A brief overview of some terms relating to data and health

Open data describes any data that can be freely accessed, (re)used and shared by anyone without restrictions. It aims to make scientific knowledge openly available and accessible to everyone. Open source refers to any programme whose source code is made available for use or modification as users or other developers see fit. Open source software is computer software that is developed as an open public collaboration and made freely available to the public.

Opt-in means that you are giving your permission or agreeing to participate in something. Imagine you receive an invitation to join a club or a newsletter. If you decide to join, you are "opting in." It’s like saying, "Yes, I want to be part of this."

The EHDS imposes Member States to develop an opt-out possibility for secondary use of health data. Opt-out means choosing not to participate in something or saying "no" to a service, activity, or use of your data. For example, if a company sends you promotional emails, you can opt-out to stop receiving them. In health care, it refers to the ability to decline or stop certain actions, like having your data used for specific purposes. GDPR and EHDS legislation give people an easy way to opt-out, but there is a risk to it. For example, if a company sends you promotional emails, you can opt-out to stop receiving them. If fewer people share their data, researchers might not have enough information to study diseases, develop treatments, and improve healthcare practices in general. Moreover, if certain groups of people opt out (e.g., specific demographics or regions), the data may become biased. This can lead to medical findings that only apply to a narrow population and exclude underrepresented groups. Without enough data, it becomes harder for public health organizations to track disease outbreaks and to respond to public health crises effectively. People who opt out might miss benefits, such as early disease detection or being part of cutting-edge clinical trials. Someone's health condition might go unnoticed if their data isn’t included in population-wide screenings or analyses. While protecting privacy is critical, finding a balance between individual rights and collective benefits is essential for advancing healthcare and saving lives.

Outcomes data refers to information that measures the results or effects of specific actions, interventions, or processes. It’s used to understand whether goals were achieved and to evaluate the effectiveness of programs, treatments, or decisions. Outcomes data answers the question: "What happened as a result?" It shows the impact of what was done, helping people or organizations decide what’s working and what needs improvement.

Personal data is any information that can identify a specific person, either on its own or when combined with other details. It is about different pieces of information, which together can lead to the identification of a particular person, like your name, social security number, email, or phone number.

A Pod is essentially a container where you can store all of your personal data—photos, documents, preferences, health information, and much more. It's a personal data vault that only you control. The idea behind is to give individuals control over their own personal data in a way that is more private, secure, and interoperable compared to the current centralized systems we commonly use (like social media platforms or cloud storage). With a Pod, you have the ability to control who can access and use your data and under what conditions. The data can be encrypted, ensuring that only those with the correct permissions can access it. This decentralization contrasts with traditional services (like Facebook or Google), where the company holds and controls your data.

Portability refers to the ability to easily move or transfer something from one place, system, or service to another. Data portability means that you have the right to get a copy of your data in a usable format and transfer it to another service or platform. It gives you control over your information and allows you to switch services without losing access to your data. In healthcare it is moving your medical records from one doctor or hospital to another.

Primary data refers to data that you collect yourself, specifically for a particular research project or purpose. It’s original data that hasn’t been previously gathered or analyzed by someone else. You collect it directly from the source. Primary data is gathering first-hand information directly from the field, experiments, surveys, or observations. It’s new data created specifically to answer your research question or solve a specific problem. If you want to know how well a new medication works, you might conduct a clinical trial and collect data on the patients’ responses and health improvements. This data is primary because you’re gathering it directly for your specific research.

Primary use refers to the direct use of health data in providing healthcare services, such as a doctor using a patient's medical records to make a diagnosis or determine a treatment plan, and also allowing the doctors in any member state to access the patients data if necessary.

Pseudonymisation means processing research data in such a way that they can no longer be attributed to a specific person without the use of additional information like a coding key. This usually involves replacing identifiers from the data with a pseudonym (GDRP: art. 4(5)).