Online Proctoring – ClinFlows Blog

In many clinical projects like clinical trials or second opinion workflows, medical images in DICOM format are exchanged between different parties. For this reason, and in order to erase burned-in annotations, software installation is needed. The new and innovative Smart Uploader from Clinflows changes this now.

Exchanging medical images in DICOM format is the daily business of many people involved in for example developments of new medical devices, new medications and clinical trials, as well as clinical training and education respectively. However, exchanging those images often comes with obstacles: DICOM images that are typically very large in size need to be pseudonymized and burned-in annotations to be erased. Thus, usually, the installation of at least one software is necessary.

No local software installation needed and de-identifications tools embedded

We are proud to say that after months of intense development, the Clinflows-development team has managed to solve these challenges in a web application. Now, on our platform decidemedical, users can not only enjoy a tool which enables them to exchange medical data by just using a browser and not needing to install any software that would require administrator rights to do so – this is an enormous advantage, especially in hospitals, where staff is often working from different PCs as they are moving between operating rooms, cath labs or offices – they can also preview and select or de-select DICOM files to be sent at a time. By using our web-based software, users can simply open the web-browser, log in and send DICOM images on the go.

Preview and selection of DICOM series assures user control with just one tool

When using the Smart Uploader of decidemedical, a DICOM preview is created, displaying the standard DICOM structure with the item’s patient, study, series and images.

This is a great advantage, as it allows the user to de-select images which shall not be sent, be it unnecessary series or images to reduce the upload volume, and more importantly with regard to data protection the user can de-select patient protocols or other dicomized files containing private health information (PHI) which shall not be transferred. Hence, instead of first checking the content of the DICOM images on a separate local viewer, the user can now just preview series and images in the Smart Uploader during the data selection step of the upload process.

This will not only save time by potentially reducing the data volume, but it provides full control to the responsible uploader – the data controller according to GDPR – about which data are sent and follows the basic data protection rule of minimizing the shared data volume.

Transferring medical images and clinical data always means the user is dealing with sensitive patient data and this must be done with caution and in a responsible manner. This starts with the selection of what to be sent and making sure to be entitled to do so, with the consent from the patient.

Web-based erasure of burned-in annotations in DICOM images

When dealing with medical images in DICOM format one needs to understand that there are two different areas where private information from the patient can be stored. On the one hand, medical images contain so-called DICOM headers or tags. These are clearly defined headers with text or numeric information containing all sorts of data, like the time when the exam was taken, the name of the manufacturer of the diagnostic machine, the image modality, like CT, X-Ray, MRI etc. as well as information about the patient. For example, the DICOM tag (0010:0010) is reserved for the patient’s name. In decidemedical, sensitive DICOM tags are individually defined per project and then automatically removed or de-identified depending on the needs of a project.

But there is another layer which can contain patient information. These are the so-called “burned-in annotations“, which is part of the pixel information itself. Often one can find them especially in echocardiographies where the patient’s name or the name of the hospital is visible on the upper part of the echo image. These burned-in annotations can only be removed if an erasure tool is available, allowing to manually draw black boxes over the information to be hidden. Often, we had study coordinators asking us for advice on how to erase burned-in annotations as they do not have software available.

And yes, we can give advice now! We are proud that our development team has managed to offer a solution that we have not seen being offered by any other web-based service provider, in a web based, so-called zero footprint solution! In our new Smart Uploader, the user can draw a box easily, place it over the annotation and apply it to the entire DICOM series. This is very comfortable and time-saving!

Really smart tool for really comfortable processes

Yes, we know, we are doing a little bit of self-praise here, but we are very proud that our development team has come up with something really smart as our Smart Uploader.

To sum up, here’s what’s in it for you when using our new Smart Uploader:

Full control of what is uploaded by allowing a proper preview and easy DICOM data selection.
DICOM headers are automatically de-identified per project definition.
Even burned-in annotations can be erased in the browser based Smart Uploader.
No software installation needed.

That’s really unmatched. And we hope you can feel it, too: We really love what we do.

About the author:

Uwe Gladbach is a biomedical engineer, who started his career as a perfusionist in open heart surgery back in the 90ties. In more than 25 years he gained experience in the medical device industry in various positions, covering clinical research, as well as sales and operations in global positions. Uwe is the CEO and founder of ClinFlows.

