FAQs about privacy, OncoAct WGS and the Hartwig Medical Database
1. What is OncoAct WGS and what is the Hartwig Medical Database?
OncoAct WGS
OncoAct WGS is a complete DNA test for patients with cancer that was developed by Hartwig Medical Foundation (Hartwig). OncoAct WGS involves carrying out a Whole Genome Sequencing (WGS) test and generating an OncoAct WGS report with the test results. WGS maps a patient’s entire DNA profile. It enables the identification of specific characteristics and changes in the tumor DNA (genetic data) that may play a role in the development of cancer.
Hartwig Medical Database
This is a database established by Hartwig. The database currently contains the genetic profiles and specific clinical data of some 6,000 patients with metastatic cancer. Hartwig provides access to the Hartwig Medical Database for scientific research into cancer.
2. What patient data does Hartwig Medical Foundation (Hartwig) receive from the hospital?
OncoAct WGS
Hartwig asks the hospital to provide a hospital patient number and, if available, a pathology number. The hospital patient number is the number under which a patient is registered at the hospital. The hospital’s pathology department assigns a pathology number to a specific patient sample. In addition, Hartwig will ask the hospital to provide information about the type of tumor (if known) and the location of the biopsy. Hartwig requires this information to carry out OncoAct WGS.
If the patient is a participant in the GENAYA project, Hartwig will additionally request their name, initials, gender, date of birth and zip code of the patient.
This information is referred to as the registration data. Currently, the hospital provides these registration data on a form and sends it (digitally) to Hartwig.
Hartwig is working on an online registration portal for hospitals to provide the registration data to Hartwig online. Once this portal goes live, we will ask for all patient data (name, initials, gender, date of birth and zip code) to be submitted through this portal. This new process is more consistent with standard hospital practice and less prone to error.
Hartwig Medical Database
If a patient agrees to participate in the Hartwig Medical Database, Hartwig will include the results of their complete DNA test (WGS) in the database. This is the patient’s genetic profile as referred to in FAQ 1. These data are supplemented with patient clinical data. Hartwig is requesting these clinical data directly from the hospital because it is already known to the hospital. It is also possible to retrieve this clinical data from other databases or registries, such as PALGA and the NKR. The data can be retrieved by establishing linkage between the databases.
Database link
Hartwig prefers to establish linkage with other sources of patient data so that it can collect and combine even more relevant patient information. The more information available, the more valuable it will be for scientific research and for future patients as part of a learning healthcare system.
To establish the link with the external databases, Hartwig will ask the hospital to provide specific patient identifiers (name, initials, gender, date of birth and zip code). The linkage between data sources will be established by using pseudonyms in order to ensure patient privacy.
3. What patient material does Hartwig receive from the hospital?
The hospital will send Hartwig a tube of blood and a sample of tumor tissue (biopsy).
4. What data does Hartwig generate with OncoAct WGS?
To perform OncoAct WGS, Hartwig extracts DNA from a patient’s blood and from the tumor. The DNA in a tumor contains errors compared to the normal DNA (in the blood). By comparing these two versions of the DNA using Hartwig’s special software, we can identify relevant differences. A patient report is then drawn up which details all the findings. The patient report also suggests which treatments and medication may potentially be effective (or in fact unlikely to help) based on the DNA characteristics.
5. What is done with the data in the Hartwig Medical Database?
The Hartwig Medical Database contains genetic and clinical data (the ‘patient data’) of patients with metastatic cancer. Hartwig provides access to the data in the database for scientific research. This means the information can be used by as many scientists as possible for research to increase our knowledge of cancer. This knowledge will ultimately contribute to improving the care and treatment of future patients with cancer.
In addition, Hartwig can use the data in the database for quality analyses and for its own research, for example to develop and improve molecular diagnostic tests.
6. What is the legal basis under which Hartwig processes personal data as part of OncoAct WGS?
The legal basis for processing health and genetic data in OncoAct WGS is provided for in Article 6(1)(b) of the GDPR; processing is necessary for the performance of a treatment contract between the patient and the hospital/physician. Hartwig itself is not a party to this treatment contract, nor is this required.
Hartwig processes the health and genetic data of patients. The GDPR classifies such data as ‘sensitive personal data’. Hartwig must have grounds for an exception to process sensitive personal data.
Health data
The exception to the prohibition to process health data is provided for in Article 9(2)(h) of the GDPR, in conjunction with Article 30(3)(a) of the General Data Protection Regulation Implementation Act (GDPRIA). Personal data needs to be processed to enable the proper treatment of a patient by a healthcare institution. Hartwig, in its capacity and role as contributor to this proper treatment, can be considered a ‘healthcare institution’ as meant in Article 30(3)(a) of the General Data Protection Regulation Implementation Act.
Genetic data
The exception to the prohibition to process genetic data is provided for in Article 9(2)(g) of the GDPR, in conjunction with Article 28(1) of the GDPRIA. The processing of genetic data is permitted because the OncoAct WGS test concerns the same patient from whom the data in question was obtained.
7. What is the legal basis under which Hartwig can store patient data in the Hartwig Medical Database and make it available to others?
Hartwig only stores data in the Hartwig Medical Database and makes this data available to researchers with the consent of the patient. The patient can sign the consent form that accompanies the information letter they receive immediately after their treating physician suggests a WGS test. Because Hartwig itself does not have direct contact with the patients, this process is done by the hospital/treating physician. The hospital will inform Hartwig whether or not the patient has given their consent.
8. Where is patient data stored in the Hartwig Medical Database?
This data is stored on the Google Cloud Platform. The physical servers where the data is stored are in the EU (in the Netherlands, with a backup in Finland).
9. How is the information secured?
Please see the Q&A on information security for more information about the security measures.
10. How long does Hartwig retain patient data?
OncoAct WGS
If a patient does not consent to their patient data being stored in the Hartwig Medical Database, their data will be deleted after three months. In this case, Hartwig will only retain the registration data and patient report for a period of 20 years, unless other agreements are made with a hospital regarding the retention period.
Hartwig Medical Database
If a patient consents to participate in the Hartwig Medical Database, it is Hartwig’s policy to retain that data indefinitely. Hartwig regularly evaluates whether the retention of patient data still serves the purpose for which the patient gave their consent. Hartwig may determine in the future that the database is no longer needed, or for other reasons no longer serves its purpose. It will then be decided whether retention of the patient data is still justified.
Just one WGS test is enough to reveal everything you need to know to provide a patient with metastatic cancer with targeted treatment, be it a registered therapy or part of a research trial.