The BioArte Group places great importance on the privacy of personal data. All personal data and information will be kept confidential. You can find more detailed information in connection with the data controller, the data needed to be processed, the purposes and legitimate grounds, and the information regarding the retentions of the samples, the guarantees implemented for international transfers, and the existence of an internal policy by reaching out to our Data Protection Officer through the following email address [email protected] or with postal mail to the address The BioArte, Life Science Park, Triq San Giljan, San Gwann, SGN 3000.
Purpose
The purpose of processing personal data is to;
- fulfil the obligations of the services hired by you, including the collection and processing by your clinician and The BioArte of your “Personal (Health) Data” (meaning in particular and in each case insofar as provided: personal details including name and address, age/date of birth, gender, ethnicity, nationality, symptoms, and other medical information, disease, the study material/sample with identifiable genetic data, and the genetic analysis results and findings) as far as required to conduct the genetic analysis including any necessary transfers of your Personal (Health) Data between clinician and The BioArte;
- to review and maintain the quality of services provided (internal Audits and quality control);
- to be used for educational purposes, scientific publications, and presentations in an anonymous format; the results of this research might benefit the future health of the participant;
- to inform your clinician about the results of the analysis;
- to answer any queries or suggestions you may have during the process and to oversee the accurate implementation and resolution of the test, which may involve retaining personal data for an indefinite period, unless local laws of jurisdiction state otherwise;
- to reach out to you for your feedback on the services provided, carry out promotional communications (such as “cross-selling” and “up-selling”) of affiliated companies related to healthcare and scientific research undertakings, and invite you for participation in market research, targeted research initiatives, and the creation of novel products.
Research Purposes
I acknowledge that my Personal (Health) Data and the remaining sample could contribute to further research, development, and enhancement of diagnostic techniques and potential therapeutic remedies. This could ultimately lead to the provision of medical advice and guidance for me and my family members. I consent to The BioArte’s storage once anonymized, (1) of my Personal (Health) Data and analytical results; 2) of both original and processed samples and that it will be kept by The BioArte for a period of 30 years. The company will use this data, along with the remaining samples that have been pseudonymized, for scientific research (both internal and external) as well as commercial research in the field of human-related microbiome and human genetics. The aim of this research is to aid in the diagnosis and treatment of medical and genetic diseases and to gain a better understanding of the role microbiome and genetics, play in an individual’s overall health and susceptibility to diseases, as well as their potential response to treatments. Consent can be revoked at any time as explained below.
Public and private healthcare institutions, and bio-medical companies worldwide, can be granted access to the client’s pseudonymized data for research purposes, with the relevant guarantees adopted to ensure the legitimacy of the data transfer (especially if the recipient is in a non-EEA country).
Please visit https://www.thebioarte.com or contact [email protected] for updated information on the research projects in which your pseudonymised data may be used.
Retention period
Any genetic data of a personal nature (not anonymised) will be kept for a minimum of ten years from the date of sampling, after which time you can ask for them to be deleted/destroyed.
Data protection rights
In accordance with the provisions of the General Data Protection Regulation (EU) 2016/679, The BioArte requires to have an informed consent to carry out the requested tests as well as for data processing. You have the right, under the General Data Protection Regulation (GDPR) and national legislation that implements and further specifies the relevant provisions of said regulation, to access, rectify, oppose, suppress, and where applicable ask for the data concerning you to be erased. This can be achieved by contacting [email protected] and providing the documentation demonstrating your identity. The samples and associated data will be stored and saved in the laboratory, following The BioArte’s sample retention policy with data saved in a password-protected encrypted format that meets legal requirements. You understand that if data in The BioArte databases are anonymized, they cannot be destroyed upon request as it is unidentifiable and untraceable.
Data protection claims can be submitted to the competent data protection authority.
The BioArte reserves the right to carry out all or part of the analyses included in the test through certified third-party laboratories, and any results obtained this way will be inspected by The BioArte (in such cases, the relevant guarantees will be adopted to ensure data protection standards are equivalent to European standards).
Having READ and UNDERSTOOD the information above, I confirm that;
- I have been explained, read, and understood the indication, purpose, characteristics, scope, procedure, success rate, risks, complications, limitations, and economic cost of this test, and have had the opportunity to ask questions and any questions that I had were answered fully and to my satisfaction. I have also been given information on the implications of the test results, any possible follow-up, and where applicable, any further tests that might be required. I am aware that clinical and technical staff will be at my disposal for any questions or additional counselling that I may require once the results of the test are known.
- I understand that the results of this test are not a substitute for a medical diagnosis performed in a clinical setting provided by a healthcare professional. I accept that The BioArte does not take responsibility for the use, by me or my clinician, of the results obtained and any consequences of such use.
- I confirm that the information I have given, both personal and medical, is accurate and truthful. I acknowledge that the clinical team may reach out to me for additional clinical information, which may include details required for research purposes.
- In view of the complexity of the tests, results should be assessed alongside other clinical information by healthcare professionals. Consequently, I agree that the test report may be forwarded to the requesting clinician so that I can be offered the most appropriate advice.
- I am not receiving any compensation as the participant nor will I be owed any funds, at this moment or in the future, due to any invention(s) resulting from research and development using my specimen(s).
- I understand that the results of this study may be used for medical or scientific purposes and that they may be reported or published; however, I shall not be personally identified in any way, either individually or collectively.
- I have been informed that this informed consent can be withdrawn at any time.
- I agree to the extraction of my biological sample, as well as to the shipping of the sample to The BioArte facilities to perform the testing and analysis.
