The Israeli Ministry of Health (the “MOH”) has published on February 12, 2025, Directive No. 176/01, titled “Remote Access for Source Data Verification in Clinical Trials” (the “Directive”), which sets forth the conditions under which remote access to medical records may be granted for the purpose of source data verification (SDV) and source data review (SDR). The Directive reflects the MOH’s evolving approach to balancing the need for clinical data integrity with the requirements of data security, patient confidentiality, and compliance with Good Clinical Practice (GCP) standards. The Directive will enter into effect on June 1, 2025.
Key Highlights of the Directive:
Conditional Remote Access: Remote access to medical records for SDV/SDR purposes is permitted only for authorized personnel (e.g., sponsors of clinical trials, CRO representatives, regulatory auditors) and must comply with data minimization principles, ensuring access is limited to relevant clinical trial participants.
Regulatory Oversight & Security Controls: The Directive requires medical institutions to implement cybersecurity measures aligned with ISO 27001 and ISO 27799 standards, alongside other measures, such as multi-factor authentication (MFA), and time-limited access. Each healthcare institution has the discretion to adopt or decline remote access protocols.
Data Confidentiality & Compliance: The Directive does not intend to change existing law regarding the scope and types of information permitted to be accessed during authentication, monitoring, and supervision, but solely addresses the issue of remote access. Accordingly, remote SDV must align with the Patient Rights Law-1996, the Privacy Protection Regulations-2017, and additional local regulations and MOH’s guidelines governing health information security.
The MOH has invited stakeholders to review the Directive and implement internal policies accordingly to ensure compliance with these new requirements.
The content in this communication is provided for informational purposes only and is not intended to be comprehensive. It does not serve to replace professional legal advice required on a case by case basis.
