Tag: clinical studies

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DICOM GDPR

DICOM explained Part 2: GDPR, Security and Personal Information – The Challenges with DICOM Data

In part 1 of our DICOM explained-series, you already learned that imaging plays an important role in modern medicine and that the focus is on files in DICOM format. You got to know what is behind the abbreviation DICOM, how it is used in healthcare, how a DICOM file is structured and that the DICOM headers and tags contain a lot of personal data. In part 2 of our DICOM series, we will go into detail about the latter and explain what problems the data contained can cause when working with DICOMs in practice.

Of course, it has many advantages that DICOM images contain a lot of technical and personal data (you don’t remember exactly which ones? Then go back and take a look into part 1 of our DICOM explained-series here). However, this is also problematic at the same time: If DICOMs are sent unencrypted by mail on a CD, for example – as it is still regularly done today, e.g., as part of a study or to obtain a second opinion – they can be directly assigned to the patient; and this is, of course, not in compliance with data protection laws. Who would want their neighbor to find out unintentionally that they suffer from a certain illness? Especially since the General Data Protection Regulation (GDPR) came into force in May 2018, there are many discussions and unknowns that lead to uncertainty among clinicians and healthcare workers who work with medical images. There are many aspects to consider, but here we will focus on personal identifiable data in DICOM images and its technical aspects.

DICOM data: Anonymization vs. pseudonymization

In this context, there are two terms that are often misused when talking about privacy protection of medical images. “anonymization” and “pseudonymization.” Anonymization means that there is no way to retrieve or identify the patient if you only have the medical images. Often physicians or study nurses use this term when informing the patient that “all data will be completely anonymized,” for example, in the context of clinical trials or eligibility testing by outside medical experts. However, the recipient of the images, a core lab or central reader, in most cases needs to know the date of the exam and from which location the images were sent, as these identifiers are an essential parameter of the clinical trial or project. Often, the purpose of a clinical project is to obtain a second opinion on a treatment recommendation, meaning it is imperative to match the right patient to the right images and verify the outcome. In these cases, the data is absolutely not anonymous. 

Is that a problem? No. But first, you would have to obtain written consent from a well-informed patient, and second, you would have to make sure that the data processor provides a technical and organizational GDPR-compliant environment. And if data must be shared for such a purpose, one should pseudonymize the data sets as much as possible. Pseudonymization means that identifying information (name, date of birth, etc.) is removed or replaced, reducing the possibility of tracing it back to the patient.

Where can I find personal information in DICOM data?

When viewing medical images with a DICOM viewer, one does not necessarily see the personal information immediately. As described above, a patient’s personal data, but possibly also that of the operator, is part of the well-defined DICOM tags. Viewers can usually make these DICOM headers or metadata visible and even allow them to be edited.

Another source where personal data can be part of the DICOM data are the so-called “burned-in annotations”. The following example shows that the patient’s name and date of birth: As you can see the personal information Max Mustermann, born on 19 August 1938 – don’t worry, this is a fake person – is part of the pixel information and can only be removed with special tools, usually by drawing black boxes over the visible information.

Figure 1: Burned-in annotations in echocardiography

Also, DICOM studies often contain series which hold patient reports or dicomized letters with patient private information. These reports are normally in series marked with modalities like PR, SR or OT.

Depending on the needs of a clinical project, the user must be cautious and decide which information shall be shared or not. Finally, we want to mention, that the reconstruction or 3D rendering of images by an increasing special resolution, can lead to a patient identification. If for example CT or MRI slices of a head from a patient are rendered, the facial features can be reconstructed and allowing the identification of patients.

It’s our article’s objective to increase the awareness of healthcare professionals dealing with medical images and as such with personal patient information or often called Private Health Information (PHI). However, you might be glad to hear, that exchanging does not need to be complicated at all, for example with the use our dicomdrop- and decidemedical-tools.

You would like to learn about different ways to exchange DICOM files? Then stay with us: In part 3 of our DICOM explained-series, we will explain the different options available for DICOM-exchange and will tell you more about their pros and cons.

For more information on our ClinFlows-solutions, visit our website or get in touch via info(at)clinflows.com!

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Clients decidemedical DICOM

Leading medical device maker chooses ClinFlows’ decidemedical application for complex European clinical trial

A leading medical technology company headquartered in the US, trusts in ClinFlows’ decidemedical solution for its upcoming EU Trial. Via the web-based platform, the complete patient screening process of the study including the subsequent 5-year follow-up phase will be organized and conducted: All medical images (DICOM) and documents will be handed in, reviewed, and evaluated in a GDPR-compliant manner via ClinFlows’ online service.

