الملخص
Background: Direct-to-consumer (DTC) genetic testing has become widespread globally, raising concerns about genetic privacy and data misuse. In Saudi Arabia, legal frameworks such as the Personal Data Protection Law (PDPL) are evolving, and the scope of compliance among commercial genetic testing entities is unclear. This study retrospectively examines the uptake of DTC genetic services in major tertiary hospitals and explores legislative, policy, and ethical gaps that could compromise genetic privacy.
Methods: We conducted a retrospective observational study across four large tertiary hospitals in Saudi Arabia from 2018 to 2023. Data were obtained from institutional electronic health records and anonymized customer inquiry logs from commercial DTC services referenced by patients. We analyzed rates of DTC test usage, types of tests ordered, associated counseling, and privacy measures. Logistic regression was used to identify factors predicting privacy breaches or patient-reported concerns, controlling for demographics, test type, and provider setting.
Results: Of 3,542 patients who reported or documented DTC genetic testing, 762 (21.5%) expressed specific privacy concerns. The manuscript reports 48 confirmed breaches (1.4%) and model associations with incomplete consent forms, absence of counseling, and third-party data-sharing clauses; whether the modeled outcome was a breach, complaint, or combined endpoint requires verification. Most identified gaps involved unclear company policies, absent local regulations for non-medical genetic tests, and limited legal recourse in cases of misuse.
Conclusion: The records describe selected testing encounters and reported privacy events. Complaints and confirmed unauthorized disclosures are distinct outcomes. Comparisons across years require stable source coverage and a defined denominator.
الكلمات المفتاحية
- direct-to-consumer genetic testing
- genetic privacy
- Personal Data Protection Law
- informed consent
- genetic counseling
- Saudi Arabia
إقرارات
- الموافقة الأخلاقية
- NA
- الموافقة على المشاركة
- NA
- الموافقة على النشر
- NA
- التمويل
- NA
- تضارب المصالح
- NA
- مساهمات المؤلفين
- NA
- توافر البيانات
- NA
- التسجيل
- NA
- الشكر والتقدير
- NA
التعليقات
التعليق يتطلب حساباً وتسجيل الدخول.