How a leading global device company successfully uses digital review processes to launch a new TMVI system

In our first blog post, Uwe Gladbach, a biomedical engineer and Head of ClinFlows, gives us an introduction to how digital review processes can help companies from the medical sector in the area of structural heart disease. Specifically, how this can be used to launch new treatments and medical devices cross-locationally and saving time while meeting GDPR requirements. In this article, he discusses the challenges that stakeholders face when launching a new transcatheter mitral valve implantation (TMVI) system in cross-locational settings. He explains how these complex processes can be realized by using customized web-based solutions. He gives a practical step-by-step example on a digital review process and stimulates some thoughts on data privacy aspects.

How to leverage the precious medical expertise gained during clinical studies

When developing breakthrough treatment modalities for the clinical market, conducting clinical studies and trials represents an essential aspect of the process. During the different study phases, increasing numbers of patients are enrolled, and the number of participating sites increases. But still, the expertise, handling a new device by implanting physicians, is only carefully built and remains limited to the participating physicians. Furthermore, it typically starts with more straightforward cases before more anatomically or clinically complex cases are approached. Hospitals that have not participated in the early clinical trials have to build their expertise once the product is launched to the market and need to become trained to be able to handle a new device correctly and treat patients successfully. Especially in TMVI, it is crucial to select the right patients, as well as selecting the correct size for the implanted valve. Medical companies undertake enormous efforts during the product launch to support physicians to build up their skills regarding patient selection, the treatment procedure, and the handling of new devices. One of the challenges they face during these processes is that they need to continuously communicate with physicians and hospitals across the globe as well as to review patient data and DICOM images to give advice.

Extensive experience of clinical specialists and proctors plays a vital role in the success of a product launch

Now you may ask yourself, why is it so important for experts of medical companies to review all the data and images and give advice to hospitals and physicians when launching new treatments or products? Well, the answer is simple; because of their extensive and precious expertise and knowledge that is indispensable for a successful product launch, for the training of everyone involved, and, in the end, for the successful treatment of the patient.

Let me give you an example:

During last year’s PCR congress in Paris, I was talking to a clinical imaging analyst from one of the major clinical device companies who is very valued by his colleagues. During his professional career, he has been present during uncountable procedures and has contributed to a great number of successful launches and introductions of new treatments like TAVI or recent TMVR interventions. Now, on a daily basis, he reviews and measures TAVI/TMVR cases from countries all over the world and gives advice to physicians and hospitals. When being asked how many cases he had already reviewed so far, he replied: “Probably more than 10,000.” This extensive experience definitely makes him an expert in this field and enables him to give advice that many stakeholders, and patients can benefit from. We are proud that he is a seasoned user of our decidemedical platform.

From CD/DVD courier shipments to safe and efficient online processes

About ten years ago, I had a discussion with a Clinical Director from the TAVI industry, who had the task of building and organizing an infrastructure to manage the review of about 3,000 TAVI cases on an annual basis in Europe. With his team, he started reviewing CDs/DVDs of Echocardiographs, Angios, and CT images that he had received via courier shipments – you remember those plastic bag envelopes? Documenting the receipt and status of review in Excel sheets – you can imagine how time-consuming that was.

I remember thinking that there needs to be an easier way to exchange clinical data and medical images, so that sites receive a reply from medical experts more quickly and safely. So we came up with ClinFlows and started to provide our online service allowing sites to upload their medical DICOM images, (which can sometimes be volumes of several gigabytes) online via our platform decidemedical. Since then, the digital workflow and platform capabilities have evolved as browser technology has continuously progressed, offering new features and programming possibilities.

Today, our solutions enable all stakeholders of clinical projects and studies to easily exchange pseudonymized clinical data, evaluate and review them, and to communicate with each other. Thus, they can finally benefit from remote expertise and launch new products and treatment options much quicker and easier than they used to in the past.

In practice: Step-by-step-example of a digital review process of the product launch of a new TMVI system

But how does this work? Let’s make this more practical.

