In the struggle against Covid-19, medical data constitutes an essential tool in finding new treatments, developing vaccines, mitigating the spread of the virus, and assisting policy makers to make knowledgeable public-health decisions. Accordingly, in May 2020 the Ministry of Health established a Covid-19 National Repository ("the repository"). The repository includes de-identified medical data on Covid-19 patients collected by hospitals and HMOS in Israel. The repository enables researchers to obtain access to Covid-19 medical data under privacy and security controls and with Ministry of Health supervision.
The Data Available in the Repository
The material available in the repository will include data collected from the Ministry of Health, hospitals, HMOs, population health questionnaires, and other public databases.
According to the Ministry of Health's announcement in May 2020, the following hospitals and HMOs are participating in the repository: Sheba, Sha'arei Zedek, Hadassa, Ichilov, Rambam, Assaf Harofe, Maccabi, Meuhedet, and Le'umit. Others are expected to follow.
Privacy Policy and Information Security
Research will be conducted according to Israeli law (mainly, the Privacy Protection Law and the Public Health (medical experiments involving human beings) Regulations) and according to the Ministry of Health directives.
Data will be accessed via a cloud-based virtual research room, in compliance with information security and privacy protection standards. Researchers' access to the repository requires the specific approval of the Ministry of Health and research will be conducted under its supervision
In addition, data may be exported solely in aggregated and de-identified form, and after undergoing a security and de-identification procedure by the Ministry of Health.
Although the data will be de-identified, Covid-19 confirmed patients can request that their information be removed (opt-out option).
Preliminary Requirements for Accessing the Repository
Researchers can apply to receive access through a portal (under construction), and hospitals and HMOs that contributed to the repository will be prioritized. For now, access to the research room is free of charge.
Researchers are required to have approval by either an institutional Helsinki Committee (i.e., an institutional review board's approval) or to show that they filed an application to the Ministry of Health's Helsinki Committee (this committee is currently being assembled). Research for policy making purposes can be exempted from the Helsinki Committee approval requirement.
Furthermore, researchers are required to receive the approval of the Ministry of Health's Health Data Committee and to sign an MOU, confidentiality declaration and remote access agreement.
Summary
The covid-19 repository can serve as an important tool to advance medical knowledge. Utilizing the repository for medical research requires following the relevant legal standards, including privacy and security safeguards and medical research regulations.
The information in this update is based on the Ministry of Health notice in Hebrew, which can be found here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
