Glossary

1. Anonymized data 

Definition

Information that does not relate to an identified or identifiable natural person.

Explanation

Data that has been processed so all personal details are removed; making it impossible to directly or indirectly identify who the data belongs to.

Application to PHEMS

Researchers will only have access to aggregate anonymized data, and data holders (hospitals) will check this before they release any data. This means that patient privacy will always be protected.

Reference

https://iate.europa.eu/entry/result/3571003

2. Benchmarking

Definition

The process of assessing quality or performance in comparison with an established standard.

Explanation

Hospital Benchmarking is a practice to compare the performance of one hospital against the performance of others. It helps us understand how well something is working and identifies areas for improvement.

Application to PHEMS

Benchmarking is important to help hospitals improve how they take care of patients (clinical benchmarking) and way they organize their activities and resources (operational benchmarking). PHEMS will address current barriers to benchmarking by automating access to high quality data, helping hospitals improve patient outcomes and increase efficiency.

Reference

https://iate.europa.eu/entry/result/884664

3. Clinical research

Definition

Studies in human subjects, either patients or healthy volunteers, including clinical trials designed to determine human pharmacology (PK/PD), and exploratory or confirmatory safety and efficacy studies, for pre – or post-authorization activities including risk-management programs. 

Explanation

Research involving people to learn more about health, diseases, and treatments. It involves both patients and healthy volunteers. Studies can include clinical trials testing the safety and effectiveness of new drugs, or looking at how people respond to certain treatments. 

Application to PHEMS

The PHDS will allow more clinical research to take place in children and young people because it will help provide researchers access to more patient data.

Reference

https://iate.europa.eu/entry/result/3629891

4. Clinical trial

Definition

Clinical study which fulfils any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the country concerned; (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study or; (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects. 

Explanation

A planned study that tests how well a medical treatment or approach works in people. It often involves comparing a new treatment to the standard one or a placebo and may include extra tests or procedures. 

Application to PHEMS

The PHDS will help researchers conduct better, faster clinical trials by helping identify patients who might be eligible for a clinical trial across multiple hospitals within the PHDS.

Reference

https://iate.europa.eu/entry/result/1686971

5.Data access agreement

Definition

Terms under which users are provided access to the specified data, and to obtain explicit acceptance of those terms by a user prior to granting access of the data.

Explanation

A legal document that describes how someone gains access to certain data. It also describes under what conditions they can use the data, and what they are allowed or not allowed to do with it. It protects the rights of the data owner (patients).

Application to PHEMS

Users of the PHDS will have to sign a data access agreement to ensure that they handle patient data in the most secure way. 

Reference

https://security.berkeley.edu/data-access-agreement-guidelines

6.Data controller

Definition

A natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data. 

Explanation

The person or organization that decides why and how personal data is collected and used. They are responsible for protecting data and following privacy laws. 

Application to PHEMS

Data Controllers work within hospitals that are members of the PHDS. They make sure your data are safe and that no personal data gets shared in the PHDS.

Reference

https://iate.europa.eu/entry/result/2144078

7.Data holder

Definition

Legal or natural person who has the right or obligation, in accordance with the Regulation on harmonized rules on fair access to and use of data (Data Act), applicable Union law or national legislation implementing Union law, or in the case of non-personal data and through control of the technical design of the product and related services, the ability to make available certain data. 

Explanation

The individual or organization that stores data and has the authority to share it with others, based on legal or technical rights. 

Application to PHEMS

In the PHDS, data holders are hospitals.

Reference

https://iate.europa.eu/entry/result/3627421

8.Data permit

Definition

Administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the same based on conditions laid down in the relevant EU regulation. 

Explanation

An official approval that allows someone to use specific health data for research or analysis, under certain conditions and rules. 

Application to PHEMS

Each data user in the PHDS will be issued a data permit before to gaining access to the system. Prior to issuing this permit, data controllers will check that all security measures are in place so that patient privacy is protected.

Reference

https://iate.europa.eu/entry/result/3627489

9.Data provider

Definition

Organization which produces data or metadata.

Explanation

An organization or person that produced and shares data or information about data. 

Application to PHEMS

Data providers in the PHDS are hospitals or other organizations that hold electronic health records or other health related Personal Data.

Reference

https://iate.europa.eu/entry/result/3521157

10.Data Space

 Definition

Secure and standardized digital infrastructure that enables trusted data transactions among various stakeholders based on common protocols and formats supporting data sovereignty.

Explanation

Data spaces are a combination of data infrastructure (places where data are stored, accessed, processed, and shared) and governance frameworks (rules and contracts describing who has access to the data and under what circumstances).

Application to PHEMS

The final product of the PHEMS project will be the Pediatric Health Data Space (PHDS). The federated network will serve as the data infrastructure component while the PHEMS Playbook will provide the governance. The Playbook will also provide protocols for new hospitals, researchers, or innovators wishing to join the PHDS once it is established.  

Reference

https://iate.europa.eu/entry/result/3639182/en

11.Data user

 Definition

Person or organization authorized to exploit data.

Explanation

A person or group that uses data to study, analyze, or draw conclusions.

