Frequently Asked Questions

Why is the Mylvas solution Unique ?

Mylvas is a Ground breaking Medical Aggregator and a Service Facilitator Platform.

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It truly empowers the individual (patient) to manage and control his Personal Medical Record (PMR) throughout the entire world, without being constrained by languages or medical IT systems.

With mylvas the individual person has his PMR on-line, can share it for e.g. second opinion requests or provide (via a QR code) access to his records in case of an emergency. And in that case, the care handling team will get all information and records in their own language. Mylvas has incorporated a professional medical translator engine.

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For Healthcare professionals and Medical Centers, mylvas is the ideal tool for collaboration within and without the organization, delivering additional services, do load-balancing and ultimately raise the operational efficiency of the organization.

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Mylvas brings any type of medical images and documents of one patient into one silo . Any format, any size. All this in one application. Radiology studies, Pathology Studies, Dental radiology studies, Intra-oral scans, 2D photos, 3D applications, Artificial Intelligence applications, and so on.

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No need to switch from one application to another. All these studies can be viewed, annotated, uploaded, downloaded, shared etc. The solution is 100% Vendor Neutral. Everything is stored into a secure cloud environment. From the same platform all these studies can be shared between any healthcare professional. Telemedicine, expert opinions, second opinions. Electronic requests can be send to hospitals or private centers, imaging labs and AI providers. Education programs for teaching purposes is also part of the silo. Mylvas core competence are the tailor-made workflows on demand to do so:

Request for expertise: Professional <——> Professional
Request for a second opinion: Patients <——> Professional
Request for medical imaging exam: Professional <——> Imaging Centre/Hospital
Service request: Professional <——> 3D- lab/AI provider
First or Second reading: Imaging Centre/ Hospital <——> Professional
Teaching files: Professional (mentor) <——> Professional ( postdoc student )

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The users are informed via, mail/sms every time there is an new case or question coming in. An intuitive inbox guides them through the different workflows.

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And Mylvas has ……. an accounting and billing program. This is probably unique.

You can compare it with your smartphone. Before you needed a phone to make phone calls, a photo program to look at your images, a PC for your mail etc . Nobody questions anymore the value of that smartphone. Is Mylvas unique? According our customers without any doubt. A recent analysis of the CEO of company of the University of Leuven in Belgium confirmed this.

Quote: “It looks, to my great surprise there isn’t a general service like your offer”

Who are the users ?

Mylvas addresses both individual persons as any healthcare professional.

Since mylvas saves any exam report, any imaging file and covers all type of images, any healthcare professional can benefit from the solution. This opens a complete new market where the demand is great but also unexplored.

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Individual persons may carry their Personal Medical Record anywhere in the world with them and can share content with anybody wherever they are and in several languages. A true peace of mind !.

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Healthcare Professionals and / or Medical Centers.

From General Practitioner to Medical Experts, – All Medical Doctors or paramedics such as :

General Practitioners
Surgeons
Orthopedics
Neurosurgeons
Cardiologists
Pneumologists
Rheumatologists
Dermatologists
Ophthalmologists
Pathologists
Nuclear Medicine
Oncologists
Radiologists
Physiotherapists
Home care nurses
etc…
Hospitals or healthcare organizations who need to link up with external healthcare professionals, third party solutions, remote sites etc…
International Scientific Organisations use Mylvas for educational purposes.
Patients who want to exchange medical images for a second opinion

Around the Globe, from central hospitals to rural practices, from university to small healthcare centers, from private to public sector, from individual to big practices.

Why should an individual person use Mylvas ?

Despite some local initiatives for creating Individual Electronic Medical Records, most – not to say all of them – are incomplete and restricted to the network of the issuer. Files, records and images from outside the network are not present and are not added. in those systems, the individual person has no control. Forwarding, sharing is impossible, certainly outside the network of the issuer, for example: when traveling abroad!

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Imagine that something happens to you abroad, or you just want to have a medical checkup. A missing Personal Medical Record may lead to missed diagnosis, mismatch patients with his/her records, unnecessary (and often expensive) exams and even … disabilities.

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Mylvas addresses all those issues.

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With Mylvas, the individual person is fully empowered to control and manage his Personal Medical Record. The individual has full access to his cloud based files, images, exams and reports and can share and forward parts of it. In an emergency case, - e.g. a car accident- simply scanning a QR code gives the treating medical team a time-limited access to your entire personal records for fast and decisive evaluation of the situation. And this in their own language!. It avoids unnecessary and expensive exams and leads to a faster and more effective treatment.

