faq.name

The Docviser platform is not a medical device at this moment because it is not intended to be used for the purpose of diagnosing, preventing, monitoring, forecasting, treating or ameliorating oncological conditions, in the sense provided by art. 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 regarding medical devices. Its purpose is to store and archive information, more precisely diagnoses and treatment schemes entered by users in the application, for medical statistics purposes. The application does not establish a diagnosis, does not indicate or recommend the application of a certain treatment scheme, does not monitor or forecast the evolution of the disease.

The way in which it is analyzed whether a software is a medical device or not has been established at the level of the European Commission and in this framework it has been established that a software that acts on data only to store, archive or to enable their search or communication does not fall under the regulations regarding medical devices. This graphic representation indicates the main steps that must be taken to identify whether a certain software falls within the notion of a medical device or not. It is important to note that Docviser has obtained the ISO 13485 certification, demonstrating compliance with international quality management standards specific to the medical device industry. This certification reinforces our commitment to ensuring the highest level of quality, safety, and reliability in our processes and services.

As technology and regulations evolve, Docviser may become an accredited medical device, for example, by integrating with other medical devices such as a dissolution robot or the AI Machine Learning that we currently have under development. Therefore, Docviser will be able to offer patients a wider range of services and will be able to comply with all the necessary legislative standards to be recognized as a medical device.

Docviser respects the basic principles imposed by the GDPR regarding the protection of personal data and implements appropriate security measures to ensure their protection. These measures include:

• The collection and processing of users' personal data only for the purpose of providing medical services and in accordance with the provisions of the GDPR.
• Providing clear and transparent information to users regarding the personal data collected, the purposes for which it is collected and how it is used.
• The adoption of internal policies and procedures to ensure the security of personal data and the implementation of appropriate and organizational measures to prevent unauthorized or abusive access to them.
• Restricting access to personal data only to authorized personnel and training employees on the protection of personal data.
• Limiting the disclosure of users' personal data to third parties, except in cases where this is necessary for the provision of medical services provided by law.
• Providing information on the use of cookies and other similar information to collect information about them in accordance with the provisions of the GDPR.
• Docviser is GDPR and HIPAA compliant.

To learn more about the data processing and privacy policy within the Docviser platform, you can access the Docviser Privacy Policy

Personal data collected from users is used exclusively for the purpose of providing medical services and in accordance with the provisions of the GDPR. This data may be processed and stored in order to improve our services, in accordance with the provisions of the GDPR. Docviser does not disclose users' personal data to third parties, except in cases where this is necessary for the provision of medical services or required by law.

Patient data is stored in a secure cloud database within Amazon Web Services (AWS) at region eu-central-1, located in Frankfurt, Germany. AWS provides top security measures and uses encryption to protect data from unauthorized access. It is important to note that, according to EU law, personal data must be stored within the European Union. In addition, Docviser complies with all security and privacy regulations and is continuously tested using test protocols such as end-to-end testing (E2E), penetration testing, and others. These tests help maintain security and quality in terms of functionality and data privacy. Docviser is also subject to automated testing at every major release to ensure that patient data is safe.

For more information, you can consult the legal document, which confirms that the only legally binding cloud regulation is for data to be stored within the European Union.

No, Docviser is no longer in Beta and has been in production for over a year. Before the official launch, the platform was tested for three months as a pilot (Beta stage) program in Zalău County Hospital, to ensure that it is functional and can be used in real conditions. Following successful testing, the platform was officially launched and is successfully used in more than 30 hospitals in Romania, including private, municipal, county hospitals and important medical institutions. This platform is in continuous development, being updated and improved regularly to respond to medical requirements and adapt to the new needs of patients and the health system in general.