Categories
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!

Categories
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.

Categories
DICOM GDPR

DICOM explained Part 1: What is DICOM, DICOM Tags and Data Sets?

Imaging techniques play an important role in many areas of modern medicine. This applies to diagnostics and therapy, but also to research, for example, in the context of clinical trials. The most important medical image format is DICOM. 

Within clinical projects, utilizing our ClinFlows’ solutions to exchange medical images, we frequently meet users (physicians, study nurses and coordinators) who are not that familiar with the topic “DICOM”. Time for us as DICOM experts to start a series in which we explain the format and obstacles that come when dealing with it (spoiler: among others, it’s about personal data!).

In the coming time, we will gradually publish articles here in which we explain the most important background and facts about DICOM data. We start today with part 1 of our DICOM explained-series, in which you will learn what is behind the abbreviation, how the DICOM format is structured, what makes it so characteristic and what it is used for in healthcare.

DICOM: the format behind the five letters

JPEG, TIFF, PNG – almost everyone knows these file formats of images. DICOM is also an image format, but it is used primarily in the medical industry. The abbreviation DICOM stands for “Digital Imaging and Communications in Medicine”. The term already makes it clear that the format not only includes the respective image data, the pixels or its storage as a specific file format, but that the DICOM standard includes further information, which we will explain in more detail later. The DICOM standard has its origins in the 1970s, when it was still called the ACR/NEMA standard and was initiated by the American College of Radiology and the National Electrical Manufacturers Association. DICOM as we know it today has only existed since 1992. The use of this image format is intended to facilitate and standardize the exchange of medical image data.

DICOM: Open standard to exchange medical images

The DICOM format is one of the so-called open standards, openly accessible and usable by anyone. This allows many medical professionals in the fields of research and clinical practice, diagnostics and therapy to exchange, view and perform measurements of medical images independently of manufacturers.

What are DICOM Headers, DICOM Tags and Data Sets?

A set of medical images in DICOM format usually has the following overall structure: Patient – Exam – Series – Images. That is, a patient undergoes a study or examination, such as a computed tomography (CT) scan. This examination consists of several series, and each series contains multiple images (hundreds or thousands) or multiple frames (like a video, e.g., for echocardiographies).

A DICOM medical image file, such as a single CT slice, consists of two distinct parts. One is the medical image itself, the other is the DICOM header. The DICOM header is a block of data that contains specific information that complements the image, called DICOM tags. This usually includes relevant patient data such as name, age, gender and date of birth, but also a lot of technical data and parameters, such as the device used to generate the images, the names of the surgeon and the administered drugs such as contrast agents, as well as data on the imaging technique, such as pixels, matrix size or the dimensions of the image. This usually facilitates the assignment of an image to a patient. In medical jargon, this data is referred to as attributes. Depending on the image and the circumstances, certain information is mandatory, while other attributes are optional. In addition, the DICOM header has DIN standards, which are defined by law.

What are DICOM Tags good for?

The DICOM Tags are organized as a constant and standardized series; thus, they are used in the management of information belonging to medical image data. The DICOM Tags are assigned as metadata elements to each image object in medicine. These can be segmentations, definitions of surfaces, and registration numbers for the images. The format is used for both standardization and storage of the files, as well as a uniform communication protocol for sharing. As data elements, tags consist of an attribute that is used for identification. Usually they are composed of hexadecimal numbers (XXXX,XXXX) with a comma in the middle. If necessary, a further subdivision into the group and element number is possible. In this way, DICOM tags are easier to read, and patient data can be printed directly on them when developing X-ray images. In this way, the X-ray image and the associated data are combined digitally in one file.

What DICOM Tags are available?

There are a variety of DICOM tags that assist in organizing medical image data as well as searching for them. These include, for example:

DescriptionNumber
Accession Number0008,0050
Procedure Creation Date0014,4076
Modality0008,0060
Patient’s Birth Name0010,1005
Operator’s Name0007,1070
Patient’s ID0010,0020
Patient’s Birth Date0010,0030
Patient’s Body Mass Index0010,1022
Table 1, DICOM Tags

Thanks to the numbers, an extremely large amount of information can be assigned to the images, which is immediately recognized by the medical authorities. By the way: A full list of all DICOM tags can be found at MITA (The Medical Imaging Technology Association) or NEMA here.

In the next part of our DICOM explained series, we will dive deeper into the topic: Among others, you will learn more about the problems that the data contained in DICOM files pose for working with them. Stay tuned!

Categories
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

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

Categories
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

Categories
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

Categories
Non classé

“80 percent of success lies in preparation”

I am convinced that “80 percent of success lies in preparation” when it comes to the role of medical images (DICOM) in the development of medical devices.

In my guest article for the German trade journal MED engineering (please find the current issue here), I tell you why I see it that way.

You can download the article here:


Thanks, MED engineering for featuring us!

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, which offers e-solutions for clinical workflows.

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.