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Moreover, mylvas allows individuals to ask for a second opinion regarding a medical issue. Therefore, parts of the records, accompanied with your request can be sent through mylvas to any specialist worldwide. In this case, mylvas facilitates the process and the financial compensation of the second opinion provider.

‍Is the Mylvas solution worldwide available ?

YES, Mylvas is an online platform where all the tools are accessible on the cloud,

You have internet ? Then you have Mylvas access.

Currently the basic platform is available in 4 languages – French English – Dutch – German – other languages are under review based on our clients needs.

However, a professional medical translator engine is embedded, allowing translating any report or exam into a huge amount of languages...

Is Mylvas a teleradiology company ?

No!. Mylvas does not address the teleradiology market as such. But it can and is also used by radiologist because the Mylvas approach is different to the traditional teleradiology companies.

Traditional teleradiology companies typically handle DICOM studies only. Most of the time the complete history of the patient is missing. A study conducted by the European society of radiology highlighted the disadvantages and threats of teleradiology.
This study was published in Insight Imaging, 2013,“European Teleradiology now and in the future: results of an online survey”; E. R. Ranschaert and F. H. Barneveld Binkhuysen

*The main disadvantage of outsourcing by teleradiology is the insufficient integration of patient history and/or previous studies (69 %), while limited communication with clinicians seems to be the second greatest drawback (68 %).
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Mylvas allows radiologists having access to the full imaging history of the patient, not limited to DICOM studies and also the relevant medical information. On top one of the core assets of Mylvas is the seamless communication with clinicians and other healthcare professionals. The clinicians are also granted access to the full imaging files and results of their patients.

*The main threats and dangers perceived due to teleradiology outsourcing, as summarized are: the fear of losing control over the business (61 %), the fear of reducing the quality of reports (54 %), creation of instability in the job market and in radiologists’ income (49 %). Forty-eight percent perceive teleradiology outsourcing as a threat to providing good patient care.

This problems is also acknowledged by the Mylvas solution. Therefore, Mylvas does not employs radiologists. Moreover it leaves control of the users over their business and don’t interfere with the job market and in radiologist income. Also, quality control of the reports and quality of care of the patients are guaranteed by the experts.

Mylvas only provides the tools to organize teleradiology services.

Why are there almost no general solutions for pathology images ?

The market of digital pathology technology is growing. It is on the verge of becoming a mainstream option for routine diagnostics. Faster whole slide image scanning has paved the way for this development, but implementation on a large scale is challenging on technical, logistical, and financial levels. *Initially, only single screenshots of histological images captured through a microscope’s optics were digitized mostly for detailed evaluation in research settings for documentation and teaching. Technical advances in scanning speed and decreased costs have made whole slide imaging (WSI) the standard for future, large-scale, high-throughput DP.Journal of Clinical medicine, 2020; Digital Pathology: Advantages, Limitations and Emerging Perspectives Stephan W. Jahn,1,* Markus Plass,1 and Farid Moinfar1,2

The high resolution images require new systems of storage due to large file sizes. *One challenge for adopting the technology is the lack of a universally accepted file format for virtual slides. There are several manufacturers in the field and each has not only its own approach to these issues, but also its own image analysis software. Virtual microscope systems are widely used and are trusted to provide high quality solutions for teleconsultation, education, quality control, archiving, veterinary medicine, research and other fields.Biotechnic & Histochemistry, 2015; Applications and challenges of digital pathology and whole slide imaging; C Higgins 1

Mylvas implemented and build a resilient and secure infrastructure to hold such large, sensitive data pools. Whole Slide Imaging (WSI) is the Mylvas standard. But, any other formats and single slices can also be integrated. Mylvas tackled the problems of the different commercial systems, each with their propriety format. One of the disadvantages of such propriety systems is that “non client” users stay deprived of having access to the imaging files.

Mylvas brings all the different files and formats in one single application. Every Mylvas user can handle any format.

The intuitive collaboration tool handles many of the logistical problems and the pricing of the Mylvas solution is competitive and very affordable.

Why should dental professionals use Mylvas ?

There are many different dental professionals active in dental care. As there is the general dentist, the oral surgeon, the orthodontist, the endodontist, the periodontist, the dental and maxillofacial radiologist and so on. They have one thing in common, the need for dental images. But also, here we see more and more different image formats. Such as Cone Beam CT, Panoramix, RX dental images, Intraoral scans and standard pictures (often via smartphone).

