The Silicon Review
The very nature of the healthcare sector is to collect personal data from the patients to deliver healthcare services. But how the data of patients are managed is also an important factor to note. Data protection regulation is present in almost every sector. Still, it is one step ahead in the healthcare segment because new regulations continue to give patients control over their personal data that is collected by the healthcare professional. Healthcare organizations are tasked with protecting personal data, and they can be held liable if there is any personal data breach. New regulations will mitigate risks and prevents the encountering of breaches.
Many companies are generally concerned about the new data protection regulations coming into effect, but companies like MyData-TRUST ensures that the clients are prepared. MyData-TRUST is a company exclusively dedicated to the Life Sciences sector, and it supports Life Sciences Companies to be prepared for data protection regulations. The company provides strategic, operational, and organizational support, making an important contribution both legally and technically to the Data Protection implementation’s success. MyData-TRUST always aims to give its clients the keys to reach full compliance with Data Protection regulations and ensure the data’s protection.
In conversation with Xavier Gobert, CEO, and Head of Operational Department of MyData-TRUST
Q. Can you brief us about your data security services?
MyData-TRUST imparts education and training on the various intricacies of the GDPR landscape to its clients. This helps clients in understanding and evaluating the challenges posed by the complex GDPR. The company performs a gap analysis to determine its clients’ critical processes and map the flow of their data. It ascertains the steps necessary to ensure successful compliance with regulations.
We operate Data-Protection-Officer-as-a-Service (DPOaaS) and Data-Protection-Representative-as-a-Service (DPRaaS), for companies to have access to skilled and certified people with extensive experience across numerous sectors such as legal, IT, and life sciences. This helps MyData-Trust and the client to work in tandem towards both pharmaceutical R&D and GDPR compliance. Adding to this, the firm extends legal support to its clients and sets up Binding Corporate Rules for transactions with companies outside the EU.
Q. What motivated you to provide a dedicated security platform for life sciences?
Life Science industry deals with health data collected from patients. Health data is sensitive data, and a patient is a vulnerable subject. All activities dealing with these are considered likely, resulting in a high risk to natural persons’ rights and freedoms. Then, the compliance to the Regulation must, therefore, be strictly adhered to and thoroughly implemented.
Q. More significant the network, more prominent, is the issue. Do you think your services are ready to cater to the needs of never-ending digital transformation?
MyData-TRUST has worked with about 230 projects in the life sciences sector, which showcases its expertise. When one of their clients wanted to use the compassionate use program on a patient whose condition was critical, MyData-TRUST was called in to handle the data transfer of the patient’s records to the medical company. Managing the documentation and taking care of patients’ rights was challenging, which MyData-TRUST carried out with precision. In another instance, a company developing mobile applications wanted to design an app. Subjects involved in a clinical procedure could easily provide data and set reminders for appointments with doctors with their smartphones. MyData-TRUST had consultations with Google and Apple and made the app compliant with both GDPR and the app store rules.
Q. Modern data breaches are equally automated. How do you help organizations to fight fire with fire?
We support companies to be proactive in stating “Data Breach Readiness.” Companies must have a strategic approach to data protection with their people’s training and the operationalization of their activities with policies and SOPs, additionally to risk assessments. Then, they must develop a tactical approach with vulnerability assessment, internal audits, and stress tests.
Q. How efficient is your data protection expertise? Do you have qualifies individuals who can keep your service standards up and running?
Our teams are composed of lawyers, IT experts and clinical professionals with tracked records. They receive an in-house training of six months, and in the end, they are certified by the University a Maastricht. They perfectly know the Regulation with its specificities, and they can match with clinical research priorities. Our activities are driven by SOPs and Policies. We perfectly apply the principle of accountability. “If it’s not written, it doesn’t exist!”
Q. There are other players in this vertical. How do you distinguish yourself from the rest?
MyData-TRUST is unique because we bridge the GDPR knowledge with the clinical expertise. We have the perfect understanding of our clients’ business needs, and we know how to leverage the GDPR to frame with the clinical research requirements.
Q. Do you have any new services ready to be launched?
On the solutions front, MyData-TRUST’s privacy management solution PrivaREG is a centralized platform integrating standard reports and streamlining communication to subjects and authorities, which is compliant with the local government specificities. This is a collaborative tool to assess and monitor data protection for a consolidated register of data processing activities.
Q. What are your plans for the development of your company?
With MyData-TRUST achieving service maturity, our innovation team is working to innovate its solutions portfolio. We strongly believe that GDPR can improve the capacity in clinical research in the coming future. The recruitment and retention of the patients for the clinical trials can improve if the companies become compliant. Data protection is not a constraint. It is a way to bring in more security to the patient’s data, and consequently attain patient centricity.
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Leader behind the success of MyData-TRUST
Xavier Gobert is the Head of the Operational Department and serves as the Chief Executive Officer of MyData-TRUST. He is a highly respected and dedicated professional with more than 23 Years of experience with proven and successful records in multicultural team management and business consulting provided to all levels of an organization.
He has an overall experience of 15 years’ in CDISC and DM and has perfect knowledge of EMA and FDA regulations and guidelines. He successfully operated in multicultural teams in big pharmaceutical organizations as well as IT and clinical services providers. Xavier has an in-depth knowledge of all regulations that can impact clinical research, including the GDPR. He is certified as Data Protection professional.