News, ISO Certifications

It's official- Chino.io the only DBaaS provider with ISO13485

Trento, Italy. 11th December

We at Chino.io are proud to announce that we have become the first medical DB as a Service provider to receive ISO 13485 certification.

ISO 13485:2016 is a standard for medical device manufacturers that is a requirement in many markets globally (including the EU, Canada, Australia and soon the US). The standard allows a company to demonstrate that they have a rigorous quality management system in place. It goes beyond the usual ISO 9001 standard, which applies across all business sectors.

ISO 13485 provides a route for medical device and application developers to meet the high requirements for a QMS suitable for health applications. It incorporates Medical Device Directives, regulations, responsibilities and shows their commitment to the safety and quality of medical devices.

Chino.io offers clients a secure cloud-based database specifically designed for medical data storage. Our service makes it easy to store data securely, compliantly and efficiently using our simple APIs. By becoming certified, we significantly reduce the compliance burden on clients when they use our service. Without certification, clients need to audit the quality management processes of their suppliers and create a document demonstrating that they are compliant. However, as we are certified, they are able to avoid this, saving time and making it easier to get their products to market.

What is Chino.io?####

Our Mission is to help digital health innovators to solve legal barriers. Chino has been founded in 2015 by Jovan Stevovic (CEO) and Stefano Tranquillini (CTO), two friends and Ph.D. colleagues at the University of Trento. Jovan has been doing working in health IT industry and researching on privacy and medical record sharing issues, while Stefano has built different multi-tier web and mobile health applications.

The idea of Chino originates from their past experience. Initially (from 2011) Chino was a research project and stand for Cloud Health Interoperability Platform. Now the shift has moved to security and services for application developers, but the vision remained the same: building a digital health platform that removes obstacles and enables developers to innovate in a complex environment like healthcare.

Why is our service important?

In the market right now there are 165.000 applications. Yet, a study on 1211 apps shows that 85% of them are not compliant, for various factors. Another study shows that 66% do not even use a secure transmission channel. This means that your data is collected, but not encrypted, over the internet and any person with a basic knowledge of IT can access them. This trend puts at a serious risk the sensitive data of people, but also the business of all the applications that are not compliant with GDPR (EU) and HIPPA (US).

The full compliant system can take more than a year of work and requires skills that span different professional figures just for setting up the system, then the system has to be maintained, adapted, updated and fixed. Its cost is of over six figures. For application developers identifying relevant laws, extracting rules and obligations, and implementing required solutions within their applications could be extremely challenging, expensive and risky in case of errors.

The integration of Chino.io takes less than two weeks for both developed or new systems and can be used with or without an existing backend. Chino.io ensures the highest level of data security such us encryption at a record level, granular access control logs, immutable audit logs, right to be forgotten, and all requirements defined by EU and US data protection laws for healthcare.

Chino.io clients:

From startups, hospitals and medical device development companies distributing their products in EU and US. Including Italian Telecom, British Telecom (BT), Neocogita.

Projects we participate in:

Our team contributes to developing cybersecurity by participating in HII - Trusted data with service ecosystem and C3ISP - Collaborative and Confidential Information Sharing and Analysis for Cyber Protection.

Chino.io awards:

EIT Digital Challenge: 1st Prize Winner at EIT Digital Idea Challenge 2014 on Privacy, Security & Trust.
eHealth EU SME Competition: Among 8 best eHealth SMEs in EU at the eHealth Week Competition 2015 organized by EU Commission
SME Instrument Beneficiary: Among 5% of the EU SME companies that have been awarded on for innovation on Cyber Security topic.

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About Ruta Naujokaite

Strategic thinker developing innovative strategies for the Digital Health sector.
  • Berlin, Germany