Again Mylvas brings this into one Silo per patient and allows sharing among the different players.

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One of the challenges for dental practitioners is high investment for the different radiology modalities (CBCT, Panoramix etc.) Not every practice can afford to have all imaging facilities. Therefore there is the need to collaborate and to refer patients to other practices or hospitals just for the imaging procedure. Using the Mylvas communication tool makes this easy for both parties and guarantee the patient returns to the dental practitioner who requested the examination. Thanks to the STL 3D models, made by the intraoral scans the imaging file can be transferred to 3D labs who return digital treatment plans ore 3D printed implants ore other devices, as for orthodontics.

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Such as the fact, that there are different manufacturers in the field and each has not only its own approach to these issues, but also its own image analysis software. As patients move around sometimes those propriety formats can not be viewed by everyone. Another recurring problem is that typically patient treatment can take several years. Local archives are in many cases not fit for such a long storage or the images needs to be send over each time again.

Mylvas guarantees long time archiving. Being vendor neutral there are no issues with propriety software and every professional, having access rights to the specific patient can always view all the images, regardless location or time.

How does Mylvas differs from a traditional PACS ?

Dedicated PACS systems exist since several years, some standards have been established to enable interconnectivity (DICOMWeb, HL7, … ) In all cases a heavy IT organization need to be in place.

Also, traditional PACS systems do not allow other image formats other as DICOM. Mylvas offer in its solution as well a DICOM viewer as a Pathology viewer and a STL viewer.

Internal communicating between specialists, if possible, is often restricted due to high training needs, high licensing costs, and heavy development times.

As soon as these traditional systems need to communicate with the external world the costs, time and expertise result in a total “no go”.

Mylvas is exactly meant to bridge systems or professionals with plugin facilities to existing systems.

‍How does Mylvas differs from a Web Based PACS ?

To answer to the traditional systems most of the Imaging managements (PACS) vendors have developed web function, from just adding a web connector to a full web PACS.

However the system architecture of these system and logical functions are exactly the same as traditional PACS. Providing communication, workflows accounting function would require a complete redesign of theses system.

Mylvas has been designed as a web platform , a communication tool around a dedicated workflow. PACS and images management is only one part of our system

‍Where are the Mylvas servers located ?

All IT components are hosted with a hosting service provider OVH with specific HDS (Health Delivery System) contract. this contract is compliant with the following certifications with no submission to the Cloud Act and not subject to US law:

ISO/CEI 27001
GDPR/RGPD
SOC I-II type 2
Anti-DDoS protection
HTTPS Domain access

The current hosting is in Lille France but OVH offer the same HDS/ GDPR compliance hosting in

London (ERI), United Kingdom
Frankfurt (FRA), Germany
Warsaw (WAW), Poland

Having no personal data stored outside the hosting services , the HDS certification guaranty to our platform GDPR/RGDP compliance. We have implemented on the platform all the requirements regarding:

Registration
Login
e-mail
Logs
File Storage
Administration access

Healthcare data hosting compliance in Europe and HDS compliance in France

‍Is Mylvas compliant with local privacy regulations ?

Discussing the criticality of protecting sensitive patient information, many people often throw around three terms: confidentiality, security and privacy. While many people use these terms interchangeably, they actually refer to separate but related concepts. Privacy protects the rights of an individual to control the information that the institution collects, maintains and shares with others. Privacy requirements typically arise in two forms. First, many institutions adopt privacy policies based on their own principles. Second, a variety of laws and regulations impose privacy requirements. As there is GDPR in Europe, HIPAA in the US, Data protection Act in the UK etc. As a first step Mylvas checks with the individual institution or healthcare professional if they have some specific requirements beyond the local legal regulatory regulations. If this is the case, Mylvas makes sure these expectations can be met. Regarding the Mylvas clients in the European Union, Mylvas is GDPR compliant. Mylvas has an external DPO, his own responsible data controller, a declaration of confidentiality. Mylvas has a solution to perform Privacy Impact Assessment and keeps a register of processing activities. Etc. To comply with the legal regulations of other countries, Mylvas checks with his business partner what needs to be done in order to meet those regulations.

Is the Mylvas solution secure ?

Confidentiality is one of the foundational concepts of cybersecurity.

However, confidentiality is only one of three core concepts that together make up the foundation of cybersecurity work. The remaining two principles are integrity and availability.

