Validate a digital health product’s compliance across data, clinical safety, evidence, and usability, all under one trusted framework.
Who it’s for: Suppliers and buyers needing a first‑time review, a refresh, or an enhanced standard.
One-off price: £675
The ORCHA Global Baseline (OBR v6) is the world’s most widely adopted and adapted assessment standard for digital health technologies. It provides a structured, objective review of apps and digital tools across three core domains: Data Privacy, Professional/Clinical Assurance, and Usability & Accessibility.
It evaluates whether a product safely manages data (in line with GDPR and ISO 27001), meets clinical safety and regulatory expectations (such as MHRA, FDA, and NICE Evidence Standards Framework), and offers a usable, accessible design following best-practice standards (like WCAG 2.1 and ISO 9241). The review process applies a consistent scoring framework to identify compliance strengths and risks, with continuous monitoring to ensure quality is maintained as products evolve.
OBR (Standard): 1–3 weeks from receipt of complete documentation
Start your ORCHA assessment today and open the door to global market access, compliance confidence, and trusted distribution.