“We are excited to see this complex exchange of medical images and study documents, within such groundbreaking clinical trial, realized on our decidemedical platform, involving multiple prominent researchers in the cardiovascular space”, says Uwe Gladbach, founder and CEO of ClinFlows.

The online submission and review of required data allows fast turn around times between the study teams, when it comes to subject eligibility checks – also very beneficial for the patients to be treated in a timely manner.

ClinFlows’ decidemedical platform has registered users from 96 countries worldwide and is in use since more than 10 years.

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Case Study Clients decidemedical

Case Study: How to send angiograms in DICOM format in investigator-initiated multicenter coronary stent study COMPARE 60/80 HBR

The collection of medical images often plays a vital role to analyze the efficiency of new treatment options researched in clinical studies. The safe and regulatory compliant transfer of DICOM images from the participating sites to the Corelab must be realized in a user-friendly manner. A special challenge is the typically small budgets available for investigator-initiated studies and still, a regulatory compliant way has to be found to get the medical images from A to B. The study management from the Cardio Research Department Maasstad Hospital, Rotterdam, of the COMPARE 60/80 HBR investigator initiated, multicenter, randomized clinical trial have chosen ClinFlows’ web based dicomdrop-solution to safely collect the angiograms from the 11 participating sites in the Netherlands enrolling 736 patients.

Client:

Cardio Research Department Maasstad Hospital, Rotterdam, the Netherlands supported by a grant of SMT (Sahajanand Medical Technologies Pvt. Ltd), a leading global developer and manufacturer of minimally invasive cardiovascular devices. The study is sponsored by the Research Maatschap Cardiologen Rotterdam Zuid, associated with the Maasstad Ziekenhuis Rotterdam, the Netherlands.

Project:

Investigator-initiated, multicenter, randomized controlled study, COMPARE 60/80 HBR: Comparison of the Supraflex Cruz 60 micron stent strut versus the Ultimaster Tansei 80 micron stent strut in a High Bleeding Risk PCI population.

Project Background:

In PCI patients at high bleeding risk (HBR), international guidelines recommend a shorter duration of dual antiplatelet therapy (DAPT). While this reduces the risk of bleeding, it may also increase the risk of stent thrombosis and ischemic events. The solution for PCI patients with HBR could be the use of ultrathin stent struts, as these may reduce ischemic events with a shorter duration of DAPT. COMPARE 60/80 HBR was initiated to investigate just this. From 2020 to 2023, under the leadership of Pieter Smits, M.D., Maasstad Ziekenhuis, Study Chairman and Principal Investigator, PCI use of the ultra-thin stent strut (60 µm) Supraflex Cruz will be compared with use of the thin strut (80 µm) Ultimaster Tansei among 736 patients with HBR. The study results may open new treatment options for PCI patients with HBR. Patients are followed for 12 months.

Challenge:

All angiograms of the index procedures, or any planned staged or unplanned procedures have to be sent to the Cardio Research Department in Rotterdam by the 11 participating sites. CERC Europe, Paris, France, will perform the analysis of the angiograms. The challenge was to find a very cost-effective and easy-to-use DICOM transfer tool, which provides an automated pseudonymization of DICOM tags and meets all GDPR requirements. 

Solution:

For the safe transfer of the DICOM images, the Cardio research team of Maasstad Hospital has chosen ClinFlows’ web-based solution dicomdrop since the start of the COMPARE 60/80 HBR study. With just a few clicks, the eleven participating sites can use the platform to send their angiograms in DICOM format to Rotterdam in a very uncomplicated, fast, and GDPR-compliant way thanks to the integrated pseudonymization options. The application allows the coordinator to create a project within dicomdrop and to invite the participating sites to join the project. The sites can enter a case reference which is automatically inserted in the uploaded DICOM tags, to assure clear subject identification. The coordination team in Rotterdam receives a download link to collect the data, which are only stored on ClinFlows high-end, high-security servers in Europe. All uploaded data are automatically deleted from the dicomdrop-servers after ten days to minimize the risk and assure a high-end data privacy protection. All the sites have to do is to register on dicomdrop once in order to upload DICOMs within the Compare 60/80 HBR project.