Integrity protects information from unauthorized modification. Access controls are the major mechanism used to enforce integrity requirements. Availability ensures that information is available for use by authorized individuals at the time they need it.

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There are serveral ways to access the mylvas platform. Either by desktop, IPad or via an App on an Android or Apple phone.

It must be stressed that Mylvas is not a "Life-Style App". In case a mobile phone or an IPad is being used to access, the local browser or app serves only as a window to the back-end platform that is centrally hosted. In NO circumstances, data is saved or stored locally on the phone or the IPad.

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In case data are shared, either via the mylvas platform or via e-mail, we never send data over the e-mail. Only links are sent. Data, exams, reports or image files never leave the mylvas servers.

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Mylvas has all the folowing mechanisms in place to assure a maximum security:

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Registration: We control the identity of each actor registering into the system. Each healthcare professional has a specific ID number provided by the relevant organisation MOH or region depending the country.
Login: A double verification procedure and single login process is implemented depending of the country/actor configuration.
Email after registration or if changed in the profile the new email and/or telephone is validated via a link with hash code valid only one time
User password is encrypted with the email address using the CRYPT_BLOWFISH algorithm to create the HASH before been stored on the server, therefore the plain user password is unknown and IT administrators cannot login as the user.
Password changed is validated via an emailed link with hash code valid only one time.Second level verification is made via a 6 digit code sent on the user telephone used during the registration procedure.
e-mail: Each actor has a standard email gmail, hotmail, or any other domain specific email. this email address is used for administrative communication between Mylvas and the user. No personal related data are sent to these emails. Each country can have different encrypted email based on local regulation, and we are working on a general encrypted email ( like ProtonMail )
When an encrypted email is defined for a given country, if the actor provides the corresponding email address all patient personal data email will be send to this address.
If no encrypted email is given the only way to access personal patient data is by login into the platform.
Logs: Some tables of the database keep track of creation, modification and validation date_time. but for auditing purpose an independent log table is used keep track of the following information for each user: User Id, Date, Time, Action.
No personal patient data is stored into the logs only action type and ID reference to database rows.
Files & Storage: Text files uploaded on the server can only be PDF format they are converted into Binary file and store inside the database the temporary file is deleted. this process is reverted when a file is requested by the user.
Therefore the database access and login process controls all file access as well. the online text editor stores the saved files in JSON format into the database, then when the file is validated a PDF file is generated.
DICOM files can be uploaded via web workers directly from the web platform interface. then a new DICOMDIR file is generated and the DICOM Server rest API is used to « dcmsend » the study to the PACS. The temporary DICOM files if any are then deleted. The user can download DICOM on a per study basis via the web platform interface that will generate a server to server call to make a zip file of the study and send it as a blob to the client.. no temporary DICOM or Zipped study file is stored on the server
Duration of storage is configured by> country and by actors in number of month after termination of the task
Administrator Access: No third party administrative access is granted , only Mylvas staff can have admin privilege. There is two level of administrative access:
Level 1: In principal level 1 access is to monitor the system and its usage by the healthcare actors providing them support and data correction of data directly into the database upon their request.This level does not allow the IT administrator to access patient personal data
Level 2: Anytime an IT administrator needs to access personal medical data of a patient for maintenance, debugging, or any other reason. The Data protection Officer of the company need to be notified of the reason and need to accept it, then all the process is registered into a proper data access log fil.

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How does Mylvas handle confidentiality ?

Confidentiality is ensuring only authorized person has access to confidential data. Registration process is not automatic, Mylvas is checking Medical professional ID with the relevant national authorities , in certain countries it is online in others offline but in all cases a medical professional is granted access only when his license is verified.

Patient data are the responsibility of the Medical doctor in charge of a Diagnostic or the individual patient. Nobody else can access them unless he gives access to some parts of the data files to another professional in the system. In all cases, that is with the consent of the individual patient.

For study purposes DICOM exam can be or are systematically anonymized before been uploaded into the platform.

Can Mylvas upload huge size studies ?

Yes, there is theoretically no limit of the size. Mylvas is handling transfers and uploads in 4 different ways

Direct file upload

If the file is smaller than 20Mb of size the upload goes directly. This usually is the case for 2D images or small 3D-STL files For bigger studies or files, especially Pathology ( up to 3Gb and more) the upload process does truncate the file and use webWorkers to proceed the upload. Next, on the server the file is reconstructed and processed.

