda. Utverzhden Pravitel'stvom Rossijskoj Federacii 09. 01. 2025. (In Russ.)

44. Gavrilov D, Gusev A, Korsakov I, Novitsky R, Serova L. Feature Extraction Method from Electronic Health Records in Russia, in Proceedings of the FRUCT’26. pp. 497-500. April 2020.

45. Makarova E., Andreichenko А., Kazakova М, Ivanov D, Gusev А. Depersonalisation оf Medical text data with a view to developing and implementing artificial intelligence systems. Legal Informatics. 2024; 3: 96-105. (In Russ.) doi: 10.24682/1994-1404-2024-3-96-105.

46. GOST R ISO 22077-1-2017 Health informatics. Medical waveform format. Part 1. Encoding rules. Available at: https://docs.cntd.ru/document/1200146051. Accessed 10. 05. 2025. (In Russ.)

47. GOST R ISO 22077-91064-2017. Health Informatics. Standard communication protocol. Part 91064. Computer-assisted electrocardiography. Available at: https://docs.cntd.ru/document/1200147099. Accessed 10. 05. 2025. (In Russ.)

48. GOST R ISO/IEC 27038-2016. Information technologies. Security techniques. Specification for digital redaction. Available at: https://docs.cntd.ru/document/1200136904. Accessed 10. 05. 2025. (In Russ.)

49. GOST R 71674-2024. Artificial intelligence in routine clinical practice. DICOM dataset for algorithm testing. Dataset deidentification and monitoring for presence of personal data. Available at: https://docs.cntd.ru/document/1309958855. Accessed 10. 05. 2025. (In Russ.)

50. Borisov SA, Bosov AA, Ivanov DE. Application of Simulated Computer Modeling to the Problem of Depersonalization of Personal Data. Model and Algorithm for decontamination by synthesis. Programming. 2023; 5: 19-34. (In Russ.) doi: 10.31857/s0132347423050023.


Review

For citations:


Stolbov A.P. On the issue of depersonalization and use of real-world data. Medical Doctor and Information Technologies. 2025;(2):32-53. (In Russ.) https://doi.org/10.25881/18110193_2025_2_32

Views: 61


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1811-0193 (Print)
ISSN 2413-5208 (Online)