Result:

From 2020 until today, more than 700 patients have already been recruited in this study and around 800 angiographies have already been transferred via dicomdrop. 

Client feedback:

“For the success of our study, it is crucial to have a reliable and stable technology for online image transmission. Furthermore, the whole process has to be simple, fast and secure. dicomdrop fulfills exactly these points. We are happy to have relied on this tool from the very beginning of the study and thus to gain new insights for PCI patients with HBR as quickly as possible,” says Ria van Vliet, Project Manager at Cardio Research Department, Maasstad Ziekenhuis.

Want to learn more about how our clients benefit from our solutions in practice? Simply get in touch via info(at)clinflows.com or find out here, how a leading TAVI manufacturer manages case reviews and eligibility checks to serve clients and here, how to provide clinical decision support during post-training phase.

Image source: Freepik.com / pressefoto

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anniversary Team

10 years of ClinFlows: “Business is done by, with and for people.” 

Interview with company founder Uwe Gladbach

In this interview on ClinFlows’ 10th anniversary, founder Uwe Gladbach provides insights into his very personal funding story and gives outlooks on the company’s future as well as the development of the industry.

When you look back ten years, why did you decide to found ClinFlows back then?

Well, it was actually more or less by chance. At the end of 2010, I had the opportunity to take over a software from a failed startup. Based on my many years of experience in various management positions in medical technology, I was convinced that this software would add a lot of value to the medical industry: remember that the internet was different back then and sending gigabytes around the globe was a huge deal. At the same time, after 20 years of being an employee, I felt that it would be great to start my own business and do “my own thing”. No sooner said than done, ClinFlows was founded together with Jeff our CTO .

Wasn’t it a big step for you to become self-employed?

Yes, it definitely was. But the anticipation of self-determination outweighed it. I found the idea exciting of taking responsibility for all the strategic decisions of my own business, setting the right priorities, and being confronted with the good and, of course, sometimes not so good results. In any case, I haven’t regretted my decision for a second so far and I think the fact that our products decidemedical and dicomdrop are now used in 94 countries and by the big players in the industry speaks for itself.

What is it like today: What do you like best about your work?

Well, one the one hand, it’s being in touch with the most innovative technologies in medicine, the progressiveness of our industry, developing state-of-the art technology that helps people. And on the other hand, it’s our global reach, connecting specialists worldwide for the benefit of the patient and the impact this has on the individual and their health.

What moment in the last ten years with ClinFlows stands out in your mind?

There are many special moments when you lead a company for 10 years. For me, the above-average team spirit and the high level of customer orientation in ClinFlows are of the utmost importance. One situation that has particularly stuck in my memory is therefore the following:

At the beginning of each year – when Covid-19 is not dominating the world – we typically spend a few days with the entire ClinFlows team at a winter sports resort – we call it the ClinFlows WinterCamp. There, we discuss strategies, do roundtable discussions, and hold internal meetings. And, of course, we also enjoy some nice ski days together. 

Years ago, there was this evening after skiing when the whole team was sitting in an Italian restaurant after a very sporty day, all pretty exhausted and tired and ready to spend a nice evening together. But then my phone rang and a customer from California was on the line, complaining that there was a problem, and she couldn’t retrieve some medical images from our platform, which she urgently needed because the patient needed surgery the same day, thus the case review was urgent. When I described the situation to my team, one immediately grabbed his tablet, the other trudged through the snow to get his laptop from the hotel. And then we all sat at the table in the restaurant, reviewed the situation and fixed the problem so the data could be reviewed and the patient operated. No one groaned, everyone was very focused and motivated. That was a very satisfying moment for all of us.

What was the most important lesson you learned in ten years of ClinFlows?

Clearly, “Business is done by, with and for people.” I think it’s quite important to keep reminding ourselves of this, because even though we are software providers and thus deal mainly with IT and artificial intelligence, the focus on people and health drives us. 

Let’s venture a look into the future: Where do you think your industry will develop in the next 10 years?

I am convinced that artificial intelligence will play an increasingly important role as well as personalized medicine to provide individual treatment plans and options. In the space of clinical trials it will be most interesting to see developments with regard to the concept around Human Digital Twins and its consequences to speed up innovation in medicine.  

Thank you, Uwe, for the open conversation!

Categories
Team

May we introduce? Our new team member Sam!

Our new colleague Samuel Mayer Watts has recently joined ClinFlows to support us at operations. In a short interview, he reveals how he came to ClinFlows and what he enjoys most in his private life.

