MyCleft Personal Data Protection Notice

Background to Malaysian Cleft Database (MyCleft)

• The development of MyCleft has been approved by UiTM ethics committee for the express purpose of contributing to improve patient treatments and outcomes.
• The collection, use, disclosure, and access to data are all conducted in accordance with legal, ethical and national best practice guidelines.
• The MyCleft website provides the contact details in the event of questions, concerns, and complaints about the MyCleft.
• The MyCleft is not permitted to identify patients by law and that, to maintain absolute security and confidentiality, anyone wanting to use any of the data from the Database will be required to obtain approval.
• All personal information is kept strictly confidential: all data will be anonymised and aggregated in any presentations or publications and no patients or hospitals will be identified by name in reports.
• The Data Security Policy explains the security related to the collection, storage, and accessibility of the information in the Database.
• Anonymity and pseudonymity is impracticable for the MyCleft as identification of individuals is required in order to:
  • Make the necessary changes to patients’ records e.g. opting-out from the registry; editing erroneous data.
  • Due to the nature of cleft, cohort follow up of the patients is required
    • However anonymity is preserved in the way that the data are used e.g. reports, and presentations.
    • Patients can opt-out their personal data at any time.
• The MyCleft collects personal information which is directly related to its functions and activities.
• The MyCleft user can enter only required information on the Mycleft web tool.
• The MyCleft data are summarised to provide information that can inform clinical practice and policy in cleft care. All data reported are deidentified and aggregated.
• The MyCleft user is guided by the MyCleft Data Access Policy which outlines how data may be used and supplied.
• Any persons wishing to undertake research using MyCleft data need to submit a proposal, as well as having appropriate ethical clearances. Data are only supplied to researchers, in approved studies, in a non-identifiable format.
• Identifiable data are only used for data linkage or data quality checking processes by authorised staff/entities according to appropriate approvals for data linkage and the MyCleft Quality Assurance and Data Management Processes Policy.
• All MyCleft personnel sign a Confidentiality Agreement.
• All MyCleft users sign a User Agreement which outlines the user policy.
• The Mycleft server and backups are maintained in Malaysia.No data are held offshore.
• The Mycleft Quality Assurance and Data Management Processes outlines the data verification processes employed by the MyCleft.
• The MyCleft conducts regular reviews of data completeness and discrepancies for
• determining case ascertainment.
Data quality checks are also built into the MyCleft
• Web application to ensure the quality of the data submitted.
• The MyCleft Data Security Policy provides guidelines for all security-related aspects for the registry.
• MyCleft data are collected via a web tool that requires password access.
• The servers are maintained in a secured data centre with state-of-the-art facilities.
• Personal information are encrypted.
• Data are backed up on a daily, weekly and monthly basis. Business continuity plan is in place in the event the web application is down.
• The Database Forms provides details on the information entered into the database.
• To ensure that any missing or discrepant data are corrected, the MyCleft conducts regular data cleaning activities in consultation with the hospital staff.
• A systematic data quality audit process is also in place.
• All inaccurate information is amended by the MyCleft office when it is notified or becomes aware that particular information is incorrect.
• An audit trail of web tool edits is maintained within the database.
• Registrants can amend their personal details in MyProfile.
• Softcopy data since beginning will be retained permanently.