In a project for a global leading medical device company that recently started to launch a new transcatheter mitral valve implantation (TMVI) system, we realized a customized workflow on our platform DecideMedical, which is used by hospitals in 87 countries worldwide. The task was to set up a workflow that allows review of several thousand cases per year while being in line with GDPR. As well as involving the industry partner with its administrative team, the Field Clinical Specialist (FCS), external medical proctors (physicians) and the sites uploading their clinical cases. Now, the working process is as follows:

Site creates an account. The administrative team sends an access code to the site, allowing the heart team at the hospital to create an account on decidemedical and to create and submit cases to the project.
Enter the clinical data. The site enters clinical data and uploads echocardiographs in DICOM format and submits the case to the expert team (FCS) of the medical device company. DICOM headers are automatically de-identified during upload. The experts are automatically notified by email when a new case is submitted.
Review the data. The FCS responsible reviews the data (preview or download) and informs the site if the case is or is not eligible for TMVI and asks the site to continue with providing CT imaging. When the site adds the multiphase CT imaging, the expert is notified and downloads the CTs from DecideMedical and runs an analysis on a specialized image analyzing software, like 3Mensio (Esaote).
Get the expertise of a medical proctor. Optionally, the FCS can push the case to one of their medical proctors to receive his or her opinion assisting in the review process. The proctor is notified automatically by DecideMedical when a case is available for review, and the proctor can respond to the FCS within DecideMedical.
Receive a final judgement. Based on the review outcome, the FCS sends the final reply and judgment about the patient’s eligibility for the treatment back to the site, which is notified about the availability of the review by email.

Thanks to web-solutions the patient is ready for treatment within hours

This review process can be carried out – depending on the party’s availability – in just hours. Hence, the patient can probably be treated the same or next day. The hospital can now proceed with the intervention, considering the opinion of the reviewer. Of course, at all times, the treating physician remains responsible.

Embedded discussion tools enhance the communication between the parties and store all case information centrally and safely.

We are convinced the time is over for sending CDs via couriers or having field force personnel from the industry picking up CDs at the hospital by car. We know it still happens… it’s like picking up paper letters by hand instead of using email. Obviously, this is very inefficient and not regulatory-compliant at all.

Watch out and protect patient privacy in line with GDPR

Talking of which, since May 2018, the General Data Protection Regulation (GDPR) has been in force, especially protecting the privacy of EU patients.

GDPR is worth a separate article and will be covered on this blog in more detail in the near future. However, I would like to give you some food for thought about dealing with patient data.

Are you aware of the fact that you are not allowed to forward patient data to anyone if the patient has not provided and signed their informed consent? And do you know which information the consent form must contain?
Do you know the difference between the “anonymization” and “pseudonymization” of data and the consequences with regard to GDPR?
Do you know about DICOM headers and its difference to burned in annotations on DICOM data?
Do you know in which country your patient data is stored and that the USA is a third-party country with regard to data storage according to GDPR, leading to certain requirements?

Yes, we know, these regulatory questions can be quite confusing and demanding, but please be cautious about them. Physicians, medical experts, as well as the different stakeholders of the medical device industry dealing with sensitive health data, must understand their role and be aware of their legal responsibilities and consequences.

Exchanging sensitive data within seconds can be done – while meeting GDPR requirements

We love the field of new treatment options with its tremendous drive for innovation, with wonderful, passionate people and a mature clinical study culture. And we work ambitiously to make the development of new, innovative, and helpful treatments as easy and fast as possible.

That’s why our online tools allow us to configure the required and individual workflows needed for the various clinical projects and to work in compliance with the GDPR. ClinFlows, as a data processor, provides the certified IT infrastructure, is ISO 9001 certified, and has been successfully audited by numerous companies.

We are excited and grateful that due to these reasons, our services are used all over the globe and connect the clinical community for the patient’s benefit.

And to conclude this article, I would like to promise you one thing. We will keep on doing what we love the most. That is supporting the launch of new treatment modalities and breakthrough technologies, by making the workflow of clinical studies and proctoring projects in multiple market segments, easier, faster, and regulatory-compliant.

About the author:

Uwe Gladbach is a biomedical engineer, who started his career as a perfusionist in open-heart surgery back in the 90s. Over more than 25 years, he gained experience in the medical device industry in various positions, covering clinical research as well as sales and operations in global positions. Uwe is the CEO and founder of ClinFlows.