DICOM studies Uploads

Any types of DICOM study from any DICOM compliant modality can be transferred to the server, it can be series with multiple instances files or series with one file containing all instances. We only accept raw Dicom files, not compressed, to avoid any loss in image quality.

Automatic WebDav transfer

WebDav is the standard file transfer protocol (used by Dropbox, or Google Drive for example) it can be configured on any local PC to link directly to a professional inbox or even a patient image folder. Using WebDav can make transfer of pictures from a mobile phone or from a digital intra oral scan automatic.

Direct Modality to DICOMWeb

Mylvas handle its internal DicomWeb server to receive any type of Dicom study directly from a modality using DicomSend and store procedure configured with the correct AE Tittle

Where are the Mylvas servers located ?

All IT components are hosted with a hosting service provider OVH with specific HDS (Health Delivery System) contract. This contract is compliant with the following certifications with no submission to the Cloud Act and not subject to US law:

ISO/CEI 27001
GDPR/RGPD
SOC I-II type 2
Anti-DDoS protection
HTTPS Domain access

The current hosting is in Lille France but OVH offer the same HDS/ GDPR compliance hosting in

London (ERI), United Kingdom
Frankfurt (FRA), Germany
Warsaw (WAW), Poland

Having no personal data stored outside the hosting services , the HDS certification guaranty to our platform GDPR/RGDP compliance. We have implemented on the platform all the requirements regarding:

Registration
Login
e-mail
Logs
File Storage
Administration access

Does Mylvas allows an installation on local servers ?

YES, the full Mylvas platform can be installed on a local server either and can even be split into several server ( application server / dabs server )

This is done especially to comply with local regulations requiring that all medical data should be kept in the country of the patient.

Our central database will keep the license and encryption keys of each user.

In order to enable the collaborative work with peers around the world information about professional is made globally available, but all medical and individual patient data are keep local.

‍How is anonymization of patient data being done ?

DICOM studies contain a header with patient and somemedical information. We are using this information to automatically create the patient's profile. There are two possibilities for achieving anonymization:

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Option 1: Create a dummy patient first and upload a study to a DICOM folder. After the upload, the server will modify all headers of the instances and generate new DICOM UIDs and patient data to match the details of the dummy patient.
Option 2: Upload a study as a Pathology case. A unique case number is generated, along with dummy patient data (Name, Date of Birth, ID, etc.). These details are then updated across all the DICOM instances.

This anonymization process applies only to DICOM studies, as patient data is not present in other types of images.

How does Mylvas integrates with third party solutions ?

Mylvas is an open platform using standard protocols and tools. There are 3 ways to integrate Mylvas into and existing IT environment

Using native functionalities.The standard WebDav protocol, available in Mylvas can be used and configured on any local machine or server to automatically upload data files into a given patient folder making integration with third party tools smooth and easy.
Connection from an existing PACS or ModalityUsing the standard DicomWeb protocol any PACS or modality can be configured to send data directly to the Mylvas platform
Service Plugin: The open architecture enable us to install any plugin to receive specific data using a preprocessor robot to incorporate them into the platform, for example:
AI connector to pre-process DICOM study to tag specific lesion or pathology
HL7 connector to create patient records
Specific Viewer used by a professional group
Online Cloud based PACS to retrieve data

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What is the Mylvas business model ?

Mylvas is a SAAS based service, subscription based.

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Every year, individual persons or healthcare professionals or medical centers are charged for an automtaic renewable subscription.
that subscription may of course be terminated. The general terems and conditions are referred.

How are Healthcare professionals being selected ?

Every healthcare professional can register but the registration process is not automatically,
Mylvas is checking the medical professional ID with the relevant national authorities , in certain countries it is online in others offline.

But in all cases a medical professional is granted access only when his license is verified.

‍How does Mylvas handles additional services ?

On top of the regular subscription fee, mylvas offers the flexibility to charge for additional services such as but not limited to:

Modality ( specially for radiologists )
First opinion
Expert opinion between peers
Second Opinion ( request from a patient )

In some cases, mylvas may add an handling fee. Mylvas invoices the requesting party taking into account all local tax and duties.

‍Do receive Mylvas professional subscribers a billing overview?

Each Mylvas professional subscriber will receive at the end of month a statement with credit / debit column based on his activity. Paid requests made and paid request received.

Eventually, Mylvas will pay to the bank account of the professional the positive balance before the 5th day of the following month.

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