Application to PHEMS

Data users will get access to the PHDS in order to conduct research or benchmarking.

Reference

https://www.iso.org/obp/ui/#iso:std:iso:5127:ed-2:v1:en:term:3.13.4.04

12.Decentralized health data ecosystem

 Definition

System where healthcare data is managed and shared in a distributed manner, often using blockchain technology, rather than being stored and controlled by a central entity.

Explanation

A system where health data is stored and managed across different locations instead of one central place. Different technologies, like blockchain, are often used to keep the data safe.

Application to PHEMS

The PHDS is a decentralized health data ecosystem because data never leaves the hospital where it is located.

Reference

https://bitfury.com/content/downloads/research-decentralized-e-health-architecture.pdf#:~:text=security%20of%20medical%20data%20and%20offer%20a,clinical%20data%2C%20while%20also%20protecting%20confidential%20medical

13.Electronic health record system

 Definition

System for recording, retrieving and manipulating information in electronic health records (EHR). EHR is a comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form and providing for ready availability of these data for medical treatment and other closely related purposes. 

Explanation

A digital system used by healthcare providers to store a person’s medical history, treatments, test results, and other health information. 

Application to PHEMS

The EHR is one of the main sources of data for the PHDS.

Reference

https://iate.europa.eu/entry/result/3579815

14.Federated analytics (FA)

 Definition

Analysis framework where the data does not move, and instead analytical queries/code researchers write is sent to the data. The data can be distributed across different silos.

Explanation

A method of analyzing data from multiple locations without actually sharing the raw data. Each location keeps its data private but shares the results of its analysis to build a bigger picture.

Application to PHEMS

The PHDS is a federated network. All of the data stay within the hospitals and follow the safety and security procedures of those hospitals. Data users in the PHDS receive only aggregated analytical results but the sensitive personal health data is never released from data controller’s systems

Reference

https://federated-analytics.ac.uk/

15.Federated Node (FN)

 Definition

Independent system or device that collaborates with others in a decentralized network to perform shared tasks, often without sharing raw data. 

Explanation

A tool that works as part of a larger federated network to help analyze or process data. It integrates with existing systems, allowing data controllers to keep patient data secure and private. 

Application to PHEMS

PHEMS has developed an open-source federated node that has been deployed in current PHEMS hospitals. Learn more about the FN by going to: (link to Ross’s blog on our website).

16.Metadata

 Definition

A set of data that is described and gives information about other data. 

Explanation

Information about other data – for example, who created the data, when it was collected, and what it describes. 

Application to PHEMS

Researchers will be able to use metadata to discover relevant datasets within the PHDS.

Reference

https://iate.europa.eu/entry/result/918814/en-en

17.Pseudonymized data

 Definition

Data that does not directly identify an individual and can only be traced to an individual’s identity by someone in possession of a decoding key.

Explanation

Data where direct patient identifiers, like a name or ID number, have been replaced with a code or number other number. 

Application to PHEMS

In the PHDS all of the data provided to data users will be fully anonymized or aggregated. No pseudo- anonymized data will be provided, further protecting patient privacy.

Reference

https://iate.europa.eu/entry/result/3549402

18.Standard Operating Procedures (SOPs)

 Definition

Step-by-step instructions for performing a routine activity. SOPs should be followed the same way every time to guarantee that the organization remains consistent and in compliance with industry regulations and business standards.

Explanation

Written steps or instructions that people follow to make sure a task is done the same way every time. This helps improve quality, safety, and consistency. 

Application to PHEMS

To help others join the PHDS, we are developing a Playbook that will include Standard Operating Procedure (SOPs). These will help hospitals with everything from implementing a new benchmarking case to letting researchers know how to participate in the ecosystem.

Reference

https://www.techtarget.com/searchbusinessanalytics/definition/standard-operating-procedure-SOP

19.Synthetic data

Definition

Annotated information that computer simulations or algorithms generate as an alternative to real-world data. The concept of synthetic data generation is to take an original data source (dataset) and create new, artificial data with similar statistical properties from it.

Explanation

Written steps or instructions that people follow to make sure a task is done the same way every time. This helps improve quality, safety, and consistency. 

Application to PHEMS

The PHDS will generate anonymous synthetic data sets based on the real data in participating hospitals. This will help overcome the challenge of limited data in pediatrics and let researchers use tools, like machine learning, to improve patient care. All synthetic data generated in PHEMS will follow strict anonymization rules to ensure that personal information is removed, and privacy of the original source data is fully protected.

Reference

https://iate.europa.eu/entry/result/3626713

20.Workspace provider

Definition

Entity that offers a secure and managed environment where users can access, analyze and collaborate on data. This typically includes tools for data storage, computation, visualization, and governance, enabling multiple stakeholders (e.g. analysts, data scientists and external partners) to work with shared or federated datasets within defined access controls.

Explanation

An organization that offers a secure online platform where users can access and analyze data. Secure workspaces typically offer tools for collaboration, visualization, and privacy controls.

Application to PHEMS

Workspace Providers offer a point of entry to the PHDS. Commercial Workspace Providers may choose to join the PHDS to provide their services to PHDS users.