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Clients Clients decidemedical General Non classé

MedAlliance relies on ClinFlows’ decidemedical for world’s largest DEB study

We are proud to announce that MedAlliance has chosen to rely on our decidemedical platform for its Selution DeNovo Study, which is the world’s lagest DEB study ever conducted. With the help of our web-based platform decidemedical, the participating sites located all over the world can hand in their medical data and images (DICOM) associated with approximately 3,300 patients for review and valuation in a GDPR-compliant manner. 

MedAlliance is an innovative, privately-owned medical technology company specialized in the development and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. The Swiss company has its headquarter in Nyon with further offices located in Germany, UK, USA and the Republic of Singapore.

We are very pleased to be able to contribute to such an important clinical trial with our secure and efficient online technology!

If you want to learn more, you can read our related press release here:

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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

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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.

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Clients

Hermes Medical Solutions is official licensee of our web based decidemedical solution

We are proud to announce great news: Hermes Medical Solutionsthe leading company when it comes to imaging software in Nuclear Medicine and Molecular Imaging, signed an agreement to license our worldwide used decidemedical platform. Through the collaboration, a seamless data flow can be utilized, allowing sites to safely transfer their image data (in DICOM format) via the web based decidemedical platform to the image analysis and processing servers of Hermes Medical Solutions. International research projects and clinical studies will now profit from a most safe transfer and efficient workflow solution in combination with the best tools available in Nuclear Medicine when it comes to providing vendor neutral, multimodality software for most innovative diagnostic and discovery of personalized treatment options for patients.

The Stockholm-based company has been recognized for clinical excellence and innovation for over 40 years, providing independent, vendor-neutral software solutions in Molecular Imaging and Nuclear Medicine. 

We are very much looking forward to expanding our activities into the Nuclear Medicine market with Hermes Medical Solutions!

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Clients

ClinFlows’ software helps children with heart disease across the globe

Congenital cardiac malformations are the main cause of death among children. Worldwide, more than 6 million children suffer from heart diseases, while 80 percent of newborns affected by these malformations do not survive in developing countries. Bambini Cardiopatici nel Mondo, an Italian nonprofit organization (NGO), works hard to change this condition. Along with other groups, the NGO leads medical missions abroad to visit, treat and operate on children affected by congenital heart diseases. Furthermore, it provides training and education to physicians and health personnel. 

Our platform supports global communication about children’s clinical cases

Our donation allows the NGO to use our web-based decidemedical online platform at no cost, benefiting children across the world. This software allows the NGO to share clinical data and medical images among various stakeholders involved in the treatment of children in various countries.

By using the platform, hospitals can submit cases with clinical information and medical images online. As soon as cases are uploaded, the medical team at Bambini Cardiopatici nel Mondo is notified, allowing the team to review and download the provided case information. With this information, case eligibility and treatment options can be discussed and advice provided – all centralized, remotely and quickly.

“This collaborative initiative allows us to further improve our activities aimed at treating and increasing life expectancy for children with heart diseases. At the same time, it helps us to develop distance learning and the real-time exchange of experience and training between doctors and healthcare professionals in developing countries where our association operates,” said Prof. Alessandro Frigiola, president of Bambini Cardiopatici nel Mondo. “The online application also improves the safety, accuracy and timeliness of diagnosis and follow-up for children who need our evaluation.” In total, as part of the donation for the NGO, up to 100 sites can participate and discuss 600 cases annually.

A real matter of the heart for us at ClinFlows

We are very impressed by the work done by the organization and its health professionals to help children with heart diseases around the world. In my first job, I worked as a perfusionist in the operating room, where I observed many children being operated on by skilled and passionate heart surgeons. Therefore, it is a real honor to contribute to this group’s efforts through the donation of our online solution to ease the work of Prof. Frigiola and these hard-working teams. In the truest sense of the word: this is a real matter of the heart for 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
GDPR

ECJ invalidates Privacy Shield – what does this mean for you and your company?

The European Court of Justice (ECJ) declared the Privacy Shield invalid in its ruling (C-311/18) on 16 July 2020. We have summarized here what this can mean for you and your company.

