Categories
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.

Categories
General

Welcome to the Clinflows Blog!

In this blog, we will share with you information about what we love to do the most: e-solutions for clinical workflows.

We are eager to share with you ideas on how to more efficiently manage your clinical projects and the exchange of clinical data and medical images. Most importantly, how to do so while being regulatory compliant and respecting data privacy rules so that all stakeholders can act easier and faster, and so patients will get the best treatment available as soon as possible.

Here’s what you can look forward to when reading the ClinFlows blog:

  • We’ll share with you information and best practice examples about the latest developments in e-solutions for clinical projects, research, and trials that require clinical decision support. This will include specific cases, success stories, before and after articles, and other highlights from the world of ClinFlows.
  • We’ll let you know what industry experts, manufacturers, and physicians think about the digitalization of healthcare and how they integrate e-solutions into their clinical projects.
  • We’ll provide background knowledge on online patient eligibility checks, screening workflows, and medical proctoring activities as well as on how e-solutions can help when monitoring new product cases, supporting product launches, or creating awareness for new treatment modalities.
  • We’ll introduce you to the people who make ClinFlows what it is.
  • We’ll share valuable expert knowledge on IT topics relating to e-solutions for clinical workflows.
  • We’ll answer your questions about digital solutions for the medical market and associated challenges such as data privacy aspects.

Some thoughts on our future articles

We promise to do everything we can to keep our blog interesting and diverse and to provide added value. We are passionate about our mission of enabling stakeholders of clinical research and trials to fulfill their work as efficiently and easily as possible by sharing clinical data and medical images (DICOM) online while meeting data regulation requirements. We greatly look forward to sharing our expertise. However, please note that all opinions and views expressed in our blog posts are personal perspectives.

If you have any comments, questions or wishes, please do not hesitate to contact us at any time – we will be very happy to come back to you at short notice.

And lastly, thank you for reading and visiting our blog. We are thrilled to have you here!

Stay tuned!

The ClinFlows Blog Team