Controlling my genome with my smartphone: first clinical experiences of the PROMISE system.
Big data democratization
Data security
Digital health
Genetic data transfer
Privacy
Whole-genome sequencing
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
09
06
2021
accepted:
13
09
2021
pubmed:
26
10
2021
medline:
3
6
2022
entrez:
25
10
2021
Statut:
ppublish
Résumé
The development of Precision Medicine strategies requires high-dimensional phenotypic and genomic data, both of which are highly privacy-sensitive data types. Conventional data management systems lack the capabilities to sufficiently handle the expected large quantities of such sensitive data in a secure manner. PROMISE is a genetic data management concept that implements a highly secure platform for data exchange while preserving patient interests, privacy, and autonomy. The concept of PROMISE to democratize genetic data was developed by an interdisciplinary team. It integrates a sophisticated cryptographic concept that allows only the patient to grant selective access to defined parts of his genetic information with single DNA base-pair resolution cryptography. The PROMISE system was developed for research purposes to evaluate the concept in a pilot study with nineteen cardiomyopathy patients undergoing genotyping, questionnaires, and longitudinal follow-up. The safety of genetic data was very important to 79%, and patients generally regarded the data as highly sensitive. More than half the patients reported that their attitude towards the handling of genetic data has changed after using the PROMISE app for 4 months (median). The patients reported higher confidence in data security and willingness to share their data with commercial third parties, including pharmaceutical companies (increase from 5 to 32%). PROMISE democratizes genomic data by a transparent, secure, and patient-centric approach. This clinical pilot study evaluating a genetic data infrastructure is unique and shows that patient's acceptance of data sharing can be increased by patient-centric decision-making.
Sections du résumé
BACKGROUND
BACKGROUND
The development of Precision Medicine strategies requires high-dimensional phenotypic and genomic data, both of which are highly privacy-sensitive data types. Conventional data management systems lack the capabilities to sufficiently handle the expected large quantities of such sensitive data in a secure manner. PROMISE is a genetic data management concept that implements a highly secure platform for data exchange while preserving patient interests, privacy, and autonomy.
METHODS
METHODS
The concept of PROMISE to democratize genetic data was developed by an interdisciplinary team. It integrates a sophisticated cryptographic concept that allows only the patient to grant selective access to defined parts of his genetic information with single DNA base-pair resolution cryptography. The PROMISE system was developed for research purposes to evaluate the concept in a pilot study with nineteen cardiomyopathy patients undergoing genotyping, questionnaires, and longitudinal follow-up.
RESULTS
RESULTS
The safety of genetic data was very important to 79%, and patients generally regarded the data as highly sensitive. More than half the patients reported that their attitude towards the handling of genetic data has changed after using the PROMISE app for 4 months (median). The patients reported higher confidence in data security and willingness to share their data with commercial third parties, including pharmaceutical companies (increase from 5 to 32%).
CONCLUSION
CONCLUSIONS
PROMISE democratizes genomic data by a transparent, secure, and patient-centric approach. This clinical pilot study evaluating a genetic data infrastructure is unique and shows that patient's acceptance of data sharing can be increased by patient-centric decision-making.
Identifiants
pubmed: 34694434
doi: 10.1007/s00392-021-01942-8
pii: 10.1007/s00392-021-01942-8
pmc: PMC9151530
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
638-650Subventions
Organisme : Bundesministerium für Bildung und Forschung
ID : 16KIS0364
Informations de copyright
© 2021. The Author(s).
Références
Nat Rev Genet. 2011 Sep 27;12(11):745-55
pubmed: 21946919
Am J Phys Anthropol. 2015 May;157(1):58-70
pubmed: 25582401
J Psychosom Res. 2002 Feb;52(2):69-77
pubmed: 11832252
J Law Biosci. 2014 Dec 20;2(1):56-68
pubmed: 27774180
PLoS One. 2014 May 08;9(5):e96886
pubmed: 24809478
Methods Mol Biol. 2015;1296:119-36
pubmed: 25791596
Public Underst Sci. 2020 Oct;29(7):702-717
pubmed: 32664786
Eur J Hum Genet. 2013 Jun;21(6):580-4
pubmed: 23676617
Appl Transl Genom. 2014 Sep 28;3(4):100-4
pubmed: 27294022
Stud Health Technol Inform. 2020 Jun 16;270:1061-1065
pubmed: 32570544
Lancet. 2010 May 15;375(9727):1749-51
pubmed: 20434765
J Am Coll Cardiol. 2019 Dec 10;74(23):2921-2938
pubmed: 31806137
J Community Genet. 2017 Jul;8(3):173-181
pubmed: 28382417
Herz. 2018 Mar;43(2):123-130
pubmed: 29260236
Nat Rev Cardiol. 2021 Sep;18(9):649-665
pubmed: 33953382
PLoS Genet. 2014 Mar 20;10(3):e1004224
pubmed: 24651127
J Eval Clin Pract. 2012 Jun;18(3):560-6
pubmed: 21210901
Nat Rev Genet. 2008 May;9(5):406-11
pubmed: 18379574
PLoS Genet. 2014 Sep 25;10(9):e1004572
pubmed: 25254375
Blood. 2017 Jul 27;130(4):453-459
pubmed: 28600341
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S467-72
pubmed: 22588767
Genes (Basel). 2014 Aug 29;5(3):739-47
pubmed: 25178093
Eur J Hum Genet. 2014 Aug;22(8):964-8
pubmed: 24281371
Nat Genet. 2021 Jan;53(1):2-8
pubmed: 33414545
NPJ Genom Med. 2016 Jan 13;1:
pubmed: 28567303
Public Health Genomics. 2011;14(1):17-25
pubmed: 20339285
Br Med Bull. 2017 Sep 1;123(1):35-45
pubmed: 28910995
Expert Rev Anticancer Ther. 2012 Oct;12(10):1289-97
pubmed: 23176617
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S383-412
pubmed: 22588759
Am J Hum Genet. 2012 Mar 9;90(3):502-10
pubmed: 22365152
Science. 2011 Feb 11;331(6018):728-9
pubmed: 21311016
Nat Rev Genet. 2009 May;10(5):331-5
pubmed: 19308065
J Genet Genomics. 2021 Jul 20;48(7):540-551
pubmed: 34023295
Genome Med. 2016 Jun 23;8(1):71
pubmed: 27338147
PLoS Genet. 2009 Oct;5(10):e1000665
pubmed: 19798440
Value Health. 2013 Jun;16(4):564-73
pubmed: 23796290
Front Pharmacol. 2015 Mar 26;6:61
pubmed: 25859217
Genet Res Int. 2015;2015:364960
pubmed: 25883807
Clin Genet. 2020 Mar;97(3):483-491
pubmed: 31833061
PLoS One. 2017 May 9;12(5):e0177158
pubmed: 28486511
Trends Biotechnol. 2017 Jun;35(6):486-489
pubmed: 28363406
Nature. 2009 Oct 8;461(7265):747-53
pubmed: 19812666
Nat Rev Genet. 2010 Jun;11(6):415-25
pubmed: 20479773