Cure51, a Paris-based biotech company, maintains a clinical and molecular database of exceptional cancer survivors. Its hospital partners required HDS and ISO 27001 compliance before entrusting it with health data. We supported the company from the initial assessment through to certification.
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Cure51 studies the rare patients who survive the most aggressive forms of cancer to pave the way for new therapies. Its work is based on clinical and molecular data provided by hospitals, including the AP-HP, and oncology centers.
These partners were looking for a strong guarantee: HDS certification, based on ISO 27001. For a rapidly growing startup, the challenge was twofold. The company had to meet complex regulatory requirements specific to the healthcare industry without slowing down the team’s momentum.
Cure51 lacked both a clear methodology and the technical expertise to complete this dual certification on its own. On the recommendation of its AWS partner, the team chose Feel Agile.
Together with Cure51, we developed a prioritized action plan and then equipped the team to manage its own management system.
Three days of remote gap analysis on ISO 27001:2022 and HDS v2. The assessment resulted in a prioritized action plan.
Project Launch: WSIS Scope, Roles, and Realistic Timeline. [TO BE CONFIRMED: Date of the kick-off meeting]
Pre-structured HDS documentation, ISO checklists, risk analysis, security policy, business continuity plan, and change management. In parallel, Feel Agile Learning training sessions to help teams adapt to the new environment.
A four-day internal audit, involving about ten employees, from management to technical teams. The nonconformities identified were addressed prior to certification.
A dedicated Feel Agile expert resolved the final critical issues that had been slowing down the process for several weeks.
Let's work together to prepare for your HDS and ISO 27001 certification, from the initial assessment to the audit.