How did you come to ClinFlows and why?

I found a job offer on the internet that included exactly the position I wanted to have. I thought it was serendipitous and the company description sounded great and innovative, so I did not hesitate to apply and hand in my CV.

What is part of your job at ClinFlows? What are the things you take care of on a daily basis?

As Project Manager Operations, I have the responsibility of running daily operations, which means that I am the first contact for our clients that among others are major medical device manufacturers. One of my most important tasks is to understand their needs when it comes to medical image (DICOM) transfers and to tailor our platform to their individual requirements. 

What did you do before joining ClinFlows’ team?

Before joining the ClinFlows team I had been working as an in-house Clinical Research Associate at a multinational Clinical Research Organization. There, I monitored sites to support them in making sure study protocol expectations were being met.

How were your first weeks at ClinFlows? 

My first weeks at ClinFlows went by really fast, I hit the ground running, and was taught all the particulars of the complex system. At the moment, I am still learning, but learning by doing, which in my opinion is the best way to do so. The team was very warm and welcoming. The only thing I did not like is that I wanted to get to know everything at once.

Your job in three words?

BEST.JOB.EVER! Just kidding… I’d say: Patients. Service. Images.

Work is only half of life. What do you like to do in your spare time?

I am the proud father of two girls, and I love to spend my time with them. Next to this, I regularly practice Win Tsun Kung Fu.

What things do you always carry with you?

Since 2020, well… a mask. But my everyday carry includes my phone, a multitool, a lighter, ear buds, and a lucky silver coin.

What food could you not live without?

Since I have been living in Germany since 2012, I miss all the food from Mexico where I grew up, especially Mexican street food. But of what is available I can’t live without having Sushi occasionally, or slow cooked ribs.

What can you laugh about?

Absolutely everything! But if you would like me to be more precise: a good pun, a quick-witted response, even jokes that come with word play I find funny. Also, I enjoy watching stand-up comedy very much!

Which moment was so beautiful that you would like to relive it?

Tough question, as there are many… If I had to choose one single moment it would be my wedding day. I had been in a long-distance relationship for over 10 years to my now wife. It was the culmination of love, dedication, patience, sacrifice, and commitment that truly taught me that with enough effort and against all odds I can achieve everything of what I truly want in life.

We are looking forward to working with Sam and wish him a lot of fun with us at ClinFlows!

Are you also looking for a new challenge? Then get in touch via info@clinflows.com

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anniversary Clients

10 Years of ClinFlows, 10 Years of Collaboration with NeoChord

10 years of ClinFlows means 10 years of collaboration with NeoChord, a privately held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation. Betty, Sr. Manager Patient Selection & Analysis, told us why. Thank you so much, NeoChord, for your many years of trust in our platform

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Case Study clinical decision support decidemedical GDPR

Case study: How to provide clinical decision support during post-training phase

They are essential to our health: new medical products. Every year, medical device manufacturers, biotech companies, and pharmaceutical companies spend billions to develop them – and then millions to train and educate physicians to know how to use them and how to best help patients. But what happens after that, and how can medical product manufacturers support physicians when it comes to treating real people?

Once a medical product or treatment has been developed, various methods are initially used in the training phase. These range from descriptions and instructions supported by e-learning platforms, videos and audio files to sophisticated training centers with hands-on learning in real operating room facilities with training on animals or cadaver explants. Simulation software and 3D-printed artificial materials to mimic real-world scenarios are also emerging technologies for training and preparing physicians to use new treatments.

Time gap between training and first patient treatment

All of these efforts are designed to prepare medical teams for the moment when a real patient is to be treated. Right after training, what usually happens first is…. nothing! That’s because often the first treatment of a real patient doesn’t happen until weeks or months after training. This is the moment when training and reality meet. 

Now it’s up to the physician in his or her clinic to decide whether the patient meets the criteria for a particular implant or interventional treatment. The physician may need to select the right size implant or decide on the access route. 

Assessment of medical images vital during post-training-phase

Medical images play a key role in the best treatment outcome, such as methodological selection and determining the size of an implant. And this is where medical device manufacturers can come in: Namely, by supporting physicians with a second opinion at these critical moments. But this is not always so easy and, above all, often too slow, for example because of a physical distance. It is not uncommon, for example, for the attending physician and his patient to be located in Europe, but the manufacturer in the USA, and for medical images to be exchanged by mail.

