GDPR Guidelines & MedTech Industry
The functioning and progress of our modern society is largely based on the collection and processing of increasing public customer data, guided by GDPR rules. However, the development of the MedTech Industry progresses slower than visualised by medical practices, as it is limited by a multitude of privacy laws. Therefore, MedTech Europe calls for more harmonisation of GDPR interpretation and application and avoid inconsistencies of GDPR implementations across the EU.
Clarification or more consistent application of the GDPR across Europe is urgently needed, especially around the rules on processing health data for research purposes by medical technology ('MedTech') product manufacturers. The medical technology industry is at the forefront of research and innovation and need to take part in the conversation discussing access to and exchange of health data for research purposes.
The MedTech industry aims at an improved and expanded sharing of, and access to, health data to improve healthcare access, quality and outcomes as well as advance scientific research. The MedTech industry's digital health solutions envision to turn raw data into datasets of high value that can become precious research tools that improve the lives and health of people.
Congruent with the MedTech industry objective, the European Health Data Space (EHDS) project aims to advance and accelerate the digital transformation of healthcare, by ensuring that data is compatible and easily transferred. The EHDS wants to accelerate the digital transformation of Europe's healthcare systems and create conditions for better and more controlled use of heath data by, amongst other things, building a trustworthy health data ecosystem, improving the quality of health data and creating an institutional infrastructure for easy access to health data.
However, while making data usage more accessible and transparent to individuals, one has to be careful of malicious intentions. It is important that companies are not required to disclose the purposes of their research or innovation project in a way that would reveal business sensitive information to potential competitors.
Kailona providing a tailored solution
Kailona is a medical based Electronic Health Record (EHR) software specifically designed to store, encrypt and retrieve medical healthcare information. Kailona transforms individuals into owners of their own healthcare data as opposed to users. With Kailona a person will have full control over their healthcare data. As a Kailona user, a person can encrypt and safely store ones' sensitive healthcare data and choose to use it according to their needs, whenever required. Furthermore, specific encrypted data can be made available and shared with medical practices if required, without troubles about privacy intrusion.
As such, Kailona can solve or reduce the barriers that the EHDS project might encounter, as it, amongst other functions, empowers citizens to access and manage their own health data. In other words, Kailona is an improved electronic health record system or digital health tool that enables citizens' right to portability of health data, one of the main barriers encountered by the EHDS project.