Guiding data users: interview with Dr Zdenka Dudová on TEHDAS2 draft guideline on data access and requests
Zdenka Dudová, PhD, Analyst in the Advanced Data Management department at the Masaryk University’s Institute of Computer Science, led the development of the TEHDAS2 draft guideline on good application practice for data access and requests.
The guideline helps data users navigate the complexities of accessing and requesting health data under the European Health Data Space (EHDS) regulation.
In this interview, Dr Dudová discusses the guideline’s purpose and the importance of stakeholder feedback from the ongoing public consultation.
This draft guideline aims to assist individuals in navigating the data access application or data request process under the EHDS. Could you walk us through the key steps involved?
During this part of the user journey, the applicant becomes a data user. We basically guide them through three key steps.
First is preparation. This is where we explain what the applicant needs to do before starting the application process – things like knowing their obligations, rights and responsibilities, and what documents they will be asked to share.
Second is the applicants’ needs identification, where we outline the available options for applying for data.
Finally, the third one is the timelines clarification step. Here we go over the expected timeframes for each part of the process and explain the roles and responsibilities of the parties involved, such as the applicant, health data access bodies and data holders, so the applicant knows what to expect at each stage.
Now, as an applicant, you can either apply for data access or request aggregated statistical results. It’s important to clarify the difference between these two options, so applicants can make an informed choice.
Whether you’re a policymaker, industrial partner, researcher or healthcare provider, you have the same rights and obligations. Everyone fills out the same form and this is the beauty of the whole system – the transparency!
With the guideline document, the applicant will be well-oriented on what is possible regarding the data access and/or request, and this should simplify the thinking about the project and purpose of the data.
What are some common challenges that applicants might face?
In my opinion, the biggest challenge is to understand the HealthData@EU as a whole and to know what you as an applicant need from it.
With the guideline document, the applicant will be well-oriented on what is possible regarding the data access and/or request, and this should simplify the thinking about the project and purpose of the data.
I work in biobanking, and in that field, we encourage researchers to do a so-called feasibility search before they start shaping their projects. It means that when you know what biospecimens or data are available, you can draft your projects more easily.
Who is this guideline intended for? What types of individuals or organisations typically need to access or request health data, and for what purposes?
I already mentioned several categories of potential data applicants for whom the guideline is written.
It is quite a list and includes public authorities, healthcare providers, researchers and research institutions, private entities and companies, developers of AI systems for healthcare, educational institutions, national health care authorities and natural persons.
This list shows why the data access application and data request form should be detailed – simply because there are many possible needs to access or request health data. Even though the regulation strictly defines certain purposes of the health data use (you can find the list in Article 53), applicants must still clearly indicate why they need to access the personal-level health data or why they request the statistical and aggregated data. This way the health data access bodies can make an informed decision about data access or request.
In the guideline, we explain in simple language what constitutes an allowed purpose for secondary use of health data and give examples to help applicants identify the purpose of their data use.
Filling out a data access application or data request can be complex. How does this guideline make the process clearer and easier to follow?
Yes, I fully agree. When we were thinking how to encourage people to fill out the form properly with all the necessary details, without immediately scaring them off due to its length, one of my colleagues in our writing group came up with a nice idea. We decided to structure the chapter describing the data access application and data request form into “why”, “what”, “examples” and “tips” sections. This makes the text very easy to navigate, providing a clear overview of the fields which applicant fills out.
I highly recommend reading that chapter and giving us feedback on the structure, the examples provided and the tips to help make the text interesting and beneficial.
Together with the other TEHDAS2 guidelines, this guideline supports the cross-border use of health data in Europe. Why is that important, and what benefits could it bring?
Access to different data categories specified in the regulation (Article 51) for secondary use should first and foremost benefit society.
Research and development of new medicines, medical devices, and healthcare products and services at fair prices for Union citizens (Article 53) are the reason why we are building the HealthData@EU infrastructure. It should also improve access to these products and services across all member states.
By harmonising data access application practices, this guideline helps overcome legal and technical barriers, creating a more integrated and efficient European Health Data Space. Seamless application processes enable researchers to access larger, more diverse datasets. Ultimately, this can lead to more robust research outcomes that advance medical knowledge, improve patient care and help authorities track and respond to health threats more effectively.
[Stakeholder input] ensures that the guideline is both comprehensive and practical, addressing the real-world needs and concerns of those who will be using it.
Stakeholders are invited to provide feedback on this draft guideline. Why is their input important, and how can it help improve the final version?
Stakeholder input is important for several reasons. It ensures that the guideline is both comprehensive and practical, addressing the real-world needs and concerns of those who will be using it. Feedback from a diverse range of stakeholders, including public authorities, healthcare providers, researchers and private entities, helps to identify any gaps or ambiguities in the guideline.
I like this collaborative approach because it enhances the relevance and usability of the final document and increases the likelihood of successful implementation and adherence to the guideline. By incorporating the insights and suggestions, the final version of the guideline will be more robust, user-friendly and effective in facilitating data access and requests.
The first TEHDAS2 public consultation is open until 28 February 2025. You can find the draft guideline on data access and requests and other documents open for feedback on the Public consultations page.
Share away!