Clinical decision support via web-based tools to ensure the best treatment possible

A straightforward and secure solution here can be provided by web-based clinical decision support tools, such as our GDPR-compliant online solution decidemedical, which has been used by the medical device industry for ten years. With its help, clinicians can upload their clinical data and medical images and submit them securely and compliantly to industry experts to either get their opinion on the suitability of a case or industry provides sizing services. Clinical experts from the manufacturer review and measure the medical images using specialized imaging software and submit their assessments to the physician via the web-based platform to recommend the best treatment option and implant size.

The benefits to the physician, the industry – and most importantly, the patient – from using web-based Clinical Decision Support tools in the post training phase are clear:

  • Utilization of existing medical expertise,
  • available worldwide,
  • fast turnaround time,
  • enables a controlled product launch,
  • efficient customer support,
  • compliance with regulations, and it’s
  • accessible from anywhere – no software required.

How do you manage physician support in the post-training phase? And how does your clinical team share medical images with the different sites?

Discuss here or contact us at info(at)clinflows.com

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Case Study Clients decidemedical

Case study: How a leading TAVI manufacturer manages case reviews and eligibility checks to serve clients

When launching innovative medical treatments, reviewing cases, and doing eligibility checks is of vital importance. Implanting physicians, who are located all over the world, benefit from the expertise and the support of the clinical specialists of the medical device company when treating their patients. This case study shows how communication via our clinical software decidemedical can simplify the associated complex processes for everyone involved in an easy, efficient, and regulatory-compliant manner. Skilled people combined with smart tools result in safety and excellent benefits for the patients!

Client:

One of the worldwide leading TAVI (Trans Aortic Valve Implantation) manufacturers 

Challenge:

The heart valve manufacturer, which has a highly skilled support team in the Netherlands and California, offers GDPR-compliant, fast, and easy clinical decision sizing- and support-services to its physicians which are located all over the world. Clinical information and medical images (CTs, Echos, Angios) have to be exchanged in a GDPR compliant manner. 

Solution:

On its web-based platform decidemedical, ClinFlows sets up individualized workflows based on the client’s requirements. With secured access, participating sites, from all around the world, can upload clinical data and medical images such as echos, CT’s, and angios of their potential TAVI patients. Defined DICOM tags, included in the medical images are automatically anonymized resulting in a pseudonymized data set. As soon as physicians upload a new case, the TAVI-support team is notified. The team members can directly download the clinical data and medical images, process and analyse them and send their final report as well as recommendations to the treating physician via decidemedical. The physician, in turn, is notified by email that the case has been reviewed and can consider the expert’s measurements and recommendations when treating the patient.

Workflow in practice (based on decidemedical real audit trail data):

10:11am: In the morning, a physician from Czech Republic logs in to ClinFlows’ decidemedical platform via his web-browser. The physician creates a case, enters clinical information, and uploads CT data. The individual DICOM tags included in the CT images are automatically anonymized resulting in a pseudonymized, GDPR-compliant data set.

10:16am: Only five minutes later, the physician hits the submit button to send the filled case to the company’s expert team for review, who is notified via email.

10:41am: The expert located in the Netherlands logs in to ClinFlows decidemedical platform, downloads the CT data from the Czech Republic and starts the analysis and measurements.

12:25pm: Right before lunch, the expert finishes the task and uploads the analysis outcome, i.e., the detailed report containing measurements and screenshots to decidemedical. A notification is automatically sent to the physician straight away.

1:08pm: The Czech physician logs in to decidemedial and reviews the analysis report he uploaded less than 3 hours ago.

Result:

It took the physician just 5 minutes to upload a TAVI case to decidemedical including several hundreds of MegaByte of CT data – and he didn’t even need to install any software. Despite the local distance, after 2 hours and 14 minutes only, a detailed TAVI expert analysis report was made available to him via decidemedical – in an easy, safe and compliant way. This presents a great way to support physicians, leverage medical expertise and offer excellent client service.

How does your team organize case reviews, eligibility checks or similar tasks? What challenges do you face when doing so?

Discuss here or contact us at info(at)clinflows.com

Image: ijeab – de.freepik.com

Categories
Online Proctoring

New web-based Smart Uploader allows DICOM preview and erasure of burned-in annotations without software installations

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.

Categories
Online Proctoring

When patient selection is key

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:

  1. 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.
  2. 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.
  3. 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).
  4. 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.
  5. 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.