Stone Web Viewer, Open source projects in the clinical environment

General
1

Hello dear Orthanc community,

I would like to ask you a few questions in the context of my master thesis. The questions are intended to cover a broad area and should be answered from your point of view (please do not reference sources!). So if you do not have an answer to some questions, just answer them partially or leave them out. Partial answers will still help me and multiple answers are very welcome!

  1. The Stone Web Viewer has no approval (FDA/CE etc.). Is it not wanted or are there other reasons behind it (e.g. technical requirements, time, money, etc.)?

  2. What would have to be done to solve the problems described, or what measures and solutions would be needed to maintain regulatory approvals without jeopardizing data and patient safety (e.g internatonial standards, automated Testing etc.)?

  3. More generally, what do you think needs to be done to ensure or even improve security (of the system and the patients) while facilitating the access of open source projects to the market or to clinical environments in the medical field?

  4. What are the technical details (key components) of the Stone Web Viewer and which technologies are used (e.g. WebAssembly)? In particular, which advantages do these technologies have compared to other methods?

  5. What are your wishes for the further development of the Stone Web Viewer? (e.g. additional tools, AI to support diagnosis, etc.).

  6. Is there an up-to-date and understandable documentation? Do you receive active and helpful support? What makes it stand out?

I look forward to your answers and wish you a sunny weekend!
Best regards
Patryk

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Dear Patryk,

Sorry for the delay. Here are some explanations:

1- The now-unmaintained Osimis Web viewer was certified as a CE MDD Class-1 medical device by the Osimis company between roughly 2017 and 2019. The certified version of the viewer (referred to as “Osimis Web viewer PRO”) could be bought by hospitals, and shared almost all its source code with the free and open-source version of the viewer. FDA certification was never sought, mainly because the company was Belgium-based.

The certified version was abandoned by Osimis because it was not generating enough revenue to cover the huge cost of the CE certification (there was a clear lack of interest from hospitals). Because of this experience, there is currently no plan to certify the Stone Web viewer by ourselves.

2- The main difficulties are to find a market fit to generate enough revenue, to raise money to pay professional consultants and certification bodies (especially with the new, significantly more complex MDR regulation that would classify such viewers as Class-2 medical devices), and to comply with a “waterfall” model of software development. In our case, the latter aspect would consist in “freezing” a selected version of the Stone Web viewer (which is developed in an agile way, just like most free and open-source software), then to run certification on this frozen version (which requires dedicated human resources, documentation writers, dedicated traceability software, project managers,…). This is not just a matter of money, but also a matter of processes.

3- From my personal point of view, we mainly need legal experts in the domain of medical regulation who want to embrace and support free and open-source software (beyond the specific case of the Stone Web viewer). Just like some lawyers joined Richard Stallman to bootstrap the GPL license in the 80’s. This is the first step before convincing business owners to create companies that would sell certified version of free and open-source software for healthcare.

Also note that CE and FDA certifications are not necessary, strictly speaking, to allow the use of specific software inside European and US-based hospitals. Indeed, from my understanding, hospitals and physicians may decide to use any software, provided they assume any risks associated with its use. Certification is above all a way of shifting responsibility for a medical problem onto a company (provided the intended uses covered by the certification were respected by the hospital/physician). For this reason, CE/FDA certification is also a powerful marketing message to attract client hospitals/physicians (even outside of Europe and USA), as it highlights the “serious” character of the company.

4 and 5- This is discussed in the reference paper about the Stone Web viewer.

6- Check out the Orthanc Book.

DISCLAIMER: I am not an expert in medical regulation in any way, so please treat this post with extreme caution.

Kind Regards,
SĂ©bastien-

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