Data protection, the exchange of data and what has to be considered – I know that this is not a very funny or entertaining topic. Nevertheless, it is one of great importance, especially in the healthcare market. Why? 

Because in our healthcare market, doctors and industry personnel deal with patients’ personal data on a daily basis and transmit it online, whether for clinical studies, sending medical images (DICOM) to CoreLabs or to obtain a second opinion from medical experts for screening purposes or to check the suitability of a patient for a particular treatment – sometimes across several continents. And here comes the problem:

Following the rejection of the Safe Harbor Agreement in October 2015, the replacement Privacy Shield, which was a self-certifying mechanism for U.S. companies to comply with privacy requirements when transferring personal data from the EU to the United States, was declared invalid in July 2020.

European personal data not protected in the USA: U.S. government may use communications providers to monitor foreign individuals

The reason: the ECJ found that the US surveillance programmes allow the US authorities to carry out large-scale surveillance activities that do not comply with the principles of European standards, in particular with regards to necessity and proportionality. An example of this is the hotly debated Section 702 of the FISA (Foreign Intelligence Surveillance Act), a key provision of the FISA Amendments Act of 2008, which allows the U.S. government, with the help of electronic communications service providers to conduct targeted surveillance of foreign persons located outside the United States in order to obtain foreign information.

Furthermore, the mechanism of the so-called “ombudsperson” embedded in the Privacy Shield does not actually offer a realistic possibility for the persons concerned to bring their legal dispute before an independent court, as provided for in the Charter of Fundamental Rights of the European Union.

The problematic situation was clearly expressed by Mr. Schrems, the founder of the NOYB-European Center for Digital Rights, who stated during a hearing before the EU Commission on September 3: “(…)we have a fundamental clash of laws. We have in the European Union, the Charter of Human Fundamental Rights and in the US, FISA (…) there is a legal clash (…) having two different obligations on the legislative level, in the US to have surveillance and in the EU the obligation to privacy (…)“.

Why could this be a problem for European companies?

Well, the answer is simple: If you and your company rely on service providers for the exchange of European patient data, then you need to check: 

1. where are the data hosted – US or EU?

2. where is the company located processing your data?

If you host your patient data on US servers, or utilize services from a data processor which has its headquarters located in the USA your data is at risk to be surveilled.

The question now is what the European data protection authorities will do about it. It must be remembered that the European Court of Justice’s ruling obliges the authorities to act as the ruling is binding. Their measures are under discussion and must be awaited.

So we are not only dealing with a complex legal situation that makes it difficult for the industry to operate and make clear decisions, but also with questions such as: Are the standard contractual clauses sufficient or should supplementary measures be taken? At present, we also do not know what the consequences of the measures to be taken by the data protection authorities will be.

Will data from your EU patients be transferred to the USA?

I am often surprised when I speak to senior clinical or business managers in the healthcare industry who have to manage the transfer of personal data of patients, such as medical images as part of clinical monitoring or study projects. Often, they have little knowledge of the current discussions regarding data transfer between the EU and the US – often they don’t even know in which country their project data is hosted. Also, the term “anonymized” data is often used incorrectly, because in fact, data is usually only pseudonymized, which has completely different legal consequences than anonymization.

I can clearly recommend any manager who manages the transfer of personal patient data: Make every effort to understand where the relevant data is hosted and whether it is hosted by a U.S. or EU entity that handles the data, so that you can assess how much of a risk the U.S. authorities are monitoring. 

The solution: Hosting European patient data on European servers using European providers

It is clear that it will be almost impossible to prevent the US authorities from monitoring EU-US data transfers and that it will take years, if ever possible, to resolve these issues legally.

Therefore, for the security of the privacy of our patients in Europe in the context described above, it is strongly recommended to ensure that the data is hosted in Europe by a European company as data processor – only then will the US authorities not have access to the data.

And guess what, yes, that is exactly what we offer at ClinFlows: ClinFlows only uses dedicated servers located in Europe to process data – because the security of the patient data we process is our top priority.

And we promise you: We will continue to monitor the recommendations of data protection authorities to ensure that appropriate mechanisms are implemented and that our services remain secure for all parties involved.

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.

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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.